Tough Times Ahead for New Medicines under NHS England?

You’d be forgiven for missing it with the vast array of new agencies and the policy documents, guidance, consultations and ‘engagement’ activity they’re doing on in the ‘new’ NHS in England, but on the 4th April NHS England (formerly the NHS Commissioning Board) set out 15 commissioning policies in 250 pages.  They’re important, as they set out the approach NHS England will take when they’re spending some £20 billion plus worth of services.  Not only that, the new Clinical Commissioning Groups (CCGs) who are responsible for the rest of the over £100billion budget of the NHS in England, are likely to take a leaf out of NHS England’s book when they look at investment and dis-investment themselves. 

Medicines in focus
The policies arguably focus on medicines (although other technologies would also be covered, such as devices); ranging from Individual Funding Requests (IFR), funding of NICE guidance, and funding medicines for those patients taking part in and/or following the closure of clinical trials.  Only 6 of the 15 documents are more general, and even then medicines feature as part of the overall package of services and treatments that NHS England will be considering.

Setting the tone
The documents set the tone for how NHS England will approach decisions to invest or even cut services.  Key themes include:

• Value for money dominates. The documents mention whether something is affordable, affordability, value for money, and cost effective/ness no less than 98 times.  The first line of their overarching guidance notes their ‘fixed budget’. NHS England will also take a ‘take it or leave it’ approach to guidance because it’s just too expensive to implement all NICE guidance, let alone guidance from others like the Royal Colleges. NHS England will follow guidance for technologies positively appraised by NICE, because that is a legal requirement.  And price negotiation is listed as an ‘option’ when “useful treatments which are not cost effective or not affordable although they are clinically-effective.” NHS England do say other criterion will apply, but reading the policies it’s hard to see how much they could sway decisions.

• Tough scrutiny when considering investing in new services and treatments. NHS England only want to invest in those services and treatments that are ‘of proven cost effectiveness’.  If that’s missing, then funding will be linked with research to fill that gap.  Business cases and the evidence they draw on need to be viewed with ‘confidence’ by NHS England, suggesting little tolerance of uncertainty.  Those who can’t deliver that to NHS England are unlikely to get the funding that they want.

• Strict rules. NHS England will be strict about requests for funding that may come in via the IFR route for example; clinicians must get the Trust management to sign off on the application and NHS England won’t consider it unless all the i’s have been dotted, and the t’s crossed.  The ‘rule of rescue’ is simply ruled out too.  And if there are more than 5 patients who are alike with treatment costing more than £100,000 (or perhaps £150,000 as both figures are mentioned), no IFR funding will flow; instead it will be considered as part of the usual approach to funding new services.  NHS England is also clear that it will not necessarily be the one to pick up funding of medicines after clinical trials or pay for unproven or experimental treatments.  That’s for those who initiated the trial to do, or at least make it clear to patients what will happen once the trial ends.

• Constrained support for R&D. NHS England say that commissioner support for R&D is ‘highly desirable’ but should be seen in the context of ‘constraints’.  Not exactly a sign that NHS England will be committing much to R&D in the future.

‘Interim’ policies
The NHS England commissioning policies just published are not the last word though.  All of them are marked ‘interim’ and will be subject to further discussion. What that means though isn’t clear (who will they be talking to, and will they listen?), and what could happen is that these simply become the de facto commissioning approaches at the centre of the new NHS in England.

Leela Barham is an independent health economist. You can contact her on: leels@btinternet.com