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Indication: Adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
CADTH recommends that Keytruda should be reimbursed by public drug plans for the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions if certain conditions are met.
Keytruda should only be covered to treat patients aged 18 years and older with RCC of clear cell subtype and previous nephrectomy, with or without surgery to remove 1 or more metastases, who are at intermediate-high or high risk of the tumour returning, and without prior systemic therapy for advanced RCC. Patients should also be in relatively good health.
Keytruda should only be reimbursed if prescribed by a clinician with experience in RCC management, in specialized clinics with expertise in systemic treatment and immunotherapy delivery, and if the price of Keytruda is reduced. Keytruda should not be used in combination with other adjuvant cancer treatments.
Evidence from a clinical trial demonstrated that in patients with RCC who previously underwent nephrectomy, or nephrectomy with complete removal of metastases, those who were treated with Keytruda remained free of cancer for longer than those who were treated with placebo.
Keytruda is not considered cost-effective compared to routine surveillance alone. Economic evidence suggests that a 26% price reduction is needed to ensure Keytruda is cost-effective at a $50,000 per quality-adjusted life-year (QALY) threshold.
Based on public list prices, Keytruda is expected to cost the public drug plans $74,947,286 over 3 years.
RCC is a type of kidney cancer that begins from the lining of the kidney tubules. Nine out of 10 kidney cancers are RCCs. Clear cell RCC is the most common subtype of RCC, occurring in about 8 out of 10 people with RCC. Cancer staging is used by doctors to predict the likely course of the disease and make treatment decisions. In patients who are at risk of the cancer returning, additional treatment after surgery, known as adjuvant therapy, may be given to lower the chance of the cancer coming back.
There are no effective treatments available for patients with RCC in the adjuvant setting. Patients with RCC are in need of adjuvant treatment options with an acceptable toxicity profile that can improve health benefits.
Treatment with Keytruda is expected to cost approximately $11,733 per 28 days.
The CADTH pCODR Expert Review Committee (pERC) recommends that pembrolizumab be reimbursed for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, only if the conditions listed in Table 1 are met.
Evidence from 1 ongoing, phase III, double-blind, randomized controlled trial (KEYNOTE-564; N = 994) comparing the efficacy and safety of pembrolizumab with placebo for adjuvant treatment of adult patients with RCC after nephrectomy, or nephrectomy with complete resection of metastatic lesions, demonstrated that treatment with pembrolizumab (200 mg given every 3 weeks by IV infusion, for a total duration of 1 year) resulted in added clinical benefit with a statistically significant and clinically meaningful improvement in disease-free survival (DFS) (hazard ratio [HR] = 0.68; 95% CI, 0.53 to 0.87; P = 0.001) compared to placebo. The effect of adjuvant pembrolizumab on overall survival (OS) could not be determined due to the limitations associated with the immature survival data, and uncertainty on the effect of subsequent cancer therapies used in the trial. However, pERC agreed with the clinical experts that DFS is likely to be correlated with OS in the adjuvant setting, and that DFS itself is a meaningful outcome for patients with RCC in this setting.
Patients identified a need for effective adjuvant treatment options with an acceptable toxicity profile that could reduce the risk of disease recurrence, improve quality of life, and lengthen survival. pERC concluded that adjuvant therapy with pembrolizumab meets some of the needs identified by patients, including a need for effective treatments with manageable side effects and DFS benefit. pERC was unable to draw any conclusions on the effect of pembrolizumab on health-related quality of life (HRQoL) due to the exploratory nature of patient-reported outcomes in the trial, and a lack of established minimally important differences (MIDs) for HRQoL outcomes in the patient population of interest.
Using the sponsor-submitted price for pembrolizumab and publicly listed prices for all other drug costs, the incremental cost-effectiveness ratio (ICER) for pembrolizumab was $93,053 per QALY, compared with routine surveillance alone. At the sponsor-submitted price, pembrolizumab is not cost-effective at a $50,000 per QALY willingness-to-pay (WTP) threshold for adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and complete resection of metastatic lesions. A reduction in price is required for pembrolizumab to be considered cost-effective at this threshold.
Reimbursement Conditions and Reasons.
