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NICE to assess drug value

pharmafile | March 22, 2013 | News story | Sales and Marketing EMIG, NHS, NICE, VBP 

NICE will be responsible for assessing the full value of medicines – taking into account their benefit to patients and to society as a whole – when Value-Based Pricing (VBP) comes into force next year.

The government made the announcement in its response to the House of Commons health select committee’s report on the changing role of NICE.

“The move will give NICE a crucial role in the future VBP arrangements for branded medicines,” the Department of Health said.

NICE’s role going forward has been a bone of contention since former health secretary Andrew Lansley suggested that its function would be downgraded, as the prelude to creating an entirely new drug appraisal system.

There was a quiet U-turn on that in June 2011 when the government said NICE would retain its central power of directing the NHS on the use of medicines.

For it to go from the brink of obscurity to – two years on – an even more powerful role in medicines assessment suggests a degree of confusion in strategic policy making, critics argue.

But it is the nuts and bolts of NICE’s expanded remit which worries pharma now.

The addition to NICE’s current drug evaluation role had been trailed by the government, but the Ethical Medicines Industry Group (EMIG) is cautious, pointing out that since VBP itself has not yet been clearly explained, ‘assessing NICE’s role is impossible’.

EMIG chairman Leslie Galloway said: “We still have many unanswered questions as to how value will be assessed, who will assess it and how value will be measured in terms of clinical use.”

There is too little clarity on how VBP will work and how ‘value’ itself will be defined – and Galloway questioned whether NICE can capture value outside of the constraints of the QALY.

The organisation’s misgivings arose in particular around the idea of so-called ‘societal’ benefits because “there is no definitive agreement on how benefits will be classified”.

EMIG is also worried that VBP will make the assessment process too lengthy and expensive, particularly for low volume, high value medicines produced by EMIG companies.

“Given the paucity of information about the proposed shape of the new pricing scheme, EMIG believes that there are still many questions to answer and issues to resolve before today’s news can be fully understood,” Galloway concluded.

Striking a similar note, ABPI chief executive Stephen Whitehead said: “What will determine whether VBP works for the pharmaceutical industry, the NHS and most importantly patients is not who does the assessment, but how it is done and what goes into it.”

He added: “This has yet to be determined and we are working hard to secure a policy which will deliver for patients in the future.”

NICE was re-established as a new statutory body, now called the National Institute for Health and Care Excellence, under the Health and Social Care Act 2012.

The new name reflected the extension of its role to include social care in a bid to help integrate services from the NHS, plus social care and public health sectors.

The organisation is to develop a healthcare quality standard on “long-term conditions, people with co-morbidities and complex needs” and a social care quality standard on “management of physical and mental co-morbidities of older people in community and residential care settings”.

While no doubt aware of pharma’s worries, health minister Lord Howe glossed over questions of detail, saying: “We are delighted to announce the central role NICE will take in assessing the value of new medicines. This will allow us to draw on NICE’s world-leading expertise as we develop the VBP scheme.”

There is a tacit admission in Westminster and Whitehall that a great deal of detail still needs to be inked in. “The role of NICE is developing and growing as it takes on new responsibilities in social care,” Lord Howe concluded.

NICE will work with the DH and other stakeholders to plan how it will undertake its role in assessing the value of new medicines, the government said.

The health select committee published its report in January after a number of fact-finding sessions, as NICE looked to appoint Professor David Haslam as its new chairman.

Adam Hill

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