Listing of Drugs Reimbursed by Quebec Public Insurance Plan: Actor Strategies not Consistent with Plan Objectives

Transcription

1 Listing of Drugs Reimbursed by Quebec Public Insurance Plan: Actor Strategies not Consistent with Plan Objectives Caroline Cambourieu, Ph. D. (c) Lise Lamothe, Associate Professor André-Pierre Contandriopoulos, Full Professor 2011 Annual CAHSPR Conference Halifax, Nova Scotia, May 11 th 2011

2 Presentation plan 1- Background 2- Objectives 3- Methodology 4- Conceptual framework 5- Results 6- Conclusion

3 Background: Québec Public Prescription Drug Insurance Plan Brief description QPPDIP: Set up in January, 1 st Objective: Cover all Quebecers who are not eligible to a private plan, regardless of their financial situation. Allow reasonable and equitable access to the prescription drugs they need. Mixed Plan : Everyone must be covered by prescription drug insurance. Two types of insurance plans offered: private plans (group insurance or employee benefit plan), the public plan (administered by the Régie d assurance maladie du Québec-RAMQ) Private Plan 59% 4,6 million pers. Public Plan 41% 3,3 million pers. 3

4 Background - QPP Facts : Constant increase in QPP drug utilization Constant increase in QPP drug expenditures Sector highly regulated and subject to new regulation targeting prescription drug expenses and better drug utilization Problematics : Limited efficacy of regulations targeting drug optimal utilization and drug costcontainment QPP Long term viability questionned Impact on financing structure of Ministry of Health Budget Impacts on other Ministry budget Hypothesis : Utilization levels of prescription drugs are determined by strategies of actors belonging to the prescription drugs utilization scheme and by their relations. These strategies and relations are not compatible with regulations targeting QPP drug optimal utilization and drug cost-containment

5 Objectives General: Better understand the context in which regulators introduce regulations Specific Describe and analyze the context of the QPPDIP formulary listing phase Identify key actors Identify regulation regarding these key actors Describe their behaviors towards regulation

6 Methodology Research Strategy : Descriptive qualitative revelatory type. Hypothetical-inductive approach. Single Case: Québec Public Prescription Drug Insurance Plan utilization scheme. Unit of analysis: General practitioners, specialists, pharmacists, regulatory agencies, generic drug manufacturers, patented drug manufacturers, patients representatives. Sample: Purposeful sampling: snowball type. Sample units: n=42. Data collections: Open-ended interviews. Other sources: Scientific Literature, grey litterature, government documents. Analysis tool : Strategic Analysis of Organizations (Crozier & Friedberg, 1981; Friedberg, 1997).

7 Conceptual Framework Prescription Drug Utilization Scheme Regulatory agencies Drug manufacturers Patient representatives Prescription Drug Utilization Gen. Pract. - Specialists Pharmacists Source: adapté de Redwood,1993.

8 Conceptual Framework Québec Public Plan Prescription Drug utilization scheme description and analysis in three different steps: - Step 1- Formulary listing -Step 2- Prescription -Step 3- Access Prescription Drug Utilization QPP

9 Results: Key actors 1- Regulatory agencies: Health Canada, Quebec Ministry of Health and Social Services, Quebec Ministry of Economic development, Conseil du médicament du Québec. 2-Brand name manufacturers 3- Generic manufacturers

10 Results : Regulation regarding Brand name manufacturers 1- Regulation before formulary listing Federal Obtaining a Notice of compliance (NOC), Health Canada 2- Regulation to submit a demand to list a drug Provincial Manufacturer recognition (PPB) Minister of Health Act respecting prescription drug insurance List the Drug on the regular list or on the exceptions list Minister of Health Act respecting prescription drug insurance Drug evaluation process Conseil du médicament Act respecting prescription drug insurance 3- Regulation once the drug is listed on the formulary Authorization to prescribe an exceptions List drug Allow price indexation and limit prices increase Agreement on manufacturers contribution- Establish commercial practice rules Maintain rule for 15 years Manufacturers commitment to invest 10% of sales in R&D Bill C-22 (1987) Provincial Federal Negociate general and specific partnership agreements with manufacturers Conclude agreement on financial risk sharing with manufacturers Conduct an exchange forum with Health ministry, Eco. Devpt. Ministry, industry Brand name drug price control PMPRB - Health Canada

11 Results: Regulation regarding Generic manufacturers 1- Regulation before formulary listing Federal Obtain NOC- Bioequivalence Health Canada 2- Regulation to submit a demand to list a drug Provincial Manufacturer recognition (PPB) Minister of Health Act respecting prescription drug insurance List the Drug on the regular list or on the exceptions list Minister of Health Act respecting prescription drug insurance Drug evaluation process Conseil du médicament Act respecting prescription drug insurance 3- Regulation once the drug is listed on the formulary Allow price indexation and limit price increase Establish commercial practice rules Negociate general and specific partnership agreements with manufacturers Provincial Lighten formulary listing administrative process Control generic prices

12 Results: Brand name manufacturer behaviors Adopt strategies whose impacts are not coherent with regulation objectives Patent clusters, patent extension, horizontal differentiation, etc Delay market entrance of less expensive drugs Selling pseudo-generics: less generic manufacturers competition and drugs higher expenses Non-respect of 10% investment in R&D commitment Brand name manufacturers behaviors Lack of transparency : Opacity concerning R&D research costs Discourse adapted according to types of actors Influence all actors behaviors Blackmail strategy regarding formulary listing: try to influence regulators for a regular listing instead of an exception listing Mobilize all actors (prescriptors, patients, media) to put pressure at political level to react against regulation measures that don t satisfy their strategies

13 Results :Generic manufacturers Lack of transparency: Unknown business settlements with pharmacists Generic manufacturers behaviors Influence regulators decisions New price control regulation coming into effect: timing imposed by manufacturers Adopt strategies whose impacts are not coherent with regulation objectives Price control mechanisms: benefit pharmacist but disadvantage patients and government (generic prices still very high in Québec) Patent litigation : reduce gvt price settlement mechanism efficacy (make market entrance of smaller manufacturers more difficult)

14 Find evidence of: Only three key actors : regulatory agencies, brand name manufacturers, generic manufacturers Drug manufacturers have discourses that are very coherent with QPP objectives Drug manufacturers have strategies whose impacts are not coherent with QPP objectives Illustration of the complexity of that environment (three major actors and multiple regulations) Question the adequation and the efficacy of existing regulations

15 THANK YOU! Questions???????