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Acute Migraine Agents Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1131
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Elyxyb™ (celecoxib) Oral solution |
Acute treatment of migraine headaches with or without aura in adults Limitations of Use: Elyxyb is not indicated for the preventive treatment of migraine. |
|
12 |
Migranal® (dihydroergotamine mesylate)* Nasal Spray |
Acute treatment of migraine headaches with or without aura Not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine |
*generic available |
1 |
Reyvow® (lasmitidan) Tablet |
Acute treatment of migraine with or without aura in adults Limitations of Use: REYVOW is not indicated for the preventive treatment of migraine. |
|
2 |
Trudhesa™ (dihydroergotamine mesylate) Nasal aerosol |
Acute treatment of migraine with or without aura in adults Limitations of Use: Not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine |
|
10 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Migraine and Cluster Headache Management |
Migraine is a common disabling primary headache disorder with high prevalence, ranking second globally in terms of years lost to disability.(6) Typical characteristics of the headache are unilateral location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity, and association with nausea and/or photophobia and phonophobia. Migraines can present with or without aura, unilateral fully reversible visual, sensory, or other central nervous system symptoms that usually develop gradually and are most-often followed by headache and associated migraine symptoms.(4) The International Classification of Headache Disorders 3rd Edition (ICHD-3) Diagnostic Criteria:(4)
The IHS notes that cluster periods usually last between 2 weeks and 3 months.(4) Migraine prevention may be of benefit in those with the following:(6,7,13)
The American Headache Society (AHS) and the American Academy of Neurology (AAN) suggest the following agents for the prevention of migraine:(3)
The 2021 American Headache Society Consensus Statement recommends the following indications for initiating treatment acute treatment with gepants and ditans agents:(13)
Lasmiditan is a selective serotonin 5HT-1F receptor agonist that lacks vasoconstrictor activity. Lasmiditan is structurally different than triptans and therefore constitutes a new class of drugs called “ditans”.(13) Ditans are selective for the 5HT-1F receptor and its mechanism of action is neuronal without evidence of vasoactive effects.(14) Triptans non-specifically bind to the 5HT-1B and 5HT-1D receptors and with varying affinity bind the 5HT-1F receptors, causing direct vascular vasoconstriction. The safety, tolerability, and efficacy of co-administering lasmiditan with a triptan or a gepant has not been assessed.(13) Patients who do not respond to initial therapy with a triptan, may benefit from a second triptan or different therapy such as use of a gepant (ubrogepant or rimegepant) or a ditan (lasmiditan).(6) The 2021 American Headache Society Consensus Statement recommends the following indications for initiating treatment with a Calcitonin Gene-Related Peptide (CGRP) agent:(13)
The Medical Letter Treatment Guidelines (2023) and Institute for Clinical Systems Improvement Guideline Diagnosis and Treatment of Migraine Headache - Drugs for Migraine states that a triptan is the drug of choice for moderate to severe migraine. The short-acting oral serotonin (5-HT1B/1D) receptor agonists (triptans) sumatriptan (IMITREX, and others), almotriptan (Axert, and generics), eletriptan (RELPAX), rizatriptan (Maxalt, and generics), and zolmitriptan (Zomig, and generics) are similar in efficacy.(15,17) Onset of pain relief generally occurs 30-60 minutes after administration. The longer-acting oral triptans naratriptan (Amerge, and generics) and frovatriptan (Frova, and generics) have a slower onset of action and lower initial response rate than other triptans, but they are better tolerated. Patients with migraine who have nausea or vomiting may not be able to take an oral triptan. Intranasal triptan formulations have a more rapid onset of action than oral tablets, but their efficacy is partially dependent on GI absorption of the portion of the dose that is swallowed. Use of sumatriptan nasal powder (ONZETRA Xsail) results in a faster rise in sumatriptan plasma concentrations and higher peak concentrations than use of a similar dose of sumatriptan nasal spray, suggesting that a larger portion of the dose is absorbed intranasally with the powder. Subcutaneously administered sumatriptan relieves pain faster (in about 10 minutes) and more effectively than other triptan formulations, but it causes more adverse effects.