1) The document discusses the changing regulatory environment in Canada for drug reimbursement, including new PMPRB pricing guidelines and the increasing influence of CADTH and PCPA in determining reimbursement. 2) It notes that PMPRB reforms may require new drugs to be priced at or below existing treatments, weakening the ability to negotiate pricing. HTA submissions need to demonstrate value beyond price to gain reimbursement. 3) Provinces face budget pressures that have led to policies favoring generics and biosimilars over optimized therapies, influencing CADTH and PCPA decisions and lengthening the time for new drugs to be reimbursed.

1. New Definition of Access
Access to
Care
Access to
Treatmen
t
1
Outcomes

2. 2-3+ yrs
12 mos
5-6 mos
6-12 mos
Median 10 mos
3-12 mos

3. Environment- Multi Directional Regulatory Process
CADTH
PMPRB/Pricing
PCPA
Payers
Provincial/Private
RINVOQ
REIMBURSMENT
How do we elevate the value of RINVOQ as
optimized Standard of Care in a multi
directional regulatory process
to gain Reimbursement?

4. Group 1- PMPRB RINVOQ Case
Scenario- PMPRB regulatory changes are likely to be in place at the time
RINVOQ launch in AD. PMPRB is likely to stream new drug classes
and drugs that change standard of care into Stream A. Drugs that enter
with little clinical improvement or 2nd,3rd in class will be stream B and be
considered at lowest price established by competitors. Continuous HTA
review of market size and multi indications will determine price. PMPRB
also plans to include semi transparent rebates of existing drugs in class
and require new entry drugs price at or below rebated price.

5. CADTH –Clinical-Clinical Case Context
In this multidirectional reimbursement environment the Role of HTA and CADTH criteria is
becoming more of a mechanism used by the Provinces and PCPA to position lower
pricing or even recommend lowest price biologic price (Skyrizi) with very little recognition
of value of optimized therapy. Our submissions need to remove as many obstacles from
the PCPA/Provincial negotiations and pricing. In other words weaken the PCPA and
Provincial government (BATNA) or position down stream.
In this context please consider the following questions

6. PCPA- Case Study Context
Driven by the provinces to reduce pricing and alleviate biologic budget
pressures the PCPA has been influencing CADTH and policy (Biosimilar first)
to aggressively negotiate pricing while limiting recognition of the value or
clinical efficacy of optimized therapies. Multi-indication drugs continue to be a
problem in pricing strategy for provinces. PMPRB implementation may
drastically alter industry capacity to negotiate lower pricing with the PCPA
office. Finding a definition of value is critical in each future negotiation.

7. Payers- Case Study Environment Context
continue to play out at both a national and provincial territorial level. These new
challenges include:
National Pharmacare: The call for National Pharmacare has become a rallying cry for
combatting a perceived crisis in access to medications in Canada.
PMPRB Reform: PMPRB reforms are now being characterized as an essential first step
ensuring the Canadians realize the true benefit of National Pharmacare.” The suggested
mechanisms drastically change how we launch and if we launch drugs in Canada. It also
impacts private payer pricing with semi transparent pricing.
Provincial/Territorial Drug Spending Restraint: Even more directly impactful has been
the degree to which provincial and territorial governments have simply failed to invest in
new medicines. At the heart of delays in Time to List (TTL) is the pervasive lack of
budgetary resources directed to drugs compared with other line items in provincial and
territorial health budgets. It is no longer when will they list but a prioritization of which
drugs they will list?
Biologic First Principal: Another mechanism to control cost of the rising entry of biologic
medicines in Canada and the advent of policies such as tiering, NMS, generic framework
are evident in Canada.
The provinces have reformed generic and branded medicines utilizing the policies listed

8. Provincial Reimbursement Advisor, Nov. 2017 APRIL 13 2018 – AbbVie RD Consult
8
Atlantic Drug Plans – Time to Listing
• Atlantic Canada has some the longest listing delays in the country.

9. Areas of Influence
What can we do?
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10. Budget and Planning
Annual Financial Management Cycle
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11. Areas of Influence
What can we do?
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