AUGUST: NICE ASSESSMENT OUTCOMES
Roche’s Rozlytrek recommended as monotherapy for solid tumors expressing a neurotrophic tyrosine receptor kinase gene fusion
The drug is recommended Rozlytrek (entrectinib) in adult and pediatric patients (12 years and older) patients who have:
Locally advanced metastatic cancer or where surgical resection is likely to result in severe morbidity
Were not previously treated with NTRK inhibitor
No satisfactory treatment options are available
The company has agreed to a commercial agreement that enables NHS to obtain entrectinib with a discount. At list price, the cost of treatment with entrectinib for one year is nearly £ 62,000.
England’s cost watchdog has commented that the drug targets a specific genetic mutation, which posed challenges in appraising the drug candidate. The drug target a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Entrectinib is placed as a final option for treating cancer; it can be administered if the patient was prior treated with all the available NHS commissioned treatments.
The drug has been recommended for use within the Cancer Drugs Fund.
Roche’s Rozlytrek recommended for ROS1-positive advanced non-small-cell lung cancer (NSCLC)
NICE has recommended Rozlytrek (entrectinib) for ROS1-positive advanced non-small-cell lung cancer (NSCLC) as a first-line treatment. NICE has recommended the product only if the company agrees for the commercial access agreement.
NICE has agreed that patient experts would prefer to have an oral dosage form ROS1 positive NSCLC. ROS1 positive mutations are rare in patients with NSCLC, with only 2% of NSCLC patients have ROS1 positive mutations.
The company has submitted two Phase 1 studies (ALKA and STARTRK‑1) and one Phase 2 study (STARTRK‑2) for the appraisal. NICE agreed that entrectinib shows a high overall response rate and slows disease progression.
NICE accepted that Rozlytrek is cost-effective, the drug is likely to have an ICER value of less than £50,000 per QALY gained versus PEM+PLAT. It was considered to be acceptable for end-of-life treatments.
NICE recommended Astellas Xospata for FLT3 positive AML
NICE has recommended Xospata (gilteritinib) for FLT3mutation-positive acute myeloid leukemia. The drug is administered as monotherapy. NICE recommended Xospata not to be administered as maintenance therapy for patients who underwent hematopoietic stem cell transplant.
The company has agreed to provide a commercial agreement to have a positive recommendation.
FLT3 mutations are associated with poor outcomes and a high relapse rate. NICE agreed that new treatment options are welcome, which improve the survival and quality of life. NICE commented that oral dosage form improves the quality-of-life benefits for patients. Also, patients who were on Xospata live longer compared to patients who were on chemotherapy.
The company has submitted the ADMIRAL study for the assessment. NICE considered salvage chemotherapy as an appropriate comparator; the median overall survival was increased from 5.6 months to 9.3 months compared to salvage chemotherapy.
NICE commented on the lack of robust evidence in patients who underwent transplantation.
The ICER value was less than £50,000 per QALY compared to the salvage chemotherapy. NICE has accepted that this is within the range, at which it is considered to be acceptable for life-extending treatment.
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