The National Institute for Health and Care Excellence (NICE) has published its final appraisal document (FAD) for Ocrevus (ocrelizumab) in primary progressive multiple sclerosis (PPMS), not recommending the drug. Final NICE Guidance on the matter is expected in late October.
The manufacturer, Roche, is pointing to a technicality around pricing. In July 2018 NICE published Guidance recommending Ocrevus for relapsing-remitting multiple sclerosis (RRMS) in limited circumstances in which other cheaper drugs are not suitable. NICE accepts a single price per product, and does not generally allow ‘indication-specific pricing’ in which price is allowed to vary in accordance with differing efficacy across multiple indications. This means that even if a drug is less effective in a second indication, the original price must be used, resulting in a weaker cost-benefit analysis. Roche has suggested that an inability to use indication-specific pricing is the main issue restricting its ability to get approval from NICE.
Companies have the option of effectively reducing their prices by providing discounts under a Patient Access Scheme (PAS). Roche’s approval for the RRMS indication was subject to such a PAS. However the presence of an existing PAS creates complexities for companies in implementing further discounts:
Cautionary MAP InsightsA company in this situation has the opportunity to revise a PAS for all indications after a FAD is published, which would lower pricing for the existing indication as well as that which is under review. Technically, it is possible to submit a different price for a specific indication, via a new, ‘different’ PAS. However, even a simple discount in these circumstances, when different to the first indication, results in the arrangement being classified as a ‘complex PAS’. Such PAS are notoriously difficult to get approved and there are only single digit examples of these being approved in the past.
More information on Patient Access Schemes.