Access to medicine is at a critical crossroads

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NICE if you can get it

 

Is speed of access to new medicines for patients getting better? According to NICE it is. The world-renowned drug assessor has even published a feature with the snappy title: Patients getting faster access to cancer drugs as NICE approves three quarters of the Cancer Drugs Fund.

The news came as NICE announced that it was approving sorafenib, a treatment for progressive liver cancer. Its positive appraisal marks the 18th of 24 drugs NICE was asked by NHS England to appraise, as part of the new Cancer Drugs Fund (CDF). All have been approved for routine NHS use.

In order to achieve these decisions, however, manufacturers have been required to provide price discounts and, in some cases, additional data. Some have been required to enter into ‘Managed Entry Agreements’ with the NHS whereby their approval is contingent on the satisfaction of further, real-world evidence, that will be re-considered at a later point in time to evaluate longer-term patient access, and an acceptable price.

It remains to be seen how these future negotiations will operate and whether short-term, wider patient access will be restricted or even reversed. This would prove controversial and highly disappointing to patients.

This news might not be giving us the full picture, however. The ABPI released a report in July, produced by the Institute for Health Economics, based in Sweden, which suggested that the UK is trailing behind the rest of Europe in the treatment of cancer. The submission added that the NHS spends over 20% less of its overall healthcare budget on cancer than the rest of the EU.

According to the study, British patients have worse survival rates after five years, compared to the European average in nine out of 10 cancers, only exceeding the EU average in melanoma.

The functionality of the new CDF, operating under NICE, might well help to correct this course over time and, it’s true, cancer outcomes depend not just on new generations of treatments, but overall service investment and quality.

There are also challenges to the speed by which patients are accessing new medicines outside oncology. The UK’s Office for Health Economics also published a new review earlier this year comparing access to medicines for patients with rare, so-called ‘orphan’, diseases in the UK and other European countries.

Commissioned by Shire Pharmaceuticals, it found that despite efforts at a European level to incentivise the research of new treatments for rare conditions and accelerate patient access, the UK has not kept apace with other countries.

 

Race for life

Speed of access to innovation has been recognised by Government as an area of focus for the life sciences industry post-Brexit. In July, the new life sciences minister, Lord O’Shaughnessy, announced that there would be an extra £86m made available to boost uptake of technology and innovation in the NHS as part of the long-awaited implementation of the Government’s Accelerated Access Review (AAR), which originally kicked off in early 2015.

O’Shaughnessy said: “The Government’s ambition is that NHS patients get world-leading, life-changing treatments as fast as possible. That can’t happen unless we support medical innovation and tear down the barriers, like speed to market and access to funding that can get in the way, especially for SMEs.”

The Government’s position and narrative are encouraging, although the funding announcement offers only an element of the changes recommended in the final AAR report. It is also tightly focussed on SMEs and funding for the Academic Health Science Network; regional bodies that are intended to open up collaborations between the NHS, academia and industry.

Hope is now being pinned on the direction and contents of the forthcoming Government Life Sciences Industrial Strategy. This plan, first mentioned in the Government’s broader Industrial Strategy Green Paper, published in January 2017, intends to make the UK the best place in the world to invest in life sciences, with comparatively rapid access to new medicines being a critical part of achieving this ambition.

In addition, the House of Lords Science and Technology Committee has now opened an inquiry into the Life Sciences Industrial Strategy. It specifically asks whether the Government has structures in place to support the life sciences sector, how the NHS can use procurement to stimulate innovation and if the content of the new strategy, when published, will effectively contribute to this.

According to the Committee, the UK life sciences sector contributed £30.7bn to the economy in 2015 and supports over 480,000 jobs. Pharma will need to successfully make the case that speed of patient access is essential, not only to improved health outcomes for UK patients, but in terms of decisions to invest in the UK.

Government will need to show that it is genuinely open to widespread reform and willing to reimburse approved innovation at as quickly as other comparable countries.

 

Time wasting

Of the medicines used to treat rare diseases thatreceived a license by the European Medicines Agency between 2001 and 2016, the average time to reimbursement in France and Italy was 19 months on average. It was almost immediate in Germany, due to how its health system appraises such products. In England it takes 28 months.

Moreover, there are concerns among patient organisations and manufacturers about new rules for NICE’s Highly Specialised Technology (HST) process. They will introduce new thresholds for cost-effectiveness and a cap on the acceptable total annual cost to the NHS in England, causing further slowdown and possibly shutting out access to some new medicines.

 

Alex Ledger is Deputy Managing Director at Decideum – the views expressed here are entirely his own. Go to decideum.com