1. REIMBURSEMENT, MARKET ACCESS & PRICING
Mike McCarthy, Principal,
Grosso McCarthy
Robert Kulik, Principal Consultant, Patient Access Solutions Inc.

2. Payers of Prescription Drugs in Canada
Public Payers:
Federal / Provincial Drug Plans:
65 years and older, social assistance, catastrophic drug costs (income based)
Hospital in-patients - covered by hospital budget.
Cancer products – separate cancer agencies in Western Canada and Ontario.
Vaccines: provincial public health agencies.
Specific disease programs e.g., MS, hGH, CF, transplant etc.
Blood products: Canadian Blood Services, Hema Quebec.
Private Insurers:
19.5 million Canadian have access to some form of private insurance coverage.
Employer sponsored drug coverage for employees and their families.
Three insurance companies represent 2/3 of covered “lives” in Canada.
Out of Pocket:
Non-funded medications (i.e. fertility (outside of Quebec), erectile dysfunction etc.).
Co-insurance and deductibles.

3. Who Pays for What?

4. Health Technology Assessment in Canada
The provinces, territories and federal government have centralized health technology assessment (HTA) in Canada where manufacturers must submit a clinical and economic dosser for evaluation. Three programs:
Common Drug Review (CDR).
Pan Canadian Oncology Drug Review (pCODR).
Quebec’s Institut national d'excellence en santé et en services sociaux (INESSS).
Unlike Health Canada, the HTA body asks manufacturers:
Are the new product’s efficacy, safety/tolerability benefits worth paying for in the population of patients covered under our programs?
Can we rely on the data presented to be certain the reported benefits will be realized in the real world?
HTA bodies only make recommendations for funding; final decisions rest with the provincial, territorial and federal drug plans. In Quebec, INESSS makes funding recommendations directly to the Minister of Health.

5. Market Access in Canada – Choose Your Adventure!
Private Payers
Public Payers
Managed
23%
Open
70%
Health Technology Assessment
CDR/pCODR
Institut national d'excellence en santé et en services sociaux (INESSS)
9 Provincial 5 Federal and 3 Territorial Drug Plan
Decisions
Québec
Decision
Pan Canadian Pricing Alliance Negotiations
Note: Quebec has just joined pCPA

6. Getting The Basics Right the First Time
Health Economics
CDR
PMPRB
Submission
Clinical Dossier
Patient Services
GR/PR
Pricing
INESSS
Private Payers
BIAs

7. Charting a Course for Market Access
Limited resources means prioritizing activities and making tough decisions – you can’t do everything
Quickly identifying where the business comes from
Speed - maximizing every day “on formulary”

8. Hoops and Hurdles Provinces are struggling with budgets
Price of niche/orphan drugs - Sticker shock versus true budget impact
Growing concern with pipeline and line extensions of niche and orphan products
Fear of establishing funding precedent:
Looking at PII and PIII clinical development programs and applying limited information to funding decisions
Questions relating to fair return on investment are beginning to be raised by some jurisdictions

9. Influencing Government
Behind the scenes bureaucrats run the day-to-day business of government
To influence them you must:
Identify the key stakeholders, both within government and externally
Align your objectives with their priorities
identify who and what will impact them
Build a case that demonstrates mutual benefit

10. Mobilizing the Patient Community
Has proven to date to be the most effective way to influence negotiations at all levels (PCPA and provincial coverage)
puts public pressure on governments for a favourable outcome
Traditional media, social media and direct engagement have all proven effective
Important for companies to remain arms length

11. pCPA Background
Initially driven by Ontario’s former Premier Dalton McGuinty
Announced following the 2010 annual Premiers’ Council of the Federation
Work is undertaken at the Council of the Federation’s Health Care Innovation Working Group
Provinces alternate leading the group with Ontario and Nova Scotia currently leading

12. pCPA Process
Source: Pan-Canadian Pricing Alliance, The “Goliath of Market Access, October 2013

13. pCPA Challenges
Differences in public drug plan structures, priorities and goals
Existing confidential product listing agreements add complexity
Lack of a formal process or governance structure
Lack of transparency and vehicle for broader public communication and input
Stakeholder uncertainty as a results
No dedicated resources
Participation on individual negotiations by Provinces/Territories is not mandatory
Time to listing after completed negotiations varies across jurisdictions
Need for Provinces/Territories to maintain their decision making authority

14. pCPA and Niche/Orphan Products
pCPA can be both a blessing and a curse for small biopharmaceutical companies
Current structure best suited for products that deal with larger populations
Niche/orphan products very complicated – difficult to operationalize an agreement at the pan-Canadian table

15. pCPA Continued
Difficult to come to an innovative agreements with so many players – very tough job for lead province,
Price, Price, Price
No one in charge and everyone is in charge – where is the decision-maker?
Hopeful for resolution following current consultation process

16. As of September 30 2014: 48 pCPA negotiations completed
There are 9 negotiations currently underway
The PCPA has recommended that negotiations for 9 brand name drug products be considered by each Province/Territory individually
There are 16 drug products for which the PCPA has decided not to negotiate collectively or individually at the provincial-territorial level

17. Final thoughts
Need to find ways to bridge the gap between the requirements of small biopharmaceutical companies and tough choices that governments make
Important to illustrate the challenges of the small company to government – understand unique perspectives
Need to work honestly, transparently, and with mutual respect.

18. Orphan Medications in Canada
All governments are struggling with health care budgets – Canada not an exception.
Challenges with funding new and innovative therapies – orphan/rare disease medications continues to be an important subject in Canadian pharmaceutical policy discussions.
Canada does not have an Orphan Drug/rare disease policy like many other developed countries.
Orphan medications are reviewed through the same health technology review process in Canada as drugs for more “common” diseases.
Health Canada is developing a framework for the designation, authorization and monitoring of orphan drugs.
The province are also working on a funding framework.

19. Provincial and Territorial Orphan Drug Funding Initiative
The provinces are also working on a funding framework for orphan medications.
April 2014, the Minister of Health of Alberta announced that the provincial and territorial governments would work together to establish a national framework for a pan-Canadian approach for coverage of orphan drugs. Alberta lead the efforts to examine potential funding mechanisms.
In September 2014, provincial and territorial ministers of health announced the establishment of a working group led by Alberta, British Columbia and Ontario to explore how to manage the cost of rare disease drug therapies with evidence-based approaches to funding.

20. Thank You
Michael McCarthy Grosso McCarthy 65 Queen Street West Suite 2010, P.O. Box 68 Toronto, ON M5H 2M
Robert Kulik Patient Access Solutions Inc. 55 Princeton Road Toronto, ON M8X 2E