Group calls for new model of care for migraine

Current recommendations for migraine care do not reflect recent advances in the scientific understanding of migraine disease.

The National Headache Foundation (NHF) has released new migraine care recommendations that challenge health insurance payers for unequal treatment of migraine patients.

“Current models of care have not kept pace with the many advances in treatment,” the NHF said in a statement.1

Payers should adopt patient-centered models of care, in which the clinician – in collaboration with the patient – ​​is the primary decision-maker and selects a treatment that meets the patient’s goals and treatment needs, the NHF said.

“Clinicians and patients are understandably upset that payers are forcing them to use older medications, some of which aren’t even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist,” he said. said Tom Dabertin, CEO and executive of the NHF. director.

“For too long, migraine patients have been treated differently than others with prescription drug-related medical issues,” Dabertin added.

Scientific understanding of migraine has advanced significantly in recent years, providing patients with better-tolerated and better-studied treatments, including anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs), oral CGRP antagonists (gepants) and agents targeting serotonin receptors, the NHF noted.

“There is also a growing awareness among clinicians that what was once considered sufficient efficacy for successful migraine control is, in fact, inadequate,” the NHF said. “Unfortunately, the models of care established by payers and the resulting treatment paradigms have not kept pace with these advances.”

The position of NHF is that the choice of treatment for migraine:

  • should ultimately be determined by the clinician, in collaboration with the patient, based on that patient’s individual needs and that patient’s outcome
  • should not be determined solely by a stepped model of care
  • should not be determined by a single algorithm, including models that focus primarily on costs rather than results

The organization’s specific recommendations are outlined below.

For patients with a minimum of 8 migraine days per month – a number that constitutes high frequency or chronic migraine – the NHF recommends that the clinician be given the opportunity to select the most appropriate preventative treatment, with unlimited access to medication FDA-approved preventatives, for the following reasons:

  • 8 or more migraine days constitute a significant fraction (25% or more) of the month;
  • patients with less time to recover between incidents are more likely to experience a transformation into chronic migraine and more than 15 days per month; and studies suggest that patients with 8-14 headache days/month have a similar level of disability to those with 15-19 headache days/month.
  • For patients with 4-7 migraine days per month, a modified stepped care model is recommended. In this model, patients should first try 1 generic medication for migraine prevention, unless a patient has a contraindication or, in the clinician’s judgment, should not receive it.

This list of generic drugs includes:

  • Topiramate
  • Divalproex, sodium valproate
  • Timolol
  • Propranolol
  • Candesartan
  • Metoprolol
  • Venlafaxine
  • Nortriptyline
  • Amitriptyline

Topiramate, divalproex, sodium valproate, timolol, and propranolol are FDA-approved for migraine prevention. The other drugs are commonly used but have not been approved for this indication.

“If a drug on this list has failed to provide the patient with benefit in terms of migraine severity and/or frequency, or is found to have intolerable side effects, the clinician should be free to select the next most appropriate FDA-approved preventative treatment, based on each patient’s needs and circumstances,” the NHF said.

In the preventive care model recommended by the NHF, a patient is considered to have “tried and failed” with a given medication if at least 1 of the following conditions apply:

  • Patient does not show an adequate response to treatment after a 2-4 month trial, where response is defined as a 50% reduction in the number of migraine days per month during preventive treatment compared to the number of migraine days per month before the start of therapy.
  • The patient cannot tolerate the drug due to its side effects, such as hypotension on beta-blockers, cognitive impairment on topiramate, and weight gain on amitriptyline.

At the time of the decision, the patient has a documented history of having “tried and failed” the medication due to intolerance or lack of benefit from the treatment.

  • The patient has a comorbidity and/or other contraindications that preclude the clinician from prescribing the drug.
  • For the treatment of acute migraine, the NHF approves a modified stepped model of care, in which patients must try 2 generic drugs: first a generic triptan, then any other generic drug, including another triptan or NSAID .

Once a patient has “tried and failed” with 2 of these generic drugs, the clinician can select another suitable treatment based on the patient’s needs. These therapies include acute FDA-approved agents such as lasmiditan (Reyvow) or a gepant (ubrogepant [Ubrelvy], rimegepant [Nurtec ODT]; or atogepant [Qulipta]).

Similar to the preventive care model recommended by the NHF, a patient is considered to have “tried and failed” with acute migraine medication if at least 1 of the following conditions apply:

  • Patient is not migraine pain free and functional within 2 hours of treatment after majority of attacks OR patient has recurrence of migraine symptoms within 24 hours of treatment.
  • The patient does not tolerate the drug because of its adverse effects (eg, tightness in the throat and/or chest with triptans).
  • The patient has a documented history of medications that were either ineffective or intolerable due to side effects.
  • The patient has a comorbidity and/or other contraindication that prevents the clinician from prescribing the drug. This list includes uncontrolled hypertension, coronary artery disease and reversible cerebral vasoconstriction syndrome for triptans or gastric ulcer and renal failure for NSAIDs.

Reference

1. National Headache Foundation Position Statement on the Treatment of Migraine. National Headache Foundation. January 19, 2022. Accessed January 20, 2022. https://headaches.org/2022/01/19/national-headache-foundation-position-statement-on-the-treatment-of-migraine/

About Antoine L. Cassell

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