The potential role of NICE in the value-based assessment of drugs has been significantly affected by the negotiation of a new pricing scheme (the “2014 PPRS”) between the Government and the industry. The agreement
effectively fixes the total cost of drugs to the NHS in each of the five years covered by the scheme and restricts the behaviour of NICE in certain ways. The response of NICE is currently subject to public consultation.
The following is an extract from the Heads of Agreement for the 2014 PPRS.
• An objective of this agreement is to improve patient access and outcomes. NICE will undertake
all elements of assessment for a broader definition of value.
• NICE will not negotiate, publicly set or publicly indicate prices.
• The basic
cost-effectiveness threshold will be retained at a level consistent with the current range and not changed for the duration of the agreement.
• NICE will consult publicly before implementing changes
arising from the DH Terms of Reference for value assessment.
• The Terms of Reference DH sets NICE for value assessment will not prevent NICE Appraisal Committees from applying deliberation in the
assessment process. The Terms of Reference state that NICE should “encompass the different valuation of ‘End of Life’ treatments in the current approach within the system of Burden of Illness weights.”
• Companies may request value-based appraisal of their new medicines, and such requests will not be unreasonably refused.
• DH will work with Industry and NICE to support further consideration
of issues and potential resolutions around the use of unlicensed comparators and optimising the contribution to NICE’s work of independent Evidence Review Groups.
• Timings for the NICE value
assessment process are expected to be comparable with the current timetable for Single Technology Appraisals.
• DH supports the establishment of written ABPI working agreements with NICE and NHS England,
a NICE Industry Council and an NHS England Industry Council.
• The role of NICE is well established in providing guidance and guidelines for medicines use and the NHS will not seek to duplicate
this activity nor to further qualify, reinterpret or modify national guidance.