021 Form

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Pharmacy Medical Policy Anti-Migraine Policy Table of Contents Authorization Information Summary
Coverage Criteria Background Appendix
Policy History References

Policy Number: 021 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B • Botulinum Toxin Injections Medical Policy #006

Prior Authorization Information

Policy ☒ Prior Authorization ☒ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 3/15/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

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Summary This is a comprehensive policy covering prior authorization, step therapy and quantity limit requirements for drugs used in the treatment of acute migraine headaches, prevention of chronic migraine headaches, and cluster headaches.
Coverage Criteria Treatment of Acute and Chronic Migraines
No Requirements • For mild to moderate migraines, simple OTC analgesics such as NSAIDS, acetaminophen combinations with caffeine.
• For nausea or vomiting: ondansetron (quantity limits apply – see limits found in Policy #621B). For symptoms that do not respond to antiemetics and simple OTC analgesics, drugs from the triptan class may be indicated. If the symptoms do not respond to triptans or triptans are contraindicated or not tolerated, CGRP antagonists should be considered. Opiates should be considered a last resort. Please see below for related prior authorization requirements for Triptans and CGRP antagonists. The current guidelines for treatment of migraines recommend the use of preventive therapies for patients who have greater than or equal to 4 migraine days per month, are overusing acute medications, or have disability. Even though drugs used for prevention of chronic migraines are less well studied, the American Headache Society and the American Academy of Neurology also recommends the same drugs used for the prevention of episodic migraines (i.e., 4 – 14 migraine days per month) for use in prevention of chronic migraine (i.e., headache on > 15 days per month for greater than 3 months).
BCBSMA formulary coverage options for some drugs recommended by the American Headache Society and the American Academy of Neurology for migraine prevention include the following medications but are not limited to:

Treatment of Acute Migraines – Triptans
Serotonin 5-HT1 receptor agonists also known as Triptan medications are indicated for the treatment of acute migraine with or without aura in adults.
Step Therapy Requirements The step therapy requirements applied to coverage of triptans is as follows:
Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 Naratriptan Covered, QCD Covered without prior authorization. rizatriptan Covered, QCD sumatriptan Covered, QCD Step 2 Almotriptan Covered, QCD Requires prior use of ONE step 1 medication OR history of prior use of Frovatriptan Covered, QCD Eletriptan Covered, QCD • amitriptyline • Gabapentin • nadolol • valproate • atenolol • lithium • propranolol • verapamil • divalproex • metoprolol • topiramate • venlafaxine

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Sumatriptan / naproxen Covered, QCD any step 2 medication in this table within the previous 130 days.

See below for prior use criteria. zolmitriptan Covered, QCD Zolmitriptan Nasal Spray Covered, QCD Zomig ® Nasal Spray (zolmitriptan) Covered, QCD Step 3 Brekiya (dihydroergotamine) NFNC%%, QCD

Requires prior use of ONE step 1 medication AND ONE step 2 medication OR history of prior use of a step 3 medication in this table within the previous 130 days.

See below for prior use criteria Dihydroergotamine spray Covered, QCD Amerge ® (naratriptan) Covered, QCD Imitrex ® Tablets (sumatriptan) Covered, QCD Imitrex ® Nasal Spray (sumatriptan) Covered, QCD Migranal Spray NFNC%%, QCD Tosymra Covered, QCD Imitrex ® STATdose (sumatriptan) NFNC, QCD Maxalt / MLT® (rizatriptan) NFNC, QCD Frova ® (frovatriptan) NFNC, QCD Imitrex ® Injection (sumatriptan) NFNC, QCD Onzetra ® (sumatriptan) NFNC, QCD Relpax ® (eletriptan) NFNC, QCD Symbravo (meloxicam/rizatriptan) NFNC, QCD Treximet ® (sumatriptan / naproxen) NFNC, QCD Trudhesa ™ (dihydroergotamine) NFNC%%, QCD Zembrace ™ Symtouch ™ (sumatriptan) NFNC, QCD Zomig ® (zolmitriptan) Tablets NFNC, QCD Zomig ZMT ® (zolmitriptan) NFNC, QCD QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization; ST – Step Therapy; NFNC – Non-formulary Non-covered %% - must try generic Dihydroergotamine spray as an alternative to meet formulary exception approval. Length of Approval 24 months
Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.
Treatment of Acute Migraines – Calcitonin Gene-Related Receptor (CGRP) Antagonists - Nurtec ODT ®, Ubrelvy ®, Zavzpret TM Nurtec ODT, Ubrelvy, and Zavzpret are indicated for the acute treatment of migraine with or without aura. However, while Nurtec ODT is also indicated for the preventive treatment of episodic migraine Ubrelvy and Zavzpret are NOT indicated for preventive treatment of migraine. Prior Authorization Requirements The prior authorization requirements for CGRPs for acute treatment of migraines: Drug Formulary Status (BCBSMA Commercial Plan) Requirement

