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Indication: As monotherapy for adjuvant treatment following resection and platinum-based chemotherapy for patients with non–small cell lung cancer whose tumours have programmed death-ligand 1 expression on 50% or more of tumour cells
CADTH recommends that Tecentriq be reimbursed by public drug plans after surgery and chemotherapy for the treatment of patients with stage II to stage IIIA non–small cell lung cancer (NSCLC) whose tumour is positive for programmed death-ligand 1 (PD-L1) in at least 50% of tumour cells (TCs) and does not have an abnormal EGFR or ALK gene if certain conditions are met.
Tecentriq should only be covered to treat adult patients (18 years or older) with stage II to stage IIIA NSCLC whose tumour is positive for PD-L1 in at least 50% of TCs and does not have an abnormal EGFR or ALK gene.
Tecentriq should only be used alone after surgery and chemotherapy. Tecentriq should only be reimbursed if it prescribed by a specialist and if the patient is in relatively good health (i.e., has a good performance status, as determined by a specialist). Tecentriq should not be reimbursed if the patient is not a candidate for surgery or chemotherapy. The cost of Tecentriq must be lowered to be cost-effective and affordable.
NSCLC is the most common type of lung cancer. In those with NSCLC, unusual growth of cells takes place inside the lungs or lining of the airways and forms into tumours. Cancer that is stage I, II, or IIIA is considered early stage, meaning the tumour has not spread to other parts of the body.
The intention of surgery for early-stage NSCLC is to cure patients. However, it is possible for cancer to return for some patients who have had surgery; therefore, there is a need for treatment options that can prevent cancer from returning.
Treatment with Tecentriq is expected to cost approximately $9,035 per 28-day cycle.
The CADTH pan-Canadian Oncology Drug Review Expert Review Committee (pERC) recommends that atezolizumab be reimbursed as monotherapy for adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to IIIA (per the American Joint Committee on Cancer [AJCC], 7th edition) NSCLC whose tumours have PD-L1 expression on 50% or more of TCs and do not have EGFR or ALK genomic tumour aberrations only if the conditions listed in Table 1 are met.
One phase III, multicentre, open-label, randomized study (IMpower010) demonstrated a clinically meaningful disease-free survival (DFS) benefit (DFS hazard ratio [HR] = 0.47; 95% confidence interval [CI], 0.29 to 0.75; P value = 0.0012) with atezolizumab versus best supportive care (BSC) in patients with stage II to stage IIIA NSCLC following complete resection and adjuvant cisplatin-based chemotherapy. Atezolizumab addresses an unmet need for this patient population with poor prognosis and high risk of disease recurrence.
Patients expressed a need for an additional treatment option that has manageable side effects, delays disease progression, improves survivorship, and maintains quality of life. Patients highlighted the importance of maintaining their independence and functionality to minimize the burden on caregivers and loved ones. Given the totality of the evidence, pERC concluded that atezolizumab met some of the needs identified by patients in terms of an additional treatment option that delays disease recurrence.
Using the sponsor-submitted price for atezolizumab, the incremental cost-effectiveness ratio for atezolizumab was $68,858 per quality-adjusted life-year (QALY) compared with active surveillance. At this incremental cost-effectiveness ratio, atezolizumab is not cost-effective at a $50,000 per QALY willingness-to-pay threshold for adult patients with completely resected stage II to stage IIIA NSCLC who received platinum-based chemotherapy and whose tumours have PD-L1 expression on 50% or more of TCs and do not have EGFR or ALK mutations. A reduction in price is required for atezolizumab to be considered cost-effective at a $50,000 per QALY threshold.
Reimbursement Conditions and Reasons.
