Galcanezumab-gnlm (Emgality) Form

Galcanezumab-gnlm (Emgality®) is a calcitonin gene-related peptide (CGRP) receptor antagonist. FDA Approved Indication(s) Emgality is indicated in adults for the: • Preventive treatment of migraine
• Treatment of episodic cluster headache Policy/Criteria It is the policy of health plans affiliated with Centene Corporation® that Emgality is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Migraine Prophylaxis (must meet all):

1. Diagnosis of episodic or chronic migraine;
   2. Provider’s attestation that member experiences ≥ 4 migraine days per month for at least 3 months;
   3. Age ≥ 18 years;
   4. Failure of at least 2 of the following oral migraine preventative therapies, each for 8 weeks and from different therapeutic classes, unless clinically significant adverse effects are experienced or all are contraindicated: antiepileptic drugs (e.g., divalproex sodium, sodium valproate, topiramate), beta-blockers (e.g., metoprolol, propranolol, timolol), antidepressants (e.g., amitriptyline, venlafaxine);

2. If currently receiving treatment with Botox® for migraine prophylaxis and request is for concurrent use of Botox and Emgality (i.e., not switching from one agent to another), all of the following (a, b, and c): a. Sufficient evidence is provided from at least two high-quality, published studies in reputable peer-reviewed journals or evidence-based clinical practice guidelines that provide all of the following (i – iv): Case studies or chart reviews are not considered high-quality evidence i. Adequate representation of the member’s clinical characteristics, age, and diagnosis;
   ii. Adequate representation of the prescribed drug regimen;
   iii. Clinically meaningful outcomes such as a reduction in monthly migraine or headache days; Page 1 of 8

   CLINICAL POLICY Galcanezumab-gnlm iv. Appropriate experimental design and method to address research questions (see Appendix E for additional information); b. Member has experienced and maintained positive response to Botox monotherapy as evidenced by a ≥ 30% reduction in migraine days per month from baseline following at least 2 quarterly injection (6 months) of Botox monotherapy; c. Despite Botox monotherapy, member continues to experience ≥ 4 migraine days per month and/or severe migraine headaches that result in disability and functional impairment;

3. Emgality is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig®, Ajovy®, Vyepti™, Nurtec®, Qulipta™, Ubrelvy™);
4. Dose does not exceed: a. Loading dose: 240 mg (2 injections) once; b. Maintenance dose: 120 mg (1 injection) once monthly. Approval duration: 3 months
   B. Episodic Cluster Headaches (must meet all):
   
   1. Diagnosis of episodic cluster headaches;
   2. Provider’s attestation that member has a history of ≥ 2 cluster periods lasting from 7 days to 1 year each and separated by ≥ 3 months;
5. Age ≥ 18 years;
   
   4. Failure of verapamil at a dose of 360 mg per day, unless contraindicated or clinically significant adverse effects are experienced;
6. Emgality is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig, Ajovy, Vyepti, Nurtec, Qulipta, Ubrelvy);
7. Dose does not exceed both of the following (a and b): a. 300 mg once monthly; b. 3 injections once monthly. Approval duration: 3 months
   C. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   Page 2 of 8

   CLINICAL POLICY Galcanezumab-gnlm II. Continued Therapy A. Migraine Prophylaxis (must meet all):

10. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
11. Member has experienced and maintained positive response to therapy as evidenced by provider’s attestation of a reduction in migraine days per month from baseline;
    
    3. Emgality is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig, Ajovy, Vyepti, Nurtec, Qulipta, Ubrelvy);
12. If request is for a dose increase, new dose does not exceed 120 mg (1 injection) once monthly. Approval duration: 6 months B. Episodic Cluster Headaches (must meet all):
    
    1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
13. Member is responding positively to therapy as evidenced by provider’s attestation of a reduction in cluster headache attack frequency;
14. Provider’s attestation or pharmacy claims history to confirm that member meets one of the following (a or b): a. Member has not received more than 12 months of consecutive treatment; b. It has been at least 3 months since the member last received Emgality;
15. Emgality is not prescribed concurrently with other injectable or oral CGRP inhibitors (e.g., Aimovig, Ajovy, Vyepti, Nurtec, Qulipta, Ubrelvy);
16. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 300 mg once monthly; b. 3 injections once monthly. Approval duration: 6 months (up to a total of 12 months per cluster period) C. Other diagnoses/indications (must meet 1 or 2):

17. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or Page 3 of 8

    CLINICAL POLICY Galcanezumab-gnlm b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

18. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents; B. Chronic cluster headaches. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CGRP: calcitonin gene-related peptide
    FDA: Food and Drug Administration ICHD: International Classification of Headache Disorder Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Anticonvulsants such as: divalproex (Depakote®), topiramate (Topamax®), valproate sodium Beta-blockers such as: propranolol (Inderal®), metoprolol (Lopressor®), timolol, atenolol (Tenormin®), nadolol (Corgard®) Antidepressants/tricyclic antidepressants such as: amitriptyline (Elavil®), venlafaxine (Effexor®) verapamil Migraine Prophylaxis Refer to prescribing information or Micromedex Dose Limit/ Maximum Dose Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Migraine Prophylaxis Refer to prescribing information or Micromedex Refer to prescribing information or Micromedex Episodic Cluster Headache 120 mg PO TID Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Off-label use 360 mg/day Page 4 of 8

    CLINICAL POLICY Galcanezumab-gnlm Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): none reported Appendix D: General Information
    • In clinical trials, a migraine day was defined as any calendar day in which the patient reported either a headache that lasted at least 2 consecutive hours and met International Classification of Headache Disorder (ICHD)-3 diagnostic criteria for migraine (with or without aura) or probable migraine (subtype in which only 1 migraine criterion is absent), or a day when a headache of any duration was treated with migraine-specific medications (triptans or ergots). • Although Emgality given as either 120 mg SC once monthly or 240 mg SC once monthly showed a statistically significant decrease in migraine days per month compared to placebo as the primary outcome in the EVOLVE-1, EVOLVE-2, and REGAIN pivotal trials, there was no clinically significant difference between the two dosing regimens, and thus no significant additional benefit conferred from using a higher dose of Emgality. This is consistent with the FDA-approved maintenance dose of 120 mg SC once monthly. • According to the ICHD-3 diagnostic criteria for cluster headaches, episodic cluster headaches occur in periods lasting from seven days to one year and are separated by periods of remissions that are at least 3 months. Chronic cluster headaches (affecting 10- 15% of patients), on the other hand, occur for longer than a year without remission or with a remission that lasts less than 3 months. Of note, Emgality has only demonstrated efficacy in episodic cluster headaches. It failed to meet its primary endpoint in its chronic cluster headache phase 3 trial. Appendix E: Appropriate Experimental Design Methods • Randomized, prospective controlled trials are generally considered the gold standard; however:
    o In some clinical studies, it may be unnecessary or not feasible to use randomization, double-blind trials, placebos, or crossover. o Non-randomized prospective clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs. • Case reports and chart reviews are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.
    V. Dosage and Administration
    Indication Migraine prophylaxis Loading dose: 240 mg SC once Dosing Regimen Episodic cluster headaches Maintenance dose: 120 mg SC once monthly 300 mg (administered as three consecutive injections of 100 mg each) SC at the onset of the cluster period, and then monthly until the end of the cluster period Maximum Dose 120 mg/month 300 mg/month Page 5 of 8

    CLINICAL POLICY Galcanezumab-gnlm VI. Product Availability
    • Single-dose prefilled pen: 120 mg/mL • Single-dose prefilled syringe: 100 mg/mL, 120 mg/mL VII.