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Area Drug and Therapeutics Committee

Cumulative list of Scottish Medicines Consortium “Not recommended” Medicines January 2018

The following medicines are not recommended for use within NHS Scotland for the specific indications as listed below. For further information please refer to the SMC website www.scottishmedicines.org. For access to these medicines an Individual Patient Treatment Request (IPTR) must be completed – refer to Section 16 Code of Practice for Medicines Management for further information.

SMC Generic (Trade) name Indication Number 1260/17 5-aminolaevulinic acid (as Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable hydrochloride) 78mg/g gel for surgical treatment due to possible treatment-related morbidity and / or poor (Ameluz®) cosmetic outcome in adults. 16/02 90% omega-3-acid ethyl esters Treatment of hypertriglyceridaemia (Omacor®) 400/07 Abatacept 250mg powder for in combination with , for the treatment of moderate to severe concentrate for solution active rheumatoid arthritis in adult patients who have had an insufficient (Orencia) ® response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor. Superseded by NICE MTA195: Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor 417/07 Adalimumab 40mg solution for Treatment of severe, active Crohn’s disease, in patients who have not injection (Humira®) responded despite a full and adequate course of with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such Superseded by NICE MTA187: Infliximab (review) and adalimumab for the treatment of Crohn's disease 824/12 Adalimumab (Humira®) Treatment of moderately active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies 800/12 Adalimumab (Humira®) pre- Treatment of moderately to severely active ulcerative colitis in adult patients filled pen, pre-filled syringe and who have had an inadequate response to conventional therapy including vial corticosteroids and 6- (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Superseded by NICE MTA 329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262). 1173/16 Adalimumab (Humira®) Pre- Treatment of moderate to severe chronic plaque in adult patients who filled Pen, Pre-filled Syringe are candidates for systemic therapy. (This licence extension relates to previous and Vial SMC advice (468/08). 1208/16 Adalimumab (Humira®) Treatment of moderately active Crohn's disease in paediatric patients (from 6 40mg/0.4ml Pre-filled Syringe years of age) who have had an inadequate response to conventional therapy and Pre-filled Pen including primary nutrition therapy and a corticosteroid and/or an Adalimumab (Humira®) immunomodulator, or who are intolerant to or have contraindications for such 40mg/0.8ml Pre-filled Syringe therapies. and Pre-filled Pen Adalimumab (Humira®) 40mg/0.8ml vial for paediatric use 1209/16 Adalimumab (Humira®) Treatment of non-infectious intermediate, posterior and panuveitis in adult 40mg/0.4ml Pre-filled Syringe patients who have had an inadequate response to corticosteroids, in patients in and Pre-filled Pen need of corticosteroid-sparing, or in whom corticosteroid treatment is Adalimumab (Humira®) inappropriate. 40mg/0.8ml Pre-filled Syringe Superseded by NICE MTA 460: Adalimumab and dexamethasone for treating and Pre-filled Pen non-infectious uveitis 1305/18 Adalimumab 40mg/0.4mL pre- Treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 filled syringe and pre-filled pen/ years of age who have had an inadequate response to or are intolerant to adalimumab 40mg/0.4mL conventional therapy, or in whom conventional therapy is inappropriate 40mg/0.8mL vial for paediatric use (Humira®)

Medicines Utilisation Unit, January 2018 Page 1 of 17 1230/17 Abatacept (Orencia®) 125mg Treatment of highly active and progressive disease in adult patients with solution for injection (pre-filled rheumatoid arthritis not previously treated with methotrexate. syringe) 125mg solution for injection in pre-filled pen 250mg powder for concentrate for solution for infusion 1287/17 Abatacept 125mg solution for Alone or in combination with methotrexate for the treatment of active psoriatic injection (pre-filled syringe); arthritis in adult patients when the response to previous disease-modifying anti- 125mg solution for injection in rheumatic drug (DMARD) therapy including methotrexate has been inadequate, pre-filled pen; 250mg powder and for whom additional systemic therapy for psoriatic skin lesions is not for concentrate for solution for required. infusion (Orencia®) 1174/16 Afatinib (Giotrif ®) 20 mg/30 As monotherapy for the treatment of locally advanced or metastatic non small mg/40 mg/50 mg film-coated cell lung of squamous histology progressing on or after platinum-based tablets . 564/09 Agomelatine 25mg tablets Major depressive episodes in adults (Valdoxan) 1257/17 Alectinib hydrochloride As monotherapy for the treatment of adult patients with anaplastic lymphoma (Alecensa®) 150mg hard kinase positive advanced non-small cell lung cancer previously treated with capsules crizotinib. 352/07 Alglucosidase alfa infusion Treatment of Pompe disease (Myozyme®) 462/08 Aliskiren (Rasilez®) Essential hypertension 660/10 Amifampridine (Firdapse®) Treatment of Lambert-Eaton Myasthenic Syndrome in adults 5/02 Anakinra (Kineret®) Rheumatoid arthritis 1116/15 Anakinra (Kineret®) 100mg Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, solution for injection in a pre- adolescents, children and infants aged 8 months and older with a body weight filled syringe of 10 kg or above, including: • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) • Muckle-Wells Syndrome (MWS) • Familial Cold Autoinflammatory Syndrome (FCAS) 242/06 Aprepitant capsules (Emend®) Prevention of and associated with moderately emetogenic cancer chemotherapy 498/08 Aripiprazole tablets; Treatment & prevention of moderate to severe manic episodes in bipolar 1 orodispersible tablets; oral disorder solution (Abilify®) 762/12 Asenapine 5mg, 10mg Treatment of moderate to severe manic episodes associated with bipolar I sublingual tablet (Sycrest®) disorder, in adults 1131/16 Ataluren 125mg, 250mg, Treatment of Duchenne muscular dystrophy resulting from a nonsense 1,000mg granules for oral mutation in the dystrophin gene, in ambulatory patients aged 5 years and older. suspension (Translarna®) 980/14 Avanafil (Spedra®) 50mg, Treatment of erectile dysfunction in adult men 100mg and 200mg tablets 1175/16 (Vidaza®) 25 mg/ml Treatment of adult patients aged 65 years or older who are not eligible for powder for suspension for haematopoietic stem cell transplantation (HSCT) with acute myeloid leukaemia injection (AML) with >30% marrow blasts according to the World Health Organisation (WHO) classification. 803/12 Azilsartan medoxomil Treatment of essential hypertension in adults (Edarbi®) 20mg, 40 mg and 80mg tablets 804/12 Azithromycin dihydrate Local antibacterial treatment of conjunctivitis caused by susceptible strains: (Azyter®) 15 mg/g, eye drops, - Purulent bacterial conjunctivitis, solution in single-dose - Trachomatous conjunctivitis caused by Chlamydia trachomatis container 166/05 Beclometasone dipropionate Treatment of mild to moderate ulcerative colitis in active phase, as add-on tablets (Clipper®) therapy to 5-ASA containing drugs, in patients not responding to 5-ASA therapy in active phase 786/12 Belatacept powder for In combination with corticosteroids and a mycophenolic acid, is indicated for concentrate for solution for prophylaxis of graft rejection in adults receiving a renal transplant. It is infusion 250mg vial and recommended to add an interleukin-2 for induction therapy disposable syringe (Nulojix®) to this belatacept-based regimen 205/05 Bemiparin injection for sub- Prevention of clotting in the extracorporeal circuit during haemodialysis cutaneous administration (Zibor®) 206/05 Bemiparin, 25,000 IU/ml Treatment of established deep vein thrombosis, with or without pulmonary injection for sub-cutaneous Medicines Utilisation Unit, January 2018 Page 2 of 17 administration (Zibor®) embolism, during the acute phase 203/05 Bemiparin, injection for sub- Prevention of thromboembolic disease in pts undergoing general surgery cutaneous administration (Zibor®) 701/11 2.5 mg/mL Front line treatment of indolent non-Hodgkin's lymphomas as monotherapy in powder for concentrate for patients who have progressed during or within 6 months following treatment solution for infusion (Levact®) with rituximab or a rituximab containing regimen 700/11 Bendamustine 2.5mg/mL Front line treatment of multiple myeloma (Durie-Salmon stage II with progress powder for concentrate for or stage III) in combination with prednisone for patients older than 65 years solution for infusion (Levact®) who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or containing treatment 622/10 Betamethasone valerate Treatment of inflammatory skin disorders which do not respond to treatment 2.25mg medicated plaster with less potent corticosteroids, such as eczema, lichenification, lichen planus, (Betesil®) granuloma annulare, palmoplantar pustulosis and mycosis fungoides 221/05 Bevacizumab infusion First line treatment of metastatic colorectal cancer (Avastin®) 387/07 Bevacizumab (Avastin®) Combination with for first-line treatment of patients with metastatic breast cancer 425/07 Bevacizumab (Avastin®) First-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer 459/08 Bevacizumab (Avastin®) In combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer Superseded by NICE MTA178: Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma 469/08 Bevacizumab vials (Avastin®) In combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the colon or rectum Superseded by NICE MTA242: Cetuximab (monotherapy or combination chemotherapy), bevacizumab (in combination with non- chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy 778/12 Bevacizumab, 25mg/mL, In combination with is for first-line treatment of patients with concentrate for solution for metastatic breast cancer in whom treatment with other chemotherapy options infusion (Avastin®) including or is not considered appropriate 853/13 Bevacizumab, 25mg/mL, In combination with and , is indicated for treatment of concentrate for solution for adult patients with first recurrence of platinum-sensitive epithelian ovarian, infusion (Avastin ®) fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents 1190/16 Bevacizumab (Avastin®) 25 In combination with erlotinib for first-line treatment of adult patients with mg/ml concentrate for solution unresectable advanced, metastatic or recurrent non-squamous non-small cell for infusion lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. 1275/17 Bevacizumab 25mg/mL In combination with carboplatin and paclitaxel for the treatment of adult patients concentrate for solution for with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or infusion (Avastin®) primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. 1293/17 Bezlotoxumab 25mg/mL Prevention of recurrence of Clostridium difficile infection (CDI) in adults at high concentrate for solution for risk for recurrence of CDI infusion (Zinplava®) 730/11 Bilastine (Ilaxten®) Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria 485/08 Bosentan film coated tablets Reduce the number of new digital ulcers in patients with systemic sclerosis and (Tracleer®) ongoing digital ulcer disease. 523/08 Bosentan film-coated tablets Treatment of pulmonary arterial hypertension (Tracleer®) 679/11 Botulinum toxin type A Temporary improvement in the appearance of moderate to severe glabellar (Azzalure®) lines 695/11 Botulinum toxin type a Temporary improvement in the appearance of moderate to severe glabellar (Bocouture®) lines 680/11 Botulinum toxin Type A Temporary improvement in the appearance of moderate to severe glabellar (Vistabel®) lines 986/14 Botulinum toxin type A 50, 100 Focal lower limb spasticity, including the treatment of ankle disability due to

