NICE backs government drugs access review which may lead to HTA reform

Country : UK

Keywords :
LONDON, Mar 19 (APM) - The UK’s NICE has backed a government-led review into access to innovative drugs, as part of the health technology assessment (HTA) body’s calls for wider discussions on changes to the health system.
The NICE board on Wednesday agreed on the HTA body’s 'strategic and business plan for 2015-2018'. In it, NICE welcomed the ‘Innovative Medicines and Medical Technologies Review’ announced by the Department of Health in late 2014.
“The review will look at the development, regulation, evaluation and adoption of life sciences products. We are enthusiastic participants in this review,” NICE said.
The 2015-18 strategy paper said the review tied in with NICE’s calls in September for all stakeholders within the health system to jointly assess the process of bringing a novel drug from the lab to the market. This came after there was no consensus from interested parties on how to introduce cost-effectiveness reviews that consider the wider societal impact of a drug. (APMHE 39724)
The strategic plan said: “In 2014, we consulted on terms of reference provided by the Department of Health for broadening of the methods for value assessment of branded pharmaceuticals.
“It was clear from the response to this consultation, that much of what concerns those interested in the rapid adoption of effective and cost effective health technologies is beyond the reach of changes to our methods.
“As a result, we called for a wider conversation about broader system changes, and in this context we welcome the Innovative Medicines and Medical Technologies Review.”
The DH announced its plans for an Innovative Medicines and Med Tech Review in November (APMHE 40514); the terms of reference for the review were published by the DH last week.

Reform of NICE, MHRA to be considered

Of particular note, is that the roles of NICE and the UK’s drugs regulator the MHRA may be reformed - something the Association of the British Pharmaceutical Industry called for when the DH announced the broad scope of the review. (APMHE 40514)
The terms of reference states it will specifically look at potential reform of:
:: “Regulation - how we could more quickly assess the safety and efficacy of innovations by adapting systems and better exploiting our unique advantages as an integrated healthcare system with world-renowned research medicine ethics and infrastructure;
:: “Reimbursement - how we might adapt our systems of health economic assessment to: reflect technological advances in genomics, precision medicine and informatics; take time and risk out of the traditional Research and Development model; and better exploit the potential of our integrated healthcare system to pioneer new models of reimbursement for innovative products, including payment by results and Evaluation through Commissioning; and,
:: “Uptake - how the NHS can better support and drive medical innovation (including through specialist commissioning).”

Assess early access scheme and role of real-world data

It will also take a wide-angle lens on drugs' adoption, assessing “the long term landscape for innovation adoption” and “aligning existing assets and initiatives,” and “strengthening the early access to medicines scheme” - introduced a year ago (APMHE 37638)
It will also consider the role of real-world data collection and monitoring and ways in which the National Health Service can “collaborate to provide real life evidence of utility and cost effectiveness”.
In addition, it will look beyond the UK’s borders, analysing best practice internationally on adoption of innovation, it said.

No changes to existing PPRS

The DH notes, however, that the review will not: “Change the existing PPRS (drugs pricing) agreement for branded medicines, negotiated with industry, which lasts for five years.
"The work could however consider issues relating to reimbursement prior to regulatory approval, the extent to which existing flexibilities and incentives for innovative medicines could be better used to overcome barriers, and any potential longer-term pricing and reimbursement issues.”
Speaking to APM on Thursday, a spokeswoman for the DH said there was no set mandate for the completion of the review, but the researchers, led by Sir Hugh Taylor, chair of Guy’s and St Thomas’ NHS Foundation Trust, have been told to report back to the government “later in the year”.
The terms of reference document for the review can be accessed here:



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