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Indication: For the treatment of adult patients with unresectable, locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and programmed death receptor-1 or programmed death-ligand 1 inhibitor therapy
CADTH recommends that Padcev should be reimbursed by public drug plans for the treatment of advanced or metastatic urothelial cancer (UC) if certain conditions are met.
Padcev should only be covered to treat adult patients with UC who have already received treatment with a platinum-containing chemotherapy regimen, and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor for advanced or metastatic disease.
Padcev should only be reimbursed if prescribed as monotherapy by a clinician who has experience treating patients with advanced UC and if the price of Padcev is reduced.
UC is the most common form of bladder cancer that begins in the urothelial cells of the urinary tract. Bladder cancer is the fifth most common cancer in Canada, with an estimated 12,200 new cases diagnosed per year. The most common symptom of UC is blood in the urine, and frequent, painful urination.
Most patients with UC will relapse after initial treatment. There are no treatment options for patients who have failed initial treatment consisting of platinum-based chemotherapy and PD-1 and PD-L1 inhibitors.
Treatment with Padcev is expected to cost approximately $17,718 per patient per 28-day cycle.
The CADTH pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommends that enfortumab vedotin be reimbursed for the treatment of adult patients with unresectable, locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor therapy only if the conditions listed in Table 1 are met.
One open-label, phase III randomized controlled trial (RCT) (Study EV-301) comparing enfortumab vedotin to standard salvage chemotherapy with docetaxel, paclitaxel, or vinflunine in adult patients with locally advanced or metastatic UC who had received a platinum-containing chemotherapy and who had experienced disease progression or relapse during or following treatment with PD-1 or PD-L1 inhibitors, demonstrated that treatment with enfortumab vedotin resulted in added clinical benefit with a statistically significantly prolonged overall survival (OS) (hazard ratio [HR] = 0.702; 95% confidence interval [CI], 0.556 to 0.886; P = 0.00142) and progression-free survival (PFS) (HR = 0.615; 95% CI, 0.505 to 0.748; P < 0.00001) compared to chemotherapy. The confirmed overall response rate (ORR) was also statistically significant in favour of enfortumab vedotin at 40.6% compared to 17.9% for chemotherapy (P < 0.001).
Patients identified a need for treatment options that could result in longer survival, longer remission, fewer severe side effects, and improved quality of life. pERC agreed there was considerable unmet need in this setting. Results of Study EV-301 suggested no difference between enfortumab vedotin and chemotherapy in measures of health-related quality of life (HRQoL); however, pERC considered the HRQoL results to be immature with low completion rates, thus no conclusions could be drawn on the effect of enfortumab vedotin on these outcomes based on the available evidence. Given the totality of the evidence, pERC concluded that enfortumab vedotin is an effective treatment for patients who have experienced disease progression on platinum-based chemotherapy and on PD-1 or PD-L1 inhibitors, and that it meets some of the needs identified by patients, including a need for treatments that halt disease progression and recurrence. pERC considered that enfortumab vedotin was associated with a significant but manageable toxicity profile.
Using the sponsor-submitted price for enfortumab vedotin and publicly listed prices for all other drug costs, the incremental cost-effectiveness ratio (ICER) for enfortumab vedotin was $506,439 per QALY compared with a taxane comparator (docetaxel or paclitaxel).
At this ICER, enfortumab vedotin is not cost-effective at a $50,000 per QALY WTP threshold for adult patients with metastatic UC who have previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. A reduction in price of at least 93% is required for enfortumab vedotin to be considered cost-effective at a $50,000 per QALY threshold.
Reimbursement Conditions and Reasons.
Issues that may impact the drug plan’s ability to implement a recommendation as identified by pERC and the drug plans are summarized in Table 2.
Implementation Guidance from pERC.
Enfortumab vedotin has a Health Canada indication for the treatment of adult patients with unresectable locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor therapy.
Enfortumab vedotin is a fully human immunoglobulin G1Κ antibody and microtubule-disrupting agent monomethyl auristatin E antibody-drug conjugate via a protease-cleavable linker directed against Nectin-4. It is available as 20 mg and 30 mg single-use vial lyophilized powder for solution for IV infusion only, at a dose of 1.25 mg/kg (up to a maximum for 125 mg for patients ≥ 100 kg) administered intravenously over 30 minutes on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
To make its recommendation, the Committee considered the following information:
One patient advocacy group, Bladder Cancer Canada, provided input for the review of enfortumab vedotin in locally advanced or metastatic UC. Bladder Cancer Canada is a nationally registered Canadian charity and is the first and only Canadian patient advocacy organization dedicated to bladder cancer issues. Supported by a medical advisory board and a medical research board consisting of the top bladder cancer specialists across Canada, its mission is to help patients with bladder cancer and their support teams address the day-to-day issues of this disease; increase awareness among the public and medical community; and fund research into the diagnosis, treatment, and elimination of the disease. Bladder Cancer Canada’s vision is patient support, awareness, and research to create a world where bladder cancer is “just a memory.”
