Read PACpacket08_29_2006_FINAL text version

Proposed Preferred Drug List

with

Clinical Criteria

Proposal for TennCare

August 29, 2006

ANTI-INFECTIVE AGENTS

LENGTH OF AUTHORIZATIONS:

Duration of therapy (unless otherwise specified) 1. Is there any reason the patient cannot be changed to a medication not requiring prior approval within the same class? Acceptable reasons include: Allergy to medications not requiring prior approval Contraindication to or drug-to-drug interaction with medications not requiring prior approval History of unacceptable/toxic side effects to medications not requiring prior approval 2. The requested medication may be approved if both of the following are true: If there has been a therapeutic failure of at least one medication within the same class not requiring prior approval The requested medications corresponding generic (if a generic is available and preferred by the State) has been attempted and failed or is contraindicated

3. The requested medication may be approved if the following is true: An indication which is unique to a non-preferred agent and is supported by peer-reviewed literature or an FDA approved indication exists.

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Tetracyclines

RECOMMENDATION

Three chemical entities (doxycycline, minocycline and tetracycline) in this class have a demonstrated safety and efficacy profile that allow them to be considered therapeutic alternatives to one another. Demeclocycline has demonstrated efficacy, but its side-effect profile (induction of diabetes insipidus syndrome in some patients) may limit its use as an anti-infective, but allows it to have a unique place in the treatment of the syndrome of inappropriate antidiuretic hormone (SIADH).

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Oral Tetracyclines

PREFERRED DEMECLOCYCLINE (compares to Declomycin®) DOXYCYCLINE (compares to Vibra®-tabs and Vibramycin® and equivalent to Adoxa® was recently approved on 6.2.06) MINOCYCLINE (compares to Dynacin®, Minocin®) TETRACYCLINE (compares to Sumycin®) NON-PREFERRED ADOXA®, ADOXA® PAK (doxycycline monohydrate) 50mg, 75mg, 100mg tabs DECLOMYCIN® (demeclocycline) DORYX® (doxycycline) DYNACIN® (minocycline 50mg, 75mg, 100mg tabs) MINOCIN® (minocycline) MONODOX® (doxycycline 50mg, 100mg monohydrate) MYRAC® (minocycline) SUMYCIN® (tetracycline) VIBRAMYCIN® (doxycycline) VIBRA-TABS®(doxycycline)

References Chopra I. New developments in tetracycline antibiotics: glycylcyclines and tetracycline efflux pump inhibitors. Drug Resist Updat. 2002 Jul-Aug;5(3-4):119-25 Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006 Feb;54(2):258-65.

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Tetracyclines Indicated for Non-Systemic Infections

RECOMMENDATION

Subantimicrobial doses of tetracyclines have been used for non-systemic infections (ie periodontal disease, acne and rosacea) predominantly for their anti-inflammatory effects (not anti-bacterial effects) and theoretical decreased ability to induce resistance. This class of tetracyclines has demonstrated safety and efficacy and may be considered as therapeutic alternatives to existing agents. It is recommended that the agents in this class be subject to clinical criteria as alternatives exist and also so as to ensure that these agents are not used inappropriately for systemic infections.

COMMITTEE VOTE

APPROVED

DISAPPROVED

APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Oral Tetracyclines indicated for non-systemic infections

PREFERRED NON-PREFERRED ARESTIN®CC, (minocycline sustained release microspheres, 1mg) ORACEA® CC, QL (doxycycline 40mg (30mg IR and 10mg DR beads) PERIOSTAT®CC, QL (doxycycline hyclate) 20mg tab SOLODYN® CC, QL (minocycline 45mg, 90mg, 135mg)

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

PROPOSED CRITERIA

Recommended Criteria for Arestin® (minocycline sustained release microspheres) Arestin® (minocycline sustained release microspheres) will be approved when both of the following conditions are met: o It is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis or when used as part of a periodontal maintenance program which includes good oral hygiene, and scaling and root planing. o In patients with any of the following: 1.Multiple sites unresponsive to mechanical debridement 2. Acute infections 3. Medically compromised patients 4. Presence of tissue-invasive organisms and ongoing disease progression Length of Authorization:

References Arestin®.(minocycline hydrochloride). Package insert. OraPharma. 2.16.01. Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006 Feb;54(2):258-65. The Research, Science and Therapy Committee of the American Academy of Periodontology Position on the Treatment of Plaque-Induced Gingivitis, Chronic Periodontitis, and Other Clinical Conditions. J Periodontol 2001;72:1790-1800

One year

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

-------------------------------------------------------------------------------------------------------------------------------------------------------------------

RecommendedCriteria for Periostat® (doxycycline 20mg tab) Periostat® (doxycycline 20mg capsules) will be approved when both of the following conditions are met: o When used as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. o In patients with any of the following: 1.Multiple sites unresponsive to mechanical debridement 2. Acute infections 3. Medically compromised patients 4. Presence of tissue-invasive organisms and ongoing disease progression

References Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. Periostat®.(doxycycline hyclate tablets). Package insert. CollaGenex Pharmaceuticals.March 31, 2004 Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006 Feb;54(2):258-65. The Research, Science and Therapy Committee of the American Academy of Periodontology Position on the Treatment of Plaque-Induced Gingivitis, Chronic Periodontitis, and Other Clinical Conditions. J Periodontol 2001;72:1790-1800.

Length of Authorization:

One year

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

Recommended Criteria for Oracea® (doxycycline 40mg (30mg IR and 10mg DR beads) Oracea® (doxycycline 40mg capsules) will be approved for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients who have attempted, failed, or have a contra-indication to at least one of the following: · Topical antibiotics (any of the following) 1. Metronidazole (Metrogel®) 2. Azelaic acid (Azelex®, Finacea®) 3. Erythromycin (A/T/S® solution, gel), OR · The recipient requires long ­term therapy with an oral antibiotic Length of Authorization: One year

References Baldwin HE. Oral therapy for rosacea. J Drugs Dermatol. 2006 Jan;5(1):16-21. Drugs for Acne, Rosacea and Psoriasis. Treatment Guidelines from the Medical Letter. Vol 3 (35) July 2005. Nally JB, Berson DS. Topical therapies for rosacea. J Drugs Dermatol. 2006 Jan;5(1):23-6. Oracea®.(doxycycline hydrochloride). Package insert. CollaGenex Pharmaceuticals.May 6, 2006. Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006 Feb;54(2):258-65.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

----------------------------------------------------------------------------------------------------------------------RecommendedCriteria for Solodyn® (minocycline 45mg, 90mg, 135mg extended release tab) Solodyn® (minocycline extended release) will be approved if all of the following are true: 1. Diagnosis is the treatment of non-nodular moderate to severe acne vulgaris with inflammatory lesions. 2. Recipient has failed, has an intolerance, contraindication or adverse reaction to at least two of the following agents: · Topical antibiotics (such as the following examples below) 1. Metronidazole (Metrogel®) 2. Azelaic acid (Azelex®, Finacea®) 3. Erythromycin (A/T/S® solution, gel) 4. Clindamycin (Cleocin T®) · Topical keratolytic agent/Antibacterial agents (such as benzoyl peroxide, salicyclic acid preparations) OR 3.The recipient requires long ­term therapy with an oral antibiotic Length of Authorization:

References Drugs for Acne, Rosacea and Psoriasis. Treatment Guidelines from the Medical Letter. Vol 3 (35) July 2005. Goulden V. Guidelines for the management of acne vulgaris in adolescents. Paediatr Drugs. 2003;5(5):301-13. Ozolins M, Eady EA, Avery AJ, et al.Comparison of five antimicrobial regimens for treatment of mild to moderateinflammatory facial acne vulgaris in the community: randomised controlled trial. Lancet. 2004 Dec 18-31;364(9452):2188-95. Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006 Feb;54(2):258-65. Solodyne® (minocycline extended release). Package Insert. Medicis. May 8, 2006. Tan HH. Antibacterial therapy for acne: a guide to selection and use of systemic agents Am J Clin Dermatol. 2003;4(5):307-14.

One year

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Glycopeptides

RECOMMENDATION

Currently the only oral glycopeptide available is oral vancomycin. The only FDA labeled indication for oral vancomycin is that of the treatment of Clostridium difficile-associated diarrhea. Oral vancomycin is considered a product whose safety and efficacy demonstrate that it is a therapeutic alternative to the only other alternative therapy (metronidazole) for C. difficile. Routine use of oral vancomcyin may contribute to the emergence of vancomycin-resistant Enterococcus species such that all oral vancomycin products should be reserved and subject to criteria in order to preserve its long term usefulness and decrease emergent resistance.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Oral GlycopeptidesCC

PREFERRED NON-PREFERRED VANCOCIN®CC (vancomycin 125mg, 250mg pulvules)

PROPOSED CRITERIA Recommended Criteria for oral Vancocin® (vancomycin)

1. The recipient must have a diagnosis of C. difficile colitis 2. Before authorization of oral vancomycin the recipient will need to have tried and failed oral metronidazole unless there is a contra-indication, adverse reaction or drug to drug interaction that would preclude the recipient using metronidazole. (Note that the following is a common list (not all inclusive) of reasons why metronidazole may not be appropriate and oral vancomycin may be approved) · The recipient is either pregnant or a child under the age of 10 years of age · The recipient is severely ill · The recipient is receiving an alcohol related compound (interaction with metronidazole) · The recipient is allergic to metronidazole · The organism if resistant to metronidazole · There is evidence to suggesting the diarrhea is caused by Staphylococcus aureus · The recipient failed metronidazole in the past · The diarrhea is a suspected recurrent C.difficile colitis Length of Authorization: References One year

Fekety R. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 1997 May;92(5):739-50. Mylonakis E, Ryan ET, Calderwood SB. Clostridium difficile--Associated diarrhea: A review. Arch Intern Med. 2001 Feb 26;161(4):52533.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Aminoglycosides

RECOMMENDATION

Both neomycin and paromomycin are classified as oral aminoglycosides and both agents have similar antibacterial spectrums. Paromomycin has additional spectrum of activity against protozoa and cestodes which differentiates the drug from neomycin. With the difference in spectrum, the two drugs although in the same pharmacologic class, are not considered equivalent.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Oral Aminoglycosides

PREFERRED NEOMYCIN Sulfate tablets (500mg) NEO-FRADIN® (neomycin 125mg/5ml oral solution) HUMATIN® (paromomycin sulfate) NOTE: Kantrex® (Kanamycin is no longer made) NON-PREFERRED

References "Neomycin" www.factsandcomparisons.com accessed July 20, 2006 "Paromomycin" www.factsandcomparisons.com accessed July 20, 2006

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August 29, 2006 Tennessee PAC

ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: ORAL ANTIPARASITIC AGENTS: Amebicides, Antihelmintics, Antiprotozoals, Anti-malarials

RECOMMENDATIONS

This class contains various agents of different pharmacologic properties used in the treatment of parasitic infections. The drugs in this class are not considered clinically equivalent to each other as no one agent is the drug of choice for all parasitic infections. Nitzaoxamide (Alinia®) although considered the drug of choice for the treatment of Cryptosporidium parvum has been shown to be a safe and effective therapeutic alternative to other therapies in the treatment of Giardia lamblia.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: ORAL ANTIPARASITIC AGENTS: Amebicides , Antihelmintics, Antiprotozoals, Anti-malarials

PREFERRED BILTRICIDE® (praziquantel) CHLOROQUINE Phosphate (Tablets:250 mg (equiv. to 150 mg base)) DARAPRIM® (pyrimethamine) DAPSONE FANSIDAR® (sulfadoxine and pyrimethamine) HUMATIN® (paromomycin sulfate) MALARONE® (atovaquone and proguanil) MEFLOQUININE (compares to Lariam®) MEPRON® (atovaquone) QUININE PENTAMIDINE PRIMAQUINE STROMECTOL® (ivermectin) YODOXIN® (iodoquinol) Benzimidazoles ALBENZA® (albendazole) MEBENDAZOLE (compares to Vermox®) MINTEZOL® (thiabendazole) Note: Hetrazan® (diethylcarbamazine) is available on compassionate use NON-PREFERRED ALINIA®CC (nitazoxanide) ARALEN® Phosphate (chloroquine phosphate Tablets:500 mg (equiv. to 300 mg base) LARIAM® (mefloquinine)

Benzimidazoles VERMOX® (mebendazole)

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ANTI-INFECTIVE AGENTS

PROPOSED CRITERIA

RecommendedCriteria for Alinia® (nitazoxanide) Alinia® (nitazoxanide) will be authorized for: 1. The treatment of diarrhea caused by Cryptosporidium parvum (or suspected Crysptosporidium parvum in

immunocompromised recipients)

2. The treatment of diarrhea caused by Giardia lamblia if the recipient has : · Failed metronidazole · Has a contra-indication, intolerance, adverse drug reaction or other reason not to use metronidazole Length of Authorization: One year

References Chang DJ, Lamothe M, Stevens RM, Sigal LH. Dapsone in rheumatoid arthritis. Semin Arthritis Rheum 1996 Jun;25(6):390-403. Drugs for Parasitic Infections. The Medical Letter. August 2004. Ioannidis JP, Cappelleri JC, Skolnik PR, Lau J, Sacks HS. A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens. Arch Intern Med. 1996 Jan 22;156(2):177-88. Nitazoxanide (Alinia®) ­ A new anti-protozoal agent. The Medical Letter. April 14, 2003. Nzila A, The past, present and future of antifolates in the treatment of Plasmodium falciparum infection. Journal of Antimicrobial Chemotherapy (2006) 57, 1043-1054. Warnock AC, Rimland D. Comparison of trimethoprim-sulfamethoxazole, dapsone, and pentamidine in the prophylaxis of Pneumocystis carinii pneumonia. Pharmacotherapy. 1996 Nov-Dec;16(6):1030-8. Wolf R, Tuzun B, Tuzun Y. Dapsone: unapproved uses or indications. Clin Dermatol. 2000 Jan-Feb;18(1):37-53

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Anti-Tuberculosis Agents

RECOMMENDATIONS

The drugs in this class are not considered clinically equivalent to each other as no one agent or combination of agents is considered the drug of choice in all situations. The antitubercular drugs can be divided into three classes: those that are bacteriocidal (ie INH and to a lesser degree rifampin), those that are sterilizing (ie rifampin and PZA) and those that eliminate all bacterial populations and help to decrease the emergence of resistance. When used in combinations and at different times during the course of the disease, these agents can effectively treat TB. Within the rifamycin class each agent has a superior and inferior aspect in the varied types of TB recipients seen such that no one agent can be recommended to treat all recipients.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW:ANTI-INFECTIVE AGENTS: Oral Anti-tuberculosis Agents

PREFERRED ETHAMBUTOL (compares to Myambutol®) ISONIAZID PASER® (aminosalicylcic acid) PYRAZINAMIDE SEROMYCIN® Pulvules (cycloserine) TRECATOR-SC® (ethionamide) Rifamycins for Systemic Infections ISONARIF® (300mg rifampin, 150mg isoniazid) MYCOBUTIN® (rifabutin) PRIFTIN® (rifapentine) RIFAMATE® (rifampin/isoniazid) RIFAMPIN (compares to Rifadin® and Rimactane® RIFATER® (120mg rifampin, 50mg isoniazid, 300mg pyrazinamide) NON-PREFERRED MYAMBUTOL® (ethambutol)

Rifamycins for Systemic Infections RIFADIN® (rifampin) RIMACTANE® (rifampin)

References Controlling Tuberculosis in the United States Recommendations from the American Thoracic Society, CDC, and the Infectious Diseases Society of America. November 4, 2005 / 54(RR12);1-81 Drugs for Tuberculosis. Treatment Guidelines from the Medical Letter: vol 2(issue 28) December 2004.

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ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Non-Absorbable Rifamycins

RECOMMENDATION

Rifaximin (Xifaxan®) is the only non-absorbable rifamycin available. Rifaximin (Xifaxan®) is approved for traveler's diarrhea and the only FDA approved drug for hepatic encephalopathy; however, both lactulose and neomycin have been used off-label. Although efficacy of the product has been demonstrated, there are theoretical concerns surrounding the use of rifaximin (Xifaxan®). Concerns and questions regarding the use of rifamycins (the class) as monotherapy for other indications other than tuberculosis is whether their use will result in the development of rifampin-resistant tuberculosis and the development/induction of resistance in S. aureus. Rifaximin (Xifaxan®) is considered a product whose efficacy and safety demonstrates that it is a therapeutic alternative to currently available therapies and should be subject to the recommended criteria below.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Non-Absorbable Rifamycins

PREFERRED NON-PREFERRED XIFAXAN®CC (rifaximin)

PROPOSED CRITERIA

Criteria Xifaxan® (rifaximin) Xifaxan® (rifaximin) will be authorized if either #1 or #2 are true: 1.The treatment of traveler's diarrhea caused by non-invasive strains of Escherichia coli that can not be treated with another agent such as: · A fluroquinolone [ie Ciprofloxacin (Cipro®)] OR · Azithromycin (Zithromax®) 2. The treatment of hepatic encephalopathy Length of Authorization: References One year

Castelli F, Saleri N, Tomasoni LR, Carosi G. Prevention and treatment of traveler's diarrhea. Focus on antimicrobial agents. Digestion. 2006;73 Suppl 1:109-18. Liu Y, Cui J, Wang R, Wang X, Drlica K, Zhao X. Selection of rifampicin-resistant Staphylococcus aureus during tuberculosis therapy: concurrent bacterial eradication and acquisition of resistance. J Antimicrob Chemother. 2005 Dec;56(6):1172-5.. Rendi-Wagner P, Kollaritsch H. Drug Prophylaxis for Travelers' Diarrhea. Clinical Infectious Diseases. 2002;34:628-33. Rifaximin (Xifaxan®) for Travelers' Diarrhea. The Medical Letter on Drugs and Therapeutics. Vol 46(Iss 1191). September 13, 2004 :74-76. Travellers' diarrhoea: contemporary approaches to therapy and prevention. DuPont HL. Drugs. 2006;66(3):303-14.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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ANTI-INFECTIVE AGENTS

NEW: ANTI-INFECTIVE AGENTS: Oral Sulfonamides, Folate Antagonists and Combination Products

RECOMMENDATION

The sulfonamides, folate antagonists and combination products represent a group of agents whose coverage encompasses a range of gram positive and gram negative organisms and varying disease states. These agents still have a place in the treatment predominantly of urinary tract infections and some respiratory infections. All of the agents within this class show similar efficacy against E. coli, Klebsiella, Proteus mirabilis, and staphylococcus; and therefore, can be used for UTIs and other infections caused by susceptible bacteria. Trimethoprim/sulfamethoxazole has more FDA-approved indications than the other agents in this class, including use in treatment and prophylaxis of pneumocystis carinii (PCP), treatment of traveller's diarrhea, and treatment of shigellosis enteritis. Therefore, all of these agents can be considered therapeutic alternatives, with the exception of trimethoprim/sulfamethoxazole.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS NEW: ANTI-INFECTIVE AGENTS: Oral Sulfonamides, Folate Antagonists, and Combination Products

PREFERRED GANTRISIN® Pediatric (sulfisoazole oral suspension) PRIMSOL® (trimethoprim oral solution) SULFADIAZINE (generic only) SULFISOXAZOLE (generic only ­ compared to Gantrisin® tablets ­ to be discontinued ­ available until supplies last) TRIMETHOPRIM (compares to Proloprim®) TRIMETHOPRIM/ SULFAMETHOXAZOLE (compares to Bactrim®,Bactrim® DS, Septra®, Septra DS®)

References Epstein BJ, Gums JG. Optimal pharmacological therapy for community-acquired pneumonia: the role of dual antibacterial therapy. Drugs. 2005;65(14):1949-71 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754.

NON-PREFERRED BACTRIM® (trimethoprim/sulfamethoxazole) BACTRIM® DS (trimethoprim/sulfamethoxazole) PROLOPRIM® (trimethoprim) SEPTRA® (trimethoprim/sulfamethoxazole) SEPTRA DS® (trimethoprim/sulfamethoxazole)

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ANTI-INFECTIVE AGENTS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Penicillins and Related Compounds

RECOMMENDATION

The penicillins are bactericidal antibiotics that include natural and semisynthetic derivatives (aminopenicillins and the penicillinase resistant penicillins). There are differences in the agents in the subclasses in regards to: the resistance to gastric inactivation, inactivation by beta-lactamase and corresponding spectrum of activity (which is enhanced by the addition of a beta-lactamase compound such as clavulanic acid). Due to differences in the subclasses of penicillins at least one agent in each of the subclasses should be present in order to have full spectrum of coverage.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Penicillins and related compounds

PREFERRED AMOXICILLIN AND CLAVULANATE Potassium (compares to Augmentin®, Augmentin® ES 600) AMOXICILLIN (compares to Amoxil®, Trimox®) AMPICILLIN (compares to Principen®) DICLOXACILLIN OXACILLIN PENICILLIN VK (compares to Veetids®) NON-PREFERRED AMOXIL® (amoxicillin) AUGMENTIN® (amoxicillin and clavulanate) AUGMENTIN ES® (amoxicillin and clavulanate) AUGMENTIN XR® (amoxicillin and clavulanate) DISPERMOX® (amoxicillin tablets for oral suspension) GEOCILLIN® (carbenicillin) PRINCIPEN® (ampicillin) TRIMOX® (amoxicillin) VEETIDS® (penicillin VK)

References Augmentin XR The Medical Letter · Vol. 45 (Issue 1148) January 20, 2003 McCormack PL, Keating GM.Amoxicillin/clavulanic acid 2000mg/125mg extended release (XR): a review of its use in the treatment of respiratory tract infections in adults. Drugs. 2005;65(1):121-36 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

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ANTI-INFECTIVE AGENTS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Cephalosporins

RECOMMENDATION

First Generation Cephalosporins Within the First Generation Cephalosporins the three agents are products whose safety and efficacy demonstrate that they may be considered therapeutic altenatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

