Controversial new drug approval system unveiled
Patients face longer waits for some treatments, experts warn
Thursday, 16 March 2017
Changes to the National Institute for Health and Care Excellence (NICE) drug evaluation system have been announced, prompting angry responses from the drug industry and health charities.
NICE’s board yesterday approved changes that it said will mean patients will benefit from access to the most cost-effective treatments nearly five months faster and the changes will come into effect from next month.
However, the drug industry and leading health charities said this will mean there is an additional hurdle to clear that could add as much as a three-year delay before patients can access some treatments.
NICE bases its approval on a measure which looks at years of good quality of life (QALY) added by a drug and usually approves drugs which cost less than £30,000 for each additional year of quality life.
The new plans will create an extra hurdle that could affect one in five new medicines across all diseases.
NICE’s new approach involves a budget impact test, where drugs that will cost more than £20 million in any one of their first three years of use will trigger commercial discussions between the company and NHS England to mitigate the impact on the rest of the NHS.
In cases where agreement to minimise the impact of those drugs cannot be reached, NHS England will be able to choose to apply to NICE for an extended period in which to introduce the drug in a phased way, usually for no more than three years.
At the same time, drugs for very rare diseases will be evaluated against a sliding scale, so that the more the medicine costs the greater the health benefit it must provide to be approved for routine NHS use by NICE.
NICE will also introduce a new fast-track option for appraising treatments that offer good value for money with the intention that these will be available to patients a month after they are licensed.
NICE said it would also introduce greater flexibility in how it evaluated treatments for very rare conditions under its Highly Specialised Technologies programme.
The changes have been made following a joint public consultation with NHS England launched in October last year.
NICE admitted that the changes were designed to address the challenge of providing faster access to innovative, cost-effective treatments alongside the need to safeguard the “future financial sustainability” of the NHS.
Sir Andrew Dillon, NICE chief executive, said: “We are taking forward the proposal for more flexibility in the adoption of technologies into the NHS which are cost effective but which have a predicted budget impact of £20 million or more during the first three years.
“Companies will have the opportunity of confidential negotiations with NHS England, to help avoid and minimise delays in patients having access to treatments recommended by NICE.
“We believe these and the other changes that have now been approved will enhance our ability to optimise access to innovative treatments in the light of the significant financial challenge facing the NHS.”
Sarah Woolnough, Cancer Research UK’s executive director of policy and information, said the move was unacceptable and that cancer patients could die as a result of the changes.
“If NICE thinks a cancer treatment is clinically effective and represents value for money, then patients should receive it without delay,” she said. “A system that could add up to a three-year delay before patients can access treatments deemed clinically and cost effective is unacceptable. Cancer patients may lose their lives whilst they wait.”
The drug industry was also unimpressed by NICE’s plans, saying they would delay use of cost-effective medicines.
Association of the British Pharmaceutical Industry (ABPI) chief executive Mike Thompson said: “These new plans will prevent patients from receiving NICE-approved, cost-effective medicines, undermining their basic 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.”
Jeremy Hughes, chief executive at the Alzheimer's Society: “Drug companies and the NHS must work together to ensure this new test would not delay long-awaited new drugs for dementia.
“It must not stop relatively inexpensive treatments being made available to patients - a treatment that could help every person with dementia would have to cost less than £23.50 per year to face this new test.”