Primary Care Rebate Schemes
Primary Care Rebate Schemes (PCRS) are contractual arrangements initiated by pharmaceutical companies, directly or via third party companies, which offer financial rebates on particular branded medicines.
In response to a wave of queries about Primary Care Rebate Schemes, LPP has published some principles designed to help primary care organisations maximise benefits and avoid potential pitfalls. You may download these via the link under 'Supporting Information' on the right.
Information on the pan-London Primary Care Rebate Schemes Sub-group, which discusses rebate schemes, is available via the link on the right under 'More Information'.
It was unclear to the London Primary Care Medicines Use and Procurement QIPP group if such schemes are permitted under current regulations and legislation. There was also concern that a PCRS should offer genuine benefits to the NHS and patients, and not become an administrative burden. To help to manage these very real concerns, LPP obtained legal advice. We are now satisfied that the schemes are not unlawful per se. However, they need to meet certain requirements to avoid falling foul not only of the Drug Tariff and the controls on pricing under the NHS Act 2006, but of a raft of other UK legislation including the Medicines Act, Human Medicines Regulations, the Bribery Act and EU laws.
What is also clear is that a prescriber’s first responsibility is to act in a patient’s best interests. Financial considerations come second. Our advice is that participation in any PCRS should be agreed at a statutory organisational level, not agreed at GP practice level. Once agreed, a rebate scheme becomes a contractual agreement between the manufacturer and an NHS legal entity, usually a CCG. We have produced good practice guidance for Primary Care Organisations on how to robustly scrutinise and implement any proposed scheme. These principles can be found on this section of the LPP website.
The overarching principles align with those identified in Strategies to achieve cost-effective prescribing (DH, October 2010). These include ensuring that decisions to initiate treatment or change a patient’s treatment regime should be based on up-to-date best clinical evidence or guidance, and that health professionals should base their prescribing decisions on individual assessments of their patient’s clinical circumstances.
Practical considerations highlighted in the LPP guidance include avoiding schemes which encourage the exclusive use of a particular drug, and ensuring that a formal written contract is in place including an exit strategy to allow flexibility to respond to significant new clinical evidence or changes in market conditions. Volume-based schemes should be viewed with particular caution.
We encourage the pharmaceutical industry to ensure that their rebate scheme documents are clearly identified by date and version number to ensure that they are uniquely identifiable to all parties at all times.