Pharma attacks plan to ration new drugs in England

Plans to ration and delay use of novel drugs in England have been condemned by the pharma industry and a health charity.

The industry has lashed out at the decision, which it  says break a government manifesto pledge to provide access to medical advances - and says it even breaches patients’ rights under the NHS Constitution.

NHS England and NICE have been consulting on changes to cost-effectiveness appraisals of new medicines – through the health technology assessments of more commonly used drugs, and the highly specialised commissioning process reserved for treatments for very rare diseases.

The proposals were first published in late 2016, and include a new budgetary impact assessment of medicines that cost the system more than £20 million per year. These proposals were ratified by NICE’s board on Wednesday.

While the plans have to be agreed by NICE as well, NHS England is the true driver of the new cost cap, as it oversees the budget for specialist medicines, and has been looking for ways to control these costs for some time.

The NHS in England is under intense pressure as demand for services keeps rising, while government funding has risen, but not in line with this demand.  The budget squeeze is already hitting patient care, with waiting times in emergency care and cancer both failing to meet performance targets for many months.

Now it's time for the drugs budget to feel the squeeze. Should a medicine’s budgetary impact exceed the £20 million threshold within any of the first three years, this would trigger a “commercial negotiation”, according to the plan ratified by NICE's board today.

According to the document, “should this negotiation fail to conclude or not fully resolve the budget impact issues, NHS England would be able to apply to NICE to vary the funding requirement in order to phase introduction of the product over a longer period to help manage its impact on the NHS.”

Although NICE has given some ground in other areas, this has proven to be a major concern for pharma.

[caption id="attachment_21182" align="alignnone" width="175"] The ABPI's Mike Thompson[/caption]

In a statement, the Association of the British Pharmaceutical Industry (ABPI) chief executive, Mike Thompson, said: “Today’s proposals from NICE/NHS England break the Conservative Party’s 2015 Manifesto promise to speed up the introduction of cost-effective medicines into the NHS.”

The cutbacks will make thousands of patients wait longer for treatment for conditions like heart disease, cancer and diabetes, said Thompson.

“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.”

Hadrian's Wall for medicines

Steve Bates, the chief executive of the BioIndustry Association, which represents the biotech sector, went even further.

He said the new rationing would mean patients in England would lose out, relative to Scotland, where the rules won't apply.

The changes “will build a Hadrian’s Wall for English patients who will no longer be able to access innovative new treatments that will continue to be available in Scotland,” said Bates, who called for an urgent rethink.

Compromise on rare disease drugs

However another controversial proposal in the original plan has been amended – originally the plan envisaged a £100,000 per QALY limit for medicines for very rare diseases.

With medicines such as Alexion’s Kanuma costing in excess of £360,000 per year, industry felt that the threshold was too low.

The proposals ratified today change that – the threshold is weighted according to the QALY gained, with £300,000 per QALY the upper limit for drugs that extend life by more than 30 years.

Sara Trafford-Jones, vice president and general manager, Alexion UK, said the compromise outlined in the document fell short of the company’s expectations.

She said: “The UK is a recognised leader in research, treatment and care for rare diseases, which could be challenged with the changing and uncertain access landscape for new treatments and therapies. Ultimately, this will call into question whether companies will still look to England as a place to launch their products and make investments.”

Also expressing concern was charity Alzheimer's Research UK. Its chief executive Hilary Evans said she had 'significant concerns' that the move could mean delays for people with dementia accessing future treatments.

This sentiment is likely to be echoed by other patient groups, though it looks unlikely that there will be a change of heart about introducing the new rules, which come into force on 1 April.