Using Managed Entry Agreements as an Effective Tool to Handle the Uncertainty in Health Technology Assessments
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Abstract
Although the access to innovative medicines is usually informed by health technology assessment reports, underlying uncertainties in HTA may delay such access. Managed Entry Agreements may provide a promising solution to handle such uncertainty through focusing on value for information. Notably, majority of MEA designs include volume-based pricing and not outcome-based pricing strategies – which is an optimal access pathway for rare disease drugs. This is attributed to transparency issues regarding MEA content. This article proposes a framework which may be helpful which considering MEA within the context of low-and-middle-income countries using an interdisciplinary approach. This included needs assessment, value framework, governance, and choice of outcomes.
References:
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26. Maskineh C, Nasser SC. Managed Entry Agreements for Pharmaceutical Products in Middle East and North African Countries: Payer and Manufacturer Experience and Outlook. Value Health Reg Issues. 2018 Sep 1;16:33–8.
1. Godman B, Bucsics A, Vella Bonanno P, Oortwijn W, Rothe CC, Ferrario A, et al. Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets. Front Public Health. 2018 Dec 5;6:328.
2. root-causes-unvailability-delay-cra-final-300620.pdf [Internet]. [cited 2021 Nov 12]. Available from: https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
3. Panteli D, Edwards S, Richardson E, Palm W, Mossialos E. Policy brief [Internet]. Ensuring access to medicines: How to stimulate innovation to meet patients’ needs? [Internet]. European Observatory on Health Systems and Policies; 2018 [cited 2021 Nov 12]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526401/
4. Bouvy JC, Sapede C, Garner S. Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe. Front Pharmacol. 2018 Mar 27;9:280.
5. Garrison LP, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr PE, et al. Performance-Based Risk-Sharing Arrangements—Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force. Value Health. 2013 Jul 1;16(5):703–19.
6. Medicare Coverage Document - Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development [Internet]. [cited 2021 Dec 23]. Available from: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=27
7. NHS England » Cancer Drugs Fund [Internet]. [cited 2021 Dec 23]. Available from: https://www.england.nhs.uk/cancer/cdf/
8. Dabbous M, Chachoua L, Caban A, Toumi M. Managed Entry Agreements: Policy Analysis From the European Perspective. Value Health. 2020 Apr 1;23(4):425–33.
9. Macaulay R. Managed Access Agreements: A New Model Pathway for The Reimbursement of Non-Oncology Drugs in England Approved Under European Adaptive Pathways? Value Health. 2016 Nov 1;19(7):A505.
10. Adaptive pathways | European Medicines Agency [Internet]. [cited 2021 Dec 23]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/adaptive-pathways
11. Castro HE, Malpica-Llanos T, Musila R, Konduri N, Amaris A, Sullivan J, et al. Sharing knowledge for policy action in low- and middle-income countries: A literature review of managed entry agreements. Med Access Point Care. 2019 Jan 1;3:2399202619834246.
12. Innovative pharma contracts: When do value-based arrangements work? | McKinsey [Internet]. [cited 2021 Jul 8]. Available from: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/innovative-pharma-contracts-when-do-value-based-arrangements-work
13. Charter R. Managed Entry Agreements for Medical Devices: Great Opportunity or Major Challenge? :9.
14. Dunlop WCN, Staufer A, Levy P, Edwards GJ. Innovative pharmaceutical pricing agreements in five European markets: A survey of stakeholder attitudes and experience. Health Policy. 2018 May 1;122(5):528–32.
15. Jarosławski S, Toumi M. Market access agreements for pharmaceuticals in Europe: diversity of approaches and underlying concepts. BMC Health Serv Res. 2011 Oct 8;11:259.
16. Kanavos P, Ferrario A, Tafuri G, Siviero P. Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements. Glob Policy. 2017;8(S2):84–92.
17. Grimm S, Strong M, Brennan A, Wailoo A. REPORT BY THE DECISION SUPPORT UNIT. :146.
18. Lucas F. Improving market access to rare disease therapies: A worldwide perspective with recommendations to the industry. Med Access Point Care. 2018 Jan 1;2:2399202618810121.
19. Facey KM, Espin J, Kent E, Link A, Nicod E, O’Leary A, et al. Implementing Outcomes-Based Managed Entry Agreements for Rare Disease Treatments: Nusinersen and Tisagenlecleucel. PharmacoEconomics [Internet]. 2021 Jul 7 [cited 2021 Jul 8]; Available from: https://doi.org/10.1007/s40273-021-01050-5
20. Pauwels K, Huys I, Vogler S, Casteels M, Simoens S. Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future. Front Pharmacol. 2017 Apr 4;8:171.
21. Wenzl M, Chapman S. Performance-based managed entry agreements for new medicines in OECD countries and EU member states. 2019;(115). Available from: https://www.oecd-ilibrary.org/content/paper/6e5e4c0f-en
22. Thanimalai S, Choon WY, Lee KK-C. Stakeholder views of managed entry agreements: A literature review of national studies. Health Policy OPEN. 2021 Dec 1;2:100032.
23. Value-based-procurement-report_0.pdf [Internet]. [cited 2021 Nov 12]. Available from: https://www.medtecheurope.org/wp-content/uploads/2016/06/Value-based-procurement-report_0.pdf
24. Charter R. Managed Entry Agreements for Medical Devices: Great Opportunity or Major Challenge? In 2017. Available from: https://www.ispor.org/docs/default-source/presentations/1277.pdf?sfvrsn=c268f734_1
25. 2019_LeapfrogToValue.pdf [Internet]. [cited 2021 Nov 12]. Available from: https://static1.squarespace.com/static/5db772d44638535b2114f2e6/t/5ddea52751c72e2c5edacd77/1574872363413/2019_LeapfrogToValue.pdf
26. Maskineh C, Nasser SC. Managed Entry Agreements for Pharmaceutical Products in Middle East and North African Countries: Payer and Manufacturer Experience and Outlook. Value Health Reg Issues. 2018 Sep 1;16:33–8.
| Files | ||
| Issue | Vol 5, No 4 (2021) | |
| Section | Review Article | |
| DOI | https://doi.org/10.18502/htaa.v5i4.10164 | |
| Keywords | ||
| Healthcare Service Accessibility medicines HTA cost benefit analysis quality adjusted life years | ||
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Chhaya V, Khambholja K. Using Managed Entry Agreements as an Effective Tool to Handle the Uncertainty in Health Technology Assessments. Health Tech Ass Act. 2022;5(4).
