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NICE launches VBA consultation

Published on 27/03/14 at 08:25am
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NICE has today launched its consultation into how value-based assessment of drugs will work in practice, which will run for the next three months until 20 June.

This is part of the renewed PPRS scheme, the new drug pricing policy for the UK, which came into force in January and was set to be a value-based pricing system, but has been downgraded to ‘value-based assessment’ (VBA).

NICE says: “The new proposals include ways to take into account more systematically and explicitly the severity of a disease, as well as the effect that diseases and conditions have on our capacity to engage in society.”

The details of this remain vague but UCB chief executive Roch Doliveux has been one of several pharma leaders to express their disappointment with the new arrangements. “I’m disappointed that we could not have a new system that was based on value for patients,” he says.

PPRS means that the £12 billion NHS patented drugs budget for England must remain at that level for this year, and grow by no more than 2% until 2017 - which in effect limits how much money the pharma industry in the UK is allowed to make.

The ABPI says it is looking forward to helping NICE shape how things will look in the future.

“Value based assessment has the potential to allow NICE to use a broader definition of value in order to reflect more fully the value that medicines bring to patients and society,” adds Paul Catchpole, ABPI director of value and access.

Pharma’s trade body wants VBA to help increase access to medicines for conditions that impose a “substantial burden on patients and society”.

Catchpole continues: “There is, however, a huge amount of work to be done to make this happen, and we hope that NICE will embrace the changes that are needed.”

The ABPI’s main bugbear is that NICE approves what it believes are too few new cancer medicines - but it also says there are issues with unpredictability in the current system and murky frameworks on how decisions are made, which means pharma and the NHS can find difficulty in planning around patients’ needs.

“The vital role of patients should not be overlooked by NICE when assessing medicines and we hope the opportunity will also be taken to allow greater contributions from patients and clinicians in the appraisal decision making process,” Catchpole goes on.

“We have a particular concern about the potential impact of incorporating NICE’s existing ‘end of life criteria’ into the new system,” he concludes. “We need to ensure that this does not lead to fewer medicines for patients at the end of their life, being approved.”

NICE has already pledged that there will be no age discrimination in whatever test it chooses, and likewise it will not use gender or any of the other ‘protected’ characteristics under equalities legislation to make its decisions.

Pharma had voiced concern about this question because, as Ethical Medicines Industry Group (EMIG) chairman Leslie Galloway told Pharmafocus last year, “there is no definitive agreement on how benefits will be classified”.

NICE chief executive Sir Andrew Dillon said today: “These proposed changes to the way we value new treatments will add further clarity to our recommendations, and enable our independent advisory committees to explore more fully the potential these treatments have to improve outcomes for patients.”

In a statement NICE adds: “We want to consider the wider impact of a disease on people’s ability to be part of society.”

The watchdog defines this “as the loss in a person’s capacity to engage with society as a result of living with the disease or condition, compared with their capacity to engage with society without the condition, measured in QALYs”.

It proposes to calculate ‘wider societal impact’ by measuring the absolute shortfall in QALYs - subtracting the QALYs expected as a consequence of having the condition from the total QALYs expected for people with the same age and gender distribution without the condition.

Adam Hill

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