ph-991131
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Acute Migraine Agents Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-991131

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

Acute Migraine Agents Prior Authorization with Quantity Limit

TARGET AGENT(S)

Nurtec ODT™ (rimegepant)

Reyvow® (lasmiditan)

Ubrelvy™ (ubrogepant)

PROGRAM PRIOR AUTHORIZATION AND QUANTITY LIMIT TARGET AGENTS

Brand (generic)

GPI

Multisource Code

Quantity Limit

(per day or as listed)

Nurtec (rimegepant)

75 mg orally disintegrating tablet

67701060707220

M, N, O, Y

45 tablets / 90 days

Reyvow (lasmiditan)

50 mg tablet

67406540600310

M, N, O, Y

8 tablets / 30 days

100 mg tablet

67406540600320

M, N, O, Y

8 tablets / 30 days

Ubrelvy (ubrogepant)

50 mg tablet

67701080000320

M, N, O, Y

16 tablets / 30 days

100 mg tablet

67701080000340

M, N, O, Y

16 tablets / 30 days

 

 

 

 

 

 

 

 

 

 

 

 

PRIOR AUTHORIZATION AND QUANTITY LIMIT CRITERIA FOR APPROVAL

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient has a diagnosis of migraine AND ALL of the following:
      1. The requested agent is being used for acute migraine treatment

AND

      1. 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. The patient has an intolerance or hypersensitivity to acute triptan therapy

OR

        1. The patient has an FDA labeled contraindication to ALL acute triptan agents

AND

      1. The patient will NOT be using the requested agent in combination with another acute migraine agent (i.e., triptan, 5HT-1F, ergotamine, acute CGRP)

AND

      1. Medication overuse headache has been ruled out

OR

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

OR

    1. 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. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

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

AND

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

OR

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

AND

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

AND

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

AND

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

AND

      1. The patient has >4 migraine headaches per month AND ONE of the following:
        1. The patient is currently being treated with a migraine prophylactic medication (i.e. anticonvulsants [divalproex, valproate, topiramate], beta blockers [i.e. atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [i.e. amitriptyline, venlafaxine], candesartan, prophylactic CGRP [e.g. Aimovig, Ajovy, Emgality, Vyepti], onabotulinum toxin A [Botox])

OR

        1. The patient has an intolerance or hypersensitivity to therapy with anticonvulsants, beta blockers, antidepressants, candesartan, prophylactic CGRP, AND onabotulinum toxin A

OR

        1. The patient has an FDA labeled contraindication to ALL anticonvulsants, beta blockers, antidepressants, candesartan, prophylactic CGRP, AND onabotulinum toxin A

OR

        1. The prescriber has provided information that the patient’s migraine is manageable with acute therapy alone

AND

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

Length of Approval: 12 months

Renewal Evaluation

Target Agent(s) 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

  1. ONE of the following:
    1. The requested agent is being used for acute migraine treatment AND ALL of the following:
      1. The prescriber has provided information indicating improvement in acute migraine management with the requested agent

AND

      1. The patient will NOT be using the requested agent in combination with another acute migraine agent (i.e., triptan, 5HT-1F, ergotamine, acute CGRP)

AND

      1. Medication overuse headache has been ruled out

OR

    1. BOTH of the of the following:
      1. The patient has another FDA approved indication, or the patient has another indication that is supported in compendia (AHFS, or DrugDex 1 or 2a level of evidence) for the requested agent

AND

      1. The patient has received benefit from the requested agent

AND

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

AND

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

OR

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

AND

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

AND

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

AND

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

AND

      1. The patient has >4 migraine headaches per month AND ONE of the following:
        1. The patient is currently being treated with a migraine prophylactic medication (i.e. anticonvulsants [divalproex, valproate, topiramate], beta blockers [i.e. atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [i.e. amitriptyline, venlafaxine], candesartan, prophylactic CGRP [e.g. Aimovig, Ajovy, Emgality, Vyepti], onabotulinum toxin A [Botox])

OR

        1. The patient has an intolerance or hypersensitivity to therapy with anticonvulsants, beta blockers, antidepressants, candesartan, prophylactic CGRP, AND onabotulinum toxin A

OR

        1. The patient has an FDA labeled contraindication to ALL anticonvulsants, beta blockers, antidepressants, candesartan, prophylactic CGRP, AND onabotulinum toxin A

OR

        1. The prescriber has provided information that the patient’s migraine is manageable with acute therapy alone

AND

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

Length of Approval:  12 months

FDA APPROVED INDICATIONS AND DOSAGE1-3

Agent(s)

Indication(s)

Dosage

Reyvow®

(lasmiditan)

Tablet

Acute treatment of migraine with or without aura in adults

Recommended dose is 50 mg, 100 mg, or 200 mg taken orally as needed

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

Nurtec ODT™

(rimegepant)

Orally disintegrating tablet

Acute treatment of migraine with or without aura in adults

Recommended dose is 75 mg taken orally

The maximum dose in a 24-hour period is 75 mg.

