An official website of the United States government
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Indication: As adjuvant therapy after tumour resection in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
CADTH recommends that Tagrisso should be reimbursed by public drug plans as adjuvant therapy after tumour resection for the treatment of adult patients with stage IB-IIIA (American Joint Committee on Cancer [AJCC] 7th edition staging system) non–small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations only if certain conditions are met.
Tagrisso should only be covered to treat adult patients (≥ 18 years) who have complete surgical resection of stage IB-IIIA (AJCC 7th edition staging system) or stage IIA to IIIB (AJCC 8th edition staging system) NSCLC with a confirmed sensitizing EGFR mutation (exon 19 deletion and/or exon 21 L858R substitution mutation), with or without chemotherapy after surgery, good performance status, and no significant relevant disease conditions. Patients should start treatment with Tagrisso within 10 weeks of surgery if chemotherapy was not given after the surgery, or within 26 weeks if chemotherapy was given after the surgery.
Tagrisso should only be reimbursed for a total duration of 3 years, if prescribed by clinicians trained in treating cancer and experienced in the treatment of NSCLC, and if the cost of Tagrisso is reduced. Patients should be regularly monitored and treatment with Tagrisso should be stopped in patients with unacceptable toxicity or whose disease has recurred.
Evidence from 1 clinical trial showed that patients treated with Tagrisso have a longer period of disease-free survival than patients who received treatment with placebo. Further, Tagrisso has a manageable toxicity profile. Tagrisso met patient needs in that it delays the return of disease and increases the length of time patients live without lung cancer.
Based on CADTH’s assessment of the health economic evidence, Tagrisso does not represent good value to the health care system at the public list price and requires an 82% price reduction. Tagrisso is expected to increase costs to the public drug plans by $130,498,368 over 3 years.
Lung cancer is the most diagnosed cancer and the leading cause of cancer deaths in Canada. In 2020, it was estimated that there would be 29,800 new cases of lung cancer and 21,200 deaths from lung cancer. NSCLC accounts for approximately 88% of lung cancer cases in Canada. Survival from all stages and histologies of lung cancer is poor, with an overall 5-year net survival of 19%.
There is an unmet need to decrease disease recurrence and improve survival in patients with NSCLC.
Treatment with Tagrisso is expected to cost approximately $107,557 per patient per year.
The CADTH pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) recommends that osimertinib should be reimbursed as adjuvant therapy after tumour resection in patients with stage IB-IIIA (American Joint Committee on Cancer [AJCC] 7th edition staging system) non–small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations only if the conditions listed in Table 1 are met.
One phase III, double-blind, randomized placebo-controlled trial (ADAURA, N = 682) in adult patients with completely resected stage IB-IIIA EGFR mutation-positive (defined as EGFR exon 19 deletions or exon 21 [L858R] substitution mutations) NSCLC, demonstrated that adjuvant treatment with osimertinib resulted in a statistically significant and clinically meaningful prolongation in disease-free survival (DFS) compared to placebo. In patients with stage II-IIIA NSCLC, the primary analysis population, median DFS was not reached in the osimertinib group and was 19.6 months (95% CI, 16.6 to 24.5) in the placebo group (hazard ratio [HR] = 0.17; 95% CI, 0.12 to 0.23; P < 0.0001). In the overall population of stage IB-IIIA patients, the median DFS was not reached in the osimertinib group and was 27.5 months (95% CI, 22.0 to 35.0) in the placebo group (HR = 0.20; 95% CI, 0.15 to 0.27; P < 0.0001). The DFS benefit was observed regardless of whether patients had received post-operative adjuvant chemotherapy. Patients identified a need for treatments that delay disease recurrence and improve DFS, and pERC agreed that osimertinib meets this need. Patients also expressed a need for adjuvant treatments that provide a cure and maintain quality of life with limited side effects. The ADAURA trial results were based on an interim analysis at which time the data on overall survival (OS) and health-related quality of life (HRQoL) were considered immature; therefore, no conclusions could be drawn on the effect of osimertinib on these outcomes based on the available evidence. However, pERC acknowledged that a DFS benefit of the magnitude observed in the ADAURA trial is likely to be associated with positive impacts such as improvement in patient quality of life by delaying the presentation of advanced or metastatic disease which is associated with substantial morbidity. Although the overall incidence of adverse events (AEs) was higher in patients treated with osimertinib, the toxicities observed were consistent with the known safety profile of osimertinib and pERC considered them manageable for clinicians who have experience with the drug from its use in the metastatic setting.