Lung cancer is 1 of the most commonly diagnosed cancers and is the leading cause of cancer deaths in Canada, with NSCLC accounting for approximately 88% of lung cancer cases. Approximately half of NSCLC cases in Canada are stage I to III at diagnosis, and one-third of patients with NSCLC have operable disease. Early-stage NSCLC (i.e., stages I to IIIA per the AJCC, 7th edition) is often asymptomatic. When patients do present with symptoms, these are usually nonspecific and difficult to directly attribute to lung cancer. The most common symptoms include fatigue, cough, chest or shoulder pain, hemoptysis, weight loss, dyspnea, hoarseness, bone pain, and fever. Diagnostic procedures include imaging with CT, PET, and/or MRI scans, bronchoscopy with or without endobronchial ultrasound, and tissue biopsy. Pathologic testing of biomarkers on lung biopsy specimens assists in determining treatment options and risk stratification. The 5-year net survival for lung cancer is 22%. The high mortality rate associated with lung cancer reflects both its high incidence rate and its low survival rate.
The primary goal of treatment for patients with stage IB to IIIA NSCLC (per the AJCC, 7th edition; the equivalent stages using the AJCC, 8th edition, are stages IIA to IIIB) is to cure and prolong life. The secondary goal of treatment is to delay disease relapse, thereby allowing patients a longer period of time living disease-free. Attaining these treatment goals primarily involves surgical resection of the tumour, followed by adjuvant cisplatin-based doublet chemotherapy.
Atezolizumab was approved by Health Canada on January 14, 2022, as monotherapy for adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to stage IIIA (according to the AJCC, 7th edition) NSCLC whose tumours have PD-L1 expression on 50% or more of TCs. Atezolizumab is an Fc-engineered humanized immunoglobulin G1 monoclonal antibody. It is available as IV infusion and the dosage recommended in the product monograph is 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks.
To make its recommendation, the committee considered the following information:
The information in this section is a summary of the input provided by the patient groups that responded to CADTH’s call for patient input and from the clinical expert(s) consulted by CADTH for the purpose of this review.
Patient input was provided by 2 groups: LCC and the Lung Health Foundation. LCC is a national charity, a member of the Global Lung Cancer Coalition, and serves as a resource for lung cancer education, patient support, research, and advocacy. The Lung Health Foundation, formerly known as the Ontario Lung Association, is charity that provides education, and programs and services for patients and health care providers, as well as invests in research and policy improvement in lung health. LCC collected thoughts and experiences from 9 patients with NSCLC and small cell lung cancer, and from 1 caregiver (this included patients from Canada, the US, the UK, and Australia) in December 2021 via phone interviews and environmental scans. The Lung Health Foundation conducted phone interviews with 3 patients (1 each from Ontario, Manitoba, and Quebec) from September to October 2021, as well as with a registered nurse and a certified respiratory educator.
Patient respondents from both surveys reported difficulty with coping with their diagnosis and noted that they felt like there was “no hope, no light and [they were] less human” due to the poor prognosis of lung cancer. These feeling were amplified when the cancer was detected late. Patient respondents also reported that cancer-related symptoms were hard to manage. While the physical symptoms of shortness of breath, cough, and fatigue were reported to be mild, psychosocial effects such as anxiety, distress, depression, and some of the harsh side effects from chemotherapy, radiation, and surgery (e.g., nausea, vomiting, neuropathy, lung injury) were harder to manage. Similarly, the psychosocial burden placed on family members and caregivers impacted their emotional well-being, ability to travel and socialize, and work life.
Patient respondents deemed the following outcomes as important: delayed disease progression and increased long-term remission to ultimately improved survivorship; minimal side effects from treatments; maintenance of independence and functionality (to minimize burden on caregivers and loved ones); and full and worthwhile quality of life. Respondents from both surveys emphasized a lack of treatment options for patients with positive PD-L1 driver mutation lung cancer to reduce a risk of recurrence after post-surgery chemotherapy. Patients emphasized wanting a choice in therapy that works in the early stages of disease (as opposed to the metastatic stage) with durable efficacy to maintain stable disease and increase chance of cure.
