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Calcitonin Gene-Related Peptide (CGRP) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91033

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

POLICY REVIEW CYCLE

Effective Date

Date of Origin   

07-01-2025           

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Aimovig® 

(erenumab-aooe)

Subcutaneous SureClick® prefilled autoinjector

Subcutaneous prefilled syringe

Preventive treatment of migraine in adults

1

AJOVY®

(fremanezumab-vfrm)

Subcutaneous prefilled autoinjector

Subcutaneous prefilled syringe

Preventive treatment of migraine in adults

2

Emgality®  

(galcanezumab-gnlm)

Subcutaneous prefilled pen

Subcutaneous prefilled syringe

Preventive treatment of migraine in adults

Treatment of episodic cluster headache in adults

3

Nurtec ODT® 

(rimegepant sulfate)

Orally disintegrating tablet

Acute treatment of migraine with or without aura in adults

Preventive treatment of episodic migraine in adults

8

QULIPTA®

(atogepant)

Tablet

Preventive treatment of migraine in adults

21

UBRELVY® 

(ubrogepant) 

Tablet

Acute treatment of migraine with or without aura in adults

Limitations of Use: UBRELVY is not indicated for the preventive treatment of migraine. 

9

Zavzpret™

(zavegepant)

Nasal spray

Acute treatment of migraine with or without aura in adults

Limitations of Use: Zavzpret is not indicated for the preventive treatment of migraine. 

18

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Migraine and Cluster Headache Management

Migraine is a common disabling primary headache disorder with high prevalence, ranking second globally in terms of years lost to disability.(22) Typical characteristics of the headache are unilateral location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity, and association with nausea and/or photophobia and phonophobia. Migraines can present with or without aura, unilateral fully reversible visual, sensory, or other central nervous system symptoms that usually develop gradually and are most-often followed by headache and associated migraine symptoms.(5)

The International Classification of Headache Disorders 3rd Edition (ICHD-3) Diagnostic Criteria:(5)

Indication

Diagnostic Criteria

Migraine without aura
  1. At least five attacks fulfilling criteria B-D
  2. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  3. Headache has at least TWO of the following: 
    1. unilateral location
    2. pulsating quality 
    3. moderate to severe pain intensity
    4. aggravation by causing avoidance of routine physical activity 
  4. During headache at least ONE of the following:
    1. nausea and/or vomiting
    2. photophobia and phonophobia
  5. Not better accounted for by another ICHD-3 diagnosis 

Migraine with aura
  1. At least two attacks fulfilling criteria B and C
  2. One or more of the following fully reversible aura symptoms: 
    1. visual 
    2. sensory 
    3. speech and/or language
    4. motor
    5. brainstem
    6. retinal
  3. At least THREE of the following: 
    1. at least one aura symptom spreads gradually over 5 minutes or more
    2. two or more aura symptoms occur in succession 
    3. each individual aura symptom lasts 5-60 minutes
    4. at least one aura symptom is unilateral 
    5. at least one aura symptom is positive
    6. the aura is accompanied, or followed within 60 minutes, by headache
  4. Not better accounted for by another ICHD-3 diagnosis

Chronic Migraine
  1. Headache (migraine-like or tension-type-like) on greater than or equal to 15 days/month for greater than 3 months AND fulfilling B and C
  2. Occurring in patient who has had at least 5 attacks fulfilling
    1. criteria B-D for migraine without aura (noted above) and/or
    2. criteria B and C for migraine with aura (noted above)
  3. On greater than or equal to 8 days/month for greater than 3 months, fulfilling any of the following: 
    1. criteria C and D for migraine without aura (noted above)
    2. criteria B and C for migraine with aura (noted above) 
    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

