Companies are expected to implement, through adaptive pathways, a common scientific advisory process involving regulators and DHTA bodies, which has already been done for some of the pilot products. This process is expected to result in an integrated generation plan in which regulatory applications would be supplemented by DHTA applications. Those requests would be transposed into relevant instruments at national level, such as managed entry agreements, in accordance with national procedures and guidelines, as charging and reimbursement are the responsibility of the Member States. Actual evidence gathered after the first authorisation would be used to supplement – not replace – the initial authorisation requirements and could allow for a better understanding of the optimal use of the product (e.g.B. Subgroups of patients and responders) to maximize effects and minimize risk. The cost of care in hospitals has risen rapidly in Finland. To understand the current state of MEA use in hospitals, Medaffcon conducted a survey in 2017 to understand what other methods are used as flat-rate discounts to facilitate access to hospital care. The survey focused on managed entry agreements that provide access to patented medicines made over the past 2 years (2015-2017). In Australia, a series of entry agreements have been developed to allow for national coverage of new drugs. Non-outcome-oriented agreements are generally price agreements that include price or quantity discount agreements. As of February 2013, there were at least 71 special price agreements, including 26 for drugs limited to hospital use. Agreements based on health objectives can be concluded at the individual level or at the population level.
At the individual level, 28 drugs were funded and subjected to monitoring rules that demonstrated an appropriate benefit within the individual; Some of these drugs also had price agreements. At the population level, only a results-based agreement has been implemented for bosentan, a drug for pulmonary hypertension. In May 2010, a Memorandum of Understanding between the Australian government and Medicines Australia, the leading pharmaceutical industry organization, provided for the possibility for industry to request review of an “entry-on regime” as part of the application process for funding for drugs of high clinical necessity. It includes the possibility of a randomised controlled studies (RCT) system Although this form of control in Australia has not yet been highlighted, several funding recommendations were made by the decision committee in 2012/2013 regarding the evolution of the evidence. In addition, as soon as a product has been made available to patients, paying agencies have indicated that once a product has been made available to patients, it has been excluded from the list where the evidence is no longer impossible to cover due to the lack of mechanisms facilitating delisting and weak social support for the withdrawal of reimbursement decisions based on economic evidence. These results have implications for health sector stakeholders, as while results-based management agreements are needed to facilitate market access, there is a need to address the lack of infrastructure in many countries, which would easily facilitate data collection, and to identify viable models and mechanisms. Despite these challenges, there are also examples of the successful and comprehensive use of results-based management entry agreements….