Formulary Group work programme
Forthcoming submissions 2014
This list is indicative and may be subject to change.
Adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo®) - SMC 682/11 - Formulary Group advice will be published by the 29th April 2014. (Indication: cutaneous treatment of acne vulgaris when comedones, papules and pustules are present).
Afatinib - SMC 920/13 - in progress. (Indication : as monotherapy, for the treatment of EGFR tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s)).
Aflibercept - SMC 878/13 - in progress. (Indication: in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen).
Aflibercept - SMC 954/14 - in progress. (Indication: for adults for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion).
Aripiprazole - SMC 891/13 - in progress. (This SMC advice relates to an extension of the marketing authorisation for treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older).
Atomoxetine - SMC 909/13 - in progress. (Indication: treatment of attention-deficit/hyperactivity disorder (ADHD) in adults as part of a comprehensive treatment programme).
Azithromycin - SMC 950/14 - Formulary Group advice will be published by 29th April 2014. (Indication: the treatment of community acquired pneumonia (CAP) and pelvic inflammatory disease (PID) due to susceptible organisms in adult patients where initial intravenous therapy is required).
Dapagliflozin - SMC 799/12 - in progress. (Indication: for use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control).
Dimethyl Fumarate - SMC 886/13 - Formulary Group advice will be published by the 29th April 2014. (Indication: treatment of adult patients with relapsing remitting multiple sclerosis).
Eltrombopag - SMC 919/13 - in progress. (Indication: in adult patients with chronic hepatitis C virus infection, for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy).
Fluticasone furoate/vilanterol(Relvar Ellipta®) - SMC 953/14 - in progress. (Indication: symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy).
Lenalidomide - SMC 441/08 - in progress. (Indication: in combination with dexamethasone, for the treatment of multiple myeloma in adult patients who have received at least one prior therapy).
Lipegfilgrastim (Lonquex®) - SMC 908/13 - Formulary Group advice will be published by 29th April 2014. (Indication under review: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)).
Macitentan (Opsumit®) - SMC 952/14 - Formulary Group advice will be published by 29th April 2014. (Indication under review: as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension in adult patients of World Health Organisation Functional Class II to III).
Nalmefene - SMC 917/13 - in progress. (Indication: for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms, and who do not require immediate detoxification).
Ondanestron - SMC 912/13 - in progress. (Indication: in adults: Prophylaxis and treatment of acute and delayed nausea and vomiting induced by chemotherapy, and radiotherapy. Prophylaxis and treatment of post-operative nausea and vomiting.
In paediatric populations:Management of chemotherapy-induced nausea and vomiting in children aged ≥6 months and prophylaxis and treatment of post-operative nausea and vomiting (PONV) in children aged ≥4 years).
Eviplera® - SMC 951/14 - Formulary Group advice will be published by 29th April 2014. (Indication: treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with viral load ≤100,000 HIV-1 RNA copies/mL).
Teriflunomide - SMC 940/14 - Formulary Group advice will be published by the 29th April 2014. (Indication: treatment of adults with relapsing remitting multiple sclerosis (MS)).