Plans by 4 Countries to Subsidize Cost of Newer MS Drugs May Weight on US

A cost-effectiveness analysis of reimbursement recommendations for four relatively new multiple sclerosis (MS) treatments made by agencies in four countries — Australia, Canada, Sweden, and the U.K. — found overwhelming support (88 percent) for either full or restricted reimbursement for each therapy.

The analysis, performed by the Decision Resources Group, is likely to inform the work of the Institute for Clinical and Economic Research (ICER) and the California Technology Assessment Forum, which are assessing disease-modifying MS therapies in the U.S.

The analysis included 25 health technology assessment decisions in those countries for Lemtrada (alemtuzumab), Aubagio (teriflunomide), Tecfidera (dimethyl fumarate), and Plegridy (pegylated interferon beta 1a).

Decision Resources —  a Massachusetts company providing analysis and insights to the healthcare industry — found that the final negotiated prices of the drugs were commonly judged acceptable to the seven health technology assessment agencies, based on cost-effectiveness analysis or cost minimization strategies. The reviews were, however, concerned about how newer drugs could impact budgets.

In some cases, recommendations were only issued for drugs that had their prices capped or reduced relative to comparator treatments. Patient access schemes and risk-sharing arrangements were often considered in reimbursement decisions, such as for Aubagio in England, Scotland, and Australia.

Also, the review found that some recommendations were restricted to certain patient groups. For example, Aubagio in the U.K. was only recommended for patients without highly active or rapidly progressing and severe relapsing-remitting MS. This was based on analyses showing that the treatment’s greatest cost-effectiveness was seen in patients with less aggressive disease.

Different economic models were used in the 25 analyses, but all had comparable budget-impact, cost-minimization and cost-utility analyses. Assessment agencies used cost-minimization analysis after studies had shown non-inferiority versus a comparator drug, while cost-utility analyses measured value based on effectiveness.

Comparator drugs did not differ much among analyses. Those examining the impact of a decision on healthcare budgets or who followed a cost-minimization approach frequently compared newer therapies to beta interferon, Copaxone (glatiramer acetate), or Gilenya (fingolimod). In cost-utility or other cost-effectiveness analyses, Copaxone was the most common comparator, followed by the beta interferons or Gilenya.

“Every day payers weigh the efficacy offered by newer therapies against their resulting price,” Roy Moore, principal director of Global Market Access Insights at Decision Resources Group, said in a press release. “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 … 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.,” Moore added.

John Crowley, PhD, principal Business Insights Analyst at Decision Resources, concluded: “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 … Novel treatments that do not stand apart from the pack may also struggle.

“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.”