Performance-based agreements: the way of the future?
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Performance-based agreements: the way of the future? – Annabelle Jerram – The Second Plenary Session of ISPOR saw lively discussion on whether performance-based agreements (PBAs) represent a win-win situation for payers, patients and drug developers, or whether they are irrelevant to reimbursement decision-making. What is the future for PBAs and will they become the exception or the rule? A performance-based agreement is a contract between a developer and a payer that links reimbursement with the performance of the product in the post-marketing environment. They acknowledge that at market entry, there are uncertainties around a drug’s likely performance and value. For example, there may be a lack of information on clinical effectiveness, QoL or budgetary impacts, or inadequate safety data. Both parties agree to share the risks that arise from these uncertainties, accepting penalties and rewards depending on future ’real life’ performance and outcomes (for example, QALYs gained, tumour response or percentage of patients reaching a target biomarker level). The agreements also specify who bears the cost of supplying the additional information required. Agreements may take various forms: • performance guarantees (reimbursement tied to clinical outcomes like survival) • conditional reimbursement (reimbursement tied to patient participation in research) • financial utilisation (price volume agreements or capitation/dose caps) • risk-based models (reimbursement tied to patient characteristics, could include differential pricing by indication); and • clinical practice models (reimbursement tied to impact of test results on practice patterns). In the session, titled ’Performance-based Agreements - Theory to Practice’, the pros and cons of PBAs were put forward by speakers from the US, UK and Europe. While industry representative Dr. Jens Grueger of Pfizer Ltd, Surrey, UK presented a mainly positive argument, M. N¨ oel Renaudin from France’s Ministry of Health considered such agreements less relevant to decisions made in France. Also presenting were Professors Sean Sullivan from the University of Washington, Seattle, USA and G´erard de Pouvourville from Ecole Sup´erieure des Sciences Economiques et Commerciales, Cergy-Pontoise, France. According to Professor Sullivan, most of the experience with PBAs lies in Europe and Australia, and he outlined agreements that exist for bortezomib in the UK and bosentan in Australia. He also mentioned three pharmaceuticals (simvastatin, risedronic acid and sitagliptin/metformin) for which such agreements are in place in the USA. These kinds of contracts have become more common, as the traditional model for accessing reimbursement has given way to the principles of risk sharing. The need for this paradigm shift, argued Professor de Pouvourville, reflects various factors, including for companies, the greater risk of facing restricted indications, product withdrawals and legal action around potential adverse effects.
Advantages of risk-sharing... For industry, rather than simply agreeing to p
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