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Nurtec ODT ® (rimegepant) PA, QCD PA Required Ubrelvy ® (ubrogepant) PA, QCD PA Required Zavzpret ™ (zavegepant) PA, QCD PA Required Length of Approval 12 months
QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization

Nurtec ODT®, Ubrelvy ®, and Zavzpret ™ may be covered for the acute treatment of migraines when ALL of the following criteria are met:

1. Age 18 years or older; AND

2. Previous trial with an inadequate response, adverse reaction, or contraindication to at least TWO (2) triptan medications (e.g., naratriptan, rizatriptan, sumatriptan, etc.).

   Preventative Treatment of Migraines – Calcitonin Gene-Related Receptor (CGRP) Antagonists
   Prior Authorization Requirements The prior authorization requirements for CGRPs for preventative treatment of migraines: Drug Formulary Status (BCBSMA Commercial Plan) Requirements
   Nurtec ODT ® (rimegepant) PA, QCD PA Required Ajovy ® (fremanezumab) PA, QCD PA Required Emgality ® (galcanezumab) PA, QCD PA Required Qulipta ® (atogepant) PA, QCD PA Required Aimovig ® (erenumab) NFNC, PA, QCD Non-formulary exception and PA Required Vyepti ® (eptinezumab)%% NFNC, PA, QCD Non-formulary exception and PA Required Length of Approval 12 months
   QCD - Quality Care Dosing (quantity limits policy #621B); PA – Prior Authorization; NFNC – Non-formulary Non- covered; %%- This medication also is available under the Medical benefit and has Medical UM/Prior Authorization.

   Ajovy ®, Emgality ®, and Nurtec ODT ®

   Ajovy, may be covered for the preventative treatment of episodic migraines when ALL of the following criteria are met:

3. Patient is at the age consistent with FDA labeling of requested drug: a. Age 18 years or older b. Age 6-17 and weigh 45 kg or more

   AND

4. Previous trial with an inadequate response, adverse reaction, or contraindication to at least TWO (2) different classes of medications recommended for preventive treatment of migraines (e.g., beta blocker, anti-depressants, calcium channel blockers, anticonvulsants).

   Emgality, Nurtec ODT may be covered for the preventative treatment of episodic migraines when ALL of the following criteria are met:

5. Age 18 years or older; AND
6. Previous trial with an inadequate response, adverse reaction, or contraindication to at least TWO (2) different classes of medications recommended for preventive treatment of migraines (e.g., beta blocker, anti-depressants, calcium channel blockers, anticonvulsants).

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Emgality ® may be covered for the prevention of episodic cluster headaches when ALL of the following criteria are met:

3. Diagnosis of episodic cluster headaches – defined as having at least 2 cluster periods lasting from 7 days to 1 year, separated by pain-free remission periods lasting at least 1 month; AND

4. Age 18 years or older; AND

5. Unable to achieve a reduction in weekly cluster headache attack frequency with preventative medication(s).

   Qulipta ® Qulipta ® may be covered for the preventative treatment of migraines when ALL of the following criteria are met:

6. Age 18 years or older; AND

7. Previous trial with an inadequate response, adverse reaction, or contraindication to at least TWO (2) different classes of medications recommended for preventive treatment of migraines (e.g., beta blocker, anti-depressants, calcium channel blockers, anticonvulsants).

   Aimovig ®, Vyepti ® Non-formulary drugs Vyepti ® or Aimovig ® may be covered for the preventative treatment of episodic migraines when ALL of the following criteria are met:

8. Age 18 years or older; AND

9. Meets BCBSMA Non-Formulary Exception criteria requirements with trial and failure of at least TWO (2) covered formulary CGRP alternatives for preventive treatment of episodic migraines (i.e., Ajovy ®, Emgality ®, and Nurtec ODT ®).