(15) American Headache Society (AHS) (2015): Triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan [oral, nasal spray, injectable, transcutaneous patch], zolmitriptan [oral and nasal spray]) are effective (Level A) and considered by AHS guidelines (2015) to be the gold standard for acute treatment of moderate to severe migraine headaches.(7) Dihydroergotamine is recommended for use as a second- or third-line therapy for select patients or for those with refractory migraine. Intranasal dihydroergotamine has strong evidence of effectiveness but more adverse effects than triptans because of its decreased receptor specificity.(11) An assessment of new migraine treatments by the AHS (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 non-specific nonsteroidal anti-inflammatory drugs (NSAIDs), non-opioid analgesics, acetaminophen, or caffeinated combinations (e.g., aspirin/acetaminophen/caffeine). The recommendation remains that prescribers must consider medication efficacy and potential medication-related adverse effects, potential adverse events, patient-specific contraindications to use with a particular medication, and drug-drug interactions when prescribing acute medications for migraine.(6,7,13) The American Academy of Neurology (AAN) 2010 Guideline: Acute and preventive pharmacologic treatment of cluster headache (CH) state that sumatriptan subcutaneous injection and zolmitriptan nasal spray are first-line options for acute treatment of CH.(16,17) American Headache Society Since the publication of the 2010 AAN review, re-reviewed in 2016, there is no new data from randomized, double-blind, controlled trials that contribute to determining the efficacy or safety for a number of acute treatments, including specifically sumatriptan and zolmitriptan. For acute treatment, sumatriptan subcutaneous, zolmitriptan nasal spray, and high flow oxygen remain the treatments with a Level A recommendation.(18) Guidelines suggest that prophylactic therapy should be started and continued for the duration of the CH 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.(5,16,22) Corticosteroids can be used as transitional or bridging therapy until another prophylaxis agent is established.(22) Corticosteroids may be used by some practitioners for short periods of CH.(5,16) 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:(8)
The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(9)
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.(19,20,21) However the 2021 American Headache Society consensus statement states that CGRP monoclonal antibody treatment (e.g., eptinezumab-jjmr, erenumab, fremanezumab, galcanezumab) may be added to greater than or equal to one established preventative treatment, based on clinical judgement, in adults who meet the ICHD-3 criteria for the following conditions:(4,13)
|
||||||||||||
Medication overuse headache (MOH) |
The European Headache Federation and WHO consensus article (2019) states the following:(8)
|
||||||||||||
Safety |
Elyxyb has the following boxed warnings:(12)
Elyxyb is contraindicated in the following:(12)
Migranal has the following boxed warning:(1) Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. Migranal is contraindicated in the following:(1)
Reyvow has no FDA labeled contraindications for use.(2) Trudhesa has the following boxed warning:(10) Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Trudhesa with strong CYP 3A4 inhibitors is contraindicated. Trudhesa is contraindicated in the following:(10)
|
REFERENCES
Number |
Reference |
1 |
Migranal prescribing information. Bausch Health US, LLC. September 2022. |
2 |
Reyvow prescribing information. Eli Lilly and Company. September 2022. |
3 |
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. |
4 |
International Classification of Headache Disorders-3 (ICHD-3). International Headache Society. 2018. |
5 |
