Payers' Forum Europe

Oct 21, 2013 - Oct 22, 2013, Berlin, Germany

Engage with NHS, HAS, G-BA, AIFA, Spain and more to understand what Payers and HTAs want to enable you to create Value Adding Propositions

Managing Outcomes-Based Reimbursement through ‘Patient Access Schemes’

eyeforpharma talks with Andrew Stainthorpe, Associate Director of NICE’s Patient Access Scheme Liaison Unit (PASLU), about risk-sharing agreements (or ‘Patient Access Schemes’), and the how pharma can collaborate with regulators to ensure their success.



What are Patient Access Schemes (PAS)? As Andrew explains, “these are schemes that help moderate the price of a new technology for a given disease as considered in the NICE Technology Appraisal process. In these arrangements the list price of the drug remains unchanged, while the actual price of the drug is discounted in order to facilitate patient access.” Their rationale is in the context of the UK list price being used as a reference price in a range of countries.

Viewed globally, there is potential for more of this type of risk-share scheme

A voluntary agreement between the Pharma industry body, the Association of the British Pharmaceutical Industry (ABPI) and the Department of Health, the Pharmaceutical Price Regulation Scheme (PPRS) included agreed principles for Patient Access Schemes in 2009. The PPRS defines the main types of schemes: which range from the simplest type of PAS - a financial-based scheme where a discount at source is agreed, through to outcome-based schemes which tie reimbursement to an agreed clinical outcome. PASs can be considered for medicines  which are referred to NICE for technology appraisal.  “Viewed globally, there is potential for more of this type of risk-share scheme   used to facilitate price variation particularly as new and innovative medicines are marketed at high cost and many countries have finite resources to spend on healthcare.”

Making a success of these schemes depends on both the pharma companies who submit proposals and the NHS who implement them.  PASLU has the job of assessing whether scheme proposals meet criteria agreed in the PPRS. Andrew adds that both PASLU and pharma companies are aware of the potential for schemes to be a burden to both company and NHS. “The NHS finds some schemes quite burdensome, but makes the effort and implements them because it’s a means to gain access to important new medicines for NHS patients. It is true that some of these schemes are quite involved, and that was one of the reasons the Department of Health commissioned NICE to set up PASLU. Each new scheme added to the cumulative burden, and some of them were quite burdensome.  The NHS was not specifically resourced for the management of PASs. Each new scheme adds a proverbial new straw to the camel’s back.”

Overall there are many benefits in making the process as simple as possible for all parties

Responsibility for these schemes is spread among several areas of the NHS, although Andrew comments that pharma companies are often innovative in ways that seek to assist the implementation of their schemes. “There are various places within the NHS where such schemes might generate work. This can include planning for the commissioners, and implementation within the pharmacy and the financial teams of the hospitals. The pharmacy helps with tracking patients, and the finance teams deal with the financial reconciliations and attributions.  Clinicians are sometimes involved - such as to make sure they are notifying and bringing patients into the schemes appropriately.  Overall there are many benefits in making the process as simple as possible for all parties.  Pharma can do much to facilitate the success of a scheme proposal by:

  • Having an effective early dialogue with the NHS
  • Discussing their ideas early with the Department of Health and PASLU
  • Tailoring their scheme to the existing NHS service as closely as possible.

Although the PPRS does allow the use of outcomes-based PASs there are relatively few such proposals in England and Wales as such schemes often generate new activity for NHS and the manufacturer.  However, it does offer clear evidence of the success of a medicine. In this way a Pharma company can provide a direct demonstration of the value of its medicines.  This might also be facilitated through the use of other activities such as a register or another existing ways of monitoring patient outcomes and tie the scheme into that. Using such approaches can allow schemes to operate with adding additional burden to the NHS.  These are the approaches the more imaginative manufacturers are using in their schemes proposals.  A manufacturer thinking of sponsoring a patient register or monitoring scheme should follow best practice to ensure it is operated in  an open-access and transparent way, such that the relevant and anonymised information is open to those with legitimate interests, including the pharma companies themselves. This may be a route by which a company might use to develop an outcomes-based PAS for use in the NHS.”

Another simplification appreciated in the NHS is a succinct scheme agreement with clear terms and conditions that need to be adhered to. “In the past Companies had put in place some quite challenging compliance criteria which sometimes the NHS trusts found difficult to meet.  This led to missed rebates from the company and further bureaucracy to resolve the situation. Historically, those conditions have been around a missed dose or a failure to meet a deadline. PASLU liaises with the company to try to set such terms and conditions at thresholds which the NHS can achieve, so that the scheme is inclusive rather than exclusive. The more you define and complicate these arrangements, the more burdensome they become to track and monitor.”

It is conceivable that outcomes-based schemes might be advantageous to both payer and manufacturer, making management of appropriate reimbursement a lot easier

Personalized medicine, with its specification of smaller and smaller patient populations, presents new issues for the operation of national PASs: “getting down to the individual level and tailoring to the patient would bring different challenges.” However, there may be some areas where an individual focus is manageable, even necessary.  Patient Access Schemes might be used for orphan drugs. These drugs are very high cost for very small numbers of patients. “It is conceivable that outcomes-based schemes might be advantageous to both payer and manufacturer, making management of appropriate reimbursement a lot easier perhaps linked to individual patient outcomes for these diseases.”

Lastly, Andrew believes that a good dialogue between pharma and PASLU is crucial for the success of PAS. “It is PASLU practice to engage with the industry, in order to make sure our processes are pertinent and that there is good industry understanding of what we do. We have industry dialogue days, we talk very closely with the Association of the British Pharmaceutical Industry (ABPI) and we have a representative of the ABPI on the Expert Panel. We try and engage with manufacturers so that within the terms of the PPRS, we can facilitate the best outcomes for all parties. Where there is a slight divergence between what a manufacturer proposes in a PAS and what might work best in the NHS, we will try and have a dialogue and guide towards the best approach. We do not see that there are sides in this process as we share the same goal of getting the right drugs available for the patient – that is why they are called Patient Access Schemes! The government is committed to providing the right drugs to the patients that need them, but resources are finite, so the aim is to make arrangements that allow patients access to drugs at affordable prices rather than drawing a line in the sand and saying we can’t cross it. Within the PPRS umbrella, there is flexibility and open-mindedness about potential schemes and how they might operate.”



Payers' Forum Europe

Oct 21, 2013 - Oct 22, 2013, Berlin, Germany

Engage with NHS, HAS, G-BA, AIFA, Spain and more to understand what Payers and HTAs want to enable you to create Value Adding Propositions