English NHS must fund value based pricing system drugs
This article was originally published in SRA
England's Department of Health has given pharmaceutical companies a little more clarity on what the new value-based pricing system might have in store when it confirmed that the National Health Service in England will have to fund drugs that are subject to the new system1. The news could mean fewer barriers than anticipated to the uptake of new medicines. Nevertheless the BioIndustry Association, representing UK biotech firms, warned that the new VBP system could make the UK a less attractive location to launch medicines.
"The NHS will be required to fund drugs already recommended by NICE [ie England's health technology appraisal body, the National Institute for Health and Clinical Excellence], as well as drug treatments subject to the value-based pricing regime," said the DH in its response to a report from the NHS Future Forum2. The government launched the forum as part of its "listening exercise" on its controversial Health and Social Care Bill, which aims to reform the NHS. The forum's report contains recommendations on these reforms.
It was not clear whether the NHS would fund drugs going through the new system or how it would operate in the context of the new GP consortia, which will be responsible for commissioning health services including drugs. The UK government's consultation on its proposals for a new VBP system, which will replace the current PPRS system from January 2014, did not address this issue. But industry bodies and NICE had warned that uptake of drugs could be thwarted by local access barriers and the reticence of local GP consortia even after a drug has been awarded a value-based price.
Both NICE and the Association of the British Pharmaceutical Industry, the UK's pharmaceutical industry association, had urged that the VBP system should incorporate a mechanism similar to that which obliges Primary Care Trusts to make money available for drugs recommended in NICE guidance (even though, in practice, some PCTs are slower than others to fund certain drugs).
"We believe that there is a risk that patients and health professionals who want to use the drugs made available under the new arrangements may find it difficult to do so unless the new arrangements retain these powerful national reference points," said NICE in its consultation response. Meanwhile, the ABPI said that the new system must ensure there are "no regional or local blocks once a medicine has gained an agreed value based price and so has theoretical national access".
Uptake is affected by a lack of a national mandate. Drugs that are not on NICE's radar are generally picked up by local assessment groups, which can reach different conclusions despite basing assessments on the same data. Industry has complained that there is little engagement with industry, transparency, consistency or a fair appeals process. "Industry is very tired of this, it's very expensive and can delay the uptake of a product by four years, what we want is an end to this," said Leslie Galloway, chairman of the Ethical Medicines Industry Group, earlier this year.
A host of important uncertainties about VBP still remain. Which drugs will be subject to the new VBP system? How will VBP work alongside GP commissioning? How will the arrangements affect other parts of the UK such as Scotland, Wales and Northern Ireland?
The BIA has other reservations about the new system. "We are concerned that it will not incentivise R&D and will cause confusion when trying to establish value of a medicine because of varying amounts of data and not necessarily being able to compare that data with the 'gold standard'. Therefore the BIA thinks it could make the UK a less attractive location to launch a medicine as there will be too many hurdles to overcome to define value, hurdles which don't exist in the current PPRS system," said Nigel Gaymond, the BIA's chief executive3.
References
1. UK DH, Government response to the NHS Future Forum report, 20 June 2011, www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_127444
2. NHS Future Forum recommendations to Government, 13 June 2011, www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_127443
3. Personal communication, BIA, 21 June 2011