New Product Evaluations - a Resource for Medicines Management

August 2015 Number 152

New product evaluations - a resource for medicines management

What this is: A list of new product evaluations that are freely available to NHS staff via the internet. The list is updated monthly.

How to find the evaluation you want:  Look at the table below.  Products are listed in alphabetical order, by generic drug or device name.  If a product contains two or more drugs it will be listed by brand name.  If an evaluation has been produced in the last 31 months, it will say who did it and when.  If an evaluation is currently ‘In production’ it will say who is doing it and when it is due.  Evaluations that are highlighted in red are newly-produced evaluations that have been added to the list this month.

To read the full-text evaluation: In most cases there is a direct link to the evaluation; these are available by clicking the blue hyperlink in the ‘reviewer / publication date’ column of the table.

NICE: Technology appraisals are produced following a series of consultations. Information is published at specific stages of the appraisal process. If the final appraisal is not yet available, there will be a link to available interim documents. Please note that the publication date listed for these items is the anticipated publication date for the final appraisal.

Who produces the evaluations? Groups included in this list that produce evaluations are:  AWMSG – All Wales Medicines Strategy Group  NICE – National Institute for Health and Care  LCNDG – London Cancer New Drugs Group Excellence  LNDG – London New Drugs Group  NICE-ES – NICE Evidence Summary  LMEN - London Medicines Evaluation Network  NHSC – NIHR Horizon Scanning Research &  MTRAC – Midland Therapeutic Review & Advisory Intelligence Centre Committee  RDTC – Regional Drug & Therapeutics Centre  NETAG / NTAG – North East / Northern Treatment  SMC – Scottish Medicines Consortium Advisory Group  UKMi – United Kingdom Medicines Information

Status – what does this mean? Not launched – the product is not commercially available in the UK. Launched – the product has been launched in the UK and is licensed for the stated indication. New indication – the product has been launched in the UK and is licensed for the stated indication, but the indication stated is not the first indication for which the drug was initially licensed. Unlicensed indication – the product has been launched in the UK but is not licensed for the stated indication.

Specified high cost drugs (tariff excluded) This column indicates which drugs appear on the 2015/16 list of high cost drugs exclusions or on the chemotherapy regimens list and consequently are ‘Tariff excluded’. The list is updated annually, with no in-year updates. The information in the table should be used as a guide only; drugs launched after publication of the lists may be Tariff excluded but do not appear in the list and would have to be negotiated locally. There may be drugs in this document which have yet to be launched and consequently may not appear on either list. This document does not give any indication as to potential Tariff position of new drugs.

North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected] New product evaluations Number 152

The evaluations:

Reviewer / Tariff Drug name Indication Status publication date excluded

Postmenopausal osteoporosis – first- Abaloparatide Not launched NHSC Oct 14 and second-line

Rheumatoid arthritis after failure of SMC Apr 13 conventional disease-modifying anti- Launched (Resubmission) rheumatic drugs NICE Apr 13

NICE due Oct 15 Rheumatoid arthritis Launched YES Abatacept (In production – update)

Moderate-to-severe active polyarticular juvenile idiopathic New indication AWMSG Feb 14 arthritis in patients aged six years and older – second-line

Abatacept (sub- Moderate-to-severe active rheumatoid Launched SMC Aug 13 YES cutaneous) arthritis in adults

NICE due TBC (In production)

Asymptomatic or mildly symptomatic SMC due Oct 15 prostate cancer, after failure of (In production) Abiraterone androgen deprivation therapy, when New indication YES chemotherapy is not yet clinically SMC Feb 15 indicated AWMSG Sep 14

LCNDG Jan 13

Non-small cell lung cancer in adults who are not candidates for potentially curative surgery and/or radiation New indication SMC Jun 15 therapy, in combination with carboplatin

Breast cancer as a substitute for Unlicensed LCNDG Jan 13 docetaxel/paclitaxel indication Abraxane (nab- YES paclitaxel) NICE due TBC (In production)

Metastatic pancreatic cancer – first- SMC Feb 15 New indication line in combination with gemcitabine (Resubmission) AWMSG Sep 14

NHSC Jan 13

Chronic obstructive pulmonary Aclidinium Launched NICE-ES Jan 13 disease

Actikerall (5-fluorouracil Hyperkeratotic actinic keratosis Launched RDTC Apr 13 and salicylic acid)

Reviewer / Tariff Drug name Indication Status publication date excluded

Active enthesitis-related arthritis in AWMSG Jun 15 New indication patients aged six years and older SMC May 15 Severe chronic plaque psoriasis in SMC Jul 15 children and adolescents – second- New indication line NHSC Dec 14 Ankylosing spondylitis and axial NICE due Oct 15 New indication spondyloarthritis (non-radiographic) (In production) Axial spondyloarthritis New indication SMC Apr 13

NICE due Oct 15 Rheumatoid arthritis Launched (In production – update) Adalimumab YES RDTC May 13

Juvenile idiopathic polyarticular AWMSG Aug 13 New indication arthritis SMC Jul 13

NICE Feb 15 Moderate-to-severe active ulcerative New indication NTAG Dec 14 colitis – second-line Appraisal report Recommendation

Severe active Crohn's disease in AWMSG Aug 13 patients aged six to 17 years – New indication second-line SMC Jul 13 Cutaneous treatment of acne vulgaris Adapalene (Epiduo when comedones, papules and Launched SMC Apr 14 Gel) pustules are present

Non-small cell lung cancer Launched SMC Mar 14

Locally-advanced, recurrent or Afatinib Unlicensed metastatic head and neck squamous NHSC Apr 13 indication cell carcinoma – second-line

In combination with FOLFIRI AWMSG Jun 15 chemotherapy in adults with NICE Mar 14 metastatic colorectal cancer that is Launched resistant to, or has progressed after, SMC Mar 14 an oxaliplatin-containing regimen (Resubmission)

LMEN Feb 15

LNDG Mar 13

Aflibercept NICE Jul 13 Age-related macular degeneration Launched SMC Apr 13 YES NETAG Jan 13 Appraisal report Recommendation

Visual impairment due to macular SMC Apr 14 oedema secondary to central retinal Launched vein occlusion NICE Feb 14

Reviewer / Tariff Drug name Indication Status publication date excluded

Visual impairment due to macular SMC due Sep 15 oedema secondary to branch retinal New indication (In production) vein occlusion NHSC Dec 14

Aflibercept NICE Jul 15 YES

Visual impairment due to diabetic LMEN Apr 15 New indication macular oedema SMC Nov 14

NHSC Jun 13

NETAG Apr 15 Airsonett laminar flow Treatment of uncontrolled allergic Launched Appraisal report device asthma Recommendation

SMC due TBC Akynzeo (netupitant Chemotherapy-induced nausea and (In production) Launched and palonosetron) vomiting NICE-ES due Jan 16 (In production)

SMC due TBC Albiglutide Type 2 diabetes Not launched (In production)

Advanced ALK-positive, non-small Not launched NHSC Aug 15 cell lung cancer – first-line

Alectinib Locally advanced or metastatic ALK- positive, non-small cell lung cancer Not launched NHSC Aug 15 following failure of crizotinib

SMC Jul 14 Alemtuzumab Multiple sclerosis, relapsing-remitting Launched NICE May 14

Alicaforsen Pouchitis – second-line Not launched NHSC Nov 13

Relapsed or refractory peripheral T- Alisertib cell lymphoma – second and Not launched NHSC Mar 14 subsequent line AWMSG Oct 14

SMC Oct 14 Alogliptin Type 2 diabetes Launched (Resubmission) MTRAC May 14

NICE-ES May 13

Emphysema associated with alpha-1 Alpha-1 antitrypsin antitrypsin deficiency – maintenance Not launched NHSC Dec 14 YES (Respreeza) therapy

Alpha-mannosidase, recombinant, human Alpha mannosidosis Not launched NHSC May 14 YES (Lamazym)

Alprostadil cream Erectile dysfunction Launched NICE-ES Dec 14 Ameluz (5- Actinic keratosis of mild to moderate aminolaevulinic acid Launched AWMSG Dec 13 intensity on the face and scalp hydrochloride)

Anorexia-cachexia in advanced non- Anamorelin Not launched NHSC Nov 13 small cell lung cancer

Reviewer / Tariff Drug name Indication Status publication date excluded AWMSG Mar 15

Anoro Ellipta SMC Feb 15 Chronic obstructive pulmonary (umeclidinium and Launched (Resubmission) disease vilanterol) MTRAC Jan 15

NICE-ES Nov 14 NETAG Jan 13 Not launched – Anti-thymocyte globulin Appraisal report Aplastic anaemia – first-line named patient YES (horse) Recommendation only LCNDG Jan 13

Stroke prevention in patients with NICE Feb 13 New indication atrial fibrillation SMC Feb 13

Apixaban NICE Jun 15 Treatment and prevention of venous New indication SMC Mar 15 thromboembolic events NHSC Jul 13 High risk neuroblastoma in children APN311 Not launched NHSC Jul 15 and adolescents – first-line NICE due Oct 15 Chronic plaque psoriasis Launched (In production) SMC Jun 15 Unlicensed Ankylosing spondylitis NHSC Nov 13 indication YES Apremilast NICE due Oct 15 (In production) Psoriatic arthritis Launched SMC Jun 15

NHSC Jan 13

Psoriasis Launched NHSC Jan 13 Anticoagulation in adults with heparin- induced thrombocytopenia type II who SMC Aug 13 Argatroban Launched require parenteral antithrombotic (Resubmission) therapy

Moderate-to-severe manic episodes SMC Sep 13 Aripiprazole in bipolar I disorder in adolescents New indication aged 13 years and older NICE Jul 13 NTAG Apr 15 Appraisal report Recommendation Aripiprazole (Abilify Maintenance treatment of New indication Maintena) schizophrenia in adults AWMSG Aug 14 SMC May 14

NICE-ES Mar 14

Asfotase alfa Hypophosphatasia Not launched NHSC Nov 13 YES

Asparaginase, erythrocyte Acute lymphoblastic leukaemia – Not launched NHSC Feb 15 encapsulated second-line (GRASPA)

Reviewer / Tariff Drug name Indication Status publication date excluded MAGE-A3 positive malignant Astuprotimut-R melanoma, stage III – adjuvant Not launched NHSC Apr 13 therapy Asunaprevir and Chronic hepatitis C virus infections Not launched NHSC Sep 13 YES daclatasvir genotype 1 and 4 Asunaprevir, beclabuvir Hepatitis C virus infection, genotype 1 Unlicensed NHSC Feb 15 YES and daclatasvir – first- or second-line formulation CFTR class I nonsense mutation Ataluren Not launched NHSC Aug 15 mediated cystic fibrosis Locally advanced or metastatic non- Not launched NHSC Aug 15 small cell lung cancer – second-line Atezolizumab Urothelial bladder cancer – second Not launched NHSC Jul 15 and subsequent line Attention-deficit hyperactivity disorder SMC due Dec 15 in children, adolescents and adults Launched (In production) aged ≥6 years Atomoxetine AWMSG Feb 14 Attention-deficit hyperactivity disorder Launched SMC Nov 13 SMC due Sep 15 (In production)

AWMSG Jul 15 Avanafil Erectile dysfunction Launched NICE-ES Aug 14

MTRAC Aug 14

SMC Jun 14 Thrombocytopenia in chronic liver Not launched NHSC Oct 14 Avatrombopag disease prior to surgery YES Immune thrombocytopenic purpura Not launched NHSC Jan 13 NICE Feb 15

