April May For adults for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion.

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Nora Lindsey
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April May 2014 Recommended for use within NHS Scotland April May 2014 aflibercept intravitreal (Eylea ) 954/14 For adults for the treatment of visual impairment due to macular oedema secondary to

1 April May 2014 Recommended for use within NHS Scotland April May 2014 aflibercept intravitreal (Eylea ) 954/14 For adults for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion. Formulary & Rationale for noninclusion Included in formulary for the aripiprazole (Abilify) 962/14 Maintenance treatment of schizophrenia in adult Included in formulary for the patients stabilized with oral aripiprazole. The treatment of community acquired Not Included in formulary because pneumonia (CAP) and pelvic inflammatory decision is that the medicine does 950/14 azithromycin (Zedbac) disease (PID) due to susceptible organisms in not represent sufficient added benefit to other adult patients where initial intravenous therapy is required. comparator medicines to treat the condition in question. certolizumab pegol (Cimzia) 960/14 For the treatment of adult patients with severe Non-formulary specialists have active axial spondyloarthritis. not requested addition to formulary. dimethyl fumarate (Tecfidera) 886/13 Treatment of adult patients with relapsing Included in formulary for the remitting multiple sclerosis. In combination with other antiretroviral dolutegravir (Tivicay) 961/14 medicinal products for the treatment of Human Included in formulary for the Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age Treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to rilpivirine 25mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg tablet (Eviplera ) 951/14 the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with viral load 100,000 HIV-1 RNA copies/ml. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera Included in formulary for the RECOMMENDED MEDICINES FOR RESTRICTED USE Recommended for Restricted use within NHS Scotland April May 2014 Formulary & Rationale for non- Page 1 of 7

2 inclusion adapalene 0.1%/benzoyl Cutaneous treatment of acne vulgaris when 682/ Included in formulary for the peroxide 2.5% gel (Epiduo ) comedones, papules and pustules are present. approved indication Symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a with an exacerbation history despite regular bronchodilator therapy. fluticasone furoate/vilanterol 953/14 forced expiratory volume in 1 second (FEV1) (Relvar Ellipta) <70% predicted normal (post-bronchodilator) Formulary application currently under review In combination with dexamethasone, for the treatment of multiple myeloma in adult patients 441/08 lenalidomide (Revlimid) who have received at least one prior therapy Prescribing would be under SCAN regime (This resubmission relates to patients who have received only one prior therapy). Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients myeloid leukaemia and myelodysplastic syndromes). lipegfilgrastim, 6mg, solution 908/13 treated with cytotoxic chemotherapy for for injection (Lonquex ) malignancy (with the exception of chronic Prescribing would be under SCAN regime macitentan (Opsumit) As monotherapy or in combination, is indicated would not commence treatment 952/14 for the long-term treatment of pulmonary with this drug but would continue treatment arterial hypertension in adult patients of World initiated at specialist unit Health Organisation Functional Class II to III. MEDICINES NOT RECOMMENDED Is Not Recommended for use within NHS Scotland April May 2014 Formulary & Rationale for noninclusion cobicistat (Tybost) 933/13 infliximab (Remicade) 374/07 Pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults. Treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine Not approved not approved for use in Not approved not approved for use in Page 2 of 7

3 or azathioprine, or who are intolerant to or have medical contraindications for such therapies. June July 2014 Recommended for use within NHS Scotland June July 2014 budesonide gastro-resistant granules (Budenofalk ) 970/14 defibrotide (Defitelio ) 967/14 fluticasone furoate / vilanterol (Relvar Ellipta ) 966/14 Induction of remission in patients with mild to moderate active Crohn s disease affecting the ileum and/or ascending colon. Treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. For the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (longacting beta2-agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists RECOMMENDED MEDICINES FOR RESTRICTED USE Recommended for Restricted use within NHS Scotland June July 2014 sofosbuvir 400mg tablet (Sovaldi ) canagliflozin (Invokana ) 964/14 963/14 In combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Formulary & Rationale for noninclusion Non formulary specialists do not support formulary inclusion Product would not be used in Formulary application currently under review Formulary & Rationale for noninclusion Included in formulary for the approved indication Non formulary specialists do not support formulary inclusion Page 3 of 7

4 MEDICINES NOT RECOMMENDED Is Not Recommended for use within NHS Scotland June July /14 For the treatment of erectile dysfunction in adult avanafil (Spedra ) men. Single disease modifying therapy in highly active relapsing remitting multiple sclerosis 979/14 natalizumab (Tysabri ) (RRMS) for adult patients aged 18 years and over with high disease activity despite treatment with glatiramer acetate. In combination with gemcitabine for the firstline treatment of adult patients with metastatic /14 paclitaxel albumin (Abraxane ) adenocarcinoma of the pancreas. Formulary & Rationale for noninclusion Not approved not approved for use in Not approved not approved for use in for this indication. Not approved not approved for use in August September 2014 Recommended for use within NHS Scotland August September 2014 Formulary & Rationale for noninclusion RECOMMENDED MEDICINES FOR RESTRICTED USE Recommended for Restricted use within NHS Scotland August September 2014 ocriplasmin (Jetrea ) Thrombogenics tocilizumab (RoActemra ) Roche 892/13 982/14 In adults for the treatment of vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. In combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who Formulary & Rationale for noninclusion Product would not be used in Included in formulary for the approved indication Page 4 of 7

5 have either responded inadequately to, or who were intolerant to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. MEDICINES NOT RECOMMENDED Is Not Recommended for use within NHS Scotland August September 2014 colestilan (BindRen ) Mitsubishi Pharma lubiprostone (Amitiza ) Sucampo racecadotril (Hidrasec ) Abbott Healthcare Products Ltd. umeclidinium bromide / vilanterol (Anoro ) GSK 939/14 977/14 818/12 978/14 Treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. For the treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other nonpharmacological measures (e.g. educational measures, physical activity) are inappropriate. Complementary symptomatic treatment of acute diarrhoea in infants (older than three months), and in children, together with oral rehydration, and the usual support measures, when these measures alone are insufficient to control the clinical condition and when causal treatment is not possible. As a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Formulary & Rationale for noninclusion Not recommended for use in - not recommended by Not recommended for use in - not recommended by Not recommended for use in - not recommended by Not recommended for use in - not recommended by Page 5 of 7

6 October November 2014 Recommended for use within NHS Scotland October November 2014 Formulary & Rationale for noninclusion RECOMMENDED MEDICINES FOR RESTRICTED USE Recommended for Restricted use within NHS Scotland October November 2014 Formulary & Rationale for noninclusion MEDICINES NOT RECOMMENDED Is Not Recommended for use within NHS Scotland October November 2014 Formulary & Rationale for noninclusion Page 6 of 7

7 Standard on Formulary s Included in formulary for the approved indication Prescribing would be under SCAN regime Not Included in formulary because decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question; would not commence treatment with this drug but would continue treatment initiated at specialist unit Product would not be used in Not Included in formulary because clinicians do not support the formulary inclusion; Not recommended for use in - not recommended by Page 7 of 7

MINUTES MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY, P.M. IN THE ESTATES MEETING ROOM

MINUTES MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY, 11/06/2014 @ 12.30 P.M. IN THE ESTATES MEETING ROOM Attendees: Alan Brown (minutes), Liz Leitch, Alison Wilson, Paul Neary, Ros Anderson,