IDEAS home Printed from https://ideas.repec.org/p/ehl/lserod/128168.html
   My bibliography  Save this paper

A strategic framework for synergizing managed entry agreement efforts to access pharmaceutical products in Saudi Arabia-results from a multi-stakeholder workshop

Author

Listed:
  • Al-Omar, Hussain Abdulrahman
  • Almuhsin, Asma Abdulaziz
  • Almudaiyan, Lolwa Hamad
  • Al-Najjar, Amal Hassan
  • Abu Esba, Laila Carolina
  • Almodaimegh, Hind
  • Altawil, Esraa S.
  • Yousef, Consuela Cheriece
  • Khan, Mansoor Ahmed
  • Alyahya, Khalid
  • Alamre, Jehan
  • Maraiki, Fatma
  • Espin, Jaime
  • Tarricone, Rosanna
  • Kanavos, Panos

Abstract

Managed entry agreements (MEAs) between manufacturers and healthcare payers allow health systems to maximize patients' access to treatments while maintaining financial sustainability. However, to work efficiently, MEAs need to be integrated into a country's formal pricing, reimbursement, and market access processes. This study proposes a country-specific MEA framework for pharmaceutical products and sheds light on the key enablers of optimal implementation of MEAs in Saudi Arabia. This mixed-methods study was conducted through secondary data collection derived from systematic literature search followed by a half-day multi-stakeholder workshop hosted in Riyadh, Saudi Arabia including representatives from different governmental, quasi-governmental, and private sectors, all of whom had a job role related to pharmaceutical pricing, reimbursement, and market access. A predefined and validated set of questions was used to guide the workshop discussion with props and prompts to elicit more insights on MEAs design and framework from the participants. The workshop discussion and interactions were digitally recorded to enable verbatim transcription, followed by a thematic analysis. Ten themes emerged from the workshop discussion with majority guided the framework design: (1) access to innovative medications; (2) stakeholder views about MEAs; (3) early dialogue; (4) prioritization of MEAs for pharmaceutical products; (5) the regulatory landscape; (6) designing a technical framework for MEAs; (7) innovative payment models; (8) health system governance; (9) challenges for successful implementation; and (10) stakeholder engagement. In Saudi Arabia, MEAs are perceived as strategic levers to enable health system to navigate the access paradox, particularly for innovative and high-cost therapies. Nevertheless, having in place a robust Saudi-specific framework and anchored regulations and policies is essential to ensure that MEAs enhance-rather than compromise-access, sustainability, and equity. As therapies grow more complex, Saudi Arabia must adopt agile, evidence-adaptive MEAs policy and structure to remain fit for purpose.

Suggested Citation

  • Al-Omar, Hussain Abdulrahman & Almuhsin, Asma Abdulaziz & Almudaiyan, Lolwa Hamad & Al-Najjar, Amal Hassan & Abu Esba, Laila Carolina & Almodaimegh, Hind & Altawil, Esraa S. & Yousef, Consuela Cheriec, 2025. "A strategic framework for synergizing managed entry agreement efforts to access pharmaceutical products in Saudi Arabia-results from a multi-stakeholder workshop," LSE Research Online Documents on Economics 128168, London School of Economics and Political Science, LSE Library.
    • Handle: RePEc:ehl:lserod:128168
    as