----------------------------------------------------------------------------------------------------------------------------------Second Generation Cephalosporins Within the Second Generation Cephalosporins there are four chemical entities, cefprozil, cefuroxime, loracarbef and cefaclor. Cefprozil and cefuroxime are considered therapeutic alternatives to one another as they have similar antimicrobial activity and side-effect profiles. Cefprozil and cefuroxime are considered superior over cefaclor and loracarbef due to their in-vitro activity over S. pneumoniae and H. influenzae.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

----------------------------------------------------------------------------------------------------------------------------------Third Generation Cephalosporins Within the third generation cephalosporins there are five chemical entities that can be considered therapeutic alternatives to one another based on their antimicrobial spectrum and recent guidelines.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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ANTI-INFECTIVE AGENTS

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Cephalosporins

PREFERRED NON-PREFERRED First Generation Cephalosporins CEFADROXIL (compares to Duricef®) DURICEF® (cefadroxil) CEPHALEXIN (compares to Keflex®) KEFLEX® (cephalexin) CEPHRADINE (compares to Velosef®) KEFLEX® 333, 750mg (cephalexin) KEFTAB® (cephalexin) VELOSEF® (cephradine) Second Generation Cephalosporins CEFPROZIL (compares to Cefzil® tabs and CEFACLOR (compares to Ceclor®, Ceclor CD®) suspension) CEFTIN® (cefuroxime) CEFUROXIME (compares to Ceftin®) CECLOR® (cefaclor) CEFTIN® (cefuroxime suspension) CECLOR CD® (cefaclor extended release) CEFZIL® (cefprozil) LORABID® (loracarbef) RANICLOR® (cefaclor chew tabs) Third Generation Cephalosporins CEDAX® (ceftibuten) SPECTRACEF® (cefditoren) CEFPODOXIME (compares to Vantin® tabs) VANTIN® (cefpodoxime suspension) OMNICEF® (cefdinir caps and susp) SUPRAX® (cefixime suspension and tabs)

References Cazzola M, Matera MG. Donner CF. Pharmacokinetics and pharmacodynamics of newer oral cephalosporins. Clin Drug Invest 1998;16(4): 335-336 Epstein BJ, Gums JG. Optimal pharmacological therapy for community-acquired pneumonia: the role of dual antibacterial therapy. Drugs. 2005;65(14):1949-71 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Herpetic Antivirals

RECOMMENDATION

Famciclovir (Famvir®) and Valacyclovir (Valtrex®) are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another. Acyclovir (Zovirax®) is the only agent that has been studied and approved for the treatment of varicella zoster virus (VZV ); therefore, it along with at least one other long acting herpetic antiviral agent should be available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Herpetic Antivirals

PREFERRED ACYCLOVIR (compares to Zovirax® tabs, caps, oral susp) FAMVIR®QL (famciclovir) VALTREX®QL (valacyclovir) NON-PREFERRED ZOVIRAX® (acyclovir) (tabs, caps, oral susp)

References Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006; 55(RR-11) 1-100. Drugs for Non-HIV Viral Infections. Treatment Guidelines from The Medical Letter. Vol. 3 (Issue 32). April 2005. Klassen TP, Belseck EM, Wiebe N, Hartling L. Acyclovir for treating varicella in otherwise healthy children and adolescents. Cochrane Database Syst Rev. 2004;(2):CD002980 .

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza A Antivirals

RECOMMENDATION

All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another when given within 48 hours after the onset of illness in the treatment of influenza A virus. Both agents have been shown to decrease the duration of illness by approximately one (1) day when given within 48 hours. Additionally, both products have demonstrated safety and efficacy when used as prophylaxis against influenza A. If resistance patterns change during the 2006-2007 flu season and/or CDC recommendations change, then action will be taken immediately to adjust agents as preferred or nonpreferred.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza A Antivirals

PREFERRED AMANTADINE (compares to Symmetrel®) RIMANTADINE (compares to Flumadine®) NON-PREFERRED

References Antiviral drugs for prophylaxis and treatment of influenza. The Medical Letter. Volume 47 (issue 1222) November 21, 2005. http://www.fda.gov/cder/foi/esum/2004/21087,21246_Tamiflu_clinical_BPCA.pdf CDC Alert. http://www.cdc.gov/flu/han011406.htm Harper SA, Fykuda K, Uyeki TM etal. Prevention and Control of Influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. July 29, 2005/54(RR08);1-40. Tamiflu. Tamiflu Pediatric Adverse Events: Questions and answers http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza A and B Antivirals ­ Neuraminidase Inhibitors

RECOMMENDATION

Both zanamivir (Relenza®) and oseltamivir (Tamiflu®) when used to treat influenza A or B have been shown to reduce clinical illness and viral shedding by one (1) day if started within 48 hours after the onset of symptoms. The neuramidase inhibitors have both demonstrated efficacy; however, safety issues may vary as zanamir (Relenza®) is not recommended for use in patients with underlying airway disease such as asthma or COPD. In terms of prophylaxis, both agents have shown efficacy; however, zanamivir (Relenza®)has not been proven effective for prophylaxis of influenza in the nursing home setting, and oseltamivir (Tamiflu®) is the only agent approved for prophylaxis in children one (1) to twelve (12) years of age for both influenza A and B. Due to the efficacy of these agents to decrease flu-like symptoms for approximately only one (1) day and the varied prevalence of influenza B it is recommended that these agents be subject to the following criteria. If resistance patterns change during the 2006-2007 and CDC recommendations change, then action will be taken immediately to adjust agents as preferred or non-preferred.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza A and B Antivirals ­ Neuraminidase Inhibitorscc

PREFERRED NON-PREFERRED RELENZA® CC, (zanamivir) TAMIFLU® CC (oseltamivir)

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PROPOSED CRITERIA

Recommended Criteria: Tamiflu® (oseltamivir) will be approved if any of the following are true: · For all patients diagnosed with influenza B by a Rapid Type ID test or by culture, Tamiflu® can be authorized if started within 48 hours of onset of symptoms. · For suspected cases of avian influenza species (optimal doses and duration of treatment are not known, but will be dealt with on a case by case basis if such cases occur) · For propylaxis of close contacts of a recipient with known influenza B Length of authorization:Tamiflu® may be used for prevention of influenza A & B for the duration of peak influenza in communities or for outbreak control in high risk populations. Thus length of authorizations may vary. Relenza® (zanamivir) will be approved if any of the following are true · For all patients diagnosed with influenza B by a Rapid Type ID test or by culture, Relenza® can be authorized if started within 48 hours of onset of symptoms. · For suspected cases of avian influenza species (optimal doses and duration of treatment are not known, but will be dealt with on a case by case basis if such cases occur) · For propylaxis of close contacts of a recipient with known influenza B Length of authorization: allowed each 6 months.

References Antiviral drugs for prophylaxis and treatment of influenza. The Medical Letter. Volume 47 (issue 1222) November 21, 2005. http://www.fda.gov/cder/foi/esum/2004/21087,21246_Tamiflu_clinical_BPCA.pdf CDC Alert. http://www.cdc.gov/flu/han011406.htm Harper SA, Fykuda K, Uyeki TM etal. Prevention and Control of Influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. July 29, 2005/54(RR08);1-40. Tamiflu. Tamiflu Pediatric Adverse Events: Questions and answers http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

For date of service only. In addition, only 1 course of therapy will be

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza Intranasal Vaccinations

RECOMMENDATION

Influenza live virus (FluMist®) is considered a product whose efficacy and safety demonstrate that it is a therapeutic alternative to other currently available agents.

COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION

RE-REVIEW: ANTI-INFECTIVE AGENTS: Influenza Intranasal Vaccinations

PREFERRED NON-PREFERRED FluMist® CC, QL (Influenza Virus Vaccine Live, Intranasal)

PROPOSED CRITERIA

Criteria for FluMist® (influenza intranasal vaccine) FluMist® will only be authorized if all of the following are true: · The patient is unable to receive the intramuscular injection due to insufficient muscle mass or muscle wasting · The patient must be a healthy adult or child between the ages of 5-49.

References Antiviral drugs for prophylaxis and treatment of influenza. The Medical Letter. Volume 47 (issue 1222) November 21, 2005. http://www.fda.gov/cder/foi/esum/2004/21087,21246_Tamiflu_clinical_BPCA.pdf CDC Alert. http://www.cdc.gov/flu/han011406.htm Harper SA, Fykuda K, Uyeki TM etal. Prevention and Control of Influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. July 29, 2005/54(RR08);1-40. Tamiflu. Tamiflu Pediatric Adverse Events: Questions and answers http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION

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NEW: ANTI-INFECTIVE AGENTS: Cytomegalovirus (CMV) Oral Antivirals

RECOMMENDATION

Oral valganciclovir (Valcyte®) has largely replaced oral ganciclovir (Cytovene®) in clinical practice. Valganciclovir (Valcyte®) is an oral prodrug of ganciclovir (Cytovene®) with a high oral bioavailability that is able to achieve plasma concentrations similar to that of IV administered ganciclovir (Cytovene®). Valganciclovir (Valcyte®) has shown to be effective in the treatment of cytomegalovirus (CMV) retinitis and has been shown to be as effective as ganciclovir in the prevention of CMV disease in solid organ transplants (with the exception of liver transplant). Although a pro-drug of ganciclovir, valganciclovir (Valcyte®) has exhibited differing results in the prevention of CMV in liver transplant patients such that it has not yet gained FDA approval for use, nor has it consistently shown efficacy or superiority to ganciclovir (Cytovene®) in this group of patients. At this time it is recommended that both agents be preferred for their possible differentiating properties.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Cytomegalovirus (CMV) Oral Antivirals

PREFERRED GANCICLOVIR (compares to Cytovene®) VALCYTE® (valganciclovir) NON-PREFERRED CYTOVENE® (ganciclovir)

References Drugs for Non-HIV Viral Infections. Treatment Guidelines from The Medical Letter · Vol. 3 (Issue 32) April 2005 Jain A, Orloff M, Kashyap R, Lansing K, Betts R, Mohanka R, Menegus M, Ryan C, Bozorgzadeh A. Does valganciclovir hydrochloride (valcyte) provide effective prophylaxis against cytomegalovirus infection in liver transplant recipients? Transplant Proc. 2005 Sep;37(7):3182-6. Winston DJ, Busuttil RW. Randomized controlled trial of oral ganciclovir versus oral acyclovir after induction with intravenous ganciclovir for long-term prophylaxis of cytomegalovirus disease in cytomegalovirus-seropositive liver transplant recipients. Transplantation. 2003 Jan 27;75(2):229-33.

