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SMC ID Date Medicine Indication
SMC2113 10/12/2018 brivaracetam (Briviact) Treatment of partial onset seizures with our without secondary generalisation in children from 4 years of age to 15.
SMC2119 10/12/2018 pertuzumab (Perjeta) For use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
SMC2143 10/12/2018 pembrolizumab (Keytruda) As monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy.
SMC2121 10/12/2018 ocrelizumab (Ocrevus) Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
SMC2111 10/12/2018 ciclosporin (Verkazia) treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents (until the age of 18)
SMC2112 10/12/2018 nivolumab (Opdivo) as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
SMC2133 12/11/2018 evolocumab (Repatha) In adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors.
SMC2103 12/11/2018 atezolizumab (Tecentriq) As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: − after prior platinum-containing chemotherapy, or − who are considered cisplatin ineligible
SMC2105 12/11/2018 dinutuximab beta (Qarziba) For the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
SMC2107 12/11/2018 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)
SMC2108 12/11/2018 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.
SMC2094 08/10/2018 ipilimumab (Yervoy) Treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older.
SMC2124 08/10/2018 cenegermin (Oxervate) Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
SMC2125 08/10/2018 lenalidomide (Revlimid) As monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
SMC2126 08/10/2018 sirolimus (Rapamune) Treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
SMC2104 08/10/2018 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).
SMC2095 08/10/2018 cabozantinib (Cabometyx) Treatment of advanced renal cell carcinoma in treatment-naïve adults with intermediate or poor risk per IMDC criteria.
SMC2089 08/10/2018 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).
SMC2088 08/10/2018 hydrocortisone (Alkindi) for the replacement therapy of adrenal insufficiency in infants, children and adolescents (aged from birth to <18 years old).
SMC2097 08/10/2018 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.
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Advice due date SMC meeting date Medicine Indication
14/01/2019 04/12/2018 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.
14/01/2019 04/12/2018 arsenic trioxide (Trisenox) In combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene
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.
11/02/2019 08/01/2019 tisagenlecleucel (Kymriah) Treatment of paediatric and young adult patients up to 25 years with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse
11/02/2019 08/01/2019 tofacitinib (Xeljanz) For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent
11/02/2019 08/01/2019 pembrolizumab (Keytruda) In combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations
11/02/2019 08/01/2019 cabozantinib (Cabometyx) treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk per IMDC criteria
11/02/2019 08/01/2019 dabrafenib (Tafinlar) In combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection
11/02/2019 08/01/2019 rivaroxaban (Xarelto) Co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events
08/04/2019 05/03/2019 erenumab (Aimovig) for the prophylaxis of migraine in adults who have at least 4 migraine days per month
08/04/2019 05/03/2019 mepolizumab (Nucala) Add-on therapy for children (6y+), adolescents, and adults with severe refractory eosinophilic asthma
08/04/2019 05/03/2019 testosterone (Testavan) For replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
08/04/2019 05/03/2019 certolizumab pegol (Cimzia) Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
08/04/2019 05/03/2019 rufinamide (Inovelon) as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older
08/04/2019 05/03/2019 blinatumomab (Blincyto) as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
13/05/2019 02/04/2019 doxylamine succinate and pyridoxine hydrochloride (Xonvea) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
Q1 2019 Q1 2019 liposomal formulation of daunorubicin & cytarabine (Vyxeos) Treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AMC-MRC)
Q1 2019 Q1 2019 tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B‑cell lymphoma (DLBCL) after two or more lines of systemic therapy
Q2 2019 Q2 2019 abemaciclib (Verzenios) Women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
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