Using the sponsor submitted price for osimertinib, and publicly listed prices for all other drug costs, the incremental cost-effectiveness ratio (ICER) for osimertinib was $328,026 per quality-adjusted life-year (QALY) compared to active surveillance. At this ICER, osimertinib for adult patients (aged ≥ 18 years) with completely resected, early-stage EGFR mutation-positive NSCLC is not cost-effective at a $50,000 per QALY willingness-to-pay (WTP) threshold. A reduction in price of 82% is required for osimertinib to be considered cost-effective at a $50,000 per QALY threshold. Due to immature data on OS, there is a high degree of uncertainty regarding QALY gains, meaning that a further price reduction may be required if these have been overestimated by the CADTH base case.
Reimbursement Conditions and Reasons.
pERC’s responses to the implementation questions submitted from the public drug plans are also summarized in tabular format in Appendix 1.
Osimertinib (Tagrisso) has a Health Canada indication for adjuvant therapy after tumour resection in patients with stage IB-IIIA (AJCC 7th edition) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Osimertinib is an oral EGFR TKI. It is available as 40 mg and 80 mg tablets and the Health Canada–approved dose is 80 mg taken once a day.
To make their recommendation, pERC considered the following information:
CADTH received 4 submissions from patient groups for this review from the CCSN, LCC, LHF (formerly Ontario Lung Association), and CanCertainty. The CCSN is a national network of patients, families, friends, community partners, and sponsors who promote the best standards of care regarding early diagnosis, timely treatment, follow-up care, support, survivorship, and quality of end-of-life care. LCC is a national, charitable organization that provides resources for lung cancer education, patient support, research, and advocacy. The LHF is a charity that focuses on respiratory illness and lung health that provides programs and services to patients and health care providers, invests in lung research, and advocates for improved policies on lung health. CanCertainty is made up of more than 30 Canadian patient groups, cancer health charities, and caregiver organizations who, along with oncologists and cancer care professionals, work to improve the affordability and accessibility of cancer treatments. For their submissions, CCSN and LCC conducted interviews with Canadian patients (n = 18 and n = 6, respectively) diagnosed with stages IB to IIIA NSCLC. The LHF conducted an online survey, for which they received responses from 11 patients with lung cancer and 2 family caregivers, and online focus groups including 7 patients and 3 caregivers. CanCertainty developed their submission based on published reports relating to lung cancer statistics and Canadian drug coverage as well as a past survey the group had conducted of more than 1,600 Nova Scotia residents from the general population.
The symptoms and challenges of lung cancer patients noted as being most significant were fatigue, shortness of breath, cough, difficulty fighting infection, and chest tightness. Other health issues that were mentioned include pain, wheezing, reduced appetite, weight loss, anxiety, and sadness. Patients reported that having lung cancer interfered with their daily lives and their ability to work, complete household chores, exercise, enjoy leisure activities, and socialize. Patients also noted the negative impact cancer had on taking day trips, thinking positively about the future, mental health, relationships with others, and the time spent both managing symptoms and attending appointments.
The patients surveyed by CCSN, LCC, and LHF identified improvements in the following outcomes as important: cure, delaying disease recurrence, limiting side effects, and maintaining quality of life. Further, patients surveyed by CanCertainty emphasized the need for a treatment that is accessible and affordable. The CCSN felt that patients valued DFS and its association with improved quality of life. Patients from the LCC submission felt that new medications for lung cancer should not interfere with daily living and should allow individuals to maintain their independence similar to before having cancer. The LHF patient respondents also emphasized better symptom reduction and management along with improving quality of life and not just extension of life.
The clinical panel reported that current treatment for Canadian patients with surgically resected stage IB-IIIA (AJCC 7th edition), EGFR-mutated NSCLC is adjuvant chemotherapy followed by active surveillance or active surveillance alone. The goal of adjuvant treatment is to treat microscopic metastatic disease, reduce the risk of recurrence, improve the chance for a cure, and improve OS. The clinical experts noted that while adjuvant chemotherapy is beneficial, recurrence rates are high in these patients. The clinical experts reported that when NSCLC recurs it is typically in a setting where it is no longer curable and treatment intent is palliative. The clinical panel indicated that better treatments are needed to decrease disease recurrence and improve OS. In the absence of improved longevity, the clinical experts noted that other important outcomes of adjuvant therapy may be to delay the presentation of advanced disease, in the context where presenting with advanced disease has high morbidity (e.g., new brain metastasis). The clinical panel indicated that adjuvant therapy is not intended to improve symptoms.