In Canada, kidney and renal pelvis cancers were reported as the seventh most common cancers among males (5,200 new cases; 2.8% disease-related deaths) and the 12th most common among females (2,600 new cases; 1.7% disease-related deaths) in 2021. Almost 50% of kidney tumours are detected incidentally and many of them are asymptomatic. Classic symptoms (flank pain, visible haematuria, and palpable abdominal mass) are usually associated with more advanced disease stages as well as poorer prognosis. Around 65% of individuals are typically diagnosed while the tumour is confined to primary site (local disease), while a smaller proportion of patients are diagnosed when the tumour is spread to regional lymph nodes and metastatic sites (16% at regional and 16% at distant stages). Survival rates among patients with RCC largely depend on clinical factors such as tumour stage, grade, RCC subtype, presence of sarcomatoid features, local extent of tumour, presence of regional nodal metastasis, and evidence of metastatic disease at presentation. Estimated rates of 5-year metastasis-free survival among individuals with low, intermediate, and high Stage, Size, Grade and Necrosis (SSIGN) scoring risk are more than 95%, approximately 80%, and below 40%, respectively.
In Canada, the current standard of care for non-metastatic RCC is nephrectomy. Adjuvant treatment is not recommended in patients with non-metastatic RCC following nephrectomy, and current oncologic standard of care for these patients is observation.
Pembrolizumab has been approved by Health Canada for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Pembrolizumab is a high affinity humanized monoclonal antibody that blocks the programmed cell death receptor 1 (PD-1) pathway. It is available as powder for solution for infusion 50 mg, and solution for infusion 100 mg/4 mL vial. The recommended dosage for pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks, administered as an IV infusion until disease recurrence, unacceptable toxicity, or up to 1 year (12 months) or 17 doses for 200 mg or 9 doses for 400 mg, whichever is longer, in patients without disease recurrence.
To make their recommendation, the committee considered the following information:
One response to CADTH’s call for patient input was received from KCC, which is a national community that provides support and education to patients living with kidney cancer and advocates for their care. The information used to inform the submission was based on 4 online surveys conducted by KCC in 2018 and March 2022, then in collaboration with the International Kidney Cancer Coalition (IKCC) in 2020, and by IKCC in May 2021. Direct input was also collected in March 2022 from 1 American patient with RCC who had experience with pembrolizumab. The 2018 survey supported a previous submission reviewed by CADTH by reporting on the challenges met by patients and caregivers living with kidney cancer. Among the 2,012 respondents of the 2020 international survey, 241 were living in Canada, of which 205 (85%) were patients with kidney cancer, 34 (14%) were caregivers, and 2 (0.8%) were undisclosed. A total of 141 patients with RCC responded to the 2021 survey. Among the 106 respondents to the 2022 survey, 65 (61%) patients and caregivers were living in Canada.
KCC reported that a large proportion of patients with RCC may eventually experience disease recurrence after nephrectomy leading to a substantially shortened life expectancy. The patient group input indicated that in the absence of adjuvant therapy options, patients with intermediate to high risk of recurrence experience anxiety and emotional distress from the expectation of recurrence and progression of disease. Nearly half (49%) of survey respondents indicated they would accept adjuvant immunotherapy if the therapy reduced the risk of disease recurrence by 40% to 50%. Approximately 50% of respondents indicated they would accept the risk of side effects associated with steroid use to manage the side effects of adjuvant immunotherapy if that level of risk is in the range of 20% to 25%.
According to the 1 patient who had experience with pembrolizumab in the adjuvant setting, the side effects of the treatment — including slight occasional rash, slight fatigue, and hyperkalemia — were manageable.
KCC emphasized that there is currently an unmet need for an effective adjuvant therapy for kidney cancer to reduce the risk of disease recurrence and improve patient outcomes, including a reduction in the number of patients who incur metastatic disease and the costs associated with RCC care.
Clinical experts consulted by CADTH emphasized that there is an unmet need among patients at a higher risk of recurrent disease after surgery for kidney cancer. Currently, there is no approved adjuvant treatment in this setting. The experts reported that pembrolizumab would be offered as a monotherapy in the adjuvant setting after resection of kidney cancer in patients at intermediate-high or high risk of recurrence. In the opinion of the clinician experts consulted, patients with clear cell carcinoma that have M1 resected metastases would benefit most from adjuvant treatment, followed by pT3-pT4 patient population (those at high risk of recurrence) and T2, grade 3 to 4 patient population (those at intermediate risk of recurrence). The experts identified patients with autoimmune diseases requiring steroids as those who should not receive adjuvant pembrolizumab. The clinical experts noted that OS and DFS represent important outcomes for the assessment of patient’s response to treatment. Discontinuation of treatment was recommended by the clinical experts in case of disease recurrence or intolerable treatment toxicities. The experts reported that treatment administration and monitoring should be undertaken by a medical oncologist in an outpatient or community cancer setting.
