Prescription Drug Access & Governance

• PHAR 315 Midterm Exam covers governance principles and pharmacare options.
• Focus: coordinated healthcare and pharmaceutical policies promoting equitable and sustainable health for Canadians

Objectives of Governance Principles

• Access: Ensuring all Canadians have equitable access to medically necessary prescription drugs without financial barriers.
• Appropriateness: Medications are prescribed and used based on the best evidence regarding risks and benefits.
• Safety: Prescription drugs are licensed only when they offer benefits outweighing harms.
• Value: Prescription drugs are competitively priced and represent value for money within Canada's healthcare system.

Actions of Governance Principles

• Public coverage: Universal public coverage of necessary medications with minimal direct patient changes.
• National standards: Implementation of national standards for medication safety and quality.
• Information systems: Universal e-prescribing and drug information systems across provinces.
• Enforcement: Direct governmental enforcement of drug market regulations
• Data transparency: Publication of all relevant scientific data in regulatory decisions and lifecycle evidence.
• Efficient market: Streamlined market entry for generics and biosimilars, as well as evidence-based substitutions.
• Price control: Price regulations based on reasonable limits and economic fundamentals.
• Supply contracts: Pan-Canadian contracts to supply drugs for the public plan.

Expanding Healthcare Coverage in Canada

• A surge in media attention to long-term care (LTC) due to COVID-19 prioritized the issue.
• A major problem is access to primary care and GP burnout, which hasn't improved alongside LTC attention.
• Policy scholars advocate for universal access, similar to Medicare, supported by evidence.
• Policy advisors consider fiscal and political realities, avoiding changes to prevent potential blame or lack of government credit.

Federal Government's Role in Pharmacare Expansion

• Delaying tactics are used by the federal government, despite evidence supporting Medicare benefits.
• Excessive studies have been employed instead of implementing proven solutions.
• The term "bilateral axis" refers to government vs. the medical profession, affecting Medicare expansion due to lack of unified voice.

Political Constituents and Objectives of Pharmacare

• Constituents include physicians, retail pharmacies, private insurance, pharmaceutical companies, and the public.
• Additional consideration: policy scholars, government advisors, pharmacists, healthcare providers, economists, and ethicists.

Current System of Prescription Drug Coverage in Canada

• Prescription drugs are not fully included in Medicare.
• About 20% of Canadians lack sufficient drug coverage, but most have some form through various payers.
• Federal programs (NIHB, Veteran Affairs, RCMP); worker compensation boards, provincial plans, and private insurance are payers.
• Public plans vary widely in generosity, scope, and criteria.
• Saskatchewan has the highest amount of publicly funded drug spending.
• Lower-income individuals are less likely to afford prescriptions and have adequate private insurance.

Qualifying for Drug Coverage

• Private insurance companies are designed to be profitable.
• Pre-existing conditions: Coverage may be declined or premiums are increased for targeted conditions.
• Community rating: Healthy and wealthy subsidize the sick and poor via higher plan costs within group plans.

Critiques of Current System

• Medically necessary drugs are not always publicly funded.
• Inconsistent coverage exists across jurisdictions.
• Coverage/access is not solely need-based.
• Competing goals of public and private plans lead to uncoordinated efforts.

Options for Expanding Drug Coverage

• Medicare Model: A public, single-payer system providing medically necessary services without financial cost.
• It allows for universal access to all residents, ruling out risk-based premiums, which are based on income rather than health status.
• Comprehensive coverage includes restrictions based on evidence.
• Accessible without user fees.
• Drugs not on the formulary aren't covered if seen as not medically necessary or excessively priced.
• Rule of exclusivity says taking money for "medically necessary" drugs and use it for "unnecessary" deemed drugs may be unethical
• MedicareLite (Cost Sharing):
• The universal public plan has cost-sharing through deductibles, co-insurance, copayments, or prescription fees. Private insurance is allowed for costs not covered by the public plan.
• Pan-Canadian Option: Expands the public payer role to cover the uninsured (20%), with a new public plan as the default.
• Existing public plans or private plans can be maintained, but those with private plans aren't covered by the public plan.
• Limited switching, incentives to opt-out, possible tax refunds for private insurance users, and perceived quality differences exist.

