- The National Institute for Health and Care Excellence, a U.K. government agency that provides guidance on the use of medicines, on Monday finalized its decision not to recommend coverage of Roche's Ocrevus in primary progressive multiple sclerosis.
- According to the agency, the cost-effectiveness estimates for Ocrevus compared with best supportive care alone "are much higher than those NICE normally considers an acceptable use of limited NHS resources" — meaning NICE couldn't recommended the drug despite there being no treatment currently available in this indication in the U.K.
- Ocrevus gained approval in Europe in January 2018 for both relapsing and primary progressive MS. But in separate decisions made earlier this year, NICE advised NHS not to cover the drug for either indication. NICE ultimately reversed its recommendation for relapsing MS, though only for patients who weren't able to take Sanofi's Lemtrada and could obtain the drug through a discount patient access scheme.
Ocrevus (ocrelizumab) is the first disease-modifying therapy available for primary progressive MS, which affects about 15% of people with the neurological disease. Following its U.S. approval, Ocrevus' launch became one of the best ever in the MS market.
The bulk of Ocrevus sales have thus far come from the U.S. Across the Atlantic, the drug's high list price, which was $65,000 per year as of the end of 2017, hasn't sat well with NICE. The agency noted Roche's base-case model for cost-effectiveness differed from the model NICE preferred in several ways that would further increase the incremental cost-effectiveness ratio if applied.
As there is currently no current comparator drug, the NICE decision is based on the cost against best supportive care, which Keith Jordan, communications, policy and access director at Roche U.K., explained makes the drug's cost-effectiveness hard to assess.
"This is the first treatment for [primary progressive MS] to market, and it can delay patients needing to use a wheelchair for up to seven years," Jordan said in an interview with BioPharma Dive. "We are extremely disappointed that patients will not be able to access the only licensed drug for [primary progressive MS]. We have offered up a number of solutions to gain access for patients, but so far NICE has not applied any flexibility."
One solution suggested by Jordan is using different prices for the primary progressive and relapsing forms of the disease, but NICE and NHS England are not allowed to take this approach under rules from the U.K.'s Department of Health. Jordan, however, remains encouraged that NICE is open to further discussion.
In the first half of 2018, Ocrevus sales were roughly $1 billion globally, with Europe accounting for $80 million of that sum. While the U.K. isn't one of the largest drug markets in the world, it is considered a key source of European sales for multinational drugmakers.
The MS Society, a U.K. research and advocacy group, called NICE's decision disappointing and has launched a petition calling for NICE, Roche and NHS England to make Ocrevus available at an affordable price.