NHS England's drug evaluations? A waste of resources, says pharma
Reviews of new medicines carried out by NHS England are wasteful and should end, according to UK pharma industry leaders.
The Association of the British Pharmaceutical Industry (ABPI) says there are far too many different mechanisms for reviewing new drugs at local and national levels in the UK, and wants to see this cut back and rationalised.
NHS England has emerged as the most powerful body in the health service in recent years, and performs a huge range of roles.
It's most important job is managing England's health service budget of around £100 billion, passing on about 70 per cent of this to Clinical Commissioning Groups (CCGs) to spend on local services, which it then performance manages.
The remaining money NHS England spends itself on commissioning national specialised services, such as cancer care, treatment of hepatitis C and cystic fibrosis, including the drugs used.
NHS England reviews the cost and clinical effectiveness of new specialised medicines and procedures – despite NICE already having a very similar remit.
A recent example is NHS England's decision to approve wider use of Vertex's cystic fibrosis drug Kalydeco. In hepatitis C, NICE has led on the appraisal of new breakthroughs such as Gilead's Harvoni – despite NHS England's attempts to take over the process.
NHS England says its centralised, national commissioning has helped improve specialised care across England, but many think the body is over-stretched and over-reaching its remit.
Now UK pharma industry leaders have spoken out, calling for a rationalisation of the system.
Speaking at an informal press briefing, ABPI acting chief executive Alison Clough said it was now time for NHS England to stop its cost and clinical effectiveness appraisals.
Asked about NHS England's medicines appraisals Clough said, "What a waste of resources," and called on the duplication and second-guessing between it and NICE to end.
Clough said that this role should be left to NICE, which has a more tried-and-tested and more transparent methodology.
ABPI President John Kearney, also UK managing director of Amgen, agreed, and indicated that NHS England's 'do-it-yourself' appraisals weren't robust enough.
This chimes with the views of other stakeholders; and at least one NHS England clinical leader has admitted its reviews can't match NICE's health economic expertise.
Clough says there are many other local and regional tiers of decision-making, such as CCG formularies and the Greater Manchester Medicines Management Group, which complicate decision making and create regional variations in medicines uptake.
The ABPI wants to see all these duplications of decision-making scrapped, so that the NHS can 'do its value assessment once' via NICE, says Clough. She says this would then allow pharma companies to discuss how to optimise the use of approved medicines with local NHS bodies and NHS England.
The comments from Alison Clough and John Kearney reflect what the industry wants from an ongoing review of UK market access, the Accelerated Access Review (AAR). The ongoing consultation is looking for ways to create a 'lit runway' for high-value innovation in medicines and medical technologies, and is due to produce its recommendations by the end of this year.
But could it happen?
Despite pharma's rational argument for simplifying the decision-making process, there are a number of reasons why this may never happen.
NHS England won't want to relinquish its own cost-effectiveness reviews because it wants to keep a tight grip on NHS spending. The Department of Health has allowed it to take direct control of huge swathes of England's health service to prevent financial and clinical crisis; in this climate, it seems unlikely to be stripped of its decision-making powers on high cost drugs.
NHS England's inexperience was exposed by a legal challenge to its decision-making process last year, but it has now bounced back, and has warned pharma that market access for new specialised drugs will be tightly controlled.
Meanwhile the Treasury-backed Greater Manchester devolution of health and social care is a flagship policy, and any moves to halt this regional autonomy will be resisted.
That means expectations of the AAR among the pharma industry frontline are low. However the Review must also be seen to be helping the UK life sciences, one of the country's most important sectors, so it is down to the ABPI and other pharma leaders to win as many meaningful reforms as possible.
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