Approaches to Pharmaceutical Regulation in Europe and the USA

PMPRB Symposium, Ottawa

October 7, 2002

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Table of Contents

Approaches to Pharmaceutical Regulation in Europe and the USA

Agenda

Health and Pharmaceutical Policy, 1974 - 2002

PPT Slide

Resource allocation and pharmaceuticals: the Supply-side

Rate of Return Regulation

Bi-lateral comparisons of ex-manufacturer prices (UK=100)

Multi-lateral comparisons of ex-manufacturer prices (UK=100)

Research and Development Tax Incentives in Selected Countries: Summary of Policies

Price Setting Regulation

Pricing & Reimbursement Methodologies: Managing the Supply Side

Pricing & Reimbursement Methodologies: Controlling the Supply Side

Reference Pricing variations

Types of “Agreements”

Health Economics: Official Requirements

PPT Slide

There is Significant Variation in the Time it Takes Products to Access Price-Regulated Markets

PPT Slide

Cox-2 inhibitors have generally achieved price premia relative to branded NSAIDs

Entry prices at starting dosages for new type II diabetes treatments

Price Cuts in France Become Become More Regular and Can be Significant

PPT Slide

Lots of different prices …

… continued

How representative are these prices?

Medicare – Part B and AWP

Discounts from AWP, 2001

Medicare – The Future

The role of FSS price

Pharmaceutical Policy in 7 States (Connecticut, Delaware, Florida, Maine, Massachusetts, New Hampshire, New York)

States’ source of disillusionment

Key issue: maintain quality of care whilst containing increasing costs (but also manage budgets more effectively & reduce waste)

Policy framework: OBRA 1990 & 1993

… States’ gradual transformation

Measures at state level - I

Measures at state level - II

Reference pricing - which version?

“Reference” Pricing in the US

Physician incentives - feasibility? - budgetary incentives? - carrots or sticks?

Physician incentives - feasibility

Voluntary Incentive Scheme

Admission into the “positive” list - criteria - definition of innovation

Formulary Management

Aggressive bargaining - P/Q? - Periodic reviews?

Rebates & discounts over and above Medicaid requirements

Overall concluding remarks

Presentation Author

Panos Kanavos, Lecturer in International Health Policy, LSE Health and Social Care, UK


PMPRB Email

pmprb@pmprb-cepmb.gc.ca

 

PMPRB Symposium 2002, List of Presentations

http://www.pmprb.com/symposium2002/present-e.html