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SCOTTSDALE -- Which patients should get the new calcitonin gene-related peptide (CGRP) monoclonal antibodies for migraine prevention -- and what will payers agree to?

These are issues the American Headache Society (AHS) will address in an upcoming position paper, said AHS executive committee member David Dodick, MD, of the Mayo Clinic, at the .

With three CGRP inhibitors approved by the FDA this year -- erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality) -- access to the new drugs is an emerging question for patients and physicians.

"We anticipated that these therapies were going to be costly, and we anticipated that would limit access for patients," Dodick said in a plenary session here. To that end, the AHS plans to publish a consensus statement with criteria "to guide clinicians and hopefully, reimbursement authorities in the United States, as to which patients should get access to these therapies."

The recommendations will indicate that, to start treatment with monoclonal antibodies to CGRP or its receptor, patients should have either:

• Diagnosis of episodic migraine, with or without aura, of 4 to 7 monthly headache days per month and both (a) an inability to tolerate or inadequate response to a 6-week trial of at least two of the following drugs: topiramate (Topamax), divaloproex sodium/valproate sodium (Depakote), beta-blockers, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or other Level A or B treatments according to , and (b) at least moderate disability defined by or .
• Diagnosis of ICHD-3 episodic migraine, with or without aura, of 8 to 14 monthly headache days per month and meet the criteria outlined in (a) above, without having to document moderate disability. "We believe that if patients have 8 to 14 monthly headache days per month, the majority will have moderate disability anyway," Dodick noted.
• Diagnosis of ICHD-3 chronic migraine and meet either the criteria outlined in (a) above, or have an inability to tolerate or inadequate response to a minimum of two quarterly injections of onabotulinum toxin A (Botox).

The paper also will outline criteria for reauthorizing use once CGRP monoclonal antibody treatment is started. "The reauthorization duration should be indefinite and guided by patient response and health care provider attestation," Dodick said.

CGRP monoclonal antibodies can be used as adjunctive therapy; they have no specific contraindications and a favorable systemic adverse event profile, Dodick pointed out. "One can imagine that these antibodies would be appropriate for patients who have had previous drug intolerance, or for patients with co-morbid or co-existent diseases that could be worsened by current preventive drugs," he said.

But CGRP monoclonal antibodies come with caveats, mainly around the fact that women of reproductive age are the biggest population of migraineurs. "There's no safety data for pregnant women," Dodick said. "One of the issues is that these drugs have a long half-life. If you've not been having family planning conversations with your patients consistently before, you certainly have to now when you're starting one of these antibodies. We don't know the extent to which they are safe for a pregnant woman or for a developing fetus." There's also no safety data about their use in women who are lactating.

There are many unanswered questions about CGRP monoclonal antibodies -- more unanswered questions than answered ones, Dodick observed. But the AHS position paper will be a first step toward helping physicans use the treatments in clinical practice.

"We believe this is important; we believe we have taken a real advocacy position for our patients," Dodick said. "We have tried to be good stewards of resources and be conscious of cost-effective health care, but we also have tried to outline the type of patient we think should have access to these new and emergent therapies."