CGRP Therapy – Enhanced & Net Results

• Aimovig® (erenumab-aooe) 
• Ajovy® (fremanezumab-vfrm) 
• Emgality®(galcanezumab-gnlm)
• Nurtec™ ODT (rimegepant)
• Qulipta™ (atogepant)
• Ubrelvy™ (ubrogepant) 
• Zavzpret™ (zavegepant) 

• For the preventive treatment of migraine in adults (Aimovig, Ajovy, Emgality, & Qulipta) 
• For the preventive treatment of episodic migraine in adults (Nurtec ODT) 
• Treatment of episodic cluster headache (Emgality only) 
• For the acute treatment of migraine with or without aura in adults (Nurtec ODT, Ubrelvy, & Zavzpret)

Initial Coverage Criteria 

For patients that are new to the plan and currently taking the medication, the criteria pertain to when the patient started the medication.

1. The requested medication is Emgality 100mg/mL; AND 
   1. The patient has been diagnosed with episodic cluster headache; AND 
      1. The patient is experiencing up to but not exceeding 8 headache attacks per day; AND 
      2. The patient is experiencing at least 1 attack every other day; AND 
      3. The patient has experienced at least 5 attacks; AND 
      4. The patient has had at least 2 cluster periods, lasting 7 to 365 days; AND 
      5. The patient’s cluster periods are separated by a pain-free remission period of at least 3 months; AND 
      6. Emgality will be used at the onset of an episodic cluster headache; AND 
      7. The medication will NOT be used for the prevention of cluster headache when symptoms are NOT present; AND 
      8. Emgality will be discontinued at the end of the cluster period; OR 
2. The requested medication is Ubrelvy; AND 
   1. The patient is being treated for acute migraine with or without aura; AND 
      1. Ubrelvy will not be taken concomitantly with another acute migraine therapy (e.g., Nurtec ODT, Zavzpret, 5HT-1F, ergotamine, triptan); AND 
      2. The patient has tried and failed ONE unrestricted triptan product; OR 
         1. The patient has a clinical intolerance/contraindication to all unrestricted triptan products on the formulary that have not been tried; OR 
3. The requested medication is Zavzpret; AND 
   1. The patient is being treated for acute migraine with or without aura; AND 
      1. Zavzpret will not be taken concomitantly with another acute migraine therapy (e.g., Nurtec ODT, Ubrelvy, 5HT-1F, ergotamine, triptan); AND 
      2. The patient has tried and failed or has a clinical intolerance/contraindication to Nurtec ODT and Ubrelvy; AND 
      3. The patient has tried and failed ONE unrestricted nasal triptan product; OR 
         1. The patient has a clinical intolerance/contraindication to ALL unrestricted triptan products on the formulary that have not been tried; OR 
4. The requested medication is Nurtec ODT; AND 
   1. The patient has been diagnosed with episodic migraine (defined as less than 15 headache days per month); AND 
      1. Over the last 3 months the patient has experienced at least ONE of the following: 
         1. The patient has ≥ 4 migraine headache days per month; OR 
         2. Migraine attacks are attributed to a diminished quality of life despite the use of acute rescue medications; OR 
         3. The patient has contraindications to acute therapies; OR 
         4. The patient has tried and received inadequate response to acute therapies; OR 
         5. The patient has serious side effects to acute therapies; OR 
         6. The patient is at risk of medication overuse headache without preventative therapy; 
      2. The patient will not be started on a botulinum toxin agent and has not been treated with a botulinum toxin agent in the last 3 months; AND 
      3. The patient is not taking another calcitonin gene-related peptide (CGRP) receptor antagonist that is being used for migraine prophylaxis (Aimovig, Ajovy, Emgality, Qulipta, Vyepti, etc.); OR 
         1. The patient will discontinue the other CGRP for prophylaxis prior to beginning therapy with the requested medication; OR 
   2. The patient is being treated for acute migraine with or without aura; AND 
      1. Nurtec ODT will not be taken concomitantly with another acute migraine therapy (e.g., Ubrelvy, Zavzpret, 5HT-1F, ergotamine, triptan); AND 
      2. The patient has tried and failed ONE unrestricted triptan product; OR
         1. The patient has a clinical intolerance/contraindication to all unrestricted triptan products on the formulary that have not been tried; OR 
5. The requested medication is Aimovig, Ajovy, Emgality 120mg/mL, or Qulipta; AND 
   1. ONE of the following: 
      1. The patient has been diagnosed with chronic migraine (defined as greater than or equal to 15 headache days per month) and over the last 3 months the patient has experienced the following: 
         1. A minimum of 15 headache days per month; AND 
         2. A minimum of 8 migraine days per month; OR
      2. The patient has been diagnosed with episodic migraine (defined as less than 15 headache days per month) and over the last 3 months the patient has experienced at least ONE of the following: 
         1. The patient has ≥ 4 migraine headache days per month; OR 
         2. Migraine attacks are attributed to a diminished quality of life despite the use of acute rescue medications; OR 
         3. The patient has contraindications to acute therapies; OR 
         4. The patient has tried and received inadequate response to acute therapies; OR 
         5. The patient has serious side effects to acute therapies; OR 
         6. The patient is at risk of medication overuse headache without preventative therapy; AND 
   2. The patient will NOT utilize the requested agent in combination with a botulinum toxin agent for migraine prophylaxis; OR 
      1. The patient will utilize the requested agent in combination with a botulinum toxin agent for the treatment of chronic migraine; AND 
         1. The patient is continuing to experience ≥ 4 migraine headache days per month after treatment with ONE of the following preventative therapies for chronic migraine (medical record documentation required): 
            1. At least a 3-month trial with a calcitonin gene-related peptide (CGRP) receptor antagonist (medical record documentation required); OR 
            2. At least a 6-month trial (2 injection cycles) with a botulinum toxin agent (medical record documentation required); AND 
   3. The patient is not taking another calcitonin gene-related peptide (CGRP) receptor antagonist that is being used for migraine prophylaxis (Aimovig, Ajovy, Emgality, Qulipta, Vyepti, etc.); OR
      1. The patient will discontinue the other CGRP for prophylaxis prior to beginning therapy with the requested medication; AND 
6. For products that require Value PA, refer to the Value PA UM Criteria.

