Alberta Pharmaceutical STRATEGY Stakeholder Consultation September 2008

Jonathan Denis, MLA, -Egmont

Submitted to Honourable Minister Health and Wellness

Background and Summary of Recommended Consultation Process: Actions from Stakeholders:

Alberta Health and Wellness Minister 1) Focus on the patient Ron Liepert announced the creation of a Health • Support should be provided for wellness Action Plan for Alberta in April 2008. A key initiatives to avoid prescription drug use in the component of this plan is the development first place; however, when required, drug therapy of a pharmaceutical strategy. may provide a cost effective benefit to patients. In order to obtain stakeholder input into • Appropriate drug therapy typically results in the strategy, Minister Liepert requested that increased life expectancy, quality of life and Jonathan Denis, MLA for Calgary-Egmont, productivity, and decreased reliance on other meet with key stakeholders, summarize their more expensive aspects of the health care system. comments, and make key recommendations. • Alberta Health and Wellness should empower The terms of reference for the consultation patients to be informed and active participants and the individuals and groups represented in wellness and health care choices. are listed as attachments.

From July 1, 2008 to August 8, 2008, 2) Ensure access to therapy while Mr. Denis held meetings with 16 stakeholder requiring fair and equitable groups representing patients, physicians, patient contributions pharmacists, employers, benefit providers, • Barriers with existing programs include and the pharmaceutical industry. To start each without limitation: discussion, Mr. Denis posed a single question - cost – “What direction do you believe government - gaps in drug benefit listings should be taking for a pharmaceutical strategy - delays in granting access to new therapies and why?” Discussion and further questions - lack of funding for complementary and from both sides followed. All groups were alternative medicines (CAM) within programs also given the option of providing a written • Ensure consolidation of government plans and submission by August 8, 2008 to clarify consistency across said plans. and supplement the discussion. In addition to written submissions resulting from the • The naming of government benefit plans as meetings, input was received from four other “Alberta Blue Cross” plans causes confusion interested parties. as there are many public and privately funded Alberta Blue Cross drug plans. • Stakeholders recognize that program mechanisms should ensure cost sharing among individuals, employers and government.

3 • A provincial strategy should be instituted to Recommendation Two: ensure catastrophic drug coverage is available as cost should not be a barrier to access to There are times when patients do not necessary therapies. tolerate or benefit from therapies available on the drug benefit list. These patients may • Prioritize protection to ensure coverage benefit from treatment with other drugs. is available for lower income Albertans. For this group of patients, it is recommended • Implement an independent consideration that a process for independent consideration process for specific patients including approval be established. This process should involve of drugs for non-approved indications. the individual’s physician and pharmacist. A request and review process that considers anticipated benefit and outcomes, risk and Recommendation One: cost of therapy should be established. Currently, the Government of Alberta delivers drug benefits through five separate Recommendation Three: agencies: Alberta Health and Wellness, Children and Youth Services, Employment Mandate full disclosure of all cost components and Immigration, Seniors and Community of a prescription on the receipt (drug Supports and Solicitor General and Public cost to government or private insurance, Security. It is recommended that the drug drug cost to patient, and dispensing fee) benefit programs offered by these agencies to ensure patients are aware of their own be consolidated into a single consistent contributions and the contributions of program administered by one authority. employers and government to their care so The program should support access to patients are better able to evaluate the value appropriate and necessary therapies, while of the service provided. This will also create cost sharing fairly with individuals and additional competition between pharmacies employers where applicable. This new and keep dispensing fees at a continually program should be promoted and recognized reasonable level. as a Government of Alberta program.

