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Calcitonin Gene-Related Peptide (CGRP) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1033
This prior authorization program applies to Blue Partner, Commercial, GenPlus, NetResults A, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
7/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Aimovig® (erenumab) Subcutaneous autoinjector |
Preventive treatment of migraine in adults
|
|
1 |
Ajovy® (fremanezumab) Subcutaneous autoinjector Subcutaneous prefilled syringe |
Preventive treatment of migraine in adults |
|
2 |
Emgality® (galcanezumab) Subcutaneous autoinjector 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 |
|
19 |
Qulipta™ (atogepant) Tablet |
Preventive treatment of episodic migraine in adults |
|
21 |
Ubrelvy® (ubrogepant) Tablet |
Acute treatment of migraine with or without aura in adults |
|
20 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Migraines |
The diagnostic criteria for chronic migraine require the inclusion of all of the following:(5)
Migraine prevention may be of benefit in those with the following:(4,6,7)
The American Headache Society (AHS) also includes patient preference as a consideration.(7) The American Headache Society (AHS) and the American Academy of Neurology (AAN) suggest the following agents for the prevention of migraine:(4)
The 2018 American Headache Society Consensus Statement (updated 2021) recommends the following indications for initiating treatment with a Calcitonin Gene-Related Peptide (CGRP) agent:(7,22)
Triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan), are considered by American Headache Society guidelines (2015) to be the gold standard for acute treatment of moderate to severe migraine headaches.(8) An assessment of new migraine treatments by the American Headache society (2018; updated 2021) reaffirms previous migraine guidelines. The update 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 nonsteroidal anti-inflammatory drugs, non-opioid analgesics, acetaminophen, or caffeinated combinations (e.g., aspirin/acetaminophen/caffeine). The recommendation also remains that prescribers must consider medication efficacy and potential medication-related adverse effects when prescribing acute medications for migraine.(7,22) The European Headache Federation and WHO consensus article (2019) states the following:(13)
The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(14)
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 American Headache Society consensus statement states that CGRP mab (monoclonal antibody) treatment (e.g., eptinezumab-jjmr, erenumab, fremanezumab, galcanezumab) may be added to greater than or equal to 1 established preventative treatment, based on clinical judgement, in adults who meet the International Classification of Headache Disorders, 3rd edition criteria for the following conditions:(5,22)
|
Cluster Headaches |
The International Headache Society (IHS) lists the following as diagnostic criteria for cluster headaches:(9)
For episodic cluster headaches, the IHS lists the following diagnostic criteria:(9)
The IHS notes that cluster periods usually last between 2 weeks and 3 months.(9) Guidelines suggest that prophylactic therapy should be started and continued for the duration of the cluster headache period. Prophylactic pharmacological therapy includes verapamil, corticosteroids, lithium, topiramate, melatonin, gabapentin, valproic acid, ergotamine and capsaicin. Verapamil is commonly considered the first option for prophylactic therapy in practice.(10,11,12) Corticosteroids can be used as transitional or bridging therapy until another prophylaxis agent is established.(10) Corticosteroids may be used by some practitioners for short periods of cluster headaches.(11,12) The American Academy Neurology lists the following agents as option that maybe considered or should be advised as preventative treatments:
The European Headache Federation and WHO consensus article (2019) states the following:(13)
|
Medication overuse headache (MOH) |
The European Headache Federation and WHO consensus article (2019) states the following:(13)
|
Safety(1-3,19-21) |
Atogepant, erenumab, fremanezumab, galcanezumab, rimegepant, and ubrogepant have no black box warnings. Ubrogepant is contraindicated with concomitant use of strong CYP3A4 inhibitors. |
REFERENCES
Number |
Reference |
1 |
Aimovig prescribing information. Amgen, Inc. October 2022. |
2 |
Ajovy prescribing information. TEVA Pharmaceuticals. October 2022. |
3 |
Emgality prescribing information. Eli Lilly. March 2021. |
4 |
Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337-1345 |
5 |
ICHD-3 Classification. International Headache Society. 2018. |
6 |
Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. September 26, 2000; 55 (6). |
7 |
The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. American Headache Society. 12/10/2018. Available at https://onlinelibrary.wiley.com/doi/10.1111/head.13456. |
8 |
Marmura M, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55:3–20. |
9 |
Cluster headache. International Headache Society Classification ICHD-II. Available at: https://ichd-3.org/3-trigeminal-autonomic-cephalalgias/3-1-cluster-headache/. |
10 |
Weaver-Agostoni, J. Cluster headache. American Family Physician. 2013 Jul 15;88(2):122-128. |
11 |
Goadsby PJ. Information for health care professionals: treatments for cluster headache. 2018 June. Available at: https://americanheadachesociety.org/wp-content/uploads/2018/06/Goadsby-Cluster-Headache.docx. |
