Alberta Pharmaceutical

STRATEGYStakeholder Consultation September 2008

Jonathan Denis, MLA, Calgary-Egmont

Submitted to Honourable Ron Liepert

Minister Alberta Health and Wellness

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Background and Consultation Process:

Alberta Health and Wellness Minister Ron Liepert announced the creation of a Health Action Plan for Alberta in April 2008. A key component of this plan is the development of a pharmaceutical strategy.

In order to obtain stakeholder input into the strategy, Minister Liepert requested that Jonathan Denis, MLA for Calgary-Egmont, meet with key stakeholders, summarize their comments, and make key recommendations. The terms of reference for the consultation and the individuals and groups represented are listed as attachments.

From July 1, 2008 to August 8, 2008, Mr. Denis held meetings with 16 stakeholder groups representing patients, physicians, pharmacists, employers, benefit providers, and the pharmaceutical industry. To start each discussion, Mr. Denis posed a single question – “What direction do you believe government should be taking for a pharmaceutical strategy and why?” Discussion and further questions from both sides followed. All groups were also given the option of providing a written submission by August 8, 2008 to clarify and supplement the discussion. In addition to written submissions resulting from the meetings, input was received from four other interested parties.

Summary of Recommended Actions from Stakeholders:

1) Focus on the patient• Supportshouldbeprovidedforwellness

initiatives to avoid prescription drug use in the first place; however, when required, drug therapy may provide a cost effective benefit to patients.

• Appropriatedrugtherapytypicallyresultsinincreased life expectancy, quality of life and productivity, and decreased reliance on other more expensive aspects of the health care system.

• AlbertaHealthandWellnessshouldempowerpatients to be informed and active participants in wellness and health care choices.

2) Ensure access to therapy while requiring fair and equitable patient contributions

• Barrierswithexistingprogramsincludewithout limitation:- cost- gaps in drug benefit listings- delays in granting access to new therapies

- lack of funding for complementary and alternative medicines (CAM) within programs

• Ensureconsolidationofgovernmentplansandconsistency across said plans.

• Thenamingofgovernmentbenefitplansas“AlbertaBlueCross”planscausesconfusionas there are many public and privately funded AlbertaBlueCrossdrugplans.

• Stakeholdersrecognizethatprogrammechanisms should ensure cost sharing among individuals, employers and government.

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• Aprovincialstrategyshouldbeinstitutedtoensure catastrophic drug coverage is available as cost should not be a barrier to access to necessary therapies.

• Prioritizeprotectiontoensurecoverage is available for lower income Albertans.

• Implementanindependentconsiderationprocess for specific patients including approval of drugs for non-approved indications.

Recommendation One:

Currently, the Government of Alberta delivers drug benefits through five separate agencies: Alberta Health and Wellness, ChildrenandYouthServices,EmploymentandImmigration,SeniorsandCommunitySupportsandSolicitorGeneralandPublicSecurity.It is recommended that the drug benefit programs offered by these agencies be consolidated into a single consistent program administered by one authority. The program should support access to appropriate and necessary therapies, while cost sharing fairly with individuals and employers where applicable. This new program should be promoted and recognized as a Government of Alberta program.

Recommendation Two:

There are times when patients do not tolerate or benefit from therapies available on the drug benefit list. These patients may benefit from treatment with other drugs. For this group of patients, it is recommended that a process for independent consideration be established. This process should involve the individual’s physician and pharmacist. A request and review process that considers anticipated benefit and outcomes, risk and cost of therapy should be established.

Recommendation Three:

Mandate full disclosure of all cost components of a prescription on the receipt (drug cost to government or private insurance, drug cost to patient, and dispensing fee) to ensure patients are aware of their own contributions and the contributions of employers and government to their care so patients are better able to evaluate the value of the service provided. This will also create additional competition between pharmacies and keep dispensing fees at a continually reasonable level.

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3) Hold the program participants accountable and ensure transparent processes are implemented

• Thereshouldbestrictconflictofinterestguidelines for care providers supporting patients to manage their health.

• Adoptguidelinesonappropriatehealthcareprovider - pharmaceutical industry relations tolimitimpactofindustryoninfluencingprescribing.

