Mallinckrodt Pharmaceuticals announced the results of three retrospective analyses that studied H.P. Acthar Gel in three distinct patient populations — relapsing multiple sclerosis (MS), systemic lupus erythematosus (SLE), and sarcoidosis. Results from each study, which focused on the product from a health economics perspective, were presented in poster sessions at the recent Academy of Managed Care Pharmacy’s (AMCP) 2016 Managed Care & Specialty Pharmacy annual meeting.
H.P. Acthar Gel (repository corticotropin injection, RCI) is a U.S. Food and Drug Administration (FDA)-approved injectable drug for the treatment of multiple indications, including for use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus. SLE is also among the indications generating the drug’s largest net sales.
The study, described in Abstract M17 and titled “Real-world treatment patterns and demographic, clinical and economic characteristics of systemic lupus erythematosus patients initiating repository corticotropin injection therapy,” was further detailed in a company press release. It described the clinical and economic health profile of SLE patients initiating the RCI. The study evaluated 9,944 eligible SLE patients, identified from the nationally representative HealthCore Integrated Research Database. Twenty-nine (0.3%) patients initiated RCI, on average, at 23 months after diagnosis, and were followed for an average of 24 months. Patients on the Acthar therapy were, on average, were 45 years old and 90% were female.
Researchers observed medical costs specific to SLE-related symptoms, and those specifically related to the use of Acthar. Such observations included a medical cost offset, as there was a reduction in hospitalization costs but an increase in all-cause or SLE-related pharmacy costs after initiation of Acthar. According to the release, patients saw a reduction in per patient per month (PPPM) medical costs related to SLE after Acthar initiation compared to the pre-initiation period, $3,011 vs. $893. This was mainly a result of a reduction of PPPM costs for SLE-related hospitalization ($2,444 vs. $434). Furthermore, in comparison to the Acthar pre-initiation period, there was a 20.2% reduction in the rate of hospitalizations (238 vs. 190 patients per 1,000 patient year) and a 12.6% reduction in the rate of all-causes emergency department visits (238 vs. 208 patients per 1,000 patient year) during the Acthar post-initiation period. But overall post-initiation PPPM costs were higher ($6,774 vs. $11,167), the study noted, largely due to pharmacy costs ($905 vs. $7,443).
Researchers identified some limitations in the study, namely the possible underestimation of the overall burden of disease, as the study focused on a commercial payer’s perspective. Moreover, the small sample size of the patient population resulted in differences that were not statistically significant, with the exception of hospitalizations. The company sponsored this study, and similar analyses for acute relapses of MS and sarcoidosis.