12 |
Francis GJ, Becker WJ, Pringsheim TM. Acute and preventative pharmacologic treatment of cluster headache. August 03, 2010; 75 (5). |
13 |
Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition). Journal of Headache and Pain. (2019) 20:57. |
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. |
15 |
Tepper S, Ashina M, Reuter U, Brandes JL, Doleil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, 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 |
Reference no longer used |
19 |
Nurtec prescribing information. Biohaven Pharmaceuticals Inc. April 2022. |
20 |
Ubrelvy prescribing information. Allergan USA, Inc. March 2021. |
21 |
Qulipta prescribing information. AbbVie Inc. October 2021. |
22 |
Ailani J, Burch RC, Robbins MS, on behalf of the 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(7):1021-1039. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
Qulipta |
atogepant tab |
10 MG ; 30 MG ; 60 MG |
M ; N ; O ; Y |
N |
1. Preferred |
|
Aimovig |
erenumab-aooe subcutaneous soln auto-injector |
140 MG/ML ; 70 MG/ML |
M ; N ; O ; Y |
N |
1. Preferred |
|
Ajovy |
fremanezumab-vfrm subcutaneous soln auto-inj |
225 MG/1.5ML |
M ; N ; O ; Y |
N |
1. Preferred |
|
Ajovy |
fremanezumab-vfrm subcutaneous soln pref syr |
225 MG/1.5ML |
M ; N ; O ; Y |
N |
1. Preferred |
|
Emgality |
galcanezumab-gnlm subcutaneous soln auto-injector |
120 MG/ML |
M ; N ; O ; Y |
N |
1. Preferred |
|
Emgality |
galcanezumab-gnlm subcutaneous soln prefilled syr |
100 MG/ML ; 120 MG/ML |
M ; N ; O ; Y |
N |
1. Preferred |
|
Nurtec |
rimegepant sulfate tab disint |
75 MG |
M ; N ; O ; Y |
N |
1. Preferred |
|
Ubrelvy |
ubrogepant tab |
100 MG ; 50 MG |
M ; N ; O ; Y |
N |
1. Preferred |
|
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 |
Effective Date |
|
||||||||||
Nurtec |
Rimegepant Sulfate Tab Disint 75 MG |
75 MG |
16 |
TABS |
30 |
Days |
|
|
|
|
Qulipta |
Atogepant Tab |
30 MG |
30 |
TABS |
30 |
Days |
|
|
|
|
Qulipta |
Atogepant Tab |
10 MG |
30 |
TABS |
30 |
Days |
|
|
|
|
Qulipta |
Atogepant Tab |
60 MG |
30 |
TABS |
30 |
Days |
|
|
|
|
Ubrelvy |
Ubrogepant Tab 100 MG |
100 MG |
16 |
TABS |
30 |
Days |
|
|
|
|
Ubrelvy |
Ubrogepant Tab 50 MG |
50 MG |
16 |
TABS |
30 |
Days |
|
|
|
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML |
140 MG/ML |
1 |
INJDV |
28 |
Days |
|
|
|
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML |
70 MG/ML |
1 |
INJDV |
28 |
Days |
|
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML |
120 MG/ML |
1 |
INJDV |
28 |
Days |
|
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML |
100 MG/ML |
9 |
SYRNGS |
180 |
Days |
|
|
|
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML |
120 MG/ML |
1 |
SYRNG |
28 |
Days |
|
|
|
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML |
225 MG/1.5ML |
3 |
INJDVS |
84 |
Days |
|
|
|
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML |
225 MG/1.5ML |
3 |
SYRNGS |
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 |
|
Ajovy |
fremanezumab-vfrm subcutaneous soln auto-inj |
225 MG/1.5ML |
|
Ajovy |
fremanezumab-vfrm subcutaneous soln pref syr |
225 MG/1.5ML |
|
Emgality |
galcanezumab-gnlm subcutaneous soln auto-injector |
120 MG/ML |
|
Emgality |
galcanezumab-gnlm subcutaneous soln prefilled syr |
100 MG/ML ; 120 MG/ML |
|
Nurtec |
rimegepant sulfate tab disint |
75 MG |
|
Qulipta |
atogepant tab |
10 MG ; 30 MG ; 60 MG |
|
Ubrelvy |
ubrogepant tab |
100 MG ; 50 MG |
|
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 |
|
Qulipta |
Atogepant Tab |
30 MG |
|
Qulipta |
Atogepant Tab |
10 MG |
|
Qulipta |
Atogepant Tab |
60 MG |
|
Ubrelvy |
Ubrogepant Tab 100 MG |
100 MG |
|
Ubrelvy |
Ubrogepant Tab 50 MG |
50 MG |
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 140 MG/ML |
140 MG/ML |
|
Aimovig |
Erenumab-aooe Subcutaneous Soln Auto-Injector 70 MG/ML |
70 MG/ML |
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Auto-Injector 120 MG/ML |
120 MG/ML |
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 100 MG/ML |
100 MG/ML |
|
Emgality |
Galcanezumab-gnlm Subcutaneous Soln Prefilled Syr 120 MG/ML |
120 MG/ML |
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Auto-inj 225 MG/1.5ML |
225 MG/1.5ML |
|
Ajovy |
Fremanezumab-vfrm Subcutaneous Soln Pref Syr 225 MG/1.5ML |
225 MG/1.5ML |
|
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence Length of Approval: For migraine prophylaxis: 6 months. For agents that require a loading dose for new starts, approve the loading dose noted with the quantity limits table above AND the maintenance dose for the remainder of 6 months. For cluster headache treatment: 6 months All other indications: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
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 |
QL with PA |
Target Agent(s) will be approved when ONE of the following is met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence Length of Approval: Initial: For migraine prophylaxis: 6 months. For agents that require a loading dose for new starts, approve the loading dose noted with the quantity limits table above AND the maintenance dose for the remainder of 6 months. For cluster headache treatment: 6 months All other indications: 12 months Renewal: 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.
Commercial _ PS _ Calcitonin Gene-Related Peptide (CGRP) Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023