Co-payment Model for Vaccine-Preventable Diseases

Overseen By Emily Black, PharmD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Immunization Research Network

Disqualifiers: Private insurance coverage

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on vaccine accessibility and cost, so it's unlikely that your current medications would be affected.

What data supports the effectiveness of the Transitional Stepped Co-payment Model treatment?

Research suggests that reducing co-payments for valuable treatments can improve patient compliance and outcomes, potentially lowering long-term healthcare costs. This indicates that a co-payment model, like the Transitional Stepped Co-payment Model, could be effective in encouraging the use of preventive measures such as vaccines. ^{1 2 3 4 5}

Is the co-payment model for vaccine-preventable diseases safe for humans?

The safety of vaccines is monitored through systems like the Vaccine Adverse Event Reporting System (VAERS) and post-authorisation safety studies (PASS), which track and evaluate any adverse events after vaccination. These systems help ensure that vaccines are safe for public use by identifying and managing any potential risks. ^{6 7 8 9 10}

How does the co-payment model for vaccine-preventable diseases differ from other treatments?

The co-payment model for vaccine-preventable diseases is unique because it focuses on reducing the financial burden on patients by reforming payment methods, such as increasing reimbursement rates and implementing case-based payments, rather than altering the medical treatment itself. This approach aims to make healthcare more affordable and accessible, especially for low-income groups, by addressing the economic barriers to accessing vaccines. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this pilot demonstration and evaluation project is to increase the accessibility and uptake of recommended immunizations in the general public by implementing a transitional stepped co-payment model in community pharmacies in Nova Scotia and Ontario for the delivery of recommended but unfunded vaccines until full public funding is available. The main question it aims to answer is: * Can a transitional stepped co-payment model through pharmacies for the delivery of recommended but unfunded vaccines (e.g., Shingrix, FluMist) increase the accessibility and uptake of recommended immunizations among various stakeholders until full public funding is available? Participants will: * Receive a reduced cost of the vaccine (if eligible) through this transitional stepped co-payment funding model, as part of routine care (following standard pharmacy practice). * Complete a feedback and satisfaction survey exploring their thoughts on the transitional stepped co-payment model, their satisfaction with the co-payment model, their perception on vaccinations in general and specifically about recommended but unfunded vaccines, and their demographics (such as gender, age, education, race/ethnicity).

Research Team

Emily Black, PharmD

Principal Investigator

Dalhousie University

Eligibility Criteria

This trial is for the general public in Nova Scotia and Ontario who are interested in receiving recommended but unfunded vaccines at a reduced cost. Participants will be involved in routine care and provide feedback on their experience with the co-payment model.

Inclusion Criteria

Selection of community pharmacies based on population size, stable pharmacy patients, availability and interest of community pharmacies and professionals, sufficient numbers of qualified pharmacy professionals for vaccinations, lack of substantial health care spill over to adjacent communities

Geographically separated communities to minimize health care spill over

Recruitment of pharmacies in different locations around the province(s) ensuring comparable socioeconomic status and separation to reduce shopping around

Exclusion Criteria

Patients with private insurance coverage for the vaccine at participating pharmacies in Nova Scotia and Ontario

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a transitional stepped co-payment funding model within community pharmacies in Nova Scotia and Ontario

6 months

Ongoing visits to participating pharmacies

Evaluation

Participants complete surveys to evaluate the acceptability and feasibility of the co-payment model

6 months

Follow-up

Participants are monitored for vaccine uptake and satisfaction with the co-payment model

30 months

Treatment Details

Interventions

• Transitional Stepped Co-payment Model

Trial Overview The study tests a transitional stepped co-payment model where participants pay less for certain vaccines like Shingrix and FluMist at pharmacies. The aim is to see if this approach boosts vaccine uptake before these immunizations receive full public funding.

Participant Groups

Group I: Community Pharmacy Sites (Step 4) Experimental Treatment 1 Intervention

A pharmacy site in Nova Scotia and Ontario will be assigned to pilot Step 4 of the transitional co-payment model for the duration of the pilot study.

Group II: Community Pharmacy Sites (Step 3) Experimental Treatment 1 Intervention

A pharmacy site in Nova Scotia and Ontario will be assigned to pilot Step 3 of the transitional co-payment model for the duration of the pilot study.

Group III: Community Pharmacy Sites (Step 2) Experimental Treatment 1 Intervention

A pharmacy site in Nova Scotia and Ontario will be assigned to pilot Step 2 of the transitional co-payment model for the duration of the pilot study.

Group IV: Community Pharmacy Sites (Step 1) Experimental Treatment 1 Intervention

A pharmacy site in Nova Scotia and Ontario will be assigned to pilot Step 1 of the transitional co-payment model for the duration of the pilot study.

Who Is Running the Clinical Trial?

Canadian Immunization Research Network

Lead Sponsor

Trials

12

Recruited

10,600+

Canadian Center for Vaccinology

Collaborator

Trials

12

Recruited

6,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Findings from Research

The Vaccine Adverse Event Reporting System (VAERS) is a crucial safety monitoring system for U.S.-licensed vaccines, co-managed by the CDC and FDA, that collects reports of adverse events following vaccination.

As of June 30, 2017, VAERS has improved its reporting process by introducing an online tool (VAERS 2.0) that allows individuals to submit adverse event reports more easily, enhancing the efficiency of vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Announcement: Implementation of the Vaccine Adverse Event Reporting System 2.0 Reporting Form. [2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of co-pay assistance on patient, clinical, and economic outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The lessons of Medicare's prospective payment system show that the bundled payment program faces challenges. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Vaccination versus "wait and treat": how to subsidize them? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Payment incentives and integrated care delivery: levers for health system reform and cost containment. [2022]

5. Israel pubmed.ncbi.nlm.nih.gov

[Can linking co-payment for drugs to evidence on treatment value improve health outcomes and contain healthcare costs?]. [2011]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Surveillance and compensation claims for adverse events following immunization from 2011 to 2016 in the Republic of Korea. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Facts About Vaccine Safety. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

ADVANCE system testing: Can coverage of pertussis vaccination be estimated in European countries using electronic healthcare databases: An example. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Announcement: Implementation of the Vaccine Adverse Event Reporting System 2.0 Reporting Form. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of the capitation compensation mechanism among pulmonary tuberculosis patients with a full period of treatment. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Impact of an innovative financing and payment model on tuberculosis patients' financial burden: is tuberculosis care more affordable for the poor? [2020]

13. Germany pubmed.ncbi.nlm.nih.gov

Analysis of multi drug resistant tuberculosis (MDR-TB) financial protection policy: MDR-TB health insurance schemes, in Chhattisgarh state, India. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Multi-source financing for tuberculosis treatment in China: key issues and challenges. [2022]

15. Ireland pubmed.ncbi.nlm.nih.gov

The landscape of community health insurance in India: an overview based on 10 case studies. [2022]