The pharma industry and patient groups are warning of significant delays in accessing innovative medicines on the NHS after a new budget impact threshold was waved through by health officials.

The National Institute for Health and Care Excellence (NICE) has now confirmed that, from next month, any new medicines found to be cost effective but likely to overshoot the budget impact limit of £20 million during the first three years will be subject to a second process for price negotiation before they can be made available on the NHS.

The Institute said the budget test will be used to trigger discussions about potential commercial agreements between NHS England and companies, in order to manage the budget impact of introducing high cost treatment and, according to its chief executive Sir Andrew Dillon, “to help avoid and minimise delays in patients having access to treatments recommended by NICE”.

However, the Association of the British Pharmaceutical Industry (ABPI) insists the plans not only break the government’s Manifesto promise of speeding up the introduction of new medicines into the NHS but also breaches patient rights under the NHS Constitution.

“Thousands of patients will wait longer for treatment for conditions like heart disease, cancers and diabetes while medicines which stand to benefit the most people are caught up in the system. If the NHS became more effective in its planning it could manage the introduction of new medicines in a coherent way,” said ABPI chief executive, Mike Thompson.

Falling behind

“Use of new medicines in the UK is already poor with patients seven times more likely to get a newly launched medicine in places like Germany or France. While Scotland and Wales are both making strides in improving the use of new medicines, English patients face more barriers. As we head towards Brexit we should be catching up with Europe not falling further behind.”

Novartis said it recognises the challenges faced by the NHS but “introducing additional measures to constrain investment in medicines proven to be cost-effective and to improve or save lives will further disadvantage patients in England”.

“We had hoped that our discussions with the Government on their new industrial strategy might lead to an improved UK environment for science and innovation. Decisions such as this will not only mean delays to UK patients' access to many medicines, but will also make the Government’s industrial strategy ambitions much harder, if at all possible, to achieve,” noted Haseeb Ahmad, managing director and country president UK.

Also commenting on the change, Hilary Evans, chief executive of Alzheimer’s Research UK, said the charity “has significant concerns that this measure could mean delays for people with dementia accessing future treatments.

“There is a huge unmet need and with so many people likely to benefit from any new dementia drugs, it is very possible that such treatments may cost more than £20m a year. We recognise the funding pressures that currently exist for the NHS, but we believe the budget impact test is not the right tool to fix this complex challenge. In line with the ambition of the Accelerated Access Review, the introduction of new treatments must be better supported by early discussion between NHS England and companies to find solutions over funding.”

Under the system update NICE is also introducing a new fast-track option for appraising treatments which, with a predicted cost per extra year of quality-adjusted life of under £10,000, offer exceptional value for money. The Institute said it will consider widening the scope of the process to include medicines with higher QALYs in future.

Plans allowing greater flexibility in how NICE evaluates treatments for very rare conditions under its Highly Specialised Technologies programme have also been approved, under which treatments deemed to provide significant QALY benefits can now being assessed against a maximum threshold of £300,000 per QALY, rather than the £100,000 per QALY limit in the original proposal.

“As well as significantly speeding up access for patients for the most cost effective new technologies, NICE’s new approach also shows that the NHS is prepared to pay far more for highly specialised treatments that can transform patients’ quality of life,” said NHS England’s acting director for Specialised Commissioning, John Stewart.


“We are committed to working closely with companies that are willing to price their products responsibly and this new flexibility will help us develop innovative win/win/win agreements – good for patients, good for taxpayers and good for those companies that are willing to price responsibly."

However, Steve Bates, chief executive of the BioIndustry Association, argued that the “decision by NICE and NHS England to implement this new policy in just two and half weeks’ time sends an immediate, stark, negative signal to the global life science investors and companies that the UK needs to attract in the Brexit era. The changes announced will limit patient access to novel, breakthrough potentially life-saving medicines, especially for rare diseases - an area of research the UK government has prioritised in the 100,000 Genome project”.

“The UK government now needs to act fast to turn this lose/lose/lose situation for rare disease NHS patients, the UK life science sector and the Union into a win/win/win by seeing the big picture and reconsidering this initial NICE & NHS England policy in the context of the UK’s upcoming life science strategy,” he said.