Decision Resources Group finds that 88 percent of health technology assessment (HTA) reviews that examined several recently-launched multiple sclerosis (MS) therapies in terms of cost effectiveness ultimately recommended reimbursing these therapies either fully, or in a restricted fashion.
The analysis of 25 decisions by seven agencies in four countries for Sanofi Genzyme’s Lemtrada (alemtuzumab) and Aubagio (teriflunomide), and Biogen’s Tecfidera (dimethyl fumarate) and Plegridy (pegylated interferon beta 1a), found that the final negotiated prices of these therapies were typically deemed acceptable to HTA agencies based on cost-effectiveness analysis or cost-minimization strategies, although feedback from HTA/dossier reviewers raised concerns about the impact of newer drugs on their budgets. In the examination of payer decisions in Australia, Canada, Sweden, and the United Kingdom within DRG’s Global Market Access Solution HTA database, a consistent theme regarding price concerns emerged in the assessments, which in some cases led to recommendations being issued only for drugs for which prices were capped or reduced vs. comparator treatment. The value of patient access schemes or risk-sharing arrangements also emerged as a theme, appearing in reimbursement decisions such as for Aubagio in England, Scotland, and Australia.
Other key findings from the Global Market Access Solution’s Health Technology Database update on MS:
In certain cases such as Aubagio in the United Kingdom, recommendations were restricted to specific populations, such as those that do not have highly active or rapidly evolving severe relapsing-remitting MS, where the greatest cost-effectiveness was seen.
In assessing the newer therapies, the preferred economic model varied by payer, but with comparable use of budget impact, cost-minimization and cost-utility analysis. Cost-minimization analysis was used after non-inferiority vs. a comparator was demonstrated, whereas cost-utility analysis measured value-for efficacy.
The choice of economic comparator for the four drugs did not vary appreciably by the economic model employed. Those examining budget impact or following a cost-minimization approach typically pitted the newer therapies vs. a beta interferon or Copaxone (Teva’s glatiramer acetate) or Gilenya (Novartis’ fingolimod). For those using cost-utility or another cost-effective model, Copaxone was again the most common comparator, followed by the beta interferons or Gilenya.
When utilizing a cost-utility assessment model, the resulting incremental cost effectiveness ratios fell within the reasonable range for payers (less than £30,000 in the United Kingdom and CA$45,000 in Canada).
Insights from Roy Moore, Principal Director of Global Market Access Insights at Decision Resources Group:
“Every day payers weigh the efficacy offered by newer therapies against their resulting price. In the four years since these therapies first received market authorization in the markets queried, our analysis found that payers were balancing cost and efficacy attributes by seeking discounts in many cases. When applied to the cost-utility models, these drugs were therefore cost-effective.”
“The decisions by global payers will serve as an interesting backdrop for U.S. health-economic decision-makers. Over the next few months the Institute for Clinical and Economic Research (ICER) and the California Technology Assessment Forum are assessing the disease-modifying MS therapies. Based on ICER determinations for other indications, it remains to be seen if the MS drugs are seen as cost effective in the U.S. “
Insights from John Crowley, Ph.D., Principal Business Insights Analyst at Decision Resources Group:
“With 14 approved treatments, the MS market is fragmented. Developers of new products face a high bar to demonstrate meaningful clinical differentiation of their drug from the growing mix of highly-expensive oral, injectable, and infusible products approved for relapsing MS patients. This challenge may impact cost-effectiveness analyses as well, especially for the coming wave of follow-on products advancing through the late-phase pipeline for relapsing MS. Novel treatments that do not stand apart from the pack may also struggle, as seen with NICE’s initial negative opinion on Biogen/AbbVie’s Zinbryta (daclizumab). Moving forward, real clinical achievements, such as success in underserved progressive MS populations, or price concessions likely will be necessary for new products to optimize reimbursement terms.” –John Crowley, Ph.D., Principal Business Insights Analyst