In the treatment of bronchial cancer, the specialties TAGRISSO 40 mg and TAGRISSO 80 mg film-coated tablet (osimertinib) benefit from an extension of coverage (100% reimbursement in the city and approval for communities)[[1, 2]in the following indication:
- adjuvant treatment, after complete tumor resection, and after adjuvant chemotherapy if indicated, of adult patients with stage IB – IIIA non-small cell lung cancer (NSCLC) with activating mutations in the epidermal growth factor receptor (EGFR) by deletion of exon 19 or substitution of exon 21 (L858R).
In this indication, in accordance with the marketing authorization (AMM), TAGRISSO is used as monotherapy.
As a reminder, the prescription of TAGRISSO is hospital-based and reserved for oncology specialists or doctors competent in oncology.
A limited scope of care compared to the MA
Compared to the indication of the Marketing Authorization granted in May 2021 (cf. Boxed), the reimbursable therapeutic indication (RTI) is more restricted in accordance with the opinion issued by the Transparency Commission (CT)[[3]in 2022 and reassessed in 2023[[6]. It only concerns adjuvant treatment, after complete tumor resection, and after adjuvant chemotherapy if indicated, adult patients with stage IB–IIIA non-small cell lung cancer (NSCLC) with activating mutations in the epidermal growth factor receptor (EGFR) by deletion of exon 19 or substitution of exon 21 (L858R ).
In ITR, the actual medical benefit (SMR) is important.
The SMR is insufficient in the other situations provided for by the Marketing Authorization, that is to say when treatment with TAGRISSO has not been preceded by adjuvant chemotherapy;
The improvement in actual benefit (ASMR) is moderate (III) compared to the current management strategy based on the results of the ADAURA study[[4, 5]and new overall survival data demonstrating superiority of osimertinib on this criterion[[6].
According to the ADAURA study (phase III, randomized, double-blind, two-parallel-group trial), the superiority of osimertinib compared to placebo is demonstrated in terms of disease-free survival.[[3]and overall survival[[6]:
- in stage II-IIIA patients (hierarchical secondary endpoint), HR=0.49; IC95% [0,33-0,73] [[6];
- in stage IB-IIIA patients (total population, prioritized secondary endpoint), HR=0.49; IC95% [0,34-0,70] [[6].
The CT emphasizes that in “adjuvant situation, patients must be treated until disease recurrence or unacceptable toxicity occurs and a treatment duration greater than three years has not been studied”.
Dosage recommendations
The recommended dosage is 80 mg of osimertinib once per day (1 tablet of TAGRISSO 80 mg).
The TAGRISSO 40 mg dosage is prescribed when a dose reduction is necessary, to manage adverse effects.
