2 The technology

2 The technology

Description of the technology

Osimertinib (Tagrisso, AstraZeneca) is a small-molecule inhibitor that targets the sensitising and T790M mutant forms of the epidermal growth factor receptor (EGFR)-tyrosine kinase receptor.

Marketing authorisation

Osimertinib has a conditional marketing authorisation for 'the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC)'. The marketing authorisation is conditional on the company submitting the clinical study report of the phase III AURA3 study comparing osimertinib with platinum-based doublet chemotherapy (expected June 2017).

Adverse reactions

The most common adverse reactions associated with osimertinib include diarrhoea, rash, dry skin, and a reduction in platelet count and some white blood cells. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

80 mg taken orally once a day until disease progression or unacceptable toxicity.

Price

£5,770.00 per pack (30 tablets) of 80 mg tablets and £5,770.00 per pack (30 tablets) of 40 mg tablets (excluding VAT; MIMS online and company correspondence). Treatment is continued until disease progression.

The pricing arrangement considered during guidance development was that the company (AstraZeneca) had agreed a patient access scheme with the Department of Health. This scheme would provide a simple discount to the list price of osimertinib with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS. The managed access agreement agreed in September 2016 replaced the patient access scheme.

  • National Institute for Health and Care Excellence (NICE)