In May, the US Food and Drug Administration (FDA) approved erenumab (Aimovig), the first in a new class of migraine drugs — the calcitonin gene-related peptide (CGRP) antagonists. At least three more are in the pipeline.
The approval of the CGRP inhibitors has been widely anticipated. And while not all neurologists embrace their merits, headache specialists who spoke to Neurology Today expressed concerns about the hoops they may have to jump through to get prior authorization for the drugs.
In at least two states, the biggest commercial insurance company — a Blue Cross Blue Shield plan in both cases — has a prior authorization policy that requires CGRP-inhibitor prescribers to be certified in headache medicine by the United Council for Neurologic Subspecialties (UCNS).
The problem: Relatively few physicians — fewer than 500 physicians nationally — hold the certification. In Florida, one of the states where an insurer requires the subspecialty certification, only 28 physicians have the credential; in Nebraska, another state with the restriction, just three physicians are certified.
For that reason, the restriction is likely to limit access to the new therapies for many patients who might benefit from them.
“To place such arbitrary limitations on who can prescribe [the CGRP inhibitors] makes no sense,” said Elaine C. Jones, MD, FAAN, chair of the Academy's Payment Policy Subcommittee. The subcommittee is preparing a letter to urge insurers not to restrict access based on arbitrary limitations, and instead to cover erenumab when it is prescribed by a qualified provider, for example, a neurologist, pain specialist, or UCNS-certified headache specialist.
No insurers notified UCNS that its certification was to be used as a prior authorization criteria; nor did it advocate for the policy. But it does think there is value in seeking the expertise of a UCNS-certified specialist.
“Certification should not be used as a means for payors to limit access to treatment but rather as a means of identifying qualified providers,” said UCNS Executive Director Brenda Riggott. “Physicians who are UCNS-certified in headache medicine have proven they meet defined eligibility criteria relating to licensure, training, clinical practice, and expertise in their medical subspecialty,” she said.
“UCNS certification provides payors, health care providers, and patients with a recognized standard that a physician has met the certifying criteria to provide quality care in the subspecialty area and the process has the oversight of respected leaders in the field of neurology.”
Noah Rosen, MD, who serves on the UCNS board of directors, said he think that restrictions are in order in the short term. Requiring prescribers to be certified subspecialists might be appropriate until neurologists learn how the drugs perform in real-world use, said Dr. Rosen, director of Northwell Health's Headache Center and associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Great Neck, NY.
“Although erenumab is one of the best-studied preventive treatments in the field, we still don't know the intricacies of its use,” he said. Low-frequency side effects, efficacy, and safety for patients with comorbid conditions and the appropriate length of treatment are all unknown at this point, he pointed out.
“However,” Dr. Rosen added, “in the longer term, if it is to really to reach the people it needs to get to — the 38-plus million Americans who have migraine, probably half of whom require something preventively — then general neurologists and primary care physicians should be permitted to prescribe this medication.”
Like Dr. Rosen, Elizabeth Loder, MD, MPH, is UCNS-certified in headache medicine but she does not support the use of headache certification as a preauthorization criterion. She believes the insurers who do so are trying to limit access to the drugs to control access — and their costs.
“Certification is not intended as a way to ration access to new treatments,” said Dr. Loder, chief of the division of headache in the department of neurology at Brigham and Women's Hospital and professor of neurology at Harvard Medical School. “I don't like to see insurers trying to achieve one goal — saving money — by invoking board certification status as a necessary requirement for prescribing expensive, new specialty medications.”
THE ICER REPORT
But, Dr. Loder said, excitement about erenumab and its soon-to-be competitors must be tempered by two things: (1) clinical trial results that show, on average, a modest benefit, and 2) no data about the drug's long-term safety.
An analysis of 11 trials for migraine treatments by the Institute for Clinical and Economic Review (ICER) — an independent non-profit research organization that evaluates medical evidence — said CGRP inhibitors, on average, produce a reduction in migraine days comparable in magnitude to those provided by existing treatments.
