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SMC ID Date Medicine Indication
SMC2110 13/08/2018 denosumab (Xgeva) prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with haematological malignancies involving bone.
SMC2109 13/08/2018 bosutinib (Bosulif) For treatment of adult patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemia.
SMC2084 13/08/2018 patiromer sorbitex calcium (Veltassa) For the treatment of hyperkalaemia in adults in patients with advanced CKD (stage 3-4) on RAAS inhibitor treatment who develop hyperkalaemia.
1342/18 13/08/2018 glycerol phenylbutyrate (Ravicti) As adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
1341/18 13/08/2018 niraparib tosylate monohydrate (Zejula) As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
SMC2012 13/08/2018 alectinib hydrochloride (Alecensa) As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
558/09 13/08/2018 sapropterin (Kuvan) Treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.
745/11 13/08/2018 conestat alfa (Ruconest) Treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency
1337/18 09/07/2018 lutetium 177Lu oxodotreotide (Lutathera) Unresectable or metastatic, progressive, well differentiated (G1 and G2) somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours in adults.
1336/18 09/07/2018 atezolizumab (Tecentriq) for NSCLC Treatment of adult patients with locally advanced ot metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq.
SMC2098 09/07/2018 brentuximab vedotin (Adcetris) treatment of adult patients with CD30+ cutaneous T-cell lymphoma after at least one prior systemic therapy.
SMC2099 09/07/2018 ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
SMC2100 09/07/2018 midostaurin (Rydapt) as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or mast cell leukaemia.
SMC2101 09/07/2018 raltegravir (Isentress) in combination with other anti-retroviral medicinal products in the treatment of human immunodeficiency virus in neonates.
SMC2017 09/07/2018 progesterone (Lubion) Indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.
1344/18 09/07/2018 ocrelizumab (Ocrevus) Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features
1335/18 09/07/2018 tivozanib (Fotivda) For the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC.
SMC2016 11/06/2018 fluticasone/formoterol (flutiform k-haler) Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. • flutiform k-haler) is indicated in adults and adolescents aged 12 years and above.
1330/18 11/06/2018 midostaurin (Rydapt) for AML Treatment of adult patients with newly diagnosed acute myeloid leukaemia who are FLT3 mutation positive in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy.
1328/18 11/06/2018 inotuzumab ozogamicin (Besponsa) As monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia. Adult patients with Philadelphia chromosome positive relapsed or refractory B cell precursor acute lymphoblastic leukaemia should have failed treated with at least 1 tyrosine kinase inhibitor.
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Advice due date SMC meeting date Medicine Indication
10/09/2018 07/08/2018 eslicarbazepine acetate (Zebinix) For adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.
10/09/2018 07/08/2018 dolutegravir rilpivirine (Juluca) For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).
10/09/2018 07/08/2018 bictegravir-emtricitabine-tenofovir alafenamide (Biktarvy) For the treatment of adults infected with HIV-1 without any known mutations associated with resistance to the individual components.
10/09/2018 07/08/2018 tocilizumab (RoActemra) For the treatment of Giant Cell Arteritis (GCA) in adult patients.
10/09/2018 07/08/2018 obinutuzumab (Gazyvaro) In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).
10/09/2018 07/08/2018 dupilumab (Dupixent) For treatment of moderate-to-severe atopic dermatitis.
10/09/2018 07/08/2018 pembrolizumab (Keytruda) (urothelial carcinoma) As monotherapy for the treatment of locally advanced or metastatic or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy (first line)
08/10/2018 04/09/2018 ixekizumab (Taltz) Treatment alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug therapies.
08/10/2018 04/09/2018 ipilimumab (Yervoy) Treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older.
08/10/2018 04/09/2018 anakinra (Kineret) Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
08/10/2018 04/09/2018 cabozantinib (Cabometyx) Treatment of advanced renal cell carcinoma in treatment-naïve adults with intermediate or poor risk per IMDC criteria.
08/10/2018 04/09/2018 gemtuzumab ozogamicin (Mylotarg) Combination therapy with daunorubicin and cytarabine (DA) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive AML, except acute promyelocytic leukaemia (APL).
12/11/2018 02/10/2018 fampridine (Fampyra) is indicated for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (expanded disability status score [EDSS] 4–7)
12/11/2018 02/10/2018 fosaprepitant (IVEMEND) Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.
10/12/2018 06/11/2018 semaglutide (Ozempic) Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
10/12/2018 06/11/2018 ocrelizumab (Ocrevus) Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
14/01/2019 04/12/2018 ertugliflozin (Steglatro) In adults aged 18 years and older with T2DM as an adjunct to diet and exercise to improve glycaemic control: • As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. • In addition to other medicinal products for the treatment of diabetes.
14/01/2019 04/12/2018 tofacitinib (Xeljanz) In combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy.
Q1 2019 Q1 2019 pertuzumab (Perjeta) For use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
TBC 05/06/2018 letermovir (Prevymis) Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant
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