The information provided by Bladder Cancer Canada was gathered through an online survey and telephone interviews conducted between May 27, 2021, and June 11, 2021. Most survey respondents were from Canada, with a small number from the US. Additionally, telephone interviews were conducted in June 2021 with 2 patients from Canada who had experience with enfortumab vedotin. In total, 38 patients diagnosed with stage II or higher muscle-invasive bladder cancer (of which one-third of patients reported living with locally advanced or metastatic bladder cancer) and 6 caregivers to someone with these diagnosis completed the survey.
Many patients and caregivers reported that symptoms of bladder cancer, including fatigue, lack of sleep, and loss of strength and stamina were problematic, but manageable, while some patients indicated that having bladder cancer has had a minimal impact on their day-to-day lives. Additional symptoms such as blood in the urine, pain in the abdomen and bones, decreased mobility, and difficulty or pain when urinating were also commonly reported. Issues related to continence, including frequent need for urination and loss of control, urostomy and catheter management, and urinary tract infections, were the most commonly reported symptoms impacting the day-to-day life of patients as they resulted in additional planning, discomfort, and time lost. Moreover, financial impacts related to the costs of catheter and urostomy supplies that are not covered by some provincial governments were reported to impact the already limited financial resources of patients and caregivers.
Patients cited experiencing a number of side effects with current treatments, including fatigue, constipation, low blood cell count, loss of appetite, neuropathy, nausea and vomiting, hair loss, insomnia, diarrhea, and mouth sores. Most patients also reported that there were minimal barriers to accessing treatment for their bladder cancer; however, some mentioned that they did have difficulties due to travel distance, treatment cost, unavailability of treatment in Canada, no access to a physician, and requiring time off work to receive treatment. Two patients had experience with enfortumab vedotin through a clinical trial. These patients noted that side effects of treatment with enfortumab vedotin were temporary and manageable compared to the previous treatments they’d received. When asked what key values about enfortumab vedotin have been important to them as patients, they said that the treatment has given them their “life back again,” allowing them to resume the activities that they enjoy. Patients with experience with enfortumab vedotin highlighted the importance of having publicly funded access for this treatment.
Overall, patients and caregivers hoped for fewer and less severe side effects than those experienced with current bladder cancer treatments, as well as treatments that induced remission or were curative. Specifically, patients cited that new treatments would ideally slow or stop disease progression, recurrence and spread; reduce pain, fatigue, and impaired sexual function; increase energy levels and strength; improve mental health, continence and urination control; and result in fewer or no infections and avoidance of surgery.
In patients with incurable locally advanced or metastatic UC, the clinical expert identified an unmet need for an effective third-line treatment option after progression with platinum chemotherapy and a PD-1 or PD-L1 inhibitor. The mainstay of treatment for patients who are incurable is cytotoxic platinum-based chemotherapy with gemcitabine with or without cisplatin. Maintenance avelumab was reported to show an OS benefit and is likely to become a funded standard of care. Pembrolizumab is now a funded second-line standard of care in Canada following demonstration of a survival benefit after progression despite first-line chemotherapy, displacing second-line taxane therapy. The only options following immunotherapy are paclitaxel and docetaxel, which have modest response rates and treatment durations. Enfortumab vedotin would provide a new option to taxane therapy. The clinical expert noted that identifying patients who would respond to enfortumab could not be done, and that patients at this stage are typically under the care of expert medical oncologists, who would be able to identify progressive disease to initiate new treatment. Response to treatment would rely on improvement in symptoms, which would be assessed before treatment and/or evidence of objective tumour shrinkage on imaging. The clinical expert also stated that there are additional adverse events with enfortumab vedotin that may require assessment by ophthalmologists or dermatologists.
