following a full submission assessed under the orphan equivalent medicine process:
osimertinib (Tagrisso®) is accepted for restricted use within NHSScotland.
Indication under review: as monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
SMC restriction: treatment with osimertinib is subject to a three-year clinical stopping rule.
In a placebo-controlled phase III study, osimertinib significantly improved disease free survival (DFS) in patients with completely resected EGFR mutation-positive NSCLC.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- osimertinib (Tagrisso)
- SMC ID:
- SMC2383
- Indication:
Adjuvant treatment after complete tumour resection in adult 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.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 08 November 2021