Presentation (CTI)

OBJECTIVES: Restrictive prescribing criteria (RPC) are policy tools used by payers and other healthcare decision makers to shape prescribing, dispensing, and reimbursement decisions for therapeutic products. Despite their growing relevance to pharmaceutical policy, there is limited synthesis of how RPC differ across major health systems; the motivations driving their adoption; and how they may affect clinical practice, access to treatment, health outcomes, and patient experience.
METHODS: We conducted a structured scoping review of scientific and grey literature across 16 large healthcare markets. PubMed, Embase, Scopus, and Overton were searched for records published from 2006 onward. Eligible sources described real-world policies intentionally limiting or conditioning medication access. Policies focused solely on oncology, rare diseases, diagnostics, radiology, or surgery were excluded. Data were extracted on jurisdiction, implementing actor, restriction type, therapeutic area, rationale, and reported impacts. Findings were synthesised thematically.
RESULTS: After deduplication, 947 records were screened, 543 underwent full-text review, and 184 sources were included. RPC mechanisms were classified into four categories: prioritisation and authorisation, eligibility criteria, provider constraints, and dispensing constraints. Cost containment was the most frequently reported rationale; Other motivations included comparative-effectiveness, evidence uncertainty, novel or misaligned endpoints, pricing and benchmarking, lifecycle changes, risk mitigation, and managed-entry arrangements. RPC were associated with changes in medicine choice, prescribing autonomy, referral patterns, administrative workload, and responsibilities across provider types. Reported access impacts included coverage denial, delayed initiation, treatment interruptions, greater reliance on specialist or hospital-based care, and inequities based on resource or health literacy disparities. Evidence on outcomes was limited, but studies reported poorer adherence, prolonged uncontrolled symptoms, disease progression, hospitalisation, and serious adverse events.
CONCLUSIONS: While RPC may help control expenditure and support evidence-based prescribing, our review suggests that they can also reshape care delivery, patient access, and health outcomes. Payers and policymakers should consider these unintended consequences when designing and reviewing prescribing restrictions.