Prime Therapeutics LLC recently issued the following announcement.
A study by pharmacy benefit manager Prime Therapeutics LLC (Prime) designed to forecast the potential use and cost of eculizumab (Soliris®), a drug billed through the medical benefit, to treat Myasthenia Gravis (MG) found the expanded use could lead to nearly a twofold increase in Soliris forecasted cost trend in 2018 and beyond. Prime researchers will present the findings from their Silver Ribbon awarded study at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy 30th Annual Meeting April 23-26 in Boston.
MG is a rare neuromuscular disease affecting 15 in 100,000 people. It is characterized by varying degrees of weakness of the skeletal muscles of the body and is caused by a breakdown in communication between nerves and muscles.
In October 2017, the U.S. Food and Drug Administration (FDA) approved the intravenous drug Soliris, in addition to the two previously approved ultra-rare orphan conditions, for adult patients with generalized MG who are anti-acetylcholine receptor (AchR) antibody positive – possessing a blood protein found in most people with MG. With a wholesale acquisition cost (WAC) of more than $700,000 for the first year of therapy, this new indication required integrated medical and pharmacy claims data forecasting to prepare health plans for the potential impact to expenses and overall trend.
For the study, Prime analyzed 2016 pharmacy and medical claims data for 15 million commercially insured members 18 years or older with a MG diagnosis. Of the 1,574 members identified, 511 (32 percent) had at least one medical or pharmacy claim for an immunosuppressant drug or immune globulin. Of the 511 members, 51 members (10 percent) were assumed to be anti-AchR positive and refractory to other therapies. Therefore, these members could potentially be eligible for treatment with Soliris according to criteria from the drug’s phase three clinical trial. Researchers used the $704,000 WAC for the first year of therapy and assumed 100 percent member adherence rate to Soliris therapy for one year.
The study showed that prior to the label extension and impact of new MG claims, there was already a 53 percent increase in Soliris per member per month (PMPM) expenditures – from $0.38 the first quarter of 2016 to $0.58 the third quarter of 2017. Assuming this upward trend continues, PMPM in the third quarter of 2018 is expected to be $0.74.
With new Soliris use among members according to the clinical trial inclusion criteria, the potential new impact to spend is an additional $0.20 – for a total PMPM in third quarter of 2018 of $0.94. Soliris is likely to be used at a much higher rate (up to 74 percent) in individuals with MG who are anti-AchR positive, regardless of disease severity. We assume 30 percent of these members will begin Soliris for MG, and the potential new impact to spend is an additional $1.37 PMPM – for a total PMPM in third quarter of 2018 of $2.11.
“Given the high cost of Soliris and its approval for use by the majority of MG patients, forecasting this drug’s potential utilization and cost is crucial to helping our health plan clients understand the impact of the new, broader FDA-approved use,” said Catherine Starner, PharmD, BCPS, health outcomes consultant senior principal, Prime Therapeutics. “With this study, we see the important role a utilization management program plays in ensuring appropriate cost-effective Soliris use. Our study shows it’s essential to use integrated medical and pharmacy claims data to perform drug utilization forecasting, especially for rare conditions treated with a high cost specialty drug.”
Original source can be found here.
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