Read Pharmacy Medical Necessity Guidelines: Migraine Medications text version

Pharmacy Medical Necessity Guidelines Migraine Medications

Document ID#: Subject: Effective Date:

2153988 Migraine Medications January 10, 2012

Type of Review - Case Management Type of Review ­ Clinical Review RX Administrative Process (Internal Use Only) LPN/RN

Clinical Documentation and Prior Authorization Required Not Covered Pharmacy (RX) or Medical (MED) Benefit

Note: This pharmacy medical necessity guideline applies to commercial products. For Tufts Health Plan Medicare Preferred members, please refer to the Tufts Medicare Preferred Step Therapy Criteria. Background, applicable product and disclaimer information can be found on the last page.

Overview

FDA-approved Indications ® Amerge is indicated for · Acute treatment of migraine attacks, with or without aura in adults. Axert is indicated for · Acute treatment of migraine attacks, with or without aura in adults. · Acute treatment of migraine headache pain in adolescent's age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more. FrovaTM is indicated for · Acute treatment of migraine attacks, with or without aura in adults. Maxalt is indicated for · Acute treatment of migraine attacks, with or without aura in adults. RelpaxTM is indicated for · Acute treatment of migraine attacks, with or without aura in adults. sumatriptan is indicated for · Acute treatment of migraine attacks, with or without aura in adults (oral, nasal, injection) · Injection: Acute treatment of cluster headache episodes in adults. SumavelTM DoseProTM is indicated for · Acute treatment of migraine attacks, with or without aura in adults. · Acute treatment of cluster headache episodes. Zomig is indicated for · Acute treatment of migraine attacks, with or without aura in adults (oral, nasal spray).

® ® ®

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Pharmacy Coverage Guidelines

Note: Prescriptions that meet the initial step therapy requirements, will adjudicate at the point of service. If the Member does not meet the initial step therapy criteria, the prescription will deny at the point of service with a message indicating that prior authorization (PA) is required. Refer to the Coverage Criteria below and submit prior authorization requests to Tufts Health Plan using the Universal Pharmacy Medical Review Request Form for Members who do not meet the step therapy criteria at the point of service.

Please refer to the table below for formularies and medications subject to this policy: Drug Tufts Health Plan Massachusetts Commercial Formulary Tufts Health Plan Generic Focused Formulary Tufts Health Plan R.I. Formulary

Step-1

sumatriptan Covered naratriptan Covered Covered Covered Covered Covered

Step-2

Frova Maxalt/Maxalt MLT Zomig/Zomig ZMT Alsuma Amerge Axert Imitrex Relpax Sumavel Dosepro Requires prior use of a drug on Step-1 or Step2 Not Covered Requires prior use of a drug on Step-1 or Step-2 Requires prior use of a drug on Step-1 or Step2

Automated Step Therapy Coverage Criteria The following stepped approach applies to Migraine Medication coverage by Tufts Health Plan: Step 1: Step 2: Medications on Step-1 are covered without prior authorization. Tufts Health Plan may cover medications on Step-2 if the following criteria are met:

·

The Member has had a 30-day trial of one (1) Step-1 or Step-2 medication within the previous 180 days as evidenced by a paid claim under the prescription benefit administered by Tufts Health Plan.

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Coverage Criteria for Members not meeting the Automated Step Therapy Coverage Criteria at the Point of Sale Step 2: Tufts Health Plan may cover Step 2 medications if the following criteria are met:

·

The member has had a 30-day trial of a Step-1 or Step-2 medication as evidenced by physician documented use, excluding the use of samples.

Limitations

1. Tufts Health Plan does not authorize coverage of non-covered medications through this step therapy program. Please refer to the Pharmacy Medical Necessity Guidelines for Non-Covered Drugs with Suggested Alternatives and submit a formulary exception request to Tufts Health Plan as indicated. 2. The following quantity limitations apply for any strength and combination of the following Migraine Therapy. Please refer to the Pharmacy Medical Necessity Guidelines for Drugs with Dispensing Limitations and submit a formulary exception request for those Members requiring higher quantities.

· · · · · · · · · · · · · · ·

Amerge tablets - 9 tablets per 30 days Axert tablets- 6 tablets per 30 days Frova tablets- 9 tablets per 30 days Imitrex injection- 4 injections (2 kits)/30 days or 4 injections (4 vials)/30 days Imitrex nasal spray- 5 mg: 2 boxes (12 spray unit devices)/30 days; 20 mg: 1 box (6 spray unit devices)/30 days Imitrex tablets- 9 tablets per 30 days Maxalt/Maxalt-MLT- 9 tablets per 30 days naratriptan - 9 tablets per 30 days Relpax- 6 tablets per 30 days sumatriptan injection- 4 injections (2 kits)/30 days or 4 injections (4 vials)/30 days sumatriptan nasal spray- 5 mg: 2 boxes (12 spray unit devices)/30 days; 20 mg: 1 box (6 spray unit devices)/30 days sumatriptan tablets- 9 tablets per 30 days Sumavel- 4 injections/30 days Zomig spray- 1 box (6 spray units)/30 days Zomig tablets/ Zomig-ZMT-2.5 mg: 6 tablets/30 days; 5 mg: 3 tablets/30 days

Codes

None.