Advanced and/or metastatic renal cell SMC Nov 13 Axitinib New indication YES carcinoma – second-line (Resubmission)

LNDG Jan 13

Unlicensed Azacitidine Acute myeloid leukaemia – first-line NHSC Oct 14 YES indication Community acquired pneumonia and AWMSG Aug 14 pelvic inflammatory disease due to Azithromycin (Zedbac) Launched susceptible organisms where initial IV SMC Apr 14 treatment is required Unlicensed Long-term use in cystic fibrosis NICE-ES Nov 14 indication Azithromycin Long-term use in non-cystic fibrosis Unlicensed NICE-ES Nov 14 and bronchiectasis indication Suppression of chronic pulmonary SMC Jan 15 infections due to Pseudomonas (Resubmission) Aztreonam aeruginosa in patients with cystic Launched YES fibrosis aged six years and older – AWMSG Mar 13 third-line

Moderate-to-severe rheumatoid Baricitinib Not launched NHSC Jul 15 arthritis

Reviewer / Tariff Drug name Indication Status publication date excluded Advanced non-small cell lung cancer Bavituximab – second line in combination with Not launched NHSC Aug 15 docetaxel

Pulmonary multidrug resistant Bedaquiline Launched AWMSG May 15 YES tuberculosis in adults NICE due TBC Belimumab Systemic lupus erythematosus Launched YES (In production) Relapsed follicular lymphoma Unlicensed LCNDG Jan 13 refractory to rituximab indication

Advanced indolent non-Hodgkin's and Unlicensed mantle cell lymphoma – with rituximab LCNDG Mar 13 indication first-line YES Bendamustine With rituximab for relapsed indolent B- cell and mantle cell lymphoma Unlicensed LCNDG Mar 13 including relapsed/ refractory indication Waldenström’s macroglobulinaemia

Unlicensed Multiple myeloma – fourth-line LCNDG Apr 13 indication

Benralizumab Uncontrolled asthma – second line Not launched NHSC Aug 15

Prevention of venous Betrixaban Not launched NHSC Oct 14 thromboembolism – first-line

Advanced ovarian cancer in Unlicensed Bevacizumab 7.5mg/kg combination with paclitaxel and NICE-ES Oct 13 YES indication carboplatin – first-line EGFR positive, advanced or Unlicensed metastatic non-small cell lung cancer, NHSC Aug 15 indication in combination with erlotinib – first-line

NTAG Sep 14 - update Unlicensed Age-related macular degeneration Appraisal report indication Recommendation

Macular oedema secondary Unlicensed NTAG Feb 14 to retinal vein occlusion indication

Recurrent or persistent stage IVB cervical cancer – in combination with New indication NHSC May 14 chemotherapy

Unlicensed High-grade glioma – third-line LCNDG Mar 13 indication

Bevacizumab Platinum-resistant recurrent epithelial YES ovarian, fallopian tube, or primary peritoneal cancer in combination with SMC due Sep 15 New indication paclitaxel, topotecan, or pegylated (In production) liposomal doxorubicin – second or third-line

SMC due Nov 15 (In production – Advanced epithelial ovarian, fallopian resubmission) tube, or primary peritoneal cancer in New indication combination with paclitaxel and SMC Jan 15 carboplatin – first-line (Resubmission)

NICE May 13

Recurrent platinum-sensitive epithelial SMC Mar 13 ovarian, fallopian tube, or primary New indication peritoneal cancer NICE May 13

Reviewer / Tariff Drug name Indication Status publication date excluded

Relapsed platinum-resistant ovarian New indication NICE Aug 15 Bevacizumab YES cancer – second-line New indication NHSC Jan 13 Reduction of elevated intraocular Bimatoprost solution in pressure in chronic open-angle single-dose container Launched SMC Mar 13 glaucoma and ocular hypertension in (Lumigan UD) adults Bimatoprost and timolol Reduction of intraocular pressure in (Ganfort; preservative- adults with open-angle glaucoma or Launched SMC Oct 13 free) ocular hypertension Permanent disability related to multiple sclerosis relapses – add on Not launched NHSC Apr 15 Biotin therapy to current immunomodulators Primary and secondary progressive Not launched NHSC Apr 15 multiple sclerosis ‒ first-line

Relapsed or refractory Philadelphia- Blinatumomab negative B-precursor acute Not launched NHSC May 14 lymphoblastic leukaemia

SMC due Sep 15 Mantle cell lymphoma New indication (In production)

Bortezomib AWMSG Oct 14 YES Multiple myeloma Launched NICE Apr 14

SMC Jan 14 Chronic phase, accelerated phase, SMC Feb 15 and blast phase Philadelphia (Resubmission) Bosutinib chromosome positive chronic Launched myelogenous leukaemia – second- NICE Nov 13 line Adults with overactive bladder with symptoms of urinary incontinence, urgency and frequency who are not New indication SMC Dec 13 adequately managed with anticholinergics

Adults with neurogenic detrusor AWMSG Dec 13 overactivity due to subcervical spinal cord injury or multiple sclerosis, who New indication

Botulinum type A are not adequately managed with SMC Oct 13 neurotoxin (Botox) anticholinergics SMC Apr 13 Chronic migraine New indication (Resubmission)

Unlicensed Chronic anal fissure NICE-ES Jun 13 indication

SMC Jul 14 Post-stroke lower limb spasticity New indication NHSC Feb 14 YES

Reviewer / Tariff Drug name Indication Status publication date excluded Cutaneous T-cell lymphoma, CD30+ Launched NHSC Jul 15

Hodgkin’s lymphoma, in adults at high risk of residual CD30+ following Launched NHSC Jul 13 autologous stem cell transplant YES Brentuximab vedotin Hodgkin’s lymphoma or systemic AWMSG Jun 15 anaplastic large cell lymphoma – Launched relapsed or refractory SMC Oct 14

Systemic anaplastic large cell Launched LCNDG Mar 13 lymphoma - relapsed or refractory SMC Jan 15

MTRAC Jul 14

Brimonidine Facial erythema of rosacea Launched NICE-ES Jul 14

RDTC Jun 14

MTRAC Apr 14

Brodalumab Moderate-to-severe plaque psoriasis Not launched NHSC May 14 YES

Post-operative ocular inflammation Bromfenac Launched AWMSG May 14 following cataract extraction

Bucelipase-alfa To improve growth and development Not launched NHSC Jun 13 (Kiobrina) in pre-term infants Autoimmune hepatitis New indication SMC May 15 Induction of remission in patients with mild to moderate active Crohn’s New indication SMC Jun 14 disease affecting the ileum and/or Budesonide ascending colon

(Budenofalk) SMC Jan 13 Symptomatic relief of chronic (capsules) Launched diarrhoea due to collagenous colitis SMC Jan 13 (granules)

Induction of remission in patients with SMC due Oct 15 Budesonide mild to moderate active ulcerative Launched (In production) (Cortiment) colitis NICE-ES Jun 15

Locally advanced or metastatic breast Buparlisib Not launched NHSC Jul 15 cancer in combination with fulvestrant

Metastatic renal cell carcinoma – Unlicensed NHSC Jul 15 second-line indication

Cabozantinib Progressive, unresectable locally SMC Mar 15 advanced or metastatic medullary Launched thyroid carcinoma AWMSG Jan 15

Caffeine citrate Primary apnoea of premature Launched SMC Sep 13 (Peyona) newborns

Hyperkalaemia, in patients with acute Calcium polystyrene and chronic renal insufficiency, sulphonate (Sorbisterit) Launched SMC Aug 13 including patients undergoing dialysis

treatment NICE Jun 14

Canagliflozin Type 2 diabetes mellitus in adults Launched SMC Jun 14

RDTC Mar 14

Reviewer / Tariff Drug name Indication Status publication date excluded

Cryopyrin-associated periodic syndromes in adults, adolescents and Launched SMC Jun 13 children aged two years and older

Systemic juvenile idiopathic arthritis – NICE-ES Mar 14 Canakinumab New indication YES second-line SMC Nov 13

NICE-ES Jul 13 Gouty arthritis in adults New indication SMC Jun 13 NICE-ES due Sep 15 Reduction of thrombotic (In production) cardiovascular events in patients with Launched coronary artery disease undergoing NICE Jul 15 percutaneous coronary intervention Cangrelor SMC Jun 15

Prevention of coronary thrombosis in NICE Jul 15 Unlicensed patients undergoing cardiovascular indication surgery NHSC Apr 13 Peripheral neuropathic pain in non- SMC Oct 14 Capsaicin (Qutenza) Launched diabetic adults (Resubmission) Aggression, agitation and behavioural Unlicensed Carbamazepine NICE-ES Mar 15 disturbances in dementia indication

Relapsed and/or refractory multiple Carfilzomib Not launched NHSC Sep 13 myeloma

Carglumic acid Hyperammonaemia Launched SMC Oct 13 YES

Cat PAD (ToleroMune Cat allergen-induced Not launched NHSC Nov 13 YES Cat) rhinoconjunctivitis – first-line

Cediranib Ovarian cancer – second-line Not launched NHSC Mar 14 Complicated skin and soft tissue Ceftaroline Launched SMC Jan 13 infections Hospital-acquired pneumonia excluding ventilator-associated Ceftobiprole Launched SMC Jul 15 pneumonia and community-acquired pneumonia Prophylaxis of postoperative Cefuroxime Launched SMC Dec 13 endophthalmitis after cataract surgery Unlicensed Cetirizine High-dose use in urticaria NICE-ES Jul 14 indication ALK-positive advanced non-small cell SMC due Nov 15 Ceritinib lung cancer, previously treated with Not launched (In production) crizotinib Early rheumatoid arthritis, in Unlicensed NHSC Jul 15 combination with methotrexate indication

Rheumatoid arthritis, in combination NICE due Oct 15 with methotrexate following failure of Launched (In production – update) non-biological DMARD therapy RDTC May 13 Certolizumab YES Adults with severe active axial New indication SMC May 14 spondyloarthritis

AWMSG Oct 14

Active psoriatic arthritis – second-line New indication SMC Jul 14

NICE-ES Jun 14

Reviewer / Tariff Drug name Indication Status publication date excluded

Metastatic colorectal cancer, RAS Cetuximab New indication SMC Jan 15 YES wild type patients

Spinal anaesthesia in adults where Chloroprocaine the planned surgical procedure should Launched SMC Aug 13 hydrochloride (Ampres) not exceed 40 minutes

Cholecalciferol (InVita Prevention and treatment of vitamin D Launched SMC Dec 14 D3) deficiency Inborn errors of primary bile acid Cholic acid (Orphacol) Launched NHSC Mar 14 synthesis – first-line NICE due Dec 15 Severe keratitis in adults with dry eye (In production) Launched disease – second-line SMC due Oct 15 (In production) Ciclosporin Reperfusion injury prevention prior to percutaneous coronary intervention Unlicensed NHSC May 14 for ST-segment elevation acute indication myocardial infarction Treatment and prevention of angioedema attacks in adults and Cinryze (C1 inhibitor) Launched AWMSG Feb 13 adolescents with hereditary angioedema Cisplatin liposomal Head and neck cancer in combination Unlicensed NHSC Sep 13 (Lipoplatin) with fluorouracil formulation