Medicines Utilisation Unit, January 2018 Page 3 of 17 and 200 units (Botox®) lower limb spasticity associated with stroke in adults

1283/17 Brodalumab 210mg solution for Treatment of moderate to severe plaque psoriasis in adult patients who are injection in pre-filled syringe candidates for systemic therapy (Kyntheum®) 740/11 Bromfenac (Yellox®) 0.9 mg/ml Treatment of postoperative ocular inflammation following cataract extraction in eye drops solution adults 1198/16 Budesonide/formoterol 200 Treatment of patients with chronic obstructive pulmonary disease (COPD) with micrograms/6 Inhalation forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal powder and 400 (post bronchodilator) and an exacerbation history despite regular micrograms/12 Inhalation bronchodilator therapy powder (Symbicort Turbohaler®) Budesonide/ formoterol 200 micrograms/6 micrograms per actuation, pressurised inhalation, suspension (Symbicort ®) 116/04 Buprenorphine (Transtec®) Treatment of moderate to severe cancer pain and severe pain that does not patch respond to nonopioid analgesics 234/06 Buprenorphine transdermal Severe opioid responsive pain conditions which are not adequately responding patch 7-day formulation to non-opioid analgesics (BuTrans®) 1022/15 Cabozantinib 20mg and 80mg Treatment of adult patients with progressive, unresectable locally advanced or hard capsules (Cometriq®) metastatic medullary thyroid carcinoma. 693/11 Calcium acetate Treatment of hyperphosphataemia associated with chronic renal insufficiency 435mg/magnesium carbonate in patients undergoing dialysis (haemodialysis, peritoneal dialysis) 235mg tablet (Osvaren®) 658/10 Canakinumab (Ilaris®) 150 Cryopyrin-Associated Periodic Syndromes in adults, adolescents and children mg/ml, powder for solution for aged 4 years and older with body weight above 15 kg injection 882/13 Canakinumab (Ilaris ®) 150 mg Treatment of Cryopyrin-Associated Periodic Syndromes in adults, adolescents powder for solution for and children aged 2 years and older with body weight of 7.5 kg or above injection(Ilaris®) including: • Muckle-Wells Syndrome • Neonatal-Onset Multisystem Inflammatory Disease / Chronic Infantile Neurological, Cutaneous, Articular Syndrome • Severe forms of Familial Cold Autoinflammatory Syndrome / Familial Cold Urticaria presenting with signs and symptoms beyond cold-induced urticarial skin 883/13 Canakinumab (Ilaris ®) 150 mg Symptomatic treatment of adult patients with frequent gouty arthritis attacks (at powder for solution for least 3 attacks in the previous 12 months) in whom non-steroidal anti- injection(Ilaris®) inflammatory drugs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate 926/13 Canakinumab (Ilaris®) 150mg Treatment of active Systemic Juvenile Idiopathic Arthritis in patients aged two powder for solution for injection years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate 1210/16 Canakinumab (Ilaris®) 150mg Treatment of active Still's disease including Adult-Onset Still's Disease who powder for solution for injection have responded inadequately to previous therapy with non-steroidal antiinflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. 1268/17 Canakinumab 150mg powder Treatment of the following autoinflammatory periodic fever syndromes in for solution for injection adults, adolescents and children aged 2 years and older: (Ilaris®) • tumour necrosis factor receptor associated periodic syndrome • hyperimmunoglobulin D syndrome / mevalonate kinase deficiency • Familial Mediterranean Fever 1070/15 Cangrelor (Kengraxel®) Co-administered with acetylsalicylic acid for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 703/11 Cannabinoid oromucosal spray Add-on treatment for symptom improvement in patients with moderate to (Sativex®) severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity and who demonstrate clinically significant

Medicines Utilisation Unit, January 2018 Page 4 of 17 improvement in spasticity related symptoms during an initial trial of therapy