Two clinicians from the Ontario Health (Cancer Care Ontario) (OH-CCO) Genitourinary Cancer Drug Advisory Committee and a group of Canadian physicians (17 in total) who treat bladder and who, with the support of Bladder Cancer Canada, a Canadian patient advocacy organization dedicated to bladder cancer issues, provided input for this review. The Ontario Health (Cancer Care Ontario) Drug Advisory Committee provides timely evidence-based clinical and health system guidance on drug-related issues in support of Cancer Care Ontario’s mandate, including the Provincial Drug Reimbursement Programs and the Systemic Treatment Program. The group of Canadian physicians represent the specialty from across Canada in both academic and community settings and share Bladder Cancer Canada’s goal to improve the management of bladder cancer.
The clinicians agreed that there was no standard of care for patients with advanced UC post-platinum chemotherapy, post-immunotherapy, representing an unmet need in these patients. Enfortumab vedotin is indicated in the third-line setting. Alternative third-line options would be non-platinum chemotherapy, for which there is little evidence of efficacy and for which the toxicity rate is much higher, or FGFR-targeted therapy, which would not be favoured for the reasons of unavailability of FGFR testing in Canada. Experts agree that enfortumab vedotin will redefine the current treatment paradigm as aside from taxanes, which are associated with significant toxicity, there are no other beneficial therapies in this setting. Offering enfortumab vedotin to all eligible patients would provide them with hope for improved life expectancy with tolerable side effects. The clinician group stated that throughout treatment, patients would be assessed for toxicity and clinical progression every month, with imaging every 2 months to 3 months. Bloodwork should be performed before each treatment cycle, and patients should be seen by their treating oncologist following each cycle. Patients with disease that has metastasized to the bones should also have a bone scan. When considering treatment discontinuation, the clinician group noted that decisions to discontinue treatment should be made in consultation with the patient and would include progressive disease, worsening symptoms, severe adverse events, deterioration to end of life, dose-limiting toxicity resulting in intolerable adverse effects such as significant neuropathy, or the patient wishes to discontinue treatment for any number of personal reasons.
Although no marked experience with enfortumab vedotin was mentioned, the clinicians consider this drug of great importance in the management of bladder cancer, filling an unmet need for patients requiring treatment following progression on platinum-based chemotherapy and immunotherapy. The approval of enfortumab vedotin would give medical oncologists an option to offer to patients with advanced UC that has progressed on first- and second-line therapy. Enfortumab vedotin offers significant OS benefit compared to taxane chemotherapy, with tangible benefits for patients. Enfortumab vedotin would offer a longer life expectancy with preservation of quality of life, as the drug is generally well tolerated. For a patient population with such a poor prognosis, the inclusion of enfortumab vedotin in the treatment algorithm has the potential to significantly improve the outcomes associated with bladder cancer.
The clinical experts consulted by CADTH provided advice on the potential implementation issues raised by the drug programs.
Responses to Questions From the Drug Programs.
Study EV-301 was a global, open-label, phase III RCT comparing enfortumab vedotin to standard salvage chemotherapy regimens in adults with locally advanced or metastatic UC who had received a platinum-containing chemotherapy and who had experienced disease progression or relapse during or following treatment with PD-1 or PD-L1 inhibitors. Patients were randomized 1:1 to receive enfortumab vedotin (n = 301) 1.25 mg/kg on days 1, 8, and 15 of every 28-day cycle, or standard chemotherapy consisting of paclitaxel, docetaxel, or vinflunine (n = 307) on day 1 of each 21-day cycle until disease progression. The primary end point of the EV-301 study was OS, with secondary end points of PFS, ORR, disease control rate, and HRQoL.
Baseline characteristics of Study EV-301 were well balanced between treatment groups; however, may have enrolled a healthier group of patients with a younger median age and lower Eastern Cooperative Oncology Group (ECOG) performance status (PS) compared to the Canadian population. In Study EV-301, patients were mostly White (51.6%), male (77.3%), with a median age of 68 years. Most patients were ECOG 1 (59.9%) and had metastatic disease (95.2%).
In the final primary efficacy analysis of Study EV-301, the median OS was 12.88 months (95% CI, 10.58 to 15.21) in the enfortumab vedotin arm, and 8.97 months (95% CI, 8.05 to 10.74) in the chemotherapy arm. Enfortumab vedotin was associated with a statistically significantly prolonged OS compared to chemotherapy (HR: 0.702; 95% CI, 0.556 to 0.886; P = 0.00142). Results for all sensitivity and subgroup analyses were consistent with the primary analysis.