Attention deficit hyperactivity disorder Unlicensed Clonidine NICE-ES Mar 13 in children and young people indication Unlicensed Clopidogrel Transient ischaemic attack NICE-ES Dec 13 indication Treatment of focal spasticity, including Clostridium botulinum arm symptoms, in conjunction with Launched SMC Jan 13 YES toxin A (Dysport) physiotherapy Sialorrhoea associated with adult Clostridium botulinum Unlicensed Parkinson’s disease and paediatric NHSC Apr 15 type A (Xeomin) indication cerebral palsy Cobicistat HIV-1 infection Launched SMC May 14 YES Previously untreated BRAFV600- mutation-positive, unresectable, Cobimetinib locally advanced or metastatic Not launched NHSC Aug 14 melanoma with vemurafenib – first- line SMC due Nov 15 Co-careldopa Advanced levodopa-responsive Launched (In production - YES (Duodopa) Parkinson’s disease – second-line resubmission)

Vitamin D insufficiency in adults and SMC Feb 13 Colecalciferol Launched elderly (Desunin)

Unlicensed Colesevelam Bile salt malabsorption NICE-ES Oct 13 indication SMC Feb 15

AWMSG Oct 14 Hyperphosphataemia in adults with Colestilan Launched chronic kidney disease on dialysis SMC Aug 14 (Resubmission)

UKMi Dec 13

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Bronchiectasis – non-cystic fibrosis NICE-ES Jan 14 indication Colistimethate Pseudomonas lung infection in cystic Launched NICE Mar 13 YES fibrosis NICE due TBC Dupuytren's contracture Launched (In production) Collagenase New indication LMEN Aug 15 YES clostridium histolyticum Peyronie’s disease – first-line SMC May 15 New indication NHSC Dec 14

Contrave (prolonged release naltrexone and Obesity Not launched NHSC Nov 13 bupropion)

Advanced mucinous epithelial ovarian Cositecan Not launched NHSC Aug 14 cancer – second-line

Non-small cell lung cancer, ALK- Unlicensed positive, locally advanced or NHSC Feb 15 indication metastatic – first-line Crizotinib SMC Oct 13 Non-small cell lung cancer – Launched (Resubmission) second-line NICE Sep 13

Locally advanced or metastatic Custirsen hormone-relapsed prostate cancer – Not launched NHSC Feb 14 first and second-line

Complex perianal fistula in adults with Cx601 (Alofisel) Not launched NHSC Apr 15 luminal Crohn’s disease – second-line Treatment of acute deep vein NICE Dec 14 thrombosis (DVT) and/or pulmonary Dabigatran New indication embolism (PE) and prevention of SMC Oct 14 recurrent DVT and PE

Metastatic BRAF V600E-positive non- Unlicensed small cell lung cancer, in combination NHSC Aug 15 indication with trametinib Dabrafenib Unresectable or metastatic melanoma SMC Mar 15 Launched with a BRAFV600 mutation in adults NICE Oct 14 NICE due Nov 15 (In production) Chronic hepatitis C virus infection in Daclatasvir Launched YES adults AWMSG May 15

SMC Nov 14

Daclizumab High Yield Relapsing forms of multiple sclerosis Unlicensed NHSC Aug 14 YES Process – first- or second-line indication

Daclatasvir and Chronic hepatitis C virus infections Not launched NHSC Sep 13 YES asunaprevir genotype 1 and 4 Daclatasvir and Chronic hepatitis C infection with and Launched NHSC Mar 14 sofosbuvir without ribavirin Acute bacterial skin and skin structure SMC due Dec 15 Dalbavancin Not launched infections in adults (In production)

Reviewer / Tariff Drug name Indication Status publication date excluded SMC Jul 14 (Resubmission) Dapagliflozin Type 2 diabetes mellitus Launched NICE Jun 13

MTRAC Feb 13 SMC Jul 14

NTAG Jun 14 Appraisal report Recommendation

Dapoxetine Premature ejaculation Launched NICE-ES May 14

LMEN Jan 14

MTRAC Nov 13

LNDG Nov 13 Cardiovascular risk reduction in Darapladib patients with coronary heart disease – Not launched NHSC Jun 13 add on therapy Relapsed or refractory multiple Not launched NHSC Aug 15 myeloma – monotherapy

Daratumumab Relapsed or refractory multiple myeloma, with lenalidomide and Not launched NHSC Aug 15 dexamethasone

Darbepoetin Cancer treatment-induced anaemia Launched NICE Nov 14

HIV-1 infection in patients aged 12 to AWMSG May 14 New indication 17 years and weighing at least 40kg SMC Mar 14

Darunavir HIV-1 infection in antiretroviral- AWMSG Jul 15 YES experienced children aged at least 3 years and weighing at least 15kg, with New indication SMC Jul 15 low-dose ritonavir and other antiretrovirals SMC Apr 13 Chronic hepatitis C in adults, in combination with Viekirax (ombitasvir, Dasabuvir Launched SMC Jun 15 YES paritaprevir and ritonavir), with or without ribavirin

Decitabine Acute myeloid leukaemia Launched SMC Jan 13

Deferasirox Treatment of chronic iron overload Launched SMC Apr 13 YES

AWMSG May 15 Hepatic veno-occlusive disease in Defibrotide patients undergoing haematopoietic Launched SMC Jun 14 YES stem-cell transplantation LNDG Sep 13 Prostate cancer - advanced, hormone NICE due TBC Degarelix Launched dependent (In production) Delta-9- Symptom improvement in adults with tetrahydrocannabinol/ moderate-to-severe spasticity due to Launched AWMSG Aug 14 cannabidiol (Sativex) multiple sclerosis – second-line

Reviewer / Tariff Drug name Indication Status publication date excluded Osteoporosis in men at increased risk New indication SMC Nov 14 of fractures Treatment of postmenopausal Launched MTRAC Jan 14 Denosumab osteoporosis

Unlicensed Glucocorticoid-induced osteoporosis NHSC Mar 14 indication

Nocturia and nocturnal polyuria in Unlicensed Desmopressin men with lower urinary tract NICE-ES Apr 13 indication symptoms

NICE Jul 15

Dexamethasone SMC May 15 intravitreal implant Diabetic macular oedema New indication YES (Ozurdex) LMEN Sep 14

NTAG Feb 14

Dexamethasone Prevention and treatment of post- intraocular injection Not launched NHSC Jan 13 ocular surgery inflammation (Verisome) Diltiazem 2% topical Chronic anal fissure Not launched NICE-ES Jan 13

Dimethyl fumarate Plaque psoriasis Not launched NHSC Nov 13 YES

Dimethyl fumarate NICE Aug 14 Relapsing-remitting multiple sclerosis Launched YES (Tecfidera) SMC Apr 14

Unlicensed Dimethyl sulfoxide 50% Interstitial cystitis NICE-ES Feb 14 indication

High risk neuroblastoma – Dinutuximab Not launched NHSC May 14 maintenance therapy

AWMSG Sep 14

Dolutegravir HIV infection Launched SMC May 14 YES

LNDG Jan 14

Promoting tolerance of enteral feeds Unlicensed Domperidone NICE-ES Jul 13 in children and young people indication Doxorubicin, pegylated NICE due TBC Ovarian cancer – advanced, recurrent Launched YES liposomal (In production) NICE-ES Apr 15 Duaklir Genuair Chronic obstructive pulmonary SMC Apr 15 (aclidinium and Launched disease formoterol) RDTC Mar 15 MTRAC Jan 15

SMC due TBC Dulaglutide Type 2 diabetes Launched (In production) NICE-ES Jun 15

DuoResp Spiromax Chronic obstructive pulmonary (budesonide and Launched MTRAC Jan 15 disease formoterol fumarate) SMC Oct 14 Dymista (azelastine Allergic rhinitis Launched (Resubmission) and fluticasone) UKMI Nov 13

Reviewer / Tariff Drug name Indication Status publication date excluded

Prevention of recurrence of C3 Unlicensed NICE-ES Jun 15 glomerulopathy post-transplant indication

Atypical haemolytic uraemic New indication AWMSG Aug 15

syndrome New indication NICE Jan 15 Eculizumab Shiga-Toxin producing Escherichia Unlicensed coli haemolytic-uraemic syndrome – NHSC Jun 13 indication first-line

Paroxysmal nocturnal Launched SMC Sep 13 YES haemoglobinuria

Stroke prevention in patients with MTRAC due Mar 16 Launched atrial fibrillation (In production)

SMC due Nov 15 Launched Treatment and prevention of venous (In production) Edoxaban thromboembolism in adults Launched NICE Aug 15

Prevention of stroke and systemic SMC due Nov 15 embolism in adults with nonvalvular Launched (In production) atrial fibrillation and other risk factors

HIV-1 in infection in adults, adolescents and children aged three SMC due TBC Efavirenz Launched YES months or older and weighing at least (In production) 3.5kg Treatment of haemophilia A in adults Efraloctocog alfa Not launched NHSC Sep 13 YES and children

Eftrenonacog alfa Haemophilia B Not launched NHSC Nov 13

Eliglustat Gaucher disease Not launched NHSC Jun 13 YES

NTAG Sep 14 - update Appraisal report Post-coital contraception for patients Recommendation EllaOne (Ulipristal) who present between 72 and 120 Launched hours NETAG Jan 13 - Update Appraisal report Recommendation

SMC due Sep 15 Elosulfase alfa Mucopolysaccaridosis, type IV A Launched YES (In production)

Multiple myeloma in combination with lenalidomide and dexamethasone – Not launched NHSC Jul 15 Elotuzumab first-line Relapsed or refractory multiple Not launched NHSC Jul 13 myeloma

Reviewer / Tariff Drug name Indication Status publication date excluded

Severe aplastic anaemia – second- Unlicensed NHSC Oct 14 line indication

Thrombocytopenia in adults with AWMSG Jul 14 New indication chronic hepatitis C infection SMC Dec 13 Eltrombopag YES Chronic immune thrombocytopenic Unlicensed NHSC Aug 14 purpura in children indication

Chronic immune (idiopathic) Launched NICE Jul 13 thrombocytopenic purpura

Irritable bowel syndrome (diarrhoea- Eluxadoline Not launched NHSC Oct 14 predominant) – first-line

NICE Mar 15

SMC Oct 14 Empagliflozin Type 2 diabetes Launched

NICE-ES Mar 14

BRAF V600 mutation-positive Encorafenib melanoma with binimetinib – first- and Not launched NHSC Oct 14 second-line

Chronic hepatitis B virus infection in AWMSG May 15 Entecavir nucleoside-naive patients aged two to New indication YES 18 years SMC May 15 Metastatic castration-resistant prostate cancer after failure of androgen deprivation therapy when New indication SMC Aug 15 chemotherapy is not yet clinically Enzalutamide indicated YES

Metastatic castration-resistant NICE Jun 14 prostate cancer, after docetaxel Launched therapy SMC Nov 13

Epoetin Cancer-treatment induced anaemia Launched NICE Nov 14 Epratuzumab Systemic lupus erythematosus Not launched NHSC Feb 15 YES Locally advanced or metastatic breast Launched SMC Aug 15 cancer – second-line Eribulin YES Advanced non-small cell lung cancer Unlicensed NHSC Jun 13 – third-line indication Non-small-cell lung cancer that has NICE due TBC progressed following prior Launched (In production) Erlotinib chemotherapy YES Adjuvant treatment of EGFR-positive Unlicensed NHSC Jan 13 non-small cell lung cancer indication