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Hepatitis C Oral Antivirals

RECOMMENDATION

The use of ribavirin with peginterferon alpha has produced higher results than with the use of peginterferon alone and is considered the regimen of choice for chronic HCV. All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Hepatitis C Oral Antivirals

PREFERRED RIBAVIRIN [200 mg tabs and caps (generic of COPEGUS® and REBETOL®)] RIBASPHERES [200 mg tab and caps, 400 mg tab, 600 mg tab (ribavirin)] RIBAPAKTM (ribavirin dose pack) REBETOL® (ribavirin 40 mg/ml oral solution)

References Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006; 55( RR-11) 1-100. Drugs for Non-HIV Viral Infections. Treatment Guidelines from The Medical Letter · Vol. 3 (Issue 32) April 2005 Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):225-30. Nelson M, Matthews G, Brook MG, Main J; BHIVA Coinfection Guideline Committee;British HIV Association. BHIVA guidelines on HIV and chronic hepatitis: coinfection with HIV and hepatitis C virus infection (2005). HIV Med. 2005 Jul;6 Suppl 2:96-106. Tien PC; Veterans Affairs Hepatitis C Resource Center Program; National Hepatitis C Program Office. Management and treatment of hepatitis C virus infection in HIV-infected adults: recommendations from the Veterans Affairs Hepatitis C Resource Center Program and National Hepatitis C Program Office. Am J Gastroenterol. 2005 Oct;100(10):2338-54.

NON-PREFERRED COPEGUS® [200 mg caps (ribavirin)] REBETOL® [200 mg tabs (ribavirin)] RIBATAB® [400 mg, 600 mg tabs (ribavirin)]

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Pegylated Interferons

RECOMMENDATION

All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another in the treatment of Hepatitis C. Both agents have been studied in the treatment of Hepatitis B, albeit only pegylated interferon alpha 2a (Pegasys®) has the current FDA labeled indication.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Pegylated Interferons

PREFERRED PEG-INTRON® QL (pegylated interferon alpha 2b) PEGASYS® QL (pegylated interferon alpha 2a)

References Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006; 55( RR-11) 1-100. Drugs for Non-HIV Viral Infections. Treatment Guidelines from The Medical Letter · Vol. 3 (Issue 32) April 2005 Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):225-30. Flink HJ, van Zonneveld M, Hansen BE, de Man RA, Schalm SW, Janssen HL; HBV 99-01 Study Group. Treatment with Peg-interferon alpha2b for HBeAg-positive chronic hepatitis B: HBsAg loss is associated with HBV genotype. Am J Gastroenterol. 2006 Feb;101(2):297-303. Nelson M, Matthews G, Brook MG, Main J; BHIVA Coinfection Guideline Committee;British HIV Association. BHIVA guidelines on HIV and chronic hepatitis: coinfection with HIV and hepatitis C virus infection (2005). HIV Med. 2005 Jul;6 Suppl 2:96-106. Tien PC; Veterans Affairs Hepatitis C Resource Center Program; National Hepatitis C Program Office. Management and treatment of hepatitis C virus infection in HIV-infected adults: recommendations from the Veterans Affairs Hepatitis C Resource Center Program and National Hepatitis C Program Office. Am J Gastroenterol. 2005 Oct;100(10):2338-54.

NON-PREFERRED

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NEW: ANTI-INFECTIVE AGENTS: Non-Pegylated Interferon Alphas

RECOMMENDATION

The non-pegylated alpha interferons share common biological activities such as antiviral activity, antiproliferative activity and immunomodulatory effects; however, the extent of the activity may vary amongst the subtype of the alpha interferon. The INF alfa-2a and INF alpha-2b subtypes share the closest activity and have exhibited similar results in the treatment of Hepatitis C; however they are still considered second line agents to their pegylated counterparts. The INF alfa-2a and INF alpha-2b products (RoferonA®, Intron A®) have demonstrated efficacy and safety such that they may be considered therapeutic alternatives for one another. Rebetron ® (alfa-2b and 200mg ribavirin) differs only in that it is a combination product with ribavirin. Infergen® (interferon alpha-con-1) differs from other recombinant products (IFN alpha-2a and alpha-2b) by 20 amino acids. IFN alpha-con-1 (Infergen®) is indicated for chronic hepatitis C viral infections and is the only IFN proven to be effective in the treatment of nonresponders. Interferon alpha-n3 (Alferon N®) is only used in the treatment of cancer and includes the treatment of veneral and genital warts. There are differences in the activity of INF alpha-con-1 (Infergen®) and INF alpha-n3 (Alferon N®) such that neither agent can be deemed as a therapeutic alternative to one another.

COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS:

NEW: ANTI-INFECTIVE AGENTS: Non-Pegylated Interferon Alphas

PREFERRED ALFERON N® (interferon alfa-N3) INTRON A® (interferon alfa-2b) INFERGEN® (interferon alfa-con-1) REBETRON® (interferon alfa-2b and 200mg ribavirin) ROFERON-A® (interferon alpha-2a)

References Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006; 55( RR-11) 1-100. Drugs for Non-HIV Viral Infections. Treatment Guidelines from The Medical Letter · Vol. 3 (Issue 32) April 2005 Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):225-30. Mailliard ME, Gollan JL. Emerging therapeutics for chronic hepatitis B. Annu Rev Med. 2006;57:155-66 Selmi C, Lleo A, Zuin M, Podda M, Rossaro L, Gershwin ME. Interferon alpha and its contribution to autoimmunity. Curr Opin Investig Drugs. 2006 May;7(5):451-6. Tien PC; Veterans Affairs Hepatitis C Resource Center Program; National Hepatitis C Program Office. Management and treatment of hepatitis C virus infection in HIV-infected adults: recommendations from the Veterans Affairs Hepatitis C Resource Center Program and National Hepatitis C Program Office. Am J Gastroenterol. 2005 Oct;100(10):2338-54.

NON-PREFERRED

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NEW: ANTI-INFECTIVE AGENTS: Oral Hepatitis B Antivirals

RECOMMENDATION

The agents in this class vary in resistance patterns, tolerance, side-effects and efficacy in recipients who have chronic HBV infection and concurrent co-infection with HIV/HBV such that at this time all they are not considered therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Oral Hepatitis B Antivirals

PREFERRED BARACLUDE® (entecavir) EPIVIR-HB® (lamivudine) HEPSERA® (adefovir) NON-PREFERRED

References Entecavir (Baraclude) for Chronic Hepatitis B;The Medical Letter .Vol 47: Issue 1210 . June 6, 2005 Drugs for Non-HIV Viral Infections Treatment Guidelines from The Medical Letter.Vol. 3 ( Issue 32); April 2005. Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, et al.BEHoLD AI463027 Study Group. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2006 Mar 9;354(10):1011-20.

NEW: ANTI-INFECTIVE AGENTS: Monoclonal Antibodies for Prevention of Respiratory Syncitial Virus (RSV)

RECOMMENDATION

Guidelines from the American Academy of Pediatrics (AAP) recommend the use of palivizumab for prophylaxis of RSV in high risk infants, children younger than 24 months with chronic lung disease, and certain preterm infants. However, the guidelines state that due to the high cost of this drug, immunoprophylxis should not be considered for infants who do not meet the established risk criteria. For this reason, it is recommended that Synagis be available only for infants meeting the criteria established by the AAP.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Oral Hepatitis B Antivirals

PREFERRED SYNAGIS®CC (palivizumab) NON-PREFERRED

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PROPOSED CRITERIA

Criteria for Synagis (palivizumab) Synagis® may be approved for patients under the age of 2 years meeting the following criteria. For patients less than 6 months of age at the onset of the RSV season: · If patient was born at 32 weeks' gestation or earlier - May approve therapy beginning October 1st with a last date of therapy not after the end of the RSV season (April 30th). · If the patient was born at 32-35 weeks' gestation, the patient must have two or more of the following risk factors for severe RSV disease: o Exposure to environmental air pollutants, including tobacco smoke o Child care out of the home (>4hours per week) o Siblings attending school or day-care o Congenital abnormalities of the airways o Severe neuromuscular disease o Long distance from hospital care, defined as 30 miles or 30 minutes distance o Low birth weight (<2500 Gm) For patients less than 12 months of age at the onset of the RSV season: · If the patient was born at 28 weeks' gestation or earlier - May approve therapy beginning October 1st with a last date of therapy not after the end of the RSV season (April 30th). For patients less than 24 months of age at the onset of the RSV season: · If the patient has Chronic Lung Disease (formerly called bronchopulmonary dysplasia), that has required daily respiratory medications or treatments within the previous 6 months May approve therapy beginning October 1st with a last date of therapy not after the end of the RSV season (April 30th). · If the patient has a diagnosis of hemodynamically significant congenital heart disease (those receiving medication to control CHF, those with moderate to severe pulmonary hypertension, or those with cyanotic heart disease) - May approve therapy beginning October 1st with a last date of therapy not after the end of the RSV season (April 30th). Diagnosis criteria must be established via a phone call/fax to the call center. Claims will be denied for those infants and children with hemodyamically insignificant heart disease including: · Secundum atrial septal defects · Small ventricular septal defect · Pulmonic stenosis · Uncomplicated aortic stenosis · Mild coarctation of the aorta · Patent ductus arteriosus · Mild cardiomyopathy in patients who are not receiving medical therapy · Heart lesions adequately corrected by surgery unless the patient continues to require medication for CHF

References American Academy of Pediatrics Committee on ID and Comm on Fetus and Newborn-Prevention of RSV Infection.: Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. (Policy Statement) Pediatrics. Dec 2003; 112(6): 1442-6.

Robinson R, Nahata M. Respiratory syncitial virus (RSV) immune globulin and palivizumab for prevention of RSV infection. AJHP. 2000; 57(3): 259-64. Paes BA. Current strategies in the prevention of respiratory syncytial virus disease. Paediatric Respiratory Reviews. 2003; 4: 21-7.

Facts and Comparisions, www.factsandcomparison.com USPDI, Micromedix, 2004

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COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oxazolidinones - Oral

RECOMMENDATION

Linezolid (Zyvox®) is currently the only agent in the class of oxazolidinones which serves to treat primarily resistant gram positive cocci. The arrival of this agent is important, when the emergence of resistance to last line drugs is rapidly spreading. However, careful use of this agents is important if long-term value is to be preserved such that the agent is recommended to have the criteria in place prior to approval to ensure its appropriate use.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oxazolidinones - Oral

PREFERRED NON-PREFERRED ZYVOX®CC, QL (linezolid)

PROPOSED CRITERIA

Criteria for Zyvox® (linezolid) Zyvox® · For all requests for Zyvox® by mouth, the patient must have a diagnosis as listed below: o Vancomycin-resistant Enterococcus faecium infections o Vancomcyin-resistant Enterococcus faecalis infections o Methicillin-resistant Staph aureus (MRSA) infections · The patient must have culture documentation of the aforementioned diagnoses Length of Authorization:

References Livermore DM. Quinupristin/dalfopristin and linezolid: where, when, which and whether to use? J Antimicrob Chemother. 2000 Sep;46(3):34750. Hughes, WT. Armstrong D, Bodey GP et al. 2002 Guidelines for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer. Clinical Infectious Diseases. 2002;34:730-751 (update in progress ­ to be issued Spring 2007) Zyvox. DHCP Letter.http://www.fda.gov/medwatch/SAFETY/2001/zyvox.pdf

Dependent upon diagnosis and length of therapy needed to treat. Maximum 14 days of therapy is recommended; however exceptions may exist.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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NEW: ANTI-INFECTIVE AGENTS: Nitrofurans - Oral

RECOMMENDATION

All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Nitrofurans - Oral

PREFERRED NITROFURANTOIN MACROCRYSTALS (compares to Macrodantin®) NITROFURANTOIN monohydrate/macrocrystals (compares to Macrobid®) NON-PREFERRED FURADANTIN (nitrofurantoin oral susp) MACRODANTIN® (nitrofurantoin macrocrystals) MACROBID® (nitrofurantoin monohydrate/macrocrystals)

References Hooton TM, Besser R, Foxman B, et al. Acute uncomplicated cystitis in an era of increasing antibiotic resistance: a proposed approach to empirical therapy. Clin Infect Dis 2004;39:75-80. Kallen AJ, Welch HG, Sirovich BE. Current antibiotic therapy for isolated urinary tract infections in women. Arch Intern Med. 2006 Mar 27;166(6):635-9. Zhanel GG, Hisanaga TL, Laing NM, DeCorby MR, Nichol KA, Weshnoweski B, Johnson J, Noreddin A, Low DE, Karlowsky JA; for the NAUTICA Group; Hoban DJ. Antibiotic resistance in Escherichia coli outpatient urinary isolates: final results from the North American Urinary Tract Infection Collaborative Alliance (NAUTICA). Int J Antimicrob Agents. 2006 Jun;27(6):468-75.

