Wednesday, 14 September 2011

Why say no? 1. Non-submissions

Just the standard reminder before I start: these are my personal opinions and interpretations, not those of the SMC.

Once upon a time in a galaxy far, far away I wrote a Briefing Note for SMC members on the top 10 reasons why submissions fail.  While SMC’s formal evidence requirements haven’t changed since then, everyone involved will recognize that ‘norms’ for expected evidence do move over time – our attitude to indirect comparisons being one example but refinements in techniques for extrapolation being another.

So what would a more recent ‘top 10 reasons’ list look like?  I picked a recent 12 month period (covering 2010-2011) and looked at the SMC guidance. 

I was surprised to find that SMC had issued 56 pieces of ‘not recommended’ guidance in that period, as that is 4 per month and the monthly meetings do not feel that negative.  However, when I found out that the number one reason for the ‘not recommended’ guidance was that the company had declined the opportunity to make a submission, that made more sense. At a monthly meeting, those do not involve a discussion, so given that 21 of the 56 fitted that description, a total of 35 not recommended following an in-depth discussion (3 per month) feels about right.

But before we move on, why do companies not submit?  My guess would be there are a variety of reasons.  One could be that this is for a new indication or license extension that the company does not especially wish to pursue in terms of promotion, for whatever reason e.g. patent is about to expire.  Another possibility is that a company has assessed the case they can present, predicts a ‘not recommended’ decision, and decides not to commit to the costs involved.  A third possibility is that the indication is only for a few patients and the company feels the money would not be well-spent on a submission as they are happy to rely on local funding requests for individual patients.

In some situations, non-submissions are very efficient.  If prescribers in Scotland are not very interested in a medicine, why would the company incur costs and the SMC use up its time reviewing the case?  The key issue is whether the local NHS and prescribers have the information they need to do their job, and I can see no evidence they feel this is a problem in the vast majority of cases.

Do non-submissions indicate the SMC’s submission process is too difficult?  I don’t think it does – there is a basic requirement to put the company’s clinical effectiveness and cost-effectiveness evidence in the public domain.  Is that really too difficult to do?  It could be done more concisely, but why should some companies have to make a full submission when others do not?  If any submissions could be cut back then in my own view it should be ones where we have another addition to a therapeutic class at similar costs; it’s not usually these medicines that are non-submissions.

One concern would be if a medicine for a rare condition is left to local funding request panels and they make different decisions across Scotland – while this would be understandable on one level, in that local health boards may have different spending priorities, on another level – postcode-based access to medicines, it would be difficult to defend.

Part of the answer is, of course, for companies to make a submission to SMC, who will then make an assessment of their evidence available to all concerned: this shared starting point for debate is likely (in my view) to reduce variation between local panels making decisions.

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