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

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.

Pharmaceutical companies' views on a health technology assessment (HTA) entity in Saudi Arabia.

Saudi Arabia is undergoing a massive healthcare transformation to fulfill its new, national "Vision 2030." To align with this objective, Saudi Arabia is establishing a new, independent and evidence-based health technology assessment (HTA) entity to help it maximize health gains through efficient use of resources. This study was designed to ascertain how pharmaceutical companies perceive the creation of such a national HTA entity in Saudi Arabia; what they think about it and expect from it. To achieve the study's aim, we held a workshop in Riyadh, Saudi Arabia, lasting four and a half hours and hosted by the Saudi Ministry of Health (MOH). We invited 16 market access directors and managers from different multinational pharmaceutical companies to discuss the establishment of a national HTA entity. The findings from the workshop were structured around three axes: vision and remit; HTA method; and implementation and practical considerations. Overall, the pharmaceutical company participants were positive about HTA's value for the Saudi healthcare system and expressed willingness to adapt to meet its future requirements.

What local experts expect from a health technology assessment (HTA) entity in Saudi Arabia: workshop conclusions.

Objectives: Saudi Arabia is undergoing a massive health-care transformation to fulfill its new, national 'Vision 2030.' To align with this objective, Saudi Arabia is establishing a new, independent and evidence-based health technology assessment (HTA) entity to help it maximizes health gains through efficient use of resources. This study was designed to ascertain how local experts perceive the creation of such a national HTA entity in Saudi Arabia; what they think about it and expect from it.Methods: To achieve study aim, we held two workshops in Riyadh, Saudi Arabia, each lasting three and a half hours and each hosted by the Saudi Ministry of Health (MOH). We invited 26 local experts from a variety of professional backgrounds to discuss the establishment of a national HTA entity.Results: The findings from experts workshops were structured around four axes, namely vision and remit; services provided and technologies covered; process and method; and implementation and practical considerations.Conclusion: This paper discusses the findings of the local experts convened at the workshops relative to their expectations for and views about a national HTA entity within Saudi Arabia.