The secondary end point of PFS was in line with the primary end point. Enfortumab vedotin was associated with a statistically significantly prolonged PFS compared to chemotherapy (HR = 0.615; 95% CI, 0.505 to 0.748; P < 0.00001), with a median PFS of 5.55 months (95% CI, 5.32 to 5.82) in the enfortumab vedotin arm, and 3.71 months (95% CI, 3.52, 3.94) in the chemotherapy arm. Sensitivity and subgroup analyses for PFS were consistent with the overall analysis.
HRQoL was assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EQ-5D and was a secondary outcome of Study EV-301. In the enfortumab vedotin arm, change in scores from baseline to week 12 for functional scales of the EORTC QLQ-C30 ranged from 2.17 (standard deviation [SD] = 16.20) for emotional functioning to −5.12 (SD = 23.80) for social functioning. In the chemotherapy arm, change from baseline scores at week 12 ranged from 3.27 (SD = 18.06) in emotional functioning to −9.15 (SD = 26.29) in role functioning. For symptom scores in the enfortumab vedotin arm, the change from baseline at week 12 ranged from 5.77 (SD = 32.56) for appetite loss to −6.96 (SD = 26.26) for pain, while in the chemotherapy arm, scores ranged from −1.63 (SD = 27.90) for insomnia to 6.64 (SD = 22.56) for fatigue. For the EQ-5D, the mean change from baseline to week 12 for the Visual Analogue Scale was −1.8 (SD = 16.6) for enfortumab vedotin and −5.3 (SD = 14.5) for the chemotherapy arm.
ORR was a secondary outcome of Study EV-301. The confirmed ORR was statistically significant in favour of enfortumab vedotin with an ORR of 40.6% compared to 17.9% for the chemotherapy arm (P < 0.001). A total of 4.9% and 35.8% of patients achieved confirmed complete response and partial response in the enfortumab vedotin arm, respectively, compared to 2.7% and 15.2% in the chemotherapy arm. Results for sensitivity and subgroup analyses for ORR were comparable to the primary analysis.
The overall incidence of treatment-emergent adverse events (TEAEs) was consistent between the enfortumab vedotin (98.0%) and taxane chemotherapy arms ||||||||; however, there were imbalances in the specific TEAEs experienced in either arm, with differences of 5% of greater for enfortumab vedotin in 15 preferred term TEAEs. The incidence of serious adverse events was higher in the enfortumab vedotin arm compared to the taxane chemotherapy arm (46.6% versus ||||), with acute kidney injury occurring most frequently in the enfortumab vedotin arm (6.4% versus ||||), and febrile neutropenia occurring most frequently with taxane chemotherapy (1.4% versus ||||). Withdrawals due to adverse events and TEAEs resulting in death were similar between the enfortumab vedotin arm and the taxane chemotherapy arm (17.2% versus ||||||, and 7.1% versus ||||, respectively). The most common reason for withdrawals due to adverse events was peripheral sensory neuropathy occurring in 2.4% and |||| of patients in the enfortumab vedotin and taxane chemotherapy groups.
The incidence of notable harms, including infusion-related reactions (IRRs), ocular disorders, skin reactions, and peripheral neuropathy, was generally more frequent in the enfortumab vedotin arm than the chemotherapy arm. IRRs were the least frequently occurring group of notable harms in 9.1% versus |||| of patients in the enfortumab vedotin and taxane chemotherapy arms, respectively. Drug eruption was the most common IRR with enfortumab vedotin (5.7% versus ||||), while general systemic IRR was most frequent in the taxane chemotherapy arm (1.4% versus ||||). Incidence of treatment-emergent ocular disorders was higher in the enfortumab vedotin arm compared to the taxane chemotherapy arm (28.0% versus ||||), the most frequent being increased lacrimation (10.1% versus ||||), dry eye (6.4% versus ||||), and conjunctivitis (6.4% versus ||||). Skin reactions were more frequent in the enfortumab vedotin arm (53.7%) compared to the taxane chemotherapy arm (||||). The most frequently occurring skin reactions were rash (16.9% versus ||||), maculopapular rash (16.9% versus||||), stomatitis (9.1% versus ||||), and drug eruption (8.8% versus ||||). Peripheral neuropathy events occurred in 50.3% and |||| of patients in the enfortumab vedotin and taxane chemotherapy arms, respectively. The majority of notable harms were of mild-to-moderate severity.