1140/16 Capsaicin (Qutenza®) 179mg Treatment of peripheral neuropathic pain in diabetic adults either alone or in cutaneous patch combination with other medicinal products for pain. 309/06 Carbetocin injection (Pabal®) Prevention of uterine atony and excessive following delivery of the infant by Caesarean section under epidural or spinal anaesthesia 1171/16 60mg powder for In combination with lenalidomide and dexamethasone for the treatment of adult solution for infusion (Kyprolis®) patients with multiple myeloma who have received at least one prior therapy. 30/03 Caspofungin acetate Treatment of invasive aspergillosis (Caspofungin®) 788/12 Catumaxomab (Removab®) 10 Intraperitoneal treatment of malignant ascites in patients with EpCAM-positive and 50 microgram concentrate carcinomas where standard therapy is not available or no longer feasible for solution for infusion 1146/16 Ceftolozane/tazobactam Treatment of the following infections in adults: 1g/0.5g powder for concentrate • Complicated intra-abdominal infections for solution for infusion • Acute pyelonephritis (Zerbaxa®) • Complicated urinary tract infections 1306/18 Ceftaroline fosamil 600 mg Treatment of powder for concentrate for  complicated skin and soft tissue infections in children from the age of 2 solution for infusion (Zinforo®) months  community-acquired pneumonia in children from the age of 2 months 1307/18 Ceftazidime/ avibactam Treatment of the following infections in adults: 2g/0.5g powder for concentrate  complicated intra-abdominal Infection (cIAI) for solution for infusion  complicated urinary tract infection (cUTI), including pyelonephritis ® (Zavicefta )  hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)  infections due to aerobic Gram-negative organisms in adult patients with limited treatment options 410/07 (Celebrex®) Ankylosing spondylitis 1155/16 Certolizumab pegol (Cimzia®) Treatment of severe, active and progressive RA in adults not previously treated 200 mg solution for injection with MTX or other DMARDs 155/05 Cetuximab infusion (Erbitux®) Treatment of epidermal growth factor receptor -expressing metastatic colorectal cancer in combination with Superseded by NICE MTA242: Cetuximab (monotherapy or combination chemotherapy), bevacizumab (in combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy 547/09 Cetuximab infusion (Erbitux®) Treatment of squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease 885/13 Chloroprocaine hydrochloride, Spinal anaesthesia in adults where the planned surgical procedure should not 10mg/mL, solution for injection exceed 40 minutes. (Ampres®) 86/04 Cilostazol (Pletal®) Improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis Superseded by NICE MTA223: Peripheral arterial disease - cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate 271/06 Cinacalcet (Mimpara®) tablets Reduction of hypercalcaemia in patients with parathyroid cancer 513/08 Cinacalcet (Mimpara®) tablets Reduction of hypercalcaemia in patients with primary hyperparathyroidism 217/05 Clarithromycin oral suspension Treatment of acute and chronic infections (ClaroSip®) 933/13 (Tybost®) 150 mg Pharmacokinetic enhancer of 300 mg once daily or 800 film coated tablet mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults 1191/16 Cobimetinib (Cotellic®) 20mg In combination with vemurafenib for the treatment of adult patients with film-coated tablets unresectable or metastatic melanoma with a BRAF V600 mutation. 690/11 Colesevelam 625mg film- In combination with ezetimibe, with or without a statin, in adult patients with coated tablets(Cholestagel®) primary hypercholesterolaemia, including patients with familial hypercholesterolaemia 451/08 Colesevelam Hydrochloride • primary hypercholesterolaemia, co-administered with an HMG-CoA (Cholestagel®) reductase inhibitor (statin), as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients not adequately controlled with a statin alone. • monotherapy as adjunctive therapy to diet for reduction of elevated total and Medicines Utilisation Unit, January 2018 Page 5 of 17 LDL- cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. 939/14 Colestilan 1g film-coated tablet, Treatment of hyperphosphataemia in adult patients with chronic kidney disease 2g and 3g granules sachet (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. (BindRen®) Marketing authorisation withdrawn 1st April 2015 1059/15 Collagenase clostridium Treatment of adult men with Peyronie’s disease with a palpable plaque and histolyticum (Xiapex®) curvature deformity of at least 30 degrees at the start of therapy 745/11 Conestat alfa (Ruconest®) Treatment of acute angioedema attacks in adults with hereditary angioedema 2100 U powder for solution for due to C1 esterase inhibitor deficiency injection 633/10 Corifollitropin alfa (Elonva®) Treatment of Controlled Ovarian Stimulation in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology program 164/05 liposomal injection Intrathecal treatment of lymphomatous meningitis (DepoCyte®) 987/14 Dapoxetine hydrochloride Treatment of premature ejaculation in adult men aged 18 to 64 years 30mg and 60 mg film-coated tablets (Priligy®) 1141/16 Daptomycin (Cubicin®) powder Treatment of paediatric (1 to 17 years of age) patients with complicated skin for concentrate for solution for and soft-tissue infections. injection or infusion 273/06 Darbepoetin alfa (Aranesp®) Symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy 265/06 Darbepoetin alfa (Aranesp®) Treatment of symptomatic anaemia in cancer patients with non-myeloid SureClick malignancies receiving chemotherapy 371/07 Dasatinib tablets (Sprycel®) Treatment of Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy 846/12 50 mg powder for Treatment of adult patients aged 65 years and above with newly diagnosed de concentrate for solution for novo or secondary acute myeloid leukaemia (AML), according to the World infusion (Dacogen ®) Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy 866/13 Deferasirox 125mg, 250mg Treatment of chronic iron overload requiring chelation therapy when and 500mg dispersible tablets deferoxamine therapy is contraindicated or inadequate in patients with non- (Exjade®) transfusion-dependent thalassaemia syndromes aged 10 years and older 670/10 Denosumab 60mg solution for Bone loss associated with hormone ablation in men with prostate cancer at injection in pre-filled syringe increased risk of fractures (Prolia®) 752/11 Denosumab (Xgeva®) 120 mg Prevention of skeletal related events (pathological fracture, radiation to bone, solution for injection spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. Superseded by NICE MTA265 – Denosumab for the prevention of skeletal- related events in adults with bone metastases from solid tumours 1013/14 Denosumab (Prolia®) 60 mg Osteoporosis in men at increased risk of fractures solution for injection in a pre- filled syringe 1119/15 Denosumab (Xgeva)®) 120mg Adults and skeletally mature adolescents with giant cell tumour of bone that is solution for injection unresectable or where surgical resection is likely to result in severe morbidity 751/11 Dexamethasone (Ozurdex®) Treatment of adult patients with inflammation of the posterior segment of the 0.7 mg intravitreal implant eye presenting as non-infectious uveitis Superseded by NICE MTA 460: Adalimumab and dexamethasone for treating non-infectious uveitis 419/07 Dexrazoxane (Cardioxane®) Prevention of chronic cumulative cardiotoxicity caused by or use in advanced and/or metastatic cancer patients after previous containing treatment 361/07 Dexrazoxane infusion Treatment of anthracycline extravasation (Savene®) 667/10 Diclofenac 4% spray gel Symptomatic relief of mild to moderate pain and inflammation following acute (Mobigel Spray®) blunt trauma of small and medium-sized joints and periarticular structures 199/05 Diclofenac gel patches Local symptomatic treatment of pain in epicondylitis and ankle sprain (Voltarol® Gel Patch) 209/05 concentrate and In combination with prednisolone for the treatment of patients with metastatic solvent for solution for infusion, hormone refractory prostate cancer (mHRPC). single dose vials (Taxotere®) Superseded by NICE MTA101: Docetaxel for the treatment of hormone- Medicines Utilisation Unit, January 2018 Page 6 of 17 refractory metastatic prostate cancer

333/06 Docetaxel injection Combination with and 5- for treatment of patients with (Taxotere®) metastatic gastric adenocarcinoma 659/10 Docetaxel (Taxotere®) 20 In combination with doxorubicin and for the adjuvant mg/1ml and 80 mg/4ml and treatment of patients with operable node-negative breast cancer 160 mg/8ml concentrate for solution for infusion 23/03 Drospirenone, ethinylestradiol Combined oral contraceptive (Yasmin®) 514/08 Duloxetine (Cymbalta®) Treatment of generalised anxiety disorder capsules 436/07 Eculizumab (Soliris®) Treatment of paroxysmal nocturnal haemoglobinuria. Evidence of clinical benefit of eculizumab in the treatment of patients with PNH is limited to patients with a history of transfusions 767/12 Eculizumab (Soliris®) 300 mg In adults and children for the treatment of patients with atypical haemolytic resub concentrate for solution for uraemic syndrome (aHUS). infusion 915/13 Eculizumab 300mg In children for the treatment of patients with paroxysmal nocturnal concentrate for solution for haemoglobinuria. Evidence of clinical benefit of Soliris in the treatment of infusion (Soliris®) patients with PNH is limited to patients with history of transfusions 1130/16 Eculizumab 300mg/30mL vial In adults and children, for the treatment of patients with paroxysmal nocturnal concentrate for solution for haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients infusion (Soliris®) with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. 1072/15 Elosulfase alfa, 1mg/mL Treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS concentrate for solution for IVA) in patients of all ages infusion (Vimizim®) 1183/16 Elotuzumab (Empliciti ®) Treatment of multiple myeloma in combination with lenalidomide and 300mg and 400mg powder for dexamethasone in adult patients who have received at least one prior therapy. concentrate for solution for infusion 1164/16 Eltrombopag olamine Treatment in adult patients with acquired severe aplastic anaemia (SAA) who (Revolade®) 25 mg / 50 mg were either refractory to prior immuno-suppressive therapy or heavily film-coated tablets pretreated and are unsuitable for haematopoietic stem cell transplantation. 1292/18 Eluxadoline, 75mg and 100mg In adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). film-coated tablets (Truberzi®) 747/11 Entecavir, 0.5mg and 1mg film- Treatment of chronic hepatitis B virus infection in adults with decompensated coated tablets and 0.05 mg/mL disease oral solution (Baraclude®) 267/06 Epinastine (Relestat®) Symptoms of seasonal allergic conjunctivitis eyedrops, solution 415/07 Erdosteine capsules (Erdotin®) Expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults 382/07 Erlotinib (Tarceva®) Metastatic pancreatic cancer 664/10 Erlotinib, 25, 100 and 150mg As monotherapy for maintenance treatment in patients with locally advanced or film-coated tablets (Tarceva®) metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy 475/08 Escitalopram (Cipralex®) Treatment of social anxiety disorder 406/07 Escitalopram tablets and oral Treatment of obsessive compulsive disorder drops (Cipralex®) 257/06 Esomeprazole tablets Prevention of gastric and duodenal ulcers associated with NSAID therapy in (Nexium®) patients at risk 274/06 Esomeprazole tablets Healing of gastric ulcers associated with NSAIDs (Nexium®) 227/05 Estradiol 1mg and 2mg Prevention of osteoporosis drospirenone 2mg tablets (Angeliq®) 583/09 Estradiol/dienogest (Qlaira®) Oral contraception 1262/17 Etelcalcetide 2.5mg, 5mg, and Treatment of secondary hyperparathyroidism (HPT) in adult patients with 10mg solution for injection chronic kidney disease (CKD) on haemodialysis therapy. (Parsabiv®) 576/09 Etoricoxib (Arcoxia®) Ankylosing spondylitis 847/12 Etoricoxib 30mg, 60 mg, 90mg Short-term treatment of moderate pain associated with dental surgery & 120 mg film-coated tablets

Medicines Utilisation Unit, January 2018 Page 7 of 17 (Arcoxia®)

787/12 Everolimus (Votubia®) 2.5mg Treatment of patients aged 3 years and older with subependymal giant cell and 5mg tablets astrocytoma associated with tuberous sclerosis complex who require therapeutic intervention but are not amenable to surgery 884/13 Everolimus (Votubia ®) 10mg Treatment of adult patients with renal angiomyolipoma associated with tablets tuberous sclerosis complex who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. 1117/15 Everolimus (Certican®)  Prophylaxis of organ rejection in adult patients at low to moderate 0.25mg, 0.5mg and 0.75mg immunological risk receiving a cardiac transplant tablets  Prophylaxis of organ rejection in patients receiving a hepatic transplant 1288/17 Everolimus 0.25mg, 0.5mg and Prophylaxis of organ rejection in adult patients at low to moderate 0.75mg tablets (Certican®) immunological risk receiving an allogenic renal transplant. 528/09 Extended release epidural Relief of post-operative pain following major orthopaedic, abdominal or pelvic morphine (DepoDur®) surgery 789/12 Fampridine 10mg prolonged- Improvement of walking in adult patients with multiple sclerosis with walking release tablets (Fampyra®) disability 947/13 Fentanyl citrate (Breakyl®) Treatment of breakthrough pain in adults with cancer who are already receiving 200mcg, 400mcg and 800mcg maintenance opioid therapy for chronic cancer pain. buccal film 1207/16 Fentanyl (Ionsys®) 40 Management of acute moderate to severe post-operative pain in adult patients micrograms per dose transdermal system 691/11 Fenticonazole 2% vaginal Treatment of vulvovaginal candidiasis cream and 200mg/600mg vaginal capsules (Ginoxin®) 1202/16 Ferric maltol 30mg hard In adults for the treatment of iron deficiency anaemia (IDA) in patients with capsules (Feraccru®) inflammatory bowel disease (IBD). 1269/17 Follitropin delta 12 micrograms, Controlled ovarian stimulation for the development of multiple follicles in 36 micrograms and 72 women undergoing assisted reproductive technologies such as an in vitro micrograms solution for fertilisation or intracytoplasmic sperm injection cycle. injection (Rekovelle®) 261/06 Fondaparinux (Arixtra®) Prevention of venous thromboembolic events 262/06 Fondaparinux (Arixtra®) Treatment of acute deep vein thrombosis and treatment of acute pulmonary embolism 287/06 Fondaparinux injection Prevention of venous thromboembolic events in high risk patients undergoing (Arixtra®) abdominal surgery 668/10 Fondaparinux sodium Treatment of acute symptomatic spontaneous superficial-vein thrombosis of 1.5mg/0.3mL solution for the lower limbs without concomitant deep-vein thrombosis injection, prefilled syringe (Arixtra®) 1294/17 Fulvestrant 250 mg solution for Treatment of oestrogen receptor positive, locally advanced or metastatic breast injection (Faslodex®) cancer in postmenopausal women not previously treated with endocrine therapy. 471/08 Glucosamine as hydrochloride Relief of symptoms in mild to moderate osteoarthritis of the knee tablets (Alateris®) 729/11 Glucosamine sulphate Mild to moderate osteoarthritis of the knee (Dolenio®) 647/10 Glucosamine sulphate Relief of symptoms in mild to moderate osteoarthritis of the knee (Glusartel®) 1,500mg powder for oral solution 200/05 Glyceryl trinitrate rectal Chronic anal fissures ointment (Rectogesic®) 946/13 Golimumab (Simponi®) 50 mg Treatment of moderately to severely active ulcerative colitis in adult patients and 100mg solution for who have had an inadequate response to conventional therapy including injection corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Superseded by NICE MTA 329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262). 1199/16 Golimumab (Simponi®) 50 mg In combination with methotrexate for the treatment of polyarticular juvenile solution for injection idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with methotrexate.

Medicines Utilisation Unit, January 2018 Page 8 of 17 666/10 Histamine dihydrochloride, 500 Maintenance therapy for adult patients with acute myeloid leukaemia in first microgram/0.5ml, vial remission concomitantly treated with interleukin-2 (Ceplene®)

1157/16 Human alpha1-proteinase For maintenance treatment, to slow the progression of emphysema in adults inhibitor 1,000mg powder and with documented severe alpha1-proteinase inhibitor (A1-PI) deficiency. solvent for solution for infusion (Respreeza®) 848/12 Hydrocortisone 5mg and 20mg Treatment of adrenal insufficiency in adults tablets (Plenadren®) 582/09 Hydroxycarbamide (Siklos®) Prevention of recurrent painful vaso-occlusive crises in symptomatic Sickle Cell Syndrome 171/05 Ibritumomab tiuxetan Preparation of a radiopharmaceutical incorporating Yttrium 90 for rituximab- (Zevalin®) relapsed or refractory CD20+ follicular B-cell non-Hodgkin’s lymphoma 499/08 Ibritumomab tiuxetan 1.6mg/ml Consolidation therapy after remission induction in previously untreated patients (Zevalin®) with follicular lymphoma 1258/17 Ibrutinib (Imbruvica®) 140mg In combination with bendamustine and rituximab for the treatment of adult hard capsules patients with chronic lymphocytic leukaemia who have received at least one prior therapy 1212/16 (Zydelig®) 100-mg, In combination with ofatumumab for the treatment of adult patients with chronic 150-mg film-coated tablets lymphocytic leukaemia:  who have received at least one prior therapy, or  first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies 391/07 Idursulfase infusion Long-term treatment of patients with mucopolysaccharidosis II (MPS II, also (Elaprase®) known as Hunter syndrome) 426/07 (Glivec®) Relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) as monotherapy 427/07 Imatinib (Glivec®) Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (PH + ALL) in combination with chemotherapy 428/07 Imatinib (Glivec®) Myelodysplastic/ myeloproliferative diseases associated with platelet -derived growth factor receptor gene re-arrangements. 429/07 Imatinib (Glivec®) Advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-PDGFRα rearrangement 430/07 Imatinib (Glivec®) Unresectable dermatofibrosarcoma protuberans (DFSP) and recurrent and/or metastatic DFSP in patients who are not eligible for surgery 923/13 Imatinib (Glivec ®) 100 mg / Treatment of paediatric patients with newly diagnosed Philadelphia 400 mg film coated tablets chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy 934/13 Imiquimod (Zyclara®) 3.75% Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, cream visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate 101/04 Infliximab (Remicade) Treatment of ankylosing spondylitis, in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. Superseded by NICE MTA143: Adalimumab, etanercept and infliximab for ankylosing spondylitis 363/07 Infliximab 100mg powder for Maintenance treatment of severe, active Crohn's disease, in patients who have intravenous infusion not responded despite a full and adequate course of therapy with a (Remicade) corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies Superseded by NICE MTA187: Infliximab (review) and adalimumab for the treatment of Crohn's disease 364/07 Infliximab 100mg powder for Maintenance treatment of fistulising, active Crohn's disease, in patients who intravenous infusion have not responded despite a full and adequate course of therapy with (Remicade) conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Superseded by NICE MTA187: Infliximab (review) and adalimumab for the treatment of Crohn's disease 374/07 Infliximab intravenous infusion Treatment of moderately to severely active ulcerative colitis in patients who (Remicade®) have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contra-indications for such therapies Superseded by NICE MTA 329: Infliximab, adalimumab and golimumab for

Medicines Utilisation Unit, January 2018 Page 9 of 17 treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262). 739/11 Infliximab (Remicade®) 100 Treatment of moderately active Crohn’s disease in adults who have not mg powder for concentrate for responded despite a full and adequate course of therapy with a corticosteroid solution for infusion and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies 254/06 Inhaled insulin inhalation Treatment of adults with type 1 or 2 diabetes mellitus powder (Exubra®) Marketing authorisation withdrawn January 2008 1060/15 Insulin degludec (Tresiba®) Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year 825/12 Interferon beta-1a (Rebif®) Patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis 345/07 Interferon beta-1b injection Treatment of single demyelinating event with an active inflammatory process (Betaferon®) 1289/17 Ibrutinib 140-mg hard capsules As a single agent for the treatment of adult patients with previously untreated (Imbruvica®) chronic lymphocytic leukaemia (who do not have 17p deletion or TP53 mutation). 689/11 Ivabradine (Procoralan®) 5mg Symptomatic treatment of chronic stable angina pectoris in coronary artery and 7.5 mg film coated tablets disease adults with normal sinus rhythm, in combination with beta-blockers, in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm 827/12 Ivacaftor 150mg film-coated Treatment of cystic fibrosis in patients age 6 years and older who have a tablets (Kalydeco®) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene 1134/16 Ivacaftor 50mg and 75mg Treatment of children with cystic fibrosis (CF) aged 2 years and older and granules in sachet (Kalydeco®) weighing less than 25kg who have one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. 1193/16 Ivacaftor 150mg film-coated Treatment of patients with cystic fibrosis (CF) aged 18 years and older who tablets (Kalydeco®) have an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene 1100/15 Ketoconazole (Ketoconazole Treatment of endogenous Cushing’s syndrome in adults and adolescents HRA®) 200mg tablets above the age of 12 years. 65/03 Ketotifen (Zaditen® eye drops) Symptomatic treatment of seasonal allergic conjunctivitis 1231/17 Lacosamide (Vimpat®) 50mg, As monotherapy in the treatment of partial-onset seizures with or without 100mg, 150mg, 200mg film- secondary generalisation in adult and adolescent (16-18 years) patients with coated tablets/ 10mg/mL epilepsy. solution for infusion/ 10mg/mL syrup 231/06 Lanreotide (Somatuline® LA) Treatment of thyrotrophic adenomas 640/10 Lanthanum carbonate Phosphate binding agent for use in the control of hyperphosphataemia in adult chewable tablets (Fosrenol®) patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels 768/12 Lapatinib (Tyverb®) 250 mg Treatment of patients with breast cancer, whose tumours overexpress HER2 film-coated tablets (ErbB2) in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor Superseded by NICE MTA 257: Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone- receptor-positive breast cancer that overexpresses HER2 526/09 Lapatinib film-coated tablets In combination with capecitabine, for the treatment of patients with advanced or (Tyverb®) metastatic breast cancer whose tumours overexpress ErbB2 (HER2) 925/13 Lapatinib (Tyverb®) 250 mg Treatment of adult patients with breast cancer, whose tumours overexpress film-coated tablets HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. 100/04 Laronidase (Aldurazyme®) Treatment of mucopolysaccharidosis I 1211/16 Lenalidomide (Revlimid®) Treatment of adult patients with relapsed or refractory mantle cell lymphoma. 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg hard

Medicines Utilisation Unit, January 2018 Page 10 of 17 capsules 483/08 Lidocaine 70mg/Tetracaine Surface anaesthesia of the skin in connection with needle puncture and in 70mg (Rapydan® 70mg/70mg cases of superficial surgical procedures (such as excision of various skin medicated plaster) lesions and punch biopsies) on normal skin in adults; or for surface anaesthesia of the skin in connection with needle puncture on normal intact skin in children from 3 years of age 1217/17 Liposomal irinotecan Treatment of metastatic adenocarcinoma of the pancreas, in combination with hydrochloride trihydrate (as fluorouracil (5-FU) and leucovorin (), in adult patients who have irinotecan sucrosofate salt), progressed following gemcitabine based therapy 5mg/mL concentrate for solution for infusion (Onivyde®) 1192/16 Liraglutide (Victoza®) 6 mg/ml As monotherapy for the treatment of adults with type 2 diabetes mellitus to solution for injection in pre- achieve glycaemic control when diet and exercise alone do not provide filled pen adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance or contraindications. 1247/17 Liraglutide (Saxenda®) As an adjunct to a reduced-calorie diet and increased physical activity for 6mg/mL solution for injection in weight management in adult patients with an initial Body Mass Index of pre-filled pen  ≥ 30kg/m² (obese), or  ≥ 27kg/m² to < 30kg/m² (overweight) in the presence of at least one weight- related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. 956/14 Lomitapide (Lojuxta®) 5mg, 10 Adjunct to a low-fat diet and other lipid-lowering medicinal products with or mg, 20mg hard capsules without low density lipoprotein apheresis in adult patients with homozygous familial hypercholesterolaemia. 484/08 Loteprednol etabonate 0.5% Post-operative inflammation following ocular surgery 5mg/ml (Lotemax® 0.5% eye drops, suspension) 977/14 Lubiprostone, 24 micrograms Treatment of chronic idiopathic and associated symptoms in soft capsules (Amitiza®) adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate 1136/16 Lumacaftor 200mg, ivacaftor Treatment of cystic fibrosis (CF) in patients aged 12 years and older who are 125mg film-coated tablet homozygous for the F508del mutation in the CF transmembrane conductance (Orkambi®) regulator (CFTR) gene. 94/04 Macrogol 4000 (Idrolax®) Treatment of constipation in adults and children aged ≥ 8 years 458/08 tablet (Celsentri®) In combination with other antiretroviral medicinal products, for treatment- experienced adult patients infected with only CCR5-tropic HIV-1 detectable 1282/17 Maraviroc 20mg/mL oral In combination with other antiretroviral medicinal products for treatment- solution, 25mg, 75mg, 150mg experienced adolescents and children of 2 years and older and weighing at and 300mg film-coated tablets least 10kg infected with only CCR5-tropic HIV-1 detectable. (Celsentri®) 500/08 Melatonin 2mg prolonged- Monotherapy for the short-term treatment of primary insomnia characterized by release tablets (Circadin®) poor quality of sleep in patients who are aged 55 or over 57/03 Memantine (Ebixa®) Moderately severe to severe Alzheimer's disease Superseded by NICE MTA217: Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease 1272/17 Mercaptamine, 25mg and Treatment of proven nephropathic cystinosis 75mg (as bitartrate), gastro- resistant hard capsules (Procysbi®) 1308/18 Metformin hydrochloride Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, 500mg, 750mg and 1000mg overweight patients with impaired glucose tolerance and/or impaired fasting prolonged release tablets glucose, and/or increased HbA1C who are: (Glucophage SR®) • at high risk for developing overt type 2 diabetes mellitus and • still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months 497/08 Micafungin powder for solution Treatment of oesophageal candidiasis in adult, elderly, and adolescent (≥16 for infusion (Mycamine®) years of age) patients 497/08 Micafungin powder for solution Prophylaxis of Candida infection in adults, elderly, and children (including for infusion (Mycamine®) neonates) undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have for 10 or more days 517/08 Miconazole muco-adhesive Treatment of oropharyngeal candidiasis in immunocompromised patients buccal tablets (Loramyc®) 542/09 Micronised progesterone Adjunctive use with oestrogen in post-menopausal women with an intact uterus 100mg, 200mg capsules (HRT) (Utrogestan®)

Medicines Utilisation Unit, January 2018 Page 11 of 17 632/10 Miglustat (Zavesca®) Treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease 328/06 tablets (Lysodren®) Treatment of advanced adrenal cortical carcinoma 63/03 Modafinil (Provigil®) Excessive daytime sleepiness associated with obstructive sleep apnoea/ hypopnoea syndrome On 22 July, 2010 the European Medicines Agency recommended restricting the use of modafinil. This SMC advice has been withdrawn 183/05 Modafinil tablets (Provigil®) Treatment of excessive sleepiness associated with moderate to severe shift work sleep disorder On 22 July, 2010 the European Medicines Agency recommended restricting the use of modafinil. This SMC advice has been withdrawn 734/11 Naproxen/esomeprazole Symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing 500mg/20mg modified release spondylitis in those at risk of developing NSAID-associated gastric and/or tablets (Vimovo®) duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient 979/14 Natalizumab (Tysabri®) 300 Single disease modifying therapy in highly active relapsing remitting multiple mg concentrate for solution for sclerosis (RRMS) for adult patients aged 18 years and over with high disease infusion activity despite treatment with glatiramer acetate 1184/16 Necitumumab (Portrazza®) In combination with gemcitabine and cisplatin chemotherapy for the treatment 800mg concentrate for solution of adult patients with locally advanced or metastatic epidermal growth factor for infusion receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. 588/09 Nepafenac (Nevanac®) Prevention and treatment of postoperative pain and inflammation associated with cataract surgery 93/04 Nicotinic acid modified release Treatment of dyslipidaemia, particularly in patients with combined mixed tabs (Niaspan®) dyslipidaemia, characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol, and in patients with primary hypercholesterolaemia, either in combination with a HMG-CoA reductase inhibitor (statin), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate or as monotherapy in patients who do not tolerate HMG-CoA reductase inhibitors 1285/18 Nivolumab 10mg/mL Nivolumab as monotherapy is indicated for the treatment of locally advanced concentrate for solution for unresectable or metastatic urothelial carcinoma in adults after failure of prior infusion (Opdivo®) platinum-containing therapy 898/13 Nomegestrol acetate/estradiol Oral contraception (Zoely®) 2.5 mg/1.5 mg film- coated tablets 1286/18 Obinutuzumab, 1,000mg, Obinutuzumab in combination with chemotherapy, followed by obinutuzumab concentrate for solution for maintenance therapy in patients achieving a response, for the treatment of infusion (Gazyvaro®) patients with previously untreated advanced follicular lymphoma 1220/17 Oestrogens, conjugated, Treatment of oestrogen deficiency symptoms in postmenopausal women with a bazedoxifene acetate uterus (with at least 12 months since the last menses) for whom treatment with (Duavive®) 0.45mg / 20mg progestin-containing therapy is not appropriate. modified-release tablets 626/10 Ofatumumab, 100mg Treatment of chronic lymphocytic leukaemia in patients who are refractory to concentrate for solution for and alemtuzumab infusion (Arzerra®) 1237/17 Ofatumumab (Arzerra®) Treatment of adult patients with relapsed CLL in combination with fludarabine 100mg & 1000mg concentrate and cyclophosphamide. for solution for infusion 624/10 Olanzapine 210mg, 300mg, Maintenance treatment of adult patients with schizophrenia sufficiently 405mg powder and solvent for stabilised during acute treatment with oral olanzapine prolonged release suspension for injection (ZypAdhera®) 1281/17 Opicapone 50mg hard Adjunctive therapy to preparations of levodopa / DOPA decarboxylase capsules (Ongentys®) inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. 266/06 Oxycodone (OxyNorm®) Treatment of post-operative pain injection 541/09 Oxycodone/naloxone Treatment of severe pain which can be adequately managed only with opioid prolonged release tablets analgesics (Targinact®) 1071/15 Paclitaxel albumin In combination with carboplatin for the first-line treatment of non-small cell lung (Abraxane®) cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. 272/06 Palifermin (Kepivance®) Treatment of oral in bone marrow transplantation

Medicines Utilisation Unit, January 2018 Page 12 of 17 702/11 Paliperidone 1.5mg, 3mg, 6mg, Treatment of psychotic or manic symptoms of schizoaffective disorder 9mg, 12mg prolonged release tablets (Invega®) 453/08 Paliperidone prolonged release Treatment of schizophrenia tablets (Invega®) 769/12 Panitumumab (Vectibix®) 20 Treatment of patients with wild-type KRAS metastatic colorectal cancer in first- mg/ml concentrate for solution line in combination with FOLFOX; in second-line in combination with FOLFIRI for infusion for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) 486/08 Panitumumab concentrate for Treatment of patients with EGFR expressing metastatic colorectal carcinoma. solution for infusion (Vectibix®) Superseded by NICE MTA242: Cetuximab (monotherapy or combination chemotherapy), bevacizumab (in combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy 1082/15 Panitumumab (Vectibix®) Treatment of adult patients with wild-type RAS metastatic colorectal cancer first-line in combination with FOLFIRI Superseded by NICE MTA 439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer 27/02 Parecoxib (Dynastat®) Short term treatment of post-operative pain 478/08 capsules Prevention and treatment of secondary hyperparathyroidism associated with (Zemplar®) chronic renal insufficiency (chronic kidney disease [CKD] Stages 3 and 4) patients and chronic renal failure (CKD Stage 5) patients on haemodialysis or peritoneal dialysis. 288/06 Paricalcitol injection Prevention & treatment of secondary hyper-parathyroidism in patients with (Zemplar®) chronic renal failure undergoing haemodialysis 815/12 Pasireotide (Signifor®) 0.3mg, Treatment of adult patients with Cushing’s disease for whom surgery is not an 0.6 mg and 0.9 mg solution for option or for whom surgery has failed injection 820/12 Pazopanib 200mg, 400mg film- Treatment of adult patients with selective subtypes of advanced soft tissue coated tablets (Votrient®) sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy 84/03 Pegylated liposomal Monotherapy for treatment of metastatic breast cancer doxorubicin (Caelyx®) 503/08 Pegylated liposomal In combination with bortezomib for the treatment of progressive multiple doxorubicin concentrate for myeloma in patients who have received at least one prior therapy and who solution for infusion (Caelyx®) have already undergone or are unsuitable for bone marrow transplant 1087/15 Pembrolizumab 50mg powder As monotherapy for the treatment of advanced (unresectable or metastatic) for concentrate for solution for melanoma in adults. This submission relates to use in adults previously treated infusion (Keytruda®) with ipilimumab. 268/06 (Alimta®) Monotherapy for locally advanced or metastatic non-small cell lung cancer after prior chemotherapy 642/10 Pemetrexed 100mg, 500mg Monotherapy for the maintenance treatment of locally advanced or metastatic powder for concentrate for non-small cell lung cancer in patients whose disease has not progressed solution for infusion (Alimta®) immediately following platinum-based chemotherapy 1200/16 Perampanel (Fycompa®) 2mg, Adjunctive treatment of primary generalised tonic-clonic seizures in adult and 4mg, 6mg, 8mg, 10mg and adolescent patients from 12 years of age with idiopathic generalised epilepsy. 12mg film-coated tablets 897/13 Pertuzumab 30mg/mL In combination with trastuzumab and docetaxel in adult patients with human concentrate for solution for epidermal growth factor-2 (HER2)-positive metastatic or locally recurrent infusion (Perjeta®) unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease 1121/16 Pertuzumab 420mg In combination with trastuzumab and chemotherapy for the neoadjuvant concentrate for solution for treatment of adult patients with human epidermal growth factor receptor 2 infusion vial (Perjeta®) (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. 35/03 Pimecrolimus 1% cream Treatment of mild to moderate atopic dermatitis (Elidel®) 1229/17 Pitolisant (Wakix®) Treatment of narcolepsy with or without cataplexy in adults 4.5mg/18mg film-coated tablets 1138/16 (Pixuvri®) 29 mg As monotherapy for the treatment of adult patients with multiply relapsed or power for concentrate for refractory aggressive Non Hodgkin B-cell Lymphomas. solution for infusion 771/12 Prednisone (Lodotra®) 1 mg, 2 Treatment of moderate to severe, active rheumatoid arthritis in adults mg and 5 mg modified-release particularly when accompanied by morning stiffness

Medicines Utilisation Unit, January 2018 Page 13 of 17 tablets

339/06 Pregabalin (Lyrica®) Treatment of generalised anxiety disorder in adults 389/07 Pregabalin capsules (Lyrica®) Treatment of central neuropathic pain 653/10 Prucalopride 1mg and 2mg Symptomatic treatment of chronic constipation (women) tablets (Resolor®) 744/11 Quetiapine (Seroquel XL®) 50 Add-on treatment of major depressive episodes in patients with Major mg, 150 mg, 200 mg, 300mg Depressive Disorder who have had sub-optimal response to antidepressant 400 mg prolonged-release monotherapy. tablets 549/09 Quetiapine 25mg, 100mg, Treatment of major depressive episodes in the framework of bipolar disorder 200mg, 300mg tablet (Seroquel®) 489/08 Rabbit anti-human thymocyte Prevention of graft rejection in renal transplantation immunoglobulin, powder for solution for infusion (Thymoglobuline®) 832/12 Racecadotril (Hidrasec®) Symptomatic treatment of acute diarrhoea in adults when causal treatment is 100mg capsules not possible 818/12 Racecadotril 10mg, 30mg Complementary symptomatic treatment of acute diarrhoea in infants older than granules for oral suspension three months and in children, together with oral rehydration and the usual (Hidrasec Infants®, Hidrasec support measures, when these measures alone are insufficient to control the Children®) clinical condition 1156/16 Ramucirumab (Cyrmaza®) 10 In combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) for the mg/ml concentrate for solution treatment of adult patients with metastatic colorectal cancer with disease for infusion progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. 1165/16 Ramucirumab (Cyrmaza®) 10 In combination with docetaxel for the treatment of adult patients with locally mg/ml concentrate for solution advanced or metastatic non-small cell lung cancer with disease progression for infusion after platinum-based chemotherapy. 1176/16 Ramucirumab (Cyramza®) 10 In combination with paclitaxel for the treatment of adult patients with advanced mg/ml concentrate for solution gastric cancer or gastro-oesophageal junction adenocarcinoma with disease for infusion progression after prior platinum and fluoropyrimidine chemotherapy As monotherapy for the treatment of adult patients with advanced gastric cancer or gastrooesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate 565/09 Ranolazine, 375mg, 500mg Add-on therapy for symptomatic treatment of patients with stable angina and 750mg prolonged-release pectoris who are inadequately controlled or intolerant to first-line antianginal tablets (Ranexa®) therapies 243/06 Rasagiline tablet (Azilect®) Treatment of idiopathic Parkinson’s disease – monotherapy (without levodopa) 255/06 Rasagiline tablet (Azilect®) Treatment of idiopathic Parkinson’s disease as adjunct therapy (with levodopa) in patients with end of dose fluctuations 1118/15 Regorafenib (Stivarga®) 40mg Adult patients with metastatic colorectal cancer (CRC) who have been film-coated tablets previously treated with, or are not considered candidates for, available therapies 1233/17 Reslizumab 10mg/mL As add-on therapy in adult patients with severe eosinophilic asthma concentrate for solution for inadequately controlled despite high-dose inhaled corticosteroids plus another infusion (Cinqaero®) medicinal product for maintenance treatment 472/08 Retapamulin (Altargo®) Impetigo and infected small lacerations, abrasions, or sutured wounds 875/13 Rifampicin, isoniazid, Initial treatment of tuberculosis according to World Health Organisation pyrazinamide, ethambutol guidelines hydrochloride film-coated tablets (Voractiv®) 808/12 Rifaximin 200mg film coated Treatment of travellers' diarrhoea that is not associated with any of: tablets (Xifaxanta®)  Fever  Bloody diarrhoea  Eight or more unformed stools in the previous 24 h  Occult blood or leucocytes in the stool. 341/07 Rimonabant tablet (Acomplia®) Obesity Marketing authorisation withdrawn 23rd October 2008 424/07 Risedronate sodium (Actonel®) Osteoporosis in men at high risk of fractures 1062/15 Rivaroxaban 2.5mg film-coated Co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine Medicines Utilisation Unit, January 2018 Page 14 of 17 tablets (Xarelto®) is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. 310/06 Rivastigmine (Exelon®) Treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease 635/10 Roflumilast 500 microgram Maintenance treatment of severe chronic obstructive pulmonary disease (FEV1 resub tablets (Daxas®) post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment 725/11 Rosuvastatin, 5mg, 10mg, Prevention of major cardiovascular events in patients who are estimated to 20mg, film-coated tablets have a high risk for a first cardiovascular event as an adjunct to correction of (Crestor®) other risk factors 612/10 Rupatadine (Rupafin®) Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and adolescents 1166/16 phosphate Treatment of adult patients with polycythaemia vera who are resistant to or (Jakavi)®) 5mg, 10mg, 15mg intolerant of hydroxyurea. and 20mg tablets 1259/17 Safinamide (Xadago®) 50mg / Treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on 100mg film-coated tablets therapy to a stable dose of Levodopa alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.

450/08 Salmeterol/Fluticasone 50/500 Symptomatic treatment of COPD (FEV1 50% to <60%) microgram inhaler (Seretide 500 Accuhaler®) 558/09 Sapropterin 100mg soluble Treatment of hyperphenylalaninaemia in adult and paediatric patients with tablets (Kuvan®) phenylketonuria and for the treatment of hyperphenylalaninaemia in adult and paediatric patients with tetrahydrobiopterin deficiency. 958/14 Saxagliptin (Onglyza®) 2.5mg Monotherapy in adult patients aged 18 years and older with type 2 diabetes & 5mg film-coated tablets mellitus to improve glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. 1235/17 Selexipag, 200 microgram, 400 Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients microgram, 600 microgram, with WHO functional class (FC) II to III, either as combination therapy in 800 microgram, 1,000 patients insufficiently controlled with an endothelin receptor antagonist (ERA) microgram, 1,200 microgram, and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in 1,400 microgram, 1,600 patients who are not candidates for these therapies. microgram film-coated tablets (Uptravi®) 68/03 Sertraline (Lustral®) Post traumatic stress disorder in women 423/07 Sevelamer hydrochloride Control of hyperphosphataemia in adult patients receiving peritoneal dialysis tablets (Renagel®) 246/06 Sodium oxybate oral solution Treatment of cataplexy in adult patients with narcolepsy (Xyrem®) 321/06 Sorafenib tablets (Nexavar®) Treatment of patients with advanced renal cell carcinoma Superseded by NICE MTA178: Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma 367/07 Standardised allergen extract Treatment of grass pollen induced rhinitis and conjunctivitis of grass pollen oral lyophilisate (Grazax®) 816/12 Strontium ranelate (Protelos®) Treatment of osteoporosis in men at increased risk of fracture 2g granules for oral suspension 1270/17 Sufentanil citrate 15 Management of acute moderate to severe post-operative pain in adult patients. micrograms sublingual tablets (Zalviso®) 343/07 Sunitinib capsule (Sutent®) Treatment of advanced and/or metastatic renal cell cancer 384/07 Sunitinib 12.5mg, 25mg, 50mg Treatment of advanced and/or metastatic renal cell carcinoma (MRCC) capsules (Sutent) Superseded by NICE MTA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma 849/12 Tadalafil 5mg film coated Treatment of the signs and symptoms of benign prostatic hyperplasia in adult tablets (Cialis®) males 877/13 Tafamidis meglumine 20mg Treatment of transthyretin amyloidosis in adult patients with stage 1 soft capsules (Vyndaqel®) symptomatic polyneuropathy to delay peripheral neurologic impairment 1248/17 Talimogene laherparepvec Treatment of adults with unresectable melanoma that is regionally or distantly (Imlygic®) 106 and 108 plaque metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other forming units (PFU)/mL visceral disease.

Medicines Utilisation Unit, January 2018 Page 15 of 17 solution for injection 773/12 Tapentadol (Palexia®) 50 mg Relief of moderate to severe acute pain in adults, which can be adequately film-coated tablets managed only with opioid analgesics. 1139/16 Teduglutide (Revestive®) 5mg Treatment of adult patients with Short Bowel Syndrome power and solvent for solution for injection 631/10 Telmisartan (Micardis®) Cardiovascular prevention or type 2 diabetes mellitus with documented target organ damage 1015/14 Telavancin hydrochloride Treatment of adults with nosocomial pneumonia (NP) including ventilator (Vibativ®) 250 mg and 750 mg associated pneumonia, known or suspected to be caused by methicillin- powder for concentrate for resistant Staphylococcus aureus (MRSA). solution for infusion 96/04 (Foscan®) Palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy 617/10 Temsirolimus (Torisel®) Treatment of adult patients with relapsed and/or refractory mantle cell lymphoma 1238/17 Treatment of chronic hepatitis B in adults and adolescents (aged 12 years and (Vemlidy®) 25mg film-coated older with body weight at least 35 kg). tablets 487/08 Teriparatide 20micrograms/ Osteoporosis associated with sustained systemic glucocorticoid therapy in 80microlitres, solution for women and men at increased risk for fracture injection, prefilled pen (Forsteo®) 490/08 Teriparatide, 750 micrograms/ Treatment of osteoporosis in men at increased risk of fracture 3ml solution for injection prefilled pen (Forsteo®) 398/07 Testosterone 300mcg/24 hours Treatment of hypoactive sexual desire disorder in bilaterally oophorectomised transdermal patch (Intrinsa®) and hysterectomised (surgically induced menopause) women receiving concomitant oestrogen therapy. 1000/14 Tetracaine / lidocaine 70 mg/g Local dermal anaesthesia on intact skin prior to dermatological procedures in + 70 mg/g cream (Pliaglis®) adults 790/12 15mg and 100mg In combination with other chemotherapy medicinal products: powder for concentrate for 1) with or without total body irradiation (TBI), as conditioning treatment prior solution for infusion to allogeneic or autologous haematopoietic progenitor cell transplantation (Tepadina®) (HPCT) in haematological diseases in adult and paediatric patients; 2) when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. 1224/17 Ticagrelor 60mg film-coated Co-administered with acetylsalicylic acid for the prevention of atherothrombotic tablets (Brilique®) events in adult patients with a history of myocardial infarction and a high risk of developing an atherothrombotic event. 1101/15 Tigecycline (Tygacil®) 50 mg Treatment in children from the age of eight years for the following infections: powder for solution for infusion • complicated skin and soft tissue infections, excluding diabetic foot infections • complicated intra-abdominal infections 868/13 Timothy grass pollen Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis allergen75,000 SQ-T oral in adults and children (5 years or older), with clinically relevant symptoms and lyophilisate (GRAZAX®) diagnosed with a positive skin prick test and/or specific IgE test to grass pollen 1020/14 Tocilizumab (RoActemra®) 20 Treatment of severe, active and progressive rheumatoid arthritis in adults not mg/ml concentrate for solution previously treated with methotrexate. for infusion 1201/16 Tocilizumab (RoActemra®) Treatment of severe, active and progressive rheumatoid arthritis in adults not 162mg Solution for Injection in previously treated with methotrexate. Pre-Filled Syringe 696/11 Tocofersolan, 50mg/mL, oral E deficiency due to digestive in paediatric patients solution (Vedrop®) suffering from congenital chronic cholestasis or hereditary chronic cholestasis 605/10 Tolvaptan 15mg and 30mg Treatment of hyponatraemia secondary to syndrome of inappropriate tablets (Samsca®) antidiuretic hormone secretion (adult) 366/07 infusion Treatment of patients with relapsed small cell lung cancer for whom re- (Hycamtin®) treatment with the first-line regimen is not considered appropriate Superseded by NICE MTA184: Topotecan for the treatment of relapsed small- cell lung cancer 452/08 powder for Treatment of advanced soft tissue sarcoma, after failure of anthracyclines and concentrate for solution for , or who are unsuited to receive these agents infusion (Yondelis®) Medicines Utilisation Unit, January 2018 Page 16 of 17 634/10 Trabectedin, 250 microgram, In combination with pegylated liposomal doxorubicin is indicated for the 1mg powder for concentrate for treatment of patients with relapsed platinum-sensitive ovarian cancer solution for infusion Superseded by NICE MTA 389: Topotecan, pegylated liposomal doxorubicin (Yondelis®) hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer 236/06 Tramadol/paracetamol tablet Symptomatic treatment of moderate to severe pain (Tramacet®) 386/07 Trastuzumab (Herceptin®) Combination with an aromatase inhibitor for metastatic breast cancer Superseded by NICE MTA 257: Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone- receptor-positive breast cancer that overexpresses HER2 269/06 Triptorelin 3.75mg (Gonapeptyl Treatment of advanced, hormone-dependent prostate cancer depot) 270/06 Triptorelin 3.75mg (Gonapeptyl Symptomatic endometriosis depot) 796/12 Triptorelin pamoate 11.25mg Reversible reduction of testosterone to castrate levels in order to decrease powder and solvent for sexual drive in adult men with severe sexual deviations suspension for injection (Salvacyl®) 89/04 Valdecoxib (Bextra®) Treatment of primary dysmenorrhea Marketing Authorisation for valdecoxib (Bextra) expired in March 2008 – SMC advice withdrawn 797/12 Vandetanib 100 mg / 300mg Treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in film coated tablets (Caprelsa®) patients with unresectable locally advanced or metastatic disease 501/08 Venlafaxine extended release Treatment of moderate to severe generalised social anxiety disorder/social capsules (Efexor XL®) phobia in adults 1222/17 Vernakalant (Brinavess®) Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults 20mg/ml concentrate for  For non-surgery patients: atrial fibrillation ≤ 7 days duration solution for infusion  For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration 874/13 Vildagliptin/metformin Treatment of type 2 diabetes mellitus: hydrochloride ® 50mg/ 850 mg  in combination with a sulphonylurea (i.e. triple combination therapy) as an and 50mg/1000 mg film-coated adjunct to diet and exercise in patients inadequately controlled with tablets (Eucreas®) metformin and a sulphonylureas  in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control 686/11 ditartrate 25mg/ml Monotherapy for the treatment of adult patients with advanced or metastatic resub concentrate for solution for transitional cell carcinoma of the urothelial tract after failure of a prior platinum- infusion (Javlor®) containing regimen 924/13 Vismodegib (Erivedge®) Treatment of adult patients with: 150mg hard capsules  symptomatic metastatic basal cell carcinoma  locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy 1014/14 Voriconazole (Vfend®) 50 mg Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic and 200 mg film-coated tablets/ stem cell transplant (HSCT) recipients 200 mg powder for solution for infusion / 200 mg powder and solvent for solution for infusion/ 40 mg/ml powder for oral suspension 405/07 Ziconotide, 100 micrograms/ml Severe, chronic pain in patients who require intrathecal analgesia solution for intrathecal infusion (Prialt®) 535/08 Zoledronic acid infusion Treatment of osteoporosis in men (Aclasta®) 29/02 Zoledronic acid infusion Prevention of skeletal related events in advanced prostate cancer involving (Zometa®) bone 817/12 Zonisamide (Zonegran®) 25, Monotherapy for the treatment of partial seizures (with or without secondary 50, 100mg hard capsules generalization) in adults with newly diagnosed epilepsy

Medicines Utilisation Unit, January 2018 Page 17 of 17