The safety of treating more than 15 migraines in a 30-day period has not been established.

Ubrelvy™

(ubrogepant)

Tablet

Acute treatment of migraine with or without aura in adults

Recommended dose is 50 or 100 mg taken orally

If needed, a second dose may be administered at least 2 hours after the initial dose

Maximum dose in a 24-hour period is 200 mg

The safety of treating more than 8 migraines in a 30-day period has not been established

CLINICAL RATIONALE

Migraines

The diagnostic criteria for chronic migraine requires the inclusion of all of the following:5

  1. Headache (migraine-like or tension-like) on ≥15 days per month for >3 months and fulfilling criteria B and C
  2. Occurring in a patient who has had at least five attacks fulfilling of migraine without aura and/or migraine with aura
  3. On ≥8 days per month for >3 months, fulfilling any of the following:
    1. Migraine without aura
    2. Migraine with aura
    3. Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative
  4. Not better accounted for by another ICHD-3 diagnosis.

Migraine prevention may be of benefit in those with the following:4,6,7

  • Frequent or long-lasting migraine headaches (>4 headaches/month or headaches lasting >12 hours)
  • Migraine attacks that cause significant disability or diminished quality of life despite appropriate acute treatment
  • Contraindication to acute therapies
  • Failure of acute therapies
  • Serious adverse effects of acute therapies
  • Risk of medication overuse headache
  • Menstrual migraine

The American Headache Society (AHS) also includes patient preference as a consideration.7

The American Headache Society (AHS) and the American Academy of Neurology (AAN) suggest the following agents for the prevention of migraine:4

  • Established as effective (Level A)
    • Antiepileptic drugs (AEDs)
      • Divalproex
      • Valproate
      • Topiramate
    • Beta blockers
      • Metoprolol
      • Propranolol
      • Timolol
    • Triptans
      • Frovatriptan for short term menstrually associated migraines (MAMs) prevention
  • Probably effective (Level B)
    • Antidepressants
      • Amitriptyline
      • Venlafaxine
    • Beta blockers
      • Atenolol
      • Nadolol
    • Triptans
      • Naratriptan, zolmitriptan for short term MAMs prevention

The 2018 American Headache Society Consensus Statement recommends the following indications for initiating treatment with a Calcitonin Gene-Related Peptide (CGRP) agent:7

  • Prescribed by a licensed medical professional
  • Patient is at least 18 years of age
  • ONE of the following:
    • Diagnosis of migraine with or without aura (4-7 monthly headache days) and both of the following:
      • Inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following:
        • Topiramate
        • Divalproex sodium/valproate sodium
        • Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol
        • Tricyclic antidepressant: amitriptyline, nortriptyline
        • Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine
        • Other Level A or B treatment according to AAN-AHS guideline
      • At least moderate disability (Migraine Disability Assessment Questionnaire [MIDAS] >11, Headache Impact Test-6 [HIT]-6 >50)
    • Diagnosis of migraine with or without aura (8-14 monthly headache days) and inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following:
        • Topiramate
        • Divalproex sodium/valproate sodium
        • Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol
        • Tricyclic antidepressant: amitriptyline, nortriptyline
        • Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine
        • Other Level A or B treatment according to AAN-AHS guideline
    • Diagnosis of chronic migraine and one of the following:
      • Inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following:
        • Topiramate
        • Divalproex sodium/valproate sodium
        • Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol
        • Tricyclic antidepressant: amitriptyline, nortriptyline
        • Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine
        • Other Level A or B treatment according to AAN-AHS guideline
      • Inability to tolerate or inadequate response to a minimum of 2 quarterly injection (6 months) of onabotulinum toxin A

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.8

The European Headache Federation and WHO consensus article (2019) states the following:9

