Abstract :
Access of innovative medicinal products remains ever-tortuous path due to affordability challenges (1), lengthy evidence generation process (2), and regulatory stringencies (3). As a result, significant delay in treatments are envisaged, sometimes even compromising the life of the patient. To avoid such negative consequences despite promising potential of the medicines and to provide value-based healthcare, manufacturers often consider entering into a formal agreement with third party payers for timely access of such products, known as managed entry agreements (MEA) (4). In other words, MEA is a formal document which facilitates market access to several key medicinal products despite the uncertainty of its financial or clinical impact. Given their purpose to reduce financial and outcomes related risk, they are also known as pharmaceutical risk-based sharing agreement (PRBSA). Popular nomenclature for PRBSA includes outcomes-based schemes, risk-sharing agreements, coverage with evidence development (CED), access with evidence development, patient access schemes (PASs), conditional licensing, and managed entry schemes (5).
