Valuing medicines and NHS reform – the ABPI view
pharmafile | December 10, 2010 | Feature | Sales and Marketing | ABPI, NHS reforms, Paul Catchpole, market access, value-based pricing
For those concerned with improving the value for money of medicines to the UK’s health service, the government’s White Paper on health contains initiatives to be cautiously applauded, and others that raise more questions than answers.
Value is a key driver for both the ABPI and the pharmaceutical industry, and as such is named as one of the ABPI’s four strategic imperatives, alongside Innovation, Trust and Access. Medicines are a major part of any solution that will deliver better outcomes for patients and the NHS, and our aim is to ensure that such medicines are appropriately valued and provide a cost-effective means of preventing and treating illness and disease.
The White Paper Equity and Excellence: Liberating the NHS, is certainly ambitious in its scale, but it gives rise to a degree of uncertainty and the feeling of a state of flux within the system by which new medicines are approved for use by the NHS.
Most pertinent of all in this regard is the future scope and standing of NICE.
Firstly, let me say that the ABPI is pleased that NICE is to be strengthened in its role as an independent, non-departmental public body, accountable directly to Parliament; and that its remit will be extended to include social care as well as healthcare. To our mind, anything that promotes joined-up thinking is a positive development. Clearly, NICE’s future role is very much reaffirmed through the government’s announcement.
However, looking to the future, much needs to be done by us as an industry, and by NICE itself, in respect of how to best deliver new concepts in the value-based pricing of medicines, starting from 2014 when the current PPRS (Pharmaceutical Price Regulation Scheme) ends. This calls for a markedly different approach to the assessment of medicines than is currently undertaken within NICE’s health technology appraisal systems.
Medicines provide value in many different ways, and some of those elements are already captured well by NICE. For example, it is good at measuring aspects of quality and quantity of life provided by medicines.
These are, of course, specific and very important health benefits for patients, but there are also other, wider, factors that need to be taken into account, if value-based pricing is going to work effectively.
Defining the value of medicines
At the ABPI, we believe that the defined value of a medicine should take account of the full consequences and potential savings that its appropriate use would create throughout the delivery of healthcare. For instance, a new medicine might save money by preventing or reducing complications associated with existing treatments. Cost-effectiveness is an important focus for NICE, but we also believe that factors such as unmet need, severity of disease, the value placed on extensions of life at the end of life, and the value of medicine for use in children or for socially disadvantaged populations – need to be more explicitly considered alongside. The value of a new medicine in the context of the economic lifecycle of the medicines to which it is being compared, is also an important consideration which needs careful thinking through.
This is an area of ongoing discussion between government, and the pharmaceutical industry, and it is encouraging that our input to the thinking around value-based pricing is being sought. Recognising that these elements need to be considered is only the first step though; formulating a method of measuring value more comprehensively and applying it will be the next challenge, and the devil will be in the detail. A great deal of thinking is needed to prepare the way for more comprehensive medicine value assessments from 2014.
Another dimension to this discussion about the value of new medicines is in the fast-growing area of personalised healthcare and stratified medicines, sometimes requiring the use of companion diagnostics. Again, whatever methodologies are developed to support value-based pricing of medicines, the requirements of this new dimension will also need to be taken into account. We would argue that a flexible approach to determining value needs to be taken, that provides a sound framework within which more complex calculations of value can be brought to bear.
A one-size-fits-all approach is not, in our opinion, probably going to work.
Finally, the White Paper raised interesting questions in respect of how medicines will be approved by NICE for access to the health service. Without access, it is relatively meaningless to measure value. There is now uncertainty regarding the future status of NICE guidance on medicines that have passed through its technology appraisal process.
In the past, NICE handed down national guidance, which NHS organisations were expected to implement locally. That link between national guidance and local implementation has been critical in ensuring that medicines were taken up across the NHS.
But the White Paper establishes the concept of a single NHS Commissioning Board, as well as putting a huge focus on GP-led commissioning consortia. The NHS Commissioning Board it seems may determine the status of NICE guidance.
What in the future will be the responsibilities of the NHS, in terms of ensuring equitable access to innovative new medicines?
The postcode prescribing lottery
The spectre arises of an even greater ‘postcode lottery’ for medicines than already exists in this country. There must be some concern that local decision makers will decide not to commission ‘advisory’ medicines to treat patients with rarer diseases, in favour of those that are for the greater good of a larger number of their local patient population.
Can we be sure that those rarer diseases will continue to be treated across the health service?
To our mind at the ABPI, the proposed changes provide our health technology appraisal systems with significant new challenges.
All stakeholders will need to work closely and collaboratively together to ensure we build the best system for the future, which permits patients in the UK to get access to the innovative medicines which can benefit them – and at the time they need them.
Paul Catchpole is the director of value and access at the ABPI
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