MAPPING AND ANALYSING PHARMACEUTICAL POLICY SETTINGS WORLDWIDE
Author(s)
Maniadakis N*1;Kourlaba G2;Shen J3;Holtorf AP4, Kalo Z5 1National School of Public Health, Athens, Greece, 2National and Kapodistrian University of Athens School of Medicine, Athens, Greece, 3Abbott, Basel, Switzerland, 4Health Outcomes Strategies LLC, Basel, Switzerland, 5Syreon Research Institute, Budapest, Hungary
OBJECTIVES: In the context of increasing demand and expenditure for health services it is important to elaborate policies which maximise efficiency. Pharmaceuticals account for about a fifth of total healthcare expenditure and are often target of healthcare efficiency policies. The aim of this study is to classify and grade pharmaceutical supply and demand control policies across the globe and cluster systems by regulatory rigidity. METHODS: Pharmaceutical policies and market data across 65 countries were researched in the literature with emphasis on pricing, reimbursement, dispensing, expenditure and demand control domains. Policies were classified by domains and graded through a multi-country expert survey for the degree of regulation. Cluster analysis helped to group countries by policy types. RESULTS: Pricing policies for on-patent products (with increasing degree of regulation) include: free pricing, direct negotiations, value-based-pricing, cost-plus-pricing, conditional-pricing, reference-pricing, state dictates and tenders. Cost control policies include: discounts, rebates, risk-sharing agreements, price-volume agreements, profit controls, pay-backs, claw-backs, margin cuts, price cuts, freezes, and tenders. Reimbursement policies include: variants of ATC5-based internal referencing, variants of statutory copayments, and variants of ATC4-based internal referencing. Dispensing policies were: no restrictions, indicative substitution, mandated or compulsory substitution. Demand controls include: educational campaigns, prescription aids, indicative prescription guidelines, indicative INN prescription, prescription monitoring, quotas, targets, predefined budgets, compulsory INN prescription, mandatory electronic prescription, compulsory prescription guidelines, prior/posterior approvals, sanctions and incentives for target/guidelines adherence. Cluster analysis identified a set of countries using an intermediate regulation policy approach and another with a more rigid approach. These did not differ significantly (p: 0.20) concerning pharmaceutical expenditure as % of GDP. CONCLUSIONS: A variety of policies were used in recent years for controlling pharmaceutical expenditures. Countries fall into two subsets based on the intensity of the regulation. More regulated systems do not appear to be associated with lower pharmaceutical expenditure.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PHP201
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
Multiple Diseases