Patient Support Programs are Reaching New Heights
April 17, 2023
For Canadians living with complex diseases, patient support programs (PSPs) meet critical care needs. They also serve as a source of real-world data. This information can reveal insights to healthcare providers, support academic research, and ultimately improve long-term patient care and access to therapies.
What are patient support programs?
PSPs exist to help patients move through the steps required to initiate and continue treatment with specialty pharmaceuticals. These medicines often treat chronic, serious, and rare diseases, require special handling, and generally have a high cost – which makes them more complex for patients to manage than traditional medications. Funded by drug manufacturers, PSPs address critical gaps in the Canadian health care system for patients: working with payers to secure drug reimbursement, providing drug infusion and injection services and, in some cases, providing financial assistance or compassionate drug. Along the way, PSPs gather important data.
By the numbers
PATIENT SUPPORT PROGRAMS
More than 400: Number of PSPs in Canada.1
175: Number of PSPs for oncology drugs alone.2
10: Major specialty service providers running PSPs in Canada.3
> 600,000: Canadian patients currently enrolled in PSPs.4
PSP DATA IN ACTION
75%: Percentage of Canadian patients who remain in a PSP for at least two years – which results in large patient populations for real-world data collection.7
30,000: Estimated highest number of patients enrolled in any one PSP.5
Less than 500: An estimated one-third of PSPs have fewer than 500 patients enrolled.6
100%: Of Canada’s major specialty service providers are using their PSP infrastructure to collect data.7
86%: Percentage of manufacturers and specialty service providers who say they’re expanding or enhancing their PSP data collection capabilities.7
8: Number of published peer-reviewed journal articles that include Canadian PSP data.7
Making Headlines: Patient Support Program Data
Wondering what kind of real-world evidence PSPs can generate? Here are five examples of studies that used PSP data. Click to download the full chart.
Product & therapeutic area:
GILENYA (fingolimod)
Relapsing remitting multiple sclerosis (RRMS)
Study:
Canadian experience with fingolimod: Adherence to treatment and monitoring
The Canadian Journal of Neurological Sciences Inc. (2016)
How PSP data and infrastructure was used:
Fingolimod was the first oral therapy to be approved in Canada for RRMS. Virtually all Canadian patients taking the drug (about 2,000) were enrolled in the PSP, making it an especially representative dataset. Data collected by the PSP included drug continuation rates at 12 and 24 months, as well as reasons for therapy discontinuation such as side effects and physician requests.8
Product & therapeutic area:
ENTYVIO (vedolizumab)
Inflammatory bowel disease (IBD)
Study:
The relationship between vedolizumab therapeutic drug monitoring, biomarkers of inflammation, and clinical outcomes in inflammatory bowel disease in the real-world setting
Journal of Crohn's and Colitis (2021)
How PSP data and infrastructure was used:
This study followed patients enrolled in the PSP between 2018 and 2020 and treated with vedolizumab for Crohn’s disease and ulcerative colitis. The PSP collected data from lab tests including trough concentrations of post-induction vedolizumab, albumin, fecal calprotectin, and C-reactive protein, as well as disease scores such as the Harvey-Bradshaw Index, at defined time points.9
Product & therapeutic area:
OCREVUS (ocrelizumab)
Multiple sclerosis (MS)
Study:
Pregnancy outcomes of women with multiple sclerosis treated with ocrelizumab in Canada: A descriptive analysis of real-world data
Multiple Sclerosis and Related Disorders (2022)
How PSP data and infrastructure was used:
Combining data from the PSP and a global safety database made it possible to study the safety of ocrelizumab before and during pregnancy in patients with MS – a subpopulation for whom clinical studies may not be feasible. The combined data set collected estimated conception dates and dates of ocrelizumab infusions before and during pregnancy, among other data.10
Product & therapeutic area:
LORBRENA (lorlatinib)
Non-small cell lung cancer (NSCLC)
Study:
Leveraging patient support program infrastructure to gather data to supplement HTA for rare tumors: What constitutes quality real-world evidence?
Canadian Association for Population Therapeutics (2022)
How PSP data and infrastructure was used:
This study followed 59 anaplastic lymphoma kinase-positive NSCLC patients on lorlatinib over a 20-month period. For this rare condition with a high unmet patient need, the PSP enabled the collection of data including ECOG status, prior therapy, and time-to discontinuation. The PSP also captured quality-of-life scores at baseline and at three, six- and twelve-months post-initiation.11
Product & therapeutic area:
LONSURF Trifluridine/tipiracil (FTD/TPI)
Metastatic gastric and gastroesophageal cancer
Study:
Trifluridine/tipiracil in the real-world management of metastatic gastric and gastroesophageal junction cancers in Canada
Current Oncology (2022)
How PSP data and infrastructure was used:
This study followed 123 patients on FTD/TPI over 2 years, with the PSP collecting baseline data including age, primary diagnosis, HER2 status, and prior therapies, and treatment data including therapy start and stop dates, doses, dose adjustments, and reasons for discontinuing treatment. The PSP also enabled the assessment of patients’ reimbursement status, including compassionate access to therapy, and compared time-to-reimbursement for public and private plans.12
References
1. Waldron & Associates original research.
2. BC Cancer. Manufacturer Patient Assistance Programs. January 2023. https://bit.ly/3TzbbQt
3. Drug Access Canada. Patient Program Providers. http://bit.ly/3FSjMZ0
4. Innovative Medicines Canada and Ernst & Young LLP. Innovative Medicines Canada Data Analytics and Members’ Economic Footprint and Impact in Canada. October 2017. https://bit.ly/3Z7xxKd
5. 20Sense. Innovation in Specialty Medicine: a Pipeline to Watch Closely. July 2022. https://www.20sense.ca/articles/21-02
6. 20Sense. The Canadian Patient Support Program Manufacturer Benchmarking Survey Report. July 2021.
7. RWE OBA Working Group. PSP Data Survey Results. Sept. 2020.
8. Lapierre Y et al. Canadian experience with fingolimod: Adherence to treatment and monitoring. Can J Neurol Sci 2016;1:1.
9. Afif W et al. The relationship between vedolizumab therapeutic drug monitoring, biomarkers of inflammation, and clinical outcomes in inflammatory bowel disease in the real-world setting. J Crohns Colitis 2021;15:S063.
10. Gitman V et al. Pregnancy outcomes of women with multiple sclerosis treated with ocrelizumab in Canada: A descriptive analysis of real-world data. Mult Scler Relat Disord 2022; 62:103792.
11. Vinh On P. Leveraging patient support program infrastructure to gather data to supplement HTA for rare tumors: What constitutes quality real-world evidence? Canadian Association for Population Therapeutics 2022. https://bit.ly/42Cbuyp
12. Ding P et al. Trifluridine/tipiracil in the real-world management of metastatic gastric and gastroesophageal junction cancers in Canada. Curr Oncol 2022;30:130. https://bit.ly/40OJE03