The clinical panel thought that osimertinib would be indicated for all patients with surgically resected stage IB-IIIA EGFR-mutated NSCLC for 3 years. The panel also indicated that osimertinib is not intended to replace adjuvant chemotherapy; osimertinib would be used after standard chemotherapy (if chemotherapy was indicated). The clinical panel thought that higher risk patients who decline or are unfit to receive standard chemotherapy may be best suited to receive treatment with osimertinib. The panel also thought that patients with later stage disease may have a larger benefit than those with earlier stage disease. The clinical panel indicated that patients without an EGFR mutation or intolerable toxicity (e.g., interstitial lung disease or cardiac dysfunction) to the drug would not be suitable for osimertinib. The clinical panel thought that patients with stage IB disease may be less suitable for treatment because they may have a smaller benefit from adjuvant treatment, higher cure rate from surgery, and may not want to commit to 3 years of osimertinib. The clinical panel noted that there are no data on the efficacy of osimertinib in patients with resistance mutations.
The clinical panel thought that the frequency at which response to treatment is assessed should be at the clinician’s discretion. For follow-up and toxicity management, the clinical panel indicated that they would have visits at 2 weeks and 4 weeks, blood work every 3 months, CT scans every 3 to 6 months for the first 2 years, then CT scans annually for years 3 to 5. The clinical panel indicated that they would likely perform annual CT scans and visits after 5 years for additional follow-up and treatment with osimertinib should be discontinued if the patient experiences disease recurrence or unacceptable toxicity.
Input was received from 2 clinician groups: the OH-CCO’s L-DAC and LCC. The OH-CCO’s L-DAC submission included input from 5 clinicians and the LCC submission included input from 16 clinicians. Input from the clinician groups was generally consistent with the clinical panel consulted by CADTH. The clinician groups indicated that there is a need to improve DFS and OS in patients with resected EGFR-mutated stage IB-IIIA NSCLC. The clinician groups agreed that osimertinib would not replace adjuvant chemotherapy. The clinician groups thought that patients who complete 3 years of adjuvant osimertinib and relapse at least 6 months following completion of therapy would be considered for retreatment with osimertinib therapy for advanced and metastatic disease. Like the clinical panel, the clinician groups agreed that retreatment with osimertinib in the advanced and metastatic setting after use in the adjuvant setting is a consideration, but data are not available to inform on retreatment.
The drug programs noted that osimertinib has the potential for drug-drug interactions, which could potentially increase pharmacy resource use. They also indicated that osimertinib adjuvant therapy may change the place in therapy of comparator drugs and drugs reimbursed in subsequent lines of treatment. The drug plans reported that EGFR testing is not reflexively completed for early-stage NSCLC across most Canadian jurisdictions, thus expansion of testing would be required to identify eligible patients. Lastly, the drug programs expressed concerns that the budget impact may be substantial because the duration of therapy per patient is 3 years.
The systematic review of osimertinib included 1 phase III RCT. The ADAURA trial (N = 682) is an ongoing international, multi-centre, double-blind, placebo-controlled RCT investigating the efficacy and safety of osimertinib in patients with stage IB-IIIA NSCLC with a centrally confirmed common sensitizing EGFR mutation (exon 19 deletion and/or exon 21 L858R substitution mutations, either alone or in combination with other EGFR mutations) who have undergone complete tumour resection with or without post-operative adjuvant chemotherapy. Patients were randomized in a 1:1 ratio to either 80 mg of osimertinib orally per day (N = 339) or matching placebo (N = 343). The primary outcome of the ADAURA trial is DFS by investigator assessment. Secondary outcomes are OS and HRQoL by the 36-Item Short Form Survey version 2 (SF-36 v2). The main HRQoL outcome measures of interest were TTD of the 2 summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), in the stage II-IIIA population. Exploratory end points included central nervous system (CNS) DFS, disease recurrence rate, PFS, time to next treatment, and TTD in PCS and MCS in the overall population (i.e., stage IB-IIIA).