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NEW: ANTI-INFECTIVE AGENTS: Methenamine and Combination Agents- Oral

RECOMMENDATION

All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Methenamine and Combination Agents- Oral

PREFERRED METHENAMINE mandelate (Mandelamine®) HIPREX® (methenamine hippurate) Generic combinations of methenamine and phenylsalicylate, hyoscyamine, atropine and others NON-PREFERRED MANDELAMINE® (methenamine mandelate)

Brand name combinations of methenamine and phenylsalicylate, hyoscyamine, atropine and others

References Banovac K, Wade N, Gonzalez F, Walsh B, Rhamy RK. Decreased incidence of urinary tract infections in patients with spinal cord injury: effect of methenamine. J Am Paraplegia Soc. 1991 Apr;14(2):52-4. Brumfitt W, Cooper J, Hamilton-Miller JM. Prevention of recurrent urinary infections in women: a comparative trial between nitrofurantoin and methenamine hippurate. J Urol. 1981 Jul;126(1):71-4. Schiotz HA, Guttu K. Value of urinary prophylaxis with methenamine in gynecologic surgery. Acta Obstet Gynecol Scand. 2002 Aug;81(8):743-6

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NEW: ANTI-INFECTIVE AGENTS: Misc ­ Oral Agents for UTI

RECOMMENDATION

Fosfomycin (Monurol®) is considered a product whose safety and efficacy demonstrates that it is an alternative to other currently available therapies and that it is recommended to be subject to the criteria presented.

COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Misc ­ Oral Agent for UTI

PREFERRED NON-PREFERRED MONUROL®CC (fosfomycin)

PROPOSED CRITERIA

Criteria for Monurol® (fosfomycin) Monurol® (fosfomycin) will be authorized if any of the following are true: 1. The recipient is pregnant with a urinary tract infection (UTI) 2. The recipient has a contra-indication, intolerance, previous failure or is infected with an organism resistant to sulfamethoxazole/trimethoprim (Bactrim®, Septra®, Bactrim DS®, Septra DS®) Length of Authorization:

References Fihn SD. Clinical practice. Acute uncomplicated urinary tract infection in women. N Engl J Med. 2003 Jul 17;349(3):259-66. Mazzei T, Cassetta MI, Fallani S, Arrigucci S, Novelli A. Pharmacokinetic and pharmacodynamic aspects of antimicrobial agents for the treatment of uncomplicated urinary tract infections. Int J Antimicrob Agents. 2006 Jul 6. Nicolle LE. Empirical treatment of acute cystitis in women. Int J Antimicrob Agents. 2003 Jul;22(1):1-6.

One year

COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION

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NEW: ANTI-INFECTIVE AGENTS: NITROIMIDAZOLE ORAL AGENTS

RECOMMENDATION

Both metronidazole and tinidazole appear to be equally effective in the treatment of trichomoniasis, giardiasis and amebiasis such that they may be considered therapeutic alternatives to one another. Although both agents share in vitro activity against anaerobic bacteria and H. pylori only metronidazole carries an FDA labeled indication for both. There is conflicting evidence as to whether tinidazole is effective in metronidazole resistant strains of trichomoniasis; however, authorization will be allowed if treatment failure occurs with metronidazole 2 g single dose and reinfection is excluded.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: NITROIMIDAZOLE ORAL AGENTS

PREFERRED METRONIDAZOLE (compares to Flagyl® METRONIDAZOLE ER (compares to Flagyl® ER) NON-PREFERRED FLAGYL® (metronidazole) FLAGYL® ER (metronidazole 750mg) TINDAMAX® (tinidazole)

References Crowell AL, Sanders-Lewis KA, Secor WE. In vitro metronidazole and tinidazole activities against metronidazole-resistant strains of Trichomonas vaginalis. Antimicrob Agents Chemother 2003;47:1407-9. Hager WD. Treatment of metronidazole-resistant Trichomonas vaginalis with tinidazole. SexTransm Dis 2004;31:343-5. Narcisi EM, Secor WE. In vitro effect of tinidazole and furazolidone on metronidazole-resistant Trichomonas vaginalis. Antimicrob Agents Chemother 1996;40:1121-5. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006; 55( RR-11) 1-100. Tinidazole.The Medical Letter. Vol. 46 (Issue 1190) August 30, 2004.

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ANTI-INFECTIVE AGENTS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Macrolides and Azalides

RECOMMENDATION

In the macrolide class consisting of brand and generic erythromycin products there are various formulations consisting of various salt forms and release properties that exist; however, the efficacy of erythromycin remains the same when used in equivalent dosages. The advanced generation macrolides/azalides are separated from erythromycin as these agents confer greater activity against one of the major organisms (H.influenzae) in community acquired pneumonia, bronchitis and sinusitis over erythromycin. Although both agents have been studied in the treatment of H.pylori, only clarithromycin (Biaxin®) is FDA approved. In terms of respiratory infections, the two chemical entities and formulations are considered therapeutic alternatives to one another

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Macrolides and Azalides

PREFERRED Macrolides ERYTHROMYCIN generic products Advanced Generation Macrolide/Azalide AZITHROMYCINQL (compares to Zithromax®) CLARITHROMYCIN (compares to Biaxin®) NON-PREFERRED Macrolides ERYTHROMYCIN brand name products Advanced Generation Macrolide/Azalide BIAXIN® (clarithromycin) BIAXIN XL® (clarithromycin extended release) ZITHROMAX®QL (azithromycin) ZMAX®QL (azithromycin)

References Epstein BJ, Gums JG. Optimal pharmacological therapy for community-acquired pneumonia: the role of dual antibacterial therapy. Drugs. 2005;65(14):1949-71 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754 ZMAX. The Medical Letter. 2005: Vol. 47; Issue 1218.

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RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Ketolides

RECOMMENDATION

Telithromycin (Ketek®) is considered a product whose efficacy demonstrates that it is a therapeutic alternative to currently available therapies and holds an advantage over macrolide resistant S. pneumonia. The arrival of this agent is important due to the emergence of resistant infections. Due to recent safety concerns (possible liver injury and failure) and the need to utilize these agents prudently so that long-term value is maintained it is recommended that the agent be subject to the following criteria.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Ketolides

PREFERRED NON-PREFERRED KETEK®CC (telithromycin)

PROPOSED CRITERIA

Criteria Ketek® (telithromycin) For healthy recipients in the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or previously well ambulatory community-acquired pneumonia in recipients Ketek® will be authorized if there is a previous trial (within 28 days) of any of the following antibiotics: · A pencillin, cephalosporin, sulfonamide, advanced macrolide, respiratory quinolone, doxycycline, amoxicillin/clavulanate, or ceftriaxone (note this is currently systematically in place) For recipients with comorbidities (ie COPD, Diabetes, renal failure, CHF, asthma, recent hospitalization) · A failure, trial, intolerance or suspected insusceptibility to one of the following: an advanced generation macrolide or respiratory fluoroquinolone will be required prior to authorization Length of Authorization: References One year

Blasi F, Ewig S, Torres A, Huchon G. A review of guidelines for antibacterial use in acute exacerbations of chronic bronchitis. Pulm Pharmacol Ther. 2006 Oct;19(5):361-9. Blasi F, Tarsia P, Aliberti S, Santus P, Allegra L. Highlights on the appropriate use of fluoroquinolones in respiratory tract infections. Pulm Pharmacol Ther. 2006;19 Suppl 1:11-9. Ketek (telithromycin). MedWatch. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01401.html accessed 8.1.2006. Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Nguyen M, Chung EP. Telithromycin: the first ketolide antimicrobial. Clin Ther. 2005 Aug;27(8):1144-63. Sinus and Allergy Health Partnership. Executive Summary: Antimicrobial treatment guidelines fro acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2004;130(suppl):1-45. Telithromycin (Ketek) for respiratory infections. Med Lett Drugs Ther. 2004 Aug 16;46(1189):66-8.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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NEW: ANTI-INFECTIVE AGENTS: Oral Lincosamides

RECOMMENDATION

Clindamcyin is the only orally available lincosamide and is effective agent for anaerobes and some gram positive organisms. The safety and efficacy of clindamycin has shown that it is a valuable agent in the antimicrobial armentarium.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: ANTI-INFECTIVE AGENTS: Oral Lincosamides

PREFERRED CLINDAMYCIN (compares to Cleocin® caps) CLEOCIN® Pediatric granules for oral suspension

References Dajani AS, Taubert KA, Wilson W, Bolger AF, Bayer A, Ferrieri P, Gewitz MH, Shulman ST, Nouri S, Newburger JW, Hutto C, Pallasch TJ, Gage TW, Levison ME, Peter G, Zuccaro G Jr. Prevention of bacterial endocarditis. Recommendations by the American Heart Association.. Circulation. 1997 Jul 1;96(1):358-66. Epstein BJ, Gums JG. Optimal pharmacological therapy for community-acquired pneumonia: the role of dual antibacterial therapy. Drugs. 2005;65(14):1949-71 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754

NON-PREFERRED CLEOCIN® (clindamycin caps)

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ANTI-INFECTIVE AGENTS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Quinolones

RECOMMENDATION

In the second generation quinolone sub-class, ciprofloxacin (non-sustained release formulation) is considered to be superior in terms of gram negative activity. All other agents are products whose safety and efficacy demonstrate that they may be considered therapeutic alternatives to one another. Within the second generation urinary tract infections (UTI) agents, these agents have demonstrated efficacy and safety in the treatment of UTIs, but not that of systemic infections such that they may be considered alternatives to existing therapies for UTI treatment. In the third generation quinolone sub-class, also known as the respiratory quinolones, Avelox® (moxifloxacin), Factive® (gemifloxacin) and Levaquin® (levafloxacin) may be considered therapeutic alternatives to one another in terms of the activity against organisms that cause most common respiratory illnesses. In terms of anaerobic activity, Avelox® (moxifloxacin) and Factive (gemifloxacin) share the same spectrum of activity whereas Levaquin® (levofloxacin) does not It is recommended that at least one respiratory quinolone with adequate coverage against the organisms implicated in most respiratory infections be available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFECTIVE AGENTS: Oral Quinolones

PREFERRED Second generation CIPROFLOXACIN (compares to Cipro®) OFLOXACIN (compares to Floxin®) NON-PREFERRED Second generation CIPRO® (ciprofloxacin) FLOXIN® (ofloxacin) NOROXIN® (norfloxacin)

Second generation UT I only agents

CIPRO® XR (ciprofloxacin) PROQUIN XR® (ciprofloxacin) Third generation AVELOX® (moxifloxacin)

Note: Tequin® (gatifloxacin) is no longer manufactured References Epstein BJ, Gums JG. Optimal pharmacological therapy for community-acquired pneumonia: the role of dual antibacterial therapy. Drugs. 2005;65(14):1949-71 Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Stevens DL, Bisno AL, Chambers HF, et al. Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005 Nov 15;41(10):1373-406. The official statement of the American Thoracic Society: Guidelines for the management of adults with community acquired pneumonia.AM J Respir Crit Care Med. 2001 vol 163: 1730-1754.