The clinical experts consulted by CADTH indicated that despite the current standard of care with adjuvant chemotherapy, many patients who have undergone surgical resection and adjuvant chemotherapy experience disease relapse. In the majority of these cases, the disease is often incurable. The survival benefit that accompanies adjuvant chemotherapy is modest, representing an unmet need for other effective treatments for this patient population. If adopted, atezolizumab would be an additional therapy, and not a replacement for preexisting therapies (i.e., atezolizumab would be given in addition to adjuvant chemotherapy and not instead of). Also, if adopted, atezolizumab would be offered to patients with resected NSCLC with tumours greater than 5 cm in size, or node positive tumours, regardless of size of primary tumour, with a PD-L1 tumour score of 50% or greater. According to the clinical experts, the only way to know if adjuvant therapy is successful is to follow a patient with NSCLC after completion of all curative intent therapy to disease relapse. The majority of disease relapse, as cited by the clinical experts, occurs within 5 years of completion of therapy. The clinical experts recommended that treatment with atezolizumab be discontinued in the events of dangerous or intolerable AEs, disease relapse, or patient choice to stop therapy. Atezolizumab may be administered at any outpatient cancer systemic therapy infusion unit where immunotherapy checkpoint inhibitors are already administered.
Input was received from 3 clinicians on behalf of OH-CCO DAC and 17 physicians treating lung cancer across Canada via LCC.
OH-CCO Lung and Thoracic DAC indicated the need for therapy with increased cure and OS rates. Both groups stated that patients with stage II to stage III (per UICC or AJCC, 8th edition) lung cancer have the greatest unmet need. Both clinician groups indicated that atezolizumab would supplement and/or be added to the current postoperative management of resected NSCLC after at least 1 dose of adjuvant (platinum doublet) chemotherapy, and not be a replacement for current therapies. OH-CCO Lung and Thoracic DAC indicated that patients with higher PD-L1 (> 50%), or all patients who are PD-L1 positive, are suited for atezolizumab. LCC suggests that patients with stage II to stage IIIA resected lung cancer (per UICC or AJCC, 7th edition) with a tumour positive for PD-L1 (≥ 1%), as determined by immunohistochemistry after at least 1 cycle of adjuvant therapy, regardless of stage or nodal status, are suitable for atezolizumab.
OH-CCO Lung and Thoracic DAC considered DFS a clinically meaningful outcome measure. LCC emphasized that recurrent disease (DFS) should be considered a critical outcome on its own (besides OS, which is the gold standard) given the high patient, health care, and social ramifications associated with recurrence. Both groups indicated discontinuation of therapy at disease progression and toxicity. As for the treatment settings, hospital (outpatient clinic) and any oncology settings where infusions are performed were considered appropriate prescribing settings for atezolizumab by OH-CCO Lung and Thoracic DAC and LCC, respectively. OH-CCO Lung and Thoracic DAC agreed that the end points reported in the trial can reasonably be expected to correlate with OS. Also, both clinical groups believed other strategies (e.g., a short course with only 3 doses of neoadjuvant immunotherapy with chemotherapy) would be less expensive than a full-year course of adjuvant immunotherapy.
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.
One ongoing phase III, global, multicentre, open-label, randomized study was included in the review. The IMpower010 trial compared the efficacy and safety of atezolizumab versus BSC in patients with stage IB to stage IIIA NSCLC (as per the UICC and AJCC staging system, 7th edition) following complete resection and adjuvant cisplatin-based chemotherapy. A total of 1,005 patients were randomized across 204 sites in 21 countries in North America (including 2 sites in Canada), Europe, Asia, and Australia.
The primary efficacy outcome was DFS as assessed by the investigator. Secondary efficacy outcomes included OS, 3-year and 5-year DFS rates, and DFS in the PD-L1 subpopulations defined as 50% or higher TC expression by SP263 immunohistochemistry assay in patients with stage II to stage IIIA NSCLC as defined by the UICC and AJCC, 7th edition. The IMpower010 study consisted of 2 phases: an enrolment phase and a randomized phase. In the enrolment phase, patients who had undergone completed resection of their NSCLC were screened, and if eligible, were enrolled to receive 1 of 4 cisplatin-based chemotherapy regimens (cisplatin plus vinorelbine, docetaxel, gemcitabine, or pemetrexed), based on investigator choice. Patients who were still deemed eligible to continue with the study after up to 4 cycles of cisplatin-based chemotherapy proceeded to the randomization phase in which patients were randomized in a 1:1 ratio to receive atezolizumab or BSC. The clinical report provided to CADTH presented the analysis of study data collected from the date of the first patient randomized (February 26, 2016) to the clinical data cut-off date of January 21, 2021, for the protocol-specified interim analysis for DFS.