Goadsby PJ. Information for Health Care Professionals: Treatments for Cluster Headache. American Headache Society. 2018 June. https://americanheadachesociety.org/wp-content/uploads/2018/06/Goadsby-Cluster-Headache.docx. |
6 |
American Headache Society. The American Headache Society Position Statement: Update on Integrating New Migraine Treatments Into Clinical Practice. Headache. 2021; 61(7): 1021-1039. doi: 10.1111/head.14153. |
7 |
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. |
8 |
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. https://doi.org/10.1186/s10194-018-0899-2. |
9 |
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. https://doi.org/10.1186/s10194-018-0955-y. |
10 |
Trudhesa prescribing information. Impel Pharmaceuticals Inc. August 2023. |
11 |
Mayans L, Walling A. Acute Migraine Headache: Treatment Strategies. Am Fam Physician. 2018; 97(4): 243-251. |
12 |
Elyxyb prescribing information. BioDelivery Sciences International Inc. September 2021. |
13 |
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. https://doi.org/10.1111/head.14153. |
14 |
Oswald JC, Schuster NM. Lasmiditan for the treatment of acute migraine: a review and potential role in clinical practice. J Pain Res. 2018; 11: 2221-2227. |
15 |
Drugs for Migraine. Med Lett Drugs Ther. 2023 Jun 12; 65(1678):89-96. doi:10.58347/tml.2023.1678a. |
16 |
Francis GJ, Becker WJ, Prinsheim TM. Acute and preventive treatment of cluster headache. Neurology 2010; 75(5): 463-473. |
17 |
Beithon J, Gallenberg M, Johnson K, Kildahl P, Krenik J, Liebow M, Linbo L, Myers C, Peterson S, Schmidt J, Swanson J. Institute for Clinical Systems Improvement. Diagnosis and Treatment of Headache. ICSI. Updated January 2013. https://www.icsi.org/wp-content/uploads/2019/01/Headache.pdf. |
18 |
Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. 2016; 56: 1093-106. doi:10.1111/head.12866. |
19 |
Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomized, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun; 16(6): 425-434. doi: 10.1016/S1474-4422(17)30083-2. |
20 |
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. |
21 |
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. |
22 |
Weaver-Agostoni, J. Cluster headache. American Family Physician. 2013 Jul 15; 88(2): 122-128. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Final Module |
Target Agent GPI |
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Targeted NDCs When Exclusions Exist |
Final Age Limit |
Preferred Status |
Effective Date |
|
|||||||||
|
676040300020 |
Elyxyb |
celecoxib oral soln |
120 MG/4.8ML |
M ; N ; O ; Y |
|
|
|
|
|
67000030102060 |
Migranal |
Dihydroergotamine Mesylate Nasal Spray 4 MG/ML |
4 MG/ML |
M ; N ; O ; Y |
|
|
|
|
|
674065406003 |
Reyvow |
lasmiditan succinate tab |
100 MG ; 50 MG |
M ; N ; O ; Y |
|
|
|
|
|
670000301134 |
Trudhesa |
dihydroergotamine mesylate hfa nasal aerosol |
0.725 MG/ACT |
M ; N ; O ; Y |
|
|
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Wildcard |
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Targeted NDCs When Exclusions Exist |
Age Limit |
Effective Date |
Term Date |
|
|||||||||||
67604030002020 |
Elyxyb |
Celecoxib Oral Soln |
120 MG/4.8ML |
6 |
Bottles |
30 |
DAYS |
|
|
|
|
67000030102060 |
Migranal |
Dihydroergotamine Mesylate Nasal Spray 4 MG/ML |
4 MG/ML |
8 |
mLs |
28 |
DAYS |
|
|
|
|
67406540600320 |
Reyvow |
Lasmiditan Succinate Tab 100 MG |
100 MG |
8 |
Tablets |
30 |
DAYS |
|
|
|
|
67406540600310 |
Reyvow |
Lasmiditan Succinate Tab 50 MG |
50 MG |
8 |
Tablets |
30 |
DAYS |
|
|
|
|
67000030113420 |
Trudhesa |
Dihydroergotamine Mesylate HFA Nasal Aerosol |
0.725 MG/ACT |
12 |
mLs |
28 |
DAYS |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Client Formulary |
|
|||
Elyxyb |
celecoxib oral soln |
120 MG/4.8ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Migranal |
Dihydroergotamine Mesylate Nasal Spray 4 MG/ML |
4 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Reyvow |
lasmiditan succinate tab |
100 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Trudhesa |
dihydroergotamine mesylate hfa nasal aerosol |
0.725 MG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|||
Elyxyb |
Celecoxib Oral Soln |
120 MG/4.8ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Migranal |
Dihydroergotamine Mesylate Nasal Spray 4 MG/ML |
4 MG/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Reyvow |
