New Drug Funding Program Research Articles

Nivolumab in squamous cell carcinomas of the head and neck (SCCHN): A real-world outcome study in Ontario, Canada.

e18017 Background: The CheckMate-141 trial led to the approval of nivolumab in platinum-resistant metastatic squamous cell carcinomas of the head and neck (SCCHN). We evaluated outcomes of SCCHN patients in Ontario, Canada treated with nivolumab since its funding through the New Drug Funding Program (NDFP) of Cancer Care Ontario (CCO). Methods: Retrospective review using the provincial treatment registry (CCO NDFP) was undertaken. Patient characteristics, reason for treatment, treatment length, and date of death were collected. Kaplan-Meier method was used to estimate overall survival and Cox regression to evaluate prognostic effect of selected factors. Results: 134 patients with SCCHN received nivolumab between March 2017 and March 2019. Median patient age was 63 years with 80.6% male. Nivolumab was used as second-line therapy after disease relapse within 6 months of curative-intent platinum chemotherapy (PC) in 39.6% of patients (Indication 1 – I1), used as second-line therapy post PC in non-curative intent in 42.6% of patients (Indication 2 – I2), and used as first-line therapy in non-curative intent due to contraindication for PC in 17.2% of patients (Indication 3 – I3). Median overall survival (mOS) was 5.8 months (95% confidence intervals (CI) 4.5-7.3), and one-year OS was 28.4% (CI 2.10-36.1). HPV status had no statistically significant impact on OS (p = 0.12). Patients with a lower BSA (< 1.81) had median OS of 3.9 months (CI 3.1-6.7) versus 9.0 months (CI 6.5-14.8) in those with higher BSA, HR = 0.12 (CI 0.04-0.39, p < 0.001). Differences between indications was statistically significant (p < 0.001). Patients who received nivolumab for I1 had mOS 7.2 months (CI 3.8-9.8) versus 11.9 months (CI 6.2-not reached) for I3, HR = 1.73(CI 0.94-3.16). Patients who received nivolumab for I2 had mOS 3.9 months (CI 2.9-5.4) as compared to I3, HR = 3.27(CI 1.80-5.94). Patients who received nivolumab for I2 had poorer mOS as compared to I1 HR = 1.90(CI 1.23-2.92). Conclusions: Real world data in Ontario demonstrates poorer mOS, but similar 1-year survival compared to CheckMate-141 trial. HPV status had no significant impact on mOS. Patients who received nivolumab as first-line therapy in the non-curative setting appeared to have longer mOS than those who received initial PC for non-curative intent followed by nivolumab. Patients who received nivolumab as second-line therapy post PC in non-curative intent setting as compared to within 6 months of curative-intent therapy had poorer mOS.

Clinician Perspectives of COVID-19-Related Cancer Drug Funding Measures in Ontario.

The COVID-19 pandemic has a significant impact on cancer patients and the delivery of cancer care. To allow clinicians to adapt treatment plans for patients, Ontario Health (Cancer Care Ontario) issued a series of interim funding measures for the province’s New Drug Funding Program (NDFP), which covers the cost of most hospital-delivered cancer drugs. To assess the utility of the measures and the need for their continuation, we conducted an online survey of Ontario oncology clinicians. The survey was open 3–25 September 2020 and generated 105 responses. Between April and June 2020, 46% of respondents changed treatment plans for more than 25% of their cancer patients due to the pandemic. Clinicians report broad use of interim funding measures. The most frequently reported strategies used were treatment breaks for stable patients (62%), extending dosing intervals (59%), and deferring routine imaging (56%). Most clinicians anticipate continuing to use these interim funding measures in the coming months. The survey showed that adapting cancer drug funding policies has supported clinical care in Ontario during the pandemic.

Better treatment at what cost? A study of myeloma spending.

60 Background: Multiple myeloma represents less than 1.5% of new cancer cases in Canada. Currently, the estimated median overall survival is at least 5-6 years, primarily driven by therapeutic advances over the past decade. As treatment protocols routinely use doublet and triplet combinations, there are increasing concerns about the ability of health systems to afford growing costs of treatment. To inform system planning in Ontario, we examined trends in costs and utilization of myeloma drugs funded by Ontario’s New Drug Funding Program (NDFP) and the Ontario Drug Benefit program (ODB). Methods: NDFP primarily funds IV cancer drugs while ODB funds take-home cancer drugs (THCD). Treatment volumes and government costs, including drug costs and pharmacy fees where applicable, were obtained from ODB and NDFP claims data. Based on the available data, trends were examined from the 2010/11 to the second quarter of the 2019/20 fiscal year. Results: A total of 7 myeloma drugs (3-IV cancer drugs, 4-THCD) were examined. Over 9 years (2010/11 - 2018/19), spending on publicly-funded myeloma drugs increased by 303% while treatment volumes increased by 116%. Between 2014/15 and 2018/19, bortezomib spending decreased by 72%, largely due to generic pricing policies, while lenalidomide spending increased by 158%, likely due to new indications. By 2018/19, these 7 drugs accounted for 17% of the total cancer drug costs under Ontario's publicly funded programs. NDFP spending on IV cancer drugs by the second quarter of 2019/20 has surpassed the annual expenditures in 2018/19 due to the addition of daratumumab. Conclusions: Since 2010/11, growth in Ontario's public expenditures on myeloma drugs has outpaced savings from pricing policies and this growth is mainly driven by the high cost of the novel agents.

