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Article

Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-Cell Therapy

by
Panos Kefalas
1,*,
Omar Ali
2,
Jesper Jørgensen
1,
Nick Merryfield
2,
Tim Richardson
2,
Adam Meads
2,
Laura Mungapen
1 and
Matthew Durdy
3
1
Health Economics and Market Access Department, The Cell and Gene Therapy Catapult, 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT, UK
2
Verpora, BioCity, Nottingham, UK
3
Business Development Department, Cell and Gene Therapy Catapult, London, UK
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2018, 6(1), 1511679; https://doi.org/10.1080/20016689.2018.1511679
Submission received: 12 April 2018 / Revised: 30 July 2018 / Accepted: 2 August 2018 / Published: 20 August 2018

Abstract

Background: Market access stakeholders consider the adoption of Managed Entry Agreements (MEAs), however a clearly described methodology to quantify their implementation burden is not available in the public domain. Objective: To quantify the cost of implementing a performance-based MEA at the hospital level. Methods: The analysis involved a hypothetical one-off therapy targeting Acute Lymphoblastic Leukaemia. Data collection from five NHS Hospital Trusts in England captured costs by task, job band, personnel time and capital investment. We compared the administrative burden of the standard of care (SoC) to that of adopting the therapy with or without an MEA over 10 years. Findings: The 10-year cost for the activities required to support hospital payments for the target patient population in England varied as follows: for the SoC was £447,353, compared to £1,117,024 for the novel therapy with MEA, and £245,317 without MEA. Conclusions: The higher cost associated with the SoC compared to the novel therapy without an MEA, arises from the higher frequency of infusions requiring payments and the associated mandatory data capturing requirements for oncology therapies. The novel therapy with MEA presents the greatest burden due to increased frequency of monitoring in year one to compensate for the greater uncertainty in clinical data and to inform the performance-based reimbursement.
Keywords: value-based agreements; managed entry agreement; patient access scheme; reimbursement; Chimeric Antigen Receptor T-cell therapy; acute lymphoblastic leukaemia; regenerative medicine; outcomes-based; innovative contracting value-based agreements; managed entry agreement; patient access scheme; reimbursement; Chimeric Antigen Receptor T-cell therapy; acute lymphoblastic leukaemia; regenerative medicine; outcomes-based; innovative contracting

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MDPI and ACS Style

Kefalas, P.; Ali, O.; Jørgensen, J.; Merryfield, N.; Richardson, T.; Meads, A.; Mungapen, L.; Durdy, M. Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-Cell Therapy. J. Mark. Access Health Policy 2018, 6, 1511679. https://doi.org/10.1080/20016689.2018.1511679

AMA Style

Kefalas P, Ali O, Jørgensen J, Merryfield N, Richardson T, Meads A, Mungapen L, Durdy M. Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-Cell Therapy. Journal of Market Access & Health Policy. 2018; 6(1):1511679. https://doi.org/10.1080/20016689.2018.1511679

Chicago/Turabian Style

Kefalas, Panos, Omar Ali, Jesper Jørgensen, Nick Merryfield, Tim Richardson, Adam Meads, Laura Mungapen, and Matthew Durdy. 2018. "Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-Cell Therapy" Journal of Market Access & Health Policy 6, no. 1: 1511679. https://doi.org/10.1080/20016689.2018.1511679

APA Style

Kefalas, P., Ali, O., Jørgensen, J., Merryfield, N., Richardson, T., Meads, A., Mungapen, L., & Durdy, M. (2018). Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-Cell Therapy. Journal of Market Access & Health Policy, 6(1), 1511679. https://doi.org/10.1080/20016689.2018.1511679

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