Pharma companies are warning that changes to the way the National Institute for Health & Care Excellence (NICE) and NHS England (NHSE) assess new medicines, which came into affect on April 1, will hinder patient access to the latest treatments.
In a survey of member companies of the Association of the British Pharmaceutical Industry (ABPI), 71 percent said they believe that the new system will see their companies prioritise the launch of new medicines in European countries over the UK, while 89 percent said patient access to cost-effective medicines in the UK will decrease as a result.
Under the new framework, any new medicines found to be cost effective by NICE but likely to overshoot a budget impact limit of £20 million in any year within the first three years of use will be subject to a second process for price negotiation before they can be made available on the NHS.
NICE also announced that rare disease treatments deemed to provide significant QALY benefits will be assessed by its Highly Specialised Technologies (HST) committee against a maximum threshold of £300,000 per QALY.
Health bosses argue that the new measures will "significantly speed up access for the most promising and cost effective new technologies", but no pharmaceutical company taking part in the survey said they believed either the Budget Impact Test or changes to the HST programme would increase access to new cost effective medicines.
The UK is already performing well under par on the uptake of new medicines compared to its peers: according to government data, 17 NHS patients would typically be on NICE-recommended medicines in the first year, compared to 100 patients in countries such as France, Spain and Germany, and it takes the UK five years to reach half the level of medicines being used in Europe.
Moreover, the ABPI also points to new research by the Office for Health Economics on behalf of Shire showing that it takes 27.6 months in England to make a decision on patient access to rare disease medicines versus 19.5 months in France, 18.6 months in Italy and immediate access in Germany.
Far from improving this picture, the system update looks set to fuel a further deterioration in access, critics argue.
“The day after the NHS announces plans to a deliver a cancer diagnosis in just four weeks, these measures introduce the prospect of a three-year delay for 20 percent of new cost effective medicines,” argued ABPI Chief Executive Mike Thompson.
“This means thousands of patients who stand to benefit the most, particularly those with cancer, will miss out on the very latest medical breakthroughs…patients in England are already getting a bad deal, and as we head towards Brexit we should be catching up with Europe, not introducing measures that mean we'll fall further behind”.
The industry is calling on the government “to step-in and deliver upon their Manifesto commitment to increase the use of cost effective medicines”, just days after a coalition of almost 200 patient groups representing families affected by rare and genetic conditions called for a halt to planned changes.
Led by Genetic Alliance UK, the coalition argues that proposals that limit recommendations by NICE’s HST Evaluation programme will prevent access to innovative treatments for rare genetic conditions in England, “and send a chilling message to the life sciences sector that runs contrary to messages from other parts of Government”.