Mind the Gaps – and Close Them!
January 23, 2025
Patient support programs are closing gaps by generating real-world data and helping patients get the care they need
PSPs have distinct benefits as a source of real-world data (RWD) and real-world evidence (RWE). As explained by Belinda Yap, Director of Health Economics & Outcomes Research at Innomar Strategies, “PSPs give us an opportunity to collect comprehensive data with pan-Canadian representation, particularly in the rare diseases and specialty medications. Essentially, the RWD collected through PSPs can serve as a standalone registry for Canadian patients on a particular treatment.”12
Canada’s Drug Agency (CDA-AMC) has several projects underway to guide patient registries to set up their data collection so that the resulting RWD/RWE can inform healthcare decision-making.13-16 “Our efforts focus on helping data holders, including patient support programs, assess the quality of their data and identify opportunities for quality improvement,” says Dr. Patricia Caetano, Director of Drug Data Services and Analytics at CDA-AMC. “One of our goals is to help generate fit-for-purpose data that may be suitable to inform policy decisions on drugs for rare diseases in support of the National Strategy on Drugs for Rare Diseases. By developing real-world data appraisal processes, there is greater potential to use this data in our health technology reviews.”
Through its Post-Market Drug Evaluation (PMDE) Program, which helps to answer questions about post-market drug safety and effectiveness, CDA-AMC also hopes to explore the potential of real-world data to help answer research questions. “Depending on the question we’re being asked, data from patient support programs can be part of the evidence we look at,” says Nadine Sulatycky, Manager of PDME for CDA-AMC.”14
In an ongoing effort to prepare industry-sponsored RWE for prime time, the agency recently convened an Industry Task Force to provide guidance on maximizing the reliability and rele-vance of various data sets, including data from PSPs. A key recommendation in the Task Force report: keep patient privacy and consent at the forefront, particularly as data become more widely shared for processes like post-market evaluation.15 Specifically, the report recommends strengthening the informed consent process to ensure patients are fully aware of the benefits and risks of PSP enrolment and the contribution of the PSP to generating RWE.15 (There’s clearly room for improvement in this regard: in a Canadian Arthritis Patient Alliance survey, only 64% of patients said they had received an informed consent form before enrolling in a PSP, and only 57% said they actually understood the form.3)
GOING THE EXTRA MILE FOR PATIENTS
While working to ease the administrative burden and fill data gaps, some PSP providers are also pursuing innovations that put the focus back on the stakeholder at the heart of the PSP: the patient. The initiatives listed below are leading the charge.
Filling the gaps for patients “ageing out” of pediatric care: All children with a serious medical condition – and their families – face a looming challenge: the day they “age out” of their pediatric status and need to transition to adult care. This can mean moving to a new healthcare team, losing previous sources of funding, or having fewer resources and programs available to them. PSP provider NavieGo is working on initiatives to keep patients from slipping through the cracks during this transition. During the last year of a patient’s “pediatric life,” they help patients and families take stock of their existing support network and develop a plan for finding equivalent resources within adult healthcare. “This planned approach can prevent their health outcomes from deteriorating,” notes Kelly Isaacs, Vice President of Patient Programs at NavieGo.
