A new evaluation process to be introduced April 1 by the National Institute for Health and Care Excellence to speed up the availability of the most cost-effective drugs is being criticised by pharmaceutical companies and some charities. The agency noted that under the plan, whose proposals have undergone several changes since they were unveiled for public consultation last October, drugs predicted to cost NHS England more than 20 million pounds ($24.7 million) in any one of their first three years of use, will trigger negotiations with the manufacturer.
NICE stated that if agreements to minimise the cost impact of those products cannot be reached, NHS England can ask the agency to extend the amount of time it has to introduce the drug for all patients, potentially by up to three years, compared with the current 90-day roll-out deadline. Further, NICE said drugs for very rare diseases will be appraised based on a sliding scale, "so that the more the medicine costs the greater the health benefit it must provide in order to be approved for routine NHS use." Treatments deemed to provide significant quality-adjusted life year (QALY) benefits "could benefit from being assessed against a maximum threshold of 300 000 pounds ($371 000) per QALY, rather than the 100 000 pounds ($124 000) per QALY limit in the original proposal," the agency said.
However, Cancer Research UK suggested the new plan is likely to "create an extra hurdle" that will potentially affect one in five new medicines across all diseases, adding that "the additional barrier will disproportionately affect diseases with large numbers of patients, such as breast and lung cancer." Sarah Woolnough, Cancer Research UK's executive director of policy and information, remarked "if NICE thinks a cancer treatment is clinically effective and represents value for money, then patients should receive it without delay." She argued that "a system that could add up to a three-year delay before patients can access treatments deemed clinically and cost effective is unacceptable."
Commenting on the new rules, NICE chief executive Andrew Dillon said the "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." He added that "we have agreed that we will review this in three years to see what impact it is having on allowing access to new drugs." John Stewart, NHS England's acting director for specialised commissioning, stated "this new flexibility will help us develop" agreements that are "good for patients, good for taxpayers and good for those companies that are willing to price responsibly." Last year, the NHS spent 16.8 billion pounds ($20.7 billion) on drugs, up from 13 billion pounds ($16 billion) in 2011.
Meanwhile, NICE has also indicated that it is looking to potentially broaden the fast-track approach to a wider group of treatments, including medical devices and diagnostics, over the next two years.
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