Potential Issues with Different Models

• Cream-skimming may concentrate sick and poor in public plans, raising taxpayer costs.
• P.E.I’s generic drug program caps OOP costs, reimbursing the rest for uninsured residents under 65, but only for generics.
• Private Insurance Model: Uninsured receive coverage under a compulsory setup, via private plans for those who don't have coverage.
• Reduces risk of cream skimming and lowers cost through competition among private insurers. It increases access to insurance, but lowers access to drugs from high private costs.
• Quebec has had this system since 1997 with required private insurance for those not covered publicly.

Considerations for Different Stakeholders

• Status Quo: Ensures Canadians are insured against extreme financial risks, with the government providing catastrophic coverage, and varies province to province.
• There is minimal impact on the current system with incremental costs to public funders.
• High out-of-pocket costs mean tax on the sick and the burden falls disproportionately on the poor.

Past Attempts to Expand Drug Coverage

• 1964 & 1997: Universal drug insurance plan was recommended.
• 2002: Catastrophic coverage was recommended as a first step to universal coverage.
• 2004: Catastrophic coverage and a national formulary was recommended as a first step to universal coverage.
• A national formulary defines what is medically necessary.

Standing Committee on Health Recommendations (2018)

• Recommended amending the Canada Health Act to include drugs prescribed by licensed practitioners.
• Additional funding to provinces and territories to support including prescription drugs as an insured service.

Advisory Council on National Pharmacare (2018) Federal Budget

• An independent advisory group with a mandate to determine how to implement pharmacare.
• It wasn't a priority item and was avoided due to political concerns.

A Prescription for Canada: Achieving Pharmacare For All (2018)

• A public system should be set up federally with provincial and territorial governments, and include single payer drug coverage in Canada
• Consistent with the full Medicare model.
• All Canadian residents should be eligible.
• Pocket costs for national formulary products shouldn't exceed $5 per prescription, with a $2 co-pay for essential medicines yearly, not exceeding $100 yearly.
• This violates the Medicare model: Escalation in government decisions is a concern.
• People on social assistance, government disability benefits, and federal Guaranteed Income Supplement Benefit should be exempt from co-payments.
• Drops universality and accessibility.

Limited Progress Since June 2019

• "Status Quo" means governments maintain the current system.
• Opponents: Policy advisors that do agree with the methods but share public interest values based on government orientation.
• Allies: Physicians that struggle with the duty of the patient vs duty to society, based on self-interest.
• Scholars of Health Policy: They see the data and are advocates for pharmacare.
• Adversaries: Chain pharmacies depend both on how they are going to benefit and the priorities of the owners.
• The Public: Has conflicting interests between wanting better for everyone else but not wanting to impact benefits, based on the wealth determines where you stand.

Canada's healthcare system requires changes

• There is Inconsistent and incomplete drug coverage across Canada due to public and private insurance
• Due to the patchwork system of healthcare, the higher system and patient costs, reduced administration efficiency, and greater social inequity is resulting
• People moving from hospital can result in both confusion and delays on the drug coverage and once they're discharged.

Efforts and Priorities for Healthcare Reform

• Health system reforms have focused on chronic disease management, system alignment, and hospital to community-based care shift.
• Efforts between 2000/2020 focused on collaboration and research.
• Persistent concerns involve the system's capacity to manage complex health problems, support care coordination, and promote physical integration.
• Healthcare Priorities include Addressing staffing issues beyond hiring, a creation of a national workforce that will put people where they are needed.
• Long wait times lead to disease progression, anxiety, depression, mental health flare-ups, and worsen.
• Distributed justice: first-in, first-out approach to long wait times are complicated because there is different severity, volume, etc
• Standards vary among provinces
• Government is more of a supplement rather than they replace care given by the caregivers

Canadian Long-Term Care Issues

• LTC relies on family for range of care.
• Fertility rates, smaller families, and dispersed family members decrease the availability of unpaid workers.
• Nursing home goals are very different than goals for acute care
• homes aren't staffed/structured to improve or maintain functional status of residents

