Pharmaceutical associations and payers are also spending time thinking about how to solve this challenge. For example, nice in the UK has publicly expressed its support for ABPI, the local association, in its efforts to address this issue, particularly for combined and indication-based agreements. In the discussions that took place at the ADAPT-SMART3 workshop, it was noted that apart from technical, systemic and political factors related to health, a lack of trust between payers and manufacturers could be one of the main obstacles to a wider use of results-based agreements. Payers and HTA agencies indicated that they consistently see very high prices for new products without much differentiation based on value added, while manufacturers indicated that payers seemed more concerned about the impact on the budget and are not willing to consider more complex regulations4. We believe that an adaptive signaling pathway could be a well-suited environment to address some of these trust issues for the following reasons: (i) products with adaptive signaling pathways should have a reasonable expectation of significant added value5, meaning that the questionable value of the product would be less problematic, (ii) early dialogue takes place years before the product launch, what could facilitate the development of viable payment models if there is broad agreement among stakeholders on the need for such products, and (iii) adaptive signalling products would be closely monitored once they are on the market and ways to facilitate oversight for regulatory and HTA purposes could be explored, for example in the framework of the EMA6 Registers Initiative. van de Vooren, K., Curto, A., Freemantle, N., and Garattini, L. (2015). Market Access Agreements for Cancer Drugs. J.
R. Soc. Med. 108, 166-170. doi: 10.1177/0141076814559626 It`s similar to how we still buy airline tickets like we were 30 years ago. Imagine calling the airline, asking what they have available, waiting for prices, etc., instead of going online and understanding everything quickly and easily. In a victory for the good guys, new technologies and venture capital offer better solutions. In addition to my work at PharmaCCX, many large pharmaceutical companies and payers are investing in their digital platforms to solve this challenge. Methods used. MEA, Managed Entry Agreement; EUnetHTA, European Network for Health Technology Assessment; AIM, the international association of mutual societies; MEDEV, Committee for the Evaluation of Medicinal Products; GAC, conditional marketing authorisation; ECMA, marketing authorisation in exceptional circumstances. Ferrario, A., and Kanavos, P.
(2015). Dealing with uncertainty and high prices of new medicines: a comparative analysis of the application of controlled market introduction agreements in Belgium, England, the Netherlands and Sweden. Ploughshare. Sci. Med. 124, 39–47. doi: 10.1016/j.socscimed.2014.11.003 Interviews showed that manufacturers seem more interested in studying the use of outcome-oriented agreements than cost-bearers. However, due to their complexity, the appetite of European payers and HTA bodies to use agreements that include the collection of outcome data is low. The European Medicines Agency (EMA) announced in August 2016 that after a 2-year pilot project, they would continue the adaptive signalling pathway program as part of their normal procedures.
According to Eichler et al., adaptive pathways allow for the controlled introduction of a promising drug as early as possible in the product life cycle1 (Eichler et al., 2012, 2015). In practice, this could mean that a (conditional) marketing authorisation is granted on the basis of early evidence of the positive benefit-risk profile of the medicinal product, with a proactive plan to generate additional evidence in support of the initial authorisation (Figure (Figure 1).1). However, given that all the products that participated in the EMA pilot are still years away from (possible) marketing authorisation and that the meetings held during the pilot project were confidential, it is not yet clear what impact the adaptation pathways could have on national health systems. Questionnaire responses were used to identify payers and HTA agencies that had experience with the entry agreements managed for these products. In addition, manufacturers that had marketed these products were identified and invited to participate in semi-structured interviews that addressed the same issues as the payer and HTA agency interviews. The results were presented at a 1-day workshop in July 2016. Approximately 30 people attended the workshop and represented manufacturers, payers, HTA agencies, patient representatives, healthcare representatives and scientists. During the workshop, the implications of the results were discussed and suggestions were discussed. The following section summarizes the results of the workshop review, interviews and discussions (Figure 11). A significant number of academic papers have examined the use and theoretical benefits of managed entry agreements for pharmaceuticals (Carlson et al., 2010, 2014; Stafinski et al., 2010; Klemp et al., 2011; Walker et al., 2012; Ferrario and Kanavos, 2013, 2015; Garrison et al., 2013, 2015; Morel et al., 2013; Edlin et al., 2014; Navarria et al., 2015; Faulkner et al., 2016) and the use of financially managed entry agreements (discounts and rebates) is common and widespread in European countries. We defined a managed entry agreement as any agreement between a manufacturer and a payer/provider that provides access to a health technology under certain conditions (Figure (Figure 2).2).
We reviewed the scientific and grey literature on managed entry agreements (Figure (Figure 3)3) using a snowball approach to identify publications that (a) described stakeholders` experiences with different types of managed entry agreements, (b) described different types of managed entry agreements, or (c) reported the pros and cons of using them. The resulting documents were used to develop semi-structured interview questions for interviews with key stakeholders: manufacturers (including settlement holders), payers and HTA agencies. At the same time, we sent a questionnaire to European payers and HTA agencies to ask them about the status of products that had received conditional marketing authorisation in 2006-2016 or that had been approved in exceptional circumstances. Given that no products with adaptive signaling pathways have been launched (mid-2016), we felt that this subset of marketing approvals could better reflect the launch of a product requiring further evidence. Increasing pressures on the health system, such as budget constraints and the entry into the market of costly new health technologies, have led payers and manufacturers to participate in Managed Entry Agreements (MEAs) to eliminate uncertainties and facilitate market access. .