Package advice for the lock procedure drug osimertinib (Tagrisso®)
The National Health Care Institute has completed its assessment whether osimertinib (Tagrisso®) can be included in the insured package. Osimertinib is indicated as adjuvant treatment after complete tumour resection in adults with stage IB-IIIA NSCLC with EGFR mutations. The reason for this advice was the placing of osimertinib in the so-called ‘lock procedure’ for expensive medications. The National Health Care Institute advises the Minister of Medical Care to include osimertinib in the health insurance package for the said indication, provided that the price negotiations with the marketing authorisation holder result in a lower price that is at least in line with the current price arrangement.
Registered indication
Osimertinib (Tagrisso®) is indicated as monotherapy in adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer involving tumours with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L585R) substitution mutations.
Established medical science and medical practice
The National Health Care Institute has concluded that osimertinib meets the statutory criterion of ‘established medical science and medical practice’ for the said indication. This is an effective medicinal product that substantially prolongs the disease-free interval. This is a cost-effective medicinal product for the said indication, but there are arguments to negotiate the price.
The National Health Care Institute's advice
The National Health Care Institute advises the Minister to include osimertinib in the health insurance package, provided that the price negotiations with the marketing authorisation holder result in a lower price that is at least in line with the current price arrangement.
If osimertinib for the said indication is added to the health insurance package, the National Health Care Institute will monitor the use of this medicinal product. In the context of the treatment landscape, the National Health Care Institute considers the following points:
- the initial estimate of the number of patients compared to the actual number treated;
- the cost development compared to the original estimate.