European Commission proposals to speed treatment access would mean funding decisions have to be made within 120 days for new drugs.
Bodies like NICE that make national drug-funding decisions face being fined or forced to pay damages to drug companies if they do not meet these deadlines.
The commission is proposing to replace its 1989 directive on drug reimbursement to reflect the 'increased complexity' of member states’ procedures.
NICE is exempt from the current directive, but UK ministers are considering this in light of the proposals.
The GPC and Cancer Research UK warn that imposing such strict deadlines on NICE’s decisions could force the institute to accelerate its work, making it more likely to reject expensive drugs.
NICE would need to significantly speed up its decision-making processes if its reviews were covered by the proposed directive.
NICE already takes longer on average than its current 301-day target for appraisals and the recent formal review of dabigatran ran for 765 days.
Change needed to meet time limits
GPC prescribing lead Dr Bill Beeby said NICE would need to ‘fundamentally change’ to meet such tight time limits.
‘Rapid approval may seem like it gives access to new drugs more quickly – and for patients with cancer this rapid access is a very emotive issue – but this may greatly limit the considerations able to be undertaken,’ he said.
‘Paradoxically, rapid decisions in the current economic climate may lead to faster rejection of expensive treatments with limited benefits.’
Dr Beeby said that, with fewer ‘blockbuster’ treatments ahead, most new drugs for conditions like cancer would only improve survival by a few months.
He added: ‘However long it takes to approve new treatments, we will still have to walk that difficult balance of benefit, cost and affordability inherent in a 100% publicly funded healthcare system.’
Cancer Research UK said it supported the intention behind the plans, but that NICE needed to have enough time to evaluate the available evidence.
‘We welcome efforts to get effective treatments to patients fast and this proposal from the EU is promising,’ policy manager Heather Walker told GP.
‘But there needs to be a balance between giving NICE enough time to make the right decisions and ensuring that drugs get to patients as soon as possible.’
Association of the British Pharmaceutical Industry chief executive Stephen Whitehead said that the potential impact of any changes needed to be considered carefully.
‘The duration of a NICE appraisal has a direct impact on the time it takes to bring a new medicine to market and consequently how quickly patients are able to access it on the NHS,’ he said.
‘But the decisions made by NICE have an impact on the entire life of medicines over many years, ultimately affecting which patients may benefit both now and in the future.
He added: ‘It is important to have enough time to complete a process which allows fully informed and evidence-based decisions to be made. Any proposed changes to the time taken to undertake NICE appraisals as a result of legislation would need to be weighed up carefully.’
A DH spokeswoman said the government was aware of the European Commission’s proposals and it that it was reviewing the UK’s position in relation to the proposed measures.