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ph-1033

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) Headache (migraine-like or tension-like) on greater than or equal to 15 days per month for greater than 3 months and fulfilling criteria B and C Occurring in a patient who has had at least five attacks fulfilling migraine without aura and/or migraine with aura On greater than or equal to 8 days per month for greater than 3 months, fulfilling any of the following: Migraine without aura Migraine with aura Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative Not better accounted for by another ICHD-3 diagnosis Migraine prevention may be of benefit in those with the following:(4,6,7) Frequent or long-lasting migraine headaches (greater than 4 headaches/month or headaches lasting greater than 12 hours) Migraine attacks that cause significant disability or diminished quality of life despite appropriate acute treatment Contraindication to acute therapies Failure of acute therapies Serious adverse effects of acute therapies Risk of medication overuse headache Menstrual migraine 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) Established as effective (Level A) Antiepileptic drugs (AEDs) Divalproex Valproate Topiramate Beta blockers Metoprolol Propranolol Timolol Triptans Frovatriptan for short term menstrually associated migraines (MAMs) prevention Probably effective (Level B) Antidepressants Amitriptyline Venlafaxine Beta blockers Atenolol Nadolol Triptans Naratriptan, zolmitriptan for short term MAMs prevention 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) Prescribed by a licensed medical professional Patient is at least 18 years of age ONE of the following: Diagnosis of migraine with or without aura (4-7 monthly headache days) and both of the following: Inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following: Topiramate Divalproex sodium/valproate sodium Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol Tricyclic antidepressant: amitriptyline, nortriptyline Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine Other Level A or B treatment according to AAN-AHS guideline At least moderate disability (Migraine Disability Assessment Questionnaire [MIDAS] greater than 11, Headache Impact Test-6 [HIT-6] greater than 50) Diagnosis of migraine with or without aura (8-14 monthly headache days) and inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following: Topiramate Divalproex sodium/valproate sodium Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol Tricyclic antidepressant: amitriptyline, nortriptyline Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine Other Level A or B treatment according to AAN-AHS guideline Diagnosis of chronic migraine and one of the following: Inability to tolerate (due to side effects) or inadequate response to a 6-week trial of at least 2 of the following: Topiramate Divalproex sodium/valproate sodium Beta blocker: metoprolol, propranolol, timolol, atenolol, nadolol Tricyclic antidepressant: amitriptyline, nortriptyline Serotonin-norepinephrine reuptake inhibitor: venlafaxine, duloxetine Other Level A or B treatment according to AAN-AHS guideline Inability to tolerate or inadequate response to a minimum of 2 quarterly injection (6 months) of onabotulinum toxin A 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) Individuals with migraine headaches should almost always be managed in primary care. The exception being chronic migraine, which likely requires specialist management Any headache not responding satisfactorily in primary care should be referred to a specialist In adults and children, regular high frequency use (greater than 2 days/week) of acute medication risks the development of medication-overuse headache Treatment of episodic acute migraine headaches 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 on greater than or equal to 10 days/month to avoid the risk of medication overuse headaches 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 nausea 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 For episodic migraine prophylaxis: 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 the patient is willing to take daily medication Failure of acute therapy is an indication for migraine prophylaxis For children: frequent absence from school Migraine prophylaxis agents may take 2-3 months to show efficacy Children requiring prophylactic medication should be referred to a specialist Medications which are effective in adult prophylaxis of episodic migraine include: Beta blockers: Atenolol, bisoprolol, metoprolol, propranolol Amitriptyline Topiramate Candesartan Sodium valproate Flunarizine CGRP Onabotulinum toxin A is not effective in episodic migraine When prophylaxis therapy fails: Failure may be due to subtherapeutic dosage or duration of therapy Failure of one therapy does not predict the failure of another therapy Review of the following are recommended: Diagnosis Adherence Other medications, especially for medication overuse headache causes The prophylaxis therapy should