   Background Migraine and Cluster Headache Migraine is a headache disorder characterized by recurrent moderate to severe headaches with associated symptoms. Approximately 15% of the population have migraines, with a higher prevalence in women than in men.1, The typical migraine headache is throbbing, unilateral, and aggravated by motion. Migraines are frequently associated with nausea, vomiting, photophobia, and phonophobia, although other neurological symptoms may occur. Migraine attacks can last from several hours to several days and are often preceded by transient neurological symptoms (eg, visual disturbance) known as migraine aura. Migraines are categorized as episodic or chronic depending on the frequency of attacks. Episodic migraine is defined as migraine or headache for less than 15 days per month and accounts for more than 90% of cases of migraine. Chronic migraine is defined as 15 or more headache days each month, of which at least 8 are migraine days. Migraine was previously thought to be primarily vascular, but recent evidence suggests that sensitization of pain pathways in the central nervous system may be involved.2,At least 3 messenger molecules are thought to be involved during migraine attacks: nitric oxide, 5-hydroxytryptamine, and calcitonin gene- related peptide (CGRP). CGRP is produced in both peripheral and central neurons and is a potent

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vasodilator. Some preclinical studies suggest that during a migraine, sensory neurons in the trigeminal ganglion release CGRP from their peripherally projecting nerve endings in the meninges. Cluster headache is a disabling primary headache disorder that is characterized by attacks of intense headache on 1 side of the head, with associated agitation or restlessness, as well as by cranial autonomic symptoms, such as lacrimation, conjunctival injection, and nasal congestion. Attacks last 15 to 180 minutes when untreated and can occur once or several times per day during cluster headache periods that can last for weeks to months.3, Cluster headaches, like migraines, are categorized as episodic or chronic depending on the frequency of the attacks. Episodic cluster headache is defined as at least 2 cluster periods lasting 7 to 365 days and separated by pain-free remission periods of 1 month or longer. Chronic cluster headache attacks occur for 1 year or longer without remission, or with remission periods lasting less than 1 month. Treatment Symptomatic treatment is available for both migraine attacks and cluster headaches. Initial treatment for migraine is the use of oral pain relievers, but those with severe disease typically try multiple therapies, including both non-drug (eg, exercise, diet, relaxation techniques) and drug therapies. Acute drug therapies, such as triptans, treat symptoms after they’ve started. For patients who experience more than 4 migraine days per month, preventive treatment may be recommended and include certain antidepressants, anti- seizure medications, beta-blockers, and, for those with chronic migraine, onabotulinum toxin A (see evidence review 5.01.50). Oral medications approved by the U.S. Food and Drug Administration (FDA) for migraine prophylaxis include topiramate, propranolol, timolol, and valproate. All of these medications have contraindications and side effects that limit their use. For many people, preventive therapies are not effective or have intolerable side effects. For acute management of cluster headache, oxygen and sumatriptan are typically recommended. Intranasal dihydroergotamine, intranasal lidocaine, and intranasal capsaicin are less studied alternatives in place of the first-line recommendations. Oral sumatriptan, verapamil, divalproex, and prednisone are among the agents that can be used for episodic cluster headache prophylaxis, either reducing the frequency of episodic cluster headaches or severity. Verapamil and lithium are agents used in chronic cluster headache treatment. None of these agents, however, are FDA approved for the treatment of cluster headache. This evidence review addresses humanized monoclonal antibodies (mAbs) that bind to the CGRP receptor or CGRP molecule and are designed for the prevention or treatment of migraine or cluster headache (see Table 1). The role of CGRP in cluster headache provided the rationale for utilizing humanized mAbs in preventing migraine and cluster headache. Unlike oral drug therapy, mAbs are not metabolized by the liver can remain in the body for weeks or months. Appendix Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below:

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https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

Policy History Date Action 3/15/2026 Clarified %% footnote regarding trial of generic DHE 11/2025 Updated expanded age indication for Ajovy, added Brekiya as Step 3, and updated formatting and references. 9/15/2025 Added Symbravo as Step 3 drug.
6/2025 Updated injectable CGRPs to be eligible for Smart PA