The results from the ADAURA trial presented in this review are from an unplanned interim analysis with a data cut-off date of January 17, 2020. The median follow-up for OS in the stage II-IIIA population was 26.1 months and 24.6 months in the osimertinib and placebo arms, respectively; and the median follow-up for OS in the overall population was 26.1 months and 25.9 months in the osimertinib and placebo arms, respectively. The median follow-up time for DFS in the stage II-IIIA population was 22.1 months and 14.9 months in the osimertinib and placebo arms, respectively; and the median follow-up time for DFS in the overall population was 22.1 months and 16.6 months in the osimertinib and placebo arms, respectively. The study protocol and statistical analysis plan were amended to incorporate a multiple testing procedure to account for the interim analysis, which controls the type I error for the end points of DFS and OS in the stage II-IIIA population and the overall population.
The baseline characteristics of patients were balanced between the treatment arms. In the overall population (stage IB-IIIA), the mean age of the patients was 62.1 years. The majority of patients had stage II-IIIA disease (68.3%), a WHO performance status of 0 (63.6%), adenocarcinoma histology type (96.5%), had undergone a lobectomy (95.3%), were Asian (63.6%), and female (70.1%). Most patients had received post-operative adjuvant chemotherapy (60.0%). Overall, 54.7% of patients had exon 19 deletions and 45.2% had exon 21 L858R substitution mutations.
As of the interim analysis, OS data were immature per the sponsor’s assessment. Per the trial’s multiple testing procedure, OS was formally tested in the stage II-IIIA population at the interim analysis. At the data cut-off date, 25 deaths had occurred in the stage II-IIIA patient population (5.3% maturity), comprising 8 deaths (3.4%) in the osimertinib arm and 17 deaths (7.2%) in the placebo arm. The HR was 0.40 (95% CI, 0.18 to 0.89; P = 0.0244), which did not reach statistical significance (P value < 0.0002 required). Since OS did not reach statistical significance in the stage II-IIIA primary analysis population, OS in the overall population was not formally tested for statistical significance per the multiple testing procedure. A total of 29 patients (4.3%) in the overall population had died as of the interim analysis, comprising 9 patients (2.7%) in the osimertinib arm and 20 patients (5.8%) in the placebo arm. The HR was 0.48 (95% CI, 0.23 to 1.02).
The primary end point of DFS was met at the interim analysis. In the stage II-IIIA population, 26 patients (11.2%) in the osimertinib arm and 130 patients (54.9%) in the placebo arm had experienced a DFS event. The HR was 0.17 (95% CI, 0.12 to 0.23), which was statistically significant (P < 0.0001). In the overall population, 37 patients (10.9%) in the osimertinib arm and 159 patients (46.6%) in the placebo arm had experienced a DFS event. The HR was 0.20 (95% CI, 0.15 to 0.27), which was also statistically significant (P < 0.0001). The results of the pre-specified subgroup analyses were consistent with the primary analysis of DFS in showing a benefit of osimertinib (HR of < 0.4) for all subgroups. A post-hoc exploratory analysis of DFS with disease recurrence in the CNS only also suggested an improvement with osimertinib compared to placebo (HR: 0.14; 95% CI, 0.07 to 0.27).
As of the interim analysis, the disease recurrence rate was 10.9% in the osimertinib arm and 45.8% in the placebo arm. In the osimertinib arm, disease recurrence was local regional only in 6.8% of patients, distant only in 2.9% of patients, and both local regional and distant in 1.2% patients. In the placebo arm, disease recurrence was local regional only in 17.8% of patients, distant only in 22.7% of patients, and both local regional and distant in 5.2% patients. Data on PFS and time to next treatment were immature per the sponsor’s assessment and the comparisons for these end points have not been controlled for multiple comparisons. As of the data cut-off date, | patients ( | %) in the osimertinib arm and | patients (|||%) in the placebo arm had experienced a PFS event. |||||||||| patients ( | %) in the osimertinib arm and ||||| patients (|||%) in the placebo arm had experienced a first subsequent anti-cancer therapy or death event. Of these events, patients (|||%) in the osimertinib arm and |||| patients (|||%) in the placebo arm received a subsequent anti-cancer treatment.