Cluster Headache
  1. At least 5 attacks fulfilling criteria B-D
  2. Severe to very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes (untreated)
  3. At least one of the following: 
    1. At least one of the following signs or symptoms, ipsilateral to the headache
      1. conjunctival injection and/or lacrimation
      2. nasal congestion and/or rhinorrhea 
      3. eyelid edema
      4. forehead and facial sweating
      5. miosis and/or ptosis
    2. Sense of restlessness or agitation
  4. Occurring with frequency between one every other day and 8 per day
  5. Not better accounted for by another ICHD-3 diagnosis

Episodic Cluster Headache
  1. Attacks fulfilling criteria for Cluster Headache (noted above) occurring in bouts (cluster periods)
  2. At least two cluster periods lasting 7 days to 1 years (untreated) and separated by pain-free remission periods of at least 3 months

Migraine Prevention:

The American Headache Society (AHS) position statement update (2024) states that based on ICDH-3, for those with episodic migraine (4-14 monthly migraine days) or chronic migraine (greater than or equal to 15 headache days/month), CGRP-targeting therapies should be considered a first-line migraine prevention treatment option. The guideline states that initiation of CGRP-targeting therapies should not require the prior failure of other migraine preventative drug classes. CGRP-targeting therapies are "migraine-specific" compared to other established preventative therapies. Cumulative evidence supports better efficacy, safety, and tolerability compared to any established first-line migraine prevention therapy. In addition, most CGRP-targeting therapies are labeled for episodic and chronic migraine which aids in decision making if patients spontaneously fluctuate from episodic to chronic migraine.(6) Injectable treatments (i.e., onabotulinumtoxin A, CGRP) should be evaluated at 4, 8, and 12 weeks after treatment initiation. There is data to support continued improvement beyond 3 months. An adequate trial should be assessed at 3 months for monthly administered CGRPs and 6 months for quarterly treatments. Oral treatments should be used for a minimum of 8 weeks and cumulative benefits should occur within 6-12 months of continued use.(22)

AHS Guidelines:(6)

Diagnosis 

Treatments to consider: 

Episodic migraine with or without aura (4-14 MMDs) based upon ICHD-3
  • Topiramate
  • Divalproex sodium/valproate sodium
  • Beta-blocker: metoprolol, propranolol, timolol, atenolol, nadolol
  • Candesartan
  • Tricyclic antidepressant: amitriptyline, nortriptyline
  • SNRI: venlafaxine, duloxetine
  • Other Level A or B treatments according to AAN for classification of evidence
  • CGRP: erenumab, fremanezumab, galcanezumab, eptinezumab
  • Gepants: atogepant, rimegepant

Chronic migraine with or without aura (greater than or equal to 15 MHDs) based on ICHD-3
  • Topiramate
  • Divalproex sodium/valproate sodium
  • Beta-blocker: metoprolol, propranolol, timolol, atenolol, nadolol
  • Candesartan
  • Tricyclic antidepressant: amitriptyline, nortriptyline
  • SNRI: venlafaxine, duloxetine
  • Other Level A or B treatments according to AAN for classification of evidence
  • Onabotulinumtoxin A
  • CGRP: erenumab, fremanezumab, galcanezumab, eptinezumab
  • Gepants: atogepant, rimegepant

The European Headache Federation and WHO consensus article (2019) states the following for episodic migraine prophylaxis:(13)

  • 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
    • Patient is willing to take daily medication
    • Failure of acute therapy is an indication for migraine prophylaxis
    • For children, frequent absence from school is an additional indication for prophylaxis
  • Migraine prophylaxis agents may take 2-3 months to show efficacy
  • Onabotulinumtoxin A is not effective in episodic migraine and not recommended
  • When prophylaxis therapy fails:
    • May be due to subtherapeutic dosage or duration of therapy
    • Failure of one therapy does not predict the failure of another therapy in a different class
    • Review of the following are recommended:
      • Diagnosis
      • Adherence
      • Other medications, especially for MOH causes
    • The prophylaxis therapy should be discontinued if it fails to show clear benefit
    • If all prophylaxis therapies fail, a specialist should be referred

Acute Migraine Treatment:

The AHS guidelines recommend the following indications for initiating treatment acute treatment with gepants and ditans agents:(22)

  • Prescribed by a licensed clinician
  • Patient is at least 18 years of age
  • Diagnosis of ICHD-3 migraine with aura, migraine without aura, or chronic migraine
  • Either of the following: 
    • Contraindication to or inability to tolerate triptans
    • Inadequate response to two or more oral triptans, as determined by either of the following: 
      • Validated acute treatment patient-reported outcoming questionnaire:
        • Migraine Functional Impact Questionnaire (mTOQ)
        • Migraine Assessment of Current Therapy (Migraine-ACT)
        • Patient Perception of Migraine Questionnaire-Revised (PPMQ-R)
        • Functional Impairment Scale (FIS)
        • Patient Global Impression of Change (PGIC)
      • Clinician attestation
  • At least three attacks should be treated to evaluate response and assess clinical improvement

The European Headache Federation and WHO consensus article (2019) states the following regarding the treatment of acute migraine headaches:(13)

  • Treatment 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 for 10 or more days per month to avoid the risk of MOH
      • 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 vomiting 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

The Medical Letter Treatment Guidelines (2023) state that a triptan is the drug of choice for moderate to severe migraine. The short-acting oral serotonin (5-HT1B/1D) receptor agonists (triptans) sumatriptan (IMITREX, and others), almotriptan (Axert, and generics), eletriptan (RELPAX), rizatriptan (Maxalt, and generics), and zolmitriptan (Zomig, and generics) are similar in efficacy. Onset of pain relief generally occurs 30-60 minutes after administration. The longer-acting oral triptans naratriptan (Amerge, and generics) and frovatriptan (Frova, and generics) have a slower onset of action and lower initial response rate than other triptans, but they are better tolerated. Patients with migraine who have nausea or vomiting may not be able to take an oral triptan. Intranasal triptan formulations have a more rapid onset of action than oral tablets, but their efficacy is partially dependent on GI absorption of the portion of the dose that is swallowed. Use of sumatriptan nasal powder (ONZETRA Xsail) results in a faster rise in sumatriptan plasma concentrations and higher peak concentrations than use of a similar dose of sumatriptan nasal spray, suggesting that a larger portion of the dose is absorbed intranasally with the powder. Subcutaneously administered sumatriptan relieves pain faster (in about 10 minutes) and more effectively than other triptan formulations, but it causes more adverse effects.(20)

AHS (2018, updated 2021): Triptans are effective (Level A) and considered by AHS guidelines to be the gold standard for acute treatment of moderate to severe migraine headaches. Dihydroergotamine is recommended for use as a second- or third-line therapy for select patients or for those with refractory migraine. Intranasal dihydroergotamine has strong evidence of effectiveness but more adverse effects than triptans because of its decreased receptor specificity. An assessment of new migraine treatments by the AHS lists triptans, dihydroergotamine, the oral gepants (Nurtec ODT [rimegepant] and UBRELVY [ubrogepant]), and REYVOW (lasmiditan) as effective treatment of moderate or severe acute attacks and mild to moderate attacks that respond poorly to non-specific nonsteroidal anti-inflammatory drugs (NSAIDs), non-opioid analgesics, acetaminophen, or caffeinated combinations (e.g., aspirin/acetaminophen/caffeine).(22)

Cluster Headache:

Cluster headache (CH) is the most common primary headache disorder and considered the most severe due to extreme pain, autonomic symptoms and high frequency of attacks.(19) The International Headache Society (IHS) notes that cluster periods usually last between 2 weeks and 3 months.(5)

