The flexible pricing arrangements contained within the UK’s new Pharmaceutical Price Regulation Scheme (PPRS) present new responsibilities for the National Institute for Health and Clinical Excellence (NICE) but also uncertainties, because while the PPRS provisions cover the four nations of the UK, NICE does not, a conference in London has heard.

Under the new arrangements, a company will still set the initial launch price for its new product and will be able to increase or decrease this price, as further evidence or new indications change the value that the medicine provides to patients, but only after NICE has conducted an appraisal to determine whether the revised price provides value.

However, it is not yet clear how these new arrangements will work out across the UK, Dr Carole Longston, head of technology assessment at NICE, told the Health Technology Assessment (HTA) World Europe 2008 conference yesterday. For example, while NICE guidances on multiple technology appraisals (MTAs) currently apply in Scotland, its Single Technology Appraisal (STA) guidances do not, she said.

NICE is now going into discussions with the Department of Health about the new arrangements, Dr Longston told delegates and, in answer to questions, she stressed that no proposals have been put forward for NICE STAs to be taken up in Scotland or for the Institute to take over work done by the Scottish Medicines Consortium (SMC). Nor will NICE be taking any role in the setting or negotiation of prices, she stressed.

The SMC’s vice chair, Angela Timoney, agreed that it was not yet clear how the new arrangements under the PPRS will work in practice, but said she would be happy to see innovative new products taken up early in their lives. Patient access schemes, which the new PPRS seeks to encourage, do not operate in Scotland, she added.

Dr Marc Berger, vice president for global health outcomes at Eli Lilly & Co, praised NICE for being at the forefront of engaging with the public as stakeholders, through its Citizens Council and social value judgement principles. In general, although the attitudes and preferences of society cannot be ignored in the decision-making process of HTA agencies, they are currently undervalued, he said.

NICE has endorsed the “accountability for reasonableness” (A4R) theory for assuring a fair and level playing field for decision-making on health care priority-setting, said Dr Berger. Under the A4R theory, put forward by US professors Norman Daniels and James Sabin: - such decisions and the rationales for decisions must be accessible; - the grounds for such decisions must be ones that fair-minded people can agree are relevant; - there must be mechanisms to challenge and resolve limit-setting decisions; and - there must be some form of regulation to ensure that the other conditions are met, the meeting heard.

“When we put the patient at the centre and collaborate to develop, synthesise and understand the evidence, we can find common ground,” said Dr Berger.

- The Health Technology Assessment World Conference was produced by Health Network Communications in association with the London School of Economics: