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What Principles Should Govern The Use Of Managed Entry Agreements

Garrison LJ, Carlson J, Bajaj P, Towse A, Neumann P, Sullivan S, et al. Private sector risk-sharing agreements in the United States: trends, barriers and prospects. Au J Manag. 2015;21 (9):632-40. Barros PP. The simple cost-effectiveness of risk-sharing agreements between the NHS and the pharmaceutical industry. Econ Health. 2011;20(4):461–70. The average duration of AEMs in the CEECs included in this study is 2 years, or 1 to 5 years before the renegotiation of the agreement (Table 4).

In Latvia, most agreements are permanent. In most countries, either the agreement is renewed or another agreement is signed (for example. B Slovenia). If the agreement is not renewed, funding for the drug may be suspended (for example. B Bulgaria and Romania). In Romania, there may be a deficit of 1 to 3 months after an agreement expires and before a new agreement is negotiated. During this period, the manufacturer supports the cost of the drugs for patients who have already started treatment. K Facey was promoted to board member of the NHS Forth Valley (UK) and as Chair of the HTAi Policy Forum in 2009-2010. She has received advisory fees or travel allowances from the National Institutes of Health Research, the EUnetHTA network, the Guidelines International Network, HTA agencies, patient associations, international pharmaceutical companies and government agencies. Her husband is a general practitioner in the UK. In most of the countries that were included in this study, the financial agreements contained in this study must be renegotiated regularly (usually every 1-5 years). Depending on the burden of renegotiating them, this may impose administrative burdens on the implementation of the ME, which must be taken into account when designing and implementing MEAS.

For this reason, when the MEA covers a number of drugs and its lifespan is limited and its implementation is a precondition for reimbursement, the authorities should consider whether the time invested in the negotiations is not too long and whether other options may be less cumbersome (for example. B negotiate agreements for an extended period of time). To address this problem, we examined the implementation of EEC MEAS with high-level payers, their advisors and other high-level stakeholders in these countries. In particular, we examined the reasons for the introduction of MEAs in these countries, the nature of the agreements implemented, their therapeutic priority, what happens when these agreements expire, and other approaches to better manage the arrival of new medicines on the market. We also looked at what countries define as “risk,” “risk sharing” and “high prices.” The results were used to highlight challenges and identify possible avenues for improving access to new medicines in the EEC region and beyond. The principles of legitimacy and equity in decision-making should govern AMAs with greater participation of all stakeholders (particularly clinicians and patients) in its development and greater transparency. There is a growing recognition among all stakeholders that patients should have timely access to innovative technologies that address unmet medical needs and provide good value for money (10). In recent years, health budgets have increased significantly more than inflation to meet demand and improve the quality of care. However, it is likely that these increases in health budgets will decrease in real terms, with stricter efficiency targets and more transparent processes for prioritizing technologies that can make demonstrable improvements in the quality of care and better value.

For industry as well, the cost of technological development has continued to rise over the past decade (Adams and Brantner reference1). Reference Paul, Mytelka and Dunwiddie15) create the need to streamline technology development programs to demonstrate value to all decision makers. In addition, there is the complex world of technology prices, where the list price of a drug in one country can be used as a “reference” for pricing in another country and where the price of the devices can be