At baseline, there were 229 patients with stage II to stage IIIA NSCLS and PD-L1 expression on 50% or greater of TCs. The indication population had a median age of 62 (range = 36 to 84) years, were predominantly male (72.9%) and White (70.3%), had high functional performance (57.2% with an Eastern Cooperative Oncology Group [ECOG] performance score of 0), and reported to have previously used tobacco (69.9%). At diagnosis, most patients were diagnosed at stage IIIA (48.0%) and with nonsquamous histology (59.8%). Among the 137 patients with nonsquamous histology, 94.2% were identified as having the adenocarcinoma subtype. EGFR or ALK mutation was detected in 8.7% of patients. Most patients underwent prior lobectomy (74.2%) and mediastinal lymph node dissection (81.7%).
Efficacy results are presented using the subpopulation of patients who had stage II to stage IIIA NSCLC with PD-L1 expression on 50% or more of TCs (per indication under review) unless otherwise specified.
Among the subpopulation of patients with stage II to stage IIIA disease and PD-L1 expression on 50% or more of TCs, the observed deaths at the time of the interim analysis (median = 32.2 [range, 0 to 58.8] months follow-up) were 22.8% and 9.6% in the BSC and atezolizumab treatment arms, respectively. The stratified HR was 0.40 (95% CI, 0.20 to 0.81) in favour of atezolizumab. The median OS could not be estimated in either treatment arm due to the low rate of death events at the time of the planned interim analysis. At year 3, 90.85% of patients in the atezolizumab treatment arm were event-free compared to 76.67% of those randomized to receive BSC, representing a difference in proportion of 14.27% (95% CI, 4.19 to 24.35%).
Among the subpopulation of patients with stage II to stage IIIA disease and PD-L1 expression on 50% or more of TCs, 45.6% of patients in the BSC treatment arm experienced a disease recurrence or death compared to 24.3% in the atezolizumab arm. The stratified HR for DFS was 0.47 (95% CI, 0.29 to 0.75). At year 3, 73.79% of patients in the atezolizumab arm were event-free compared to 48.61% of those randomized to receive BSC, representing a difference in event-free rate of 25.18% (95% CI, 11.01 to 39.36%).
Of those patients with stage II to stage IIA NSCLC and PD-L1 expression on 50% or more of TCs who experienced a protocol defined disease recurrence (BSC = 50; atezolizumab = 25), locoregional disease recurrence was experienced by 60% of patients in the atezolizumab treatment arm compared to 34% in the BSC arm. Distant only disease recurrence was experienced by 42% of patients in the BSC arm compared 24% in the atezolizumab arm. Central nervous system only disease recurrence was experienced by 14% of patients in the BSC arm compared to 4% in the atezolizumab arm. A combined locoregional plus distant disease recurrence was similar between the treatment arms (BSC = 18%; atezolizumab = 16%).
Among patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, 94.7% of patients who received atezolizumab compared to 69.6% who received BSC reported at least 1 AE. The top 5 reported AEs were cough (9.8% for BSC versus 14.2% for atezolizumab); nasopharyngitis (12.5% for BSC versus 8.8% for atezolizumab), arthralgia (5.4% for BSC versus 13.3% for atezolizumab), pruritis (2.7% for BSC versus 11.5% for atezolizumab), and anemia (8.0% for BSC versus 7.1% for atezolizumab). The following AEs had a difference of at least 5% between the treatment arms, with a greater proportion in the atezolizumab arm: arthralgia, asthenia, blood creatine increased, diarrhea, rash, pruritus, and pyrexia.