The American Academy of Neurology (AAN) Guidelines (2010, re-reviewed 2016): For acute treatment, sumatriptan subcutaneous, zolmitriptan nasal spray, and high flow oxygen remain the treatments with a Level A recommendation. For transitional and prophylactic therapy, suboccipital steroid injections is the only treatment with a Level A recommendation. Verapamil is the prophylactic therapy of choice, and because suboccipital corticosteroid injections are typically used for transitional prophylaxis, lithium and verapamil have the highest evidence among preventative therapies. Oral corticosteroids are commonly used for transitional prophylaxis and considered first or second line. Melatonin is another prophylactic treatment with favorable adverse effect profile.(19) 

The European Academy of Neurology Guidelines (2023): For the acute treatment of CH attacks, high flow oxygen and 6mg subcutaneous sumatriptan are still highly recommended. For prophylaxis of CH, verapamil at a daily dose of at least 240 mg (or maximum dose based on efficacy and tolerability) is recommended. Corticosteroids show efficacy for cluster headache while lithium, topiramate, and galcanezumab (only for episodic cluster headache) are recommended as alternative treatment options.(4)

The European Headache Federation and WHO consensus article (2019) states the following for CH management:(13)

  • Cluster Headache management: 
    • Acute therapies include: 
      • Triptans: 
        • Sumatriptan subcutaneous injection
        • Sumatriptan nasal spray
        • Zolmitriptan nasal spray
      • Oxygen
    • Transition and maintenance therapies include: 
      • Prednisone
      • Greater occipital nerve blockade
      • Verapamil
      • Lithium carbonate
      • Topiramate 
    • Neuromodulation is another treatment option
    • Failure of one prophylactic therapy does not predict the failure of other therapies
    • Combination prophylaxis therapy can be considered though the potential for toxicity is high
    • Long-term prophylaxis therapy may need to be continued

Combination of therapies: 

  • Migraine Prophylaxis Therapies: 
    • The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(14)
      • In episodic migraine, guidelines suggest 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, guidelines suggest to add CGRP to ongoing oral prophylaxis therapy
      • In chronic migraine patients on onabotulinumtoxin A therapy and are receiving inadequate treatment response, guidelines suggest to stop onabotulinumtoxin A therapy before starting CGRPs
      • In patients with chronic migraine who are on treatment with CGRP and may benefit from additional prevention, guidelines suggest to add on oral preventative agents
      • In patients with medication overuse, guidelines suggest to use CGRPs before or after withdrawal of acute medications
    • The clinical trials referenced in FDA labeled package inserts for the preventative CGRP agents excluded patients that had received botulinum toxin within 4 months prior to receiving the CGRP agent.(15,16,17) However, the 2021 AHS consensus statement states that CGRP monoclonal antibody treatment (e.g., eptinezumab-jjmr, erenumab, fremanezumab, galcanezumab) may be added to greater than or equal to one established preventative treatment, based on clinical judgement, in adults who meet the ICHD-3 criteria for migraines.(5,22)
  • Acute Use Therapies: 
    • Literature supports the use of gepants and triptans in combination for acute migraine therapy. All studies showed co-administration of these medications were well tolerated with a favorable safety profile.
      • Ubrogepant when co-administered with sumatriptan showed healthy patients tolerated these medications well and the slight alterations in pharmacokinetic parameters had minimal clinical relevance. Pooled Phase 3 ACHIEVE trials safety assessment supported use of optional second dose of a rescue medication for the treatment of moderate to severe headache starting 2-48 hours after initial dose of study medication. Rescue medication included triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan). Overall frequency of treatment-related adverse effects was similar among patients that took ubrogepant along with patients that took ubrogepant and a triptan rescue medication.(10)
      • Concomitant administration of oral rimegepant and subcutaneous sumatriptan in healthy adults showed no hemodynamic or pharmacokinetic interactions suggesting it is safe and well tolerated.(11)
      • The pharmacokinetic and pharmacodynamic interactions between zavegepant and triptans in healthy adults showed no statistically significant difference when co-administered compared to sumatriptan alone.(7)
    • Lasmiditan with a triptan or gepant used in combination is not recommended(20,22)
    • Triptans and ergots used in combination is contraindicated(20)
    • The safety, tolerability, and efficacy of co-administering of the following agents has not been assessed or supported in literature:
      • Two acute use CGRPs
      • Acute use CGRP with ergotamine

