Out-Law News 4 min. read

Digital technology can help speed up access to innovative treatments, say experts

Harnessing the potential of digital technology can help speed up patients' access to innovative new treatments, legal experts have said.

Life sciences specialists at Pinsent Masons, the law firm behind Out-Law.com, have welcomed the government-backed Innovative Medicines and Medical Technology Review, which is expected to recommend reforms that can deliver accelerated access to new medicines and medical technologies, such as medical devices and diagnostics, for NHS patients. The government outlined its intention to support such a review in November last year.

The review will include recommendations to the government on the roles of both National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA). Its remit will cover the full development process for medicines and treatments, through regulation, economic assessment and uptake in the NHS.

According to the newly published terms of reference of the review, Sir Hugh Taylor, who is chair of Guy’s and St. Thomas’ NHS Foundation Trust and is leading the review, and his team, will "consider new emerging technologies and the way in which technological convergence is breaking down traditional barriers between regulator categories".

The review will "consider advances in digital technology, stratified medicines and their partner diagnostics, digital devices, apps and new therapeutic technologies", and look into "whether current funding structures and ways of working best support innovation".

The review will be "holistic" and "may identify packages of measures, including tariffs, incentives, guidance, regulatory changes and clinical support to promote faster uptake and adoption; or areas where multiple regulatory pathways and multiple barriers are hindering progress", it said.

A paper published last year by Pinsent Masons, the law firm behind Out-Law.com, highlighted how technological advancements could be harnessed to improve health care. It pointed to technology as a tool to help develop personalised treatments.

"Advances in a wide range of fields from genomics to medical imaging to regenerative medicine, along with increased computational power and the advent of mobile and wireless capability are allowing patients to be treated and monitored more precisely and effectively and in ways that better meet their individual needs," the 'Connectivity in the Life Sciences and Healthcare Sectors' paper (20-page / 1.58MB PDF) said.

"The current approach to regulation of medicines poses particular challenges in the era of ‘stratified medicines’ which involves looking at smaller groups of patients to try and find ways of predicting which treatments particular illnesses (e.g. cancers) are likely to respond to," it said. "There are practical challenges in building the clinical evidence base necessary for approval under current regulatory mechanisms where patient populations are very small. The current regulatory and HTA (Health Technology Assessment) processes and policies need to evolve in response to, and in anticipation of, scientific developments that will be critical for the development of a stratified and more personalised approach to precision medicines."

The 100,000 Genome Project is an example of the drive towards stratified medicines. On Wednesday, the UK government announced that the first patients have been diagnosed through DNA sequencing under the initiative.

The Innovative Medicines and Medical Technology Review will also look at how data could be better used and measured to "drive evidence-based development and commissioning of effective innovative medicines, devices and diagnostics". It will also "identify requirements for real-time data and monitoring when innovations are applied in the NHS". The data could help "develop evidence to optimise adoption and diffusion" of innovative products, such as medical devices.

An assessment will also be made of how other countries in the world approach innovation in health care. The review is likely to look in more detail at the 'breakthrough therapy' designation scheme that the US Food and Drug Administration (FDA) operates. That scheme helps fast-track new treatments that offer a substantial improvement on existing treatments through the approvals process.

Ways of strengthening the existing Early Access to Medicines Scheme (EAMS) will also be considered as part of the regime, the government said.

Under the EAMS, drug companies have the chance to follow a fast-track process for bringing their products to market.

Drugs manufacturers seeking to benefit from EAMS framework can apply for a 'promising innovative medicine' (PIM) designation from the MHRA. A PIM designation signifies the potential of a drug for treating patients with life threatening or seriously debilitating conditions for which there is either no cure or where existing treatments are unsatisfactory during a stage at which the drug is still being developed and has not been finalised.

On obtaining a PIM designation, drugs manufacturers can then apply to the MHRA for a scientific opinion on whether available data shows that doctors should be able to prescribe the drug to patients before the product has gone through the full licensing process. For that to happen, the potential benefits must outweigh the risks.

Drug companies cannot charge for the use of their drugs under the scheme until they obtain a license for the drug, although they would be able to recover costs. It is intended, though, that medicines developed and brought into unlicensed use under the EAMS programme will stand a better chance of receiving marketing authorisation and other licence approvals and be commissioned for use by NICE across the NHS in England.

On Wednesday, the MHRA published a positive scientific opinion under EAMS for the drug Pembrolizumab (3-page / 80KB PDF) which is still being developed but has been identified as having the potential to help treat a form of skin cancer.

Clinical trials of Pembrolizumab are ongoing and the drug is currently being assessed for marketing authorisation by the European Medicines Agency.

Pembrolizumab was designated as a 'breakthrough therapy' by the FDA in the US in January 2013 and last September was granted accelerated approval by the US regulator.

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