Impact of novel chronic lymphocytic leukemia drugs on public spending.

103 Title: Impact Of Novel Chronic Lymphocytic Leukemia Drugs On Public Spending Background: Chronic lymphocytic leukemia (CLL) is a common hematologic malignancy that mainly affects the elderly. Over the past five years, the treatment pathway for CLL has dramatically changed with the emergence of multiple novel agents. In Ontario, Canada, the Ontario Drug Benefit (ODB) program and the New Drug Funding Program (NDFP) primarily provide public coverage for CLL drugs. Given advances in treatment, we evaluated utilization trends for publicly-funded CLL drugs over a five year period (fiscal years 2012/13 to 2016/17). Methods: Drugs with primary CLL indications funded under the two public funding programs (i.e., ODB and NDFP) by 16/17 were included (n = 6). Claims and costs data were obtained from the Institute for Clinical Evaluative Sciences and Cancer Care Ontario‘s datasets. Results: Over five years, expenditures on CLL drugs have increased approximately ten-fold (1000 percent), reaching nearly CAD 43 million (i.e., USD 32.8 million) in 16/17. In the front-line setting, spending on rituximab remained consistent over the five years. Spending on single agent bendamustine decreased with the introduction of obinutuzumab which became the main cost driver by 16/17. In the previously-treated CLL population, ibrutinib has dominated expenditures since it was funded in July 2015. By 16/17, ibrutinib accounted for approximately ninety eight percent of spending in the previously-treated population. Conclusions: In the past five years, public spending on CLL drugs increased rapidly and substantially with the introduction of four novel agents, and may continue to evolve as Canadian provinces consider funding additional indications or newer agents. These findings warrant exploring whether the incremental spending is providing survival benefit or improvement in patients’ quality of life in a real-world setting. Declaration of funding: None

Automating a program for the evidence-based reimbursement of oncology drugs across a complex network: Benefits and challenges.

39 Background: Ontario hospitals are reimbursed for IV chemotherapy through Cancer Care Ontario’s (CCO) New Drug Funding Program (NDFP). By 2009, 54 indications (annual budget $195MM) were managed through largely paper based processes. A new web based system (eClaims) was developed focusing on clinic workflow and integration to chemotherapy ordering systems. Interfaces were developed for CCO’s OPIS and commercial systems (HL7v3). eClaims provides users with clinical best practice, pre-approval, immediate adjudication and simple means of tracking outstanding claims. The benefits and challenges are described. Methods: Evaluation used several strategies: debriefs after each deployment; post-go live user surveys and lessons learned workshops. Results: eClaims was deployed in 80 hospitals over two years. At most sites (50/80) treatment data flows from CPOE systems to eClaims in near real time. Over 50% of claims are machine adjudicated. Newly approved indications can be posted within hours. The main learnings during the deployment process were the need to understand and adjust for hospital specific factors and the unique business relationships among clusters of hospitals. Survey responses were received at a 19% response rate. The later deployment groups reported greater satisfaction than earlier adopters with more positive responses in all categories. Workshop key theme was the need to match complex clinical workflows with design/build processes. Secondly, evaluation of historical data before migration is necessary. Conclusions: Introducing an application into complex, varied clinical workflows is difficult. The phased approach to deployment and evaluation worked, allowing for increasingly smooth go lives. Future work revolves around balancing user needs through eClaims modifications vs simplifying clinical processes to make the tool more usable.

Abstract P3-12-11: Provincial variation in utilization of adjuvant chemotherapy regimens in early stage breast cancer: Data from the cancer care Ontario new drug funding program (NDFP)

Abstract Objectives: Recent improvements in breast cancer mortality are partly due to increased utilization of appropriate systemic therapy in early stage disease. The objectives of this study were to 1. review utilization of the most effective adjuvant breast cancer regimens across Ontario, 2. identify regions where there are variations from best practices. Methods: We used data from the Ontario NDFP to determine the utilization of 8 drug regimens approved for early stage breast cancer in each of the 14 provincial local health integration networks (LHINs). The NDFP funds the use of new and expensive cancer drugs; over 90% of all cancer treatments are funded through this mechanism. In Ontario, there were an estimated 9000 new cases of breast cancer in 2011. The analysis was restricted to patients with early stage, Her2 negative breast cancer treated in 2011-12. Data were obtained from individual cancer clinics in each LHIN. We estimate that data collection was >95% complete for these regimens. Results: 3375 women were treated with an NDFP regimen. Across the province, the most commonly used regimen was FEC-D (43%), followed by TC (23%) and ddACT (21%). The remaining regimens (AC-Docetaxel, ACT q 3 wks, CEF, FEC and AC-weekly P) were used in less than 5% of cases. However, there was important regional variation. In LHIN A, ACT q 3 wks was used in 42% of cases, and no patients received FEC-D. In LHIN P, TC was used in 40% of cases. In LHIN R, only 6% of patients received FEC-D, whereas 63% received ddACT. Utilization of Adjuvant Chemo Regimens n = 3375 AC-DocetaxelddACT q2wksACT q3wksAC-weekly PCEF/FECTCFEC-DLHIN K212004109241LHIN J3417101545212LHIN Q12000640104LHIN D1530732568165LHIN V57120031027LHIN R5188390104018LHIN P2246184111115LHIN B35311182795LHIN C0588002326LHIN A0132581120LHIN H2410189109LHIN T510425466038LHIN M1011318319175263LHIN S1715004728Total (%)128 (4)708 (21)156 (5)37 (1)139 (4)766 (23)1441 (43) Conclusion: The ACT q3 wks and TC regimens are widely used. This is of concern as they are likely less effective than FEC-D or ddACT. Factors such as tumour stage, geographic distance from treatment centre and private insurance coverage for supportive care medications may also affect choice of regimen. Consensus guidelines for the adjuvant systemic therapy of breast cancer in Ontario are being developed, along with a knowledge translation strategy to disseminate the results. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-12-11.

Trends in trastuzumab utilization in Ontario: A single payer system

11534 Background: Ontario, a province of 13 million, has a single payer system for new IV cancer drugs, the New Drug Funding Program (NDFP) of Cancer Care Ontario. Trastuzumab (T) is an NDFP drug with funding for both adjuvant (adj) and metastatic (met) breast cancer. Each patient (pt) is registered as adj, or met with line of treatment (tx). Adj T is funded for pts who receive adj chemotherapy (chemo) for node+ disease or node-, >1cm. Methods: Pts who received T were identified in the NDFP from 1999–2007. Funding for met disease was from 1999 onwards and for adj tx from 7/2005 (tx allowed for those whose adj chemo ended after 10/2004). For adj T, records of further chemo were identified for pts treated in Integrated Cancer Programs, for whom complete tx information is available, 50% of all adj pts. Results: About 5,300 cases of breast cancer are diagnosed annually in ON. 1,799 patients have received met T since 1999. Initially met tx was 1st, 2nd and 3rd line, including single agent T. Since 2005 tx is more likely to be 1st line with a taxane or vinorelbine. Median duration of tx with docetaxel (D) is 7 mos, range <1 mo –28.2 mos. Since 2005, 2,217 pts have received adj T. Of these, 866 pts have complete records available and completed adj T by the end of 10/2007. Only 19 have received further chemo for mets. At most 50% of relapses would receive either no tx or hormonal tx, so we estimate that 38/886 or 4.3% of pts have relapsed after adj T. Currently, 100 pts/mo are enrolled in the NDPF, 80 for adj T and 20 for met T. Conclusions: In Ontario 960/5,300 or 18% of pts receive adj T and chemo annually. Relapses have been very infrequent (<5%) after adj T to date. In the met setting most T is given in combination with D, with a median duration of use of 7 mos. No significant financial relationships to disclose.

Willingness to pay for new hormone-refractory prostate cancer (HRPC) therapies: Experience from Ontario hospitals

6559 Background: The New Drug Funding Program (NDFP) is an IV-based government funded provincial formulary that reimburses over 90 Ontario hospitals for new and expensive anti-cancer and supportive care drugs. An expert committee considers clinical and economic evidence, including a hierarchy of benefits and evidence to inform decisions. There can be extended unpredictable delays from the time evidence is available to funding, during which hospitals decide whether to pay for therapies. This report assesses hospitals’ willingness to pay for HRPC therapies prior to a funding decision. Methods: Patterns of uptake for docetaxel (D) and zoledronic acid (Z) were analyzed from the NDFP database and compared to publication dates, hierarchy of benefits and evidence, and costs for these new HRPC therapies. Results: Analysis of NDFP data for patterns of uptake revealed an apparent cost shift from hospitals to the NDFP for D but not for Z once funding was in place. This cost shift demonstrated that despite a higher cost, shorter time from publication to funding and equivalent levels of evidence that hospitals paid for D but not for Z. The only factor that favored payment for D over Z was that D ranked higher than Z in the NDFP hierarchy of benefits: Survival was the primary outcome for D versus prevention of skeletal related events (SRE) for Z. Publication of provincial practice guidelines supporting these therapies occurred after NDFP funding was in place and would not have impacted hospitals’ decisions to pay. Despite immediate uptake of Z once NDFP funding was introduced, hospitals did not absorb the cost when funding was temporarily suspended for a 5 month period. Conclusions: Survival benefit appeared to be the primary factor impacting hospitals’ willingness to pay for unfunded HRPC therapies. This observation is consistent with the ranking of clinical benefits used to inform NDFP formulary decisions. The higher cost of D did not appear to impact hospitals’ willingness to pay. No significant financial relationships to disclose. [Table: see text]