In England and Wales, the duration of the relevant guidelines of the National Institute of Health and Care Excellence (NICE) determines the duration of the MEA, but the precise agreement must be clear and the conditions for terminating MEA must be set. A new MEA presentation is required for new indications or changes to the schematic type. In Italy, pricing and refund decisions are generally reassessed after 24 months, but the duration of the MEA can be adjusted on a case-by-case basis. MEA may be extended at the time of reassessment or content may change, illustrated by Adcetris® where a performance-based scheme was converted in July 2014 for a financial agreement for hodgkin and non-Hodgkin lymphoma. Discussions at the ADAPT-SMART3 workshop found that, in addition to technical, medical and political factors, a lack of trust between payers and manufacturers could be one of the main obstacles to the wider use of results-based agreements. Payers and HTA posts indicated that they still see very high prices for new products without much differentiation in terms of value added, while manufacturers indicated that payers appeared to be more concerned about the budget implications and were not willing to consider more complex agreements4. We believe that an adaptive pathway could be an appropriate environment to address some of these confidence issues: (i) Adaptive Pathways products should have a reasonable expectation of significant added value5, meaning that a questionable product value would not be a problem, (ii) an early dialogue takes place years before the market impact, which could facilitate the development of viable payment models in the event of broad stakeholder buy-in. these products are needed. , and (iii) Pathways adaptive products would be closely monitored as soon as they were put on the market, and ways to facilitate regulatory and hTA monitoring could be explored, for example through the EMA registration initiative6. Financial agreements in the form of rebates are the dominant form of MEA for oncology-based drugs (Figure 11).
Manage the budgetary impact. In 1994, the Saskatchewan Prescription Drug Plan and Merck-Co, Inc. entered into an agreement on the use of finasterid (Proscar) for 3 years. Finateeriide, a drug indexed to the treatment of benign prostate hypertrophy, was promoted by the manufacturer on the grounds that it would save the health care system money by reducing the need for surgery (reference Gormley, Stoner and Bruskewitz9). The manufacturer agreed to reimburse the cost of the drug in situations where a patient who received the drug was subsequently operated on. Patients had to take the drug consistently for at least 12 months and be operated on within 90 days of stopping the finasterid.