The coalition government has said its plans to introduce a value-based pricing (VBP) system for medicines from 2014 will go ahead, but respondents to its consultation on the plan have called for more details on how the system would operate in practice.
In its response to the consultation, the government notes that a number of respondents stated that the proposals, as set out in the consultation document, “were at a fairly high level, and it was felt that there was a lack of detail around how the process of assessing a medicine, and the subsequent setting of a value-based price, would operate in practice."
Moreover, "many felt that further consultation on the detail of the plans would be helpful, both for the design of the new system and for communicating what is likely to be a complex system, requiring a high level of engagement from stakeholders in order to be able to fulfil its objectives," it adds.
The consultation received 188 separate responses, and "a clear majority were supportive of the concept of moving to a VBP system and of the objectives set out in the consultation document," the government response notes. The scope of the proposals was also "generally supported," although some respondents suggested that, in a few cases, it might be worthwhile to look at including medicines already on the market before 2014, or where a separate assessment system or process may be necessary, such as for treatments for rare diseases.
"The proposal that we would be willing to pay more for medicines in therapeutic areas with the highest unmet need was met with some support, as was the suggestion that we should be willing to pay an extra premium to incentivise the development of innovative medicines," says the government. However, it adds: "less certainty was expressed about how these factors could be measured and calculated in practice as part of the VBP assessment."
In its response to the consultation, the Association of the British Pharmaceutical Industry (ABPI) pointed to the need to ensure that any new system recognises the value brought by the research-based pharmaceutical industry in developing new and innovative medicines. "The ABPI would like to see a proper understanding of the nature of pharmaceutical innovation - specifically the terms 'breakthrough' and 'incremental' need significantly more clarity," says the group.
The ABPI also tells the government that it is not clear if the provisions included in the existing Pharmaceutical Price Regulation Scheme (PPRS) to stimulate the industry's growth as part of the UK health economy will be included in VBP. "We have serious concerns that the plans to encourage and nurture life sciences via the Plan for Growth in isolation will not deliver the joined-up industrial policy that we believe is essential," it says.
The industry's preference is for a single unitary pricing and reimbursement system that includes the commitment to VBP, minimises bureaucracy and ensures rapid access for patients to new medicines, says the ABPI but, it adds: "we have still to see a clear vision of the system that will succeed the current PPRS, which has traditionally met patient needs and supported an important R&D-based UK industry."
The NHS Confederation's response to the consultation notes its concern about the feasibility of the government's timetable for implementing the new system by 2014, given the amount of research and testing which will be required to ensure the proposals will work.
Also, more needs to be known about how full transparency of the proposed system will be achieved in practice, and the Confederation still has reservations about the impact the proposals will have on driving innovation, according to chief executive Mike Farrar.
"We remain concerned about the difficulty of defining what transparency is and whether commissioners should pay a premium for innovation," he said.
"Ultimately, we are seeking a wise agreement on VBP that recognises both the value of pharmaceuticals to patients and the need to secure and develop the pharmaceutical industry in the UK," said Mr Farrar.
In a Written Ministerial Statement on the consultation's findings, Health Secretary Andrew Lansley told Parliament yesterday that work will continue on developing a VBP system. "We are modernising the NHS so we can give patients better access to the medicines they need. To do this, we need to change the way drugs are priced and ensure value for money for the NHS," he said.
It is vital that doctors "must be able to focus on what matters most - achieving the best health outcomes for their patient, not debating the price of a drug. Value-based pricing will ensure this happens," he said.
The government response to the consultation concludes by pointing out that the current PPRS is a voluntary scheme agreed with the branded pharmaceutical industry and that "our preference for VBP would be, similarly, to achieve a negotiated agreement." Forecasting that negotiations "might begin some time in 2012," it says that, in the meantime, "we look forward to continued positive and productive engagement with the full range of interested stakeholders."