Sanofi Responds to UK’s Value-Based Assessment Plans

The UK’s National Institute for Health and Care Excellence (NICE) set out their proposals for value-based assessment (VBA) in March 2014.  VBA is what value-based pricing (VBP) has essentially morphed into.

Much work is going on behind closed doors to inform responses as the consultation closing date of the 20^th June 2014 approaches. But Sanofi have gone further than some in sharing their thinking early and set out a five-point plan for what the company wants to see under VBA.  They want:

• increased role of experts by experience in appraisals;

• clarification on Burden of Illness and Wider Societal Impact to ensure committees are consistent in their approach to these additional modifiers;

• reinstatement and reform of End of Life criteria (these permit Appraisal Committees to be more flexible and ‘uplift’ the Quality Adjusted Life Years (QALYs) generated in terminal conditions; in effect raising the cost effectiveness threshold);

• new rules on the comparators to be used in NICE appraisals.

Sanofi and NICE
Sanofi has some very recent experience of being ‘NICE’d’.  Their bowel cancer drug, Zaltrap (aflibercept) was rejected in March 2014.  Jevtana (cabazitaxel) for prostate cancer was also rejected back in May 2012.

But Sanofi have also benefitted from the Cancer Drugs Fund (CDF), a ring fenced fund put in place when NICE has not yet come to a view, or when NICE says no.  And if the CDF disappears as planned in 2016, getting NICE reformed must be a longer-term aim for Sanofi.  (Although I still remain confused about the status of the CDF; how does it work when the Pharmaceutical Price Regulation Scheme [PPRS] has effectively ring-fenced expenditure on branded medicines for the whole of the NHS in England, does this not include products in the CDF?)

Will Sanofi’s views be shared by others?
Some of the issues Sanofi raised are bound to resonate across the industry, and others even with patient and carer groups.  The latter may well want a say on both Burden of Illness; who better to say what it is like living with a condition, than, well those living the condition. And Wider Societal Impact too; similarly, those with the condition, and arguably carers too, will know what they have stopped doing/done less of because of their condition.  What we don’t know is whether NICE will listen.

The VBA consultation closes in a matter of weeks.  NICE will take the responses in, and working with their methods group, cogitate on what might be do-able and what might not.  In any case, we won’t see the first decisions under VBA for some time.

Leela Barham is an independent health economist. You can access website here and contact her at leels@btinternet.com