• Thereshouldbeeffectivedialogueandappealmechanisms for all decisions.

• RestructuretheExpertCommitteewith a view to the following:

- meaningful consumer participation,- meaningful disease expert participation,- open and transparent discussion, and- accountability for decisions made.

• Addpublicmemberstothedecisionprocessto create an equitable balance between medical expert and social value in decisions.

• Tobemosteffective,theroleandexpectationsof public input into the drug benefit listing process must be well defined.

• Establishcontinualperformancemeasures,transparency checkpoints, and appeal mechanisms.

• Akeyfuturecomponentoftheprogramshould be the establishment and monitoring of measures of patient outcomes of therapy.

• UsetheHealthQualityCouncilofAlberta(HQCA)qualitymatrixasatooltoevaluate the impact of system change.

Recommendation Four:

Create transparent reporting for drug coverage decisions, a detailed rationale for the same being made available to the public. Those involved in creating the listing recommendations should abide by strict conflictofinterestguidelines,establishedand maintained with input from the Ethics Commissioner.

Recommendation Five:

Develop an enhanced drug review and listing process with improved stakeholder engagement and structured appeal mechanisms. Patients, prescribers, pharmacists, and industry should have an opportunity to provide input into drug listing recommendations. The review process should consider and base recommendations on clinical and therapeutic evidence, cost and benefit of therapy, and societal, ethical and equity perspectives.

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4) Streamline drug program processes

• AlbertaHealthandWellnessshouldworktowards harmonization/alignment of hospital and community based formularies to support continuity of care and minimal disruption of therapy as patients receive care.

• Thereshouldbeaconsistentapproachand process to review and list drugs across all categories (community, province-wide services, cancer).

• Maintaintransparencyandlistallbenefits.

• Reviewthefederalproposalofinterchangeabilityincluded in the progressive licensing structure. Adopt as appropriate to support a shortening of listing times.

• Streamlinethespecialauthorizationprocess– a lack of availability of family physicians within the province is believed to result in this program being a barrier to medication access.

• Allowpharmaciststosubmitapplicationsforspecial authorization medications.

Recommendation Six:

Make timely drug coverage decisions Establish a structured timeline for review and recommendation that is publicly available so any individual may follow a drug through the review process. Listing approval of multisource (generic) products should occur within 30 days in order to reduce costs by providing more timely access to newly marketed generic drugs. Listing for new patented medicines should occur within 120 days of Notice of Compliance or Common Drug Review recommendation to provide access to new and valued therapies.

Recommendation Seven:

Reduce the administrative burden on health care professionals through evaluation, restructuring and simplification of the special authorization policies and processes.

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5) Maintain a system-wide perspective when considering drug costs and approaching health care budgeting

• Shiftthefocusfromcosttovalueofpharmaceuticals in full context of health expenditures. Drug therapies benefit individuals by allowing them to maintain health and functioning and to avoid reliance on other aspects of health and social services.

• Drugbenefitcostsrepresent70-80percentofthe total benefit plan costs borne by employers. Accordingly, the focus of the pharmaceutical strategy must be on the whole economy of pharmacy - not just the portion funded by government.

• Individualsandemployersareconcernedtheprovince is considering shifting costs to the private sector through shortened length of hospital stays and charges for home intravenous therapy, biologics, and cancer therapies.

• Thebiggestcostdriversarenewmedicationslike the biologics.

• Itisperceivedpricescurrentlypaidforgenericproductsareinflated–changesinpolicymusttake into consideration private and public markets to ensure costs are not shifted.

• Focusingsolelyongenericrebatesmissesthe80 per cent of dollars spent on brand products and potential savings there – a balanced approach is required.

• Addressrebateswithcommunitypharmaciesthrough a consultative process. A review of theAustralianandNovaScotiamodelswassuggested as both had open government, manufacturer and community pharmacy dialogue to establish economically viable models for all.

• Alignthesystemwithdesiredbehaviorsandreward strategies that attain those behaviors.

• Toshiftpractice,rewardstopharmacistsmust be considered in addition to pharmacy rewards.

• Respectthecomplexityofthesupplychain,evolution of systems and how competition has created efficient logistics processes.

