Patient Support Programs Need Transparency, Researchers Say

Greater transparency and independent evaluation are needed to understand the impact of the patient support programs that pharmaceutical companies offer for many expensive drugs, according to researchers.

A comprehensive review of prescription medicines sold in Canada found that about 10%, or 256 of 2556 drugs, had patient support programs. These offerings were tilted heavily toward more expensive medicines. Although about 10% of drugs on the market are biologics, they represent more than half of drugs that have a patient support program.

Quinn Grundy, PhD, RN

This research should serve as “the first step” to allow further research into how well these programs serve patients, study author Quinn Grundy, PhD, RN, assistant professor of nursing at the University of Toronto, told Medscape Medical News. Neither patients nor insurers pay for patient support programs, meaning that the costs of the medicine likely cover this expense, the authors wrote.

“We need to really be able to assess whether we are getting value for money. Do these programs address health needs? If so, which supports are most cost-effective?” said Grundy.

The study was published online November 27 in the Canadian Medical Association Journal.

Costly Drugs Dominate

To examine the extent and nature of patient support programs, the researchers conducted a cross-sectional study. They identified and characterized all prescription drugs available in Canada as of August 23, 2022, using the Health Canada Drug Product and CompuScript databases.

They next searched public data for patient support programs, which they defined as services related to medication access, administration, adherence, education, storage, or disposal. They conducted a structured content analysis of web-based sources to understand what types and range of patient support programs have been offered.

The authors drew a distinction between patient support programs and patient assistance programs. They excluded the latter because they exclusively provide financial assistance such as coupons and co-pay coverage and lack other forms of support. Also excluded were programs delivered solely for a clinical study, expanded access or compassionate access programs, and risk-management programs that were required by regulators.

The researchers performed logistic regression analyses to assess the relationship between having a patient support program and a drug’s characteristics.

Of the 2214 drugs dispensed through retail pharmacies, 1632 (74%) cost $10 per unit or less, while drugs with a patient support program had a median price per unit of $208.40.

Compared with drugs with unit prices from $1.01 to $10, drugs priced from $10.01 to $100 were 8 times more likely to have a patient support program. Drugs costing $100.01 or greater per unit were 11 times more likely to have a patient support program.

Common features of patient support programs included financial assistance or reimbursement navigation (90.2%) and clinical case management provided by a nurse (87.1%).

Proprietary Data

The researchers acknowledged that their attempt at a broad look at the field was limited by the predominance of proprietary data. They had to focus on information that pharmaceutical companies have made public about their programs.

“The study relied on publicly available documents; since we did not verify this information with companies, we may have missed some supports offered by a patient support program or incorrectly classified a program as a patient assistance program if we found evidence of only financial supports,” they write.

The researchers also lacked information about the sometimes substantial discounts that manufacturers provide to insurers and customers, since these agreements are secret. “However, our findings encompass the entirety of purchases within the drug system, and total spending is still a good approximation of the market size; we anticipate that drugs that were categorized as high cost or having large market sizes would still fall into the same categories if all rebates were considered,” they write.

“An Important Foundation”

Commenting on the study for Medscape, David Renwick, interim president of the trade group Innovative Medicines Canada, said that Canadian patients, particularly those living with rare diseases or difficult-to-treat conditions, face significant barriers in accessing new approved treatments.

“Patient support programs offer immense value to patients and the broader healthcare system by supporting timely access to therapies and improving adherence,” said Renwick. “These programs provide patients with support and faster access to cutting-edge treatments that can improve, or even save, their lives.”

“I think that the methods in the paper are excellent and probably as good as one can get with these programs at this point in time,” said Michael Law, PhD, Canada Research Chair in Access to Medicines at the University of British Columbia in Vancouver. Law did not participate in the research.

“Knowing who is getting these services and who is not is critical to consider how accessible and universal this critical part of our healthcare system is,” he continued. “This paper makes it clear that some people might be getting concierge services, while others don’t, and it all depends on what drug they’re taking. We’re all paying for these programs through public drug programs and our workplace drug plans, so I think it’s critical we understand what we’re spending money on.”

The support programs tied to costly medicines are an example of drugmakers “worming their way into patient care to the detriment of medical care and public coffers,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University Medical Center in Washington, DC. She also is director of Georgetown’s PharmedOut project, which seeks to advance evidence-based prescribing. She did not participate in the research.

The current findings should encourage more scrutiny of these programs, Fugh-Berman added. “Documenting that it is the expensive drugs that beget ‘patient support’ programs is an important foundation for advocating for change on this issue.”

The Bertha Rosenstadt Research Fund, Lawrence S. Bloomberg Faculty of Nursing at the University of Toronto and the Social Sciences and Humanities Research Council supported this study. The IQVIA data were purchased using funding from the Canadian Institutes of Health Research (CIHR). Co-author Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co.

Co-author Marc-André Gagnon reported research funding from the Social Sciences and Humanities Research Council, CIHR, and the Faculty of Public Affairs at Carleton University. Co-author Mina Tadrous reports research funding from the Ontario Ministry of Health and CIHR, as well as consulting fees from the Canadian Agency for Drugs and Technologies in Health, Health Canada, and Green Shield Canada.

Fugh-Berman has been a paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical marketing practices. Law has done expert witness work for labor unions and consulting for Health Canada and Canadian Agency for Drugs and Technologies in Health unrelated to this topic.

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