drug pricing and coverage What are the 5 principles of the Canada Health Act?

What are the 5 principles of the Canada Health Act?

Universal, Accessible, Portable, Comprehensive, Public Administration.

Which services are considered “medically necessary” under the Canada Health Act

Hospital services and physician services (NOT outpatient prescription drugs or vision care).

What factors contribute to rising prescription drug spending in Canada?

• Increased use of drugs (aging population, chronic diseases)

• Shift toward newer, more expensive drugs

• Price increases

What is an Abbreviated New Drug Submission (ANDS) for?

Generic drugs – must be equivalent with same route of administration as reference product.

What does Health Canada grant when approving a drug?

Notice of Compliance (NOC) + Drug Identification Number (DIN).

When can the Special Access Program be used?

For serious/life-threatening conditions when conventional treatments:

• Have failed

• Are unsuitable

• Are unavailable in Canada

Who pays for drugs through the Special Access Program?

Could be free, paid by hospitals, insurers, or patients.

What does the PMPRB review?

Whether list prices for brand-name & biologic drugs are “excessive.”

Who can make a PMPRB complaint?

Federal Minister of Health, provincial/territorial counterparts, senior officials representing public drug programs.

What happens in a PMPRB price hearing?

Panel considers:

1. Prices in Canada

2. Prices in same therapeutic class in Canada

3. Prices in other countries

4. CPI changes (consumer price index aka inflation)

5. Other regulatory factors

Possible PMPRB outcomes?

Reduce maximum price or order repayment of excess revenues.

Who conducts reimbursement reviews in Canada?

CADTH (Canadian Drug Agency, formerly CADTH) – INESSS in Quebec.

What info must companies submit for a CDA review?

Clinical + pharmacoeconomic data.

What is the purpose of the pCPA?

Pool provincial/territorial/federal negotiating power to lower drug prices. (negotiate lower prices with manufactures)

What are the 4 steps of brand drug price negotiation in pCPA?

Initiation → Consideration → Negotiation → Completion.

Who participates in pCPA?

All provinces, territories, NIHB, CSC, VAC (veterans affairs).

Are provinces bound by pCPA negotiations?

No, they retain jurisdiction over which drugs to cover.

Factors considered in negotiations?

DA/INESSS recommendation, gaps in care, budget impact, alternatives, jurisdictional needs.

What is the Manitoba Drug Standards & Therapeutics Committee?

3 physicians + 3 pharmacists; reviews CADTH, scientific evidence, cost, benefits → makes formulary recommendations.

What are the 3 parts of the Manitoba Drug Formulary?

• Part 1 → General coverage

• Part 2 → Restricted (time/condition-specific)

• Part 3 → Exception Drug Status (requires provider application)

What is the Manitoba Pharmacare deductible?

Income-based yearly deductible (min $100, no max). Once reached, Pharmacare covers 100%.

What sub-plans exist under Manitoba coverage?

EIA Program (employment and income), Personal Care Home Drug Program, Palliative Care, Home Cancer Drug Program.

Who is eligible for NIHB?

First Nations & Inuit with federal program coverage.

What services are covered under NIHB?

Medications/supplies, dental, vision, mental health counselling, medical transportation.

What is the NIHB formulary process?

Has its own Drug Benefit List → reviewed by Drugs & Therapeutics Advisory Committee → emphasizes cost-effectiveness & substitution policies.

How does BC structure drug coverage?

Multiple plans (age, income, disease status), income-based deductibles/copays.

What about Alberta?

premium Free plans for seniors (>65), premium-based for <65, copays apply.

Ontario?

ODB for seniors (65+), LTC residents, others; OHIP+ for <24 without private insurance.

Quebec?

RAMQ public plan (for those without private insurance) – premium + copay + deductible.

What are the proposed elements of universal pharmacare?

Universal coverage, national formulary, small copayments (<$5), support for rare disease drugs, CDA role in review/negotiation.

Financial impact of universal pharmacare?

Reduce national spending by $5B; average family saves $350/year.

What is Bill C-64 (Pharmacare Act)?

Passed in Oct 2024; first step toward national pharmacare. Covers diabetes meds + contraceptives for those with provincial health insurance.

what is covered in the manitoba enhanced pharmacare program

birth control

Diabetes

HIV prevention and therapy

hormone replacement