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1/2025 Updated to move Aimovig ® and Migranal ® Spray to non-formulary, non-covered. 10/2024 Updated Qulipta’ s indication. 7/2024 Updated to add Qulipta to Covered and add a note that Vyepti is part of the Med UM program. 9/2023 Reformatted policy. Updated IC to align with 118E MGL § 51A. 8/2023 Updated policy to add Zavzpret ™ to the policy. 7/2023 Updated policy template and criteria for CGRPs for preventive treatment of migraines and updated episodic cluster headache diagnosis definition from >5 episodes to >2 periods lasting 7days to 1 year. 1/2023 Updated to move Vyepti ® and Qulipta ™ to non-covered in the policy and increase the look back period for the CGRPs. 7/2022 Clarified Step requirements and clarify previous treatment for applicable medications. 1/2022 Updated to add dihydroergotamine 4mg/mL spray and Migranal 4mg/mL spray to step 3 of the Triptans for Acute Migraine table and to add Qulipta to the policy. 11/2021 Updated to include Coverage for Nurtec ODT for Prevention and Trudhesa™ to the policy. 4/2021 Updated to add a single sourced branded Zolmitriptan Nasal Spray to Step 1 in CGRP table and Step 2 in Triptans table. 1/1/2021 Updated to add Onzetra®, Tosymra™, and Zembrace™ Symtouch™ to step 3 of the triptan step. 10/2020 Updated to add a third step to the Acute treatment section and update the policy title. 6/2020 Updated to add Step part for Ubrelvy™ & Nurtec™ and to add Vyepti™ to the prophylaxis CGRP criteria. 4/2020 Clarified list of preventive medications and added Ajovy to formulary. 10/2019 Clarified criteria for cluster headache. 7/2019 Updated to add new cluster headache indication for Emgality. 12/2018 New policy describing coverage indications for Aimovig, Ajovy and Emgality. 12/2018.

References

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9. Calcitonin Gene-Related Peptide (CGRP) Inhibitors as Preventive Treatments for Patients with Episodic or Chronic Migraine: Effectiveness and Value Final Evidence Report July 3, 2018. https://icer- review.org/wp-content/uploads/2017/11/ICERMigraineFinalEvidenceReport_070318.pdf Accessed on November 9, 2022.
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27. Mulleners WM, Kim BK, Lainez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. Oct 2020; 19(10): 814-825. PMID 32949542
28. Pozo-Rosich P, Detke HC, Wang S, et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. May 2022; 38(5): 731-742. PMID 35392739
29. Reuter U, Ehrlich M, Gendolla A, et al. Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. Feb 2022; 42(2): 108-118. PMID 34743579
30. Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. Nov 24 2018; 392(10161): 2280-2287. PMID 30360965

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30. Reuter U, Lucas C, Dolezil D, et al. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. Nov 2021; 38(11): 5465-5483. PMID 34542830
31. Riesenberg R, Gaul C, Stroud CE, et al. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. Oct 2022; 42(11-12): 1225-1235. PMID 35633025
32. Silberstein S, Diamond M, Hindiyeh NA, et al. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. Oct 06 2020; 21(1): 120. PMID 33023473
33. Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. Nov 30 2017; 377(22): 2113-2122. PMID 29171818
34. 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. Apr 24 2012; 78(17): 1337-45. PMID 22529202
35. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. Jul 2018; 38(8): 1442-1454. PMID 29848108
36. Smith TR, Janelidze M, Chakhava G, et al. Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. Dec 2020; 42(12): 2254-2265.e3. PMID 33250209
37. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. Sep 01 2018; 75(9): 1080-1088. PMID 29813147
38. Stewart WF, Lipton RB, Kolodner KB, et al. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. Oct 2000; 88(1): 41-52. PMID 11098098
39. Symbravo [package insert]. New York, NY: Axsome Therapeutics, Inc.: 2/2025.
40. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. Jun 2017; 16(6): 425-434. PMID 28460892
41. U.S. Food and Drug Administration. Emgality label. 2022; https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf. Accessed November 9, 2022.
42. Wang SJ, Roxas AA, Saravia B, et al. Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia. Nov 2021; 41(13): 1285-1297. PMID 34171973
43. Wang X, Wen D, He Q, et al. Efficacy and safety of monoclonal antibody against calcitonin gene-related peptide or its receptor for migraine patients with prior preventive treatment failure: a network meta- analysis. J Headache Pain. Sep 08 2022; 23(1): 105. PMID 36071388
44. Winner PK, McAllister P, Chakhava G, et al. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. Jun 15 2021; 325(23): 2348-2356. PMID 34128999
45. Yang M, Rendas-Baum R, Varon SF, et al. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. Feb 2011; 31(3): 357-67. PMID 20819842
46. Zavzpret ™ [package insert]. New York, NY: Pfizer Laboratories.: 3/2023