Powering Up Patient Support Program Data
April 17, 2023
To create meaningful data from patient support programs, Dr. Aastha Dolley needed the right partnerships, efficient review and approval processes, and robust predictive analytics.
Dr. Aastha Dolley, Senior Director, Medical at Taiho Canada, first saw the opportunity of patient support program (PSP) data over a decade ago. Three peer-reviewed publications later (and counting), Dr. Dolley shares what led to her team’s success, and the barriers and opportunities in harnessing PSP data to improve patient care.
How did you come to view PSP data as a potential source of actionable real-world evidence (RWE)?
I started looking at how patient support programs could help generate data that would not only be helpful to health care providers, but would also address local reimbursement and publication needs, which would ultimately impact clinical research in Canada. I spoke about this concept with Dr. Winson Cheung, a professor of medicine at the University of Calgary and principal director at Oncology Outcomes. With his guidance, we first published an article using PSP data in 2018 in Current Oncology, on duration of therapy and dose reductions in metastatic colorectal cancer patients. This paper was very well received. Since then, we’ve published two more papers in the journal, one on quality-of-life data for metastatic colorectal cancer patients and the other on understanding metastatic gastric/gastroesophageal cancer treatment outcomes in a real-world setting.
What endpoints did you measure with PSP data for these studies?
My PSP data journey began with analysis of readily available data. At first, we focused on treatment duration and reasons for discontinuation – the data available at the time. We also gathered data on dose delay, to understand if there was a specific group of patients who were more likely to have delays in receiving their next dose. We then progressed to using data to predict which patients might respond better to a particular therapy, and most recently to generating overall survival and progression-free survival data in a real-world setting.
In 2019, we decided to look at quality-of-life and overall survival data, because we knew these datasets would be valuable to the research community. I met with Dr. Cheung and asked if he could estimate these endpoints with predictive modelling, based on data extrapolated from the PSP. The answer was yes: Dr. Cheung was able to match data from US and European clinical trial programs to real-world PSP data. That’s how, in our most recent publication, we were able to take the revolutionary step of including predicted overall survival and progression-free survival data.
Has anything changed in the operational set-up of the PSP, now that you know you are using it to collect data?
The data components have largely remained the same, but we have become extremely selective in what we include in our data collection plans, to ensure we get all the information we need to conduct robust research. We have also made it easier to for physicians to fill out the patient enrolment form by replacing some open-ended questions with checklists.
“We are extremely selective in what we include in our PSP data collection plans, to ensure we get all the information we need to conduct robust research.”
We’re currently working on a fourth manuscript involving PSP data. This time, we requested that physicians complete a reenrolment form at six months, to ensure continued access for patients that responded well to therapy. Approximately two-thirds of the enrolled physicians sent us back completed forms, which gave us an appropriate study sample size. As a result, our upcoming manuscript has more robust baseline and 6-month-post-treatment data, along with progression-free and overall survival data.
Did the studies meet their goals?
Yes, especially in the big-picture sense. We wanted to help grow the clinical research footprint in Canada and to contribute to the conversation about when and how to use PSP data to support decision making, and I think we’ve achieved that. In one of the studies, we wanted to generate evidence that would help us understand the nuances between a clinical trial program and real-world data, and give physicians a snapshot of what is actually happening in Canada. The study gave us some new insights, and some of the data that we included in our paper had never been published before.
Do you think PSP data should be accepted as RWE for healthcare decision making with, for example, HTA bodies?
Yes, I do. PSPs can provide such a wealth of information, it’s a shame not to use them in this way. One current problem is that, while HTAs will consider RWE data in resubmissions, they use the same criteria to evaluate the robustness of RWE data as they do for clinical trial data. I think HTAs need to be more open to indirect comparisons, because it’s often not possible to do an RWE study with a comparator arm.
What are the largest advances in the use of PSP data for evidence generation in recent years?
PSP data has the potential to help predict outcomes and quality of life parameters. That’s powerful information! For example, PSP datasets can give predictive insights into treatment outcomes for subsets of cancer patients in the real world compared to clinical trials. We now have predictive analytic tools that were not available even five years ago, with even more opportunities to mine the data using AI technology.
“PSP data has the potential to help predict outcomes and quality of life parameters – that’s powerful information.”
What are some critical factors in the successful use of PSP data?
It’s crucial to develop the PSP enrolment form with an eye to obtaining high-quality data. Success also depends on partnerships with researchers and PSP vendors. In Taiho’s case, Bayshore Specialty Rx, our patient support program provider, has been critical to ensuring the data we collect is accurate and complete. Dr. Cheung and the team at Oncology Outcomes, who run the data analytics part of the program, have raised the bar for PSP research.
Will you continue to use PSP data to support additional evidence generation?
In anticipation of the additional indications we’ll be launching, we are prepping our PSP programs to collect even more and better data. The real-world Canadian evidence we can generate from our PSPs is a rich vein of information that, used judiciously, helps us improve care for Canadian patients.
Real-world use of trifluridine/tipiracil for patients with metastatic colorectal cancer in Canada
Samawi, H.H. et al. (2019). Current Oncology.
Quality of life in a real-world study of patients with metastatic colorectal cancer treated with trifluridine/tipiracil
Cheung, W. Kavan, P. and Dolley, A. (2020). Current Oncology.
Trifluridine/Tipiracil in the Real-World Management of Metastatic Gastric and Gastroesophageal Junction Cancers in Canada
Ding, P., Dolley, A. and Cheung, W. (2022). Current Oncology