Key Points about Long-Term Care Residents

• High risk of falls, incontinence, pressure injuries, and pneumonia.
• Staffing: few registered/licensed nurses with direct care handled by unregulated aids.
• High risk of burnout due to exploitation.
• Total spending includes a major amount by private providers in care homes in various provinces
• Public ownership of care homes is found specifically in a few Canadian provinces

Areas for improvement

• Development of interprofessional teams and there are no national strategies
• A bilaterial government structure in Canada does not allow the historic "per-fee" service
• Canada has not enough resources compared to acute care services where there is partial public funding
• Inequalitiy to mental health leads to decreased care for minority groups

Community-Based Primary Health Care (CBPHC)

• Provides holistic, spiritual, and integrative healthcare, acknowledges historical trauma, recognition, and and respect
• Challenges arise because HCP's are trained only in what is westernized
• Destigmatize traditional healing, address history of shame, and address incrae trust

Key to Enablers on CBPHC

• Lack of education in those within the system so they are not proactive
• Attitudes of healthcare: those who have to shift to increase funding has colonization
• Knowledge share should take place

Managing the High Cost of Prescription Drugs

• This is an increasingly important issue.
• Costs have continued to steadily increase since the 1980s.
• Drug costs are not based on the cost to develop the drug
• Provincial drug plans and hospitals are responsible for costs.

Free Market

• Products are produced and consumed efficiently under a system of perfect competition.
• Erosion of the market has resulted in failure
• Some have increased it to 750% depending on the market
• Some high cost medications cause side effects

Factors Contributing to Higher Prescription Drug Costs

• High-cost medications include biologics like TNF-alpha inhibitors and new cancer therapies.
• More patients use to drug resulting the patent cliff
• Growing burden of disease that results in a growing trend towards the drug

Policies Related to Prescription Drug Costs

• High prices leads to the change in listed price.
• Provinces began to mandate switching to biosimilars
• By dropping outliers such as United States and Switzerland, the new list is becoming more closer to Canada's market

Actions to Address Drug Costs

• Provinces are beginning to switching to biosimilars that helps costs, possible unethical issues could arise
• Lowering the cost of drugs, changing pricing lists, and lowering prices on certain drugs
• These ideas were abandoned and will probably lead to further solutions

Formulary Decision Pathway

• All drugs are monitored by health canada and other ministries of health
• Once there the drug is unavailable until it becomes is added
• It is evaluated on clinical value ,cost implications, ad there are numerous amount of people it affect

The CD Pathway

• Process requires increase in trust but decreases the weight
• There becomes is less efficiency but the results from reduced can benefit different expertise in the end

Price Negotiation

• A goal is to achieve more for for cheaper drugs in the process and the goal is to have more value for the the patient.
• There becomes more success in lowering the cost and with this, the time it will save the negotiate will only benefit those with provincial formularies
• To follow it there is a need for greater support and it lacks guidelines

Drug Regulation

• Drugs go to manufacturers but must negotiate with numerous amount
• As a result the PCPA has lower quality and more restrictions
• To improve it there is a need more cost effect but it takes longer to list various products
• Concerns: This may end up incentivizing companies to provide less value for their money

Drug Safety and Analysis

• It allows CDR to have an analyzed drug amount of six month
• May worry with increased cost it will cost patient

Post-market study concerns

• If drugs that are not meeting the condition will not disclosure whether the license has been suspended

Conclusion on Healthcare Management and Drug Regulations

• Current strategies to secure quicker market access require implicit acceptance of greater risk regarding safety and efficacy.
• Adaptive licensing: Allows iterative phases of evidence gathering to reduce uncertainties and license adaption.
• Seeks to balance timely access and adequate information on benefits and better-informed patient-care decisions.

Drug Side Effects Report and Regulation

• Health can needs to continue to analyze any report and it needs to be independent of the manufacturers because it is not reflective on the healthcare

Overrall

• Has less restrictions but needs to be funded more in the future and it goes a long way of improving healthcare
• Clientele Pluralism: Health Canada is required regulate drugs

Improvements to drug safety

• Can improve safety to allow more ability to make more decisions

The primary goal is ensuring access to prescription drugs for all Canadians. Appropriateness is vital for pharmaceutical governance to support coordinated healthcare. Drugs should be licensed only when proven safe.