Development of a Multi-Criteria Decision Analysis Rating Tool to Prioritize Real-World Evidence Questions for the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration.

The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug's perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health's Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations.

Pan-Canadian consensus recommendations for proton beam therapy access in Canada.

PURPOSE: Proton Beam Therapy (PBT)is a treatment option for select cancer patients. It is currently not available in Canada. Assessment and referral processes for out-of-country treatment for eligible patients vary by jurisdiction, leading to variability in access to this treatment for Canadian cancer patients. The purpose of this initiative was to develop a framework document to inform consistent and equitable PBT access for appropriate patients through the creation of pan-Canadian PBT access consensus recommendations. MATERIALS AND METHODS: A modified Delphiprocess was used to develop pan-Canadian recommendations with input from 22 PBT clinical and administrative experts across all provinces, external peer-review by provincial cancer and system partners, and feedback from a targeted community consultation. This was conducted by electronic survey and live discussion. Consensus threshold was set at 70% agreement. RESULTS: Fourconsensus rounds resulted in a final set of 27 recommendations divided into three categories: patient eligibility (n = 9); program level (n = 10); and system level (n = 8). Patient eligibility included: anatomic site (n = 4), patient characteristics (n = 3), clinical efficacy (n = 2). Program level included: regulatory and staff requirements (n = 5), equipment and technologies (n = 4), quality assurance (n = 1). System level included: referral process (n = 5), costing, budget impact and quality adjusted life years (n = 2), eligible patient estimates (n = 1). Recommendations were released nationally in June 2021 and distributed to all 43 cancer programs in Canada. CONCLUSION: A pan-Canadian consensus-building approach was successful in creating an evidence-based, peer-reviewed suite of recommendations thatsupportapplication of consistent clinical criteria to inform treatment options, facility set-up and access to high quality proton therapy.

Considerations for Developing a Reassessment Process: Report from the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration's Reassessment and Uptake Working Group.

The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration was established to develop a framework for generating and using real-world evidence (RWE) to inform the reassessment of cancer drugs following initial health technology assessment (HTA). The Reassessment and Uptake Working Group (RWG) is one of the five established CanREValue Working Groups. The RWG aims to develop considerations for incorporating RWE for HTA reassessment and strategies for using RWE to reassess drug funding decisions. Between February 2018 and December 2019, the RWG attended four teleconferences (with follow-up surveys) and two in-person meetings to discuss recommendations for the development of a reassessment process and potential barriers and facilitators. Modified Delphi methods were used to gather input. A draft report of recommendations (to December 2018) was shared for public consultation (December 2019 to January 2020). Initial considerations for developing a reassessment process were proposed. Specifically, reassessment can be initiated by diverse stakeholders, including decision makers from public drug plans or industry stakeholders. The reassessment process should be modelled after existing deliberation and recommendation frameworks used by HTA agencies. Proposed reassessment outcome categories include maintaining status quo, revisiting funding criteria, renegotiating price, or disinvesting. Overall, these initial considerations will serve as the basis for future advancements by the Collaboration.

The Canadian National System for Incident Reporting in Radiation Treatment (NSIR-RT) Taxonomy.

PURPOSE: Incident investigation, reporting, and learning are core elements of quality improvement in radiation treatment. This report describes the development of a Canadian National System for Incident Reporting in Radiation Treatment (NSIR-RT), focusing especially on the taxonomy. METHODS AND MATERIALS: The NSIR-RT was developed to provide a framework in Canada for reporting and analyzing radiation treatment incidents. A key objective was to assure compatibility with other international reporting systems to facilitate future information exchange. The Canadian community was engaged at every step of the development process through Delphi consensus building and inter-user agreement testing to promote awareness of the system and motivate broad-based utilization across the country. RESULTS: The final taxonomy was comprised of 6 data groups (impact, discovery, patient, details, treatment delivery, and investigation) and 33 data categories with predefined menu options. There was a high level agreement within the Canadian community about the final suite of data categories, and broad alignment of these categories with the World Health Organization and other American and European radiation treatment incident classifications. CONCLUSIONS: The Canadian NSIR-RT taxonomy will be implemented as an online, web-based reporting and analysis system. It is expected that the taxonomy will evolve and mature over time to meet the changing needs of the Canadian radiation treatment community and support radiation treatment incident learning on a global scale.

Cost-effectiveness analysis comparing conventional versus stereotactic body radiotherapy for surgically ineligible stage I non-small-cell lung cancer.

INTRODUCTION: In 25% to 35% of patients with early stage I non-small-cell lung cancer (NSCLC), surgery is not feasible, and external-beam radiation becomes their standard treatment. Conventionally fractionated radiotherapy (CFRT) is the traditional radiation treatment standard; however, stereotactic body radiotherapy (SBRT) is increasingly being adopted as an alternate radiation treatment. Our objective was to conduct a cost-effectiveness analysis, comparing SBRT with CFRT for stage I NSCLC in a public payer system. METHODS: Consecutive patients were reviewed using 2010 Canadian dollars for direct medical costs from a public payer perspective. A subset of direct radiation treatment delivery costs, excluding physician billings and hospitalization, was also included. Health outcomes as life-years gained (LYGs) were computed using time-to-event methods. Sensitivity analyses identified critical factors influencing costs and benefits. RESULTS: From January 2002 to June 2010, 168 patients (CFRT, n = 50; SBRT, n = 118) were included; median follow-up was 24 months. Mean overall survival was 2.83 years (95% CI, 1.8 to 4.1) for CFRT and 3.86 years (95% CI, 3.2 to not reached) for SBRT (P = .06). Mean costs for CFRT were $6,886 overall and $5,989 for radiation treatment delivery only versus $8,042 and $6,962, respectively, for SBRT. Incremental costs (incremental cost-effectiveness ratio [ICER]) per LYG for SBRT versus CFRT were $1,120 for the public payer and $942 for radiation treatment alone. Varying survival and labor costs individually (± 20%) created the largest changes in the ICER, and simultaneous adjustment (± 5% to ± 30%) confirmed cost effectiveness of SBRT. CONCLUSION: Using a threshold of $50,000 per LYG, SBRT seems cost effective. Results require confirmation with randomized data.

A multicenter assessment of the adequacy of cancer pain treatment using the pain management index.

PURPOSES: Determine adequacy of management of pain secondary to bone metastases by physicians referring to specialized outpatient palliative radiotherapy (RT) clinics in Canada; compare geographic differences in adequacy of pain management and pain severity between these cohorts; compare results with published international literature. METHODS: Prospectively collected data from three participating centers were used to calculate the Pain Management Index (PMI) by subtracting the patient-rated pain score at time of initial clinic visit from the analgesic score. Scores were 0, 1, 2, and 3 when patients reported no pain (0), mild (1-4), moderate (5-6), or severe pain (7-10), respectively, on the Edmonton Symptom Assessment System or Brief Pain Inventory. Analgesic scores of 0, 1, 2, and 3 were assigned for no pain medication, nonopioids, weak opioids, and strong opioids respectively. A negative PMI suggests inadequate pain management. RESULTS: Overall incidence of negative PMI and moderate to severe pain was 25.1% and 70.9% respectively for 2011 patients. Comparing the three participating centers, the incidence of negative PMI was 31.0%, 20.0%, and 16.8% (p < 0.0001), and severe pain was 55.5%, 48.2% and 43.4% (p < 0.0001), these correlated with a negative PMI. Patients referred to our clinics were less likely to be undertreated for their pain when compared to study results from international countries. CONCLUSION: Geographic differences in adequacy of analgesic management for painful bone metastases exist between Canadian specialized outpatient palliative RT clinics and between centers globally. Investigating reasons for these differences may provide insight into solutions to improve quality of life for these patients.

Retrospective assessment of cancer pain management in an outpatient palliative radiotherapy clinic using the Pain Management Index.

CONTEXT: The Pain Management Index (PMI) is a simple index linking the usual severity of cancer pain with the category of medication prescribed to treat it. Medication categories are derived from the World Health Organization's "analgesic ladder" approach to cancer pain, and the PMI is an indicator of the extent to which the medication prescribed corresponds to the recommended categories for mild, moderate, and severe pain. OBJECTIVES: The aim of this study was to assess prevalence of inadequate pain management in an outpatient palliative radiotherapy clinic using the PMI. METHODS: All patients with bone metastases referred for palliative radiotherapy from 1999 to 2006 were retrospectively analyzed for patient-rated pain scores (0-10 scale) and analgesic consumption. Pain scores were assigned 0, 1, 2, and 3 when patients reported no pain (0), mild (1-4), moderate (5-6), or severe pain (7-10), respectively. Analgesic scores of 0, 1, 2, and 3 were assigned when patients were prescribed no pain medication, nonopioids, "weak" opioids, and "strong" opioids, respectively. The PMI score was calculated by subtracting the pain score from the analgesic score. A negative PMI score was considered an indicator of potentially inadequate pain management by the prescriber. Descriptive statistics, Pearson's r correlation, and univariate and multivariate logistic regression analysis were used to determine the relationship of PMI over time, and the relationship with predictive factors. RESULTS: One thousand patients were included from January 1999 to December 2006. A negative PMI was calculated for 25.8% of patients at initial consultation. Prevalence of negative PMI significantly increased over years (P<0.0001). Higher Karnofsky Performance Status (P<0.0001) and breast primary cancer site (P<0.0001) were significantly associated with negative PMI after adjusting for year variable. CONCLUSION: Despite publication of numerous cancer pain management guidelines, undermedication appears to be a persistent problem for patients with painful bone metastases referred for radiotherapy.