NICE accepted Opdivo as an adjuvant treatment for wholly resected melanoma with lymph node involvement or metastatic disease
NICE said OK for Opdivo as an adjuvant treatment for completely resected melanoma in adults with lymph node involvement or metastatic disease.
Lymph node resection is considered the standard of care for stage 3 melanoma and some patients with stage 4 melanoma. Until recently, continuous monitoring is recommended after the resection of melanoma. The committee believed that there is a need for adjuvant treatment for the complete removal of the melanoma. The adjuvant therapy helps in preventing the recurrence of cancer. Keytruda (pembrolizumab) was recommended for patients who are at high risk of recurrence.
The recommendation was based on the CheckMate 238 trial. The study was a Phase-3 multi-center, randomized trial comparing the efficacy of Opdivo versus Yervoy. Patients with complete resection in either stage 3B, 3C, or four were enrolled in the trial. Significant improvement in recurrence-free survival was observed in the Opdivo arm versus the Yervoy arm. However, the overall survival data were immature.
Further, the committee was of the opinion that there are several treatment options available in case of recurrence. The data available from the Cancer Drugs Fund is limited for patients who were treated with Opdivo; only 14% of patients had subsequent treatments. Clinical experts believed that combination treatment could be provided if the patient is tolerant. NICE agreed that there is a higher degree of certainty in trial than the data available with CDF. NICE agreed that the subsequent treatment of the Opdivo arm in the CheckMate 238 trial is per the clinical practice.
BMS submitted a partitioned survival model and a state transition model for the appraisal.
NICE draft guidance recommended Novartis’ £1.79 million Zolgensma for SMA
NICE published draft guidance, which recommended the use of Zolgensma (also called onasemnogene abeparvovec) for patients of age less than 12 months.
Zolgensma is used for treating patients with SMA 1, a rare genetic disorder. Patients with SMA have a life expectancy of less than two years.
NICE stated that even though the product is highly expensive, it recommends using it within the NHS as it benefits young babies significantly.
Further, NICE suggested using Zolgensma after an initial discussion with a national multidisciplinary clinical team. This enables the patients to get the treatment who are eligible as per market authorization of the drug but were not included in the trial.
SMA is a rare neuromuscular condition caused by a mutation that results in the inadequate expression of survival motor neuron (SMN) protein. Previously NICE recommended Biogen’s Spinraza for SMA type 1, 2, or 3 patients.
It is estimated that nearly 65 children are born each year in England with SMA, 60% of who have type 1 SMA.
NICE OKs Novartis Kisqali for routine use
Improvement in the overall survival certainty and improved progression-free survival are critical drivers for the recommendation.
NICE has announced that Kisqali (ribociclib) will be available for routine use after its draft guidance. Previously the drug is recommended under Cancer Drugs Fund (CDF).
The draft guidance recommended the combination of Kisqali and fulvestrant for treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced metastatic breast cancer.
The recommendation was based on the fact that Kisqali and fulvestrant combination increase the progression-free survival and overall survival compared to fulvestrant alone.
Kisqali is the only CDK4/6 inhibitor recommended for routine use; the other two products (palbociclib, abemaciclib) are recommended under the Cancer Drugs Fund.
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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