Acthar Gel an Effective Treatment for MS Relapses at Lower Cost, Company Reports

Clinical results presented at the recent Academy of Managed Care Pharmacy (AMCP)‘s 2016 annual meeting in San Francisco showed that the use of H.P. Acthar Gel during multiple sclerosis (MS) relapses is associated with beneficial outcomes. The gel, according to its producer, is also available at a lower price than other frequently used drugs.

H.P. Acthar Gel, manufactured by Mallinckrodt Pharmaceuticals, has been used since the late 1970s for acute exacerbations of MS symptoms. The gel, which is injected to enable extended release of the drug, contains a highly purified preparation of adrenocorticotropic hormone (ACTH). ACTH triggers the body’s own corticosteroids — cortisol, corticosterone, and aldosterone — and might also affect B- and T-cells.

The drug is often prescribed for patients experiencing severe side effects of high-dose corticosteroids, or who have not responded well to corticosteroid treatment.

In the new retrospective analysis, presented at the meeting under the title “Efficacy and safety of treatments for acute relapses of multiple sclerosis: results of a systematic literature review,” the research team scrutinized 43 previously published studies exploring clinical evidence from both randomized and non-randomized trials on Acthar and other drugs used in the treatment of MS relapses.

The study compared Acthar to high-dose intravenous methylprednisolone, high-dose oral prednisone, and plasmapheresis and intravenous immunoglobulin, showing that all treatments except immunoglobulin were effective in treating relapses.

In patients with lingering symptoms after methylprednisolone treatment, the drug was also associated with a decreased resource use, and a similar cost compared with plasmapheresis.

Among patients with a two-year follow-up period, the Acthar Gel treatment was also associated with fewer hospitalizations and fewer outpatient visits, compared to patients treated with plasmapheresis or intravenous immunoglobulin. The total cost for a two-year treatment with Acthar was calculated at $175,000, compared to a cost of $208,000 for plasmapheresis or intravenous immunoglobulin.

According to a press release, the included studies were, however, highly varying in terms of patient populations, definition of efficacy outcomes, and time points of assessment. And the studies generally reported limited data on safety outcomes. Also, 13 of 23 randomized controlled trials had small sample sizes, and Acthar was evaluated in only two studies.

At the meeting, Mallinckrodt also presented data from analyses of Acthar Gel in systemic lupus erythematosus (SLE) and sarcoidosis.