be discontinued if it fails to show clear benefit If all prophylaxis therapies fail, a specialist should be referred Chronic migraine management: Chronic migraine patients should be referred to a specialist Medications with efficacy in chronic migraine include: Topiramate Onabotulinum A CGRP The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(14) In episodic migraine, it’s suggested 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, it’s suggested to add CGRP to ongoing oral prophylaxis therapy In chronic migraine patients on onabotulinumA therapy and are receiving inadequate treatment response, it’s suggested to stop onabotulinumA therapy before starting CGRPs In patients with chronic migraine who are on treatment with CGRP and may benefit from additional prevention, it’s suggested to add on oral preventative agents In patients with medication overuse, it’s suggested 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 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) Migraine with/without aura (4‒7 monthly migraine days [MMDs]) with at least moderate disability (Migraine Disability Assessment greater than or equal to 11 or 6-item Headache Impact Test greater than 50) and failure of an 8-week trial of greater than or equal to 2 preventive treatments with established efficacy (e.g., topiramate, divalproex sodium, beta-blocker, tricyclic antidepressant, and others) Migraine with/without aura (8–14 MMDs) and failure of an 8-week trial of greater than or equal to 2 established preventive treatments Chronic migraine (greater than or equal to 15 MMDs) with any level of disability and either failure of an 8-week trial of greater than or equal to 2 established preventive treatments or inadequate tolerability or response to onabotulinum toxin A for two quarterly injections
Cluster Headaches	The International Headache Society (IHS) lists the following as diagnostic criteria for cluster headaches:(9) At least 5 attacks fulfilling criteria B-D Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated Headache is accompanied by at least one of the following: ipsilateral conjunctival injection and/or lacrimation ipsilateral nasal congestion and/or rhinorrhea ipsilateral eyelid oedema ipsilateral forehead and facial sweating ipsilateral miosis and/or ptosis a sense of restlessness or agitation Attacks have a frequency from one every other day to 8 per day Not attributed to another disorder For episodic cluster headaches, the IHS lists the following diagnostic criteria:(9) Attacks fulfilling criteria A-E for cluster headache At least two cluster periods lasting 7-365 days and separated by pain-free remission periods ≥3 month 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: Civamide Suboccipital steroid injection Melatonin Verapamil Lithium The European Headache Federation and WHO consensus article (2019) states the following:(13) Cluster headache patients should be referred to specialists. 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 For chronic cluster headache patients, long-term prophylaxis therapy may be needed
Medication overuse headache (MOH)	The European Headache Federation and WHO consensus article (2019) states the following:(13) 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 also require management
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: ONE of the following: The requested agent is being used for migraine prophylaxis AND ALL of the following: ONE of the following: The patient has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND ALL of the following: Greater than or equal to 15 headache days per month of migraine-like or tension-like headache for a minimum of 3 months AND Greater than or equal to 8 migraine headache days per month for a minimum of 3 months AND The patient will NOT be using the requested agent in combination with another prophylactic use CGRP AND The requested agent and strength is FDA approved for chronic migraine prophylaxis OR The patient has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND ALL of the following: ONE of the following: The patient has greater than 4 migraine headache days per month OR The patient’s migraine headaches last greater than 12 hours OR The patient’s migraine attacks cause significant disability or diminished quality of life despite appropriate therapy with acute agents only OR The patient has contraindications to acute therapies OR The patient has tried and received inadequate response to acute therapies OR The patient has serious side effects to acute therapies OR The patient is at risk of medication overuse headache without preventative therapy AND The patient will NOT be using the requested agent in combination with another prophylactic use CGRP agent AND The requested agent and strength is FDA approved for episodic migraine prophylaxis AND ONE of the following: The patient has tried and had an inadequate response to at least one migraine prophylaxis class [i.e., anticonvulsants (i.e., divalproex, valproate, topiramate), beta blockers (i.e., atenolol, metoprolol, nadolol, propranolol, timolol), antidepressants (i.e., amitriptyline, venlafaxine), candesartan] after an adequate trial as defined by BOTH of the following: The trial length was at least 6 weeks at generally accepted doses AND The patient was greater than or equal to 80% adherent to the prophylaxis agent during the trial OR The patient has an intolerance or hypersensitivity to therapy with at least one migraine prophylaxis class listed above OR The patient has an FDA labeled contraindication to ALL migraine prophylaxis agents listed above AND ONE of the following: The requested agent is a preferred agent OR The requested agent is a non-preferred agent and ALL of the following: The patient has tried and had an inadequate response to ONE preferred agent(s) OR The patient has an intolerance or hypersensitivity to ONE preferred agent(s) OR The patient has an FDA labeled contraindication to ALL preferred agent(s) AND Medication overuse headache has been ruled out OR The requested agent is being used for the treatment of episodic cluster headache AND ALL of the following: The patient has a diagnosis of episodic cluster headache as confirmed by ALL of the following: The patient has had at least 5 cluster headache attacks AND The patient has at least two cluster period lasting 7-365 days AND The patient’s cluster periods are separated by a pain-free remission period of greater than or equal to 3 months AND ONE of the following: The patient has tried and had an inadequate response to verapamil, melatonin, corticosteroids, topiramate, OR lithium OR The patient has an intolerance or hypersensitivity to verapamil, melatonin, corticosteroid, topiramate, OR lithium OR The patient has an FDA labeled contraindication to verapamil, melatonin, corticosteroid, topiramate, AND lithium AND Medication overuse headache has been ruled out AND The requested agent and strength is FDA approved for episodic cluster headache treatment OR The requested agent is being used for acute migraine treatment AND ALL of the following: ONE of the following: The patient has tried and had an inadequate response to at least one triptan agent OR The patient has an intolerance or hypersensitivity to a triptan agent OR The patient has an FDA labeled contraindication to ALL triptan agents AND The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., triptan, 5HT-1F, ergotamine, acute use CGRP) AND Medication overuse headache has been ruled out AND The requested agent and strength is FDA approved for acute migraine treatment OR The patient has another FDA approved indication for the requested agent and route of administration OR The patient has another indication that is supported in compendia for the requested agent and route of administration AND If the patient has an FDA labeled indication,ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND 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: 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: The patient has been approved for the requested agent previously through the plan’s Prior Authorization process AND ONE of the following: BOTH of the following: ONE of the following: The requested agent is being used for migraine prophylaxis AND ALL of the following: The prescriber has provided information indicating improvement in migraine prevention (e.g., reduced migraine headache days, reduced migraine frequency, reduced use of acute abortive migraine medication) with the requested agent AND The patient will NOT be using the requested agent in combination with another prophylactic use CGRP AND ONE of the following: BOTH of the following: The patient has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND The requested agent and strength is FDA approved for chronic migraine OR BOTH of the following: The patient has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND The requested agent and strength is FDA approved for episodic migraine OR The requested agent is being used for episodic cluster headache treatment AND BOTH of the following: The prescriber has provided information indicating improvement in cluster headaches management with the requested agent AND The requested agent and strength is FDA approved for episodic cluster headache treatment OR The requested agent is being used for acute migraine treatment AND ALL of the following: The prescriber has provided information indicating improvement in acute migraine management with the requested agent AND The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., triptan, 5HT-1F, ergotamine, acute use CGRP) AND The requested agent and strength is FDA approved for acute migraine treatment OR Medication overuse headache has been ruled out OR BOTH of the following: ONE of the following: The patient has another FDA approved indication for the requested agent and route of administration OR The patient has another indication that is supported in compendia for the requested agent and route of administration AND The patient has had clinical benefit with the requested agent AND 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.