Two clinician groups provided input for this review: the Kidney Cancer Research Network of Canada and the Ontario Health Genitourinary Cancer Drug Advisory Committee. Two clinicians affiliated with the Kidney Cancer Research Network of Canada and 1 clinician on behalf of the Ontario Health Genitourinary Cancer Drug Advisory Committee contributed to this submission. The clinician groups agreed that there is an unmet need for adjuvant therapy to lower the risk of disease recurrence in patients with localized RCC following nephrectomy in Canada. The clinician groups indicated that, if funded, pembrolizumab would be the first adjuvant therapy option for patients with RCC in Canada.
Input was obtained from the drug programs that participate in the CADTH reimbursement review process. 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.
The KEYNOTE-564 trial (N = 994) is an ongoing, multi-centre, randomized, double-blind, phase III study with a primary objective to compare the efficacy and safety of pembrolizumab versus placebo as an adjuvant treatment for adult patients with RCC post-nephrectomy, or post-nephrectomy and resection of metastatic lesions. The trial was conducted in 212 sites across 21 countries, including Canada. The study enrolled patients who were 18 years of age and older with a histologically confirmed diagnosis of RCC with a clear cell component, with or without sarcomatoid features. The study included patients at intermediate-high risk or high risk of recurrence, based on pathological tumour-node-metastasis staging, Fuhrman grade, and presence of sarcomatoid features, and patients following metastatic disease who had undergone complete resection of primary and metastatic lesions. Patients were also required to be tumour-free, have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, and have no prior systemic treatment for RCC. The primary outcome investigated in the KEYNOTE-564 trial was DFS, assessed by the investigator. The key secondary outcome was OS; other secondary outcomes included disease recurrence specific survival (DRSS), event-free survival (EFS) assessed by blinded independent radiology review, safety, and HRQoL.
Patients were randomized in a 1:1 ratio to receive either pembrolizumab (200 mg IV infusion every 3 weeks; N = 496) or placebo (saline solution IV every 3 weeks; N = 498) for up to a maximum of 17 infusions or (approximately) 1 year, until confirmation of recurrence, treatment discontinuation, or study termination. Randomization was stratified based on the metastasis status variable (M0 versus M1 NED). Within the M0 group, randomization was further stratified according to the following factors: ECOG PS (0 or 1) and US participant (Yes or No). By the time of the first interim analysis (IA) (December 14, 2020), 1,406 patients were screened and 994 were randomized into the trial (496 in pembrolizumab and 488 in placebo arm). One additional analysis (the Efficacy Update Report [EUR]) was implemented after 6 additional months of follow-up, with a cut-off date of June 14, 2021.
The median age of patients enrolled in the KEYNOTE-564 study was 60 years, with the majority of participants being White (over 75%) and male (over 70%) in both treatment groups. Most patients had tumours with an absence of sarcomatoid features and belonged to the intermediate-high recurrence risk category. Baseline characteristics were equally balanced in the 2 study arms. More patients discontinued treatment in the pembrolizumab arm (38.9%) compared to the placebo arm (26.2%), primarily due to adverse events (AEs). More patients in the placebo arm (22.5%) received subsequent systemic anticancer treatment compared to the pembrolizumab arm (15.3%).
At the first IA data cut-off (December 14, 2020), the median follow-up durations were 24 months (range = 2.5 to 41.5) and 23.8 months (range = 3.5 to 41.4) for patients in pembrolizumab and placebo groups, respectively. The median OS was not reached in either treatment arm. An HR of 0.54 (95% CI, 0.30 to 0.96; P = 0.0164) was estimated for the comparison between pembrolizumab and placebo. Additional 6-month follow-up data from the EUR analysis (June 14, 2021 data cut-off) showed that the median OS was not reached in both groups, with an observed HR of 0.52 (95% CI, 0.31 to 0.86; P = 0.005).