Unlicensed Erythromycin Gastroparesis in adults NICE-ES Jun 13 indication

Reviewer / Tariff Drug name Indication Status publication date excluded Ankylosing spondylitis and axial NICE due Oct 15 New indication spondyloarthritis (non-radiographic) (In production) Severe, non-radiographic axial New indication NHSC Sep 13 spondyloarthritis Polyarthritis and extended AWMSG Dec 13 oligoarthritis in children and adolescents from the age of 2 years New indication who have had an inadequate SMC Feb 13 response to, or who have proved intolerant of, methotrexate Psoriatic arthritis in adolescents from AWMSG Dec 13 Etanercept the age of 12 years who have had an YES New indication inadequate response to, or who have SMC Feb 13 proved intolerant of, methotrexate

Enthesitis-related arthritis in AWMSG Dec 13 adolescents from the age of 12 years who have had an inadequate New indication response to, or who have proved SMC Feb 13 intolerant of, conventional therapy

NICE due Oct 15 Rheumatoid arthritis Launched (In production – update) RDTC May 13

Metastatic breast cancer - second or Etirinotecan pegol Not launched NHSC Mar 14 subsequent line

Etoricoxib Pain associated with dental surgery New indication SMC Jan 13

HIV-1 infection in antiretroviral AWMSG Dec 13 Etravirine treatment-experienced patients aged New indication YES six to 18 years SMC Sep 13 Excreas (vildagliptin Type 2 diabetes mellitus – second- New indication SMC May 13 and metformin) line adjunct SMC due Oct 15 In combination with an aromatase (In production – inhibitor for HER2-negative, resubmission) oestrogen receptor-positive locally New indication advanced or metastatic breast cancer SMC Jul 13 – second-line NICE Jul 13

Everolimus Advanced renal cell carcinoma that SMC Nov 14 YES has progressed on or after treatment New indication (Resubmission) with VEGF-targeted therapy

Renal angiomyolipoma associated New Indication SMC Jun 13 with tuberous sclerosis complex

Prevention of organ rejection in New indication NICE Jul 15 allogeneic liver transplantation

Eviplera (emtricitabine, AWMSG Jul 14 HIV-1 infection in adults Launched YES rilpivirine and tenofovir) SMC Apr 14

Reviewer / Tariff Drug name Indication Status publication date excluded Locally advanced, unresectable or metastatic pancreatic cancer – first- Not launched NHSC Apr 15 line in combination with gemcitabine

Evofosfamide Locally advanced or metastatic, unresectable soft tissue sarcoma – Not launched NHSC Dec 14 first-line, in combination with doxorubicin

Evotaz (atazanavir and SMC due Nov 15 HIV 1 infection in adults Launched YES cobicistat) (In production) Reduction of cardiovascular risk in Unlicensed Ezetimibe coronary heart disease – in NHSC Nov 13 indication combination with a statin Improve walking in adults with Fampridine multiple sclerosis with walking Launched AWMSG Sep 14 YES disability Treatment of breakthrough pain in Fentanyl citrate buccal adults with cancer who are taking Launched SMC Jan 14 tablet (Breakyl) maintenance opioid therapy for chronic cancer pain Ferumoxytol Anaemia in chronic renal disease Launched SMC Feb 13 Chronic inflammatory demyelinating Unlicensed NHSC Aug 14 polyneuropathy – second-line indication Rapidly evolving severe relapsing– SMC Apr 15 Fingolimod remitting multiple sclerosis and YES patients with high disease activity Launched despite treatment with at least one SMC Oct 14 disease modifying therapy Postural hypotension, particularly in Unlicensed Fludrocortisone NICE-ES Oct 13 the elderly indication Unlicensed Flunarizine Migraine prevention – second-line NICE-ES Sep 14 indication SMC Feb 14 (Resubmission) Fluocinolone Diabetic macular oedema Launched YES intravitreal implant NICE Nov 13

NICE Jan 13

Unlicensed Fluoxetine Hypersexuality NICE-ES Jul 15 indication

Flutiform (fluticasone propionate and Asthma Launched MTRAC Jul 14 formoterol)

Flutter device Mucus clearance Launched UKMi Jun 13

Follicle stimulating SMC Feb 15 hormone biosimilar Fertility disorders Launched (Bemfola) AWMSG Jan 15

Reviewer / Tariff Drug name Indication Status publication date excluded Treatment of infections in adults and children including neonates: acute osteomyelitis; complicated urinary tract infections; nosocomial lower respiratory tract infections; bacterial Launched SMC Mar 15 Fosfomycin meningitis; bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Multidrug-resistant urinary tract Launched NICE-ES Jul 13 infections NICE-ES Jan 15 Asthma Launched (NEXThaler) NICE-ES Jun 13 Fostair (beclometasone AWMSG Jun 15

and formoterol) Chronic obstructive pulmonary MTRAC Jan 15 New indication disease NICE-ES Sep 14

SMC Jul 14

Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast SMC due TBC Fulvestrant cancer, for disease relapse on or after Launched (In production - adjuvant antioestrogen therapy, or resubmission) disease progression on therapy with an antioestrogen Locally advanced or metastatic non- SMC due Feb 16 small cell lung cancer with activating Launched (In production - mutations of EGFR resubmission)

Non-small cell lung cancer that has NICE due TBC progressed following prior Launched Gefitinib (In production) YES chemotherapy

In combination with chemotherapy for EGFR-positive non-small cell lung Unlicensed NHSC Jul 13 cancer that has progressed following indication gefitinib therapy NICE due TBC Gemcitabine Ovarian cancer – advanced, recurrent Launched YES (In production) Gemtuzumab Acute myeloid leukaemia, with Not launched NHSC Aug 15 ozogamicin conventional chemotherapy – first-line

Gevokizumab Chronic non-infectious uveitis Not launched NHSC Jul 13 YES

SMC due Dec 15 Glatiramer acetate Relapsing forms of multiple sclerosis Launched (In production)

Glycerol Urea cycle disorders Not launched NHSC Aug 15 phenylbutyrate (hyperammonaemia)

Glyceryl trinitrate - Chronic anal fissure Not launched NICE-ES Mar 13 topical, 0.2% AWMSG Mar 13 Chronic obstructive pulmonary Glycopyrronium Launched SMC Jan 13 disease NICE-ES Jan 13

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Hypersalivation NICE-ES Jul 13 indication Glycopyrronium – oral Unlicensed Hyperhidrosis NICE-ES Jul 13 indication NICE Feb 15

NTAG Dec 14 Moderate-to-severe active ulcerative Appraisal report New indication colitis in adults – second-line Recommendation SMC Oct 14

Golimumab LMEN Mar 14 YES

Ankylosing spondylitis and axial NICE due Oct 15 New indication spondyloarthritis (non-radiographic) (In production)

NICE due Oct 15 Rheumatoid arthritis Launched (In production – update) RDTC May 13 Prevention of nausea and vomiting UKMi Nov 13 Granisetron associated with moderately or highly Launched transdermal patch emetogenic chemotherapy in adults SMC Oct 13 Grass pollen-induced rhinitis and Grazax (timothy grass conjunctivitis in patients aged five Launched SMC Apr 13 pollen allergen) years or older GS-6615 Long QT-3 syndrome Not launched NHSC Jul 15 Severe combined immunodeficiency GSK2696273 due to adenosine deaminase Not launched NHSC Aug 15 deficiency Chronic hepatitis C in adults – SMC due Sep 15 Launched genotype 3 population (In production)

NICE due Nov 15 Launched Harvoni (ledipasvir and (In production) YES sofosbuvir) Chronic hepatitis C in adults Launched AWMSG Aug 15 SMC Mar 15 Launched NHSC Jul 13

Limbal stem cell deficiency due to Holoclar Not launched NHSC Jul 15 ocular burns House dust mite allergen House dust mite allergy-induced Not launched NHSC Nov 13 immunotherapy tablet rhinitis and conjunctivitis – third-line (Mitizax)

Hydrocortisone MR Adrenal insufficiency Launched SMC Jan 13 Waldenström’s macroglobulinaemia New indication NHSC Apr 15 Newly-diagnosed chronic lymphocytic Launched NHSC Oct 14 Ibrutinib leukaemia – first-line

Relapsed or refractory chronic Launched NHSC Jul 13 lymphocytic leukaemia – second-line

Alzheimer’s disease as an adjunct to Idalopirdine Not launched NHSC Oct 14 acetylcholinesterase inhibitor therapy

Reviewer / Tariff Drug name Indication Status publication date excluded Relapsed chronic lymphocytic Unlicensed leukaemia in combination with NHSC Dec 14 indication bendamustine and rituximab Relapsed chronic lymphocytic Unlicensed NHSC Mar 14 leukaemia with ofatumumab indication

Unlicensed Indolent non-Hodgkin’s lymphoma NHSC Jul 13 Idelalisib indication

Follicular lymphoma that is refractory SMC May 15 Launched to two prior lines of treatment NICE Dec 14

Chronic lymphocytic leukaemia with SMC Mar 15 Launched rituximab NHSC Jul 13

Reversal of anticoagulation due to Idarucizumab Not launched NHSC Feb 15 treatment with dabigatran – first-line

Unlicensed Iloprost intravenous Critical limb ischaemia NICE-ES Dec 13 indication

Gastrointestinal stromal tumours in NICE Nov 14 New indication adults – adjuvant treatment AWMSG Jul 14

Newly-diagnosed Philadelphia YES Imatinib chromosome positive acute New indication SMC Oct 13

lymphoblastic leukaemia in children

Locally advanced/metastatic Unlicensed LCNDG Mar 13 chordoma indication

SMC Dec 13 Imiquimod 3.75% Actinic keratosis Launched MTRAC Jun 13 cream RDTC Apr 13 Inegy (ezetimibe and Reduction of cardiovascular risk in Unlicensed NHSC Jun 13 simvastatin) coronary heart disease indication NICE Feb 15

NTAG Dec 14 Moderate-to-severe active ulcerative Appraisal report New indication colitis in adults, second-line Recommendation

SMC May 14 (Resubmission) Infliximab YES Paediatric ulcerative colitis New indication SMC Mar 13

Ankylosing spondylitis and axial NICE due Oct 15 New indication spondyloarthritis (non-radiographic) (In production)

NICE due Oct 15 Rheumatoid arthritis Launched (In production – update) RDTC May 13

Reviewer / Tariff Drug name Indication Status publication date excluded NTAG Jun 15 Appraisal report Rheumatoid arthritis, adult Crohn’s Recommendation disease, paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative Launched SMC Mar 15 Infliximab biosimilar colitis, psoriatic arthritis, psoriasis, YES (Inflectra) ankylosing spondylitis AWMSG Mar 15 UKMi Feb 15

Ankylosing spondylitis Launched NHSC Jun 13

Psoriatic arthritis Launched NHSC Jun 13 NTAG Jun 15 Appraisal report Rheumatoid arthritis, adult Crohn’s Recommendation disease, paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative Launched SMC Mar 15 Infliximab biosimilar colitis, psoriatic arthritis, psoriasis, YES (Remsima) ankylosing spondylitis AWMSG Mar 15 UKMi Feb 15

Ankylosing spondylitis Launched NHSC Jun 13

Psoriatic arthritis Launched NHSC Jun 13 MTRAC Jun 13

Cutaneous treatment of non- RDTC Apr 13 Ingenol mebutate gel hyperkeratotic, non-hypertrophic Launched actinic keratosis in adults SMC Mar 13 NICE-ES Mar 13

Injex Needle-free insulin device Launched UKMi Apr 13

Inotuzumab Acute lymphoblastic leukaemia – Not launched NHSC Mar 14 ozogamicin second or subsequent line

Insujet Needle-free insulin device Launched UKMi Apr 13 Diabetes mellitus in adults, adolescents and children from the age New indication SMC May 15 of one year

AWMSG Jul 14

SMC Mar 14 (Resubmission)

Insulin degludec MTRAC Feb 13

Diabetes mellitus Launched NICE-ES Sep 13 (Type 1 diabetes - update)

NICE-ES Sep 13 (Type 2 diabetes - update)

NICE-ES due Oct 15 Insulin glargine Type 1 or 2 diabetes mellitus in adults Launched (In production) (Toujeo) aged 18 years and above (new formulation) SMC due Sep 15 (In production)

Diabetes mellitus in adults, SMC Apr 13 Insulin glargine adolescents and children aged 2 Launched (Lantus) years to less than 6 years AWMSG Feb 13

Reviewer / Tariff Drug name Indication Status publication date excluded Insulin glargine NICE-ES due Oct 15 Diabetes mellitus Launched biosimilar (In production)

Interferon beta-1a Acute respiratory distress syndrome – Unlicensed NHSC May 14 YES (Traumakine) first-line indication Small cell lung cancer – first-line, in Unlicensed combination with etoposide and NHSC Apr 15 indication platinum therapy Non-small cell lung cancer, stage IV Unlicensed or recurrent, with paclitaxel and NHSC Feb 15 indication carboplatin

Prostate cancer, chemotherapy-naïve, Unlicensed NHSC Feb 15 hormone-relapsed metastatic indication Ipilimumab YES Metastatic hormone-relapsed prostate Unlicensed cancer following docetaxel treatment NHSC Dec 14 indication and radiotherapy

Advanced melanoma in previously SMC Nov 14 Launched untreated adults NICE Jul 14

Advanced melanoma in adults who SMC Apr 13 Launched have received prior therapy (Resubmission) Metastatic colorectal cancer – second HA-irinotecan Not launched NHSC Mar 14 and third-line Cystic fibrosis in patients with class III New indication NHSC Aug 14 non-G551D gating mutations YES Ivacaftor Cystic fibrosis in patients aged six SMC Jun 13 years and older who have a G551D New indication (Resubmission) mutation in the CFTR gene

Unlicensed Ivermectin Resistant scabies NICE-ES Mar 14 indication

NICE-ES due Jan 16 (In production) Ivermectin 1% topical Papulopustular rosacea Launched SMC due Dec 15 cream (In production)

NHSC Aug 14 In combination with oral dexamethasone for relapsed or Not launched NHSC Mar 14 refractory systemic light chain Ixazomib amyloidosis YES

Relapsed and/or refractory multiple Not launched NHSC Mar 14 myeloma

Moderate-to-severe chronic plaque Ixekizumab Not launched NHSC Apr 15 psoriasis SMC Jun 15 Jentadueto (linagliptin Type 2 diabetes mellitus Launched AWMSG Aug 14 and metformin) SMC Feb 13

Chronic, active, ulcerative colitis – Kappaproct Not launched NHSC Oct 13 third-line

Unlicensed Ketamine (oral) Chronic pain NICE-ES Feb 14 indication

Reviewer / Tariff Drug name Indication Status publication date excluded Type 2 diabetes mellitus in Komboglyze New indication SMC Jan 14 (saxagliptin and combination with a sulphonylurea metformin) Type 2 diabetes mellitus Launched SMC Jun 13

Unresectable, locally advanced or Lanreotide metastatic gastro-enteropancreatic Launched NHSC Dec 14 neuroendocrine tumours – first-line Early HER2-positive breast cancer, Unlicensed neoadjuvant therapy in combination NHSC May 14 indication with trastuzumab

Advanced or metastatic HER2- positive breast cancer in combination New indication AWMSG Aug 13 with capecitabine – second-line

Lapatinib HER2-positive, hormone receptor- YES negative metastatic breast cancer in New indication SMC Nov 13 combination with trastuzumab – second-line

Stage I to III HER2-positive breast cancer – adjuvant therapy in Unlicensed NHSC Apr 13 combination with, or following, indication trastuzumab

NICE due TBC Laquinimod Multiple sclerosis - relapsing-remitting Not launched YES (In production) Latanoprost solution in Reduction of elevated intraocular single-dose container pressure in patients with open angle Launched SMC Jul 13 (Monopost) glaucoma and ocular hypertension Unlicensed Mantle cell lymphoma NHSC Sep 13 indication Continuous treatment of adults with previously untreated multiple SMC due Nov 15 New indication myeloma who are not eligible for (In production) transplant NICE due TBC Lenalidomide (In production) YES Multiple myeloma – second-line Launched SMC Apr 14 (Resubmission)

NICE Sep 14

Myelodysplastic syndromes New indication SMC Mar 14

LCNDG Jan 13 Lesinurad Gout Not launched NHSC Jan 13 Behavioural variant frontotemporal Leuco- Not launched NHSC Sep 13 dementia – first-line methylthioninium Alzheimer’s disease Not launched NHSC Jul 13

Neoadjuvant treatment prior to radiotherapy in patients with high risk Leuprorelin acetate New indication AWMSG Jan 15 localised or locally advanced prostate cancer

Levonorgestrel Contraception, particularly for women Launched SMC Jun 15 (Levosert) with heavy menstrual bleeding

Emergency contraception within 72 Levonorgestrel hours of unprotected sexual Launched SMC Feb 14 (Upostelle) intercourse

Reviewer / Tariff Drug name Indication Status publication date excluded

AWMSG Jul 15 Levonorgestrel 13.5mg Up to 3 years’ contraception Launched SMC Apr 15 intrauterine system NICE-ES Jun 14

Severe acute decompensated chronic Levosimendan Not launched NHSC Mar 2014 heart failure – second-line AWMSG Feb 14

MTRAC Jun 13 Irritable bowel syndrome with Linaclotide Launched SMC Jun 13 constipation NICE-ES Apr 13

RDTC Mar 13 SMC May 15 (Resubmission) Linagliptin Type 2 diabetes Launched MTRAC May 14

AWMSG Mar 13 Chemotherapy-induced neutropenia AWMSG Aug 14 (with the exception of chronic myeloid Lipegfilgrastim Launched YES leukaemia and myelodysplastic SMC Apr 14 syndromes)

Type 2 diabetes mellitus in adults Launched SMC May 15

Weight loss in obese or overweight Liraglutide Unlicensed patients with associated co- NHSC Oct 13 indication morbidities

Attention deficit/hyperactivity disorder SMC due Sep 15 New indication in adults (In production)

Lisdexamfetamine AWMSG Dec 13 Attention deficit hyperactivity disorder Launched NICE-ES May 13 in children aged six years and over SMC May 13 AWMSG Dec 13

SMC Sep 13 Lixisenatide Type 2 diabetes Launched NICE-ES Sep 13 (Update) Homozygous familial Lomitapide Launched SMC Feb 14 YES hypercholesterolaemia in adults Progressive familial intrahepatic Lopixibat Not launched NHSC Aug 15 cholestasis in paediatric patients MTRAC due Nov 15 (In production)

Acute agitation and disturbed RDTC Jun 13 Loxapine behaviors associated with Not launched schizophrenia or bipolar disorder NICE May 13 (Terminated appraisal)

LNDG Feb 13

Reviewer / Tariff Drug name Indication Status publication date excluded SMC Aug 14

Lubiprostone Constipation Launched NICE Jul 14

RDTC Mar 14 Lumacaftor and Cystic fibrosis – first-line Not launched NHSC Jan 14 YES ivacaftor NTAG Apr15 Appraisal report Recommendation

AWMSG Mar 15

Lurasidone Schizophrenia Launched LMEN Mar 15

SMC Oct 14

NICE-ES Sep 14

NICE-ES Apr 13

Inoperable gastroenteropancreatic Lutetium-177 Not launched NHSC May 14 neuroendocrine tumours Long-term treatment of adults with Macitentan pulmonary arterial hypertension Launched SMC Apr 14 YES (WHO Functional Class II to III) Magnesium aspartate Treatment and prevention of Launched SMC Jun15 dihydrate magnesium deficiency

Magnesium Unlicensed Recurrent hypomagnesaemia NICE-ES Jan 13 glycerophosphate indication

SMC Dec 13 Mannitol Cystic fibrosis Launched YES (Resubmission)

Metastatic colorectal cancer – third- MABp1 (Xilonix) Not launched NHSC Aug 15 line

Crohn’s disease, in patients intolerant of, or with an unsatisfactory response Not launched NHSC Aug 15 to, immunosuppressive drugs and/or TNF-inhibitors

Primary and relapse-free secondary progressive multiple sclerosis – first- Not launched NHSC Aug 15 line Masitinib YES Rheumatoid arthritis – second and Not launched NHSC Aug 15 subsequent line

Amyotrophic lateral sclerosis – add-on Not launched NHSC Apr 15 therapy to riluzole

Mastocytosis – second or subsequent Not launched NHSC Apr 13 line Medabon Termination of developing intra- (mifepristone and uterine pregnancy of up to 63 days of Launched SMC Nov 14 misoprostol) amenorrhoea

Medroxyprogesterone NICE-ES Jan 14 Long-acting female contraception Launched acetate SMC Sep 13

Mefenamic acid Mild to moderate pain Launched RDTC Jan 14

Reviewer / Tariff Drug name Indication Status publication date excluded Primary insomnia Launched MTRAC Oct 13

Sleep disorders in children and young Melatonin Unlicensed people with attention deficit NICE-ES Jan 13 indication hyperactivity disorder Severe refractory eosinophilic asthma Mepolizumab Not launched NHSC May 14 YES – first-line Locally advanced or metastatic, EGFR and T790M mutation positive Mereletinib Not launched NHSC Apr 15 non-small cell lung cancer – second- line Polycystic ovary syndrome in women Unlicensed Metformin NICE-ES Feb 13 not planning pregnancy indication Methyl aminolevulinate Photodynamic therapy for acne Not launched NHSC Nov 13 (Visonac) vulgaris Opioid-induced constipation in adults Unlicensed NHSC Aug 14 with chronic non-malignant pain indication Methylnaltrexone Unlicensed Opioid-induced constipation NHSC Apr 13 indication Metreleptin Generalised and partial lipodystrophy Not launched NHSC May 14 SMC due Oct 15 (In production) Orthostatic hypotension due to Midodrine Launched NICE-ES due Oct 15 autonomic dysfunction (In production)

NHSC Jul 15 Newly diagnosed FLT3-mutated acute Midostaurin Not launched NHSC Feb 14 myeloid leukaemia – first-line Migalastat Fabry disease Not launched NHSC Mar 14 MTRAC Aug 13

NICE Jun 13

Mirabegron Overactive bladder Launched SMC May 13

LNDG Mar 13

RDTC Feb 13

Induction of labour in late intrauterine Unlicensed Misoprostol (vaginal) NICE-ES Apr 13 fetal death indication SMC Oct 14 Misoprostol pessary Induction of labour Launched NICE-ES Mar 14

Mitizax (house dust House dust mite allergy-induced mite allergen Not launched NHSC Nov 13 rhinitis and conjunctivitis – third-line immunotherapy tablet) Hypersomnolence in Parkinson's Unlicensed NICE-ES due Sep 15 disease indication (In production) Modafinil Unlicensed Fatigue in multiple sclerosis NICE-ES Mar 13 indication Adult T-cell leukaemia/lymphoma – Mogamulizumab Not launched NHSC Aug 14 second and subsequent line NTAG Jun 14 Multivitamins and Age-Related Macular Degeneration Not licensed Appraisal report minerals Recommendation