Module

Clinical Criteria for Approval

Initial Evaluation

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

ONE of the following:
1. The requested agent is being used for migraine prophylaxis AND ALL of the following:
  1. ONE of the following:
    1. The patient has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND ALL of the following:
      1. Greater than or equal to 15 headache days per month of migraine-like or tension-like headache for a minimum of 3 months AND
      2. Greater than or equal to 8 migraine headache days per month for a minimum of 3 months AND
      3. The patient will NOT be using the requested agent in combination with another prophylactic use CGRP AND
      4. The requested agent and strength is FDA approved for chronic migraine prophylaxis OR
    2. The patient has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND ALL of the following:
      1. ONE of the following:
        
        The patient has greater than 4 migraine headache days per month OR
        
        The patient’s migraine headaches last greater than 12 hours OR
        
        The patient’s migraine attacks cause significant disability or diminished quality of life despite appropriate therapy with acute agents only OR
        
        The patient has contraindications to acute therapies OR
        
        The patient has tried and received inadequate response to acute therapies OR
        
        The patient has serious side effects to acute therapies OR
        
        The patient is at risk of medication overuse headache without preventative therapy AND
      2. The patient will NOT be using the requested agent in combination with another prophylactic use CGRP agent AND
      3. The requested agent and strength is FDA approved for episodic migraine prophylaxis AND
  2. ONE of the following:
    1. The patient has tried and had an inadequate response to at least one migraine prophylaxis class [i.e., anticonvulsants (i.e., divalproex, valproate, topiramate), beta blockers (i.e., atenolol, metoprolol, nadolol, propranolol, timolol), antidepressants (i.e., amitriptyline, venlafaxine), candesartan] after an adequate trial as defined by BOTH of the following:
      1. The trial length was at least 6 weeks at generally accepted doses AND
      2. The patient was greater than or equal to 80% adherent to the prophylaxis agent during the trial OR
    2. The patient has an intolerance or hypersensitivity to therapy with at least one migraine prophylaxis class listed above OR
    3. The patient has an FDA labeled contraindication to ALL migraine prophylaxis agents listed above AND
  3. ONE of the following:
    1. The requested agent is a preferred agent OR
    2. The requested agent is a non-preferred agent and ALL of the following:
      1. The patient has tried and had an inadequate response to ONE preferred agent(s) OR
      2. The patient has an intolerance or hypersensitivity to ONE preferred agent(s) OR
      3. The patient has an FDA labeled contraindication to ALL preferred agent(s) AND
  4. Medication overuse headache has been ruled out OR
2. The requested agent is being used for the treatment of episodic cluster headache AND ALL of the following:
  1. The patient has a diagnosis of episodic cluster headache as confirmed by ALL of the following:
    1. The patient has had at least 5 cluster headache attacks AND
    2. The patient has at least two cluster period 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
  2. ONE of the following:
    1. The patient has tried and had an inadequate response to verapamil, melatonin, corticosteroids, topiramate, OR lithium OR
    2. The patient has an intolerance or hypersensitivity to verapamil, melatonin, corticosteroid, topiramate, OR lithium OR
    3. The patient has an FDA labeled contraindication to verapamil, melatonin, corticosteroid, topiramate, AND lithium AND
  3. Medication overuse headache has been ruled out AND
  4. The requested agent and strength is FDA approved for episodic cluster headache treatment 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 tried and had an inadequate response to at least one triptan agent OR
    2. The patient has an intolerance or hypersensitivity to a triptan agent OR
    3. The patient has an FDA labeled contraindication to ALL triptan agents AND
  2. The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., triptan, 5HT-1F, ergotamine, acute use CGRP) AND
  3. Medication overuse headache has been ruled out AND
  4. The requested agent and strength is FDA approved for acute migraine treatment OR
4. The patient has another FDA approved 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
If the patient has an FDA labeled indication,ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
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:

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:

The patient has been approved for the requested agent previously through the plan’s Prior Authorization process AND
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 prescriber has provided information indicating improvement in migraine prevention (e.g., reduced migraine headache days, reduced migraine frequency, reduced use of acute abortive migraine medication) 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:
        
        BOTH of the following:
        
        The patient has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND
        
        The requested agent and strength is FDA approved for chronic migraine OR
        
        BOTH of the following:
        
        The patient has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND
        
        The requested agent and strength is FDA approved for episodic migraine OR
    2. The requested agent is being used for episodic cluster headache treatment AND BOTH of the following:
      1. The prescriber has provided information indicating improvement in cluster headaches management with the requested agent AND
      2. The requested agent and strength is FDA approved for episodic cluster headache treatment OR
    3. The requested agent is being used for acute migraine treatment AND ALL of the following:
      1. The prescriber has provided information indicating improvement in acute migraine management with the requested agent AND
      2. The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., triptan, 5HT-1F, ergotamine, acute use CGRP) AND
      3. The requested agent and strength is FDA approved for acute migraine treatment OR
  2. Medication overuse headache has been ruled out OR
2. BOTH of the following:
  1. ONE of the following:
    1. The patient has another FDA approved indication for the requested agent and route of administration OR
    2. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  2. The patient has had clinical benefit with the requested agent AND
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
QL with PA	Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the limit OR ALL of the following: The requested quantity (dose) is greater than the program quantity limit AND The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND If the requested agent is being used for treatment of acute migraine, the patient has greater than 4 migraine headaches per month AND ONE of the following: 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), onabotulinum toxin A (Botox)] OR 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), OR onabotulinum toxin A (Botox)] OR 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), AND onabotulinum toxin A (Botox)] OR The prescriber has provided information that the patient’s migraine is manageable with acute therapy alone AND The prescriber has provided information in support of therapy with a higher dose for the requested indication 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

Module

Clinical Criteria for Approval

QL with PA

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

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the limit OR
ALL of the following:
1. The requested quantity (dose) is greater than the program quantity limit AND
2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
3. If the requested agent is being used for treatment of acute migraine, the patient has greater than 4 migraine headaches per month AND 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), onabotulinum toxin 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), OR onabotulinum toxin 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), antidepressants (i.e., amitriptyline, venlafaxine), candesartan, prophylactic use CGRP (e.g., Aimovig, Ajovy, Emgality, Vyepti), AND onabotulinum toxin A (Botox)] OR
  4. The prescriber has provided information that the patient’s migraine is manageable with acute therapy alone AND
4. The prescriber has provided information in support of therapy with a higher dose for the requested indication

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

Length of Approval:

Initial:

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