PRIORITIES FOR STRENGTHENING SAUDI ARABIA'S HEALTH ECOSYSTEM THROUGH COMPASSIONATE ACCESS PROGRAMS
Author(s)
Mohammad Al Dossari, BSc, HTA Fellowship1, Mustafa Badawi, BSc, HTA Fellowship1, Asma Abdulaziz Al-Muhsin, MSc2, Hussain Abdulrahman Al-Omar, MSc, PhD1.
1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, 2General Directorate of Research and Studies, Deputyship of Planning and Institutional Excellence, Saudi Arabia Ministry of Health, Riyadh, Saudi Arabia.
1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, 2General Directorate of Research and Studies, Deputyship of Planning and Institutional Excellence, Saudi Arabia Ministry of Health, Riyadh, Saudi Arabia.
OBJECTIVES: To explore senior stakeholder perspectives on Saudi Arabia compassionate access programs (CAPs), identify key priories, system gaps, and enablers, and propose a Vision 2030‑aligned policy framework.
METHODS: A qualitative descriptive design was employed. Purposeful sampling with maximum variation was used to recruit stakeholders from regulatory agencies, health technology assessment (HTA) bodies, pharmacy and therapeutics committees, research institutions, payers, hospitals, pharmaceutical companies, and policy entities. Semi-structured interviews were conducted using a developed and validated topic guide. All interviews were audio-recorded and transcribed verbatim. Data were analyzed using a six-step reflexive thematic analysis approach. Two independent researchers coded iteratively.
RESULTS: Twelve stakeholders participated. Data saturation was reached after the ninth interview. Six themes—conceptual framing, access, governance, evidence, funding, and enablers—comprising 23 subthemes, emerged. A fragmented regulatory landscape without a clear and operational definition created governance gaps: weak oversight, inconsistent eligibility, and ethical ambiguity about post-approval continuity and consent. CAPs were recognized as valuable for generating real-world evidence (RWE) for Saudi patient populations, yet no data collection mandate exists. CAP-derived RWE occasionally influenced pricing and accelerated formulary inclusion, while value-based and advanced reimbursement models remain legally constrained. Enablers comprised Vision 2030 commitment, emerging RWE infrastructure, and public-private collaborations. Systemic barriers included limited awareness among clinicians, regulators, and formulary teams, impeding timely CAP use.
CONCLUSIONS: Despite a strong humanitarian foundation, findings revealed opportunities to strengthen CAPs in Saudi Arabia through developing a clear, explicit, and operational definition, ethical oversight, RWE mandates, and alignment and harmonization between the licensing authority, formulary inclusion committees, and HTA entity and processes, supporting broader Vision 2030 healthcare transformation. A centralized national registry, clear post-trial access protocols, and value-based reimbursement pilots could enhance equity, inform the regulatory landscape, and accelerate patient access to innovative therapies while promoting health system sustainability.
METHODS: A qualitative descriptive design was employed. Purposeful sampling with maximum variation was used to recruit stakeholders from regulatory agencies, health technology assessment (HTA) bodies, pharmacy and therapeutics committees, research institutions, payers, hospitals, pharmaceutical companies, and policy entities. Semi-structured interviews were conducted using a developed and validated topic guide. All interviews were audio-recorded and transcribed verbatim. Data were analyzed using a six-step reflexive thematic analysis approach. Two independent researchers coded iteratively.
RESULTS: Twelve stakeholders participated. Data saturation was reached after the ninth interview. Six themes—conceptual framing, access, governance, evidence, funding, and enablers—comprising 23 subthemes, emerged. A fragmented regulatory landscape without a clear and operational definition created governance gaps: weak oversight, inconsistent eligibility, and ethical ambiguity about post-approval continuity and consent. CAPs were recognized as valuable for generating real-world evidence (RWE) for Saudi patient populations, yet no data collection mandate exists. CAP-derived RWE occasionally influenced pricing and accelerated formulary inclusion, while value-based and advanced reimbursement models remain legally constrained. Enablers comprised Vision 2030 commitment, emerging RWE infrastructure, and public-private collaborations. Systemic barriers included limited awareness among clinicians, regulators, and formulary teams, impeding timely CAP use.
CONCLUSIONS: Despite a strong humanitarian foundation, findings revealed opportunities to strengthen CAPs in Saudi Arabia through developing a clear, explicit, and operational definition, ethical oversight, RWE mandates, and alignment and harmonization between the licensing authority, formulary inclusion committees, and HTA entity and processes, supporting broader Vision 2030 healthcare transformation. A centralized national registry, clear post-trial access protocols, and value-based reimbursement pilots could enhance equity, inform the regulatory landscape, and accelerate patient access to innovative therapies while promoting health system sustainability.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR76
Topic
Health Policy & Regulatory, Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology, Rare & Orphan Diseases