Medication overuse headache (MOH)

The European Headache Federation and WHO consensus article (2019) states the following:(13)

  • In adults and children, regular high frequency use (greater than 2 day/week) of acute medication risks the development of MOH
  • 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 require management

Safety

Atogepant is contraindicated in patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA.(21)

Erenumab-aooe is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients.(1)

Fremanezumab-vfrm is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm to any of the excipients.(2)

Galcanezumab-gnlm is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm to any of the excipients.(3)

Rimegepant is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, Nurtec ODT, or to any of its components.(8)

Ubrogepant is contraindicated in the following:(9)

  • Concomitant use with strong CYP3A4 inhibitors
  • History of serious hypersensitivity to ubrogepant or any components of UBRELVY

Zavegepant is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or to any of the components of Zavzpret.(18)

REFERENCES

Number

Reference

1

Aimovig prescribing information. Amgen Inc. August 2024.

2

AJOVY prescribing information. Teva Pharmaceuticals USA, Inc. October 2022.

3

Emgality prescribing information. Eli Lilly and Company. March 2021.

4

May A, Evers S, Goadsby PJ, et al. European Academy of Neurology guidelines on the treatment of cluster headache. European Journal of Neurology. 2023;30(10):2955-2979. doi:10.1111/ene.15956

5

Gobel H. The International Classification of Headache Disorders - ICHD-3. ICHD-3. https://ichd-3.org/

6

Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache the Journal of Head and Face Pain. 2024;64(4):333-341. doi:10.1111/head.14692

7

Bhardwaj R, Donohue MK, Madonia J, et al. Assessment of pharmacokinetic and pharmacodynamic interactions between zavegepant and sumatriptan: A phase 1, randomized, placebo-controlled study in healthy adults. Headache the Journal of Head and Face Pain. Published online October 4, 2024. doi:10.1111/head.14853

8

Nurtec ODT prescribing information. Pfizer Laboratories Div Pfizer Inc. April 2023.

9

UBRELVY prescribing information. Allergan, Inc. June 2023.

10

Jakate A, Boinpally R, Butler M, Lu K, McGeeney D, Periclou A. Evaluation of the pharmacokinetic interaction of ubrogepant coadministered with sumatriptan and of the safety of ubrogepant with triptans. Headache the Journal of Head and Face Pain. 2020;60(7):1340-1350. doi:10.1111/head.13862

11

Croop R, Ivans A, Anderson MS, et al. A phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults. Cephalalgia Reports. 2021;4:251581632110079. doi:10.1177/25158163211007922

12

Reference no longer used.

13

Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition). The Journal of Headache and Pain. 2019;20(1). doi:10.1186/s10194-018-0899-2

14

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. https://doi.org/10.1186/s10194-018-0955-y

15

Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomized, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2

16

Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640

17

Lipton RB, Cohen JM, Gandhi SK, Yang R, Yeung PP, Buse DC. Effect of fremanezumab on quality of life and productivity in patients with chronic migraine. Neurology. 2020 Aug 18;95(7):e878-e888. doi: 10.1212/WNL.0000000000010000 

18

Zavzpret prescribing information. Pfizer Laboratories Div Pfizer Inc. March 2023.

19

Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of Cluster Headache: The American Headache Society Evidence‐Based Guidelines. Headache the Journal of Head and Face Pain. 2016;56(7):1093-1106. doi:10.1111/head.12866

20

Drugs for Migraine. Med Lett Drugs Ther. 2023 Jun 12; 65(1678):89-96. doi:10.58347/tml.2023.1678a

21

QUILIPTA prescribing information. AbbVie Inc. June 2023.

