Believe it or not! Not being cost effective is not a dead end for reimbursing health technologies. There are several methods to bypass this obstacle and guarantee the reimbursement of potentially beneficial health technologies to finally reach a win-win situation for the manufacturer and the payer. One of those methods is managed entry agreements.
Reimbursement is considered the most important channel to reach proper patient access. If a health technology is adopted in the reimbursement scheme of a universal health coverage system or social health insurance plan, this guarantees fair patient access compared to non-reimbursed technologies.
In many cases, the proposed health technology is very good and effective compared to the current standard of care. However, when performing cost effectiveness analyses (CEA), the cost of the technology is high due to the extreme costs of manufacturing and R&D, so the decision depending on the CEA or budget impact analysis results should be not to reimburse this technology. Still the payer wants to adopt the new technology to offer the reimbursed patients better health care.
Managed entry agreements (MEAs) are arrangements between a manufacturer and a payer that enables access to coverage/reimbursement of a health technology subject to specific conditions. There are two main types of MEAs, which are financial based agreements and performance-based risk sharing agreements.
Financial based agreements are usually done to manage the budget impact. A simple example of a financial based agreement is presenting discount after purchasing a certain number of pieces. (e.g. the payer could buy the 1st 100 pieces for price x and any extra quantity for 0.75x). Another example is free or discounted treatment initiation.
Performance-based risk sharing agreements aims to manage the utilization of the technology in the real world and provide evidence regarding the decision uncertainty. A simple example is paying only for patients who have been treated from the drug, and not paying for patients who died or had a relapse.
There are several subtypes of those agreements, and for every case, usually a tailored agreement is done to ensure all stakeholders are benefitting; the patients by greater access to better technologies, the manufacturers by selling their health technologies to more patients and the payers by paying only limited amounts or paying only for guaranteed results.
-Morel, T., Arickx, F., Befrits, G., Siviero, P., van der Meijden, C., Xoxi, E., & Simoens, S. (2013). Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet journal of rare diseases, 8(1), 198.
-Pauwels, K., Huys, I., Vogler, S., Casteels, M., & Simoens, S. (2017). Managed entry agreements for oncology drugs: lessons from the european experience to inform the future. Frontiers in pharmacology, 8, 171.