4 3) Hold the program participants Recommendation Four: accountable and ensure transparent processes Create transparent reporting for drug coverage decisions, a detailed rationale for are implemented the same being made available to the public. • There should be strict conflict of interest Those involved in creating the listing guidelines for care providers supporting recommendations should abide by strict patients to manage their health. conflict of interest guidelines, established • Adopt guidelines on appropriate health care and maintained with input from the Ethics provider - pharmaceutical industry relations Commissioner. to limit impact of industry on influencing prescribing. Recommendation Five: • There should be effective dialogue and appeal mechanisms for all decisions. Develop an enhanced drug review and • Restructure the Expert Committee with listing process with improved stakeholder a view to the following: engagement and structured appeal mechanisms. Patients, prescribers, - meaningful consumer participation, pharmacists, and industry should have an - meaningful disease expert participation, opportunity to provide input into drug listing - open and transparent discussion, and recommendations. The review process should - accountability for decisions made. consider and base recommendations on • Add public members to the decision process clinical and therapeutic evidence, cost and to create an equitable balance between medical benefit of therapy, and societal, ethical and expert and social value in decisions. equity perspectives. • To be most effective, the role and expectations of public input into the drug benefit listing process must be well defined. • Establish continual performance measures, transparency checkpoints, and appeal mechanisms. • A key future component of the program should be the establishment and monitoring of measures of patient outcomes of therapy. • Use the Health Quality Council of Alberta (HQCA) quality matrix as a tool to evaluate the impact of system change.

5 4) Streamline drug program Recommendation Six: processes Make timely drug coverage decisions • Alberta Health and Wellness should work Establish a structured timeline for review towards harmonization/alignment of hospital and recommendation that is publicly and community based formularies to support available so any individual may follow a drug continuity of care and minimal disruption of through the review process. Listing approval therapy as patients receive care. of multisource (generic) products should • There should be a consistent approach occur within 30 days in order to reduce costs and process to review and list drugs across by providing more timely access to newly all categories (community, province-wide marketed generic drugs. Listing for new services, cancer). patented medicines should occur within • Maintain transparency and list all benefits. 120 days of Notice of Compliance or Common Drug Review recommendation to provide • Review the federal proposal of interchangeability access to new and valued therapies. included in the progressive licensing structure. Adopt as appropriate to support a shortening of listing times. Recommendation Seven: • Streamline the special authorization process – a lack of availability of family physicians Reduce the administrative burden on health within the province is believed to result in this care professionals through evaluation, program being a barrier to medication access. restructuring and simplification of the special authorization policies and processes. • Allow pharmacists to submit applications for special authorization medications.

6 5) Maintain a system-wide • Align the system with desired behaviors and perspective when considering reward strategies that attain those behaviors. drug costs and approaching • To shift practice, rewards to pharmacists health care budgeting must be considered in addition to pharmacy • Shift the focus from cost to value of rewards. pharmaceuticals in full context of health • Respect the complexity of the supply chain, expenditures. Drug therapies benefit evolution of systems and how competition individuals by allowing them to maintain has created efficient logistics processes. health and functioning and to avoid reliance • A single federal system would benefit on other aspects of health and social services. all payers and establish an ability to set • Drug benefit costs represent 70-80 per cent of prices (example: Australia). The National the total benefit plan costs borne by employers. Pharmaceutical Strategy and tenets are Accordingly, the focus of the pharmaceutical still valid – a multi-jurisdictional approach is strategy must be on the whole economy of required to attain savings that may be redirected pharmacy - not just the portion funded by to allow access to new, expensive therapies. government. • Capitalize on partnerships across western • Individuals and employers are concerned the provinces (i.e., TILMA). province is considering shifting costs to the • Product listing agreements should focus private sector through shortened length of on outcomes and results and limit total cost hospital stays and charges for home intravenous exposure. Current drug prices reflect product therapy, biologics, and cancer therapies. positioning and marketing and may not reflect • The biggest cost drivers are new medications impact on care or value. Negotiation by each like the biologics. jurisdiction separately increases costs and • It is perceived prices currently paid for generic does not support transparency in pricing. products are inflated – changes in policy must • Reference-based pricing, if considered, must take into consideration private and public be implemented so as not to disrupt patient markets to ensure costs are not shifted. care or health outcomes. • Focusing solely on generic rebates misses the 80 per cent of dollars spent on brand products and potential savings there – a balanced Recommendation Eight: approach is required. Create a co-ordinated approach to drug • Address rebates with community pharmacies procurement and drug price negotiations through a consultative process. A review of with other jurisdictions, especially but the Australian and Nova Scotia models was not limited to British Columbia. Ensure suggested as both had open government, strategies are implemented to attain value manufacturer and community pharmacy within the supply chain that provides dialogue to establish economically viable benefit to public and private payers. models for all.

