Acthar Gel of Dubious Value in Treating MS Despite its $34,000-Per-Vial Cost, Study Finds

Acthar Gel of Dubious Value in Treating MS Despite its $34,000-Per-Vial Cost, Study Finds

Medicare spent more $650 million in 2013 and 2014 on one single medication — H.P. Acthar Gel —— that was prescribed by fewer than 1 percent of clinicians to treat multiple sclerosis (MS), with questionable results.

That’s the conclusion of new research by Oregon Health and Science University (OSHU), which presented its findings Feb. 23 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 Forum, in Orlando, Florida.

Two OSHU researchers decided to investigate how much Medicare was spending on Acthar after newspapers reported that its price — once $40 per vial — had jumped from $748 in 2001 to $34,034 in 2014. That translates into more than $100,000 to treat one patient with a short course of Acthar, compared to prednisone or similar steroids that cost no more than a few hundred dollars.

With this difference in price, treating one patient with a short course of Acthar could cost over $100,000. For comparison, prednisone or similar steroids would cost no more than a few hundred dollars.

“I was shocked at how much money Medicare was paying for prescriptions of Acthar,” Dennis Bourdette, MD, said in a news release. He and Daniel Hartung, PharmD had previously written an article, “The cost of multiple sclerosis drugs in the U.S. and the pharmaceutical industry: Too big to fail?” for the journal Neurology .

Acthar, developed in the 1950s and sold in 2001 to Questcor Pharmaceuticals — which in turn was acquired in 2014 by Mallinckrodt — stimulates the adrenal glands to produce natural steroids, with similar effects as prednisone and other synthetic anti-inflammatory steroids. Mallinckrodt recently agreed to pay $100 million to settle an anti-competitive lawsuit over the drug, which brought the British company more than $1 billion in 2015 revenues, according to a legal complaint filed by the Federal Trade Commission.

“Because of the tremendous cost, you really should have evidence that it’s superior and beneficial compared to much cheaper forms of generic steroids, like prednisone,” said Hartung, noting the lack of evidence that Acthar is actually better than low-cost steroids for treating MS episodes. “We question why a small number of physicians are prescribing this extremely expensive drug when there are much cheaper alternatives.”

With support from the National Multiple Sclerosis Society, the researchers looked into publicly available data from Medicare Part D and discovered that fewer than one out of 100 clinicians actually prescribed Acthar in 2013 and 2014. In fact, just 274 neurologists, nephrologists and rheumatologists were responsible for about 40 percent of Medicare’s expenditures on Acthar; together, these physicians had prescribed Acthar 11 or more times in those two years alone.

When the U.S. Food and Drug Administration (FDA) approves a new prescription drug, Medicare must cover its cost.

“Many people are advocating for Medicare to be allowed to negotiate directly with the pharmaceutical industry,” said Hartung. “This is a good example where Medicare could save a lot of money if it had the discretion to negotiate prices or even not to cover a drug because of its high cost compared to more inexpensive alternatives. Prescribing Acthar for multiple sclerosis or other autoimmune diseases costs society too much money and is irresponsible.”

Acthar was originally developed to treat infantile spasms, a rare form of epilepsy. In recent years, it had been aggressively marketed as a treatment for other conditions, including MS.

“Physicians should stop prescribing Acthar for anything other than infantile spasms,” Bourdette concluded.

 

6 comments

  1. Arlene greene says:

    Well I use Acthar gel and have not been in the hospital once since I started the IM injection.

    Diagnosed in 1991 and hospitalized at least once or twice every year for exacerbations.

    I also had in-home infusions from various nursing agencies.

    You can be sure the cost of hospital stays and nursing services were way, way more than the cost of a five day injection done at home by the patient.

  2. Penina Scullion says:

    Is there any wiggle room in this research to account for patients that do not respond to oral or IV steroids through many tries?

  3. Patricia Cohen says:

    There are patients who for reason of other conditions that can be made worse by synthetic steroids and this alternative is well tolerated. Agree that the cost is insane, but it needs to be able to be prescribed for MS patients who cannot take synthetic steroids. Note: company will provide financial assistance to patients with private or commercial insurance but not to patients with federal or state insurance. This is discriminatory.

  4. Rhonda says:

    Let me tell you what if it weren’t for this med I would just have to suffer through extreme exacerbations. I am one of the MS patients that cannot tolerate steroids! As a matter of fact I am on a round right now from an exacerbation that has been going on over a month and I finally gave in because I can’t handle the extreme pain I am going thru. So for that your research needs to see how many of us take it specificly for this reason.

  5. KJo says:

    Then there are those of us who cannot tolerate the alternative meds but have no
    problems whatsoever with the synthetic steroids. Just like MS is different from patient
    to patient, so should our freedom to take what works for us. (I actually hate taking anything.)

    But really, why not work on developing an actual cure, or halt, to this nightmare disease? If so then more of us could work and help pay down the federal deficit.

    MS has only been known about since 1868. Are you outraged? You should be.

  6. Sandi says:

    I am a Type II Diabetic and synthetic steroids send my blood sugars so hi that my meter can’t even read it (meter only reads up to 599). I also had an allergic reaction to Solu-Medrol IV infusions I had 2 weeks ago…and the pain associated with this relapse actually got worse.

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