27 Mar 2014 Posted in ABPI statement By Press Office
"The current process is denying too many patients the medicines they should be entitled to and is now inappropriate for many of the new medicines pharmaceutical companies are currently developing for patients. On top of that, once a medicine is recommended by NICE, the NHS often puts further unnecessary barriers in the way, which prevent them reaching patients.
“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. The ultimate aim should be to increase overall access to innovative, effective medicines for conditions that impose a substantial burden on patients and society. 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 new Pharmaceutical Price Regulation Scheme (PPRS),¹ which sees the pharmaceutical industry making payments to underwrite all expenditure above agreed growth levels in the UK medicines bill for five years, sets the context for providing a game-changing and transformative opportunity to address low and slow access and poor usage of innovative medicines for patients. The PPRS presents an opportunity for NICE to now look at value based assessment differently, enabling it to take a more pro-innovative approach when reviewing medicines so that NHS patients can benefit from the deal agreed between the Government and industry.
“We need to see increased predictability in the system and clearer frameworks on how decisions are made so that pharmaceutical companies and the NHS can appropriately plan 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.
“We have a particular concern about the potential impact of incorporating NICE’s existing ‘end of life criteria’ into the new system. We need to ensure that this does not lead to fewer medicines for patients at the end of their life being approved. There is currently an issue with NICE approving too few new cancer medicines, which the new agreement must address.
“We stand ready to work alongside NICE and other stakeholders to ensure the new system encourages and endorses the use of the innovative medicines that patients need.”
¹Under the new five year voluntary PPRS, the pharmaceutical industry has agreed to keep NHS expenditure on branded medicines flat for two years, with industry underwriting any further expenditure by the NHS within agreed boundaries. After the first two years, growth levels on branded medicines have been agreed.
The new PPRS agreement represents a further evolution of value based assessment, reflecting the specific proposals in the Coalition Agreement. Moving away from price setting proposals (value based pricing) to value based assessment signals a further step-change towards the use of a broader definition of value for appraising new medicines by NICE in England and Wales.
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