    Download full text from publisher

    File URL: http://eprints.lse.ac.uk/128168/
    File Function: Open access version.
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. Simon Walker & Mark Sculpher & Karl Claxton & Steve Palmer, 2012. "Coverage with evidence development, only in research, risk sharing or patient access scheme? A framework for coverage decisions," Working Papers 077cherp, Centre for Health Economics, University of York.
    2. Panos Kanavos & Olivier Wouters & Panos Kanavos & Alessandra Ferrario & Giovanni Tafuri & Paolo Siviero, 2017. "Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements," Global Policy, London School of Economics and Political Science, vol. 8, pages 84-92, March.
    3. repec:bla:glopol:v:8:y:2017:i:s2:p:84-92 is not listed on IDEAS
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Fernando Antonanzas & Carmelo Juárez-Castelló & Reyes Lorente & Roberto Rodríguez-Ibeas, 2019. "The Use of Risk-Sharing Contracts in Healthcare: Theoretical and Empirical Assessments," PharmacoEconomics, Springer, vol. 37(12), pages 1469-1483, December.
    2. Paula K. Lorgelly & Amanda Adler, 2020. "Impact of a Global Pandemic on Health Technology Assessment," Applied Health Economics and Health Policy, Springer, vol. 18(3), pages 339-343, June.
    3. Kisser, Agnes & Tüchler, Heinz & Erdös, Judit & Wild, Claudia, 2016. "Factors influencing coverage decisions on medical devices: A retrospective analysis of 78 medical device appraisals for the Austrian hospital benefit catalogue 2008–2015," Health Policy, Elsevier, vol. 120(8), pages 903-912.
    4. Carlo Federici & Vivian Reckers-Droog & Oriana Ciani & Florian Dams & Bogdan Grigore & Zoltán Kaló & Sándor Kovács & Kosta Shatrov & Werner Brouwer & Michael Drummond, 2021. "Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 22(8), pages 1253-1273, November.
    5. Sabine E. Grimm & Xavier Pouwels & Bram L. T. Ramaekers & Ben Wijnen & Thomas Otten & Janneke Grutters & Manuela A. Joore, 2021. "State of the ART? Two New Tools for Risk Communication in Health Technology Assessments," PharmacoEconomics, Springer, vol. 39(10), pages 1185-1196, October.
    6. Marcelien H. E. Callenbach & Rick A. Vreman & Aukje K. Mantel-Teeuwisse & Wim G. Goettsch, 2022. "When Reality Does Not Meet Expectations—Experiences and Perceived Attitudes of Dutch Stakeholders Regarding Payment and Reimbursement Models for High-Priced Hospital Drugs," IJERPH, MDPI, vol. 20(1), pages 1-12, December.
    7. Seung-Lai Yoo & Dae-Jung Kim & Seung-Mi Lee & Won-Gu Kang & Sang-Yoon Kim & Jong Hyuk Lee & Dong-Churl Suh, 2019. "Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System," IJERPH, MDPI, vol. 16(2), pages 1-15, January.
    8. Dunlop, William C.N. & Staufer, Alexandra & Levy, Pierre & Edwards, Guy J., 2018. "Innovative pharmaceutical pricing agreements in five European markets: A survey of stakeholder attitudes and experience," Health Policy, Elsevier, vol. 122(5), pages 528-532.
    9. Kasper M. Johannesen & Karl Claxton & Mark J. Sculpher & Allan J. Wailoo, 2018. "How to design the cost‐effectiveness appraisal process of new healthcare technologies to maximise population health: A conceptual framework," Health Economics, John Wiley & Sons, Ltd., vol. 27(2), pages 41-54, February.
    10. Matthew Franklin & James Lomas & Simon Walker & Tracey Young, 2019. "An Educational Review About Using Cost Data for the Purpose of Cost-Effectiveness Analysis," PharmacoEconomics, Springer, vol. 37(5), pages 631-643, May.
    11. Löblová, Olga & Csanádi, Marcell & Ozierański, Piotr & Kaló, Zoltán & King, Lawrence & McKee, Martin, 2019. "Alternative access schemes for pharmaceuticals in Europe: Towards an emerging typology," Health Policy, Elsevier, vol. 123(7), pages 630-634.
    12. Reyes Lorente & Fernando Antonanzas & Roberto Rodriguez-Ibeas, 2019. "Implementation of risk-sharing contracts as perceived by Spanish hospital pharmacists," Health Economics Review, Springer, vol. 9(1), pages 1-8, December.
    13. A. Carletto & A. Cicchetti & S. Coretti & V. Moramarco & M. Ruggeri, 2019. "Money back guarantee? A cost–benefit framework of performance-based agreements (PBAs) for the reimbursement of pharmaceuticals," Eurasian Business Review, Springer;Eurasia Business and Economics Society, vol. 9(1), pages 89-101, March.
    14. Petrou, Panagiotis & Vandoros, Sotiris, 2015. "Cyprus in crisis: Recent changes in the pharmaceutical market and options for further reforms without sacrificing access to or quality of treatment," Health Policy, Elsevier, vol. 119(5), pages 563-568.
    15. Christopher McCabe & Mike Paulden & Isaac Awotwe & Andrew Sutton & Peter Hall, 2020. "One-Way Sensitivity Analysis for Probabilistic Cost-Effectiveness Analysis: Conditional Expected Incremental Net Benefit," PharmacoEconomics, Springer, vol. 38(2), pages 135-141, February.
    16. James Lomas & Miqdad Asaria & Laura Bojke & Chris P. Gale & Gerry Richardson & Simon Walker, 2019. "Correction to: Which Costs Matter? Costs Included in Economic Evaluation and their Impact on Decision Uncertainty for Stable Coronary Artery Disease," PharmacoEconomics - Open, Springer, vol. 3(2), pages 277-277, June.
    17. Hester V Eeren & Saskia J Schawo & Ron H J Scholte & Jan J V Busschbach & Leona Hakkaart, 2015. "Value of Information Analysis Applied to the Economic Evaluation of Interventions Aimed at Reducing Juvenile Delinquency: An Illustration," PLOS ONE, Public Library of Science, vol. 10(7), pages 1-15, July.
    18. Haitham W. Tuffaha & Paul A. Scuffham, 2018. "The Australian Managed Entry Scheme: Are We Getting it Right?," PharmacoEconomics, Springer, vol. 36(5), pages 555-565, May.
    19. Christopher McCabe & Richard Edlin & Peter Hall, 2013. "Navigating Time and Uncertainty in Health Technology Appraisal: Would a Map Help?," PharmacoEconomics, Springer, vol. 31(9), pages 731-737, September.
    20. Sabine Elisabeth Grimm & Mark Strong & Alan Brennan & Allan J. Wailoo, 2017. "The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment," PharmacoEconomics, Springer, vol. 35(12), pages 1287-1296, December.

    More about this item

    Keywords

    ;
    ;
    ;
    ;
    ;
    ;
    ;
    ;
    ;

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • I19 - Health, Education, and Welfare - - Health - - - Other

    NEP fields

    This paper has been announced in the following NEP Reports:

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:ehl:lserod:128168. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: LSERO Manager (email available below). General contact details of provider: https://edirc.repec.org/data/lsepsuk.html .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.