In the pre-specified TTD analyses of PCS and MCS in the stage II-IIIA population, comparisons were made without adjustment for multiple comparison testing. For the PCS score, 58 (24.9%) patients in the osimertinib arm experienced confirmed deterioration by at least 3.1 points or death compared to 39 (16.5%) patients in the placebo arm (HR: 1.43; 95% CI, 0.96 to 2.13). For the MCS score, 52 (22.3%) patients in the osimertinib arm and 52 (21.9) patients in the placebo arm experienced confirmed deterioration by at least 3.8 points or death (HR: 0.90; 95% CI, 0.61 to 1.33). The TTD in PCS and MCS scores in the overall population were analyzed as post-hoc exploratory analyses and the results were consistent with the stage II-IIIA population.
The median total exposure time to study drug was 22.5 months in the osimertinib arm and 18.7 months in the placebo arm. As of the data cut-off date, 40 (12%) patients in the osimertinib arm and 33 (10%) patients in the placebo arm had completed 3 years of treatment.
A total of 329 patients (97.6%) in the osimertinib arm and 306 patients (89.2%) in the placebo arm experienced at least 1 treatment-emergent adverse event (any grade) as of the interim analysis. The most frequently reported AEs in the osimertinib and placebo arms were diarrhea (46.3% and 19.8%, respectively), paronychia (25.2% and 1.5%, respectively), dry skin (23.4% and 6.4%, respectively), pruritis (19.3% and 8.7%, respectively), and cough (18.4% and 16.6%, respectively).
In the ADAURA trial, 54 patients (16.0%) in the osimertinib arm and 42 patients (12.2%) in the placebo arm experienced a serious adverse event (SAE) as of the interim analysis. The most frequently reported SAEs in the osimertinib and placebo arms were pneumonia (1.5% and 1.2%, respectively), cataracts (0.9% and 0%, respectively), diarrhea (0.6% and 0%, respectively), acute kidney injury (0.6% and 0%, respectively), ureterolithiasis (0.6% and 0%, respectively), and femur fracture (0.6% and 0.3%, respectively).
Withdrawals specifically due to AEs were not reported. As of the data cut-off date, a total of 33 patients (4.8%) had withdrawn from the ADAURA trial: 19 (5.6%) in the osimertinib arm and 14 (4.1%) in the placebo arm. Thirty-six patients (10.7%) in the osimertinib arm and 10 patients (2.9%) in the placebo arm had discontinued study treatment due to AEs. The most common AEs leading to treatment discontinuation in the osimertinib arm were interstitial lung disease (n = 8, 2.4%), diarrhea (n = 3, 0.9%), and decreased appetite (n = 3, 0.9%). The most common AE leading to treatment discontinuation in the placebo arm was decreased ejection fraction (n = 3, 0.9%).
A total of 29 (4.3%) patients had died as of the interim analysis: 9 patients (2.7%) in the osimertinib arm, 20 patients (5.8%) in the placebo arm.
Regarding notable harms, 8 patients (2.4%) experienced interstitial lung disease and 2 patients (0.6%) experienced pneumonitis in the osimertinib arm as of the interim analysis. No patients in the placebo arm experienced interstitial lung disease or pneumonitis. The frequency of cardiac disorder AEs was greater in the osimertinib arm compared to the placebo arm (11.0% versus 5.2%, respectively). In the osimertinib arm, 6.5% patients experienced QT interval prolongation compared to 1.2% in the placebo arm. Four patients (1.2%) in the osimertinib arm experienced congestive heart failure/cardiac failure/left ventricular dysfunction compared to zero in the placebo arm. Four patients (1.2%) in the osimertinib arm experienced atrial fibrillation compared to 1 (0.3%) in the placebo arm; 6 patients (1.8%) in the osimertinib arm experienced an arrhythmia other than atrial fibrillation compared to zero in the placebo arm. Overall, 3 patients (0.4%) experienced keratitis: 2 (0.6%) in the osimertinib arm, and 1 (0.3%) in the placebo arm. In the osimertinib arm, 70.6% experienced a skin and subcutaneous tissue disorder compared to 35.6% of patients in the placebo arm. The most common skin disorders in the osimertinib and placebo arms were paronychia (25.2% and 1.5%, respectively), dry skin (23.4% and 6.4%, respectively), pruritis (19.3% and 8.7%, respectively), and dermatitis acneiform (11.0% and 4.7%, respectively).
