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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if offering vaccines at a reduced cost through pharmacies can improve access to vaccines not fully funded, such as Shingrix or FluMist. Researchers are conducting the trial in community pharmacies in Nova Scotia and Ontario, testing several payment steps through a Transitional Stepped Co-payment Model to identify the best way to increase vaccine access. Ideal candidates for this trial are individuals seeking these vaccines without private insurance coverage. Participants will pay less for the vaccines and provide feedback on the payment model through a survey. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance vaccine accessibility for everyone.

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 prior data suggests that this transitional stepped co-payment model is safe?

Research has shown that vaccines like Shingrix and FluMist, included in this trial as recommended but not funded vaccines, have undergone thorough safety studies. Shingrix prevents shingles and is generally well-tolerated, though some people might experience mild side effects like soreness at the injection site or a mild fever. Similarly, FluMist, a nasal spray vaccine for the flu, is also well-tolerated, with side effects typically being mild, such as a runny nose or sore throat.

Both vaccines have received approval from health authorities, indicating they are safe and effective for their intended use. The trial is testing a new payment model to increase accessibility to these vaccines, not the vaccines themselves. Therefore, this trial model presents no new safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to make vaccines more affordable and accessible through a transitional stepped co-payment model. Unlike traditional payment methods, which can be a barrier for many, this model aims to reduce out-of-pocket costs by gradually adjusting the co-payment amounts at community pharmacy sites in Nova Scotia and Ontario. By testing different steps of co-payment, the trial seeks to find the most effective way to increase vaccination rates and prevent diseases, potentially changing how vaccines are funded and accessed.

What evidence suggests that this trial's transitional stepped co-payment model could be effective in increasing vaccine accessibility and uptake?

Research has shown that lowering vaccine costs can greatly increase vaccination rates. For instance, vaccinating 50% of at-risk individuals prevented hundreds of illnesses and deaths, saving many years of healthy life. This suggests that more affordable vaccines can protect more people. This trial tests the transitional stepped co-payment model to reduce vaccine costs in pharmacies. By making vaccines cheaper, this model could lead to higher vaccination rates and fewer vaccine-preventable diseases. ^{3 6 7 8 9}

Who Is on the Research Team?

Emily Black, PharmD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5647965/

Cost effectiveness of a practice-based intervention to ... In a probabilistic sensitivity analysis, the intervention was favored in 68.2% of model runs at a $50,000/QALY level and in 94.3% at $100,000/QALY. In a ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/13696998.2021.2002092

Economic evaluation using dynamic transition modeling of ... The results showed vaccinating 50% of the population at risk prevented 670 cases, 538 deaths, and 22,022 disability-adjusted life years (DALYs). The vaccine was ...

3. ajmc.com ajmc.com/view/the-role-of-health-plans-and-employers-in-fostering-vaccine-engagement

The Role of Health Plans and Employers in Fostering ... The National Vaccine Program was established in 2010 to provide broad guidance on decreasing vaccine-preventable diseases through the year 2020.

4. healthpolicy.duke.edu healthpolicy.duke.edu/sites/default/files/2025-03/Evidence%20Generation%20of%20Indirect%20Benefits%20and%20Risks%20for%20Medical%20Products%20Used%20for%20Infectious%20Diseases.pdf

Supporting Evidence Generation of Indirect Benefits and ... Vaccines, therapeutics, and diagnostics. (via their impact on individual actions) provide potential direct benefits to those who receive them by ...

5. cambridge.org cambridge.org/core/services/aop-cambridge-core/content/view/27886D1E905A32EF04A4C9CEA559E119/S2194588823000118a.pdf/sustainable_development_goal_halftime_project_benefitcost_analysis_using_methods_from_the_decade_of_vaccine_economics_model.pdf

Benefit-Cost Analysis Using Methods from the Decade of ... This analysis is focused on the economic benefits and costs of immunization programs in 80 low- and middle-income countries targeted by the Global Vaccine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11639369/

How has co-design been used to address vaccine ... Eligible studies described the co-design process used to develop interventions for addressing vaccine hesitancy and increasing vaccine confidence.

7. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2016.0462

Modeling The Economic Burden Of Adult Vaccine ... The results of this study demonstrate the need for improved uptake of vaccines among adults based on a robust analysis of the societal and individual costs ...

8. mdpi.com mdpi.com/2076-393X/12/9/979

Use of the PRECEDE-PROCEED Model in Piloting ... The primary outcome of the experiment was the COVID-19 vaccination rate, which was calculated by dividing the number of new vaccine doses ...

9. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7331a2.htm

Health and Economic Benefits of Routine Childhood... Among children born during 1994–2023, routine childhood vaccinations will have prevented approximately 508 million cases of illness, 32 million ...