  • Individuals with migraine headaches should almost always be managed in primary care. The exception being chronic migraine, which likely requires specialist management.
  • Any headache not responding satisfactorily in primary care should be referred to a specialist
  • In adults and children, regular high frequency use (>2 day/week) of acute medication risks the development of medication-overuse headache
  • Treatment of episodic acute migraine headaches should be approached in a step wise manner and should treat three attacks at each step before moving to the next step if needed:
    • Step 1:
      • Use non-opioid analgesics, plus an antiemetic when needed.
    • Step 2 for adults:
      • Use triptan products.
      • Triptans should not be used regularly on ≥10 days/month to avoid the risk of medication overuse headaches.
      • Triptan efficacy is highly variable between individuals, so patients should try different triptans and formulations. Sumatriptan subcutaneous injection should be considered when all other triptans are ineffective.
      • When nausea is present, zolmitriptan nasal spray or sumatriptan subcutaneous injection may be preferred.
    • Step 2 for children and adolescents:
      • Failure of Step 1 in children should lead to specialist referral.  No specific anti-migraine drugs have shown efficacy in children under 12 years of age
      • Failure of Step 2 in adolescents (12-17 years of age), the following have shown efficacy and are approved:
        • Sumatriptan nasal spray
        • Zolmitriptan nasal spray
  • For episodic migraine prophylaxis:
    • Indication for migraine prophylaxis include:
      • Attacks cause disability on two or more days per month
      • And acute therapy has been optimized but does not prevent this, or is poorly tolerated, or there is a risk of over-frequent use of acute therapy, even when it is effective
      • And the patient is willing to take daily medication
      • Failure of acute therapy is an indication for migraine prophylaxis
      • For children: frequent absence from school
    • Migraine prophylaxis agents may take 2-3 months to show efficacy.
    • Children requiring prophylactic medication should be referred to a specialist.
    • Medications which are effective in adult prophylaxis of episodic migraine include:
      • Beta blockers:
        • Atenolol, bisoprolol, metoprolol, propranolol
      • Amitriptyline
      • Topiramate
      • Candesartan
      • Sodium valproate
      • Flunarizine
      • CGRP
    • Onabotulinum toxin A is not effective in episodic migraine.
    • When prophylaxis therapy fails:
      • Failure may be due to subtherapeutic dosage or duration of therapy.
      • Failure of one therapy does not predict the failure of another therapy.
      • Review of the following are recommended:
        • Diagnosis
        • Adherence
        • Other medications, especially for medication overuse headache causes
      • The prophylaxis therapy should be discontinued if it fails to show clear benefit.
      • If all prophylaxis therapies fail, a specialist should be referred.
  • Chronic migraine management:
    • Chronic migraine patients should be referred to a specialist.
    • Medications with efficacy in chronic migraine include:
      • Topiramate
      • Onabotulinum A
      • CGRP

The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:10

  • In episodic migraine, it’s suggested to stop oral prophylaxis migraine agents before starting CGRPs, unless the patient previously had chronic migraine prior to prophylaxis.  In such patients, the suggestion is to add CGRP to the ongoing oral prophylaxis therapy.
  • In chronic migraine, it’s suggested to add CGRP to ongoing oral prophylaxis therapy.
  • In chronic migraine patients on onabotulinum A therapy and are receiving inadequate treatment response, it’s suggested to stop onabotulinum A therapy before starting CGRPs.
  • In patients with chronic migraine who are on treatment with CGRP and may benefit from additional prevention, it’s suggested to add on oral preventative agents.
  • In patients with medication overuse, it’s suggested to use CGRPs before or after withdrawal of acute medications

Medication overuse headache (MOH)

The European Headache Federation and WHO consensus article (2019) states the following:9

    • Prevention is preferred.
    • The four objectives of management are:
      • Stop the overused medication.
      • Recovery from MOH.
      • Review and reassess the underlying headache disorder
      • Prevent relapse while allowing acceptable use of medications
    • Comorbidities may also require management

Safety

Ubrogepant is contraindicated in concomitant use with strong CYP3A4 inhibitors.1

Rimegepant is contraindicated in patients with a history of hypersensitivity reaction to rimegepant or to any of its components.2

Lasmiditan carries no contraindications or black box warnings.3

REFERENCES:

  1. Ubrelvy prescribing information. Allergan USA, Inc. June 2020.
  2. Nurtec prescribing information. Biohaven Pharma Holdings Co, LTD. March 2020.
  3. Reyvow prescribing information. Eli Lilly and Co. December 2020.
  4. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337.
  5. ICHD-3 Classification. International Headache Society. 2018. Accessed 01/08/2021
  6. Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. September 26, 2000; 55 (6)
  7. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. American Headache Society. 12/10/2018. Available at https://onlinelibrary.wiley.com/doi/10.1111/head.13456.  Accessed 01/08/2021.
  8. 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.
  9. Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition). Journal of Headache and Pain. (2019) 20:57.
  10. Sacco S, Bendtsen L, Ashina M, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain. (2019) 20:6.

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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