Treating at-risk relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective with Mavenclad (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab), according to a study in Dutch patients.
The study, “Cost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in The Netherlands,” appeared in the journal Applied Health Economics and Health Policy.
Mavenclad, marketed by Merck KGaA (known as EMD Serono in the U.S. and Canada), was approved by the European Medicines Agency to treat highly active forms of relapsing MS in 2017. A subsequent cost-benefits analysis by NHS England determined the treatment to be a cost-effective alternative to other disease-modifying therapies (DMTs) for RRMS patients with high disease activity.
As no such study had been conducted in The Netherlands, an international team compared the cost-effectiveness of Mavenclad to that of Sanofi Genzyme’s Lemtrada and Novartis’ Gilenya in RRMS patients with high disease activity (HDA), and to Biogen’s Tysabri in those with rapidly evolving severe (RES) disease. The study was funded by Merck B.V., an affiliate of Merck KGaA in The Netherlands.
The team adapted the health-economic model used in the previous British study, and combined it with RRMS natural progression data (as a way to extrapolate relapse rates) from patients taking placebo in the CLARITY Phase 3 trial of Mavenclad (NCT00213135). The mean age at treatment start in CLARITY was 37.1 years in people with HAD, and 33.3 years for those with RES.
The health-economic model considers direct medical costs, productivity loss, informal care, and unrelated medical expenses.
Clinical parameters included conversion to secondary progressive MS, and relapse and mortality rates, while those related to treatment included comparative efficacy, waning effect — reflecting the uncertainty of long-term benefits, the team noted — adverse events, and probability of discontinuation. Each therapy’s effectiveness was determined through a statistical analysis incorporating the results of various clinical trials.
All analyses showed that treatment with Mavenclad was cost-effective for people with HDA, as reflected in 50.9% and 98.2% of such probability at a willingness-to-pay threshold of €50,000 (about $55,445) per gained quality-adjusted life-year (QALY), and a cost savings of €10,866 and €151,115 compared to Lemtrada and Gilenya. QALYs is a measure of the benefits in length of life adjusted to reflect life quality.
The model’s findings were similar comparing Mavenclad to Tysabri in patients with RES, as the probability of Mavenclad being cost-effective was 94.1% at a threshold of €50,000 per QALY gained and a cost savings of €122,986.
These outcomes were mainly driven by the lower costs of Mavenclad and by lower direct non-medical costs — especially compared to Gilenya — rather than differences in efficacy. No clinically meaningful differences in effectiveness were found, the team noted.
“The treatment of RRMS patients with cladribine tablets [Mavenclad] seems cost effective versus alemtuzumab [Lemtrada] and fingolimod [Gilenya] in HDA patients, and versus natalizumab [Tysabri] in RES patients,” the researchers wrote.
Due to a lack of head-to-head trials comparing these MS therapies and an evaluation of treatment effectiveness based on subgroup analysis, however, “the results presented in this paper should be interpreted with caution,” they added.
Of note, two of the study’s authors are or were employees at Merck B.V., while another author is an employee at EMD Serono.