The recently published Health Select Committee report on the activities of NICE reflects on how it has performed in a number of areas and touches on value-based pricing, the Cancer Drugs Fund, drugs trials and NICE’s imminent move into the social care sector.
The committee is highly critical of the delay in setting out the essentials of a move to a value-based pricing system for drugs when the current Pharmaceutical Price Regulation Scheme (PPRS) expires in 2014. A considerable amount of time has been allowed to elapse since the Government consultation on the transition opened in 2010. MPs have called for decisions to be made no later than March 2013.
The report also records that there is uncertainty about the implications of the changes proposed for the Cancer Drugs Fund, introduced in 2011, to facilitate patient access to non-NICE approved drugs, which will be superseded by the value-based pricing system. The committee calls for:
- An assessment of the outcomes for those patients whose treatment has been paid for by the Cancer Drugs Fund
- Evidence of beneficial outcomes to inform the new value-based pricing scheme and apply to treatment of conditions other than cancer
- Clarity about how drugs, which have been paid for by the fund, will continue to be made available to individual patients
MPs also express concern about the implications for the effectiveness of NICE on recent evidence about access to information from clinical drug trials. They argue that there should be both a professional and legal obligation to ensure that all regulators have access to all available research data about the efficacy and safety of pharmaceutical products in use in the UK, and that all information arising from drug trials concerning drugs that are in clinical use should be in the public domain in an accessible form. The committee urges the pharmaceutical industry to introduce a new code of practice to make this commitment effective and calls on the GMC to reiterate its guidance to doctors on the conduct of drug trials.
One of the key themes of the committee’s work in this Parliament has been the need to move to a more integrated system in order to maintain both quality of, and access to, care. It accordingly welcomes the fact that NICE is to take on responsibility for producing clinical guidance and quality standards in relation to social care, and argues that there is a real opportunity for NICE to help evolve a different model of care by creating integrated standards and clinical guidance. The MPs say that this should not just be about providing guidance to professionals treating
and caring for people with a specific condition but, should also involve advising about the most common associated co-morbidities, including mental illness. Guidance will also need to take account of what individuals want for themselves, as an important step towards a philosophy which emphasises treatment of people not conditions.
The committee also recommends that, for the enhancement of NICE’s credibility, the opinions of patients are effectively and openly represented in all its work and that NICE non-TAG guidance remains guidance, rather than an instruction, so continuing to permit local discretion and individual clinician/patient judgment. Readers are reminded however, that departures from NICE guidance should always be rational, accountable and transparent.