Nice focus: osimertinib for non-small-cell lung cancer

What’s the guidance?

TA653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer

TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer

Does it replace earlier guidance?

Yes, TA653 updates and replaces NICE technology appraisal guidance 416 on osimertinib for treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC), which was available through the Cancer Drugs Fund. TA654 updates and replaces NICE technology appraisal guidance 621 on osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer.

What does it cover?

The new guidance recommends osimertinib (also called Tagrisso and made by AstraZeneca) at two different places in the treatment pathway for locally advanced or metastatic epidermal growth factor receptor (EGFR)-positive NSCLC.

Cancer Research UK suggests that there are close to 50,000 new cases of lung cancer each year in the UK, accounting for 13% (in 2017) of all cancer cases. NSCLC refers to any cancer of the lung other than small cell lung carcinoma. Support group EGFR Positive UK explains that EGFR is a protein involved in the growth and division of healthy cells.  A mutation (damage) to the gene coding for this protein can cause cells to grow out of control and lead to cancer.

Around 1,800 people in England have advanced EGFR-positive NSCLC, and the majority are set to benefit from the new recommendations.

The positive recommendation for untreated advanced EGFR-positive NSCLC follows a rapid review of Nice’s previous guidance, which did not recommend the treatment. The company has since offered an updated commercial arrangement meaning it is now a cost-effective use of NHS resources.

Additionally, Nice has recommended osimertinib for routine use on the NHS as a second-line treatment for patients with locally advanced or metastatic EGFR-positive NSCLC with the T790M mutation. The treatment was previously available through the Cancer Drugs Fund for this group of patients, but has now been approved for routine commissioning on the NHS.

Who is it for?

• Healthcare professionals
• Commissioners and providers of healthcare
• People with EGFR mutation-positive non-small-cell lung cancer, and their families and carers

Who is affected by the condition?

EGFR-positive NSCLC is a relatively rare form of lung cancer accounting for around 10% of lung cancer cases. Currently, the first line of treatment for locally advanced stages of the disease is a daily oral dose of afatinib, erlotinib, gefitinib or dacomitinib, which have all been recommended by NICE.

What are the benefits for patients?

Osimertinib has shown the ability to improve the lives of patients with this devastating disease and is likely to extend their time with family and friends. Clinical trial evidence shows that treatment with osimertinib stalled cancer-growth longer than treatment with erlotinib or gefitinib. However, there is no direct evidence comparing the treatment with afatinib, which may be more effective than erlotinib or gefitinib.

What are the financial implications?

The company has a commercial arrangement, including a patient access scheme, which makes osimertinib available to the NHS with a discount. The size of the discount is commercial in confidence.

The estimated net financial impact of implementing TA654 can be calculated using the local resource impact template provided. The discounted price of osimertinib can be put into the template and other variables may be amended.

Implementing TA653 is not expected to have a significant impact on resources. This is because targeted treatment options (now including osimertinib) are recommended earlier in the treatment pathway for EGFR positive tumours. It is therefore anticipated that many people who have the T790M mutation would have already received osimertinib as a first-line treatment and would not receive it again if their disease progresses.

Gary Shield is resource impact assessment manager at Nice