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Systemic lupus erythematosus NICE-ES Nov 14 indication Mycophenolate Unlicensed Scleroderma NICE-ES Jul 14 indication

Mysimba (naltrexone Weight management in adults Not launched LMEN Jun 15 and bupropion) NICE Nov 14

NTAG Feb 14 Appraisal report Recommendation

AWMSG Feb 14 Nalmefene Alcohol dependence Launched NICE-ES Dec 13

MTRAC Oct 13

LNDG Oct 13

SMC Oct 13

SMC due Dec 15 (In production) Naloxegol Opioid-induced constipation Launched NICE Jul 15

RDTC Apr 15

Secondary progressive multiple Unlicensed NHSC Apr 15 sclerosis indication YES Natalizumab Highly active relapsing remitting multiple sclerosis in adults – second- New indication SMC Jun 14 line Advanced or metastatic non-small cell Necitumumab lung cancer in combination with Not launched NHSC Feb 14 gemcitabine and cisplatin – first-line Persistent pain unresponsive to other Nefopam Launched RDTC Jan 15 non-opioid analgesics Reduction in risk of postoperative Nepafenac eye drops macular oedema associated with Launched AWMSG Aug 13 cataract surgery in diabetic patients

Advanced for metastatic HER2- positive breast cancer, with Not launched NHSC Jul 15 Neratinib capecitabine – third-line

HER2-positive early breast cancer Not launched NHSC Aug 14 Locally advanced, metastatic or NICE Jul 15 Nintedanib (Vargatef) recurrent non-small cell lung Launched adenocarcinoma – second-line SMC Apr 15 YES SMC due Oct 15 Nintedanib (Ofev) Idiopathic pulmonary fibrosis Launched (In production) NHSC Jun 13 HER2-negative, germline BRCA mutated, locally advanced or Not launched NHSC Oct 14 metastatic breast cancer Niraparib High grade serous, platinum-sensitive ovarian cancer – second-line Not launched NHSC Aug 14 maintenance therapy

Reviewer / Tariff Drug name Indication Status publication date excluded Advanced or metastatic clear-cell Unlicensed renal cell carcinoma – second- or NHSC Dec 14 indication third-line

Advanced melanoma – first-line with Unlicensed NHSC Dec 14 ipilimumab indication

BRAF V600 mutation-positive Launched NHSC Dec 14 Nivolumab advanced melanoma – first-line BRAF V600 mutation- negative Launched NHSC Dec 14 advanced melanoma – first-line

Advanced melanoma – second- or Launched NHSC Dec 14 third-line

Non-small cell lung cancer – second- New indication NHSC Sep 13 line Obeticholic acid Primary biliary cirrhosis – second-line Not launched NHSC Nov 13 Indolent non-Hodgkin lymphoma, in Unlicensed combination with chemotherapy – NHSC Aug 15 indication first-line

Chronic lymphocytic leukaemia in NICE Jun 15 adults, in combination with Launched SMC Dec 14 chlorambucil – first-line

Obinutuzumab Rituximab-refractory indolent non- Unlicensed Hodgkin’s lymphoma, in combination NHSC Mar 14 indication with bendamustine – second-line

CD20-positive diffuse large B-cell Unlicensed lymphoma, in combination with CHOP NHSC Mar 14 indication – first-line Relapsing-remitting multiple sclerosis Not launched NHSC Aug 14 Ocrelizumab YES Primary progressive multiple sclerosis Not launched NHSC Aug 14 SMC Aug 14 Ocriplasmin Vitreomacular traction Launched (Resubmission) YES NICE Oct 13

Ocular lubricants Dry eye syndrome Launched UKMi Sep 13

Odanacatib Male osteoporosis Not launched NHSC Jun 13 YES Chronic lymphocytic leukaemia, in NICE Jun 15 combination with chlorambucil or New indication bendamustine SMC May 15

Ofatumumab Relapsed chronic lymphocytic Unlicensed YES NHSC Nov 13 leukaemia indication

Relapsed diffuse large B-cell Unlicensed NHSC Apr 13 lymphoma indication

NICE due Jan 16 (In production) Relapsed platinum-sensitive ovarian Olaparib Launched cancer SMC Jul 15

NHSC Jun 13

Olesoxime Spinal muscular atrophy – first-line Not launched NHSC Sep 13 YES

Reviewer / Tariff Drug name Indication Status publication date excluded NICE-ES Feb 15

Olodaterol (Striverdi Chronic obstructive pulmonary AWMSG Jan 15 Launched Respimat) disease SMC Jan 15 (Resubmission) Chronic spontaneous urticaria in NICE Jun 15 patients with inadequate response to New indication SMC Jan 15 Omalizumab antihistamines YES Severe persistent allergic asthma in Launched NICE Apr 13 patients aged six years and over

Omega-3 fatty acid Unlicensed Schizophrenia NICE-ES Sep 13 medicines indication Metastatic Met-positive gastric or Not launched NHSC Mar 14 gastro-oesophageal junction cancer Onartuzumab Metastatic Met-positive non-small cell Not launched NHSC Jul 13 lung cancer

Prevention of nausea and vomiting in Unlicensed NICE-ES Oct 14 children with gastroenteritis indication

Ondansetron Chemotherapy-, radiotherapy- and post-operative-induced nausea and Launched SMC Nov 13 vomiting

Prostate cancer, metastatic hormone- Orteronel Not launched NHSC Apr 13 YES relapsed, following chemotherapy

Treatment of acute bacterial skin and SMC due TBC Oritavancin Launched skin structure infections in adults (In production) Vulvo-vaginal atrophy in Ospemifene Not launched NHSC Jan 13 postmenopausal women

Otovent Auto-inflation device for glue ear Launched UKMi Nov 14 NICE due TBC Ovarian cancer – advanced, recurrent Launched (In production) YES Paclitaxel Locally advanced or Unlicensed metastatic bladder cancer with LCNDG Mar 13 indication cisplatin and gemcitabine Advanced ovarian cancer – Not launched NHSC Jan 14 maintenance therapy Paclitaxel

polyglutamate Glioblastoma in combination with temozolamide and radiotherapy – Not launched NHSC Sep 13 first-line Pacritinib Myelofibrosis Not launched NHSC Feb 14 Padeliporfin Localised prostate cancer – first-line Not launched NHSC Feb 15 Wild-type RAS metastatic colorectal Panitumumab cancer – first-line in combination with Launched SMC Jul 15 chemotherapy Advanced or metastatic ER- positive/HER2-negative, breast Not launched NHSC Jul 15 cancer – second-line

Palbociclib Advanced ER-positive/HER2-negative breast cancer in post-menopausal Not launched NHSC May 14 women – first-line in combination with letrozole

Reviewer / Tariff Drug name Indication Status publication date excluded NTAG Apr 15 Appraisal report Paliperidone palmitate Schizophrenia in adults Launched Recommendation

LMEN Mar 15

Prevention of nausea and vomiting associated with moderate and highly New indication SMC Aug 15 emetogenic cancer chemotherapy in patients one month of age and older Palonosetron Prevention of nausea and vomiting associated with moderately Launched SMC Feb 13 emetogenic cancer chemotherapy in adults SMC due Sep 15 Pasireotide Acromegaly in adults New indication YES (In production) Patiromer Hyperkalaemia – first-line Not launched NHSC Jul 15 Renal cell carcinoma – adjuvant Unlicensed NHSC Sep 13 therapy indication Pazopanib YES Soft tissue sarcoma – second or New indication AWMSG Dec 13 subsequent line

Pegaspargase Acute lymphoblastic leukaemia Not launched NHSC Feb 15 YES

Pegloticase Gout Not launched NICE Jun 13 YES Peginterferon alfa 2a Chronic hepatitis C in children and New indication NICE Nov 13 YES and 2b young people – with ribavirin AWMSG Jul 15 Peginterferon beta-1a Relapsing-remitting multiple sclerosis Launched YES SMC Jan 15 Peginterferon lambda- Hepatitis C Not launched NHSC Aug 14 YES 1a Pegvisomant Acromegaly Launched AWMSG Dec 13 YES Chronic hepatitis C in treatment-naïve Pegylated interferon children and adolescents aged five New indication SMC Jun 13 YES alfa-2a (Pegasys) years and above Metastatic or recurrent squamous cell carcinoma of the head and neck, in Not launched NHSC Aug 15 combination with chemotherapy – Pelareorep second-line Metastatic malignant melanoma, with or without chemotherapy – second- Not launched NHSC Aug 15 line

PD-L1 strong-positive metastatic non- New indication NHSC Aug 15 small cell lung cancer – first-line

Unresectable or metastatic melanoma SMC due Nov 15 in patients not previously treated with Launched (In production) Pembrolizumab ipilimumab

Unresectable or metastatic melanoma SMC due Nov 15 in patients previously treated with Launched (In production) ipilimumab NHSC Jul 13

Lung cancer (non-small cell, non- SMC Dec 14 Pemetrexed New indication YES squamous) – maintenance treatment NICE Apr 14

Reviewer / Tariff Drug name Indication Status publication date excluded Pentosan polysulphate Unlicensed Interstitial cystitis NICE-ES Apr 15 sodium indication

Acute uncomplicated influenza in Peramivir Not launched NHSC Oct 14 adults Adjuvant treatment of primary Unlicensed NHSC Mar 14 generalised tonic-clonic seizures indication

Perampanel Partial-onset seizures, with or without secondarily generalised seizures, in Launched MTRAC Sep 13 patients with epilepsy aged 12 years and older

With docetaxel and trastuzumab for NICE due TBC HER2 positive metastatic or locally (In production) recurrent unresectable breast cancer, Launched SMC Nov 14 YES in patients previously untreated or (Resubmission) who have relapsed post adjuvant Pertuzumab treatment LCNDG Mar 13

HER2-positive locally advanced, inflammatory or early breast cancer – New indication NHSC Feb 14 neo-adjuvant in combination with trastuzumab and docetaxel

Psychosis associated with Pimavanserin Not launched NHSC Oct 14 Parkinson’s disease – first-line SMC Aug 13 Pirfenidone Idiopathic pulmonary fibrosis Launched YES NICE Apr 13 Diffuse large B-cell lymphoma or grade 3 follicular lymphoma in Unlicensed NHSC Nov 13 combination with rituximab – second indication Pixantrone and subsequent line

Non-Hodgkin’s lymphoma – relapsed Launched NICE Feb 14 or refractory

Local dermal anaesthesia on intact Pliaglis (tetracaine and skin prior to dermatological Launched SMC Oct 14 lidocaine) procedures in adults In combination with dexamethasone Plitidepsin Not launched NHSC Jun 13 for multiple myeloma – third-line

NICE Mar 15

SMC Dec 14 Relapsed and refractory multiple Pomalidomide Launched (Resubmission) YES myeloma AWMSG Sep 14

NICE-ES Feb 14

Chronic myeloid leukaemia and SMC Apr 15 Philadelphia chromosome-positive Launched Ponatinib acute lymphoblastic leukaemia AWMSG Jan 15

Chronic myeloid leukaemia Launched NHSC Sep 13

SMC Jul 15 Posaconazole Fungal infections in adults Launched YES SMC Oct 14 Familial chylomicronaemia syndrome Pradigastat Not launched NHSC Jul 13 – first-line

