NEW YORK – The UK's National Institute for Health and Care Excellence on Tuesday recommended that the Cancer Drugs Fund provide osimertinib (AstraZeneca's Tagrisso) to early-stage EGFR-mutated non-small cell lung cancer patients in England.
NICE recommended osimertinib as an adjuvant treatment specifically for NSCLC patients who have had surgery to remove their stage IB to IIIA tumors driven by EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Eligible patients can receive the drug for up to three years.
Early-stage NSCLC patients may be cured with surgical removal of their tumors, but the cancer recurs in around 45 percent of cases. After reviewing data from the Phase III ADAURA trial, NICE believes that osimertinib may be helpful in stopping post-surgical tumor growth or even stave off relapse.
However, the data from ADAURA is still early when it comes to showing osimertinib's impact on survival. NICE concluded that while there is evidence demonstrating adjuvant osimertinib reduces the risk of cancer relapse by 80 percent, there is still uncertainty as to the therapy's ability to extend survival.
Given the immaturity of the survival data, NICE decided to recommend osimertinib through the CDF rather than through NHS. Drugs provided through the CDF are available for a period of time while the sponsors provide more evidence for NICE to appraise. Using that data, NICE issues a final decision as to whether a particular treatment should be made available through the National Health Service.
The UK's Medicines and Healthcare products Regulatory Agency authorized osimertinib for the adjuvant treatment of EGFR-mutated NSCLC patients in May. Since then, AstraZeneca has been providing the drug in this setting in a "budget-neutral basis to the NHS" while NICE conducted its cost-effectiveness appraisal.
Following NICE's recommendation, AstraZeneca will continue to make the therapy available through the CDF at an undisclosed discounted price. The list price for a month's supply of 80 mg osimertinib tablets is £5,770 ($7,681).
EGFR mutations occur in approximately 10 percent of lung cancer patients in the UK. NICE estimated that more than 600 patients in England may benefit from adjuvant osimertinib through the CDF.