Public Formulary Addition Flashcards
What two pieces of approval from Health Canada is required to market drugs in Canada?
Notice of Compliance (NOC)
Drug identification number (DIN)
What is a factor that limits access to drugs that have been approved to be marketed in Canada?
Provincial formulary addition (receive public coverage)
Before a drug is added to a public formulary, what are some steps taken to approve formulary addition?
- Health Technology Assessment (HTA) review
- Price Negotiation via pCPA
- The Final Listing Decision
What is the role of HTA organizations in Canada?
Perform pharmacoeconomic analysis to determine the costs and utility of new intervention
What are some examples of HTA agenies in Canada?
Common Drug Review (overseen by the CDA)
pan-Canadian Oncology Drug Review (pCODR), replicates the CDR for cancer drugs
INESSS (Quebec version of CDR and pCODR)
What is the purpose of the Common Drug Review process?
Assesses both clinical and economic data to determine clinical value, cost implications, and cost-effectiveness
Reimbursement recommendations are based on clinical and economic properties, and patient input/preferences
What is the benefit of including patient groups in the Common Drug Review process?
Patients have intimate knowledge about the disease and how it affects them personally (interested in hearing diverse patient experiences with disease)
Increases transparency of decision makng
Increases trust that process is fair
What are the three categories of CDR reccomendations?
- Reimburse
- Reimburse with clinical criteria/with conditions (used for costly or unfavorable increment cost-effective ratios, must acceptable for specific indications or populations)
- Do not reimburse (includes costly drugs or unfavourable incremental cost-effectiveness ratios)
Are reccomendations from Common Drug Reviews binding?
No, provinces can decide to accept ot reject reccomendations for addition to formulary
What does price negotiation after CDR look like?
This is done often when CDR reccomendation is against coverage for price reasons
Manufacturers can submit a confidential price, and is a one-time opportunity
What is a disadvantage of the CDR process before drugs are covered by provincial formularies?
While can result in better funding decisions, CDRs can delay patient access to a drug through a provincial drug plan
Can take 6-9 months on average to get through CDR, while some drugs have taken years
What is the aligned review process?
Can help reduce the amount of time wasted between regulatory approvals
HTA process begins up to 6 months prior to issuing the NOC (reduce timelines, and patients get access to drugs sooner)
More discussion between Health Canada and HTAs, efficient resolution of review issues and reduced duplication
Underutilized though
What is the pan-Canadian Pharmaceutical Alliance?
Provincial buyers get together to improve their buying power (smaller provinces stand to benefit the most)
Created to conduct negotiations with innovative and generic drug manufacturers
What is the main difference between price negotiations with generic vs. innovator drugs?
Generic drug prices are transparent and apply to the entire market
Innovator drug prices are confidential and only apply to public payers
What is the CGPA?
Canadian Generic Pharmaeutical Association
What is the agreement between pCPA and CGPA?
70 commonly prescribed drugs to be sold at 10% of brand name price
Extended for another 3 years in Oct 2023
What is the pan-Canadian Tiered Pricing Framework (TPF)?
Review slide 27
What is monopoly power?
Manufacturerers are able to extract high prices that failed to reflect actual benefit flowing to patients and health systems
What is monopsony power?
The pCPA which represents most public drug plans, can extract lower drug prices that may fail to reflect the actual and oppportunity costs of manufacturers
What is positional vs. principled negotiation?
In situations, where a buyer and seller have continued business, positional (win-lose) negotiation can damage business relationships.
Principled negotiation while does not completely minimize drug costs, but it does create goodwill with manufacturers which can be helpful in times of crisis
What is causing delays in price negotiation?
- Lack of clear guidelines regarding timelines, negotiation processes, decision-making criteria
- Expertise capacity is insufficient for the workload
- Many stakeholders (Provincial/territorial plans, federal programs, Health Canada, and the PMPRB, CDA, and patient groups)
- Poor communication between pCPA and the manufacturers due to multiple plans
What needs to be in place right before a drug can be listed on the formulary?
A signed letter of intent (LOI) following price negotiations
Not binding, but sets pricing for eventual product listing agreement
What are some next steps to improve formulary listing procedures and delays?
- Address persistent failure to meet HTA timelines despite increased funding (Greater accountability to stakeholders)
- Reduce time between HTA recommendation and start of negotiation (Firm deadline on decision to start price negotiation)
- Conditional Funding Approval (secure access while awaiting funding decisions)
What is Conditional Funding Approval?
An agreement that provides patient access to a new medication following the HTA review, while other aspects of the negotiation process continue
