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

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)

• Frequent or long-lasting migraine headaches (greater than 4 headaches/month or headaches lasting greater than 12 hours)
• Attacks interfere significantly with patients' daily routines despite acute treatment
• Contraindication to acute therapies
• Failure of acute therapies
• Adverse effects with acute therapies
• Risk of medication overuse headache (MOH)
• Patient preference

The American Headache Society (AHS) and the American Academy of Neurology (AAN) suggest the following agents for the prevention of migraine:(3)

• 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 2021 American Headache Society Consensus Statement recommends the following indications for initiating treatment acute treatment with gepants and ditans agents:(13)

• Prescribed by a licensed clinician
• Patient is at least 18 years of age
• Diagnosis of ICHD-3 migraine with aura, migraine without aura, or chronic migraine
• Either of the following: 
  • Contraindication to or inability to tolerate triptans
  • Inadequate response to two or more oral triptans, as determined by either of the following:
    • Validated acute treatment patient-reported outcoming questionnaire (mTOQ, Migraine-ACT, PPMQ-R, FIS, PGIC)
    • Clinician attestation

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)

• Prescribed by a licensed clinician
• 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 an 8-week trial of at least two 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 or equal to 11, Headache Impact Test-6 [HIT]-6 greater than 50)
  • Diagnosis of migraine with or without aura (8-14 monthly headache days [MHDs]) and inability to tolerate (due to side effects) or inadequate response to an 8-week trial of at least two 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 an 8-week trial of at least two 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 two quarterly injection (6 months) of onabotulinum toxin A

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:

• Civamide
• Suboccipital steroid injection
• Melatonin
• Verapamil
• Lithium

The European Headache Federation and WHO consensus article (2019) states the following:(8)

• Individuals with migraine headaches should always be managed in primary care with the exception being chronic migraine, which likely requires specialist management
• Any headache not responding satisfactorily in primary care or chronic migraine, should be referred to a specialist
• In adults and children, regular high frequency use (greater than 2 day/week) of acute medication risks the development of MOH
• 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 for 10 or more days per month to avoid the risk of MOH
    • 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 vomiting 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
• 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
    • Patient is willing to take daily medication
    • Failure of acute therapy is an indication for migraine prophylaxis
    • For children, frequent absence from school is an additional indication for prophylaxis
  • 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 and not recommended
  • When prophylaxis therapy fails:
    • May be due to subtherapeutic dosage or duration of therapy
    • Failure of one therapy does not predict the failure of another therapy in a different class
    • Review of the following are recommended:
      • Diagnosis
      • Adherence
      • Other medications, especially for MOH 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
• Cluster Headache management:
  • Patients should be referred to a specialist
  • 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
  • Long-term prophylaxis therapy may need to be continued

The European Headache Federation guideline states the following on combining migraine prophylaxis therapy:(9)

• In episodic migraine, guidelines suggest 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, guidelines suggest to add CGRP to ongoing oral prophylaxis therapy
• In chronic migraine patients on onabotulinum A therapy and are receiving inadequate treatment response, guidelines suggest to stop onabotulinum A therapy before starting CGRPs
• In patients with chronic migraine who are on treatment with CGRP and may benefit from additional prevention, guidelines suggest to add on oral preventative agents
• In patients with medication overuse, guidelines suggest 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.(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)

• 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 two established preventive treatments or inadequate tolerability or response to onabotulinum toxin A for two quarterly injections

Medication overuse headache (MOH)

 The European Headache Federation and WHO consensus article (2019) states the following:(8)

• • 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 require management

Safety

Elyxyb has the following boxed warnings:(12)

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use
• Elyxyb is contraindicated in the setting of coronary artery bypass graft (CABG) surgery
• NSAIDs cause an increased risk of serious gastrointestinal GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events

Elyxyb is contraindicated in the following:(12)

• Patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product
• Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
• In the setting of CABG surgery
• Patients who have demonstrated allergic-type reactions to sulfonamides

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)        

• Patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina
• Patients with uncontrolled hypertension
• Use within 24 hours of 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications, or methysergide
• Patients with hemiplegic or basilar migraine
• Patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function
• Pregnant women
• Patients who have previously shown hypersensitivity to ergot alkaloids
• Use with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure

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)

• Concomitant use of strong CYP 3A4 inhibitors
• Patients with ischemic heart disease or coronary artery vasospasm
• Patients with uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
• Patients with hypersensitivity to ergot alkaloids
• Concomitant use of other 5-HT1 agonists (e.g., sumatriptan) or ergotamine-containing or ergot-type medications within 24 hours
• Concomitant use of peripheral and central vasoconstrictors

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.

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

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

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

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

Initial Evaluation

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

1. ONE of the following:
   1. 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 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. ONE of the following:
         1. The requested agent is NOT Reyvow OR
         2. The requested agent is Reyvow AND the patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., 5HT-1F, acute use CGRP, ergotamine, triptan) AND
      3. Medication overuse headache has been ruled out OR
   2. The patient has another FDA labeled indication for the requested agent and route of administration OR
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
2. If the patient has an FDA labeled indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. There is support for using the requested agent for the patient’s age for the requested indication AND
3. 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.

*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:

1. The patient has been approved for the requested agent previously through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. ONE of the following:
   1. The requested agent is being used for acute migraine treatment AND ALL of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. ONE of the following:
         1. The requested agent is NOT Reyvow OR
         2. The requested agent is Reyvow AND the patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., 5HT-1F, acute use CGRP, ergotamine, triptan) AND
      3. Medication overuse headache has been ruled out OR
   2. The patient is using the requested agent for an indication other than acute migraine treatment AND has had clinical benefit with the requested agent AND
3. 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.

Validation:  Apply Baseline and go to Validation Options

Age Verification;Contraind., intolerance, or hypersensitivity to prereq.;Diagnosis;Prerequisites

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

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) exceeds 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 program quantity limit OR
3. ALL of the following:
   1. The requested quantity (dose) exceeds  the program quantity limit AND
   2. The requested quantity (dose) exceeds  the maximum FDA labeled dose for the requested indication AND
   3. 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, Nurtec, Qulipta, 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, Nurtec, Qulipta, 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, Nurtec, Qulipta, Vyepti), AND onabotulinum toxin A (Botox)] OR
      4. There is support that the patient’s migraines are manageable with acute therapy alone AND
   4. There is support of therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

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

-

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)

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

Effective Date

Date of Origin   

Status

07-01-2024           

Draft Pending