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SMC ID Date Medicine Indication
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.
SMC2124 08/10/2018 cenegermin (Oxervate) Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
SMC2126 08/10/2018 sirolimus (Rapamune) Treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
SMC2094 08/10/2018 ipilimumab (Yervoy) Treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older.
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.
SMC2117 10/09/2018 denosumab (Prolia) Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
SMC2015 10/09/2018 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).
SMC2093 10/09/2018 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.
SMC2091 10/09/2018 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).
SMC2011 10/09/2018 dupilumab (Dupixent) For treatment of moderate-to-severe atopic dermatitis.
1339/18 10/09/2018 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)
SMC2014 10/09/2018 tocilizumab (RoActemra) For the treatment of Giant Cell Arteritis (GCA) in adult patients.
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.
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).
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Advice due date SMC meeting date Medicine Indication
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.
12/11/2018 02/10/2018 dinutuximab beta (Qarziba) Indicated 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 (MAT) and stem cell transplantation, as well as patients with history of relapsed or refractory (R/R) neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of R/R disease and in patients who have not achieved a complete response (CR) after first line therapy, Qarziba should be combined with interleukin 2 (IL-2) (1).
12/11/2018 02/10/2018 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
12/11/2018 02/10/2018 axicabtagene ciloleucel (Yescarta) for treating relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma
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 darvadstrocel (Alofisel) Treatment of complex perianal fistula(s) in adult patients with non-active/mildly active luminal Crohn’s disease (CD), when fistula(s) have shown an inadequate response to at least one conventional or biologic therapy.
14/01/2019 04/12/2018 arsenic trioxide (Trisenox) Indicated for 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) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy)
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 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 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 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 certolizumab pegol (Cimzia) Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
Q1 2019 Q1 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
Q1 2019 Q1 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
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.
Q1 2019 Q4 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.
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