Co-payments to improve access to unfunded vaccines at community pharmacies

Addressing the Problem of Recommended But Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies

This pilot will test whether offering a co-payment option at selected community pharmacies increases uptake of recommended but publicly unfunded vaccines for people in Nova Scotia and Ontario.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Canadian Immunization Research Network (Research network)
• Locations: 2 sites (Halifax, Nova Scotia and 1 other locations)
• Trial ID: NCT06489964 on ClinicalTrials.gov

What this trial studies

This pilot demonstration will implement a co-payment model across up to eight community pharmacy sites (four in Nova Scotia and four in Ontario) to determine feasibility and acceptability among pharmacy staff and the public. Each pharmacy will be randomly assigned to pilot one of four steps of the co-payment model for the duration of the project, and uptake and implementation experiences will be tracked. The study will collect quantitative uptake data and qualitative feedback from pharmacists and patients to understand barriers, facilitators, and real-world workflow impacts. Findings will inform whether a co-payment approach in community pharmacies could be scaled or modified for broader use.

Who should consider this trial

Good fit: People in Nova Scotia or Ontario who are eligible for NACI-recommended vaccines that are not publicly funded and who regularly use one of the participating community pharmacies are ideal candidates.

Not a fit: People who live outside the study areas, who do not use the participating pharmacies, or who cannot afford any required co-payment are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, the model could increase access to recommended vaccines that are not publicly funded and reduce cost-related barriers to vaccination.

How similar studies have performed: Prior research shows cost is a common barrier and that reducing out-of-pocket cost can raise uptake, but piloting a structured co-payment mechanism in Canadian community pharmacies is a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

* Community Pharmacy Sites: Inclusion criteria for the selection of the community pharmacies will include volume of prescriptions (e.g., how busy the site it), stable pharmacy patients (e.g., patients who consistently use the same pharmacy), availability and interest of community pharmacies and community pharmacy professionals, sufficient numbers of pharmacy professionals qualified to provide vaccinations, and lack of substantial health care spill over to adjacent communities. Spill over is defined as a pattern of health-care utilization where the public regularly receive care at different regional health centres. Communities will be geographically separated to minimize potential spill over. Based on this inclusion criteria, one pharmacy from the four health zones in Nova Scotia will be selected to implement the co-payment model within their community pharmacy, while a mix of urban and rural pharmacies in Ontario will be selected to implement the co-payment model.
* Members of the Public: The participating pilot pharmacies will recruit through targeted screening members of the public who meet the vaccine-specific eligibility criteria or their substitute decision-makers for those who lack capacity to consent. Any members of the public or the substitute decision-maker who consents to participate will be eligible until the maximum number of participants we aim to recruit has been achieved. Eligible members of the public will receive the vaccines based on NACI recommendations for each product as part of routine care.
* Recommended but Unfunded Vaccines: FluMist Quadrivalent: An age-appropriate quadrivalent influenza should be used in children (2 to 17 years) without contraindications or precautions; Shingrix Vaccine: Adults 50 to 64 years of age in Nova Scotia or 50 years of age or older in Ontario without contraindications or adults 18 years of age or older if immunocompromised; and Abrysvo or Arexvy (RSV) vaccine: Adults 50 years of age or older (Arexvy) or 60 years of age and older (Abrysvo) who are at increased risk of severe RSV disease. Note: The eligibility criteria for each vaccine product may be revised during the pilot study if there are any changes in vaccine recommendations and/or funding status in Nova Scotia or Ontario.

Exclusion Criteria:

* FluMist Quadrivalent: should not be used in children or adolescents for whom it is contraindicated or for whom there are warnings and precautions; should not be used in children or adolescents already adequately immunized against influenza; not recommended for pregnant individuals, health care workers, and adult 18 to 59 years old with specific chronic health conditions; adults 60 to 64 and 65 years and old, as this vaccine is not authorized for use in these age groups; pediatric children (2 to 17 years) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the FluMist vaccine will be excluded from taking part in this study.
* Shingrix: Persons with active herpes zoster (HZ) should not be immunized with HZ vaccine; should not be used in individuals already adequately immunized against HZ; adults 65 years of age or older in Nova Scotia, as this vaccine is publicly funded for this age group; adults 65 to 70 years of age in Ontario, as this vaccine is publicly funded for this age group; and adults (50 to 64 years old in Nova Scotia and 50 years of age or older in Ontario) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the Shingrix vaccine will be excluded from taking part in this study.
* Abrysvo or Arexvy (RSV): Persons under the age 50 years should not be immunized with RSV vaccine (exception is use of Abrysvo in pregnancy), as it is not authorized for use in this age group; should not be used in individuals already adequately immunized against RSV; adults 60 years and older in Nova Scotia living in long-term care facilities or in hospital awaiting long-term care placement, as this vaccine is publicly funded for this age group; high-risk older adults (aged 60 years and older) in Ontario (e.g., residents of long-term care homes, Elder Care Lodges, or retirement homes; patients in hospital receiving alternate level of care; patients receiving hemodialysis or peritoneal dialysis; recipients of solid organ or hematopoietic stem cell transplants; individuals experiencing homelessness; and individuals who identify as First Nations, Inuit, or Métis); and adults (≥ 50 years of age (AREXVY) or 60 years of age (Abrysvo) at increased risk of severe RSV disease) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the RSV vaccine will be excluded from taking part in this study.

Where this trial is running

Halifax, Nova Scotia and 1 other locations

• Dalhousie University — Halifax, Nova Scotia, Canada (Recruiting)
• University of Waterloo — Kitchener, Ontario, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Emily Black, PharmD — Dalhousie University
• Study coordinator: Melissa Kervin, MA

Conditions Preventable Disease, Vaccine