Managed Entry Agreement Definition

Dec 12, 2020 by     No Comments    Posted under: Uncategorized

Objectives: The aim of this study is to carry out an analysis of the regulation and application of administered access agreements (MEA) for oncology drugs in different European countries. The Cost-Sharing Agreements (CSAs) provide ways for the payer and the pharmaceutical company to share the financial costs associated with the introduction of an innovative drug. CSAs can continue to be subdivided into price volume, budget and usage caps, as well as rebates. Under risk-sharing agreements (RSA), the public payer and the pharmaceutical company share the risks associated with clinical outcomes in patients treated with the innovative drug. RSAs can be defined as “result guarantees,” “guarantees of reimbursement,” “payment by result” or “continuation of conditional treatment.” For the latter, funding for treatment will only be continued for patients with some therapeutic efficacy. Several examples of difficulties related to results-based agreements are available in the literature. A Dutch evaluation of a stage III-managed oxaliplatin accession agreement for the treatment of colon cancer based on the results, which collected additional data on a patient registry, showed that patient heterogeneity made it difficult to estimate the incremental cost-effectiveness of treatment based on the data collected (Mohseninejad et al., 2015). A Dutch registry of hematological malignancy indicated that the three main problems were confused due to the indication, lack of data and insufficient number of comparable patients (Blommestein et al., 2015). In Italy, an analysis of 2006-2012 data showed that 67% of expected repayments were actually recovered through certain agreements (Navarria et al., 2015). Among the reasons identified were difficulties related to the required follow-up period, problems with reimbursement notification and insufficient (financial) incentive from the prescribing centre to participate in a program (Garattini et al., 2015); Navarria et al., 2015).

These examples underline the crucial importance of robust methods and the clear agreement of upstream stakeholders on the expectations associated with the use of the evidence to be collected. In Finland, interest in adapting MEA CONZEPT to the Finnish environment has increased. In order to achieve this goal, since the beginning of 2017, the Pharmaceuticals Pricing Board has initiated a procedure to accept conditional repayments, resulting in several confidential cost-sharing agreements.

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