Dr George J WanGeorge J. Wan, PhD, MPH
A recent analysis presented at ECTRIMS 2019, September 11-13 in Stockholm, Sweden, suggests that Mallinckrodt’s repository corticotropin injection (Acthar Gel) offers a lower cost per treatment compared to other late-line treatments for relapses in patients with multiple sclerosis (MS).1

Compared to plasmapheresis (PMP) and intravenous immunoglobulin (IVIg), which analysis revealed cost $275,407 per response, the corticotropin injection was associated with a lower cost per patient response at $126,879. The response rate with the Mallinckrodt product was 86.6% (377 of 435 patients), which was double that of PMP and IVIg’s rate of 49.9% (201 of 403 patients).

“These findings shed light on the importance of late-line treatment selection strategies for patients with acute exacerbations of MS,” wrote George J. Wan, PhD, MPH, global head, health economics and outcomes research, Mallinckrodt, and colleagues.

The treatment was approved by the FDA for a number of indications, originally given the go-ahead in 2010 for 19 conditions, including infantile spasms, MS exacerbations, and a number of other states of illness.

"Suboptimal management of MS relapses may lead to residual deficits, poor recovery and progressive disability. In addition, not all patients tolerate or respond effectively to first-line agents such as corticosteroids. As a result, healthcare providers may turn to late-line therapies," Wan said in a statement.2 "This analysis is aimed at addressing the current lack of evidence comparing the cost per response of late-line treatments for MS relapse."

The analysis showed that the total annual cost was similar for both the corticotropin injection -treated group, at $122,946, and the PMP/IVIg-treated group, at $126,412. All told, inpatient costs accounted for 3% of the total costs, while outpatient and medication costs accounted for 22% and 75%, respectively, in the corticotropin group. Comparatively, inpatient, outpatient, and medication costs accounted for 8%, 81%, and 12% in the PMP/IVIg group, respectively.

The analysis was conducted to account for 2019 US dollar inflation, with data being pulled from 2 sources, the Humana Comprehensive Health Insights Database (from January 1, 2008, through July 31, 2015) and the HealthCore Integrated Research Database (from January 1, 2006, through November 30, 2016). Broken down by database, the corticotropin injection response rate was 96.9% (189 of 195 patients) in the Humana database and 78.3% (188 of 240 patients) in the HealthCore database. In comparison, the PMP/IVIg group showed respective rates of 45.9% (112 of 244) and 56.0% (89 of 159), respectively.

Wan and colleagues did note a trio of limitations to their work, most notably that relapses were identified via treatment-seeking behavior within the 2 databases, thus treatment received outside a healthcare visit was not addressed. They also acknowledged that unrestricted enrollment could have resulted in underestimate unresolved relapses, as well as the use of  PMP and IVIg as courses of therapy. As well, the total annual cost of care did not account for treatment convenience and compliance, nor the safety profile associated with each agent.

Mallinckrodt has been exploring the use of its repository corticotropin injection in a number of other conditions, including amyotrophic lateral sclerosis (ALS). Recently, in July, a phase 2b clinical trial, dubbed PENNANT, meant to assess the safety and efficacy of the treatment in ALS was stopped based on a recommendation by the study’s independent data and safety monitoring board.3

The data and safety monitoring board did make note of the proportion of patients achieving the primary end point—completion to Week 36—stating that it “precludes a definitive determination of a treatment effect,” according to Mallinckrodt. The lack of efficacy signal for the cohort in combination with the elevated risk of pneumonia was what ultimately informed the board's recommendation. Although, Mallinckrodt stated that there will be no impact from this decision on other ongoing trials of its repository corticotropin injection formulation, as the company is “committed to responsible and ethical scientific exploration” aimed at treating critical conditions. Thus far, the company has invested upwards of $500M to the development of the Acthar Gel.

For more coverage of ECTRIMS 2019, click here.
REFERENCES
1. Wan GJ, Chopra I, Niewoehner J. Cost per response analysis of repository corticotropin injection versus other late-line treatments for multiple sclerosis relapses in adults. Presented at: ECTRIMS; Stockholm, Sweden; September 11-13, 2019. Abstract P1059.
2. Mallinckrodt Analysis Suggests Acthar® Gel (Repository Corticotropin Injection) May be a Cost-Effective Option Compared to Other Late-Line, Adult Treatments for Multiple Sclerosis Relapse [press release]. Staines-Upon-Thames, UK; Mallinckrodt; Published September 13, 2019. prnewswire.com/news-releases/mallinckrodt-analysis-suggests-acthar-gel-repository-corticotropin-injection-may-be-a-cost-effective-option-compared-to-other-late-line-adult-treatments-for-multiple-sclerosis-relapse-300917676.html. Accessed September 17, 2019.
3. Mallinckrodt Halts Phase 2B Trial Investigating the Use of Acthar® Gel (Repository Corticotropin Injection) in Amyotrophic Lateral Sclerosis (ALS) [press release]. Staines-Upon-Thames, UK: Mallinckrodt; Published July 16, 2019. biospace.com/article/releases/mallinckrodt-halts-phase-2b-trial-investigating-the-use-of-acthar-gel-repository-corticotropin-injection-in-amyotrophic-lateral-sclerosis-als-. Accessed September 17, 2019.