Value-based pricing (VBP) for medicines must reflect the burden of the disease being treated, the wider societal benefits which treatments bring and the fact that innovation is often gradual, the Association of the British Pharmaceutical Industry (ABPI) has told the government.
Moreover, a voluntary agreement for the introduction of VBP for all medicines launched after January 1, 2014 must be accompanied by another pricing structure, similar to the Pharmaceutical Price Regulation Scheme (PPRS), for products which are already on the market, the ABPI says, in its response to the government's consultation on its proposals to introduce VBP for branded medicines, which closes on March 17. These schemes need to be created through "a well-planned process of co-creation between government and the industry," it adds.
VBP alone will not guarantee gains in access to and uptake of medicines, and patient outcomes will only improve if uptake of medicines also improves, the industry group cautions. Therefore, the introduction of VBP must be completely aligned with the planned changes to the NHS, which include a number of proposed new mechanisms aimed at improving uptake of new treatments, but as these mainly apply to England only, the devolved nations must be involved from an early stage to avoid patient inequalities between the four nations, as must the new NHS Commissioning Board, it tells the government.
The "low and slow" uptake of innovative medicines is also the single largest obstacle to the UK's future leadership in the life sciences; "improving access to treatments is crucial to supporting the future of our life sciences industry and must be a consideration in creating the VBP system," it adds.
Given that only 20-30 new medicines are licensed in the UK each year and thousands of branded drugs are already on the market, it could take 20 years to move fully to a VBP system. Therefore, the scheme must be designed so that it is fully integrated into a single, workable system that provides stability and predictability, says the ABPI. It is also important to work out how the cost-effectiveness threshold, or how much the NHS is prepared to pay, for each medicine will be set, and then reviewed over time. If there is not enough evidence to come to a firm decision on value, additional approaches such as existing patient access schemes should be used, to ensure that patients are not denied access to important medical innovations, it suggests.
The industry response also sees the need for more detail on what the negotiation process would be to establish the cost of a new product once an assessment of its value has been completed, and emphasises that once the price has been agreed, it is not reassessed by the local and regional NHS.
"Following agreement of a value-based price, it will be in everyone's interests to ensure that further re-evaluations do not take place locally in the NHS, which would slow down the process for the right medicines to reach the right patients," said ABPI president Simon Jose.
Patient groups have expressed concern that input from the wider public might be excluded from the new pricing system. "Our concern is how it will work in practice and how patients and lay voices will be heard in the decision-making processes," said Jeremy Taylor, chief executive of National Voices, the coalition of health and social care organisations. "We need more clarity and are keen to work with the government and industry to ensure the future system does not have unintended side effects," he added.