†Adequate trial is defined by a minimum of 4-6 weeks for an agents used.

‡Adherence is defined as the proportion of days covered (PDC) to be 80 percent or greater over the trial period
 

Duration of Approval for Migraine: 12 weeks

Duration of Approval for Episodic Cluster Headache: 12 months

Duration of Approval for Acute Migraine:  12 weeks 

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
   1. The patient would have met criteria for approval at the time they started therapy; AND 
2. The patient is using the requested medication for migraine prevention; AND 
   1. The patient has experienced a decrease in number of migraine days or migraine frequency; AND 
   2. The patient has experienced a reduction in the need for migraine rescue medications (i.e. NSAIDS, triptans, ergot derivatives); AND 
   3. The patient will NOT be using the requested agent in combination with a botulinum toxin agent for migraine prophylaxis; OR 
      1. The patient will utilize the requested agent in combination with a botulinum toxin agent for the treatment of chronic migraine; AND 
         1. The patient is continuing to experience ≥ 4 migraine headache days per month after treatment with ONE of the following preventative therapies for chronic migraine (medical record documentation required): 
            1. At least a 3-month trial with a calcitonin gene-related peptide (CGRP) receptor antagonist (medical record documentation required); OR 
            2. At least a 6-month trial (2 injection cycles) with a botulinum toxin agent (medical record documentation required); AND 
   4. The patient is not taking another calcitonin gene-related peptide (CGRP) receptor antagonist that is being used for migraine prophylaxis (Aimovig, Ajovy, Emgality, Qulipta, Vyepti, etc.); OR 
3. The patient is using Emgality 100mg/mL for episodic cluster headache; AND 
   1. The patient has had improvement in cluster headache management with the requested medication; OR 
4. The patient is using Nurtec ODT, Ubrelvy, or Zavzpret for acute migraine headache treatment; AND 
   1. The patient continues to show migraine symptom relief from the use of the requested medication; AND 
   2. If the request is for Zavzpret, the patient has tried and failed or has a clinical intolerance/contraindication to Nurtec ODT and Ubrelvy; AND 
   3.  The requested agent will not be taken concomitantly with another acute migraine therapy (e.g., acute use CGRP, 5HT-1F, ergotamine, triptan).

