Issue link: http://clhia.uberflip.com/i/406567
TABLE OF CONTENTS 1. INTRODUCTION ..........................................................................................................................1 2. GUIDING PRINCIPLES ..................................................................................................................3 3. ANALYSIS AND RECOMMENDATIONS ..........................................................................................4 A. ENSURING SAFETY AND ENCOURAGING INNOVATION ................................................................ 4 a.1 Head-to-head Clinical Trials ................................................................................................. 4 a.2 Approval of New Drugs ........................................................................................................ 6 a.2.1 Improving Speed to Market of New Drugs............................................................... 6 a.2.2 Post-Market Review of Prescription Drugs .............................................................. 7 a.2.3 Off-Label Use ............................................................................................................ 8 B. ENSURING AVAILABILITY OF COST EFFECTIVE PRESCRIPTION DRUGS ......................................... 9 b.1 Role of the Patented Medicine Prices Review Board (PMPRB) ............................................ 9 b.1.1 Fundamental Reform to PMPRB Mandate ............................................................ 10 b.1.2 More Aggressive Use of Value-based Pricing ........................................................ 11 b.1.3 Regular Review and Adjustment of Therapeutic Class Prices ................................ 12 b.1.4 Introducing a Formal Institutional Role for Private Insurers .................................. 14 b.2 Provincial Listing Process .................................................................................................... 15 b.2.1 Product Listing Agreements (PLAs) ........................................................................ 16 b.2.2 Assessing the Value of Genetic Tests ..................................................................... 18 b.3 Bringing Generic Drugs to Market ...................................................................................... 18 b.3.1 Reducing Need for Costly Litigation ........................................................................ 19 b.3.2 Generic Interchangeability ...................................................................................... 21 b.3.3 Off-Formulary Pricing and Caps ............................................................................. 23 b.3.4 Clarity on Subsequent Entry Biologics (SEB) Approval Process .............................. 23 b.3.5 Interchangeability of SEBs and Safe Switching ...................................................... 25