Patients will have to wait longer to access some of the newest drugs, after the National Institute for Health and Care Excellence (NICE) announced that in future the NHS in England will have more time to comply with its recommendations to use the most costly drugs.
At present, the NHS has 90 days to comply with a NICE decision to make a drug available after an assessment determines that it meets the cost-effectiveness threshold; the standard is £20,000–£30,000 per quality-adjusted life year (QALY).
However, the NICE board agreed at a meeting on 15 March 2017 to introduce a £20m budget impact test to slow down the introduction of the most costly drugs.
Any drug that is expected to cost the NHS £20m or more in any of the first three years will now trigger a commercial negotiation on price in an attempt to reduce that cost burden.
If those negotiations fail, NHS England will be able to apply to NICE to vary the funding requirement to phase the introduction of the drug over a longer period of time, normally up to a maximum of three years, in order to manage the impact on the drugs budget.
In July 2016, a report from the Public Accounts Committee, which is responsible for overseeing UK government expenditures, pointed out that NHS overspending on drugs is threatening its ability to pay for other services, and that this pressure is coming from an increasing volume of expensive, but often effective, drugs.
The impact test is targeted at these drugs but could also be applied to low-cost drugs used by a large number of patients.
Data from the Health & Social Care Information Centre, the national provider of data and IT systems in health and social care, show that £20m is spent on many drugs each year. For example, in 2015, the greatest expenditure on a single drug was for fluticasone propionate inhalers, at £376m.
NICE held a joint public consultation with NHS England in 2016 on the proposals, which generated many responses from concerned charities and drug companies.
For example, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, a trade body of companies in the UK producing prescription medicines, said NICE’s plans “break the Conservative Party’s 2015 manifesto promise to speed up the introduction of cost-effective medicines into the NHS”.
“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,” he added. “If the NHS became more effective in its planning it could manage the introduction of new medicines in a coherent way.”
“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,” Thompson added.
Meanwhile, Sarah Woolnough, executive director of policy and information at research and awareness charity Cancer Research UK, said: “If NICE thinks a cancer treatment is clinically effective and represents value for money, then patients should receive it without delay. 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 while they wait.”
She added: “Manufacturers should be encouraged to price drugs responsibly, but we hope the government will reconsider the introduction of this new test.”
Source: Courtesy of National Institute for Health and Care Excellence (NICE)
Andrew Dillon, chief executive of NICE, says that the plans would be reviewed in three years “to see what impact it is having on allowing access to new drugs”.
“We’ve listened carefully to what stakeholders have been telling us throughout this consultation and made some important changes, as well as adding detail to our proposals,” he says.
These changes include introducing a new fast-track option for appraising treatments that NICE deems offer exceptional value for money, because they have a likely cost per extra year of quality-adjusted life of under £10,000 per QALY. The NHS will have to introduce such new technologies in 30 days rather than 90 days.
NICE has also signalled that it intends to consider broadening this fast-track approach to a wider group of treatments, including medical devices and diagnostics, over the next two years.
It will also have greater flexibility to approve high-cost treatments for very rare conditions evaluated under its highly specialised technologies programme. In this programme, new and existing highly specialised medicines and treatments are recommended for use within the NHS in England, because the maximum threshold per QALY gained is being raised from £100,000 in the original proposal to £300,000 per QALY.