The American Headache Society Position Statement on Integrating New Migraine Treatments Into Clinical Practice

American Headache Society

Headache

Conclusions

Patients with migraine featuring severe, disabling, or frequent attacks, as well as those who cannot tolerate or are nonresponsive to acute treatment, are candidates for preventive treatment. The decision to initiate preventive treatment should be based on the frequency of individual attacks, average number of days with migraine or moderate or severe headache, and degree of disability. The choice of treatment should be based on evidence of efficacy, provider experience, tolerability, patient preference, headache subtype, comorbid and coexistent disease, concomitant medications, and the potential for childbearing. The principles of preventive treatment with oral treatments include initiating treatment with evidence-based treatments at a low dose, titrating until clinical benefits are achieved, giving each treatment a trial of 2 to 3 months, avoiding overuse of acute treatments. Measuring the overall efficacy and tolerability of preventive treatment is a patient-driven decision made in partnership and after consultation with their healthcare provider. Validated patient-centric outcome measures that evaluate the effect of treatment on functional capacity, disability, and quality of life are important for guiding clinical treatment decisions to continue, add, combine, or switch preventive treatments.

Many evidence-based acute treatments are available, including triptans, ergotamine derivatives, NSAIDs (including aspirin), nonopioid analgesics, and analgesic combinations. As with preventive pharmacologic treatment, to individualize the choice of medication(s), evidence of efficacy, potential medication side effects, patient-specific contraindications, and drug interactions should be considered. Noninvasive vagus nerve stimulation is approved for the acute treatment of migraine pain, and single-pulse transcranial magnetic stimulation, supraorbital nerve stimulation are nonpharmacologic options that may be effective for the acute and preventive treatment of migraine, especially in those for whom pharmacologic treatment is contraindicated, poorly tolerated, ineffective, or not preferred. Empirically validated behavioral treatments with Grade A evidence for the prevention of migraine, including CBT, biofeedback, and relaxation therapies, should be considered in the management of migraine. These modalities may also be used alone or in addition to pharmacologic treatment, particularly in those with a partial therapeutic response and are excellent options for pregnant/lactating women as well as people with contraindications to certain treatments. In addition, all people with migraine will benefit from education and migraine-related lifestyle guidance.

It is the intent of the American Headache Society that this position statement will be reviewed annually and updated, if appropriate, based on the emergence of new evidence.

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Acknowledgment
The American Headache Society gratefully acknowledges the writing and editorial assistance of Mr. Christopher Caiazza.

Abbreviations
AE adverse event, CBT cognitive behavioral therapy, CGRP calcitonin gene-related peptide, DHE dihydroergotamine, FIS Functional Impairment Scale, HIT Headache Impact Test, HRQoL health-related quality of life, ICHD International Classification of Headache Disorders, IM intramuscular, IV intravenous, mAbs monoclonal antibodies, MFIQ Migraine Functional Impact Questionnaire, MHD monthly headache day, MIDAS Migraine Disability Assessment, Migraine-ACT Migraine Assessment of Current Therapy, MMD monthly migraine day, MPFID Migraine Physical Function Impact Diary, MSQ Migraine-Specific Quality of Life, mTOQ Migraine Treatment Optimization Questionnaire, NSAID nonsteroidal anti-inflammatory drug, PGIC Patient Global Impression of Change, PPMQ-R Patient Perception of Migraine Questionnaire-Revised, SC subcutaneous, WPAI Work Productivity and Activity Impairment

Table 1. ICHD-3 Criteria for Episodic and Chronic Migraine ¹
Episodic migraine
A. At least 5 attacks fulfilling criteria B–D
B. Headache attacks lasting 4–72 hours (when untreated or unsuccessfully treated)
C. Headache has at least 2 of the following 4 characteristics: Unilateral location Pulsating quality Moderate or severe pain intensity Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
D. During headache at least 1 of the following: Nausea and/or vomiting Photophobia and phonophobia
E. Not better accounted for by another diagnosis
Chronic migraine
A. Migraine-like or tension-type-like headache on ≥15 days/month for >3 months that fulfill criteria B and C
B. Occurring in a patient who has had at least 5 attacks fulfilling criteria B-D for migraine without aura and/or criteria B and C for migraine with aura
C. On ≥8 days/month for >3 months, fulfilling any of the following: Criteria C and D migraine without aura Criteria B and C for migraine with aura Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative
D. Not better accounted for by another diagnosis

ICHD, International Classification of Headache Disorders.

Table 2. Identifying Patients for Preventive Treatment ⁸ – Modified Criteria
Prevention should be…	Headache days/month	Degree of disability required^†
Offered	6 or more	None
	4 or more	Some
	3 or more	Severe
Considered	4 or 5	None
	3	Some
	2	Moderate

^†As measured by scores on the Migraine Disability Assessment scale.²⁹

Table 3. ICHD-3 Criteria for Medication Overuse Headache
A) Headache occurring on ≥15 days/month in a patient with a preexisting headache disorder
B) Regular overuse for >3 months of 1 or more drugs that can be taken for acute and/or symptomatic treatment of headache, with medication overuse defined as: 10 or more days/month for ergot derivatives, triptans, opioids, combination analgesics^†, and a combination of drugs from different classes that are not individually overused 15 or more days/month for nonopioid analgesics, acetaminophen, and NSAIDs (including aspirin)
C) Not better accounted for by another diagnosis

ICHD, International Classification of Headache Disorders; NSAID, nonsteroidal antiinflammatory drug.
^†Drugs of 2 or more classes, each with analgesic effect (eg, acetaminophen+codeine) or acting as adjuvants (eg, caffeine).