7 Recommendation Nine: • Remove incentives to fill more prescriptions by shifting to rewards for outcomes. Establish an industry relations code and • Consider models that will work in both urban conflict of interest guidelines for product and rural practice settings. promotion. Steps should be taken to ensure industry promotion of drugs to patients and • Promote a regulated role for pharmacy health care providers is aligned with best technicians, which will free up 30 per cent practices and the recommendations of of pharmacists to focus their practice on the drug program review processes. new model.

6) Promote innovation Recommendation Ten: • Albertans rated pharmacists highest of Create opportunities for pharmacists to health professional groups in the Health adopt a patient-centric professional service Quality Council of Alberta survey of patient model shifting their focus from dispensing satisfaction. medications to collaborative medication • Promote the role of the pharmacist as the management with patients and other medication expert to patients in the health care providers. system and support an expanded role. • Facilitate movement of the profession

to a clinical, service-based model. • Pharmacists are a very accessible care provider. • Pharmacists are leaving the profession today as desired practice models are not being rewarded – they are looking for a primary care network type of practice model. • Shift the focus from simply dispensing drugs to patient outcomes. • Create an unbiased source of knowledge transfer to support the use of best practices (academic detailing). • Support the provision of feedback to individual prescribers on their prescribing patterns in relation to those of their peers to support adoption of best practices. • Utilize physicians to diagnose and pharmacists to support patients in attaining outcome targets through drug therapy management.

8 appendix 1:

Stakeholder Groups and Representatives 11. Alberta Pharmacists’ Association (RxA) – Keith Stewart, Audrey Fry, Darcy Stann. 1. Creating Synergy – Alberta Voluntary Health Sector Working Together – Kathy Kovacs- 12. Canadian Pharmacists Association (CPhA) – Burns, Katie Soles, Mary Chibuk. Jody Shkrobot.

2. Alberta Disabilities Forum – Bev Matthiessen, 13. Canadian Association of Chain Drug Stores Neil Pierce. – Jim Waters, Bill Bright, Darcy Stann.

3. Seniors Advisory Council – Rosemary Biggs, 14. Canadian Federation of Independent Business Frank Horvath. – Danielle Smith (written submission).

4. Canadian Generic Pharmaceutical Association 15. College of Physicians and Surgeons of – Jim Keon, Jeff Connell, Andrew van der Alberta (CPSA) – Dr. Trevor Theman. Gugten, Elie Betito, Terry Creighton. 16. Alberta Medical Association (AMA) – 5. Sine Chadi, Imperial Equities; Jane Farnham, Dr. Lyle Middlestead, Dr. Bill Hnydyk, Cobalt Pharma; John Tse and Gail Rowan, Dr. Isabelle Chiu London Drugs. 17. Dr. Braden Manns – Chair, Canadian Expert 6. Rx and D – Alan George, Bayer Drug Advisory Committee. Pharmaceuticals; Daria Horbay, 18. Dr. Jim Silvius – Chair, Alberta Expert Pfizer Canada Inc. Committee on Drug Evaluation and 7. Scott Reinson - Merck-Frosst Therapeutics. (written submission). 19. Employer Committee on Health Care – 8. Daria Horbay, Bob Dawson – Garth Lockwood, Petro-Canada; Joan Hollihan, Pfizer Canada Inc. (written submission). Mercer; Lori Roche, WestJet

9. Alberta College of Pharmacists (ACP) – 20. Alberta Blue Cross – Ron Malin, Ray Pisani, Greg Eberhart. Dianne Balon, Graham Ferguson.

10. National Association of Pharmacy Note: Submissions were accepted up to and including Regulatory Associations (NAPRA) – August 13, 2008, notwithstanding the August 8, 2008 Carol Bouchard. deadline. Submissions received after this timeframe were not considered.

9 appendix 2:

Terms of Reference

Purpose • Consultation to be conducted with Mr. Jonathan Denis, MLA for Calgary-Egmont, representatives from the following stakeholder will conduct consultations with stakeholder groups: groups, as outlined, to receive stakeholder • Professional colleges and associations, and feedback and consultation on issues regarding educational institutions including but not the pharmaceutical strategy being developed. limited to College of Physicians and Surgeons of Alberta, Alberta Medical Association, Scope Alberta College of Pharmacists, Pharmacists’ The mandate of the MLA-Stakeholder Association of Alberta, Faculty of Pharmacy consultation is to provide advice to the Minister - University of Alberta, Faculty of Medicine - of Alberta Health and Wellness on stakeholder University of Alberta and University of Calgary feedback on appropriate directions for the • Pharmaceutical industry representatives pharmaceutical strategy being developed, which including but not limited to Canada’s will enhance Albertans’ access to drug coverage, Research-Based Pharmaceutical Companies enable greater control of public spending on (Rx&D), Canadian Generic Pharmaceutical drugs, and assist patients in improving health Association, Canadian Association for outcomes through drug therapy. Pharmacy Distribution Management (CAPDM) Responsibilities • Patient and business advocacy representatives including but not limited The MLA will be responsible to: to Canadian Association of Chain Drug • Provide advice to the Minister on stakeholder Stores, Friends of Medicare, Health Charities feedback on access, and sustainability and Coalition of Canada value options for the development of the • Representatives from the third party payer pharmaceutical strategy. (insurance) industry including but not • Receive input and comments on the program limited to the Canadian Life and Health mandate and the impact of the policy levers to Insurance Association, Alberta Blue Cross be applied to the program. Reporting: • Receive input and comments on the expert review processes under consideration by The MLA will provide a final written the Ministry. document summarizing the information and comments received for each of the • Receive input and comments on the exception components, as outlined, to the Minister by request and approval processes to be developed. August 15, 2008. The advice provided will be taken into consideration in development and implementation of a new Alberta pharmaceutical strategy.

10 Areas of Concentration 3) Expert Review Process 1) Program Mandate a) Scientific/Clinical - Structured committee with consistent a) Catastrophic (Safety net only) stakeholder review b) Mandatory Minimum Insurance b) Economic (Government steps in beyond) - Cost – Benefit c) Publicly funded (Universal plan with - Total Cost mandatory participation) c) Social/Public d) Targeted populations - Structured committee of citizens to (Seniors, children, AISH) review and recommend from a member of the public’s perspective. The basis for the decision on mandate includes access (fairness, choice, transparency), d) Definition of processes and structures to appropriateness (utilization, pharmacovigilance, balance scientific/clinical and societal/ public and provider best practice), decision public perspectives. making (stewardship, flexibility, accountability), e) Definition of exception request and value (risk, cost sustainability, economic and approval process. opportunity).

2) Policy Levers

a) Premiums b) Co-payments c) Deductibles d) Tax Credits e) Spending Accounts For additional copies of this document contact: Alberta Health and Wellness - Communications 22nd floor, 10025 Jasper Avenue Edmonton, Alberta T5J 1S6 Phone: 780-427-7164 or toll free 310-0000 Fax: 780-427-1171 E-mail: [email protected] You can find this document on the Alberta Health and Wellness website — www.health.alberta.ca

ISBN: 978-0-7785-7424-8