Exploring the status and views of managed entry agreements in Saudi Arabia: mixed-methods approach

ABSTRACT

Background

Healthcare payers are increasingly adopting managed entry agreements (MEAs) between themselves and manufacturers, to overcome the challenge of sustaining access in an era of innovative and high-cost medicines. This study aims to investigate current MEA activity in Saudi Arabia and explore the challenges encountered when implementing such agreements.

Methods

An explanatory sequential mixed-methods approach was used. Quantitative data on MEAs were collected, followed by qualitative semi-structured interviews with different stakeholders.

Results

Our questionnaire garnered responses from 18 pharmaceutical companies from 3 different continents and identified 25 agreements in Saudi Arabia since 2010. Financial-based agreements were more prevalent than outcomes-based agreements at 44% versus 32%, respectively. Stakeholders showed positive attitudes toward MEAs, valuing their benefits in facilitating market access for both costly and innovative medicines. The main challenges included data availability, administrative and financial burden, lack of expertise, confidentiality, and lack of clear regulations.

Conclusions

Despite clear implementation challenges, a growing tendency toward MEAs exists in Saudi Arabia because of the potential benefits they bring to patients, healthcare providers, payers, and manufacturers. It is believed that the newly established health technology assessment center in Saudi Arabia will bring more clarity and shape the concept of MEAs in the country.

KEYWORDS:

• Managed entry agreements
• views
• challenges
• health technology assessment
• Saudi Arabia

Article highlights

1. This study provides an overview of the to-date-unexplored types and numbers of MEAs implemented in Saudi Arabia.

2. It sheds light on the barriers currently hindering the adoption of such agreements in Saudi Arabia and could thus serve as a first step to overcoming them.

3. It provides key standards and criteria for MEA implementation as derived from stakeholders with varying nationalities and practical experiences in the Saudi market.

4. It indicates that stakeholders are as yet unclear about aspects of MEAs such as payback and how the commitments are going to be made legally binding.

5. It also demonstrates that increasing awareness of MEAs among decision-makers and healthcare providers is needed to ensure efficient use of such a tool.

Acknowledgments

The authors would like to thank all the participants for taking part in the present research.

Author contributions

HA involved in the conception, design, and supervision of the study. HG performed data collection. HA, and HG performed the analysis and all authors interpreted the data. HA and HG drafted the initial manuscript. All authors critically revised the manuscript draft. All authors approved the final version of the manuscript and are accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Ethics statement

Ethical approval was not needed to conduct this study.

Reviewer declarations

One reviewer declares being a researcher in this field and has an interest in seeing their work cited. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Additional information

Funding

This research was not funded.