This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies

5HT-1F Prior Authorization with Quantity Limit

TARGET AGENTS

Reyvow™ (lasmiditan)

PROGRAM PRIOR AUTHORIZATION AND QUANTITY LIMIT TARGET AGENTS

Brand (generic)	GPI	Multisource Code	Quantity Limit
Reyvow (lasmiditan)
50 mg tablet	67406540600310	M, N, O, Y	4 tablets / 30 days (0.1334 tablets / day)
100 mg tablet	67406540600320	M, N, O, Y	8 tablets / 30 days (0.2667 tablets / day)

 

 

 

 

 

 

 

PRIOR AUTHORIZATION AND QUANTITY LIMIT CRITERIA FOR APPROVAL

Initial Approval

Target Agents will be approved when ALL of the following are met:

1. ONE of the following:
   1. ALL of the following:
      1. The requested agent will be used for the treatment of acute migraines

AND

1. 1. 2. ONE of the following:
         1. The patient has tried and had an inadequate response to TWO acute triptan agents with differing active ingredients OR differing route of administration

OR

1. 1. 1. 2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL acute triptan agents

AND

1. 1. 3. The patient has been evaluated for and does not have medication overuse headache

OR

1. 2. ONE of the following:
      1. The patient has another FDA approved indication for the requested agent and route of administration

OR

1. 1. 2. The patient has another indication that is supported in compendia (AHFS, or DrugDex 1 or 2a level of evidence) for the requested agent and route of administration

AND

2. The patient does not have any FDA labeled contraindications to the requested agent

AND

3. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

1. 2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

1. 1. 2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

1. 1. 3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

1. 3. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

1. 1. 2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

1. 1. 3. The prescriber has submitted information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

Renewal Approval

Target Agents will be approved when ALL of the following are met:

1. The patient has been approved for the requested agent previously through the plan’s prior authorization process

AND

2. ONE of the following:
   1. ALL of the following:
      1. The requested agent will be used for the treatment of acute migraines

AND

1. 1. 2. The prescriber has submitted information indicating improvement in acute migraine management with the requested agent

AND

1. 1. 3. The patient has been evaluated for and does not have medication overuse headache

OR

1. 2. BOTH of the following:
      1. One of the following:
         1. The patient has another FDA approved indication for the requested agent and route of administration

OR

1. 1. 1. 2. The patient has another indication that is supported in compendia (AHFS, or DrugDex 1 or 2a level of evidence) for the requested agent and route of administration

AND

1. 1. 2. The patient has had improvements or stabilization with the requested agent

AND

3. The patient does not have any FDA labeled contraindications to the requested agent

AND

1. 1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

1. 2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

1. 1. 2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

1. 1. 3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

1. 3. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

1. 1. 2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

1. 1. 3. The prescriber has submitted information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months

FDA APPROVED INDICATIONS AND DOSAGE¹

Agent	Indication	Dosage and Administration
Reyvow™ (lasmiditan) tablet	Acute treatment of migraine with or without aura in adults	Recommended dose is 50 mg, 100 mg, or 200 mg once daily. No more than one dose should be taken in 24 hours. A second dose has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.

CLINICAL RATIONALE

Migraines

American Headache Society (2015): The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies state that specific medications – triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan [oral, nasal spray, injectable, transcutaneous patch], zolmitriptan [oral and nasal spray]) are effective (Level A). The evidence base for medication efficacy should be considered along with potential medication side effects, potential adverse events, patient-specific contraindications to use of a particular medication, and drug-to-drug interactions when deciding which medication to prescribe for acute therapy of a migraine attack.²

Safety

Lasmiditan carries no contraindications or black box warnings.

References:

1. Reyvow prescribing information. Eli Lilly and Co. October 2019.
2. Marmura M, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55:3–20.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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