Reviewer / Tariff Drug name Indication Status publication date excluded With percutaneous coronary NICE Jul 14 Prasugrel intervention for treating acute Launched (Update) coronary syndrome Preladenant Parkinson’s disease Not launched NHSC Jan 13 Progesterone, Supplementation of the luteal phase micronized (Utrogestan during Assisted Reproductive Launched SMC Dec 13 Vaginal) Technology cycles Rapid tranquilisation in mental health Unlicensed Promethazine NICE-ES Mar 14 conditions indication Adult males with chronic constipation Prucalopride New indication NHSC Oct 14 – third-line

Quad/Stribild AWMSG Dec 13 (elvitegravir, cobicistat, HIV infection Launched SMC Aug 13 YES emtricitabine and tenofovir) LNDG Jan 13 Unlicensed Quetiapine Generalised anxiety disorder NICE-ES May 13 indication SMC Aug 14 (Resubmission) (Infants and children)

Acute diarrhoea in infants (older than NICE-ES Mar 13 Racecadotril three months), children and adults – Launched (Adults) add on to oral rehydration therapy NICE-ES Mar 13 (Children)

AWMSG Feb 13 (Infants and children)

NICE due Jan 16 Bone metastases in patients with (In production) Radium-223 dichloride Launched castration-resistant prostate cancer SMC due Oct 15 (In production) HIV-1 infection in adults, adolescents, SMC due Nov 15 children, toddlers and infants from the Launched (In production) age of four weeks Raltegravir YES HIV-1 infection in adolescents and AWMSG Dec 13 Launched children from the age of two years SMC Sep 13

Symptoms of peripheral arterial Unlicensed Ramipril NICE-ES Jun 15 disease indication

Reviewer / Tariff Drug name Indication Status publication date excluded Metastatic colorectal cancer – Unlicensed NHSC Dec 14 second-line indication Locally advanced or metastatic non- Unlicensed small cell lung cancer – second-line, NHSC Dec 14 indication in combination with docetaxel Advanced gastric cancer and gastro- oesophageal junction Ramucirumab adenocarcinoma after prior New indication NHSC Mar 14 chemotherapy, in combination with paclitaxel

Unlicensed Hepatocellular cancer – second-line NHSC Nov 13 indication

Advanced gastric cancer and gastro- oesophageal junction Launched NHSC Sep 13 adenocarcinoma – second-line Choroidal neovascularisation and Unlicensed NHSC Feb 15 macular oedema indication

LMEN Feb 15 Age-related macular oedema Launched LMEN Jan 15

Visual impairment due to choroidal SMC Nov 13 neovascularisation secondary to New indication Ranibizumab pathological myopia in adults NICE Nov 13 YES

Diabetic macular oedema New indication NICE Feb 13

NTAG Feb 14

Macular oedema secondary to retinal NICE May 13 New indication vein occlusion SMC May 13 (Resubmission)

Unresectable or metastatic AWMSG Jul 15 Regorafenib gastrointestinal stromal tumours after New indication imatinib and sunitinib SMC Apr 15 MTRAC Jan 15

UKMi Jan 15

AWMSG Aug 14 Asthma Launched SMC Jun 14

NICE-ES Mar 14

RDTC Jan 14 Relvar Ellipta (fluticasone furoate and MTRAC Jan 15 vilanterol) MTRAC Jan 15

UKMi Jan 15 Chronic obstructive pulmonary Launched AWMSG May 14 disease SMC Apr 14

MTRAC Mar 14

NICE-ES Jun 13

Reslizumab Eosinophilic asthma Not launched NHSC Apr 15 Resperate device Hypertension Launched UKMi May 13

Reviewer / Tariff Drug name Indication Status publication date excluded Rezolsta (darunavir HIV-1 infection in patients aged at Launched SMC Aug 15 YES and cobicistat) least 18 years Chronic hepatitis C in children and Ribavirin young people – with peginterferon New indication NICE Nov 13 YES alfa UKMi Apr 13 Travellers' diarrhoea Launched (Xifaxanta) NICE Mar 15

Reduction in recurrence of overt MTRAC Jan 14 Launched Rifaximin hepatic encephalopathy in adults SMC Sep 13 (Targaxan)

Unlicensed Pouchitis NICE-ES Mar 14 indication

Higher risk myelodysplastic Rigosertib syndromes – second and subsequent Not launched NHSC May 14 YES line

EGFRvIII-positive glioblastoma Rindopepimut Not launched NHSC Feb 15 multiforme – first-line

Pulmonary arterial hypertension Launched SMC Jul 15 YES Riociguat Chronic thromboembolic pulmonary Launched SMC Dec 14 hypertension in adults

AWMSG Jan 15 Rituximab (Mabthera Non-Hodgkin's lymphoma Launched NICE-ES Sep 14 YES subcutaneous) SMC Jul 14 Unlicensed Autoimmune haemolytic anaemia NICE-ES Feb 15 indication NTAG Apr 15 Unlicensed Appraisal report Idiopathic thrombocytopenic purpura indication Recommendation NICE-ES Oct 14 Rituximab YES

Anti-neutrophil cytoplasmic antibody- NICE Mar 14 New indication associated vasculitis SMC Sep 13

Maintenance therapy following Unlicensed response to first-line LCNDG Feb 13 indication therapy in mantle cell lymphoma New indication SMC Jul 15

NICE Mar 15

Prevention of atherothrombotic events RDTC Oct 14

Rivaroxaban (Update) after acute coronary syndromes New indication NTAG Jun 14 Appraisal report Recommendation NICE Jun 13 Treatment of pulmonary embolism Rivaroxaban (PE) and prevention of recurrent deep New indication SMC Mar 13 vein thrombosis and PE in adults RDTC Mar 13

Reviewer / Tariff Drug name Indication Status publication date excluded Non-small cell lung cancer, advanced Rociletinib or recurrent with EGFR T790M Not launched NHSC Feb 15 mutation Polycythaemia vera – second-line New indication NHSC Apr 13 SMC Mar 15 Ruxolitinib Disease-related splenomegaly or YES Launched NICE Jun 13 symptoms in adults with myelofibrosis RDTC Jan 13

MTRAC due Mar 16 Safinamide Parkinson's disease Not launched (In production)

Sativex (cannabis- NTAG Dec 14 Unlicensed based oromucosal Non-multiple sclerosis pain Appraisal report indication spray) Recommendation

Moderate-to-severe active rheumatoid Sarilumab Not launched NHSC Apr 15 arthritis Type 2 diabetes Launched MTRAC May 14

In combination with insulin in adults New indication SMC Nov 14 with type 2 diabetes mellitus

As monotherapy in adults with type 2 Saxagliptin (Onglyza) New indication SMC Mar 14 diabetes mellitus

Type 2 diabetes mellitus in adults in AWMSG Dec 13 combination with metformin plus a New indication sulphonylurea SMC Dec 13

Moderate-to-severe plaque psoriasis NICE Jul 15 Secukinumab Launched YES in adults SMC Jun 15

Seretide Accuhaler (salmeterol xinafoate Chronic obstructive pulmonary Launched MTRAC Jan 15 and fluticasone disease propionate)

Pulmonary arterial hypertension in Unlicensed NICE-ES due Dec 15 neonates, including weaning from indication (In production) Sildenafil nitric oxide Unlicensed Digital ulcers NICE-ES Mar 15 indication

Simbrinza Decrease of intraocular pressure in NICE-ES Mar 15 (brinzolomide and adults with open-angle glaucoma or Launched brimonidine tartrate) ocular hypertension SMC Nov 14 Chronic hepatitis C in adults in combination with sofosbuvir (+/- ribavirin). Licence change to remove Unlicensed NHSC Apr 15 current restriction on use only in indication Simeprevir patients intolerant of interferon and in YES urgent need of treatment

NICE Feb 15 Chronic hepatitis C in adults Launched SMC Oct 14

NICE-ES due Dec 15 Sinecatechins External genital and perianal warts Not launched (In production)

Prostate cancer - metastatic, Sipuleucel-T Not launched NICE Feb 15 hormone-relapsed

Reviewer / Tariff Drug name Indication Status publication date excluded Sirolimus intravitreal Chronic non-infectious posterior Not launched NHSC Jan 13 (Opsiria) segment uveitis – first or second-line Sirukumab Rheumatoid arthritis Not launched NHSC Aug 15

SMC due Sep 15 Sitagliptin Type 2 diabetes Launched (In production) MTRAC May 14

AWMSG Dec 13 Sodium phenylbutyrate Urea cycle disorders Not launched YES SMC Nov 13

Sodium zirconium Hyperkalaemia – first-line Not launched NHSC Apr 15 cyclosilicate NICE Feb 15 Sofosbuvir Chronic hepatitis C Launched YES SMC Jun 14

Sofosbuvir plus Unlicensed Chronic hepatitis C NHSC Feb 15 GS-5816 formulation Sonidegib (formerly Locally advanced or metastatic basal Not launched NHSC Jan 13 erismodegib) cell carcinoma SMC due Feb 16 Hepatocellular carcinoma Launched (In production - resubmission) YES Sorafenib Progressive, locally advanced or metastatic, differentiated thyroid New indication SMC Jul 15 carcinoma, refractory to radioactive iodine Spiolto Respimat Chronic obstructive pulmonary SMC due Nov 15 (tiotropium and Launched disease (In production) olodaterol)

Stribild/Quad AWMSG Dec 13 (elvitegravir, cobicistat, HIV infection Launched SMC Aug 13 YES emtricitabine and tenofovir) LNDG Jan 13

Hyperphosphataemia in patients with SMC Apr 15 Sucroferric chronic kidney disease who are on Launched oxyhydroxide dialysis NICE-ES Jan 15 Reversal of neuromuscular blockade induced by rocuronium or vecuronium SMC Mar 13 Sugammadex Launched (only rocuronium-induced blockade in (Resubmission) children and adolescents) Renal cell carcinoma – adjuvant Unlicensed Sunitinib NHSC May 14 YES therapy indication Symbicort Turbohaler (budesonide and Chronic obstructive pulmonary Launched MTRAC Jan 15 formoterol fumarate disease dihydrate) Synjardy (empagliflozin Type 2 diabetes mellitus in adults – SMC due Oct 15 Not launched and metformin) second-line (In production) Tabalumab Systemic lupus erythematosus Not launched NHSC May 14 YES Prophylaxis and treatment of kidney Tacrolimus Launched SMC Apr 15 or liver allograft rejection in adults

Reviewer / Tariff Drug name Indication Status publication date excluded Duchenne muscular dystrophy New indication NHSC Aug 15

NICE-ES Apr 13 Tadalafil Benign prostatic hyperplasia New indication RDTC Apr 13

SMC Jan 13

Transthyretin amyloidosis in adult patients with stage 1 symptomatic Tafamidis Launched SMC May 13 polyneuropathy to delay peripheral neurologic impairment

Tapentadol Chronic pain Launched RDTC Jan 15

Taptiqom (timolol and Open angle glaucoma or ocular SMC due Sep 15 Launched tafluprost) hypertension in adults – second-line (In production)

NICE-ES due Dec 15 Targinact (oxycodone Restless legs New indication (In production) and naloxone) Chronic pain Launched RDTC Jan 15 Chemotherapy-naïve, metastatic Tasquinimod Not launched NHSC Dec 14 hormone-relapsed prostate cancer