22

Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache the Journal of Head and Face Pain. 2021;61(7):1021-1039. doi:10.1111/head.14153

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Qulipta

atogepant tab

10 MG ; 30 MG ; 60 MG

M ; N ; O ; Y

N

Aimovig

erenumab-aooe subcutaneous soln auto-injector

140 MG/ML ; 70 MG/ML

M ; N ; O ; Y

N

Ajovy

fremanezumab-vfrm subcutaneous soln auto-inj

225 MG/1.5ML

M ; N ; O ; Y

N

Ajovy

fremanezumab-vfrm subcutaneous soln pref syr

225 MG/1.5ML

M ; N ; O ; Y

N

Emgality

galcanezumab-gnlm subcutaneous soln auto-injector

120 MG/ML

M ; N ; O ; Y

N

Emgality

galcanezumab-gnlm subcutaneous soln prefilled syr

100 MG/ML ; 120 MG/ML

M ; N ; O ; Y

N

Nurtec

rimegepant sulfate tab disint

75 MG

M ; N ; O ; Y

N

Ubrelvy

ubrogepant tab

100 MG ; 50 MG

M ; N ; O ; Y

N

Zavzpret

zavegepant hcl nasal spray

10 MG/ACT

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Nurtec

Rimegepant Sulfate Tab Disint 75 MG

75 MG

16

Tablets

30

DAYS

Qulipta

Atogepant Tab

10 MG

30

Tablets

30

DAYS

Qulipta

Atogepant Tab

30 MG

30

Tablets

30

DAYS

Qulipta

Atogepant Tab

60 MG

30

Tablets

30

DAYS

Ubrelvy

Ubrogepant Tab 100 MG

100 MG

16

Tablets

30

DAYS

Ubrelvy

Ubrogepant Tab 50 MG

50 MG

16

Tablets

30

DAYS

Zavzpret

zavegepant hcl nasal spray

10 MG/ACT

8

Devices

30

DAYS

Aimovig

Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML

140 MG/ML

1

Injection Device

28

DAYS

Aimovig

Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML

70 MG/ML

1

Injection Device

28

DAYS

Emgality

Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML

120 MG/ML

1

Injection Device

28

DAYS

Emgality

Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML

100 MG/ML

9

Syringes

180

DAYS

Emgality

Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML

120 MG/ML

1

Syringe

28

DAYS

Ajovy

Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML

225 MG/1.5ML

3

Injection Devices

84

DAYS

Ajovy

Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML

225 MG/1.5ML

3

Syringes

84

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Aimovig

erenumab-aooe subcutaneous soln auto-injector

140 MG/ML ; 70 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ajovy

fremanezumab-vfrm subcutaneous soln auto-inj

225 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ajovy

fremanezumab-vfrm subcutaneous soln pref syr

225 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Emgality

galcanezumab-gnlm subcutaneous soln auto-injector

120 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Emgality

galcanezumab-gnlm subcutaneous soln prefilled syr

100 MG/ML ; 120 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Nurtec

rimegepant sulfate tab disint

75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qulipta

atogepant tab

10 MG ; 30 MG ; 60 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ubrelvy

ubrogepant tab

100 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zavzpret

zavegepant hcl nasal spray

10 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Nurtec

Rimegepant Sulfate Tab Disint 75 MG

75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qulipta

Atogepant Tab

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qulipta

Atogepant Tab

30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qulipta

Atogepant Tab

60 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ubrelvy

Ubrogepant Tab 100 MG

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ubrelvy

Ubrogepant Tab 50 MG

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Zavzpret

zavegepant hcl nasal spray

10 MG/ACT

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Aimovig

Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML

140 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Aimovig

Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML

70 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Emgality

Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML

120 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Emgality

Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML

100 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Emgality

Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML

120 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ajovy

Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML

225 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ajovy

Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML

225 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Indication

Preferred Target Agent(s)

Non-Preferred Target Agent(s)

Stand-Alone Target Agent(s)

Chronic Migraine Prophylaxis

Aimovig, AJOVY, Emgality, QULIPTA

 

 

Episodic Migraine Prophylaxis

Aimovig, AJOVY, Emgality, Nurtec ODT, QULIPTA

 

 

Episodic Cluster Headaches

Emgality

 

 

Acute Migraine Treatment

Nurtec ODT, UBRELVY

 

Zavzpret

Initial Evaluation

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

  1. ONE of the following:
    1. The requested agent is being used for migraine prophylaxis AND BOTH of the following:
      1. ONE of the following:
        1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

Aimovig
AJOVY
Emgality
Nurtec ODT
QULIPTA
          1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR 
          2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
        2. ALL of the following:
          1. ONE of the following:
            1. The patient has had at least 15 headache days per month of migraine-like or tension-like headache for a minimum of 3 months (chronic migraine) AND BOTH of the following:
              1. The patient has had at least 8 migraine headache days per month for a minimum of 3 months AND
              2. The requested agent and strength are FDA labeled for chronic migraine prophylaxis OR
            2. BOTH of the following:
              1. The patient has 4-14 monthly migraine days (episodic migraine) AND
              2. The requested agent and strength are FDA labeled for episodic migraine prophylaxis AND
          2. If the client has a preferred agent(s), then ONE of the following:
            1. The requested agent is a preferred agent or a stand-alone agent for the requested indication OR
            2. The patient has ONE of the following:
              1. Has tried and had an inadequate response to ONE preferred agent for the requested indication OR
              2. Has an intolerance or hypersensitivity to ONE preferred agent for the requested indication OR
            3. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication AND
          3. Medication overuse headache has been ruled out AND
      2. The patient will NOT be using the requested agent in combination with another prophylactic use CGRP OR
    2. The requested agent is being used for the treatment of episodic cluster headache AND ALL of the following:
      1. The patient has had at least 5 cluster headache attacks AND
      2. The patient has at least two cluster periods lasting 7-365 days AND
      3. The patient’s cluster periods are separated by a pain-free remission period of greater than or equal to 3 months AND
      4. ONE of the following:
        1. The patient has ONE of the following:
          1. Has tried and had an inadequate response to ONE prerequisite agent (i.e., verapamil, melatonin, corticosteroids, topiramate, lithium) OR
          2. Has had an intolerance or hypersensitivity to ONE prerequisite agent (i.e., verapamil, melatonin, corticosteroids, topiramate, lithium) OR
        2. The patient has an FDA labeled contraindication to ALL prerequisite agent(s) (i.e., verapamil, melatonin, corticosteroids, topiramate, lithium) AND
      5. The requested agent and strength are FDA labeled for episodic cluster headache treatment AND
      6. Medication overuse headache has been ruled out OR
    3. The requested agent is being used for acute migraine treatment AND ALL of the following:
      1. ONE of the following:
        1. The patient has ONE of the following:
          1. Has tried and had an inadequate response to ONE triptan agent OR
          2. Has had an intolerance or hypersensitivity to ONE triptan agent OR
        2. The patient has an FDA labeled contraindication to ALL triptan agent(s) AND
      2. The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., 5HT-1F, acute use CGRP, ergotamine) for the requested indication AND 
      3. If the client has a preferred agent(s), then ONE of the following:
        1. The requested agent is a preferred agent or a stand-alone agent for the requested indication OR
        2. The patient has ONE of the following:
          1. Has tried and had an inadequate response to ONE preferred agent for the requested indication OR
          2. Has an intolerance or hypersensitivity to ONE preferred agent for the requested indication OR
        3. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication AND
      4. The requested agent and strength are FDA labeled for acute migraine treatment AND
      5. Medication overuse headache has been ruled out OR
    4. The patient has another FDA labeled indication for the requested agent and route of administration OR
    5. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  2. If the patient has an FDA labeled indication, then ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. There is support for using the requested agent for the patient’s age for the requested indication AND
  3. The patient does not have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval: Migraine prophylaxis - 6 months; all other indications - 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

 

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 [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
  2. ONE of the following:
    1. BOTH of the following:
      1. ONE of the following:
        1. The requested agent is being used for migraine prophylaxis AND ALL of the following:
          1. The patient has had clinical benefit with the requested agent AND
          2. The patient will NOT be using the requested agent in combination with another prophylactic use CGRP AND
          3. ONE of the following:
            1. BOTH of the following:
              1. The patient has a diagnosis of chronic migraine (defined as at least 15 headache days per month of migraine-like or tension-like headache for a minimum of 3 months prior to migraine prevention therapy) AND
              2. The requested agent and strength are FDA labeled for chronic migraine OR
            2. BOTH of the following:
              1. The patient has a diagnosis of episodic migraine (defined as 4-14 monthly migraine days prior to migraine prevention therapy) AND
              2. The requested agent and strength are FDA labeled for episodic migraine OR
        2. The requested agent is being used for episodic cluster headache treatment AND BOTH of the following:
          1. The patient has had clinical benefit with the requested agent AND
          2. The requested agent and strength are FDA labeled for episodic cluster headache treatment OR
        3. The requested agent is being used for acute migraine treatment AND ALL of the following:
          1. The patient has had clinical benefit with the requested agent AND
          2. The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., 5HT-1F, acute use CGRP, ergotamine) for the requested indication AND
          3. The requested agent and strength are FDA labeled for acute migraine treatment AND
      2. Medication overuse headache has been ruled out OR
    2. The patient has a diagnosis other than migraine prophylaxis, episodic cluster headache treatment, or acute migraine treatment AND has had clinical benefit with the requested agent AND
  3. The patient does not have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity limit for Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
    3. ALL of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. If the requested agent is being used for treatment of acute migraine, then ONE of the following:
        1. The patient is currently being treated with a migraine prophylactic medication (i.e., anticonvulsants [i.e., divalproex, valproate, topiramate], beta blockers [i.e., atenolol, metoprolol, nadolol, propranolol, timolol], tricyclic antidepressants [i.e., amitriptyline, nortriptyline], SNRIs [i.e., venlafaxine, duloxetine], candesartan, prophylactic use CGRP [e.g., Aimovig, AJOVY, Emgality, Nurtec ODT, QULIPTA, Vyepti], OR onabotulinumtoxin A [BOTOX]) OR
        2. The patient has an intolerance or hypersensitivity to therapy with migraine prophylactic medication (i.e., anticonvulsants [i.e., divalproex, valproate, topiramate], beta blockers [i.e., atenolol, metoprolol, nadolol, propranolol, timolol], tricyclic antidepressants [i.e., amitriptyline, nortriptyline], SNRIs [i.e., venlafaxine, duloxetine], candesartan, prophylactic use CGRP [e.g., Aimovig, AJOVY, Emgality, Nurtec ODT, QULIPTA, Vyepti], onabotulinumtoxin A [BOTOX]) OR
        3. The patient has an FDA labeled contraindication to ALL migraine prophylactic medications (i.e., anticonvulsants [i.e., divalproex, valproate, topiramate], beta blockers [i.e., atenolol, metoprolol, nadolol, propranolol, timolol], tricyclic antidepressants [i.e., amitriptyline, nortriptyline], SNRIs [i.e., venlafaxine, duloxetine], candesartan, prophylactic use CGRP [e.g., Aimovig, AJOVY, Emgality, Nurtec ODT, QULIPTA, Vyepti], AND onabotulinumtoxin A [BOTOX]) OR
        4. There is support that the patient’s migraine is manageable with acute therapy alone AND
      3. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months. NOTE: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling AND the maintenance dose for the remainder of approval up to 12 months.

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 Blue Cross and Blue Shield of Alabama’s 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.

ALBP _  Commercial _ CSReg _ CGRP_PAQL _ProgSum_ 07-01-2025  _ © Copyright Prime Therapeutics LLC. March 2025 All Rights Reserved