References

1. 2. 3. 4. 5. 6. 7. 8. Amerge (naratriptan) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; February 2010. Axert (almotriptan) [package insert]. Titusville, NJ: Ortho-McNeil Neurologics, Inc.; April 2009. eFacts and Comparisons online. http://online.factsandcomparisons.com Frova (frovatriptan) [package insert]. Chadds Ford, PA: Endo Pharmaceuticals Inc.; April 2007. Imitrex (sumatriptan) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; February 2010. Maxalt (rizatriptan) [package insert]. Whitehouse Station, NJ: Merk & Co., INC; December 2009. Relpax (eletriptan) [package insert]. New York, NY: Pfizer; May 2008. Sumavel (sumatriptan injection) [package insert]. San Diego, CA: Zogenix, Inc.; November 2009.

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9. Treximet (sumatriptan and naproxen) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; December 2009. 10. Zomig (zolmitriptan) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2008.

Approval History

Reviewed by the Pharmacy and Therapeutics Committee on July 13, 2010. Subsequent Endorsement Date(s) and Changes Made: 1. September 14, 2010:

· Added naratriptan to Step-1 of the Migraine Medications Step Therapy program. 2. January 11, 2011: · · ·

Adjusted the coverage of the brand name drugs for the GFF; Amerge, Axert, Imitrex, Relpax, and Sumavel Dosepro are not covered. Added Alsuma to Step-2 of the Migraine Medications Medical Necessity Guidelines.

Added limitation: Tufts Health Plan does not authorize coverage of non-covered medications through this step therapy program. Please refer to the Pharmacy Medical Necessity Guidelines for Non-Covered Drugs with Suggested Alternatives and submit a formulary exception request to Tufts Health Plan as indicated. 2. January 10, 2012: Added historical look back period of 2 years for physician documented use of Step Therapy prerequisite drugs. 3. June 12, 2012:

· · ·

Administrative update: removed historical look back period of 2 years for physician documented use of Step Therapy pre-requisite drugs. Clarified step criteria to reflect that Step-2 drugs are prerequisites for drugs on Step-2.

Background, Product and Disclaimer Information

Pharmacy Medical Necessity Guidelines have been developed for determining coverage for Tufts Health Plan benefits and are published to provide a better understanding of the basis upon which coverage decisions are made. They are used in conjunction with a Member's benefit document and in coordination with the Member's physician(s). Tufts Health Plan makes coverage decisions on a case-by-case basis considering the individual Member's health care needs. Pharmacy Medical Necessity Guidelines are developed for selected therapeutic classes or drugs found to be safe, but proven to be effective in a limited, defined population of patients or clinical circumstances. They include concise clinical coverage criteria based on current literature review, consultation with practicing physicians in the Tufts Health Plan service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. Tufts Health Plan revises and updates Pharmacy Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. Pharmacy Medical Necessity Guidelines apply to all fully insured Tufts Health Plan offerings unless otherwise noted in this policy or the Member's benefit document. Check the applicable formulary in the Pharmacy section of our Web site at http://www.tuftshealthplan.com/providers to determine if the drug requires you to get prior authorization. This Pharmacy Medical Necessity Guideline does not apply to Uniformed Services Family Health Plan Members or to certain delegated service arrangements. Unless otherwise noted in the Member's benefit document or applicable Pharmacy Medical Necessity Guideline, SM Pharmacy Medical Necessity Guidelines do not apply to CareLink Members. For self-insured plans, drug coverage may vary depending on the terms of the benefit document. If a discrepancy exists between a coverage guideline and a self-insured Member's benefit document, the provisions of the benefit document will govern. Applicable state or federal mandates will take precedence. For Tufts Medicare Preferred, please refer to Tufts Medicare Preferred Step Therapy Criteria.

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Treating providers are solely responsible for the medical advice and treatment of Members. The use of this policy is not a guarantee of payment or a final prediction of how specific claim(s) will be adjudicated. Claims payment is subject to Member eligibility and benefits on the date of service, coordination of benefits, referral/authorization and utilization management guidelines when applicable, and adherence to plan policies and procedures and claims editing logic.

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Pharmacy Medical Necessity Guidelines: Migraine Medications

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