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

American Headache Society

Disclosures

Headache 

In This Article

Abstract and Introduction

Abstract

Objective: To provide healthcare professionals with updated guidance in the use of novel preventive and acute treatments for migraine in adults.

Background: The principles of preventive and acute pharmacotherapy for patients with migraine have been outlined previously, but the emergence of new technologies and treatments, as well as new formulations of previously established treatments, has created a need for an updated guidance on the preventive and acute treatment of migraine.

Methods: This statement is based on a review of existing guidelines and principles for preventive and acute treatment of migraine, as well as the results of recent clinical trials of drugs and devices for these indications. Input was sought from health insurance providers, employers, pharmacy benefit service companies, device manufacturers, pharmaceutical and biotechnology companies, patients, and patient advocates. Expert clinicians and researchers in the field of headache medicine from across North America and the European Union provided input and feedback.

Results: The principles of pharmacologic preventive treatment of migraine with oral treatments have been as follows: use evidence-based treatments when possible and appropriate; start with a low dose and titrate slowly; reach a therapeutic dose if possible; allow for an adequate treatment trial duration; establish expectations of therapeutic response and adverse events; and maximize adherence. Newer injectable treatments may work faster and may not need titration. The principles of acute treatment include: use evidence-based treatments when possible and appropriate; treat early after the onset of a migraine attack; choose a nonoral route of administration for selected patients; account for tolerability and safety issues; consider self-administered rescue treatments; and avoid overuse of acute medications. Neuromodulation and biobehavioral therapy may be appropriate for preventive and acute treatment, depending on the needs of individual patients. Neuromodulation may be useful for patients who prefer nondrug therapies or who respond poorly, cannot tolerate, or have contraindications to pharmacotherapy.

Conclusions: This statement updates prior recommendations and outlines the indications for initiating, continuing, combining, and switching preventive and acute treatments of migraine.

Introduction

Migraine is a chronic neurologic disease characterized by attacks of throbbing, often unilateral headache that are exacerbated by physical activity and associated with photophobia, phonophobia, nausea, vomiting,[1] and, in many patients, cutaneous allodynia.[2–6] About one third of patients have migraine with an aura that precedes or occurs during some attacks, while approximately three quarters of patients experience a premonitory phase prior to the onset of headache.[7] Diagnoses of migraine can be refined based on the frequency of monthly migraine days (MMDs) and monthly headache days (MHDs); patients with fewer than 15 MMDs or MHDs have episodic migraine, and those with at least 15 MHDs, of which at least 8 are MMDs, have chronic migraine (Table 1).[1]

Migraine is very common, and the burden of illness is often substantial. The 1-year period prevalence in women and men is 18 and 6%, respectively, and prevalence peaks between the ages of 25 and 55.[8–10] Attacks can significantly impair functional ability at work or school, at home, and in social situations.[11–13] Migraine ranks as the second most disabling neurologic condition globally in terms of years lost to disability.[14,15] Migraine is associated with a considerable financial burden, with annual total costs estimated at $27 billion in the United States.[16,17]

The pain and associated symptoms of migraine, as well as its life consequences, can be addressed with acute treatments, preventive treatments, or both.[18,19] However, because the severity, frequency, and characteristics of migraine vary among persons and, often, within individuals over time,[20] and symptom profiles or biomarkers that predict efficacy and side effects for individuals have not yet been identified,[21,22] optimizing treatment for particular patients remains challenging. At present, treatment plans are individualized based on patient preference; status with respect to pregnancy, lactation, or plans to conceive; the frequency and severity of attacks; the presence, type, and severity of associated symptoms; attack-related disability; prior treatment response; the presence of comorbid and coexistent illness; contraindications (eg, cardiovascular disease); factors such as body habitus and physiological measures (eg, blood pressure, heart rate); and the use of concomitant medications. A process of trial and error is often necessary before treatment can be optimized.

The development and emergence of novel medications, device technologies, novel formulations of established drug therapies, and biologics has led to much needed advances in the acute and preventive treatment of migraine. The appropriate and cost-effective integration of these new treatments is of utmost importance to prescribing healthcare providers and their patients. The American Headache Society, in keeping with its mission of improving the lives of people with headache, and in response to requests from multiple stakeholders, sought to establish clinical parameters for the initiation and continuation of novel acute and preventive treatments. Input was therefore elicited from multiple stakeholders, including health insurance providers, employers, pharmacy benefit service companies, device manufacturers, pharmaceutical and biotechnology companies, patients, patient advocates, and experts in headache medicine from North American and Europe.

This statement on the principles of migraine medical care is designed to provide healthcare professionals with guidance in the use of preventive and acute treatments. It contains information about:

  • Preventive and acute treatment goals

  • Indications for preventive treatment

  • Identification of patients who need prevention

  • Identification of patients who need a novel acute or preventive treatment

  • Successful treatment plans

Much of this information has been previously described[21,23–27] and is based on the pioneering work of Silberstein and the US Headache Consortium. Since then, studies of new neuromodulation technologies and medical therapies require updated expert guidance on the use of preventive treatment for patients with migraine. In addition, neuromodulation, pharmacotherapies, biologics, new formulations of previously established acute, migraine-specific treatments, and biobehavioral therapies have recently been evaluated. This statement updates prior recommendations. The hope is that providers will find this document helpful in selecting the appropriate patient for selected acute and preventive treatments to improve outcomes among their migraine patients with unmet needs.

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