• Asinglefederalsystemwouldbenefitall payers and establish an ability to set prices (example: Australia). The National PharmaceuticalStrategyandtenetsarestill valid – a multi-jurisdictional approach is required to attain savings that may be redirected to allow access to new, expensive therapies.

• Capitalizeonpartnershipsacrosswesternprovinces (i.e., TILMA).

• Productlistingagreementsshouldfocus on outcomes and results and limit total cost exposure.Currentdrugpricesreflectproductpositioningandmarketingandmaynotreflectimpact on care or value. Negotiation by each jurisdiction separately increases costs and does not support transparency in pricing.

• Reference-basedpricing,ifconsidered,mustbe implemented so as not to disrupt patient care or health outcomes.

Recommendation Eight:

Create a co-ordinated approach to drug procurement and drug price negotiations with other jurisdictions, especially but not limited to British Columbia. Ensure strategies are implemented to attain value within the supply chain that provides benefit to public and private payers.

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Recommendation Nine:

Establish an industry relations code and conflict of interest guidelines for product promotion. Stepsshouldbetakentoensureindustry promotion of drugs to patients and health care providers is aligned with best practices and the recommendations of drug program review processes.

6) Promote innovation• Albertansratedpharmacistshighestof

health professional groups in the Health QualityCouncilofAlbertasurveyofpatientsatisfaction.

• Promotetheroleofthepharmacistasthemedication expert to patients in the health system and support an expanded role.

• Facilitatemovementoftheprofession to a clinical, service-based model.

• Pharmacistsareaveryaccessiblecareprovider.

• Pharmacistsareleavingtheprofessiontodayas desired practice models are not being rewarded – they are looking for a primary care network type of practice model.

• Shiftthefocusfromsimplydispensingdrugsto patient outcomes.

• Createanunbiasedsourceofknowledgetransfer to support the use of best practices (academic detailing).

• Supporttheprovisionoffeedbacktoindividualprescribers on their prescribing patterns in relation to those of their peers to support adoption of best practices.

• Utilizephysicianstodiagnoseandpharmaciststo support patients in attaining outcome targets through drug therapy management.

• Removeincentivestofillmoreprescriptionsby shifting to rewards for outcomes.

• Considermodelsthatwillworkinbothurbanand rural practice settings.

• Promotearegulatedroleforpharmacytechnicians, which will free up 30 per cent of pharmacists to focus their practice on the new model.

Recommendation Ten:

Create opportunities for pharmacists to adopt a patient-centric professional service model shifting their focus from dispensing medications to collaborative medication management with patients and other care providers.

appendix 1:

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Stakeholder Groups and Representatives

1. CreatingSynergy–AlbertaVoluntaryHealthSectorWorkingTogether–KathyKovacs-Burns,KatieSoles,MaryChibuk.

2. AlbertaDisabilitiesForum–BevMatthiessen,Neil Pierce.

3. SeniorsAdvisoryCouncil–RosemaryBiggs,Frank Horvath.

4. Canadian Generic Pharmaceutical Association –JimKeon,JeffConnell,AndrewvanderGugten,ElieBetito,TerryCreighton.

5. SineChadi,ImperialEquities;JaneFarnham,Cobalt Pharma; John Tse and Gail Rowan, London Drugs.

6. RxandD–AlanGeorge,BayerPharmaceuticals; Daria Horbay, Pfizer Canada Inc.

7. ScottReinson-Merck-Frosst (written submission).

8. DariaHorbay,BobDawson– Pfizer Canada Inc. (written submission).

9. Alberta College of Pharmacists (ACP) – Greg Eberhart.

10. National Association of Pharmacy Regulatory Associations (NAPRA) – CarolBouchard.

11. Alberta Pharmacists’ Association (RxA) –KeithStewart,AudreyFry,DarcyStann.

12. Canadian Pharmacists Association (CPhA) – JodyShkrobot.

13. CanadianAssociationofChainDrugStores–JimWaters,BillBright,DarcyStann.

14. CanadianFederationofIndependentBusiness–DanielleSmith(writtensubmission).

15. CollegeofPhysiciansandSurgeonsofAlberta(CPSA)–Dr.TrevorTheman.

16. Alberta Medical Association (AMA) – Dr.LyleMiddlestead,Dr.BillHnydyk, Dr. Isabelle Chiu

17. Dr.BradenManns–Chair,CanadianExpertDrug Advisory Committee.

18. Dr.JimSilvius–Chair,AlbertaExpertCommittee on Drug Evaluation and Therapeutics.

19. Employer Committee on Health Care – Garth Lockwood, Petro-Canada; Joan Hollihan, Mercer; Lori Roche, WestJet

20.AlbertaBlueCross–RonMalin,RayPisani,DianneBalon,GrahamFerguson.

Note: Submissions were accepted up to and including August 13, 2008, notwithstanding the August 8, 2008 deadline. Submissions received after this timeframe were not considered.

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Terms of Reference

PurposeMr. Jonathan Denis, MLA for Calgary-Egmont, will conduct consultations with stakeholder groups, as outlined, to receive stakeholder feedback and consultation on issues regarding the pharmaceutical strategy being developed.

ScopeThemandateoftheMLA-Stakeholderconsultation is to provide advice to the Minister of Alberta Health and Wellness on stakeholder feedback on appropriate directions for the pharmaceutical strategy being developed, which will enhance Albertans’ access to drug coverage, enable greater control of public spending on drugs, and assist patients in improving health outcomes through drug therapy.

ResponsibilitiesThe MLA will be responsible to:

• ProvideadvicetotheMinisteronstakeholderfeedback on access, and sustainability and value options for the development of the pharmaceutical strategy.

• Receiveinputandcommentsontheprogrammandate and the impact of the policy levers to be applied to the program.

• Receiveinputandcommentsontheexpertreview processes under consideration by the Ministry.

• Receiveinputandcommentsontheexceptionrequest and approval processes to be developed.

• Consultationtobeconductedwithrepresentatives from the following stakeholder groups:

• Professionalcollegesandassociations,andeducational institutions including but not limitedtoCollegeofPhysiciansandSurgeonsof Alberta, Alberta Medical Association, Alberta College of Pharmacists, Pharmacists’ Association of Alberta, Faculty of Pharmacy -UniversityofAlberta,FacultyofMedicine-UniversityofAlbertaandUniversityofCalgary

• Pharmaceuticalindustryrepresentativesincluding but not limited to Canada’s Research-BasedPharmaceuticalCompanies(Rx&D), Canadian Generic Pharmaceutical Association, Canadian Association for Pharmacy Distribution Management (CAPDM)

• Patientandbusinessadvocacyrepresentatives including but not limited to Canadian Association of Chain Drug Stores,FriendsofMedicare,HealthCharitiesCoalition of Canada

• Representativesfromthethirdpartypayer(insurance) industry including but not limited to the Canadian Life and Health InsuranceAssociation,AlbertaBlueCross

Reporting:The MLA will provide a final written document summarizing the information and comments received for each of the components, as outlined, to the Minister by August 15, 2008. The advice provided will be taken into consideration in development and implementation of a new Alberta pharmaceutical strategy.

appendix 2:

Areas of Concentration1) Program Mandate

a)Catastrophic(Safetynetonly)

b) Mandatory Minimum Insurance (Government steps in beyond)

c)Publiclyfunded(Universalplanwithmandatory participation)

d) Targeted populations (Seniors,children,AISH)

The basis for the decision on mandate includes access (fairness, choice, transparency), appropriateness (utilization, pharmacovigilance, public and provider best practice), decision making(stewardship,flexibility,accountability),and value (risk, cost sustainability, economic opportunity).

2) Policy Levers

a) Premiums

b) Co-payments

c) Deductibles

d) Tax Credits

e)SpendingAccounts

3) Expert Review Process

a)Scientific/Clinical- Structuredcommitteewithconsistent

stakeholder review

b) Economic- Cost–Benefit- Total Cost

c)Social/Public- Structuredcommitteeofcitizensto

review and recommend from a member of the public’s perspective.

d) Definition of processes and structures to balance scientific/clinical and societal/public perspectives.

e) Definition of exception request and approval process.

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: health.ahinform@gov.ab.ca You can find this document on the Alberta Health and Wellness website —

www.health.alberta.ca

ISBN: 978-0-7785-7424-8