Among patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, at least 1 grade 3 to 4 AE was reported in 11.6% and 20.4% of patients randomized to BSC and atezolizumab, respectively. The most commonly reported grade 3 to 4 AEs were decreased neutrophil count (1.8%) in patients who received BSC; and increased alanine aminotransferase (1.8%) and abnormal hepatic function (2.7%) in patients who received atezolizumab. No grade 5 AEs were reported.
Among patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, 15% of patients who received atezolizumab reported at least 1 serious AE compared to 5.4% who received BSC. The most commonly reported serious AE was pyrexia (1.8%).
Among patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, 29.2% of patients who received atezolizumab had at least 1 dose interruption due to an AE. Reasons for the dose interruptions included hyperthyroidism (3.5%), pneumonia (2.7%), upper respiratory tract infection (1.8%), pyrexia (1.8%), rash (1.8%), and oropharyngeal pain (1.8%).
Among patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, 18.6% of patients who received atezolizumab stopped treatment due to an AE. Reasons for the discontinuation were not available for this subpopulation.
Among the overall safety population, 18.2% of patients who received atezolizumab stopped treatment due to an AE. The most common events leading to treatment discontinuation were pneumonitis (1.4%), hypothyroidism (1.4%), and increased AST (1.4%).
There were no treatment-related death data in the subpopulation of patients with stage II to stage IIIA NSCLS and PD-L1 expression on 50% or more of TCs.
Among the overall safety population, the proportion of patients who died were similar in the BSC (18.2%) and atezolizumab (19.2%) treatment arms. Of these deaths, 95.1% occurred more than 30 days from last study treatment or safety visit. Treatment-related deaths due to AEs occurred in 0.6% and 1.6% of patients in the BSC and atezolizumab arms, respectively. The majority of deaths were due to disease progression.
Among the subpopulation of patients with stage II to stage IIIA NSCLC and PD-L1 expression on 50% or more of TCs, reported immune-mediated reactions related to endocrinopathies included hypothyroidism (atezolizumab = 14.2%; BSC = 0%) and hyperthyroidism (atezolizumab = 4.4%; BSC = 1.8%). Overall immune-mediated rashes were reported by 1.8% and 18.6% of patients who received BSC and atezolizumab, respectively. One person who received atezolizumab experienced a grade 3 to 4 rash. Immune-mediated colitis (grade 3 to 4) was reported by 1 person who received atezolizumab. Immune-related pneumonitis was reported by 5.3% of patients who received atezolizumab, of which 1 was graded at 3 to 4. Immune-mediated hepatitis was reported by 4.5% and 13.3% of patients who received BSC and atezolizumab, respectively. Among patients who received atezolizumab, 5.3% experienced grade 3 to 4 immune-mediated hepatitis.
Data related to infusion-related reactions were not reported for the subpopulation of patients with stage II to stage IIIA NSCLS and PD-L1 expression on 50% or more of TCs.
The critical appraisal of the IMpower010 study by CADTH was limited by the decision made by Health Canada to amend the Notice of Compliance from the original indication population to include only the subset of the population of patients with stage II to stage IIIA NSCLC whose tumour had a PD-L1 expression on 50% or more of TCs. Randomization was stratified by sex (female versus male), tumour histology (squamous versus nonsquamous), extent of disease (stage IB versus stage II versus stage IIIA, based on the UICC and AJCC, 7th edition) and PD-L1 expression status (TC2 or TC3 and any tumor-infiltrating immune cell [IC]; IC versus TC0 or TC1 and IC2 or IC3 versus TC0 or TC1 and IC0 or IC1 using the SP142 immunohistochemistry assay). The choice of stratification factors was considered to be reasonable, and as noted in the Health Canada report, stage of disease is a known prognostic factor for NSCLC, and PD-L1 tumour performance status is a predictive factor for immunotherapy efficacy in the setting of incurable NSCLC. The enrolled subpopulation of patients that met the Health Canada indication only accounted for 22.8% of the total randomized population and was not a defined subpopulation among the primary end points for the analysis in the IMpower010 trial design. As such, the IMpower010 trial was not powered for the Health Canada indication under review. Of note, Health Canada’s decision to amend the indication to PD-L1 expression on 50% or more of TCs at the time of the interim analysis was due to uncertainty with the clinical benefit of atezolizumab in the PD-L1 1% to 49% TCs stage II to stage IIIA population; Health Canada noted that the improvement in DFS was mainly driven by the PD-L1 expression on 50% or more of TCs subgroup. Likewise, the European Medicines Agency also considered the PD-L1 expression on 50% or more of TCs subgroup the most relevant for labelling at the time of the interim analysis.
