An AAPM 2022 Meeting Highlight with Meredith Barad, MD, Nathaniel Schuster, MD, and Rashmi Halker Singh, MD
Three headache specialists tackled the challenging and ongoing issue of migraine headache, which affects about 1 in 10 people in the US, at the American Academy of Pain Medicine (AAPM) 2022 annual meeting. They focused on guidelines for migraine prevention using percutaneous interventional strategies, external neuromodulation devices as a treatment tactic, and growing knowledge of the anti-CGRP monoclonal antibodies.
Migraine Prevention Strategies: What Works
“We need to critically look at the evidence and find out if there is a rationale for the prevention of migraine,” said Meredith Barad, MD, a neurologist by training and clinical associate professor of anesthesiology, perioperative, and pain medicine, and neurology and neurological sciences at Stanford Hospital and Clinics. Her objective is to help neurologists and pain management clinicians to clearly understand the current evidence on appropriate use of percutaneous interventions for migraine prevention.
Dr. Barad chaired an expert panel brought together – in person, she pointed out, as it was pre-COVID – to address this question.
The current guidelines(https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14153) on preventive migraine treatments recommend offering prevention for individuals with 6 headache days a month without impairment, 4 a month with some impairment, or 3 a month with severe impairment. The panel also addressed episodic migraine (EM) and chronic migraine (CM), the latter of which is often described as 15 headache days or more per month. The panel combed the literature, finding 16 RCTS to evaluate, with two excluded due to inadequate outcome reporting. In evaluating the treatments, they focused on whether the selected treatment was more effective than saline or sham.
The panel’s conclusions:
Strong recommendation for onabotulinum toxin A for CM, weak for EM
Weak recommendation for greater occipital nerve blocks in CM; insufficient evidence for EM
Weak recommendation against the use of steroid and local anesthetic (LA) over LA alone for greater occipital nerve blocks (GONBs)
Weak recommendation for GONB and supraorbital (SON) blocks
Weak recommendation for sphenopalatine ganglion (SPG) block in CM
Insufficient evidence to assess trigger point injections (TPIs) with LA
Weak recommendation for pulsed radiofrequency (PRF) of the third occipital nerve (TON)
Weak recommendation for implantable stimulation over sham for CM prevention
Strong recommendation against intrathecal medication for reducing headache days per month, medication use, impairment
Practical Takeaway: “Evidence for percutaneous interventions for migraine is lacking,” as demonstrated by their analysis, Dr. Barad told PPM after the AAPM session. “There is a lot of work to do in the correct way to run an RCT.” Also important, she noted, is that “Clinical pain investigators should partner with headache specialists to focus on outcomes and follow up intervals that are meaningful and translatable to headache providers.”
External Modulation Devices for Migraine
Nathaniel Schuster, MD, a pain and headache neurologist and associate professor at UC San Diego, discussed five neuromodulation devices, with four on the market and one recently soft-launched. He described the four available devices, giving instructions on use:
Cefaly, supraorbital peripheral nerve stimulation for migraine, both acute and prevention, is available OTC. It costs $379, a one-time fee, and patients can return the device by 90 days for a money-back guarantee. It’s FDA cleared for prevention (20 minutes preferably at bedtime at 60 Hz) and for acute migraine, 60 minutes preferably early in the attack at 100 Hz.
gammaCore(http://www.gammacore.com) works by vagus peripheral nerve stimulation for migraine and cluster headache, both acute and prevention. Patient cost may be $199 a month or more. This FDA cleared device is indicated for acute migraine (2 minutes at onset, repeat if needed after 15 minutes), acute cluster headache (2 minutes on, 1 off 3 times) and chronic cluster prevention (2 minutes on, 5 off, 3 times twice daily).
sTMS mini works by occipital cortex transcranial magnetic stimulation for acute (especially aura) treatment and prevention. A prescription is required; even with insurance, costs may be $250 a month. For migraine prevention, four pulses, separated by 15 minutes can be done twice daily. For acute, three pulses at onset, repeat after 15 minutes, twice if needed.
