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NICE is unable to make a recommendation on trastuzumab deruxtecan (Enhertu) for treating HER2-mutated advanced non-small-cell lung cancer in adults after platinum-based chemotherapy. This is because Daiichi Sankyo did not provide an evidence submission. We will review this decision if the company decides to make a submission.
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Sections for TA976
Evidence-based recommendations on dabrafenib (Finlee) with trametinib (Spexotras) for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over.
Evidence-based recommendations on daratumumab (Darzalex) for newly diagnosed systemic amyloid light-chain amyloidosis in adults.
NICE is unable to make a recommendation on satralizumab (Enspryng) for preventing relapses in neuromyelitis optica spectrum disorders in adults
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Sections for TA960
Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema (TA953)
Evidence-based recommendations on fluocinolone acetonide intravitreal implant (Iluvien) for visual impairment caused by chronic diabetic macular oedema that has not responded well enough to available treatments in adults.
Dupilumab for treating moderate to severe prurigo nodularis (TA955)
Evidence-based recommendations on dupilumab (Dupixent) for treating moderate to severe prurigo nodularis in adults when systemic treatment is suitable.
NICE is unable to make a recommendation on sebelipase alfa (Kanuma) for treating lysosomal lipase deficiency that is not Wolman disease in adults. The Wolman disease population was evaluated separately in NICE highly specialised technology guidance on sebelipase alfa (HST30). The cost effectiveness of the remaining non-Wolman population has not been demonstrated at this stage.
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Sections for TA961
Human alpha1-proteinase inhibitor for treating emphysema (terminated appraisal) (TA965)
NICE is unable to make a recommendation on human alpa1-proteinase inhibitor (Respreeza) for treating emphysema in adults. CSL Behring UK has confirmed that it does not intend to launch the product in England and Wales. The reasons for this decision are primarily related to the company’s inability to offer the product at a price to meet the current threshold of cost effectiveness.
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Sections for TA965
Cabozantinib with nivolumab for untreated advanced renal cell carcinoma (TA964)
Evidence-based recommendations on cabozantinib (Cabometyx) with nivolumab (Opdivo) for untreated advanced renal cell carcinoma in adults.
Evidence-based recommendations on pembrolizumab (Keytruda) with trastuzumab and chemotherapy for untreated locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults.
NICE is unable to make a recommendation about the use in the NHS of baricitinib (Olumiant) for treating juvenile idiopathic arthritis in people 2 years and over. This is because Eli Lilly did not provide an evidence submission. We will review this decision if the company decides to make a submission.
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Sections for TA982
Ivosidenib with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation (TA979)
Evidence-based recommendations on ivosidenib (Tibsovo) with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation.
NICE is unable to make a recommendation on nivolumab (Opdivo) for adjuvant treatment of completely resected melanoma at high risk of recurrence in people 12 years and over. This is because Bristol-Myers Squibb did not provide an evidence submission. We will review this decision if the company decides to make a submission.
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Sections for TA980
Evidence-based recommendations on sebelipase alfa (Kanuma) for long-term enzyme replacement therapy in Wolman disease (rapidly progressive lysosomal acid lipase deficiency) in people aged 2 years and under when treatment starts.
Evidence-based recommendations on trastuzumab deruxtecan (Enhertu) for HER2-low metastatic or unresectable breast cancer after chemotherapy in adults.