Table 4. Treatments With Evidence of Efficacy in Migraine Prevention (Adapted from Silberstein et al ¹⁹)
Established efficacy^†	Probably effective^‡	Possibly effective^§
Antiepileptic drugs^∥	Antidepressants	ACE inhibitors: Lisinopril
Divalproex sodium^∥	Amitriptyline	Alpha-agonists
Valproate sodium^∥	Venlafaxine	Clonidine
Topiramate^∥	Beta-blockers	Guanfacine
Beta-blockers	Atenolol	Antiepileptic drugs: Carbamazepine
Metoprolol	Nadolol	Beta-blockers
Propranolol		Nebivolol
Timolol		Pindolol
Triptans: Frovatriptan^¶		Antihistamines: Cyproheptadine
OnabotulinumtoxinA³²		Angiotensin receptor blockers: Candesartan

ACE, angiotensin-converting enzyme.
^†More than 2 Class I trials based on AAN Scheme for Classification of Evidence.³³
^‡One Class I or 2 Class II studies based on AAN Scheme for Classification of Evidence.³³
^§One Class II study based on AAN Scheme for Classification of Evidence.³³
^∥Not for use in women of childbearing potential who are not using an appropriate method of birth control.^{34, 35}
^¶ Short-term prevention of menstrual migraine.
^‡‡ For prevention of chronic migraine.

Table 5. Indications for Initiating Treatment With Monoclonal Antibodies to Calcitonin Gene-Related Peptide or Its Receptor
Use is approved when ALL of the following are met:
A. Prescribed by a licensed medical provider^†
B. Patient is at least 18 years of age
C. Diagnosis of ICHD-3 migraine with or without aura^‡ (4–7 monthly headache days) and both of the following: a. 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 treatments (established efficacy or probably effective) according to AAN-AHS guideline b. At least moderate disability (MIDAS>11, HIT-6>50)
D. Diagnosis of ICHD-3 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 treatments (established efficacy or probably effective) according to AAN-AHS guideline
E. Diagnosis of ICHD-3 chronic migraine^‡ and EITHER a or b: a. 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 treatments (established efficacy or probably effective) according to AAN-AHS guideline b. Inability to tolerate or inadequate response to a minimum of 2 quarterly injection (6 months) of onabotulinumtoxinA

AAN-AHS, American Academy of Neurology-American Headache Society; HIT, Headache Impact Test; ICHD, International Classification of Headache Disorders; MHDs, monthly headache days; MIDAS, Migraine Disability Assessment.
^†Doctor of medicine, doctor of osteopathy, advanced practice provider (DDS [Doctor of Dental Surgery] or DMD [Doctor of Medicine in Dentistry or Doctor of Dental Medicine]).
^‡Patient can only meet criteria for C, D, or E.
^§Not for use in women of childbearing potential who lack an appropriate method of birth control.^{34, 35}

Table 6. Criteria for Continuation of Monoclonal Antibodies to Calcitonin Gene-Related Peptide or Its Receptor or Neuromodulation Therapy ^†
Reauthorization after initial use^‡ is approved when EITHER of the following criteria are met:
1. Reduction in mean monthly headache days of ≥50% relative to the pretreatment baseline (Diary documentation or healthcare provider attestation)
2. A clinically meaningful improvement in ANY of the following validated migraine-specific patient-reported outcome measures: a. MIDAS Reduction of ≥5 points when baseline score is 11–20 Reduction of ≥30% when baseline scores >20 b. MPFID Reduction of ≥5 points c. HIT-6 Reduction of ≥5 points

HIT, Headache Impact Test; MHD, monthly headache day; MIDAS, Migraine Disability Assessment; MPFID, Migraine Physical Function Impact Diary.
Reauthorization duration: Indefinite; guided by patient response and healthcare provider attestation.
^†Exceptions to these criteria may be made under circumstances when deemed medically indicated by the prescribing licensed healthcare provider.
^‡Initial authorization: 3 months for treatments administered monthly; for treatments delivered quarterly (every 3 months), 2 cycles of treatment (6 months).

Table 7. Assessment of Acute Treatments for Migraine ¹⁸
Established efficacy^†	Probably effective
Triptans	Ergotamine and other forms of DHE
Ergotamine derivatives	NSAIDs: ketoprofen, IV and IM ketorolac, flurbiprofen
NSAIDs: aspirin, diclofenac, ibuprofen, naproxen	IV magnesium^†
Opioids: butorphanol^§	Isometheptene-containing compounds
Combination medications	Combinations: codeine/acetaminophen, tramadol/acetaminophen^‡
	Antiemetics: prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide

DHE, dihydroergotamine; IV, intravenous; IM, intramuscular; NSAID, nonsteroidal antiinflammatory drug.
^†Consider single-pulse transcranial magnetic stimulation, noninvasive vagus nerve stimulation, or electrical trigeminal nerve stimulation in patients who prefer nondrug treatments or in whom drug treatment is ineffective, intolerable, or contraindicated.
^‡In migraine with aura.
^§Use is not recommended.

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The American Headache Society Position Statement on Integrating New Migraine Treatments Into Clinical Practice

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Appendix A

Validated Instruments That May Be Used to Measure Meaningful Change After a Therapeutic Intervention for Migraine Prevention

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Appendix B

Validated Instruments That May Be Used to Measure Meaningful Change After a Therapeutic Intervention for Acute Treatment of Migraine

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