Raising the bar for community oncology infusion clinics: Infusion clinics are fundamental to oncology care in this country, but resource limitations can significantly lengthen the wait to infusion treatment – anywhere from two weeks to over a month, depending on the region of Canada and type of cancer, according to one study.17 Privately run community infusion clinics can fill this gap in some therapeutic areas, and there’s evidence they can shorten the delay to treatment.17
On the downside, the pathway for routing patient data collected at these clinics back to the overseeing cancer centres is not well established. That’s why the Princess Margaret Cancer Centre is working with McKesson Canada to implement best practices and provide more seamless care for patients who receive infusions at McKesson’s network of community-based clinics. The hospital has inspected and accredited McKesson’s clinics and pharmacy, and the two organizations are continuing to collaborate on quality standards and best practices for information sharing.18
Sharing oncology pharmacy expertise with more patients: Pharmacists with specialized experience in oncology have the capacity to counsel cancer patients about all the complexities of their treatment. However, such pharmacists can be difficult to access outside of cancer centres and aren’t always able to provide ongoing care. To bring patients within more consistent reach of this rich expertise, some PSP providers are integrating oncology pharmacists into their oncology PSPs. For example, in Sentrex’s HAVEN Oncology PSP, cancer-centre-trained oncology pharmacists serve as patients’ main point of contact for remote consultations about issues like side effect management, treatment expectations, drug interactions, and other aspects of their medications. They also help with follow-up and coordinate communication among different members of the patient’s healthcare team, an especially valuable service in the case of drug interactions. In one case described in a recent poster, the PSP oncology pharmacists identified an interaction between two of a patient’s non-cancer medications that was causing low blood pressure, blackouts, and falls, and worked with the patient’s oncologist and family physician to adjust the medications and resolve the issue.19
Bringing it all together: When PSPs encounter an extraordinary patient scenario, they need the flexibility to roll with the situation. A case in point: an infant was referred to the Bayshore Specialty Rx program at the age of just 18 days. “I reviewed the enrolment form multiple times to confirm the birth date!” program manager Caroline Aubin recalls. “This patient was a baby with a serious illness. I couldn’t imagine the stress and anxiety the parents must have felt.” The PSP team had to coordinate across multiple teams and roles, including pharmacy staff and the pharmaceutical manufacturer, to execute every step of the baby’s care – from getting him on the medication to following up and resolving issues that came up along the way. After one year of treatment, the baby was tumour-free. “Witnessing the progress and ultimately receiving the good news brought tears of joy,” said Caroline. “We cried, we clapped, and we are hopeful for his future!”20
A reading list for PSP real-world data and evidence best practices
1. Canada’s Drug Agency’s Industry Task Force Summary Report: A synopsis of the Task Force’s formal advice to the Post-Market Drug Evaluation (PMDE) program about operationalizing, accessing, and using PSP data and other industry-sponsored RWE.
2. Data collection within patient support programs in Canada and implications for real-world evidence generation: An expert perspective on collecting data through Canadian PSPs and how to generate acceptable RWE.
3. A big leap in prescription drug promotion in Canada: A summary of how PAAB’s rules are evolving toward easier use of RWD/RWE from PSPs and market research.
4. PSP Real-World Readiness Framework Whitepaper: An initiative to develop a practical framework for healthcare system stakeholders to use when assessing reliability and relevance of PSP data.
References
3. Canadian Arthritis Patient Alliance. Webinar on Patient Support Programs Survey Results. https://www.youtube.com/watch?v=tSwDH_DUYS4
12. Innomar Strategies. Patient support programs: A significant source of real-world data. https://www.innomar-strategies.com/insights/patient-support-programs-a-significant-source-of-real-world-data
13. IQVIA. Panel session: Maximizing the Impact of Patient Registries in Rare Disease. Presentation at the Canadian Association for Population Therapeutics Conference, October 22 2024. Toronto, Canada. Minute 40:20 https://www.youtube.com/watch?v=PBwpHMyZiVY
14. CDA-AMC. Panel Session: A New Era of Innovation and Collaboration in PMDE. Presentation at CDA-AMC Symposium, September 4–6 2024. Ottawa, Canada.
15. CDA-AMC. Industry Task Force Summary Report. https://www.cda-amc.ca/sites/default/files/PDME/Industry_Task_Force_Summary_Report.pdf
16. CDA-AMC. Guidance for reporting real-world evidence. https://www.cda-amc.ca/guidance-reporting-real-world-evidence
17. Batist G, et al. Time-To-Treatment Initiation (TTI) In Community Infusion Clinics: Decreasing Wait Times For Canadian Oncology Patients. Available at: https://www.ispor.org/heor-resources/presentations-database/presentation/intl2020-3182/102051
18. University Health Network. Princess Margaret Cancer Centre and McKesson Canada partner to elevate best practices for cancer treatment in community infusion clinics. Available at: https://www.uhn.ca/corporate/News/PressReleases/Pages/Princess-Margaret-Cancer-Centre-and-McKesson-Canada-partner.aspx
19. Birch A, et al. Implementation of a remote Oncology Pharmacist in an Oncology Patient Support Program setting. Journal of Oncology Pharmacy Practice 2024; 30:2S (supplement).
20. Bayshore Healthcare. Life-saving Treatment: An infant’s journey with Bayshore Specialty Rx. Available at: https://www.bayshore.ca/2024/03/12/life-saving-treatment-an-infants-journey-with-bayshore-specialty-rx/