Third generation FACTIVE® (gemifloxacin) LEVAQUIN® (levofloxacin)

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RE-REVIEW: ANTI-INFEECTIVE AGENTS: Oral Antifungals used for OnychomycosisCC

RECOMMENDATION

The treatment of onychomycosis will not be allowed for cosmetic use and will be approved when health would be compromised without care. The two oral agents currently FDA labeled for the treatment of onychomycosis are terbinafine (Lamisil®) and itraconazole (Sporanox®). Terbinafine (Lamisil®) is considered a product whose safety and efficacy demonstrate that it is superior to itraconazole in the treatment of onychomycosis.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFEECTIVE AGENTS: Oral Antifungals used for OnychomycosisCC

PREFERRED LAMISIL®CC ,QL (terbinafine) NON-PREFERRED ITRACONAZOLE CC, QL (compares to Sporanox®) SPORANOX® CC,QL (itraconazole)

PROPOSED CRITERIA

Onychomycosis Class Criteria Antifungals will be authorized for the diagnosis of nail fungal infections (onychomycosis) if the following are present: · There is a positive lab culture · If there is an underlying disease (ie diabetes, patients peripheral vascular disease, poor circulation, immunocompromised recipients etc) Note: For the diagnosis of onychomycosis ­ itraconazole (Sporanox®) should only be approved if the recipient has failed, has an intolerance or contra-indication to terbinafine (Lamisil®) and the clinical criteria for onychomycosis has been met. Approval will not be made for cosmetic reasons. For a non-onychomycosis diagnosis, Itraconazole (Sporanox®) is unrestricted. Length of authorization: Up to 3 months. Max of 1 course per year for the diagnosis of onychomycosis.

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References

Bristow IR, Baran R. Topical and oral combination therapy for toenail onychomycosis: an updated review. J Am Podiatr Med Assoc. 2006 Mar-Apr;96(2):116-9. Evans EG, Sigurgeirsson B. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group. BMJ. 1999 Apr 17;318(7190):1031-5. Gupta AK, Gregurek-Novak T. Efficacy of itraconazole, terbinafine, fluconazole, griseofulvin and ketoconazole in the treatment of Scopulariopsis brevicaulis causing onychomycosis of the toes. Dermatology. 2001;202(3):235-8. Gupta AK, Ryder JE, Lynch LE, Tavakkol A. The use of terbinafine in the treatment of onychomycosis in adults and special populations: a review of the evidence. J Drugs Dermatol. 2005 May-Jun;4(3):302-8. Gupta AK, Ryder JE, Johnson AM. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol. 2004 Mar;150(3):537-44. Lecha M, Effendy I, Feuilhade de Chauvin M, Di Chiacchio N, Baran R; Taskforce on Onychomycosis Education. Treatment options-development of consensus guidelines. J Eur Acad Dermatol Venereol. 2005 Sep;19 Suppl 1:25-33. Sporanox® MedWatch. http://www.fda.gov/medwatch/SAFETY/2002/jul02.htm#sporan

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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RE-REVIEW: ANTI-INFEECTIVE AGENTS: Oral Antifungals Used for Systemic Infections

RECOMMENDATION

Fluconazole (Diflucan®), ketoconazole (Nizoral®), itraconazole (Sporanox®), voriconazole (Vfend®) and flucytosine (Ancobon®) are products whose safety and efficacy differ by virtue of their spectrum of activity, bioavailability, adverse effects and potential for drug interactions. Voriconazole (Vfend®) and Itraconazole (Sporanox®) share a spectrum of activity close to one another, although Voriconazole (Vfend®) appears to be more active against Aspergillus spp and some species of Candida. Careful use of Voriconazole (Vfend®) is important if long-term value is to be preserved. Itraconazole (Sporanox®) will be subject to the onychomycosis criteria, but use will be unrestricted for systemic infections. Flucytosine (Ancobon®) has both safety (potential for bone marrow depression) and efficacy (resistance emerges when used alone) issues such that it is considered an inferior product that should only be used in combination with other antifungal agents (typically IV amphotericin B).

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFEECTIVE AGENTS: Oral Antifungals Used for Systemic Infections

PREFERRED GRISEOFULVIN GRIS-PEG® (griseofulvin) GRIFULVIN V ® (griseofulvin) FLUCONAZOLE (compares to Diflucan®) KETOCONAZOLE (compares to Nizoral®) NON-PREFERRED ANCOBON (flucytosine) DIFLUCAN® (fluconazole) ITRACONAZOLECC (compares to Sporanox®) NIZORAL® (ketoconazole) SPORANOX®CC (itraconazole) VFEND® CC (voriconazole)

PROPOSED CRITERIA

Criteria for Sporanox® (itraconazole) Onychomycosis Class Criteria Antifungals will be authorized for the diagnosis of nail fungal infections (onychomycosis) if the following are present: · There is a positive lab culture · If there is an underlying disease (ie diabetes, patients peripheral vascular disease, poor circulation, immunocompromised recipients etc) Note: For the diagnosis of onychomycosis ­ itraconazole (Sporanox®) should only be approved if the recipient has failed, has an intolerance or contra-indication to terbinafine (Lamisil®) and the clinical criteria for onychomycosis has been met. Approval will not be made for cosmetic reasons. For a non-onychomycosis diagnosis, Itraconazole (Sporanox®) is unrestricted. Length of authorization: Up to 3 months. Max of 1 course per year for the diagnosis of onychomycosis.

COMMITTEE VOTE APPROVED DISAPPROVED

APPROVED with MODIFICATION

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PROPOSED CRITERIA

Criteria for Vfend® (voriconazole) Vfend® will be approved for the following diagnoses: · Treatment of invasive aspergillosis · Serious fungal infections caused by S. apiospermum and Fusarium species including F. solani in patients intolerant of or refractory to other therapy · Other serious fungal infections where other agents [ie Diflucan® (Fluconazole), Nizoral® (Ketoconazole), Sporanox® (Itraconazole)] are resistant or refractory to the fungal infection · The treatment of candidemia or esophageal candidiasis in neutropenic or nonneutropenic patients (those without low white blood cell counts) and the following Candida infections: disseminated (deep tissue) infections in skin and infections in abdomen, kidney, bladder wall, and wounds if the Candida species is resistant or suspected to be resistant to other antifungals[ie Diflucan® (Fluconazole), Nizoral® (Ketoconazole), Sporanox® (Itraconazole)] · As part of standard anti-fungal regimen in febrile neutropenic recipients Note: If started as an inpatient hospital regimen and this is a continuation of therapy via home health or in a nursing home, then the drug is approvable Length of Authorization: variable dependent upon disease state

References Boucher HW, Groll AH, Chiou CC, Walsh TJ. Newer systemic antifungal agents : pharmacokinetics, safety and efficacy. Drugs. 2004;64(18):1997-2020. Herbrecht R, Nivoix Y, Fohrer C, Natarajan-Ame S, Letscher-Bru V. Management of systemic fungal infections: alternatives to itraconazole. J Antimicrob Chemother. 2005 Sep;56 Suppl 1:i39-i48. Steinbach WJ.Antifungal agents in children.Pediatr Clin North Am. 2005 Jun;52(3):895-915, viii. Zaoutis TE, Benjamin DK, Steinbach WJ. Antifungal treatment in pediatric patients. Drug Resist Updat. 2005 Aug;8(4):235-45.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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NEW: ANTI-INFEECTIVE AGENTS: Rx Vaginal Antifungals

RECOMMENDATION

All of the products in this category have been shown to be safe and effective for the local treatment of vulvovaginal candidiasis. The available clinical studies fail to show any significant differences in response rates or tolerability between the available vaginal antifungal products. Published reviews on these agents state that differences in formulation are not considered to be clinically relevant to therapeutic outcome and are more a function of patient preference. Miconazole is active against susceptible strains of Trichophyton spp., Epidermophyton spp., Candida albicans, and Microsporium spp., whereas nystatin, terconazole, and butoconazole are active against Candida albicans. Nystatin is Pregnancy Category A and poorly absorbed; therefore this product should be available for pregnant or breast-feeding women. Based on this information, it is recommended that at least miconazole and nystatin be available within this category. The remaining vaginal antifungal products can be considered therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFEECTIVE AGENTS: Rx Vaginal Antifungals

PREFERRED MICONAZOLE 3 vaginal supp., 200 mg (compares to Monistat® 3) NYSTATIN vaginal tablets, 100,000 U TERCONAZOLE 0.4%, 0.8% (compares to Terazol® 3, 7) ZAZOLE® (terconazole) NON-PREFERRED GYNAZOLE-1® (butoconazole) MONISTAT® 3 vaginal supp. (200 mg) TERAZOL® 3, 7 (terconazole)

References

Facts and Comparisions, www.factsandcomparison.com Gynazole-1 Study Group. Butoconzaole nitrate 2% for vulvovaginal candidiasis. New single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate. J Reprod Med. 1999; 44(11): 933-8. Nyirjesy P. Chronic vulvovaginal candidiasis. American Family Physician. 2001; 63(4): Sobel, J. Vulvovaginal candidiasis: Epidemiologic, diagnostic, and therapeutic considerations. American Journal of Obstetrics and Gynecology. 1998;178:203-11. USPDI, Micromedix, 2004

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NEW: ANTI-INFEECTIVE AGENTS: Antifungals for Oropharyngeal Candidiasis

RECOMMENDATION

All agents in this category are indicated for the treatment of oropharyngeal candidiasis. Clotrimazole troches are also indicated for prevention of oropharyngeal candidiasis. However, clotrimazole troches are not indicated for use in children less than 3 years of age, whereas nystatin oral suspension can be used even in infants. Based on this information, it is recommended that at least one oral clotrimazole product and at least one oral nystatin product be available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFEECTIVE AGENTS: Rx Vaginal Antifungals

PREFERRED CLOTRIMAZOLE troches (compares to Mycelex®) NYSTATIN oral suspension, tablets, powder NON-PREFERRED MYCELEX® (clotrimazole) MYCOSTATIN® oral tablets (nystatin)

References Facts and Comparisions, www.factsandcomparison.com USPDI, Micromedix, 2004

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NEW: ANTI-INFEECTIVE AGENTS: Vaginal Antibiotics

RECOMMENDATION

The products in this class all contain 0.9% acetic acid and 0.025% oxyquinoline sulfate, and are used to maintain a vaginal pH of around 4 in order to prevent growth of infectious bacteria or fungus. They are considered to have similar efficacy and tolerability, and can be considered therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: ANTI-INFEECTIVE AGENTS: Rx Vaginal Antifungals

NON-PREFERRED ACID JELLY (oxyquinoline sulfate, ricinoleic acid, glacial acetic acid) ACIDIC VAGINAL(oxyquinoline sulfate, ricinoleic acid, glacial acetic acid) FEM PH (0.9% glacial acetic acid, 0.025% oxyquinoline sulfate) RELAGARD (0.9% glacial acetic acid, 0.025% oxyquinoline sulfate) ­ priced as brand, but more utilization

References

Facts and Comparisions, www.factsandcomparison.com USPDI, Micromedix, 2004

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LENGTH OF AUTHORIZATIONS: ONE YEAR-IF MEDICALLY JUSTIFIED.