Duration of Approval: 365 days (1 year) 

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed); AND 
5. If the request is for Ubrelvy or Zavzpret for the treatment of acute migraine and over the quantity limit; 
   1. The patient has tried and failed at least two of the following abortive migraine therapy medication classes: 
      1. NSAIDS/COX-2 Inhibitor (Ex. ibuprofen, naproxen, diclofenac, celecoxib, etc.) 
      2. Acetaminophen (Tylenol) 
      3. Ergotamine-containing products (Ex. Cafergot, Ergomar, etc.); AND 
   2. If the patient experiences > 4 migraine headaches per month: 
      1. Prophylactic therapy with Aimovig, Ajovy or Emgality has been given an adequate trial of 2-3 months; AND 
      2. The patient will continue to be treated with prophylactic therapy with Aimovig, Ajovy or Emgality; AND 
   3. The possibility of medication-induced, rebound or chronic daily headache has been considered and ruled out; OR 
6. If the request is for Nurtec ODT over the quantity limit; 
   1. It will not be approved for more than the FDA labeled maximum of 18 days per month (54 per 90 days); AND 
   2. The patient meets criteria for approval for both treatment of acute migraine and episodic migraine with Nurtec ODT.

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

1. Ailani J, Burch RC, Robbins MS, Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61:1021-39. 
2. Armanious M, Khalil N, Lu Y, et al. Erenumab and onabotulinumtoxinA combination therapy for the prevention of intractable chronic migraine without aura: a retrospective analysis. J Pain Palliat Care Pharmacother. 2021;35(1):1-6. 
3. Charles AC, Digre KB, Goadsby PJ, et al; American Headache Society. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: gpdate. Headache. 2024 Apr;64(4):333-341. 
4. Cohen F, Armand C, Lipton RB, et al. Efficacy and tolerability of calcitonin gene-related peptide-targeted monoclonal antibody medications as add-on therapy to onabotulinumtoxinA in patients with chronic migraine. Pain Med. 2021;22(8):1857-63. 
5. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. 
6. Scuteri D, Tonin P, Nicotera P, et al. Pooled analysis of real-world evidence supports anti-CGRP mAbs and onabotulinumtoxinA combined trial in chronic migraine. Toxins. 2022 Aug;14(8):529. 
7. Toni T, Tamanaha R, Newman B, et al. Effectiveness of dual migraine therapy with CGRP inhibitors and onabotulinumtoxinA injections: case series. Neurol Sci. 2021;42(12):5373-76.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

January 2025: Criteria change: Removed requirement of trial and failure of a conventional prophylaxis agent (beta blocker, anticonvulsant, antidepressant) from initial and quantity limit criteria. Removed criteria point excluding use with specific disease-related concerns. Updated diagnostic criteria for episodic cluster headache. Updated duration of approval for episodic cluster headache to 1 year. Updated QL for Nurtec to 16 tablets per 30 days regardless of indication.

October 2024: Criteria change (Ubrelvy, Nurtec ODT, Zavzpret): Added requirement that acute use CGRPs will not be taken concomitantly with another acute migraine therapy.

August 2024: Criteria update: Updated definition of episodic migraine to be ≥ 4 migraine headache days per month.

April 2024: Criteria change: Created an Essential only policy. Updated Nurtec QL for episodic migraine.

January 2024: Criteria change: Added the option for use of a botulinum toxin agent in combination with a CGRP receptor antagonist for patients continuing to experience 4 or more migraine headache days per month after treatment with either a 3-month trial of a CGRP receptor antagonist or a 6-month trial (2 injection cycles) of Botox. References added.

October 2023: Criteria update: Removed allowance of Botox in the last 3 months due to inability to see provider during COVID-19 pandemic. June 2023: Criteria update: Added new to market Zavzpret to policy.

May 2023: Criteria change (Qulipta): Expanded indication for Qulipta to include the preventative treatment of chronic migraine in adults.

March 2023: Criteria update: Added definitions for chronic and episodic migraine. No change to criteria intent.

July 2022: Criteria update: Any authorization for a botulinum toxin agent used for the same indication as the requested agent will be terminated.

January 2022: Criteria change: Reduced step requirement through a single triptan product for acute migraine use. Step through Emgality and Aimovig removed for Ajovy requests. Historical policy changes prior to 2022 can be obtained from BCBSNC Corporate Pharmacy