MS advocates fight back against NICE access policies
- For the first time in 11 years, the National Institute for Health and Care Excellence (NICE) in the UK is issuing new guidance on multiple sclerosis (MS).
- Based on its cost-utility analysis, NICE is recommending against National Health Service (NHS) coverage of Fampyra (fampridine) and Sativa (nabaliximois).
- MS advocates, including MS Society head Michelle Mitchell, have responded in anger suggesting that certain MS experts were not consulted in the decision and lack of coverage would hurt people with MS.
Biogen’s fampridine is a prolonged-release tablet developed to improve walking ability in adults, and Sativa (nabiximois), from GW Pharmaceuticals, is a cannabis-based treatment indicated for reduction of spasticity. Based on a cost-utility analysis, NICE has decided that the drugs are too expensive. Based on their analyzes, fampridine costs €160,000 ($216,526.40) per quality-adjusted life year, and Sativex costs €50,000 ($67,746) per QALY.
In an editorial published in the Daily Telegraph, Michelle Mitchell complained that the MS Society and other experts and advocates were not consulted on the final decision. In its Health Technology Assessment process, NICE wrote, “MS treatment focuses on symptom relief, reducing the severity and frequency of relapses and slowing progression of the disease.” However, when considering the spasticity treatment, NICE first-line recommendations include baclofen or gabapentin. Sativex is not included in first-line or second-line treatment recommendations. Likewise, famprimine is not listed as a recommended treatment to improve walking ability.
Pushing back makes sense in light of the fact that given enough evidence NICE has been known to change its position. For example, between December 2013 and April 2014, NICE changed its stance from “no” to “yes” regarding NHS coverage of Lemtrada (alemtuzumab) for the treatment of relapsing-remitting MS.
- PharmaTimes NICE under fire over guidance for MS drugs Fampyra, Sativex
- NICE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Fampridine for the improvement of walking ability in multiple sclerosis Draft scope (Pre-referral)
- NICE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Sativex as an add-on treatment of moderate to severe spasticity in multiple sclerosis Revised Draft Scope