CLHIA-ACCAP
CLHIA Report on Prescription Drug Policy
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CLHIA REPORTON PRESCRIPTION DRUG POLICY
1. INTRODUCTION
2. GUIDING PRINCIPLES
3. ANALYSIS AND RECOMMENDATIONS
A. ENSURING SAFETY AND ENCOURAGING INNOVATION
a.1 Head-to-head Clinical Trials
a.2 Approval of New Drugs
a.2.1 Improving Speed to Market of New Drugs
a.2.2 Post-Market Review of Prescription Drugs
a.2.3 Off-Label Use
B. ENSURING AVAILABILITY OF COST EFFECTIVE PRESCRIPTION DRUGS
b.1 Role of the Patented Medicine Prices Review Board (PMPRB)
b.1.1 Fundamental Reform to PMPRB Mandate
b.1.2 More Aggressive Use of Value-based Pricing
b.1.3 Regular Review and Adjustment of Therapeutic Class Prices
b.1.4 Introducing a Formal Institutional Role for Private Insurers
b.2 Provincial Listing Process
b.2.1 Product Listing Agreements (PLAs)
b.2.2 Assessing the Value of Genetic Tests
b.3 Bringing Generic Drugs to Market
b.3.1 Reducing Need for Costly Litigation
b.3.2 Generic Interchangeability
b.3.3 Off-Formulary Pricing and Caps
b.3.4 Clarity on Subsequent Entry Biologics (SEB) Approval Process
b.3.5 Interchangeability of SEBs and Safe Switching
c.1 Standardized Coordination Processes
c.2 Development of Common National Minimum Formulary
c.3 Development of High Cost Drug Strategy
d.1 Introduction of Prescribing Committees
d.2 Encouraging Active Consumerism
d.3 Expanding Pharmacists' Scope of Practice
E. ENSURING ACCESS TO ORPHAN DRUGS
e.1 Collaborative End-to-End Approach to Approval and Funding of Orphan Drugs
4. CONCLUSION & PRIORITIES FOR REFORM
LIST OF CLHIA RECOMMENDATIONS
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