Table 2, Cost and Cost-Effectiveness (2024)

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Osimertinib (Tagrisso): CADTH Reimbursem*nt Recommendation: 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 [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Jan.

Osimertinib (Tagrisso): CADTH Reimbursem*nt Recommendation: 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 [Internet].

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Table 2Cost and Cost-Effectiveness

Component	Description
Type of economic evaluation	Cost-utility analysis Markov model
Target population	Adult patients (aged ≥18 years) with completely resected, early-stage EGFR mutation-positive, NSCLC
Treatment	Osimertinib
Submitted drug price	Osimertinib, 40 mg: $294.68 per tablet Osimertinib, 80 mg: $294.68 per tablet
Annual cost	At the sponsor’s submitted price of $294.68 per 80 mg tablet, the annual cost of osimertinib adjuvant therapy would be $107,557 if patients remained on therapy for a full year.
Comparator	Active surveillance, consisting of no active treatment
Perspective	Canadian publicly funded health care payer
Outcomes	QALYs, LYs
Time horizon	Lifetime (38 years)
Key data source	ADAURA trial, a randomized, double-blind, placebo-controlled, multicenter phase III study evaluating the efficacy of osimertinib as adjuvant therapy following complete tumour resection with curative intent with or without adjuvant chemotherapy
Key limitations	As overall survival in the ADAURA trial was immature, it is unknown whether osimertinib confers an OS benefit compared to placebo. The impact of osimertinib adjuvant therapy on long-term DFS and the subsequent impact on OS is highly uncertain. The time to establish cure used in the model was felt to be shorter than what was considered by CADTH clinical experts. CADTH clinical experts felt that the distribution of patients across subsequent therapies used upon transitioning to local regional is not aligned with clinical practice. Additionally, cisplatin-pemetrexed was noted as the more commonly used chemoradiotherapy regimen for LR progression. Annual disease management costs for LR did not meet face validity as they were higher than those for distant metastatic disease, which was deemed inappropriate by CADTH clinical experts. AEs were assumed to only occur in the first month of treatment, which is uncertain and favours osimertinib. Health state utility values do not meet face validity, as the utility for patients who are disease free or with local regional recurrence was estimated to be higher than that of the general Canadian population in the sponsor’s submission. Time to retreatment with osimertinib upon progression to distant metastatic disease is uncertain. A relative dose intensity (RDI) sourced from osimertinib trials in the distant metastatic setting was applied in the adjuvant setting. Survival outcomes in the 2L DM setting were potentially influenced by treatment crossover in the FLAURA trial. This is likely not reflective of survival outcomes in current practice.
CADTH reanalysis results	• CADTH undertook reanalyses to address limitations relating to: survival extrapolations relating to transitions from DF to LR and DF to 1L DM; extending the time to establish cure to 5 years; aligning the distribution and type of subsequent treatments used in LR progression with Canadian clinical practice; adjusting LR disease management costs to be equal to those used in the distant metastatic health states; removing radiotherapy costs and dialysis costs for those in DF and LR; using trial-based and age-adjusted utility values; adjusting the RDI to 100% and altering 2L DM to death transition probabilities. • Compared to active surveillance, the ICER for osimertinib is $328,026 per QALY. • For osimertinib to be considered cost-effective at a WTP threshold of $50,000 per QALY compared to active surveillance, a price reduction of at least 82% would be required.

: 2L = second line; DF = disease free; DFS = disease-free survival; DM = distant metastatic; ICER = incremental cost-effectiveness ratio; LR = local regional recurrence; LY = life year; QALY = quality-adjusted life year; RDI = relative dose intensity.