And what about the pricing? ICER considered that modest benefit when it assessed the cost-effectiveness of erenumab if it were priced at $8,500 per year, as was originally projected. In a draft report last spring, ICER was not enthusiastic.
Erenumab developers Amgen and Novartis launched the drug in May at $6,900 per year, prompting ICER to give it a thumbs-up — with qualifications. Assuming a discount so that payers would pay $5,000 per year, ICER's final report said the drug is cost-effective for patients with chronic and episodic migraine, but only if other treatment options have failed them.
“The drugs were not found to be cost-effective, however, if used to treat patients who had not already tried existing preventive treatments, which are far less expensive,” ICER said in a news release in May. (ICER said its analysis also applies to fremanezumab, but not the other CGRP inhibitors because there were insufficient data to evaluate them.)
Dr. Loder thinks the price remains unjustifiably high. “The company had floated a price of $8,500 a year, so when they came out with $6,900 a year, everybody acted like it was some kind of bargain, but it's not,” she said. “It's still very much out of line with the value that these treatments bring.”
Still, demand for the emerging treatments is likely to be strong because they have less onerous side effects than existing treatments, she said.
Matthew Robbins, MD, chief of neurology at the Jack D. Weiler Hospital, part of the Montefiore Medical Center in New York City, agrees. “Because they work differently than earlier preventive therapies, the new drugs offer hope to patients who are not well served by their previous options, Dr. Robbins said.
“Will there be individual patients who have an excellent response?” Dr. Loder asked. “Yes, very likely. We see that with every drug.”
As per its standard procedure, the ICER report was reviewed by the California Technology Assessment Forum (CTAF) panel, a group of clinicians, patient advocates and others. Based on its evaluation, the CTAF panel recommended two potential prior authorization criteria for payers to determine which patients should have access to CGRP inhibitors: adults with migraine who have four or more headache days per month and patients who have inadequate response to or intolerance of two to three other migraine preventive medications and a reasonable trial of triptan medications.
The panel also addressed prior authorization criteria for providers, but without a clear recommendation. Because most patients with migraine are treated by clinicians who are not neurologists or pain management specialists, the ICER report said payers should consider allowing all clinicians to prescribe CGRP inhibitors to maximize access for appropriate patients.
On the other hand, the CTAF panel said the medications have certain features — a new mechanism of action, very limited safety data, and delivery via self-administered injection, which requires patient training — that typically require specialist prescribing when they are first introduced.
“Payers may consider both coverage options, but the policy roundtable members suggested that allowing broad prescribing is more appropriate in this case given important concerns that access would be too limited if restricted to specialists,” the report said.
WHAT PAYERS THINK
The CTAF panel did not mention UCNS certification as a criterion for prescribers, but some major payers are requiring it.
At Florida Blue, the largest commercial insurer in Florida, the policy for erenumab says: “...the prescriber is a headache specialist (e.g. neurologist, The United Council of Neurologic Subspecialties certified) or has consulted with a headache specialist.” That same wording is used in the policies for Blue Cross and Blue Shield plans in Nebraska, Kansas, and Minnesota.
Blues plans are important payers because they typically dominate their markets. Florida Blue had 49 percent of Florida's “large group” (companies with at least 101 employees) market in 2016, according to the Kaiser Family Foundation. The Blues plan in Nebraska had 52 percent of that state's large group market at that time, the Kansas plan had 77 percent, and the Minnesota plan had 31 percent.
Spokespersons for Florida Blue and Blue Cross and Blue Shield of Nebraska confirmed that their policies mean that prescribers must be UCNS-certified in headache medicine or consult with one.
But there is ambiguity the policies of some insurers, which is apt to create confusion for clinicians. Mary Beth Chambers, manager of corporate communications for Blue Cross Blue Shield of Kansas, provided this statement to Neurology Today: “We do not require that a prescriber have UCNS certification, only that they are a headache specialist or have consulted with a headache specialist; examples of a headache specialist noted in the policy is someone who is a neurologist or is UCNS certified.”