The ADAURA trial was a double-blind RCT to minimize bias. Baseline characteristics were balanced between treatment arms and few randomized patients had been lost to follow-up as of the data cut-off date. The interim analysis was not planned, and the trial is ongoing. A multiple testing procedure was employed to control overall type I error at the 5% 2-sided level for the end points of DFS and OS, which was modified to account for the unplanned interim analyses. The primary end point was met at the interim analysis since the log-rank test for DFS in patients with stage II-IIIA disease met the pre-specified threshold for statistical significance. The log-rank test for DFS in the overall population also met statistical significance for this analysis. Due to early reporting of the study, data maturity is lower than planned at the interim analysis. At the data cut-off date, the sponsor assessed the OS data to be immature. Furthermore, the comparison for OS in the stage II-IIIA population was not statistically significantly different between the treatment arms. Thus, it cannot be concluded that osimertinib confers an OS benefit compared to placebo at the time of this CADTH review. In addition, data on time to next treatment and PFS were considered of limited clinical significance by the sponsor at the time of the interim analysis due to the immaturity of the data on patients who experienced a disease recurrence event, and comparisons for these end points were not controlled for multiple comparisons. The results did not support conclusions for an effect of osimertinib on PFS and time to next treatment, and any potential clinical benefit for these outcomes is associated with uncertainty due to the immaturity of the data and lack of control from type I error. Conclusions could not be drawn for the effect of osimertinib on HRQoL end points as these end points were not adjusted for multiple comparisons. In addition, most patients have not had the opportunity to receive the planned study treatment duration of 3 years.
The osimertinib dose and treatment regimen used in the ADAURA trial aligns with the Health Canada indication. The ADAURA trial included patients who had received standard-of-care adjuvant chemotherapy, which is commonly used in Canadian practice. This also aligns with the intended use of osimertinib in Canada per the clinical experts consulted by CADTH and clinician groups that provided input, who indicated that osimertinib is not intended to replace adjuvant chemotherapy. The clinical experts consulted by CADTH thought that the eligibility criteria used in the trial were appropriate and generally reflected the characteristics of the intended patient population in Canada. However, the trial limited enrolment to patients with a WHO performance status of 0 to 1 and the clinical experts reported that many patients in their practice with resected stage IA-IIIB NSCLC have a performance status of 2. The clinical experts did not think that exclusion of patients with worse performance status limits the generalizability of the trial results. The proportion of Asian patients in the trial was higher than in the Canadian NSCLC population per the clinical experts consulted by CADTH. In addition, the ADAURA trial reported a higher EGFR mutation-positive rate than currently seen in Canada, where EGFR testing is routinely offered to patients with locally advanced and not amenable to curative intent therapy or metastatic NSCLC only.
Cost and Cost-Effectiveness.
CADTH reanalyses assumed all patients in the new drug scenario will undergo EGFR mutation testing at the time of resection; assumed 95% of patients in the reference scenario who progress to distant metastatic will receive EGFR mutation testing and have a valid result, changed the RDI to 100%, increased osimertinib uptake in year 1 and 2, and aligned the distribution of patients across subsequent therapies for local regional recurrence with the pharmacoeconomic analysis. Based on the CADTH reanalyses, the budget impact from the introduction of osimertinib adjuvant therapy is expected to be $21,723,455 in year 1, $43,365,781 in year 2, and $65,409,131 in year 3 with a 3-year total budget impact of $130,498,368.
Dr. Maureen Trudeau (Chair), Dr. Catherine Moltzan, Mr. Daryl Bell, Dr. Jennifer Bell, Dr. Kelvin Chan, Dr. Matthew Cheung, Dr. Winson Cheung, Dr. Michael Crump, Dr. Leela John, Dr. Christine Kennedy, Dr. Christian Kollmannsberger, Mr. Cameron Lane, Dr. Christopher Longo, Ms. Valerie McDonald, Dr. Marianne Taylor, and Dr. W. Dominika Wranik.
Meeting date: August 11, 2021
Regrets: Three expert committee members did not attend.
Conflicts of interest: None
Note that this appendix has not been copy-edited.
Implementation Questions From the Drug Programs.
Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.
CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.
This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.
Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third-party supplier of information.
This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.
This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.
The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.
Redactions: Confidential information in this document has been redacted at the request of the sponsor in accordance with the CADTH Drug Reimbursement Review Confidentiality Guidelines.
About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.
Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
Indication: As adjuvant therapy after tumour resection in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
Sponsor: AstraZeneca Canada Inc.
Final Recommendation: Reimburse with conditions
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
Your browsing activity is empty.
Activity recording is turned off.
See more...
