ahs guidance

Click here if your patients are having issues using their co-pay card or their co-pay is higher than normal at the pharmacy.

AHS GUIDANCE FOR TREATMENT COURSE
AHS GUIDANCE FOR ANTI-CGRP PATHWAY mAbs

Synopsis of AHS criteria for initiation and trial period for acute and preventive therapy

ACUTE THERAPIES

AHS guidance for acute therapy¹

Acute treatments are taken at the first sign of a migraine attack to reduce pain and attack-related disability.

Acute therapy considerations¹

Use evidence-based treatments, reserving migraine-specific agents for moderate or severe attacks and mild-to-moderate attacks that respond poorly to nonspecific therapies. AHS-listed acute therapies

ACUTE THERAPIES¹×

A nonoral formulation should be used in patients whose attacks are associated with severe nausea or vomiting, who do not respond well to traditional oral treatments, or who have trouble swallowing orally administered medications.

Use of acute treatments should be limited to an average of 2 headache days per week. Patients who exceed this limit should be offered preventive treatment.

PREVENTIVE THERAPIES

AHS guidance for preventive therapy¹

Preventive treatments should be considered for migraine patients with ≥4 monthly headache days or when attacks significantly interfere with patients’ daily lives despite acute treatment.

Preventive therapy considerations¹

Using evidence-based treatments is critical to the success of preventive treatment. AHS-listed oral preventive therapies

Oral Preventive Therapies^1,*×

Oral treatments should be started at a low dose and titrated slowly until the target response develops, the maximum or target dose is reached, or tolerability issues emerge.

With oral treatments, an adequate trial for oral preventive therapy is at least 8 weeks at a target therapeutic dose; if there is no response after 8 weeks at a target or usual effective dose, switching preventive treatments is recommended.

ANTI-CGRP PATHWAY mAb THERAPY

Anti-CGRP pathway mAb therapies are classified by the AHS as evidence based preventive treatments, based on reliable evidence supporting efficacy and safety. These treatments may be appropriate for both episodic and chronic migraine patients, dependent on the below specifications.¹

For episodic migraine patients, the AHS indicates initiation of anti-CGRP pathway mAb therapy after failure on ≥2 oral preventives if they continue to experience either¹:

4-7 MMDs with moderate disability
8-14 MMDs

For chronic migraine patients (≥15 MMDs), the AHS indicates initiation of anti-CGRP pathway mAb therapy if they experience¹:

Failure on ≥2 oral preventives or failure after 2 quarterly injections of onabotulinumtoxinA

Anti-CGRP pathway mAb therapy considerations¹

Anti-CGRP pathway mAbs are dosed monthly or quarterly.

The AHS recommends that the benefits of anti-CGRP pathway mAbs be assessed after 3 months of treatment for those administered monthly and 6 months for those administered quarterly.

For full AHS Guidance on the use of acute, preventive, and anti-CGRP pathway mAb therapy, refer to The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice

AHS GUIDANCE FOR ANTI-CGRP PATHWAY mAbs

AHS = American Headache Society; CGRP = calcitonin gene-related peptide; mAbs = monoclonal antibodies; MMDs = monthly migraine days.

AHS criteria for initiation and follow-up for anti-CGRP pathway mAb therapy in adult episodic migraine patients

Assess frequency and impact of migraine¹

Episodic Migraine:

4-7 MMDs with at least moderate disability (MIDAS ≥11; HIT-6 >50)

8-14 MMDs

(no disability requirement)

Chronic Migraine:

≥15 MMDs (no disability requirement)

MIDAS and HIT-6 questionnaires evaluate migraine burden

The MIDAS and HIT-6 questionnaires assess impact across these general categories^2,3:

The MIDAS Questionnaire measures the days missed or impacted by migraine over the past 3 months^2,3
The HIT-6 survey measures patient limitations and physical changes on a 5-point scale over the past 4 weeks²

Determine medication history¹

Episodic Migraine:

Inadequate response or intolerability over an 8-week trial on ≥2 prior oral preventive therapies

Chronic Migraine:

Inadequate response or intolerability over an 8-week trial on ≥2 prior oral preventive therapies OR to a minimum of 2 quarterly injections (6 months) of onabotulinumtoxinA

Preventive therapies

Oral preventive therapies

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

Other preventive therapies

OnabotulinumtoxinA^†

*Not for use in women of childbearing potential who are not using an appropriate method of birth control.

†Prevention of chronic migraine.

If patient meets criteria listed above, consider initiating anti-CGRP pathway mAb therapy¹

The patient questionnaire available for download below can help you assess migraine impact and determine whether an anti-CGRP pathway mAb may be an appropriate treatment choice.²

PATIENT MIGRAINE IMPACT QUESTIONNAIRE

Assess anti-CGRP pathway mAb effectiveness after 3 months¹

According to the AHS Consensus Statement, “With injectable CGRP mAbs, determinations of clinical benefit should be assessed after at least 3 months of treatment for those administered monthly.”

AHS GUIDANCE FOR TREATMENT COURSE

AAN = American Academy of Neurology; AHS = American Headache Society; CGRP = calcitonin gene-related peptide; HIT-6 = Headache Impact Test; mAbs = monoclonal antibodies;

MIDAS = Migraine Disability Assessment.

Indication

Aimovig^® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

Important Safety Information

Contraindication: Aimovig^® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig^® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig^® and initiate appropriate therapy.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig^® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig^® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

Monitor patients treated with Aimovig^® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig^® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig^® was discontinued in many of the reported cases.

Monitor patients treated with Aimovig^® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig^® is warranted if evaluation fails to establish an alternative etiology.

Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig^®-treated patients and more often than placebo) were injection site reactions and constipation.

Please see Aimovig^® full Prescribing Information.

Important Safety Information

Contraindication: Aimovig^® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig^® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe

References: 1. American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021. doi:10.1111/head.14153. 2. D’Amico D, Tepper SJ. Prophylaxis of migraine: general principles and patient acceptance. Neuropsychiatr Dis Treat. 2008;4(6):1155-1167. 3. Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(suppl 1):S20-S28. doi:10.1212/wnl.56. suppl_1.s20. 4. Data on file, Amgen; 2023.

PRESCRIBING INFORMATION