Government publishes detail of review linking innovation in the NHS to patient need

The Accelerated Access Review was launched earlier this year and the government has now said that establishing need, priorities and principles for innovation will be one of the review's main themes.

"How can we find a transparent way for innovators to make sure that innovation is based on patient need, and that industry, the NHS, research charities and academia collaborate to understand and respond to patient need?" those behind the review said in a statement published on the government website last week.

The review will also address issues such as the way in which new drugs, medical devices and other health technologies are developed. It will examine how to speed up patients' access to innovations within the existing "safety and efficacy process" whilst "maintaining safeguards for patients", it said.

Funding models will also be scrutinised in the review, with specific focus to be given to how to "integrate and speed up national reimbursement processes, and fund clinically and cost-effective innovation across the pathway".

The way in which local NHS bodies adopt "clinically and cost effective innovative products" has also been confirmed as a theme of the review.

Pharmaceutical companies, medical technology providers, research bodies and patients will be given an opportunity to feed into the review, the review group said.

Sir Hugh Taylor, chair of Guy’s and St. Thomas’ NHS Foundation Trust and leader of the accelerated access review, said: "We need to find a way of delivering modern, first-class healthcare in a practical, affordable and sustainable way."

"We have identified three main areas in which we believe there is significant potential for reform: regulation, reimbursement and uptake. No-one will lose out if we get this right. Patients are not alone in wanting access to the best healthcare – providers want access to that too. My team and I are determined to produce a series of recommendations for ministers that can make innovative healthcare swifter, better and more widely available," he said.

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that the UK review should also keep in mind similar initiatives going on across Europe and beyond to support innovation in health care and more timely access for patients.

"This review is to be welcomed but while its focus is on speeding up access for NHS patients it should not lose sight of what is happening on the European and world stage," Cline said.

She said the 21st Century Cures initiative in the US, the European Medicines Agency (EMA)'s adaptive pathways pilot and projects such as the New Drug Development Paradigms (NEWDIGS) program, the Innovative Medicines Initiative (IMI) and the IMI funded project, GetReal, "all have the same goal".

"That goal is to modernise the health care innovation infrastructure, incorporate a patient perspective into the drug and device approval process, support a more stratified, and personalised, approach to medicines, streamline and improve the clinical trials process and allow more innovative and flexible funding mechanisms so as to facilitate more timely access for patients to innovative treatments," Cline said.

"We have seen enormous advances in science and technology but the current regulatory system has not kept pace. The regulatory framework needs to adapt to unleash the potential of recent technological advances to offer new pathways for health monitoring, treatment and communication and facilitate the breakdown of barriers among the different silos of the health-care innovation infrastructure," she said.

Cline and other experts at Pinsent Masons highlighted some of the regulatory and commercial issues relevant to health care innovation in a paper entitled 'Connectivity in the Life Sciences and Healthcare Sectors' (20-page / 1.58MB PDF).

The Accelerated Access Review was prompted following the National Institute for Health and Care Excellence (NICE) announcement last year that agreement could not be reached on proposed reforms to its current methodology for evaluating new drugs.

At the time, NICE chief executive Sir Andrew Dillon said: "Following an extensive consultation, it’s clear that just changing NICE’s methods will not overcome concerns about how the NHS accesses new treatments. We also need to look at other processes, including the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and in the arrangements for commissioning expensive new treatments."