Similarly, median DFS was not reached in both treatment groups at the time of the first IA (December 14, 2020). The HR obtained between the pembrolizumab versus placebo was 0.68 (95% CI, 0.53 to 0.87; P = 0.001). Results from the EUR analysis, with a data cut-off of June 14, 2021, demonstrated an HR of 0.63 (95% CI, 0.50 to 0.80; P < 0.0001). Median DFS was not reached in either group at the time of the EUR.
According to the pre-specified subgroup analysis, the HRs for the DFS across the metastatic staging groups was 0.74 (95% CI, 0.57 to 0.96) for the M0 group and 0.29 (95% CI, 0.12 to 0.69) for the M1 NED group. Similar findings were observed in the EUR analysis, with 6 additional months of follow-up (for the M0 subgroup: HR = 0.68; 95% CI, 0.53 to 0.88; for the M1-NED subgroup: HR = 0.28; 95% CI, 0.12 to 0.66). EUR results of the post hoc subgroup analysis according to the recurrence risk showed the following estimates: 0.68 (95% CI, 0.52 to 0.89), 0.60 (95% CI, 0.33 to 1.10), and 0.28 (95% CI, 0.12 to 0.66) for the intermediate-high risk, high risk, and M1-NED risk groups, respectively.
HRQoL assessments included the overall least squares mean difference estimated for the pembrolizumab versus placebo arms. Among patients completing the HRQoL measures, patients in both arms appeared to experience slight deterioration in HRQoL and symptom worsening assessed at week 52. The overall least squares mean difference in the FKSI-DRS score was −0.67 (95% CI, −1.23 to −0.12). The least squares mean difference in the EORTC QLQ-C30 questionnaires was −2.57 (95% CI, −5.22 to 0.08) for global health status/quality of life and −0.91 (95% CI, −2.79 to 0.97) for physical function.
The proportion of patients with at least 1 treatment emergent AE appeared higher in the pembrolizumab arm (96.3%) than in the placebo group (91.1%). Serious AEs were reported among 20.5% of individuals who received pembrolizumab treatment, compared to 11.3% of individuals receiving placebo. There were more AEs leading to drug discontinuations (pembrolizumab versus placebo: 20.7% versus 2.0%) and treatment interruptions (25.8% versus 14.9%) in the pembrolizumab arm compared to placebo. Overall, 2 deaths were reported in the pembrolizumab arm (0.4%), and 1 death was reported in the placebo arm (0.2%).
Notable harms were higher in the pembrolizumab group than in the placebo group. Hyperthyroidism (21.1% versus 6.9%), hypothyroidism (11.9% versus 0.2%), pneumonitis (2.3% versus 1%), adrenal insufficiency (2% versus 0.2%), type 1 diabetes mellitus (1.8% versus 0%), colitis (1.6% versus 0.2%), severe skin reactions (1.6% versus 0.4%), infusion reactions (1.4% versus 1%), thyroiditis (1.2% versus 0.2%), and hepatitis (1% versus 0%) were the notable harms observed in the pembrolizumab and placebo arms, respectively.
The KEYNOTE-564 trial is an ongoing, multi-centre, randomized, placebo-controlled, double-blind study. The randomization scheme implemented in the trial minimized the risk of bias due to unknown confounders. Owning to a placebo-controlled design, potential for unblinding might have occurred due to higher frequencies of immune-related AEs in the pembrolizumab arm, compared to the placebo arm. Baseline and demographic characteristics were balanced in the 2 study arms, suggesting successful randomization. Concomitant medications permitted in the trial, as well as subsequent anticancer therapies administered, were considered appropriate by the clinician experts consulted by CADTH and reflective of treatments used in Canadian practice.
OS, DFS, and HRQoL investigated in the trial were considered clinically meaningful outcomes by the clinician experts and reflective of outcomes assessed in clinical practice. Other surrogate end points, such as DRSS and EFS, were considered of lower clinical relevance, according to the clinical experts.