Lasmiditan Succinate Tab 100 MG |
100 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Reyvow |
Lasmiditan Succinate Tab 50 MG |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Trudhesa |
Dihydroergotamine Mesylate HFA Nasal Aerosol |
0.725 MG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
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: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
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. |
PRIOR AUTHORIZATION CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS
Module |
Ops Set Up |
Validation Options |
Other Explanation |
|
Validation: Apply Baseline and go to Validation Options |
Age Verification;Contraind., intolerance, or hypersensitivity to prereq.;Diagnosis;Prerequisites |
|
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
QUANTITY LIMIT CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS
Module |
Ops Set Up |
Validation Options |
Other Explanation |
|
Validation: Apply Baseline and go to Validation Options |
Other (see Other explanation field) |
Additional criteria within the QL: *Review info - The patient is currently using a migraine prophylactic medication *Review info - The patient has an intolerance or hypersensitivity to therapy with migraine prophylactic medication *Review info - The patient has an FDA labeled contraindication to ALL migraine prophylactic medications *There is support that the patient's migraines are manageable with acute therapy alone |
DOCUMENT HISTORY
Approval Date MM/YYYY |
Approved By |
Notes |
- |
|
Original Prime Standard criteria approved by P&T UM Committee 06/2020 Original Client Specific Review Prime Standard criteria, approved by BCBS AL 07/2020 Original Implementation 9/1/2020 Prime Standard MidYear Review, with changes, approved by P&T UM Committee 08/2020 Client Specific MidYear Review, Prime Standard criteria, with changes, approved by BCBS AL 09/2020 Annual Review Prime Standard criteria, with changes to criteria, approved by P&T UM Committee 03/2021 Client Specific Annual Review Prime Standard criteria, with changes to criteria, approved by BCBS AL 04/2021 Mid-Year Review Prime Standard criteria, with changes to criteria, approved by P&T UM Committee 06/2021 Client Specific Mid-Year Review Prime Standard criteria, with changes to criteria, approved by BCBS AL 06/2021 Mid-Year Review Prime Standard criteria, with changes to criteria, approved by P&T UM Committee 09/2021 Client Specific Mid-Year Review Prime Standard criteria, with changes to criteria, to be approved by BCBS AL 09/2021 Administrative Action (addition of Trudhesa) 10/2021 Annual Review Prime Standard criteria, with changes to criteria, approved by P&T UM Committee 02/2022 Client Specific Annual Review Prime Standard criteria, with changes to criteria, approved by BCBS AL 02/2022 |
3-2023 |
BCBS AL |
Client Specific Annual Review Prime Standard criteria, with changes to criteria |
7-2023 |
|
Administrative Action (UM Claim Automation Implementation (POS edit)) |
2-2024 |
BCBS AL |
Client Specific Annual Review Prime Standard criteria, with changes to criteria |
2-2024 |
|
Administrative Action (CSReg - Step Therapy supplement requirements added) |
NOTES FOR OPERATIONS
CO Notes |
Date Created |
Last Date ANY Field Changed |
CSReg - Step Therapy requirements may not apply if the requested medication was previously approved by another health plan and documentation of a paid claim within the past 90 days is submitted |
01-23-2024 09:19:21 AM |
|
TARGET AGENTS Migranal 67000030102060 MNOY Reyvow 674065406003** MNOY Trudhesa 6700003011**** MNOY Elyxyb 6760403000**** MNOY TARGET AGENTS PREREQ with 365 day lookback triptan 674060******** MNOY NONCONCOMITANT TARGET Reyvow 674065406003** MNOY NONCONCOMITANT NOT IN HISTORY with 90 day lookback Nurtec ODT 677010607072** MNOY Ubrelvy 677010800003** MNOY Zavzpret 6770109020**** MNOY Elyxyb 6760403000**** MNOY ergotamine 67000020****** MNOY dihdroergotamine 67000030102060 MNOY BenOps: Diagnosis Code G43 |
01-23-2024 09:01:49 AM |
|
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
Status |
07-01-2024 |
|
Draft Pending |
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.
BCBSAL _ Commercial _ CSReg _ Acute Migraine Agents _PAQL _ 07-01-2024 _ © Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved