Formulary Group work programme


Forthcoming submissions 2015

This list is indicative and may be subject to change.

Aclidinium/formoterol fumarate dihydrate - SMC 1034/15 - Formulary Group advice will be published by 5th May 2015. (Indication: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease).

Atomoxetine - SMC 909/13 - in progress. (Indication: treatment of attention-deficit/hyperactivity disorder (ADHD) in adults as part of a comprehensive treatment programme).

Azelastine hydrochloride + fluticasone propionate (Dymista) - SMC 921/13 - in progress. (Indication: for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient).

Bosutinib - SMC 910/14 - Formulary Group advice will be published by 5th May 2015. (Indication: Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options).

Fingolimod - SMC 1038/15 - Formulary Group advice will be published by 5th May 2015. (Indication: as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following adult patient groups:- Patients with high disease activity despite treatment with at least one disease modifying therapy.In patients who had high disease activity despite prior disease modifying therapy in the previous year, fingolimod reduced the annualised relapse rate compared with another disease modifying therapy).

Fosfomycin - SMC 1033/15 - Formulary Group advice will be published by 5th May 2015. (Indication: for the treatment of the following infections in adults and children including neonates:
- Acute osteomyelitis
- Complicated urinary tract infections
- Nosocomial lower respiratory tract infections
- Bacterial meningitis
- Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above).

Idelalisib - SMC 1026/15 - in progress. (Indication:In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy).

Indacaterol maleate plus glycopyrronium bromide - SMC 922/13 - in progress. (Indication:maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)).

Levonorgestrel - SMC 1036/15 -Formulary Group advice will be published by 5th May 2015. (Indication: Contraception for up to 3 years).

Nepafenac - SMC 813/12 - in progress. (Indication: reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients).

Nintedanib - SMC 1027/15 - Formulary Group advice will be published by 5th May 2015. (Indication: in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy).

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).

Ponatinib - SMC 1032/15 - Formulary Group advice will be published by 5th May 2015. (Indication: Adult patients with
- Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Regorafenib - SMC 1031/15 - Formulary Group advice will be published by 5th May 2015. (Indication: Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib).

Ruxolitinib - SMC 867/13 - Formulary Group advice will be published by 5th May 2015. (Indication:the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis).

Sucroferric oxyhydroxide - SMC 1035/15 -Formulary Group advice will be published by 5th May 2015. (Indication: For the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). It should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease).

Tacrolimus - SMC 1041/15 -Formulary Group advice will be published by 5th May 2015. (Indication: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients).

Publication schedule

This web page is updated monthly, within 7 working days of publication of SMC advice.

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