1. Is there any reason the patient cannot be changed to a medication not requiring prior approval within the same class? Acceptable reasons include: Allergy to medications not requiring prior approval Contraindication to or drug-to-drug interaction with medications not requiring prior approval History of unacceptable/toxic side effects to medications not requiring prior approval Recipient's condition is clinically unstable-and changing to a medication not requiring prior approval might cause deterioration of the recipient's condition · Document clinically compelling information 2. The requested medication may be approved if both of the following are true: · If there has been a therapeutic failure to no less than a one-month trial of at least one medication within the same class not requiring prior approval.Verify via the recipient's medication history to assure medication compliance · The requested medications corresponding generic (if a generic is available and covered by the State) has been attempted and failed or is contraindicated 3. The requested medication may be approved if the following is true: An indication which is unique to a non-preferred agent and is supported by peer-reviewed literature or an FDA approved indication exists.

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HEMATOPOIETIC AGENTS

NEW: HEMATOPOIETIC AGENTS: r-ErythropoietinST

RECOMMENDATION

All agents are products whose safety and efficacy demonstrate that they are therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: HEMATOPOIETIC AGENTS: r-ErythropoietinCC

PREFERRED ARANESP®CC (darbepoetin alfa) EPOGEN® CC (epoetin alfa) PROCRIT® CC (epoetin alfa) NON-PREFERRED

PROPOSED CRITERIA

Approval Criteria 1. The patient must have one of the following diagnoses: Anemia associated with chronic renal failure Treatment of chemotherapy induced anemia for non-myeloid malignancies Retrovir® or Combivir® induced anemia Autologous blood donations by patients scheduled to undergo nonvascular surgery Patients with autonomic disorders that have anemia but only if orthostatic or postural hypotension is secondary to autonomic disorder. Examples of autonomic disorders: Primary autonomic system failure Multisystem atrophy (Shy-Drager syndrome) Pure autonomic dysautonomia Secondary autonomic system failure Brain and brainstem stroke Multiple sclerosis Spinal cord transverse myelitis; syringomyelia Tumor Tabes dorsalis Peripheral nervous system Diabetes mellitus Guillain-Barre syndrome Alcoholic polyneuropathy Human immunodeficiency virus infection Amyloidosis Porphyria Hepatitis C Treatment related anemia Any indication not mentioned above will recquire the submission of a peer reviewed study to support the use of the hematopoietic agent 2. The patient must have a hematocrit of 33 or less Note: Infants to age 6 months with a diagnosis of Anemia of Prematurity will not require lab work Length of Authorization: 6 months

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References Aranesp. Package insert. Amgen. March 23, 2006 Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL et al.American Society of Clinical Oncology; Americcan Society of Hematology. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology.Blood. 2002 Oct 1;100(7):2303-20. Epogen. Package Insert. Amgen. May 11, 2006. Procrit. Package Insert.Ortho Biotech. http://www.procrit.com/common/prescribing_information/PROCRIT/PDF/ProcritBooklet.pdf. accessed August 2, 2006.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

---------------------------------------------------------------------------------------------------------------------------------

NEW: HEMATOPOIETIC AGENTS: Colony Stimulating Factors

RECOMMENDATION

Among the G-CSF agents (filgrastim and peg-filgrastim), both products safety and efficacy demonstrate that they are therapeutic alternatives to one another. Between the GM-CSF and G-CSF agents, the ASCO 2006 guidelines on the use of white blood cell growth factors state that no recommendation can be made regarding equivalency of the two.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: HEMATOPOIETIC AGENTS: Colony stimulating factors

PREFERRED LEUKINE® (sargramostim, GM-CSF) NEUPOGEN® (filgrastim, G-CSF) NEULASTA® (pegfilgrastim, G-CSF)

References Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006 Jul 1;24(19):3187-205.

NON-PREFERRED

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August 29, 2006 Tennessee PAC

HEMATOPOIETIC AGENTS

NEW: HEMATOPOIETIC AGENTS: Interleukins

RECOMMENDATION

Oprelvekin (Neumega®) is the only approved growth factor used for the enhancement of platelets. Oprelvekin (Neumega®) is an effective agent for the prevention of severe chemotherapy-induced thrombocytopenia and appears to be safer than transfusion therapy and just as effective. It has been studied, but not approved, for use in drug-induced thrombocytopenias as well. Oprelvekin (Neumega®) represents a unique agent with demonstrated safety and efficacy.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: HEMATOPOIETIC AGENTS: Interleukins

PREFERRED NEUMEGA® (oprelvekin ,interleukin 11; IL11) NON-PREFERRED

References Neumaga.Package Insert. Genetics Institute. September 18, 2002 Ong JP, Younossi ZM. Managing the hematologic side effects of antiviral therapy for chronic hepatitis C: anemia, neutropenia, and thrombocytopenia. Cleve Clin J Med. 2004 May;71 Suppl 3:S17-21.

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UROLOGIC AGENTS

LENGTH OF AUTHORIZATIONS: 1 YEAR (unless otherwise specified)

1. Is there any reason the patient cannot be changed to a medication not requiring prior approval within the same class? Acceptable reasons include: Allergy to medications not requiring prior approval Contraindication to or drug-to-drug interaction with medications not requiring prior approval History of unacceptable/toxic side effects to medications not requiring prior approval 2. The requested medication may be approved if both of the following are true: There has been a therapeutic failure to no less than a one-month trial of at least two medication(s) within the same class not requiring prior approval. The requested medication's corresponding generic (if a generic is available and preferred by the State) has been attempted, failed, or is contraindicated. 3. The requested medication may be approved if the following is true: An indication which is unique to a non-preferred agent and is supported by peer-reviewed literature or an FDA approved indication exists.

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UROLOGIC AGENTS

NEW: UROLOGICS: Urinary Alkalizing Agents

RECOMMENDATION

All products in this category are effective in increasing the urine pH and preventing/dissolving uric acid or cystine calculi in the urinary tract. Potassium citrate products and potassium citrate/citric acid products can prevent/dissolve calcium oxalate and calcium phosphate calculi, in addition to uric acid and cystine calculi. Differences in the amount of sodium and potassium among the various products in this category may play a role in product selection for patients who are sodium restricted, hyper- or hypo-kalemic, etc. Therefore, it is recommended that at least one tri-citrate product, at least one sodium citrate/citric acid product, at least one potassium citrate product (with or without citric acid) be made available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: UROLOGICS: Urinary Alkalizing Agents PREFERRED PA REQUIRED CITRIC ACID/SODIUM CITRATE (compares to BICITRA® (citric acid/sodium citrate) Bicitra) ORACIT® (citric acid/sodium citrate) CYTRA-2® (citric acid/sodium citrate) POLYCITRA® (potassium citrate/sodium citrate/citric CYTRA-3® (potassium citrate/sodium citrate) acid) CITRA-K® (citric acid/potassium citrate) POLYCITRA-K® (citric acid/potassium citrate) TRICITRATES® (potassium citrate/sodium POLYCITRA-LC S/F® (potassium citrate/sodium citrate/citric acid) citrate/citric acid) CITROLITH® (potassium citrate/sodium citrate) UROCIT-K® (potassium citrate)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch Mayo Foundation for Medical Education and Research (MFMER). Kidney Stones. May 5, 2006. http://www.cnn.com/HEALTH/library/DS/00282.html. Accessed 08.10.2006. Citrates (systemic). http://www.drugs.com. Accessed 08.10.2006.

NEW: UROLOGICS: Urinary Acidifying Agents

RECOMMENDATION

All products in this category are effective at acidifying the urine, resulting in increased calcium solubility, and reduced odor, rash, and skin irritation from ammonia in the urine. Uroquid acid #2® contains methanamine (a urinary antibiotic) in addition to potassium phosphate (a urinary acidifier); however, the other urinary acidifying agents can be used with methenamine as well. Therefore, the available urinary acidifying products can be considered therapeutic alternatives to one another.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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UROLOGIC AGENTS

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS:

NEW: UROLOGICS: Urinary Acidifying Agents PREFERRED PA REQUIRED K-PHOS ORIGINAL® (potassium acid phosphate) UROQUID ACID #2® (methanamine mandelate/ potassium phosphate) K-PHOS #2® (potassium acid phosphate /sodium acid phosphate) PEDAMETH® (racemethionine) K-PHOS MF® (potassium acid phosphate /sodium RENACIDIN® (magnesium carbonate/citric acid/ acid phosphate) glucono-lactone) K-PHOS NEUTRAL® (dibasic sodium phosphate/ monobasic potassium phosphate/monobasic sodium phosphate) PHOSPHA NEUTRAL® (dibasic sodium phosphate/ monobasic potassium phosphate/monobasic sodium phosphate) URO-KP-NEUTRAL® (dibasic sodium phosphate/ monobasic potassium phosphate/monobasic sodium phosphate)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch

NEW: UROLOGICS: Urinary Analgesics

RECOMMENDATION

All products in this category contain phenazopyridine as an active ingredient. Phenazopyridine has been shown to exert an analgesic effect on the mucosa of the urinary tract, relieving pain, burning, urgency, and frequency associated with urinary tract infections. Phenazopyridine/hyoscyamine/ butabarbital combination products have been shown to provide additional benefit compared to phenazopyridine alone in patients experiencing detrusor muscle spasm along with pain, burning, frequency, etc. All phenazopyridine products can be considered therapeutic alternatives to one another. Likewise, all phenazopyridine/hyoscyamine/butabarbital products can be considered therapeutic alternatives to one another. However, both a phenazopyridine and a phenazopyridine/hyoscyamine/butabarbital product should be made available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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UROLOGIC AGENTS

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: UROLOGICS: Urinary Analgesics PREFERRED PA REQUIRED PHENAZOPYRIDINE (Compares to Pyridium®) PYRIDIUM® (phenazopyridine) PHENAZOPYRIDINE PLUS (Compares to PYRIDIUM PLUS® (phenazopyridine) Pyridium Plus®) URELIEF PLUS® (phenazopyridine/hyoscyamine/ butabarbital) PYRELLE HB® (phenazopyridine/hyoscyamine/ butabarbital) TRELLIUM PLUS® (phenazopyridine/ hyoscyamine/ butabarbital) URODOL® (phenazopyridine)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch

NEW: UROLOGICS: Interstitial Cystitis Agents

RECOMMENDATION

Elmiron® (pentosan polysulfate sodium) is the first oral medication approved by the FDA specifically for interstitial cystitis (IC). It is thought to help replenish the bladder lining and can be used long-term in patients with IC to relieve pain, urgency, and frequency. In contrast, the urinary analgesics, while effective at relieving pain associated with IC, should not be used long-term due to risks of serious side effects, including jaundice and anemia. For this reason, it is important to have pentosan polysulfate sodium available.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: UROLOGICS: Interstitial Cystitis Agents PREFERRED PA REQUIRED ELMIRON® (pentosan polysulfate sodium)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch Hwang P, et al. Efficacy of pentosan polysulfate in the treatment of interstitial cystitis: a meta-analysis. Urology. 1997; 50(1): 39-43. Parsons CL, Mulholland SG. Successful therapy of interstitial cystitis with pentosan polysulfate. J Urol. 1987; 138(3): 513-6.

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UROLOGIC AGENTS

NEW: UROLOGICS: Kidney Stone Agents

RECOMMENDATION

Cystagon® (cysteamine bitartrate) and Thiola® (tiopronin) exhibit similar efficacy and safety in treating cystinuria and preventing kidney stone formation. Calcibind® (cellulose sodium phosphate) can cause severe metabolic abnormalities, including hypomagnesemia, hyperoxaluria, calcium malabsorption, and iron malabsorption. Due to this serious side-effect profile, Calcibind® has a limited role in treatment today. In addition, Stonex® (eucalyptus/ bornyl/fenchone/pinene alpha-beta/camphene) has little to no clinical data to support its use. Therefore, Cystagon® and Thiola® should be considered reasonable choices for the prevention of cystine kidney stone formation, while the use of Calcibind® and Stonex® should not be encouraged at this time.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

NEW: UROLOGICS: Kidney Stone Agents PREFERRED PA REQUIRED CYSTAGON® (cysteamine bitartrate) CALCIBIND® (cellulose sodium phosphate) THIOLA® (tiopronin) STONEX® softgel (eucalyptus/bornyl/fenchone/pinene alpha-beta/camphene)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch

RE-REVIEW: UROLOGICS: Urinary Tract Antispasmodics

RECOMMENDATION

Based on the results of several head to head clinical trials, the drugs in this class can be considered equivalent with regards to efficacy (improvements in incontinence, decreased urgency/frequency, etc.). Oxybutynin has been shown to be associated with a higher incidence of adverse effects (especially dry mouth) compared to the other agents in this class. Transdermal oxybutynin is also associated with higher rates of adverse events (mainly application site reactions) compared to tolteridine. Lastly, the long-acting formulations were found to be associated with fewer adverse events than the immediate-release formulations. Based on these clinical findings, it is recommended that at least one long-acting agent, and at least one non-oxybutynin product be made available to Tenncare recipients.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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UROLOGIC AGENTS

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: UROLOGICS: Urinary Tract Antispasmodics PREFERRED PA REQUIRED OXYBUTYNIN (Compares to Ditropan®) DETROL® (tolterodine) DETROL LA® (tolterodine) OXYTROL® (oxybutynin) ENABLEX® (darifenacin) SANCTURA® (trospium) FLAVOXATE (Compares to Urispas®) DITROPAN® (oxybutynin) VESICARE® (solifenacin) DITROPAN XL® (oxybutynin) URISPAS® (flavoxate)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch

RE-REVIEW: UROLOGICS: Non-Selective Alpha-Blockers

RECOMMENDATION

All agents within this class have similar efficacy and safety profiles. While prazosin is not FDA-approved for treatment of BPH, it would be expected to provide similar benefits in BPH patients to the other nonselective alpha-blockers given its similar mechanism of action. All non-selective alpha-blockers are approved for the treatment of benign prostatic hyperplasia (BPH) and the treatment of hypertension, with the exception of Cardura XL®, which is indicated only for the treatment of BPH. Despite its extended-release formulation, Cardura XL® is associated with similar rates of hypotension as doxazosin. While Cardura XL® has lower rates of postural hypotension and dizziness than doxazosin, it does not have as favorable an adverse event profile as the selective alpha blockers. Based on this information, the non-selective alphablockers can be considered therapeutic alternatives for the treatment of BPH. In addition, all non-selective alpha blockers, with the exception of Cardura XL®, can be considered therapeutic alternatives for the treatment of hypertension.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: UROLOGICS: Non-Selective Alpha-Blockers PREFERRED PA REQUIRED DOXAZOSIN (Compares to Cardura®) CARDURA® (doxazosin) PRAZOSIN (Compares to MiniPress®) CARDURA XL® (doxazosin extended-release) TERAZOSIN (Compares to Hytrin®) MINIPRESS ® (prazosin) HYTRIN® (terazosin)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch Minipress® (prazosin) Product Information: Pfizer Inc. New York, NY. Revised February 2001. Cardura® (doxazosin) Product Information: Pfizer. New York, NY. Revised February 2005. Cardura® XL (doxazosin mesylate extended release tablets) Product Information: Pfizer. New York, NY. Revised February 2006. Hytrin® (terazosin) Product Information: Abbott Pharmaceuticals. Chicago, IL. Revised February 2001.

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UROLOGIC AGENTS

RE-REVIEW: UROLOGICS: Selective Alpha-Blockers

RECOMMENDATION

All agents within this class have similar efficacy in reducing the signs and symptoms of BPH. In addition, they have very similar adverse event profiles. Therefore, the products in this class can be considered therapeutic alternatives to one another for the treatment of BPH.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: UROLOGICS: Selective Alpha-Blockers PREFERRED PA REQUIRED UROXATRAL® (alfuzosin) FLOMAX® (tamsulosin)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch Flomax® (tamsulosin) product information. Boehringer Ingelheim Pharmaceuticals, Inc., August 2003. Uroxatral® (alfuzosin) product information. Sanofi-Synthelabo, June 2004. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170(2 Pt 1):530-547. Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998;160(5):1701-1706. Roehrborn CG. Efficacy and safety of once-daily alfuzosin in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a randomized, placebo-controlled trial. Urology. 2001;58(6):953-959. van Kerrebroec P, Jardin A, van Cangh P, Laval KU. Long-term safety and efficacy of a once-daily formulation of alfuzosin 10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study. Eur Urol. 2002;41(1):54-60. Lee E, Lee C. Clinical comparison of selective and non-selective alpha 1A-adrenoreceptor antagonists in benign prostatic hyperplasia: studies on tamsulosin in a fixed dose and terazosin in increasing doses. Br J Urol. 1997;80(4):606-611. Tsujii T. Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: a short-term open, randomized multicenter study. BPH Medical Therapy Study Group. Benign prostatic hyperplasia. Int J Urol. 2000;7(6):199-205. Roehrborn CG, Bartsch G, Kirby R, et al. Guidelines for the diagnosis and treatment of benign prostatic hyperplasia: a comparative, international overview. Urology. 2001;58(5):642-650. de la Rosette JJ, Alivizatos G, Madersbacher S, et al. EAU Guidelines on benign prostatic hyperplasia (BPH). Eur Urol. 2001;40(3):256-263.

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UROLOGIC AGENTS

RE-REVIEW: UROLOGICS: 5-Alpha-Reductase Inhibitors

RECOMMENDATION

Based on the clinical literature, all agents within this class have similar efficacy in reducing the signs and symptoms of BPH. The adverse event profiles of these products are rather similar, as well. Therefore, the products in this class can be considered therapeutic alternatives to one another for the treatment of BPH.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

RE-REVIEW: UROLOGICS: 5-Alpha-Reductase Inhibitors PREFERRED PA REQUIRED PROSCAR® (finasteride) AVODART® (dutasteride) FINASTERIDE (Compares to Proscar®)

References: Facts & Comparisons. 4.0. http://www.factsandcomparisons.com/ Thomson MICROMEDEX. http://www.thomsonhc.com/home/dispatch Proscar® (finasteride) product information. Merck & Co., Inc., July 2003 Avodart® (dutasteride) product information. GlaxoSmithKline, July 2003. Thorpe A, Neal D. Benign prostatic hyperplasia. Lancet. 2003;361(9366):1359-1367.

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DERMATOLOGIC AGENTS

NEW: DERMATOLOGICS: Oral Retinoids, Acitretin

(follow-up item from May 4, 2006 PAC Meeting)

RECOMMENDATION

Acitretin has been shown to be effective in the treatment of severe psoriasis in adults; however, because its use can be associated with serious birth defects (Pregnancy Category X), it should be tightly controlled to ensure providers are closely monitoring patients receiving this medication.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

PDL ASSESSMENT BASED ON CLINICAL RECOMMENDATIONS

PREFERRED NEW: DERMATOLOGICS: Oral Retinoids PA REQUIRED Soriatane® (acitretin)CC

Criteria for Soriatane® (acitretin) Soriatane® will be approved only for patients meeting the following criteria: · Recipient has a diagnosis of severe psoriasis (covering at least 10-20% of the body surface area). · Recipient has tried and failed, of had an intolerance or contraindication to, ALL of the following: o Topical corticosteroids o Topical antipsoriatics, including Dovonex® (calcipotriene), Tazorac® (tazarotene), anthralin, Psoriatec® (anthralin), or Taclonex® (calcipotriene/betamethasone). o Phototherapy (UVB, PUVA, etc.) · If the recipient is female: o Must have had TWO negative urine or serum pregnancy tests (one performed during the first 5 days of the menstrual period immediately preceding the beginning of Soriatane® therapy). o Must have committed to use 2 effective forms of contraception simultaneously, unless absolute abstinence is chosen or the patient has undergone a hysterectomy or is clearly postmenopausal. The 2 selected forms of contraception must be initiated at least 1 month prior to starting Soriatane® and continued for 3 years after discontinuing the drug. o Must have read and signed a Patient Agreement/Informed Consent for Female Patients form. · Recipient must NOT have impaired liver or kidney function, or abnormally elevated lipid levels. · Recipient must NOT be receiving concomitant methotrexate (due to risk of hepatitis) or tetracyclines (due to risk of increased intracranial pressure). Length of Authorization: 1 year

References Soriatane (acitretin) capsules prescribing information. Connetics. July 2004. Pardasani AG, Feldman SR, Clark AR. Treatment of Psoriasis : an algorithm-based approach for primary care physicians. American Family Physician. 61(3) : 725-33.

COMMITTEE VOTE APPROVED DISAPPROVED APPROVED with MODIFICATION

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August 29, 2006 Tennessee PAC

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