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    NICE rejection of Roche’s Ocrevus could signal more value based assessments by the regulator

The National Institute for Health and Care Excellence (NICE) has issued a negative appraisal consultation document (ACD) for Roche’s OCREVUS®▼ (ocrelizumab) in primary progressive multiple sclerosis (PPMS)– citing the high annual cost of therapy as an unacceptable burden for the NHS to bear. Despite the fact that the drug was approved by the FDA in 2017, at a discount price relative to other multiple sclerosis treatments, NICE were left unimpressed by Ocrevus’ price tag, despite demonstrated safety and efficacy in clinical trials. GlobalData, a leading data and analytics company suggest that the regulatory agency is again looking to incorporate more value based assessments into their approval process.

Ocrevus is a recombinant mAb that gained FDA approval for the treatment of both RRMS (relapsing-remitting multiple sclerosis) and PPMS (primary progressive multiple sclerosis) in March 2017. According to GlobalData’s latest report, ‘PharmaPoint: Multiple Sclerosis’, the brand rstarted selling in the US in the second quarter of 2017, generated $200M in its first quarter on the market.

Maura Musciacco, Associate Director of Neurology and Ophthalmology at GlobalData, commented, “Ocrevus is the first investigational medicine to significantly reduce the disease progression of PPMS in a large Phase III study. Furthermore, physician adoption is likely to be bolstered by Ocrevus’ similarity to Roche’s Rituxan, a drug that is already commonly prescribed off label for the treatment of MS.”

While the drug was priced at an eye-watering $65,000 per year, this actually represented a 20-25% discount on other MS therapies; which gained favour with US payers, combined with a promising clinical trial efficacy and safety data; the drug experienced a strong uptake that Roche were hoping to replicate across the remaining major markets. However, NICE issued a negative appraisal consultation document (ACD) for the drug in the treatment of PPMS, which was to be priced at £4,790 per 300mg dose.

Musciacco continued, “This rejection brings value based assessments back to the fore of discussion in regard to regulatory approval, something that NICE have previous experience with.”

In July 2013, the Department of Health issued NICE a document which contained guidelines to implement value based assessments for drugs seeking approval; which led NICE to publish a new drug approval methodology in March 2014. While this was expected to usher in a new era of value-priced drugs, the response to the new methodology was largely negative and it was eventually dropped by NICE.

Musciacco added, “Ocrevus’ rejection means that NICE may start incorporating factors outside of efficacy, safety, and tolerability in their approval process. Looking to the future, Ocrevus is likely to receive the nod for regular NHS use in the UK in the treatment of primary progressive MS for patients with active disease; however, this is likely to be a renegotiation over the price of the drug. In general, this will act as a warning to other drug developers trying to achieve a high price for their drug that NICE are focusing on value.”

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