Expert Opinion: Coverage Gaps Leave Cluster Headache Undertreated

A recent article published in Headache¹ by Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine and director of the Dartmouth Headache Center in Lebanon, New Hampshire, and colleagues exposed a gaping hole in the access to an effective first-line therapy for a portion of patients with cluster headache in the United States. In a blistering condemnation of the fallout from a regulatory decision made in 2011,² the authors wrote that “the US Centers for Medicaid and Medicare Services [CMS] has made the indefensible decision to not cover oxygen for cluster headache for patients with Medicaid and Medicare insurance, despite two positive randomized controlled trials.”^3,4

“Oxygen is a first-line abortive therapy for cluster attack,” Brian E. McGeeney, MD, MPH, MBA, assistant professor of neurology at Boston University School of Medicine in Massachusetts, told Neurology Advisor. “It is 1 of 2 first-line therapies, the other being subcutaneous sumatriptan. Everything else is not as good.” Cohen et al⁴ reported in a 2009 study that 78% of patients with cluster headache were pain-free after administration of oxygen in more than 150 attacks (95% CI, 71%-85%). Although no head-to-head trials of oxygen and subcutaneous sumatriptan have been conducted, the 2 therapies are widely considered comparable. “Oxygen is not far from the efficacy of sumatriptan,” Dr Tepper told Neurology Advisor. “It works in 15 minutes, and sumatriptan injectable works in about 10 minutes. Cluster [headache] has an incredibly fast peak intensity, so you need something that is nonoral,” he said.

The main problem with getting oxygen therapy, according to multiple sources, is that it is not well covered by payers and is not covered at all for patients on Medicare or Medicaid. Dr McGeeney agreed with the main point of the Headache¹ article: that access to oxygen therapy really should not be a problem for most people with cluster headache “because it doesn’t cost that much. But it’s a big problem if your payer won’t cover it, and CMS will not cover oxygen for cluster [headache]. That remains an enormous problem,” Dr McGeeney said.

True Costs of Oxygen

Yet another problem endemic to the payer system was revealed in a state-by-state study of the economics of oxygen.⁵ “In Alaska, it would cost between $2000 and $5000 per year for oxygen, while in Pennsylvania, New Hampshire, and Vermont, the cost is between zero and $500 per year, so there are tremendous differences in the costs per state for oxygen for episodic cluster,” Dr Tepper, a coauthor of the study, told Neurology Advisor. “For chronic cluster, the cost goes much higher because the patients don’t get a month off per year from their attacks, by definition. With chronic cluster, the cost of oxygen in Alaska is greater than $10,000, but Pennsylvania stays the same at zero to $500, and New Hampshire goes up a little to $1000 to $2000 per year,” he said.

Obstacles to Using Sumatriptan

Subcutaneous sumatriptan, which is approved by the US Food and Drug Administration (FDA) for cluster headache, presents other challenges. First, it is contraindicated in patients with vascular disease. Dr Tepper pointed out that it “narrows coronary arteries by 10% to 20% every time most people take it, and oxygen obviously doesn’t do that. Since cluster headache is often a disease of smoking men, it’s not a wise treatment to use in these patients unless you have to or unless you can document that they don’t have coronary disease,” he advised.

There are also problems with access to sufficient quantities of sumatriptan to ensure relief of all cluster attacks. Payer restrictions typically limit the number of sumatriptan doses allowed in a given month, said Matthew S. Robbins, MD, chief of neurology at the Jack D. Weiler Hospital at Montefiore Medical Center and director of inpatient services at the Montefiore Headache Center in New York, New York, in an interview with Neurology Advisor. “Sumatriptan [subcutaneous] generally works quite well and is considered safe, but the packaging states that you can’t use more than 12 mg/day of it, which is 2 of the 6-mg or 3 of the 4-mg injections. So, when people have more than 3 attacks in a day, they either have to exceed recommendations or use something else.”

The study in Headache¹ spelled out several suggestions for confronting the obstacles to getting oxygen for patients who need it. For Medicare/Medicaid patients who can pay cash (an obvious limitation among these patients), a prescription for oxygen as either a medication or unlisted durable medical equipment can be written. Some patients will buy welder’s oxygen without a prescription, but this product is less pure, costs about the same as medical oxygen, and lacks proper inspections and regulatory oversight to ensure appropriate flow rates. “Purchase is not a very good option,” said Dr Tepper, “because most cluster patients are so disabled by their disorder that they end up on Medicare and Medicaid with limited financial resources. They are the population that needs the oxygen the most, they are the population that has CMS coverage, yet this terrible, desperate problem set up by an inexcusable government decision [keeps them from that therapy].”

The experts agreed that acute treatment for this group of patients is largely nonexistent. “So then what are you left with?” Dr Tepper asked. “For a short time, we can get them the FDA-approved gammaCore noninvasive vagal nerve stimulation device, but it’s not available to Medicare/Medicaid patients, just to commercial patients,” he said. He painted a clinical picture of being handcuffed from helping patients who are suffering needlessly, with the keys plainly in view. “Our international colleagues, who are able to prescribe oxygen freely for their patients, look at this and say it’s inexplicable,” he added.

Dr Robbins, who coauthored the 2016 American Headache Society Guidelines for the Treatment of Cluster Headache,⁶ expressed similar sentiments. “Cluster headache is not a rare condition, and that’s the thing, because 1 in 1000 people in their life will have it. So it’s kind of a shame that a treatment like oxygen, which has a high quality of evidence for working, and has our guidelines from the American Headache Society giving it Level A recommendations, is not covered.”

References

1. Tepper SJ, Duplin J, Nye B, Tepper DE. Prescribing oxygen for cluster headache: a guide for the provider. Headache. 2017;57(9):1428-1430.
2. National coverage determination (NCD) for home oxygen use to treat cluster headache (CH) (240.2.2). Centers for Medicare & Medicaid Services website. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=343. Updated January 4, 2011. Accessed September 20, 2017.
3. Fogan L. Treatment of cluster headache: A double blind comparison of oxygen v. air inhalation. Arch Neurol. 1985;42:362-363.
4. Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009;302:2451-2457.
5. O’Brien M, Ford JH, Aurora SK, Govindan S, Tepper DE, Tepper SJ. Economics of inhaled oxygen use as an acute therapy for cluster headache in the United States of America. Headache. 2017;57(9):1416-1427.
6. Robbins MS, Starling AF, Pringshein TM, Becker WJ, Schwedt TJ. Treatment of cluster headache: The American Headache Society evidence-based guidelines. Headache. 2016;56:1093-1106.