New drug affordability test 'unacceptable'
16th March 2017 – Health charities and the pharmaceutical industry have criticised a new affordability test for medicines before they can be used in the NHS in England.
The National Institute for Health and Care Excellence (NICE) has approved a £20 million a year cap on the cost of new drugs in an attempt to save the NHS money.
It is estimated that the budget impact test, due to be introduced next month, will affect around 1 in 5 of all new medicines across all diseases.
One trade body representing UK bioscience companies is accusing NICE and NHS England of breaking the Conservative party's 2015 manifesto promise to speed up the introduction of cost-effective medicines into the NHS. One cancer charity has called the new hurdle "unacceptable" and has warned that patients may die as a result.
Cost – or value for patients?
Under current regulations, drugs assessed as cost-effective by NICE are recommended for routine use on the NHS. After this, the health service has 90 days before they must make the treatments available to patients.
NICE bases its decision to approve or not approve a drug on a measure which looks at how effectively it adds years of good quality life. This is known as the quality-adjusted life year, or QALY, and approval is normally given to drugs that cost less than £30,000 for each additional year of quality life.
However, NICE does not assess the total cost of that drug to the health service based on the number of patients who are likely to be eligible to receive it.
The new regulation will mean that where a drug will breach the £20 million level in any one of its first 3 years of use, NHS England will be able to halt the 90-day introduction process and use the time to go back to the manufacturer to negotiate a lower price.
In cases where no agreement can be reached, NHS England will be able to apply to NICE to delay the introduction of the drug for up to 3 years.
NICE has sweetened the changes by announcing a fast-track appraisal system for drugs of "exceptional value" which have a QALY of under £10,000.
'Patients may die'
The changes, which are being introduced to address the financial pressures on the NHS, have met with criticism.
Cancer Research UK says the additional barrier will disproportionately affect more common diseases because of the larger number of patients who would be eligible for treatment. These include breast and lung cancer.
"A system that could add up to a 3 year delay before patients can access treatments deemed clinically and cost effective is unacceptable," says Sarah Woolnough, Cancer Research UK's executive director of policy and information. "Cancer patients may lose their lives whilst they wait."