Study EV-301 was a phase III, open-label RCT. In general, patients in the 2 treatment arms did not differ with regards to baseline disease or treatment characteristics, indicating that randomization was successful. The reviewers and the clinical expert consulted by CADTH agreed that the open-label design used was appropriate; however, noted that this could potentially increase the risk of bias in the reporting of outcomes that are subjective in measurement and interpretation such as response, HRQoL, and adverse events. The primary end point of OS is an objective end point, and unlikely to be affected by biases of open-label study designs. Secondary end points of PFS and ORR are subjective, and therefore subject to potential bias. Reporting of patient-rated outcomes, such as symptom reduction and HRQoL, and some of the harms outcomes may have been biased or influenced by the patients’ or investigators’ knowledge of treatment assignment. All study outcomes were investigator-assessed and did not include full evaluation via an independent review committee to mitigate the biases associated with the open-label study design. Discontinuation rates were higher in the chemotherapy arm than the enfortumab vedotin arm (81.4% versus 92.8%, respectively), while the rate of discontinuation due to disease progression was nearly identical (58.8% versus 58.6%, respectively), which may reflect the open-label design, given that the reason for discontinuation being the result of patient and physician decision was higher in the chemotherapy arm. The study was stopped early for efficacy based on a statistically significant result for OS in favour of enfortumab vedotin. Trials that stop early for benefit may typically show a higher or better treatment effect estimate in the intervention group; however, given that the primary end point of the study, OS, was not subjective, the review teams’ concerns were minor. That said, the primary analysis was conducted early based on the information fraction (68.6%) suggesting an increased and notable risk of overestimation.
In discussion with the clinical expert consulted by CADTH, the inclusion and exclusion criteria for Study EV-301 were generally as expected for patients with locally advanced or metastatic UC; however, it was hypothesized that the patients included in the trial may reflect a less sick population than would be seen in the real world. The median age of 68 years as noted by the clinical expert to represent a younger population than expected. Additionally, the clinical expert also considered the ECOG PS of patients to be unreflective of patients at this stage of disease, as most patients would not be ECOG 0 or 1 (ECOG 0 = 40.1%; ECOG 1 = 59.9%). The chosen comparator of standard chemotherapy generally aligns with the recommended standard of care guidelines in Canada; however, vinflunine is not a treatment option available in Canadian clinical practice, and therefore any aggregate results for the chemotherapy arm need to consider the proportion of patients who may have received this treatment. In discussion with the clinical expert, it was noted that this may not affect efficacy outcomes but would impact the safety results. Given the known differences in the safety profiles of enfortumab vedotin, taxanes, and vinflunine, safety results must be interpreted with caution, and may not be generalizable. The high rate of dropouts in completion of the patient-reported outcome measures should also be taken into account when interpreting the results.
No indirect evidence was included in the sponsor’s submission to CADTH or identified in the literature search that matched the inclusion and exclusion criteria of this review.
No long-term extension studies or other relevant studies were included in the sponsor’s submission to CADTH.
Cost and Cost-Effectiveness.
CADTH identified the following key limitations with the sponsor’s analysis: the market shares for enfortumab vedotin were underestimated, median treatment durations were used instead of mean treatment durations, and relative dose intensities (RDIs) were included for all drugs that are associated with uncertainty. CADTH reanalysis increased the market shares for enfortumab vedotin, used mean treatment duration, and assumed RDIs of 100%. In the CADTH base case, the budget impact is expected to be $20,806,133 in year 1; $32,299,559 in year 2; and $46,273,397 in year 3; with a 3-year total of $99,379,089. CADTH found the budget impact to be sensitive to market share and RDI assumptions. Moreover, the eligible patient population size in this analysis is dependent on the number of patients progressing on avelumab maintenance therapy. As avelumab is not yet funded and the optimal maintenance duration is unknown, it is unclear how many patients would be eligible for treatment post-avelumab maintenance within the time horizon of this budget impact analysis.
Dr. Maureen Trudeau (Chair), Mr. Daryl Bell, Dr. Jennifer Bell, Dr. Matthew Cheung; Dr. Winson Cheung, Dr. Michael Crump, Dr. Leela John, Dr. Christian Kollmannsberger, Mr. Cameron Lane, Dr. Christopher Longo, Dr. Catherine Moltzan, Ms. Amy Peasgood, Dr. Anca Prica, Dr. Adam Raymakers, Dr. Patricia Tang, Dr. Marianne Taylor, and Dr. W. Dominika Wranik.
Meeting date: November 10, 2021
Regrets: None
Conflicts of interest: None
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Indication: For the treatment of adult patients with unresectable, locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and programmed death receptor-1 or programmed death-ligand 1 inhibitor therapy
Sponsor: Seagen Canada Inc.
Final recommendation: Reimburse with conditions
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