Blue Cross and Blue Shield of Minnesota did not respond to requests about its policy, which is posted online.
Another Blues plan — Blue Cross and Blue Shield of Alabama — includes the UCNS-certification criterion in a draft coverage policy. A spokesperson said the draft is posted on its website “in order to receive comments from providers.”
Those plans are all owner/clients of Prime Therapeutics, a pharmacy benefit manager owned by 18 Blue Cross and Blue Shield plans and representing more than 27 million members. Although some of its plans have established prior authorization criteria for erenumab, the final status of Prime's coverage policy, including prior authorization, will not be determined until the Pharmacy & Therapeutics Committee meets in September, said communications manager Denise Lecher.
When contacted by Neurology Today, some of Prime's owner/clients said they had not yet developed their coverage policies for erenumab, and some did not respond to requests for information. One owner/client — Regence BlueCross BlueShield of Oregon — requires the prescriber to be a neurologist or headache specialist but does not require UCNS certification.
Beyond that, not all of the largest national health insurers are requiring prescribers to have UCNS certification. Of the five largest, UnitedHealthcare says CGRP inhibitors must be prescribed by or in consultation with a neurologist or pain specialist, but subspecialty certification is not required. Anthem and Aetna require prior authorization, but no restrictions apply to prescribers. Humana and Cigna have not announced their coverage policy yet.
Premera Blue Cross, the second largest insurer in Washington state and the largest in Alaska, considered requiring UCNS certification for erenumab prescribers, but opted not to for the time-being, said Chad Murphy, vice president of pharmacy and strategic programs. Premera and its pharmacy and therapeutics committee will be monitoring the utilization of these new therapies and may adjust the policy regarding prescribers if there are safety issues or other data that suggest the drugs are not being prescribed according to their labeled indications, Murphy said.
Premera, which is not affiliated with Prime Therapeutics, has its own pharmacy and therapeutics committee — comprised entirely of clinicians, including a neurologist, who are not Premera employees — that reviews the evidence for therapies and decides whether to require prior authorization.
The committee relied heavily on the ICER report, Murphy said, and set this policy: Erenumab may be considered medically necessary in patients with an average of more than four migraine days per month who have failed at least three preventive migraine therapies (at least two months on each) and are receiving maximum doses of triptan abortive therapy.
Florida Blue declined an interview request, but provided a written explanation of why it requires subspecialty certification for erenumab prescribers: “Treatment of headaches can be very complicated. It requires expertise to understand the seriousness, type, and proper treatment of the headache. With more than 150 different types of headaches and numerous ways to treat, including pharmacological treatments, expertise in this area is recommended. Florida Blue's Aimovig policy supports our member's safety and appropriate treatment by requiring that the prescriber be, or is in consultation with, a headache specialist.”
That argument does not sit well with Dr. Loder. “It seems hypocritical because some of the older treatments we use potentially have just as many safety concerns as these new treatments, so you could argue that you would need an expert for those, too,” she said. “It seems self-serving to (set prescriber criteria) only for this new, expensive class of medications.”
Dr. Jones points to botulinum toxin, a migraine treatment that can be prescribed by any physician. “And it has big risks if it's not used appropriately,” she said.
Because so few physicians have the UCNS headache certification, Dr. Loder worries that insurers' coverage policies will exacerbate treatment inequities.
“We know that migraine is more common in people of low socioeconomic status, and they already have poor access to specialty care,” she said. “It will be the VIPs and those with commercial insurance who will be pushing their way to the front of the line to see board-certified specialists. So, to me, this is a deplorable development.”
Dr. Jones encouraged neurologists who have trouble getting insurers to authorize CGRP inhibitors for appropriate patients to contact the AAN Payment Policy Subcommittee. “We want to know about it so we can help have conversations with the payers,” she said.
Dr. Rosen serves on advisory boards and receives honoraria from Allergan, Amgen, Teva, Eli Lilly, and Promius; he is on the speakers bureau for Allergan. Dr. Robbins reported no conflicts. Dr. Jones is reimbursed by the AAN for travel expenses related to committee and board work.