Although DFS in patients with PD-L1 expression on 50% or more of TCs was a prespecified secondary end point, it was absent from the statistical testing hierarchy. Thus, the statistical analyses of the efficacy outcomes were conducted with no control for multiplicity, which increases the risk of false-positive conclusions. Several subgroup analyses were performed to examine the consistency of the treatment effect observed for the primary and key secondary efficacy end points. However, proper interpretation of all subgroups was not possible due to lack of sample size considerations and their absence from the statistical testing hierarchy. Moreover, data for OS were immature, and while clinical experts believe it is plausible that the findings for DFS will translate to OS, there remains uncertainty whether the findings for DFS will translate to OS.
Among the subgroup of patients with PD-L1 expression on 50% or more of TCs and stage II to stage IIIA disease, there were some minor imbalances across groups but these did not universally favour either group and may be considered reasonable given the small sample size. Additionally, minor differences in characteristics between this subgroup and the intention-to-treat population were not expected to confound the efficacy analyses.
The demographic characteristics of the study population were considered by the clinical expert to be generally reflective of the relevant population with NSCLC in Canada. The clinical experts considered the results of the IMpower010 multinational, multicentre study to be generalizable to the Canadian setting. The clinical experts did highlight a few notable differences in disease characteristics (i.e., larger proportion of patients with squamous lung cancer) and treatment regimen (i.e., cisplatin doublets containing gemcitabine and docetaxel are not commonly used in Canadian lung cancer practice in the adjuvant setting) between the trial population and the Canadian NSCLC population. Patient-important outcomes, such as HRQoL, were not reported.
No indirect treatment comparisons were included in the sponsor’s submission to CADTH or identified in the literature search.
No long-term extension studies or other relevant studies were included in the sponsor’s submission to CADTH or identified in the literature search.
Cost and Cost-Effectiveness.
CADTH identified the following limitations in the sponsor’s base case: the proportion of patients that would undergo PD-L1 biomarker testing is underestimated; the projected market share of adjuvant atezolizumab is underestimated; and there is uncertainty with the estimation of atezolizumab’s treatment duration, as it is not reflective of the product monograph. CADTH performed reanalyses, in line with clinician expert opinion, by assuming that 99% of patients who undergo surgical resection receive PD-L1 biomarker testing and increasing the projected market share of atezolizumab to 80%, 90%, and 100% in years 1, 2, and 3, respectively. Based on the CADTH reanalyses, the budget impact from the introduction of atezolizumab adjuvant therapy in the reimbursement request population is expected to be $17,525,096 in year 1, $19,914,406 in year 2, and $22,351,822 in year 3, with a 3-year total of $59,791,324. If atezolizumab were available at a 24% price reduction, the expected budget impact would decrease to $45,583,434 over 3 years. CADTH performed scenario analyses whereby patients in the new drug scenario on atezolizumab received 18 cycles of adjuvant atezolizumab to reflect the potential full-year treatment duration, as per atezolizumab’s product monograph. This led to an increase in the estimated budget impact ($67,191,267).
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: July 13, 2022
Regrets: Two expert committee members did not attend.
Conflicts of interest: None
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Indication: As monotherapy for adjuvant treatment following resection and platinum-based chemotherapy for patients with non–small cell lung cancer whose tumours have programmed death-ligand 1 expression on 50% or more of tumour cells.
Sponsor: Hoffmann-La Roche Ltd.
Final recommendation: Reimburse with conditions
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