Italian risk-sharing agreements on drugs: are they worthwhile?

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Both payers and manufacturers have shown increasing interest in risk-sharing schemes, since they are expected to serve as a mechanism for reducing uncertainty through greater investment in collecting clinical evidence once a new drug is already being used in a health care system. The underlying philosophy is to pay only for patients responding to therapy, a very challenging issue in a clinical perspective, while appealing from a political viewpoint. Recently, an international group of experts proposed to call them ‘‘Performance-Based Risk-Sharing Arrangements’’, a highly complex definition indeed [1]. These contracts exist in many varieties, generally as a reaction to the increasing costs of expensive new drugs, while more data are still needed to thoroughly assess their effectiveness. In principle, they could provide additional options to payers and manufacturers, to boost overall efficiency [2]. The ambitious goal is to help reduce the likelihood of payers adopting technologies that turn out not to be cost effective, while at the same time helping manufacturers earn profitable prices to invest in future innovative technologies. Italy is one of the countries that started early with these agreements: AIFA, the Italian drug agency, agreed on its first contract in July 2006 [3]. The complex management of these schemes, now called managed entry agreements (MEAs) by AIFA, and similar to the patient access schemes in the UK, is entirely based on web-registries. Hospital consultants are required to complete an on-line prescription form, with the patient’s identification data, therapeutic indication and dosages. The system validates each prescription and automatically requests the hospital pharmacy to release the drug. Every single prescription is tracked to monitor appropriate use of innovative and expensive specialist drugs. AIFA has published on its website a very accurate estimate of the time required by a hospital consultant and a pharmacist to complete the most important forms, even splitting these estimates for expert and non-expert professionals [4]. However, the negligible average times estimated to complete some forms—e.g. 30 s for an experienced consultant for forms focused on diagnosis, 10 s for a pharmacist for those needed for dispensing—hardly seem realistic, taking account of the varieties of drugs and indications. Twenty-nine MEAs were in force as of October 2012 [5], for 25 drugs (Table 1). Three different types of agreement can be stipulated with pharmaceutical companies: (1) costsharing (CS, n = 11), (2) risk-sharing (RS, n = 2) and (3) payment-by-results (PbR, n = 16). CS implies just a price discount, usually limited to the first 2–3 months or cycles of therapy. These discounts are normally monetary and manufacturers are expected to do a pay-back. The other two contracts are based on the rates of ‘‘non-responders’’. The manufacturer is expected to pay back part of (RS) or the full price (PbR) for each non-responding patient. If a patient meets ‘‘non-responder’’ criteria, the hospital pharmacist should apply to the manufacturer for pay-back not later than the end of the year; the manufacturer can accept or reject the proposal (requiring arbitration) [5].