The primary outcome (DFS) was assessed by the local investigators, and BICR assessments were introduced to evaluate the robustness of the DFS findings. Findings of DFS by BICR were consistent with the primary analysis, suggesting low possibility of evaluation bias. Multiplicity adjustments were implemented adequately for the analysis of DFS and OS, and sensitivity analyses were also pre-specified and conducted for DFS. The findings from the sensitivity analyses were consistent with the primary intention-to-treat (ITT) analyses. Median DFS and OS were not reached at the time of conducted interim analyses, suggesting data immaturity. More patients in the placebo arm received post-treatment anticancer therapies compared to the pembrolizumab arm, which might have produced biased estimates of OS (favouring the placebo group). Of note, surgery in patients with RCC is performed with a curative intent, and 5-year disease specific survival is lengthy in patients at intermediate risk (about 80%) and high risk of recurrence (from 40% to 55%) post-nephrectomy. Hence, longer follow-up is needed to observe the effects of adjuvant pembrolizumab on survival outcomes. The findings from the analysis of secondary and exploratory outcomes (EFS, DRSS, HRQoL) as well as defined subgroups were considered exploratory, as no multiplicity adjustments were performed. The magnitude of effect of pembrolizumab on HRQoL of patients in the adjuvant setting is uncertain due to lack of formal hypothesis testing, possible violation of missing data assumptions in the model applied, and low attrition rates.
There were several interim analyses pre-specified in the protocol before the first IA (December 14, 2020), which was used as the base for this CADTH report. Another IA (i.e., EUR) with 6 months of additional follow-up data was added in between the first and second IA to respond to potential requests from regulatory agencies. The final OS analysis will take place after approximately 200 deaths are observed between the pembrolizumab and placebo groups. Adjustments were made to account for alpha spending across the interim analyses.
The clinician experts consulted by CADTH for this review reported that the baseline characteristics and the findings of the KEYNOTE-564 can be generalizable to adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, in the Canadian setting. The administered dosage of pembrolizumab was 200 mg every 3 weeks for up to 17 doses, which is aligned with the pre-NOC Health Canada indication. The clinical experts noted that dosing of 400 mg every 6 weeks for up to 9 doses is more commonly applied in real clinical practice. Appropriateness of the placebo as the comparator was confirmed by the clinical experts, as there are no Health Canada–approved adjuvant treatment options available in Canada. According to the clinical experts, patients recruited in the pivotal trial had more frequent disease assessments and follow-up procedures compared to what would be applied in patients in real-world practice.
One sponsor-submitted, multi-centre, randomized, double-blind, phase III trial (KEYNOTE-564), comparing adjuvant therapy with pembrolizumab to placebo in patients with RCC, was included in this CADTH systematic review.
Overall, pembrolizumab improved DFS outcomes, compared to placebo, as an adjuvant treatment of patients with RCC who are at intermediate-high or high risk of recurrence after nephrectomy, or following nephrectomy and resection of metastatic lesions. However, the effects of adjuvant pembrolizumab relative to placebo on OS could not be determined because of the immature survival data, uncertain influence of subsequent treatments, and uncertainty in the correlation between DFS and OS in adjuvant treatment of RCC. Likewise, limitations with the HRQoL analyses in the single randomized controlled trial (RCT) precluded drawing conclusions about the effects of pembrolizumab on this outcome. The safety profile of pembrolizumab was similar to that observed in other trials of this drug, including the effects on the thyroid and adrenal glands. The clinician experts considered the baseline characteristics and the findings from the KEYNOTE-564 trial generalizable to patients with RCC in the adjuvant setting in Canada.
Cost and Cost-Effectiveness.
CADTH identified the following key limitations: the referral rate to oncologists may be underestimated, the assumption regarding patient enrolment in clinical trials as a comparator is inappropriate, and the use of relative dose intensity (RDI) may not accurately capture treatment costs.
CADTH’s base case revisions included: increasing the referral rate to oncologists, revising the proportion of patients who were assumed to be in clinical trials to 0%, setting RDI to 100%, and using a weight-based pembrolizumab dose. CADTH also explored uncertainty in the market uptake estimates, wastage and dose of pembrolizumab, and incident case distribution throughout the year.
Based on the CADTH’s base case, the expected budget impact for funding pembrolizumab for the adjuvant treatment of intermediate-high risk and high risk RCC in the drug plan perspective is expected to be $5,452,069 in Year 1, $26,377,162 in Year 2, and $41,832,259 in Year 3, with a 3-year budget impact of $73,661,491.
Results of CADTH’s scenario analyses demonstrate that the estimated budget impact is highly sensitive to the changes in dosing and wastage.
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: August 9, 2022
Regrets: Of the expert committee members, 2 did not attend.
Conflicts of interest: None
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Indication: Adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
Sponsor: Merck Canada Inc.
Final recommendation: Reimburse with conditions
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