• A managed entry agreement (MEA) is an arrangement between a manufacturer and the payer/provider that enables access to (or coverage/reimbursement of) a health technology, subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximise their effective use, or limit their budget impact.
• Simple MEAs such as rebates and discounts have existed for decades. These have allowed pharmaceutical manufacturers to provide discounts without compromising the official list price, thereby protecting themselves from the negative knock-on effect that a simple price reduction would have based on international reference pricing (IRP).
• More recently, more innovative contracting types, such as risk-sharing agreements and performance-based schemes, have allowed payers and manufacturers to share the risks and uncertainties arising from premiumpriced innovative agents and their use. This form of contracting is seen as particularly useful for drugs where clinical effectiveness and/or the budgetary impact may be uncertain.
Authors: Privolnev Y