DOI: 10.5683/sp3/lycqur
title: Number and characteristics of marketed prescription drugs with patient support programs in Canada 2022

description: Study design
We conducted a cross-sectional study to quantify the number and describe the characteristics of prescription drugs on the Canadian market as of August 23, 2022 with a patient support program defined as services (including but not limited to financial assistance) offered to patients prescribed a specific drug and initiated and funded by the manufacturer. We then conducted a structured content analysis of web-based sources to understand the types and range of supports provided to patients through these programs. We chose to rely exclusively on publicly available data sources to both identify and describe manufacturer-sponsored patient support programs as these are sources currently available to patients when making program enrolment decisions and policymakers seeking to understand the extent and impact of this model of care.

Sampling frame
Because the European Medicines Association defines a patient support program as services for a specific drug offered by the company holding the marketing authorization, we first sought to identify all drug companies with currently marketed, prescription products in Canada. Between June 27, 2022 and August 23, 2022, two investigators independently extracted the names of all member companies listed on the websites of the three main trade associations for the Canadian pharmaceutical industry (Innovative Medicines Canada, representing the research-based pharmaceutical industry; BIOTECanada, representing the biotechnology industry; and the Canadian Generic Pharmaceutical Association, representing generic drug manufacturers). Because trade association membership is voluntary, we supplemented this list with non-member drug manufacturers identified in previous research. Using the Health Canada Drug Product Database,two investigators independently screened the list of companies and included those with marketed, prescription products and excluded companies that were not drug manufacturers (e.g., law firms) or without currently marketed prescription drugs (e.g., products under development). Discrepancies were resolved through discussion or adjudication by a third author.

Sample and variables
Using the Health Canada Drug Product Database, one investigator searched each identified drug manufacturer and extracted the product and active ingredient name(s) for all marketed, prescription drugs. We counted a single “drug” as all dosages, formulations, or routes of administration with the same active ingredients and manufacturer since industry patient support programs are brand-specific and do not typically differentiate among these factors. We selected variables that reflect known characteristics of drugs that may be associated with having a patient support program, and for which data were publicly available. One investigator also extracted Schedule D (biologic) status, route(s) of administration, and Level 1 Anatomical Therapeutic Chemical (ATC) code from the Drug Product Database and Product Monograph and identified whether the drug had Orphan Drug Status using the searchable United States database. On the basis of type of Health Canada regulatory review (i.e. innovator or subsequent entry), clinical expertise, and knowledge about the manufacturer, two investigators independently identified the brand status of each drug as brand (i.e. “innovator” products first to market); branded generic (i.e. “subsequent entry” products which are bioequivalent or biosimilar to an existing product on the market, but given a proprietary name); or generic (i.e. “subsequent entry” products which are bioequivalent to an existing product on the market). We classified biosimilars as branded generics. We resolved discrepancies through discussion, and/or adjudication by a third author.

Identifying patient support programs and their characteristics
Our primary outcome was whether a sampled drug had an associated manufacturer-sponsored patient support program. We defined a patient support program as any combination of services or resources related to medication access, administration, adherence, education, storage, or disposal for patients prescribed a specific product and initiated, sponsored and/or operated by the company holding the product’s marketing authorization. We distinguished patient support programs from “patient assistance programs,” excluding programs that exclusively provided financial assistance (e.g., coupons, co-pay coverage, etc.); expanded or compassionate access programs; risk management programs outlined in the Product Monograph (initiated by the regulator rather than the manufacturer); and programs delivered solely for a clinical study. 

Two investigators independently performed structured searches on Google (“[company name] AND patient support program AND Canada” and “[drug brand name] AND patient support program AND Canada”) to identify industry sponsored patient support programs in Canada and resolving discrepancies through discussion. 
Using Zotero, a reference management software, two investigators independently downloaded and catalogued public-facing web pages and documents that explicitly mentioned the patient support program, the sponsoring company, and the specific drug (e.g., web pages for the program, patient portals and apps, educational materials, press releases, enrolment forms). Coders met to reconcile any discrepancies, with a third author adjudicating as necessary. We excluded web pages directed exclusively at health professionals.

We extracted characteristics of the sampled patient support programs including target population (adult, pediatric, or both), evidence of third-party administration, and the nature of supports offered (including financial assistance, reimbursement navigation, injection training, infusion coordination, education, clinical case management, pharmacy services, and material resources) and extracting relevant details (e.g., modalities, availability and access, clinician involvement). Because the definition of a patient support program continues to evolve within the literature and there are no formal regulations to guide the development of patient support programs, we included the option to select and specify “other” types of supports to ensure comprehensiveness. Coders were prompted to extract, verbatim, illustrative evidence for the presence of a particular type of support. 
 
Because we did not validate these data with drug manufacturers directly, we coded variables dichotomously as having evidence of the existence of particular supports or “no information.” 

To describe the prevalence and nature of supports offered through identified patient support programs, we developed a coding framework through an inductive approach, informed by the literature. As a team, we grouped the types of supports identified into broad categories until all identified supports were classified. We calculated the frequencies of each category and provided illustrative examples.