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Ruminations on the future of rationing in the English
NHS: No more Mr NICE guy?
Dr Keith SyrettReader in Public Law and Health Policy
University of Bristol, UK
The Government’s statement on NICE
• “We will introduce a new system of value-based pricing which will make effective treatments affordable to the NHS. Our plans will ensure licensed and effective drugs are available to NHS clinicians and patients. We will focus NICE's role on what matters most - advising clinicians on effective treatments and quality standards - rather than making decisions on whether patients should access drugs that their doctors want to prescribe.” (Department of Health, 1 November 2010).
NICE’s view• “NICE will continue to undertake an independent and objective
assessment of the benefits of new drugs. What will be different is that from 2014, it is likely that we will stop short of converting that assessment of therapeutic benefit and economic impact into a recommendation for use. I anticipate... that from 2014, section 1 of our guidance will contain a clear and concise statement of the incremental therapeutic benefit of a new drug or indication (all this seems at the moment to apply only to new drugs, by the way) and its optimal position in clinical practice, together with the outcome of the economic assessment, expressed as a QALY range or most plausible ICER, or both. The final step, which as Appraisal Committees you currently take, of making the connection between the two to formulate our recommendation on when and how to use the drug, won’t be required. A new process will take the NICE appraisal and use it to decide whether the offer price (and the ICER it has generated) represents a fair price for the NHS to pay. Our appraisal will be available to the NHS and the public, to help inform the decisions they take locally on the way the drug should be used.” (Sir Andrew Dillon, 2 November 2010)
So...• NICE’s function will tend more towards technology assessment than technology
appraisal;
• Its guidance on clinical and cost-effectiveness of new technologies will no longer connect to a mandatory funding obligation for local commissioners;
• Its guidance will inform a process of value-based pricing at national or regional level, commencing in 2014, together with local decision-making on new technologies;
• But new consortia of GPs will be responsible for determining whether such technologies (and other treatments) will be funded, on the basis of local priorities:-
“We cannot dispense with the concept of rationing, but who should do that? Currently, the person who is trusted by the patients is the GP in front of them, but the GP is not in a position to make the decision that really matters for their patients. The position we are moving to is not to dispense with the need for prioritisation, but to have prioritisation where patients have a reasonable expectation and discuss it with their clinical adviser. I actually think most of you would rather make the decision collectively rather than an organisation that isn't accountable to you.” (Secretary of State for Health, 21 October 2010)
Why the change? I• The ‘special interest’ explanation: pharmaceutical industry has always
opposed NICE and successfully lobbied government for its emasculation;
• The ‘patient-centred’/‘clinical freedom’ explanation: NICE has delayed or denied access to clinically effective treatments which patients and clinicians demand and which are often available elsewhere;
• The ‘undermining’ argument: the new Cancer Drugs Fund enables access to drugs irrespective of the NICE position on cost-effectiveness:
“The Cancer Drugs Fund is intended to ease the funding constraints which can prevent patients in such circumstances from accessing drugs which their doctors recommend for them at a time when some extra weeks or months of life may be particularly precious. The Fund should be seen as addressing a particular category of cases where NHS funding is not otherwise available.” (Department of Health The Cancer Drugs Fund: A Consultation (2010), [2.8]);
Why the change? II
• The ‘economic’ explanation: in spite of its reputation, NICE has increased NHS expenditure on drugs – other control mechanisms are needed, especially in times of fiscal austerity;
• The ‘political’ explanation: controversy over limitations to access to new technologies can be further deflected if decisions are geographically diffused to local commissioners;
• The ‘ideological’ explanation: reducing the role of the state in the health system: ‘creeping privatisation of the NHS’?
Some concerns about value-based pricing
• How is ‘value’ to be defined? Is it simply cost-effectiveness based around QALY calculations, or will other criteria be relevant?
• What is the threshold for benefit and who sets it?
• Will manufacturers price up to the threshold?
• How can increased evidential uncertainty best be addressed?
• Where will accountability for the pricing decision lie and what form will it take?
Local consortia as rationers: the Government’s view
• ‘In order to shift decision-making as close as possible to individual patients, the Department will devolve power and responsibility for commissioning services to local consortia of GP practices. This change will build on the pivotal and trusted role that primary care professionals already play in coordinating patient care, through the system of registered patient lists.Primary care professionals coordinate all the services that patients receive, helping them to navigate the system and ensure they get the best care (of course, they do not deliver all the care themselves). For this reason they are best placed to coordinate the commissioning of care for their patients while involving all other clinical professionals who are also part of any pathway of care. Commissioning by GP consortia will mean that the redesign of patient pathways and local services is always clinically-led and based on more effective dialogue and partnership with hospital specialists. It will bring together responsibility for clinical decisions and for the financial consequences of these decisions. This will reinforce the crucial role that GPs already play in committing NHS resources through their daily clinical decisions – not only in terms of referrals and prescribing, but also how well they manage long-term conditions, and the accessibility of their services. It will increase efficiency, by enabling GPs to strip out activities that do not have appreciable benefits for patients’ health or healthcare.’ (Department of Health, Equity and Excellence: Liberating the NHS, Cm 7881 (2010), [4.2]-[4.4])
Local consortia as rationers: the concerns I
• While GPs may enjoy public trust in making allocative decisions, they do not necessarily wish to undertake these, nor have the necessary expertise to do so;
• Potential for conflicts of interest between GPs’ roles as advocates for patients and as commissioners;
• Legitimacy problem: “The decision-making processes from within each consortium should be managed and conducted in a transparent and fair manner. Therefore, the mechanisms for establishing how decisions are made, how member practices views are taken in account and who sits on the board of a consortium, should all be envisaged by the policies and formal documents thatthe consortium should have in place.” (BMA General Practitioners’ Committee, Guide to the NHS White Paper: Legal Overview and Guidance on the Commissioning Proposals (2010), p.4);
But sufficient stakeholder participation in decision-making, cf NICE consultees and commentators?
Local consortia as rationers: the concerns II
• Geographic and social inequalities as a consequence of postcode prescribing and accompanying ‘medication tourism’, particularly (but not exclusively) in respect of new technologies:
“The current commissioning proposals are an England-only initiative. The devolved administrations are unlikely to undergo the structural changes that this model of commissioning entails, although they may adopt some elements of the commissioning proposals. It is therefore quite possible that variations in healthcare will develop between the home nations. These will be more noticeable for consortia, practices and patients in the border regions, and consortia in these areas will need to consider how best to respond to this situation. It is possible that there will be variations in healthcare across England as a result of the choices consortia make in redesigning local health economies to meet local need. Effectively commissioned services should reflect the needs of the local population, but it would be useful if there were a set of national minimum criteria for NHS services to ensure consistency in what patients are offered across the country.” (BMA General Practitioners’ Committee, Guide to the NHS White Paper: GP consortia commissioning: initial observations (2010), p.12);
“You could imagine busloads of sick people traversing the country based on rumours that another consortium is offering drugs that their local one isn’t.” (Dr. Laurence Buckman, Chair of GPs’ Committee, British Medical Association, 7 November 2010);
• Hence, continued (perhaps growing) instability, manifesting itself in suspicion, distrust, resistance, protest and litigation?