Nerivio is an armband remote device for electrical neuromodulation for acute migraine. Cost is $99 for 12 treatments if patient has no coverage, but can be approximately $10 with insurance coverage. FDA has cleared the device for acute migraine (45 minutes within 60 minutes of onset) and for acute migraine in adolescents.
A fifth device, Relivion, has been FDA cleared for acute migraine, “'but is not yet commercially available,” Dr. Schuster said. “This has been cleared for acute migraine only,” but the company is doing preventive studies as well. According to the product’s website, the device targets occipital and trigeminal nerves.
Neuromodulation may be offered to individuals who prefer nonpharmacological treatment or for those who don’t respond to pharmacotherapy, have contraindications, or are unable to tolerate the medicines, Dr. Schuster advised. Neuromodulation is most often used in tertiary referral clinic practice as a complement to first- and second-line therapy, but not monotherapy, he said.
Getting insurance plans to cover presents barriers at time, however. Sometimes a letter of medical necessity is required. For Dr. Schuster, the Cefaly OTC device is the easiest one to get to patients.
Practical Takeaway: Dr. Schuster sees both promise and limitation for neuromodulation in headache treatment. “There are four non-invasive neuromodulation devices currently on the market and a fifth currently in commercial soft-launch. They are nonpharmacologic treatments for patients who don’t want to take medications or for whom medications have been ineffective or not tolerated. However, they are not effective for everyone, and often either are not covered by insurance or have a significant co-pay, ” he said.
CGRP Insights for Migraine Care
New migraine treatments are greatly needed, agreed Rashmi Halker Singh, MD, FAHS, FAAN, director of the Headache Medicine Fellowship Program and associate professor of neurology at Mayo Clinic in Scottsdale. “Migraine is very prevalent,” she said and added to this is the lack of tolerability of existing treatments, with 80% of patients discontinuing oral preventive treatments by 12 months, she noted. “I have plenty of patients who have tried the traditional medications for migraines and they have not been helpful.”
Dr. Singh discussed the pros and cons of currently available medications, among them the anti-CGRP monoclonal antibodies (mAbs). Some of these target the CGRP protein (calcitonin gene-related peptide), which is prevalent in nerves supplying the head and neck. Current medications include galcanezumab (Emgality), monthly; eptinezumab (Vyepti), quarterly; fremanezumab (Ajovy), monthly or quarterly. One targets the CGRP receptor: erenumab (Aimovig), monthly.
In clinical trials, measuring more than 50% responder rates with the CGRP mAbs found 31% to 62% response; for chronic migraine, rates were 28% to 55%. “Not only did these medications have high responder rates, but fewer side effects [than other migraine drugs],” she said.
Dr. Singh said many patients in her clinical practice have tried traditional medications and not gotten relief, then find relief when they go on the mAbs. “Many experience benefits early on,” even the first day, she said.
There are caveats, however. Some new adverse events have been reported out since clinical trials. For instance, the FDA issued new warnings on hypertension and erenumab, with most people affected within the first week of the first dose. It’s crucial to know your patients’ pregnancy plans if considering mAbs, as well, she said. Women must wait 5 months from the last dose to conceive after using these medications. (More on potential long-term side effects of the CGRPs with Dr. Lawrence Robbins.)
Some people with migraine find relief from gepants (the small molecule antagonists of the CGRP receptor). These include ubrogepant (Ubrelvy) and rimegepant (Nurtec ODT), both approved for acute treatment, as well as the ditans drug lasmiditan (Reyvow), which is an antagonist at the 5-HT 1F serotonin receptor.
Practical Takeaway: “This is an exciting time in migraine treatment, with our deeper understanding of the disease and the development of new migraine therapies opening up new treatment options for patients who were previously limited,” Dr. Singh told PPM.
Disclosures: Dr. Barad is a consultant for Sprint PNS System. Dr. Schuster reports consultant work for Eli Lilly & Co., Averitas, Lundbeck, and Schedule 1 Therapeutics and has been a speaker for Eli Lilly and Averitas. Dr. Singh has no relevant disclosures.