Acute bacterial skin and skin structure Tedizolid Launched SMC Aug 15 infections in adults

Nosocomial pneumonia caused by SMC Nov 14 Telavancin Launched MRSA in adults NICE-ES Jul 14 Tempe (lidocaine and Premature ejaculation Not launched RDTC Jun 14 prilocaine spray) Lamivudine-resistant hepatitis B New indication AWMSG May 14 infection in adults

AWMSG Aug 13 Tenofovir (245mg (HIV-1 infection) YES tablets) HIV-1 infection and chronic hepatitis B infection in patients aged 12 to <18 Launched AWMSG Aug 13 years (Hepatitis B infection)

SMC Sep 13 Tenofovir (123mg, AWMSG Aug 13 HIV-1 infection in patients aged 6 to 163mg & 204mg Launched YES <12 years tablets) SMC Sep 13 HIV-1 infection in patients aged 2 to AWMSG Aug 13 <6 years, and >6 years of age for Launched whom a solid dosage form is not SMC Sep 13 appropriate

Tenofovir 33mg/g Lamivudine-resistant hepatitis B New indication AWMSG May 14 YES granules infection in adults

Chronic hepatitis B in adults and AWMSG Aug 13 adolescents aged 12 to <18 years, for (adolescents only) Launched whom a solid dosage form is not appropriate SMC Sep 13

Tenofovir alafenamide Monotherapy for chronic hepatitis B Not launched NHSC Jul 15

SMC Mar 14 Teriflunomide Multiple sclerosis – relapsing remitting Launched YES NICE Jan 14

Reviewer / Tariff Drug name Indication Status publication date excluded NTAG Jun 15 Atypical bisphosphonate-induced Unlicensed Teriparatide Appraisal report YES fractures indication Recommendation Locally advanced or metastatic Tertomotide Not launched NHSC Jan 13 pancreatic cancer

Teysuno (tegafur, Advanced gastric cancer in AWMSG Dec 13 Launched YES gimeracil and oteracil) combination with cisplatin LCNDG Jan 13

Thymosin beta-4 Epidermolysis bullosa Not launched NHSC Aug 14

Prevention of thombotic events in Unlicensed patients with acute ischaemic stroke NHSC Apr 15 indication or high risk transient ischaemic attack Ticagrelor Prevention of cardiovascular disease Unlicensed events in patients with prior NHSC Jul 13 indication myocardial infarction

Tildrakizumab Moderate-to-severe plaque psoriasis Not launched NHSC Apr 15

Unlicensed Timolol, topical Infantile haemangioma NICE-ES Aug 15 indication Ocular hypertension and chronic open Timolol (Tiopex) Launched SMC Feb 14 angle glaucoma Treatment and prevention of venous Tinzaparin thromboembolism in patients with New indication SMC Jul 15 solid tumours New indication SMC Aug 15

Tiotropium (Spiriva MTRAC Mar 15 Asthma Respimat) New indication NICE-ES Mar 15

RDTC Feb 15 Suppression of chronic pulmonary infection due to Pseudomonas Tobramycin inhalation aeruginosa in adults and children Launched NICE Mar 13 YES powder aged six years and older with cystic fibrosis AWMSG May 14

Juvenile idiopathic arthritis New indication SMC Jan 14

UKMi Dec 13

NICE due Oct 15 (In production – update)

LMEN Sep 14 Rheumatoid arthritis Launched Tocilizumab (SC preparation) YES

SMC Aug 14 (SC preparation)

Severe, active and progressive rheumatoid arthritis in adults not New indication SMC Dec 14 previously treated with methotrexate

Giant cell arteritis – first- and second- Unlicensed NHSC Feb 14 line indication

Reviewer / Tariff Drug name Indication Status publication date excluded Psoriatic arthritis – second or Not launched NHSC Jul 15 subsequent line

Chronic plaque psoriasis – second- Tofacitinib Not launched NHSC Apr 15 line

Moderate-to-severe active ulcerative Not launched NHSC Mar 14 colitis

SMC due Feb 16 Kidney disease, autosomal dominant (In production) Tolvaptan Launched polycystic NICE due Oct 15 (In production) NICE due TBC Topotecan Ovarian cancer – advanced, recurrent Launched (In production) NICE due TBC Trabectedin Ovarian cancer – advanced, recurrent Launched YES (In production) HER2 positive metastatic adenocarcinoma of the stomach or SMC due Oct 15 Trastuzumab gastro-oesophageal junction, in New indication YES (In production) combination with capecitabine or 5- fluorouracil and cisplatin – first-line NICE due TBC HER2-positive, unresectable locally Launched (In production) Trastuzumab advanced or metastatic breast cancer SMC Oct 14 YES emtansine (Kadcyla) HER2-positive locally advanced or Unlicensed NHSC Nov 13 metastatic relapsed gastric cancer indication

Trastuzumab SMC Jan 14 Breast cancer – early and metastatic Launched YES subcutaneous NICE-ES Mar 13

Decrease of elevated intraocular pressure in patients aged two months SMC due Oct 15 Travoprost New indication to <18 years with ocular hypertension (In production) or paediatric glaucoma

Recurrent epithelial ovarian, fallopian Trebananib Not launched NHSC Jan 13 tube or primary peritoneal cancer

Treclin (clindamycin Acne vulgaris when comedones, 1% and tretinoin papules and pustules are present in Launched SMC Dec 14 0.025% gel) patients aged 12 years or older

Symptomatic treatment of subacute and chronic inflammatory joint diseases in adults and adolescents Triamcinolone including: rheumatoid arthritis, SMC due Nov 15 Launched hexacedtonide juvenile idiopathic arthritis, (In production) osteoarthritis and post-traumatic arthritis synovitis, tendinitis, bursitis and epicondylitis

Triptorelin (Decapeptyl Prostate cancer New indication NICE-ES Jan 14 SR)

Triumeq (abacavir, HIV infection in adults and AWMSG May 15 dolutegravir and adolescents older than 12 years of Launched lamivudine) age weighing at least 40kg SMC Dec 14 Acute decompensated heart failure – Ularitide Not launched NHSC Apr 13 first-line

Reviewer / Tariff Drug name Indication Status publication date excluded NTAG Sep 14 - update Appraisal report Post-coital contraception for patients Launched Recommendation who present between 72 and 120 (ellaOne) hours NETAG Jan 13 - Update Ulipristal Appraisal report Recommendation

Pre-operative treatment of moderate- Launched AWMSG Aug 13 to-severe uterine fibroids (Esmya) SMC Feb 13 MTRAC Jan 15

RDTC Dec 14 Ultibro Breezhaler Chronic obstructive pulmonary SMC Dec 14 (glycopyrronium and Launched disease indacaterol bromide) AWMSG May 14

LMEN Feb 14

NICE-ES Feb 14

NICE-ES Jan 15 Chronic obstructive pulmonary Umeclidinium Launched AWMSG Jan 15 disease SMC Dec 14 Ursodeoxycholic acid Primary biliary cirrhosis and for Launched SMC Aug 13 (Ursofalk) dissolution of gallstones Unlicensed Crohn’s disease NHSC Oct 14 indication

NICE Jun 15 (Rapid review) Ustekinumab Active psoriatic arthritis in adults – YES New indication second-line NICE May 14

SMC Mar 14

Plaque psoriasis in adolescents New indication NHSC Jun 13

Aggression, agitation and behavioural Unlicensed Valproate preparations NICE-ES Mar 15 disturbances in dementia indication Locally advanced or metastatic Unlicensed differentiated thyroid cancer – NHSC Jul 15 indication second-line YES Vandetanib Aggressive and symptomatic medullary thyroid cancer in patients Launched AWMSG Sep 14 with unresectable locally advanced or metastatic disease

Recessive dystrophic epidermolysis Vavelta Not launched NHSC Jan 13 bullosa –second-line

Reviewer / Tariff Drug name Indication Status publication date excluded Launched NICE Aug 15

Crohn’s disease – second-line SMC Jul 15 Launched NHSC Apr 13

NICE Jun 15 Vedolizumab YES SMC May 15 Moderate-to-severe active ulcerative Launched NTAG Dec 14 colitis in adults – second-line Appraisal report Recommendation

NHSC Apr 13

Velaglucerase alfa Type 1 Gaucher disease Launched AWMSG Jul 14 YES Secondary hyperparathyroidism – Velcalcetide Not launched NHSC Feb 14 first-line Metastatic BRAF V600 mutation- Unlicensed positive melanoma in children and NHSC Jul 15 indication Vemurafenib adolescents YES BRAF V600 mutation-positive SMC Dec 13 Launched unresectable or metastatic melanoma (Resubmission) NTAG Dec 14 - update Chronic central serous Unlicensed Verteporfin Appraisal report chorioretinopathy indication Recommendation Moderate-to-severe storage and Vesomni (solifenacin voiding symptoms associated with Launched SMC Mar 14 and tamsulosin) benign prostatic hyperplasia

Vibro-Pulse Cellulitis and venous leg ulcers Launched UKMi Mar 14

Chronic hepatitis C in adults, in Viekirax (ombitasvir, combination with dasabuvir, with or Launched SMC Jun 15 paritaprevir and without ribavirin YES ritonavir) Chronic hepatitis C in adults, in NICE due Nov 15 Launched combination with or without dasabuvir (In production) Type 2 diabetes Launched MTRAC May 14

Type 2 diabetes mellitus – second- New indication SMC Dec 13 Vildagliptin line adjunct

Type 2 diabetes mellitus – AWMSG Feb 13 New indication monotherapy SMC Jan 13

Transitional cell carcinoma of the SMC Jul 15 Vinflunine Launched YES urothelial tract NICE Jan 13

Vipdomet (alogliptin AWMSG Oct 14 Type 2 diabetes Launched and metformin) SMC Oct 14

Virulite light therapy Cold sores Launched UKMi Dec 13

Locally advanced or metastatic basal SMC Oct 13 Vismodegib Launched cell carcinoma LCNDG Feb 13

Vokanamet (metformin Type 2 diabetes mellitus Launched SMC Jan 15 and canagliflozin)

Reviewer / Tariff Drug name Indication Status publication date excluded Acute myeloid leukaemia in patients Volasertib ineligible for intensive induction Not launched NHSC Apr 13 therapy – first-line MTRAC due Nov 15 Voraxapar Atherosclerosis Not launched (In production)

Voractiv (rifampicin, isoniazid, pyrazinamide Tuberculosis Launched SMC May 13 and ethambutol hydrochloride) Prophylaxis of invasive fungal infections in high risk allogeneic Voriconazole Launched SMC Nov 14 YES hematopoietic stem cell transplant recipients

NICE due Sep 15 Vortioxetine Major depressive disorder Not launched (In production)

Xigduo (dapagliflozin Type 2 diabetes mellitus Launched SMC Aug 14 and metformin)

SMC due Oct 15 Xultophy (insulin (In production) degludec and Type 2 diabetes mellitus Launched NICE-ES Jul 15 liraglutide) RDTC May 15

Zoely (nomegestrol NICE-ES Dec 13 Contraception Launched acetate and estradiol) SMC Jul 13 MTRAC Sep 13 Epilepsy – monotherapy Launched NICE-ES Apr 13 Zonisamide Adjunctive therapy for partial seizures NICE-ES Mar 14 in adolescents, and children aged six New indication years and above SMC Mar 14

Zucapsaicin Episodic cluster headache Not launched NHSC Nov 13

North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected]