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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
Evidence-based recommendations on olaparib (Lynparza) for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy in adults.
Evidence-based recommendations on dostarlimab (Jemperli) with platinum-based chemotherapy for treating advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency 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
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
Remdesivir and tixagevimab plus cilgavimab for treating COVID-19 (TA971)
Evidence-based recommendations on remdesivir (Veklury) and tixagevimab plus cilgavimab (Evusheld) for treating COVID-19.
NICE is unable to make a recommendation on pembrolizumab (Keytruda) with gemcitabine and cisplatin for untreated advanced biliary tract cancer in adults. This is because Merck Sharp & Dohme 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 TA966
NICE is unable to make a recommendation on melphalan flufenamide (Pepaxti) for treating relapsed or refractory multiple myeloma in adults. This is because Oncopeptides 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 TA968
Evidence-based recommendations on semaglutide (Wegovy) for managing overweight and obesity in adults.
Gefapixant for treating refractory or unexplained chronic cough (terminated appraisal) (TA969)
NICE is unable to make a recommendation on gefapixant (Lyfnua) for treating refractory or unexplained chronic cough in adults. This is because Merck Sharp & Dohme 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 TA969
Ritlecitinib for treating severe alopecia areata in people 12 years and over (TA958)
Evidence-based recommendations on ritlecitinib (Litfulo) for treating severe alopecia areata in people 12 years and over.
Tofacitinib for treating active ankylosing spondylitis (TA920)
Evidence-based recommendations on tofacitinib (Xeljanz) for treating active ankylosing spondylitis.
Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma (TA540)
Evidence-based recommendations on pembrolizumab (Keytruda) for treating relapsed or refractory classical Hodgkin lymphoma in adults.