The Public Formulary Listing Decision Pathway

Question 1

What role does Health Canada play in terms of drug approval/listing decision pathway? (One word, don’t overcomplicate it)

Answer 1

Regulator (effect and safety)

Question 2

What organizations assess value of meds (health technology assessment (HTA))? (3)

Answer 2

1. CDR (CADTH)
2. pCODR (CADTH)
3. Quebec = INESSS

Question 3

What organization is the “price negotiator” in Canada?

Answer 3

Pan Canadian Pharmaceutical Alliance (pCPA)

Question 4

Who ultimately is the decision maker/funder for drug approval/listing?

Answer 4

The provincial/territorial ministries of health and cancer agencies

Question 5

Once a drug’s safety and efficacy are established, and its manufacturing processes approved, Health Canada provides the manufacturer with a ______ __ __________, and a ____ ______________ ______. This allows the drug to be marketed in Canada

Answer 5

Notice of Compliance (NOC); drug identification number (DIN)

Question 6

Before being added to a provincial or another public formulary, a drug is subjected to three distinct steps. What are they?

Answer 6

1. Health Technology Assessment
2. Price Negotiation via pCPA
3. The Final Listing Decision

Question 7

What is the Common Drug Review/what is the purpose? (3)

Answer 7

1. The purpose of the CDR is to evaluate new drugs and all new indication submissions
2. Assesses both clinical and economic data to determine clinical value, cost implications, and cost-effectiveness.
3. Reimbursement recommendations to public payers are based on clinical and economic properties, and patient input/preferences).

Question 8

What are the benefits to including patient groups? (3)

Answer 8

1. Patients have unique knowledge about the disease and how treatment affects them
2. Increases transparency of decision-making process that often requires difficult choices
3. Increases trust that the process is fair

Question 9

Since 2016, CDR recommendations are assigned to one of three categories. What are they?

Answer 9

1. Reimburse
2. Reimburse with clinical criteria and/or conditions
   - Includes costly drugs or those with unfavourable increment cost effectiveness ratios (ICER) ; but may be acceptable for specific indications or populations
3. Do not reimburse
   - Includes costly drugs or those with unfavourable incremental cost-effectiveness ratios (ICER)

Question 10

What are the benefits of a shared approach (meaning why is the CDR is a good thing I guess)? (2)

Answer 10

1. Increased efficiency as the result of reduced duplication of effort.
   - One review by the CDR rather than 15 by the participation plans.
   - 9 provinces, 3 territories, and 3 Federal plans
2. The CDR leverages resources from the different jurisdictions and ensures all plans benefit from access to specific expertise.
   - Results in greater consistency in the review process with a higher level of quality.

Question 11

What is a drawback to the CDR?

Answer 11

Delays patient access.
Timelines have increased steadily in the past few years with many reviews exceeding both the 6-month and the 9-month standard

Question 12

Sensitive to the issue of excessive delays, CDR is working with Health Canada (HC) to cut the time between a drug receiving a NOC and a CDR funding recommendation. This is called?

Answer 12

The Aligned Review Process

Question 13

What does the Aligned Review Process allow for? (2)

Answer 13

1. Available to all biological and new drug submissions, an aligned review can reduce the time between issuing an NOC and the HTA recommendation.
2. Also allows for real time discussions between HC and HTAs, greater ability to share information, more efficient resolution of review issues and reduction of duplication, where possible

Question 14

Explain the Aligned Review Process (3)

Answer 14

1. Start up to 6 months prior to issuing the NOC
2. Timing of the aligned review will vary whether Health Canada is conducting a priority review; an NOC with Conditions review; or a regular review.
3. While having the potential to shorten the time to patient access, the process is underutilized

Question 15

What is the pan-Canadian Pharmaceutical Alliance (pCPA) and what does it do? (3)

Answer 15

1. Created to conduct negotiations with both innovative and generic drug manufacturers
2. The stated goal of the pCPA is to achieve greater value for both plans and patients.
3. Negotiates on behalf of member plans; but individual members can still negotiate on their own.

Question 16

Discuss price negotiations and the pCPA/how it works (3)

Answer 16

1. Prices negotiated for generics are generally transparent and usually apply to the entire market (public and private).
2. Prices negotiated for innovator drugs are confidential and only apply to public payers.
3. Early success – by 2014 overall generic drug prices reduced from 63% to 36%, with some as low as 18% of the brand name price.

Question 17

What does the Canadian Generic Pharmaceutical Association (CGPA) do? (3)

Answer 17

1. 70 commonly prescribed drugs reduced 25-40% (@ 10% of brand name price)
2. Project $5 billion in savings over 5 years
3. No tendering by participating provinces over the term of the agreement

Question 18

Discuss the pan-Canadian Tiered Pricing Framework (TPF). Starting with Tier 1

Answer 18

Tier 1 = When the generic product is a single source (i.e. only one
manufacturer) in the Canadian market)
% of Brand Reference Pricing:
- 85% of brand price if PLA for brand product does not exist.
- 75% of brand price if pricing PLA exists or existed at any time in the past.
- Reduces to 55% of brand price after three months of public funding.

Question 19

Discuss the pan-Canadian Tiered Pricing Framework (TPF) tier 2

Answer 19

Tier 2 = When there are 2 generics in the Canadian market
% of Brand Reference Pricing:
- 50% of brand price

Question 20

Discuss the pan-Canadian Tiered Pricing Framework (TPF) tier 3

Answer 20

Tier 3 = When there are 3 or more generic products on the Canadian market
% of Brand Reference Pricing:
- 25% of brand price for oral solids and at 35% for all other dosage forms (liquids, injectables, inhalers, etc.)

Question 21

Dicuss what monopoly/oligopoly power and monopsony/oligopsony power is in terms of negotiating drug prices and fair value

Answer 21

1. Monopoly/oligopoly power
   - Historically, manufacturers were able to extract high prices that often failed to reflect actual benefit flowing to patients and health systems.
2. Monopsony/oligopsony power
   - The pCPA, representing most public drug plans, is able currently to extract low prices that may fail to reflect the actual and opportunity costs of manufacturers

Question 22

What are the 5 steps of the pCPA negotiation process?

Answer 22

1. Following a CDR recommendation, provinces decide whether to negotiate.
   - Participation by all jurisdictions is not required.
2. If yes, a lead jurisdiction assigned.
3. Manufacture(s) invited to engage.
4. At the conclusion of a successful negotiation a letter of intent (LOI) is signed between the pCPA and the drug’s manufacturer.
   - Does not guarantee a formulary listing by any of the plans or that the plan(s) will adhere to the LOI.
5. Manufacture(s) must then negotiate product listing agreement (PLA) with each province.

Question 23

The pCPA is experiencing increasing delays in time to conclusion of successful negoation, which leads to increasing backlog of products requiring a decision. What are some of the causes of this? (4)

Answer 23

1. Lack of clear guidelines regarding timelines, negotiation processes, decision-making criteria.
2. Expertise capacity is insufficient for the workload.
3. Many stakeholders:
   - Provincial and territorial plans, Federal programs, Health Canada and the PMPRB, CADTH, and patient groups/advocates.
4. Poor communication between pCPA and the manufacturers due to multiple plans

Question 24

What happens after a successful negotiation with pCPA and a signed letter of intent (LOI) is received?

Answer 24

Manufacture(s) must then negotiate a product listing agreement (PLA) with each province.

Question 25

What is the trend with HTA and pCPA timelines?

Answer 25

Increasingly long, which delays people having access to medications despite them being approved

Question 26

What are some possible next steps to help address the problems with the pCPA and their timelines? (3)

Answer 26

1. Address persistent failure to meet HTA timelines despite increased funding. - Greater accountability to stakeholders. 2. Reduce time between HTA recommendation and start of negotiation. - Firm deadline on decision to start price negotiation. 3. Conditional Funding Approval - Secure access while awaiting funding decisions

Question 27

What is conditional funding approval?

Answer 27

An agreement that provides patient access to a new medication following the HTA review (or earlier), while other aspects of the negotiation process continue. - e.g., pricing negotiations, protocols for ongoing data assessment, etc.

Question 28

Conditional funding approval is intended for what?

Answer 28

For products with significant clinical benefit for an important unmet need and have gone through an accelerated regulatory process that creates challenges for payers. - Less evidence prior to approval and thus, greater uncertainty as to value-for-money.

Question 29

What are 2 concerns about conditional funding approval?

Answer 29

1. May incentivize companies to provide less evidence with new submissions. 2. Difficult to end conditional funding if it is determined that value-for-money is lacking.