New Product Evaluations - a Resource for Medicines Management

January 2016 Number 157

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 36 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  NSRIC – 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 157

The evaluations:

Reviewer / Tariff Drug name Indication Status publication date excluded

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

Unlicensed Psoriatic arthritis – second-line NSRIC Oct 15 indication

Rheumatoid arthritis after failure of SMC Apr 13 conventional disease-modifying anti- Launched (Resubmission) rheumatic drugs NICE Apr 13 Abatacept YES NICE Jan 16 Rheumatoid arthritis Launched (Update)

Moderate-to-severe active NICE Dec 15 polyarticular juvenile idiopathic New indication arthritis in patients aged six years and AWMSG Feb 14 older – second-line

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

Hormone-naïve metastatic prostate Unlicensed NSRIC Oct 15 cancer – first-line indication

NICE due TBC (In production) Asymptomatic or mildly symptomatic YES Abiraterone prostate cancer, after failure of SMC Oct 15 androgen deprivation therapy, when New indication SMC Feb 15 chemotherapy is not yet clinically 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 Abraxane (nab- docetaxel/paclitaxel indication YES paclitaxel) NICE Oct 15

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

NSRIC 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 moderate-to-severe SMC due May 16 hidradenitis suppurativa (acne New indication (In production) inversa) in adults – second-line AWMSG Sep 15

NTAG Sep 15 Psoriatic arthritis, sequential use of N/A Appraisal report TNF inhibitors Recommendation

Active enthesitis-related arthritis in AWMSG Jun 15 New indication patients aged six years and older SMC May 15

AWMSG Dec 15 Severe chronic plaque psoriasis in children and adolescents – second- New indication SMC Jul 15 line NSRIC Dec 14

Ankylosing spondylitis and axial NICE due Feb 16 New indication spondyloarthritis (non-radiographic) (In production) YES Adalimumab Axial spondyloarthritis New indication SMC Apr 13

NICE Jan 16 Launched Rheumatoid arthritis (Update) Launched RDTC May 13

NICE Dec 15 Juvenile idiopathic arthritis, New indication AWMSG Aug 13 polyarticular and enthesitis-related 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

Advanced or metastatic, squamous non-small cell lung cancer Unlicensed NSRIC Jan 16 progressing on or after platinum- indication based chemotherapy Afatinib Non-small cell lung cancer Launched SMC Mar 14

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

Reviewer / Tariff Drug name Indication Status publication date excluded Visual impairment due to choroidal neovascularisation secondary to New indication NSRIC Oct 15 pathological myopia

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

NICE Jul 13 Age-related macular degeneration Launched SMC Apr 13

Aflibercept NETAG Jan 13 Appraisal report Recommendation

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

Visual impairment due to macular SMC Sep 15 oedema secondary to branch retinal New indication vein occlusion NSRIC Dec 14

NICE Jul 15

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

NSRIC Jun 13

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

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

Launched SMC Jan 16

Albiglutide Type 2 diabetes Launched SMC Jan 16

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

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

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

Treatment of postmenopausal SMC due Apr 16 Alendronic acid Launched osteoporosis (In production)

Active ulcerative colitis – second-line Not launched NSRIC Jan 16 Alicaforsen Pouchitis – second-line Not launched NSRIC Nov 13

Reviewer / Tariff Drug name Indication Status publication date excluded SMC due May 16 (In production) Primary hypercholesterolaemia or Alirocumab Launched mixed dyslipidaemia NTAG Nov 15 Appraisal report Recommendation

Relapsed or refractory peripheral T- Alisertib cell lymphoma – second and Not launched NSRIC 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 AWMSG Dec 15 Alpha-1 antitrypsin antitrypsin deficiency – maintenance Not launched YES (Respreeza) therapy NSRIC Dec 14

Alpha-mannosidase, recombinant, human Alpha mannosidosis Not launched NSRIC 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)

Cryopyrin-associated periodic syndromes in patients aged eight Anakinra Launched SMC Dec 15 YES months and older with a body weight of at least 10kg

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

UKMi Sep 15

AWMSG Mar 15 Anoro Ellipta Chronic obstructive pulmonary SMC Feb 15 (umeclidinium and Launched disease (Resubmission) 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 NSRIC Jul 13

High risk neuroblastoma in children APN311 Not launched NSRIC Jul 15 and adolescents – first-line

Reviewer / Tariff Drug name Indication Status publication date excluded

NICE Nov 15 Chronic plaque psoriasis Launched SMC Jun 15

Unlicensed Ankylosing spondylitis NSRIC Nov 13 indication Apremilast YES NICE Dec 15

Psoriatic arthritis Launched SMC Jun 15

NSRIC Jan 13

Psoriasis Launched NSRIC 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

NICE due Apr 16 (In production) Asfotase alfa Hypophosphatasia Launched (Paediatric-onset) YES

NSRIC Nov 13

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

MAGE-A3 positive malignant Astuprotimut-R melanoma, stage III – adjuvant Not launched NSRIC Apr 13 therapy

Asunaprevir and Chronic hepatitis C virus infections Not launched NSRIC Sep 13 YES daclatasvir genotype 1 and 4

Asunaprevir, beclabuvir Hepatitis C virus infection, genotype 1 Unlicensed NSRIC Feb 15 YES and daclatasvir – first- or second-line formulation

CFTR class I nonsense mutation Unlicensed NSRIC Aug 15 mediated cystic fibrosis indication

NICE due TBC Ataluren Duchenne muscular dystrophy (In production) Launched (nonsense mutation) SMC due Apr 16 (In production)

Locally advanced or metastatic non- Not launched NSRIC Aug 15 small cell lung cancer – second-line Atezolizumab Urothelial bladder cancer – second Not launched NSRIC Jul 15 and subsequent line

Reviewer / Tariff Drug name Indication Status publication date excluded Attention-deficit hyperactivity disorder in children aged ≥6 years, Launched SMC Dec 15 adolescents and adults Atomoxetine AWMSG Feb 14 Attention-deficit hyperactivity disorder Launched SMC Nov 13

SMC Sep 15

AWMSG Jul 15

Avanafil Erectile dysfunction Launched NICE-ES Aug 14

MTRAC Aug 14

SMC Jun 14 Thrombocytopenia in chronic liver Not launched NSRIC Oct 14 Avatrombopag disease prior to surgery YES Immune thrombocytopenic purpura Not launched NSRIC 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 NSRIC 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 NSRIC Jul 15 arthritis

Advanced non-small cell lung cancer Bavituximab – second line in combination with Not launched NSRIC 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)

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

Prevention of venous Betrixaban Not launched NSRIC 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 Glioblastoma in combination with Unlicensed NSRIC Oct 15 lomustine – second line indication

EGFR positive, advanced or Unlicensed metastatic non-small cell lung cancer, NSRIC Aug 15 indication in combination with erlotinib – first-line

LMEN Dec 15

Wet (neovascular) age-related Unlicensed NTAG Sep 14 - update macular degeneration indication Appraisal report Recommendation

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

Recurrent or persistent stage IVB SMC due May 16 cervical cancer – in combination with New indication (In production) chemotherapy NSRIC May 14 Bevacizumab YES Unlicensed High-grade glioma – third-line LCNDG Mar 13 indication

SMC Nov 15 Advanced epithelial ovarian, fallopian (Resubmission) tube, or primary peritoneal cancer in New indication SMC Jan 15 combination with paclitaxel and (Resubmission) carboplatin – first-line NICE May 13

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

SMC Sep 15 Relapsed platinum-resistant ovarian New indication NICE Aug 15 cancer – second-line NSRIC Jan 13

Bevacizumab Wet age-related macular Not launched LMEN Dec 15 biosimilar (BCD021) degeneration

Reviewer / Tariff Drug name Indication Status publication date excluded Bevacizumab Wet age-related macular biosimilar sustained Not launched LMEN Dec 15 degeneration release depot

Sporadic inclusion body myositis – Bimagrumab Not launched NSRIC Oct 15 first-line

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

Recurrent or persistent ovarian, Binimetinib fallopian tube or primary peritoneal Not launched NSRIC Jan 16 cancer ─ second and subsequent line

Permanent disability related to multiple sclerosis relapses – add on Not launched NSRIC Apr 15 Biotin therapy to current immunomodulators Primary and secondary progressive Not launched NSRIC Apr 15 multiple sclerosis ‒ first-line

Relapsed or refractory Philadelphia- SMC due May 16 Blinatumomab negative B-precursor acute Launched (In production) lymphoblastic leukaemia NSRIC May 14

Mantle cell lymphoma in combination NICE Dec 15 with rituximab, cyclophosphamide, doxorubicin and prednisone in New indication patients unsuitable for haematopoietic SMC Sep 15 stem cell transplantation – first-line Bortezomib YES AWMSG Oct 14

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 YES NSRIC Feb 14

Reviewer / Tariff Drug name Indication Status publication date excluded

Cutaneous T-cell lymphoma, CD30+ Launched NSRIC Jul 15

Hodgkin’s lymphoma, in adults at high risk of residual CD30+ following Launched NSRIC 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

AWMSG Sep 15

SMC Jan 15

MTRAC Jul 14 Brimonidine Facial erythema of rosacea Launched NICE-ES Jul 14

RDTC Jun 14

MTRAC Apr 14

Partial-onset seizures, with or without SMC due TBC Brivaracetam secondary generalisation, in patients Not launched (In production) aged at least 16 years

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

Post-operative ocular inflammation Bromfenac Launched AWMSG May 14 following cataract extraction Bucelipase-alfa To improve growth and development Not launched NSRIC 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)

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

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

In combination with prednisone or prednisolone is indicated for the treatment of hormone refractory SMC due May 16 Cabazitaxel Launched metastatic prostate cancer previously (In production) treated with a doxetaxel-containing regimen.

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

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

Reviewer / Tariff Drug name Indication Status publication date excluded

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

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

Camellia sinensis SMC due Apr 16 extract (green tea leaf; External genital and perianal warts Launched (In production) Catephen) NICE-ES Dec 15

NICE Jun 14

Canagliflozin Type 2 diabetes mellitus in adults Launched SMC Jun 14

RDTC Mar 14

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

Reduction of thrombotic NICE-ES Nov 15 cardiovascular events in patients with Launched NICE Jul 15 coronary artery disease undergoing Cangrelor percutaneous coronary intervention SMC Jun 15 Prevention of coronary thrombosis in NICE Jul 15 Unlicensed patients undergoing cardiovascular indication surgery NSRIC Apr 13 Peripheral neuropathic pain in Launched LMEN Jan 15 diabetic adults either alone or in combination with other medicinal Launched AWMSG Dec 15 Capsaicin (Qutenza) products for pain

Peripheral neuropathic pain in non- SMC Oct 14 New indication diabetic adults (Resubmission)

Aggression, agitation and behavioural Unlicensed Carbamazepine NICE-ES Mar 15 disturbances in dementia indication

Relapsed and/or refractory multiple Carfilzomib Launched NSRIC Sep 13 myeloma

Carglumic acid Hyperammonaemia Launched SMC Oct 13 YES

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

Cediranib Ovarian cancer – second-line Not launched NSRIC 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

Reviewer / Tariff Drug name Indication Status publication date excluded

Unlicensed Cetirizine High-dose use in urticaria NICE-ES Jul 14 indication

ALK-positive advanced non-small cell NICE due TBC Ceritinib lung cancer, previously treated with Launched (In production) crizotinib SMC Dec 15

Neuronal ceroid lipofuscinosis type 2 Cerliponase alfa Not launched NSRIC Oct 15 (CLN2 disease)

Early rheumatoid arthritis, in Unlicensed NSRIC Jul 15 combination with methotrexate indication

NICE Jan 16 Launched Rheumatoid arthritis (Update) Launched RDTC May 13

Adults with severe active axial New indication SMC May 14 spondyloarthritis

NTAG Sep 15 Certolizumab Psoriatic arthritis, sequential use of YES N/A Appraisal report TNF inhibitors Recommendation

NTAG Sep 15 Appraisal report Recommendation

Active psoriatic arthritis – second-line New indication AWMSG Oct 14

SMC Jul 14

NICE-ES Jun 14

Metastatic colorectal cancer, RAS New indication AWMSG Jan 16 Cetuximab YES wild-type patients New indication SMC Jan 15

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 NSRIC Mar 14 synthesis – first-line

Severe keratitis in adults with dry eye NICE Dec 15 Launched disease – second-line SMC Oct 15

Ciclosporin Reperfusion injury prevention prior to percutaneous coronary intervention Unlicensed NSRIC 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 NSRIC Sep 13 (Lipoplatin) with fluorouracil formulation

Attention deficit hyperactivity disorder Unlicensed Clonidine NICE-ES Mar 13 in children and young people indication

Reviewer / Tariff Drug name Indication Status publication date excluded 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 NSRIC 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 Launched NSRIC Aug 14 melanoma with vemurafenib – first- line

Co-careldopa Advanced levodopa-responsive Launched SMC Dec 15 YES (Duodopa) Parkinson’s disease – second-line

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

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 LMEN Aug 15 YES clostridium histolyticum Peyronie’s disease – first-line New indication SMC May 15

NSRIC Dec 14

Conbercept Wet age-related macular oedema Not launched LMEN Dec 15

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

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

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

Reviewer / Tariff Drug name Indication Status publication date excluded Locally advanced or metastatic Custirsen hormone-relapsed prostate cancer – Not launched NSRIC Feb 14 first and second-line

Complex perianal fistula in adults with Cx601 (Alofisel) Not launched NSRIC Apr 15 luminal Crohn’s disease – second-line

Cytomegalovirus infection in patients Cytovir CMV undergoing allogeneic haematopoietic Not launched NSRIC Jan 16 stem cell transplantation

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 NSRIC Aug 15 indication with trametinib Dabrafenib Unresectable or metastatic melanoma SMC Mar 15 Launched with a BRAFV600 mutation in adults NICE Oct 14

NICE Nov 15 Chronic hepatitis C virus infection in Daclatasvir Launched AWMSG May 15 YES adults SMC Nov 14

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

Daclatasvir and Chronic hepatitis C virus infections Not launched NSRIC Sep 13 YES asunaprevir genotype 1 and 4

Daclatasvir and Chronic hepatitis C infection with and Launched NSRIC Mar 14 sofosbuvir without ribavirin

Locally advanced or metastatic EGFR Dacomitinib positive non-small cell lung cancer – Not launched NSRIC Oct 15 first-line

Acute bacterial skin and skin structure SMC due TBC Dalbavancin Not launched infections in adults (In production)

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 NSRIC Jun 13 add on therapy

Reviewer / Tariff Drug name Indication Status publication date excluded Relapsed or refractory multiple myeloma – second-line in Not launched NSRIC Jan 16 combination with bortezomib and dexamethasone

Daratumumab Relapsed or refractory multiple Not launched NSRIC Aug 15 myeloma – monotherapy

Relapsed or refractory multiple myeloma, with lenalidomide and Not launched NSRIC 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

Osteoporosis in men at increased risk New indication SMC Nov 14 of fractures

Treatment of postmenopausal Denosumab (Prolia) Launched MTRAC Jan 14 osteoporosis

Unlicensed Glucocorticoid-induced osteoporosis NSRIC Mar 14 indication

Giant cell tumour of bone in adults AWMSG Dec 15 Denosumab (XGEVA) Launched and skeletally-mature adolescents SMC Dec 15

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

Reviewer / Tariff Drug name Indication Status publication date excluded Dexamethasone Prevention and treatment of post- intraocular injection Not launched NSRIC Jan 13 ocular surgery inflammation (Verisome)

Diltiazem 2% topical Chronic anal fissure Not launched NICE-ES Jan 13

Dimethyl fumarate Plaque psoriasis Not launched NSRIC 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

NICE due Apr 16 (In production) High risk neuroblastoma – Dinutuximab Not launched SMC due TBC maintenance therapy (In production)

NSRIC May 14

Hormone-sensitive metastatic Unlicensed Docetaxel NICE-ES Jan 16 prostate cancer indication

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 Apr 16 Ovarian cancer – advanced, recurrent Launched YES liposomal (In production)

Doxorubicin-eluting Hepatocellular carcinoma Not launched NSRIC Jan 16 beads

NICE-ES Apr 15 Duaklir Genuair Chronic obstructive pulmonary SMC Apr 15 (aclidinium and Launched disease formoterol) RDTC Mar 15 MTRAC Jan 15 AWMSG due TBC Launched (In production)

Dulaglutide Type 2 diabetes Launched SMC Jan 16

Launched 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 C3 glomerulopathy in the native Unlicensed NICE-ES Dec 15 kidney indication

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

SMC due Feb 16 (In production) Atypical haemolytic uraemic New indication syndrome AWMSG Aug 15 Eculizumab NICE Jan 15

Shiga-Toxin producing Escherichia Unlicensed coli haemolytic-uraemic syndrome – NSRIC Jun 13 indication first-line

SMC due Apr 16 Paroxysmal nocturnal Launched (In production) YES haemoglobinuria SMC Sep 13

Treatment and prevention of venous SMC Nov 15 Launched thromboembolism in adults NICE Aug 15

MTRAC due Apr 16 Edoxaban (In production) Prevention of stroke and systemic Launched embolism in adults with non-valvular SMC Nov 15 atrial fibrillation and other risk factors NICE Sep 15

Launched RDTC Jun 15

HIV-1 infection children aged three Launched AWMSG Jan 16 Efavirenz months to three years and weighing at YES least 3.5kg Launched SMC Dec 15

Treatment of haemophilia A in adults Efraloctocog alfa Not launched NSRIC Sep 13 YES and children

Eftrenonacog alfa Haemophilia B Not launched NSRIC Nov 13

NICE due TBC Eliglustat Gaucher disease (type 1) Not launched (In production) YES NSRIC Jun 13

Mucopolysaccaridosis, type IV NICE Dec 15 Elosulfase alfa Launched YES (Morquio A Syndrome, MPS IVA) SMC Sep 15

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

Reviewer / Tariff Drug name Indication Status publication date excluded

Severe aplastic anaemia – second- New indication NSRIC Oct 14 line

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

Chronic immune (idiopathic) Launched NICE Jul 13 thrombocytopenic purpura

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

Launched AWMSG Jan 16

NICE Mar 15 Empagliflozin Type 2 diabetes Launched SMC Oct 14

NICE-ES Mar 14

BRAF V600 mutation-positive Encorafenib melanoma with binimetinib – first- and Not launched NSRIC 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

SMC due Mar 16 New indication Metastatic castration-resistant (In production) prostate cancer after failure of androgen deprivation therapy when New indication NICE Jan 16 chemotherapy is not yet clinically AWMSG Sep 15 YES Enzalutamide indicated New indication SMC Aug 15

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 NSRIC Feb 15 YES

Eprodisate disodium AA amyloidosis Not launched NSRIC Oct 15 AWMSG due TBC (In production)

Locally advanced or metastatic breast SMC due Mar 16 Launched cancer – second-line (In production - Eribulin resubmission) YES

SMC Aug 15

Advanced non-small cell lung cancer Unlicensed NSRIC Jun 13 – third-line indication

Non-small-cell lung cancer that has progressed following prior Launched NICE Dec 15 Erlotinib chemotherapy YES Adjuvant treatment of EGFR-positive Unlicensed NSRIC 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 Feb 16 New indication spondyloarthritis (non-radiographic) (In production)

Severe, non-radiographic axial New indication NSRIC 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

NTAG Sep 15 Psoriatic arthritis, sequential use of N/A Appraisal report TNF inhibitors Recommendation

Juvenile idiopathic arthritis, Etanercept YES polyarticular, psoriatic and enthesitis- New indication NICE Dec 15 related

Psoriatic arthritis in adolescents from AWMSG Dec 13 the age of 12 years who have had an 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 Jan 16 Launched Rheumatoid arthritis (Update) Launched RDTC May 13

Etanercept biosimilar All etanercept licensed indications Launched UKMi Jan 16 YES (Benepali)

Metastatic breast cancer - second or Etirinotecan pegol Not launched NSRIC 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 Treatment of hormone receptor- positive (HR+), human epidermal growth factor receptor 2 negative (HER2/neu-negative [HER2–]) advanced breast cancer, in SMC due Apr 16 combination with exemestane, in Launched (In production) postmenopausal women without symptomatic visceral disease after Everolimus recurrence or progression following a YES non-steroidal aromatase inhibitor (NSAI).

In combination with an aromatase SMC Oct 15 inhibitor for HER2-negative, (Resubmission) oestrogen receptor-positive locally New indication SMC Jul 13 advanced or metastatic breast cancer – second-line NICE Jul 13

Reviewer / Tariff Drug name Indication Status publication date excluded

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

Everolimus Renal angiomyolipoma associated YES 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 Locally advanced, unresectable or metastatic pancreatic cancer – first- Not launched NSRIC Apr 15 line in combination with gemcitabine

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

SMC due Jun 16 (In production)

NICE due Apr 16 Primary hypercholesterolaemia and Evolocumab Launched (In production) mixed dyslipidaemia NTAG Nov 15 Appraisal report Recommendation

Evotaz (atazanavir and Launched AWMSG Jan 16 HIV-1 infection in adults YES cobicistat) Launched SMC Nov 15

NICE due Feb 16 Hypercholesterolaemia Launched (In production)

Ezetimibe Reduction of cardiovascular risk in Unlicensed coronary heart disease – in NSRIC Nov 13 indication combination with a statin

Improve walking in adults with Fampridine multiple sclerosis with walking Launched AWMSG Sep 14 YES disability

Hyperuricaemia in adults undergoing chemotherapy for haematologic SMC due Jun 16 Febuxostat New indication malignancies at intermediate to high (In production) risk of tumor lysis syndrome

Fenfluramine Dravet syndrome – first-line Not launched NSRIC Jan 16

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 NSRIC Aug 14 polyneuropathy – second-line indication

Rapidly evolving severe relapsing– SMC Apr 15 YES Fingolimod remitting multiple sclerosis and patients with high disease activity Launched despite treatment with at least one SMC Oct 14 disease modifying therapy

Reviewer / Tariff Drug name Indication Status publication date excluded

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 Treatment of infections in adults and AWMSG Nov 15 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

Hormone-receptor positive breast Unlicensed cancer, advanced or metastatic – first- NSRIC Oct 15 indication line

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

Reviewer / Tariff Drug name Indication Status publication date excluded Locally advanced or metastatic non- SMC Dec 15 small cell lung cancer with activating Launched (Resubmission) mutations of EGFR

Non-small cell lung cancer that has progressed following prior Launched NICE Dec 15 Gefitinib YES chemotherapy

In combination with chemotherapy for EGFR-positive non-small cell lung Unlicensed NSRIC Jul 13 cancer that has progressed following indication gefitinib therapy

NICE due Apr 16 Gemcitabine Ovarian cancer – advanced, recurrent Launched YES (In production)

Gemtuzumab Acute myeloid leukaemia, with Not launched NSRIC Aug 15 ozogamicin conventional chemotherapy – first-line

Genvoya (elvitegravir, AWMSG due TBC HIV-1 infection in adults and cobicistat, emtricitabine (In production) adolescents aged over 12 years and Launched and tenofovir weighing at least 35kg SMC due May 16 alafenamide fumarate) (In production)

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

Glatiramer acetate Relapsing forms of multiple sclerosis Launched SMC Dec 15

Glycerol Urea cycle disorders Not launched NSRIC 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 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

LMEN Mar 14

SMC due Feb 16 (In production) Ankylosing spondylitis and axial YES Golimumab New indication spondyloarthritis (non-radiographic) NICE due Feb 16 (In production)

NTAG Sep 15 Psoriatic arthritis, sequential use of N/A Appraisal report TNF inhibitors Recommendation

NICE Jan 16 Launched Rheumatoid arthritis (Update) Launched RDTC May 13

Reviewer / Tariff Drug name Indication Status publication date excluded

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 NSRIC Jul 15 Severe combined immunodeficiency GSK2696273 due to adenosine deaminase Not launched NSRIC Aug 15 deficiency

AWMSG due TBC (In production)

Guanfacine ADHD in children and adolescents NICE-ES due Mar 16 Not launched hydrochloride aged 6 to 17 years – second-line (In production)

SMC due Feb 16 (In production)

Guselkumab Moderate-to-severe psoriasis Not launched NSRIC Jan 16

Chronic hepatitis C in adults – Launched SMC Sep 15 genotype 3

NICE Nov 15 Harvoni (ledipasvir and YES sofosbuvir) AWMSG Aug 15 Chronic hepatitis C in adults Launched SMC Mar 15

NSRIC Jul 13

Limbal stem cell deficiency due to Holoclar Not launched NSRIC Jul 15 ocular burns

House dust mite allergen House dust mite allergy-induced Not launched NSRIC Nov 13 immunotherapy tablet rhinitis and conjunctivitis – third-line (Mitizax)

Hydrocortisone MR Adrenal insufficiency Launched SMC Jan 13

Reviewer / Tariff Drug name Indication Status publication date excluded Chronic lymphocytic leukaemia or small lymphocytic lymphoma in Unlicensed NSRIC Jan 16 combination with bendamustine and indication rituximab – second-line

Diffuse large B-cell lymphoma with R- Unlicensed NSRIC Jan 16 CHOP – first-line indication

Relapsed and refractory marginal Unlicensed zone lymphoma – second or NSRIC Jan 16 indication subsequent line

Treatment of adults with chronic lymphocytic leukaemia who have received at least one prior therapy, or SMC due May 16 Launched first-line in the presence of 17p (In production) deletion or TP53 mutation in patients Ibrutinib unsuitable for chemo-immunotherapy Waldenström’s macroglobulinaemia New indication NSRIC Apr 15

AWMSG due TBC Mantle cell lymphoma in adults, (In production) Launched relapsed or refractory SMC due May 16 (In production)

NSRIC Oct 14 Newly-diagnosed chronic lymphocytic Launched leukaemia – first-line AWMSG due TBC (In production)

NSRIC Jul 13 Relapsed or refractory chronic Launched lymphocytic leukaemia – second-line AWMSG due TBC (In production)

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

Duchenne muscular dystrophy – first- Idebenone Not launched NSRIC Jan 16 line

Chronic lymphocytic leukaemia – first- Unlicensed NSRIC Oct 15 line with bendamustine and rituximab indication

Relapsed chronic lymphocytic Unlicensed leukaemia in combination with NSRIC Dec 14 indication bendamustine and rituximab

Relapsed chronic lymphocytic Unlicensed NSRIC Mar 14 leukaemia with ofatumumab indication

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

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

NICE Oct 15 Chronic lymphocytic leukaemia with Launched SMC Mar 15 rituximab NSRIC Jul 13

RDTC due Mar 16 Reversal of anticoagulation due to Idarucizumab Launched (In production) treatment with dabigatran – first-line NSRIC Feb 15

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Iloprost intravenous Critical limb ischaemia NICE-ES Dec 13 indication

Locally advanced or metastatic renal IMA-901 Not launched NSRIC Jan 16 cell carcinoma ─ first-line

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 NSRIC 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)

Paediatric ulcerative colitis New indication SMC Mar 13 YES Infliximab Ankylosing spondylitis and axial NICE due Feb 16 New indication spondyloarthritis (non-radiographic) (In production)

NTAG Sep 15 Psoriatic arthritis, sequential use of N/A Appraisal report TNF inhibitors Recommendation

NICE Jan 16 Launched Rheumatoid arthritis (Update) Launched RDTC May 13

NTAG Sep 15 (update) 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 NSRIC Jun 13

Psoriatic arthritis Launched NSRIC Jun 13

Reviewer / Tariff Drug name Indication Status publication date excluded NTAG Sep 15 (update) 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 NSRIC Jun 13

Psoriatic arthritis Launched NSRIC 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 NSRIC 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)

Diabetes mellitus in adults, SMC due Mar 16 Insulin detemir adolescents and children aged 1 year Launched (In production) and above

NICE-ES Dec 15 (Type 2 diabetes)

NTAG Nov 15 Appraisal report Recommendation Insulin glargine Type 1 or 2 diabetes mellitus in adults Launched (Toujeo) aged 18 years and above NICE-ES Oct 15 (Type 1 diabetes)

UKMi Oct 15

SMC Sep 15

MTRAC Jul 15

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

AWMSG Dec 15

NICE-ES Dec 15

NTAG Nov 15 Diabetes mellitus in adults, Insulin glargine Appraisal report adolescents and children aged 2 Launched (Abasaglar) Recommendation years and older UKMi Oct 15

LMEN Oct 15

MTRAC Jul 15

Interferon beta-1a Acute respiratory distress syndrome – Unlicensed NSRIC May 14 YES (Traumakine) first-line indication

Small cell lung cancer – first-line, in Unlicensed combination with etoposide and NSRIC Apr 15 indication platinum therapy

Non-small cell lung cancer, stage IV Unlicensed or recurrent, with paclitaxel and NSRIC Feb 15 indication carboplatin

Prostate cancer, chemotherapy-naïve, Unlicensed NSRIC Feb 15 hormone-relapsed metastatic indication Ipilimumab YES Metastatic hormone-relapsed prostate Unlicensed cancer following docetaxel treatment NSRIC 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 NSRIC Mar 14 and third-line

SMC due Apr 16 Isavuconazole Invasive aspergillosis Launched (In production) Cystic fibrosis in patients aged 2 years and older and weighing less than 25 kg who have one of the SMC due May 16 following gating (class III) mutations in New indication (In production) the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. Ivacaftor YES Cystic fibrosis in patients with class III New indication AWMSG Jan 16 non-G551D gating mutations New indication NSRIC Aug 14

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

Reviewer / Tariff Drug name Indication Status publication date excluded AWMSG due TBC Launched (In production)

Launched NICE-ES Jan 16 Ivermectin 1% topical Papulopustular rosacea cream Launched SMC Dec 15

Launched RDTC Oct 15

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

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

Moderate-to-severe chronic plaque Ixekizumab Not launched NSRIC 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 NSRIC Oct 13 third-line

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

Endogenous Cushing’s syndrome in Ketoconazole adults and adolescents aged over 12 Launched SMC Sep 15 years

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 AWMSG Dec 15 Lanreotide metastatic gastro-enteropancreatic Launched neuroendocrine tumours – first-line NSRIC Dec 14 Early HER2-positive breast cancer, Unlicensed neoadjuvant therapy in combination NSRIC 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 NSRIC 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

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Mantle cell lymphoma NSRIC Sep 13 indication

Previously untreated multiple AWMSG due TBC myeloma in adults who are not eligible New indication (In production) for transplant SMC Dec 15

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

Advanced or metastatic renal cell Unlicensed Lenvatinib carcinoma in combination with NSRIC Jan 16 indication everolimus – second-line

Lesinurad Gout Not launched NSRIC Jan 13

LentiGlobin BB305 Beta-thalassaemia major – first-line Not launched NSRIC Jan 16

Behavioural variant frontotemporal Leuco- Not launched NSRIC Sep 13 dementia – first-line methylthioninium Alzheimer’s disease Not launched NSRIC 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

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 NSRIC 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

Reviewer / Tariff Drug name Indication Status publication date excluded Chemotherapy-induced neutropenia AWMSG Aug 14 (with the exception of chronic myeloid Lipegfilgrastim Launched YES leukaemia and myelodysplastic SMC Apr 14 syndromes)

Unlicensed MTRAC Jan 16 indication Obesity Unlicensed RDTC Oct 15 indication Liraglutide Type 2 diabetes mellitus in adults Launched SMC May 15

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

Attention deficit/hyperactivity disorder AWMSG Oct 15 New indication in adults SMC Sep 15

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 NSRIC Aug 15 cholestasis in paediatric patients

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

SMC Aug 14

Lubiprostone Constipation Launched NICE Jul 14

RDTC Mar 14

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 NSRIC May 14 neuroendocrine tumours

Reviewer / Tariff Drug name Indication Status publication date excluded Long-term treatment of adults with Launched AWMSG Jan 16 Macitentan pulmonary arterial hypertension YES (WHO Functional Class II to III) Launched SMC Apr 14

Magnesium aspartate Treatment and prevention of AWMSG Sep 15 Launched dihydrate magnesium deficiency SMC Jun 15

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 NSRIC Aug 15 line

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

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

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

Mastocytosis – second or subsequent Not launched NSRIC 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

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

SMC due Jun 16 (In production) Severe refractory eosinophilic asthma Mepolizumab Launched NICE due Jul 16 YES in adults (In production)

NSRIC May 14

Locally advanced or metastatic, EGFR and T790M mutation positive Mereletinib Not launched NSRIC 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 NSRIC Nov 13 (Visonac) vulgaris

Reviewer / Tariff Drug name Indication Status publication date excluded Opioid-induced constipation in adults Unlicensed NSRIC Aug 14 with chronic non-malignant pain indication Methylnaltrexone Unlicensed Opioid-induced constipation NSRIC Apr 13 indication

Metreleptin Generalised and partial lipodystrophy Not launched NSRIC May 14 AWMSG Nov 15

Orthostatic hypotension due to SMC Oct 15 Midodrine Launched autonomic dysfunction NICE-ES Oct 15

NSRIC Jul 15

Newly diagnosed FLT3-mutated acute Midostaurin Not launched NSRIC Feb 14 myeloid leukaemia – first-line

Migalastat Fabry disease Not launched NSRIC 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 NSRIC Nov 13 rhinitis and conjunctivitis – third-line immunotherapy tablet)

Excessive daytime sleepiness in Unlicensed NICE-ES Sep 15 Parkinson's disease indication Modafinil Unlicensed Fatigue in multiple sclerosis NICE-ES Mar 13 indication

Adult T-cell leukaemia/lymphoma – Mogamulizumab Not launched NSRIC Aug 14 second and subsequent line

Symptoms of seasonal allergic or Mometasone furoate perennial rhinitis in children aged 3 to Launched AWMSG Dec 15 6 years NTAG Jun 14 Multivitamins and Age-Related Macular Degeneration Not licensed Appraisal report minerals Recommendation

Unlicensed Systemic lupus erythematosus NICE-ES Nov 14 indication Mycophenolate Unlicensed Scleroderma NICE-ES Jul 14 indication

Not launched MTRAC Jan 16 Mysimba (naltrexone Weight management in adults RDTC Sep 15 and bupropion) Not launched LMEN Jun 15

Reviewer / Tariff Drug name Indication Status publication date excluded 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 Dec 15

Naloxegol Opioid-induced constipation Launched NICE Jul 15

RDTC Apr 15

Secondary progressive multiple Unlicensed NSRIC 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 NSRIC 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 NSRIC Jul 15 Neratinib capecitabine – third-line

HER2-positive early breast cancer Not launched NSRIC Aug 14

Locally advanced, metastatic or NICE Jul 15 Nintedanib (Vargatef) recurrent non-small cell lung Launched adenocarcinoma – second-line SMC Apr 15

Launched NICE Jan 16 YES

Nintedanib (Ofev) Idiopathic pulmonary fibrosis SMC Oct 15 Launched NSRIC Jun 13 HER2-negative, germline BRCA mutated, locally advanced or Not launched NSRIC Oct 14 metastatic breast cancer Niraparib High grade serous, platinum-sensitive ovarian cancer – second-line Not launched NSRIC Aug 14 maintenance therapy

Reviewer / Tariff Drug name Indication Status publication date excluded Metastatic or unresectable urothelial Unlicensed NSRIC Jan 16 bladder cancer – second-line indication

Follicular non-Hodgkin lymphoma ─ Unlicensed NSRIC Jan 16 third-line indication

Unlicensed Recurrent glioblastoma – second-line NSRIC Oct 15 indication

Hodgkin lymphoma in brentuximab Unlicensed NSRIC Oct 15 treated patients – second-line indication

Hodgkin lymphoma in brentuximab Unlicensed NSRIC Oct 15 naïve patients – second-line indication

Recurrent or metastatic squamous Unlicensed cell carcinoma of the head and neck – NSRIC Oct 15 indication second-line

Diffuse large B cell lymphoma – Unlicensed NSRIC Oct 15 second-line indication

SMC due Mar 16 Nivolumab (In production) Advanced melanoma – monotherapy Launched NICE due Feb 16 (In production)

Advanced or metastatic clear-cell Unlicensed renal cell carcinoma – second- or NSRIC Dec 14 indication third-line

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

BRAF V600 mutation-positive Launched NSRIC Dec 14 advanced melanoma – first-line

BRAF V600 mutation-negative Launched NSRIC Dec 14 advanced melanoma – first-line

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

SMC due May 16 Non-small cell lung cancer – second- New indication (In production) line NSRIC Sep 13

Obeticholic acid Primary biliary cirrhosis – second-line Not launched NSRIC Nov 13

Indolent non-Hodgkin lymphoma, in Unlicensed combination with chemotherapy – NSRIC Aug 15 indication first-line

Chronic lymphocytic leukaemia in Unlicensed combination with bendamustine ─ NSRIC Jan 16 indication first-line

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

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

CD20-positive diffuse large B-cell Unlicensed lymphoma, in combination with CHOP NSRIC Mar 14 indication – first-line

Reviewer / Tariff Drug name Indication Status publication date excluded

Relapsing-remitting multiple sclerosis Not launched NSRIC Aug 14 Ocrelizumab YES Primary progressive multiple sclerosis Not launched NSRIC 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 NSRIC 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 NSRIC Nov 13 leukaemia indication

Relapsed diffuse large B-cell Unlicensed NSRIC Apr 13 lymphoma indication Launched NICE Jan 16 Relapsed platinum-sensitive ovarian Olaparib SMC Jul 15 cancer Launched NSRIC Jun 13

Advanced soft tissue sarcoma in Olaratumab Not launched NSRIC Oct 15 combination with doxorubicin

Olesoxime Spinal muscular atrophy – first-line Not launched NSRIC Sep 13 YES 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 NSRIC Mar 14 gastro-oesophageal junction cancer Onartuzumab Metastatic Met-positive non-small cell Not launched NSRIC 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 Cystic fibrosis in patients aged 12 years or older who are homozygous SMC due May 16 Orkambi (lumacaftor Not launched for the F508del mutation in the CFTR (In production) YES and ivacaftor) gene.

Cystic fibrosis – first-line Not launched NSRIC Jan 14

Reviewer / Tariff Drug name Indication Status publication date excluded Prostate cancer, metastatic hormone- Orteronel Not launched NSRIC Apr 13 YES relapsed, following chemotherapy

Treatment of acute bacterial skin and SMC due TBC Oritavancin Launched skin structure infections in adults (In production)

AWMSG due TBC (In production) Oseltamivir Influenza in children <1 year of age Launched SMC due Mar 16 (In production)

Vulvo-vaginal atrophy in Ospemifene Not launched NSRIC Jan 13 postmenopausal women

Otovent Auto-inflation device for glue ear Launched UKMi Nov 14

NICE due Apr 16 Ovarian cancer – advanced, recurrent Launched (In production) YES Paclitaxel Locally advanced or metastatic Unlicensed bladder cancer with cisplatin and LCNDG Mar 13 indication gemcitabine

Advanced ovarian cancer – Not launched NSRIC Jan 14 maintenance therapy Paclitaxel

polyglutamate Glioblastoma in combination with temozolamide and radiotherapy – Not launched NSRIC Sep 13 first-line

Pacritinib Myelofibrosis Not launched NSRIC Feb 14

Padeliporfin Localised prostate cancer – first-line Not launched NSRIC Feb 15 Advanced or metastatic ER- positive/HER2-negative, breast Not launched NSRIC Jul 15 cancer – second-line

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

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

Wild-type RAS metastatic colorectal Panitumumab cancer – first-line in combination with Launched SMC Jul 15 chemotherapy

Multiple myeloma – second line Launched NICE Jan 16

Multiple myeloma – relapsed and/or Panobinostat SMC due Feb 16 refractory, in combination with Launched (In production) bortezomib and dexamethasone

Reviewer / Tariff Drug name Indication Status publication date excluded AWMSG due TBC Pasireotide Acromegaly in adults New indication (In production) YES SMC Sep 15

Patiromer Hyperkalaemia – first-line Not launched NSRIC Jul 15

Renal cell carcinoma – adjuvant Unlicensed NSRIC Sep 13 therapy indication Pazopanib YES Soft tissue sarcoma – second or New indication AWMSG Dec 13 subsequent line

Pegaspargase Acute lymphoblastic leukaemia Not launched NSRIC 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 NSRIC Aug 14 YES 1a

Wet age-related macular Pegpleranib Not launched NSRIC Jan 16 degeneration (AMD)

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 NSRIC Aug 15 combination with chemotherapy – Pelareorep second-line Metastatic malignant melanoma, with or without chemotherapy – second- Not launched NSRIC Aug 15 line

Advanced or metastatic urothelial Unlicensed NSRIC Oct 15 cancer – second-line indication

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

Unresectable or metastatic melanoma SMC Nov 15 Pembrolizumab in patients not previously treated with Launched ipilimumab NICE Nov 15

SMC Nov 15 Unresectable or metastatic melanoma in patients previously treated with Launched NICE Oct 15 ipilimumab NSRIC Jul 13

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

Pentosan polysulphate Unlicensed Interstitial cystitis NICE-ES Apr 15 sodium indication

Acute uncomplicated influenza in Peramivir Not launched NSRIC Oct 14 adults

Reviewer / Tariff Drug name Indication Status publication date excluded Adjuvant treatment of primary Unlicensed NSRIC Mar 14 generalised tonic-clonic seizures indication

Perampanel Partial-onset seizures, with or without MTRAC Apr 16 secondarily generalised seizures, in (In production - update) Launched patients with epilepsy aged 12 years and older MTRAC Sep 13

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, SMC due Mar 16

inflammatory or early breast cancer – (In production) New indication neo-adjuvant in combination with trastuzumab and docetaxel NSRIC Feb 14

Mild foot infection in patients with Pexiganan Not launched NSRIC Jan 16 diabetic foot ulcers

Psychosis associated with Pimavanserin Not launched NSRIC 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 NSRIC 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 Relapsed and refractory multiple Not launched NSRIC Oct 15 myeloma – fourth-line Plitidepsin In combination with dexamethasone Not launched NSRIC Jun 13 for multiple myeloma – third-line AWMSG Sep 15

NICE Mar 15

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

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 NSRIC Sep 13

SMC Jul 15 Posaconazole Fungal infections in adults Launched YES SMC Oct 14

Familial chylomicronaemia syndrome Pradigastat Not launched NSRIC 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 NSRIC Jan 13

Pridopidine Huntington’s disease Not launched NSRIC Oct 15

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

Symptomatic treatment of chronic constipation in adults in whom AWMSG due TBC New indication laxatives fail to provide adequate (In production) Prucalopride relief

Chronic constipation in men – LMEN Dec 15 New indication third-line NSRIC Oct 14

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)

Bone metastases in patients with Launched NICE Jan 16 Radium-223 dichloride castration-resistant prostate cancer Launched SMC Oct 15 AWMSG Dec 15

HIV-1 infection in adults, adolescents, SMC Nov 15 children, toddlers and infants from the Launched (Chewable tablets) age of four weeks Raltegravir SMC Nov 15 YES (Granules)

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 NSRIC Dec 14 second-line indication

Locally advanced or metastatic non- Unlicensed small cell lung cancer – second-line, NSRIC Dec 14 indication in combination with docetaxel

Advanced gastric cancer and gastro- oesophageal junction Ramucirumab adenocarcinoma after prior New indication NSRIC Mar 14 chemotherapy, in combination with paclitaxel

Unlicensed Hepatocellular cancer – second-line NSRIC Nov 13 indication

Advanced gastric cancer and gastro- Launched NICE Jan 16 oesophageal junction adenocarcinoma – second-line Launched NSRIC Sep 13

Choroidal neovascularisation and Unlicensed NSRIC 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) Wet age-related macular oedema, Ranibizumab biosimilar diabetic macular oedema and retinal Not launched LMEN Dec 15 (PF582) oedema Metastatic colorectal cancer, in adults previously treated with, or who are not New indication SMC Nov 15 considered candidates for, available therapies

Regorafenib Hepatocellular carcinoma – second- Unlicensed NSRIC Oct 15 line indication

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

Reviewer / Tariff Drug name Indication Status publication date excluded MTRAC Jan 15

UKMi Jan 15

AWMSG Aug 14 Asthma Launched SMC Jun 14

NICE-ES Mar 14

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

Chronic obstructive pulmonary UKMi Jan 15 Launched disease AWMSG May 14

SMC Apr 14

NICE-ES Jun 13

Steroid-refractory acute graft versus Remestemcel-L Not launched NSRIC Oct 15 host disease – second-line

Reslizumab Eosinophilic asthma Not launched NSRIC Apr 15

Resperate device Hypertension Launched UKMi May 13

Rezolsta (darunavir HIV-1 infection in patients aged at AWMSG Sep 15 Launched YES and cobicistat) least 18 years SMC Aug 15

rhNGF Neurotrophic keratitis – first-line Not launched NSRIC Oct 15

Chronic hepatitis C in children and Ribavirin young people – with peginterferon New indication NICE Nov 13 YES alfa

Advanced hormone receptor positive, Ribociclib HER2 negative breast cancer – first- Not launched NSRIC Oct 15 line

UKMi Apr 13 Travellers' diarrhoea Launched (Xifaxanta)

NICE Mar 15

Reduction in recurrence of overt MTRAC Jan 14 Rifaximin Launched 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 NSRIC May 14 YES line

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

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

Reviewer / Tariff Drug name Indication Status publication date excluded

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

Rituximab NICE-ES Oct 14 YES

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

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

SMC Jul 15

NICE Mar 15

Prevention of atherothrombotic events RDTC Oct 14 Rivaroxaban New indication after acute coronary syndromes (Update) 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

Non-small cell lung cancer, advanced Rociletinib or recurrent with EGFR T790M Not launched NSRIC Feb 15 mutation

NICE Sep 15 Polycythaemia vera – second-line New indication NSRIC Apr 13

NICE due Mar 16 Ruxolitinib (In production) YES Disease-related splenomegaly or Launched SMC Mar 15 symptoms in adults with myelofibrosis NICE Jun 13

RDTC Jan 13

MTRAC due TBC Symptomatic chronic heart failure with (In production) Sacubitril valsartan Launched reduced ejection fraction in adults SMC due Mar 16 (In production)

MTRAC due TBC 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 NSRIC Apr 15 arthritis

Reviewer / Tariff Drug name Indication Status publication date excluded

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

NICE due Jun 16 Sebelipase alfa Lysosomal acid lipase deficiency Launched (In production)

SMC due TBC Ankylosing spondylitis – second line (In production) after DMARDs and TNF-alpha New indication inhibitors NICE due Oct 16 Secukinumab (In production) YES

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

KRAS mutation-positive advanced Selumetinib non-small cell lung cancer – second- Not launched NSRIC Oct 15 line

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

Pulmonary arterial hypertension in Unlicensed NICE-ES due Mar 16 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 NSRIC 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

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

Sirolimus intravitreal Chronic non-infectious posterior Not launched NSRIC Jan 13 (Opsiria) segment uveitis – first or second-line

Sirukumab Rheumatoid arthritis Not launched NSRIC Aug 15

SMC Sep 15 Sitagliptin Type 2 diabetes Launched MTRAC May 14

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

Reviewer / Tariff Drug name Indication Status publication date excluded

Sodium zirconium Hyperkalaemia – first-line Not launched NSRIC Apr 15 cyclosilicate

NICE Feb 15 Sofosbuvir Chronic hepatitis C Launched YES SMC Jun 14

Sofosbuvir plus Unlicensed Chronic hepatitis C NSRIC Feb 15 GS-5816 formulation

Sonidegib (formerly Locally advanced or metastatic basal AWMSG Dec 15 Not launched erismodegib) cell carcinoma NSRIC Jan 13 AWMSG due TBC Launched (In production) Hepatocellular carcinoma SMC Jan 16 Launched (Resubmission) Sorafenib YES Progressive, locally advanced or metastatic, differentiated thyroid New indication SMC Jul 15 carcinoma, refractory to radioactive iodine

Spiolto Respimat Chronic obstructive pulmonary (tiotropium and Launched SMC Nov 15 disease olodaterol)

STG 320 Allergic rhinitis Not launched NSRIC Oct 15

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

AWMSG Dec 15 Hyperphosphataemia in patients with Sucroferric chronic kidney disease who are on Launched SMC Apr 15 oxyhydroxide dialysis NICE-ES Jan 15

Acute moderate to severe post- NICE-ES due Mar 16 Sufentanil Not launched operative pain in adults (In production)

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 NSRIC 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 – Launched SMC Oct 15 and metformin) second-line

Tabalumab Systemic lupus erythematosus Not launched NSRIC May 14 YES

Prophylaxis and treatment of kidney AWMSG Sep 15 Tacrolimus Launched or liver allograft rejection in adults SMC Apr 15

Reviewer / Tariff Drug name Indication Status publication date excluded Duchenne muscular dystrophy New indication NSRIC 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

Locally advanced and/or metastatic Talazoparib breast cancer with germline BRCA 1/2 Not launched NSRIC Oct 15 positive mutation

Tapentadol Chronic pain Launched RDTC Jan 15

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

Targinact (oxycodone Restless legs syndrome New indication NICE-ES Dec 15

and naloxone) Chronic pain Launched RDTC Jan 15 Non-24-hour sleep-wake disorder in Tasimelteon Not launched AWMSG Dec 15 totally blind adults Chemotherapy-naïve, metastatic Tasquinimod Not launched NSRIC Dec 14 hormone-relapsed prostate cancer

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

Nosocomial pneumonia caused by SMC Nov 14 Telavancin Launched MRSA in adults NICE-ES Jul 14

Tempe (lidocaine and RDTC Oct 15 Premature ejaculation Not launched prilocaine spray) (Update)

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 NSRIC Jul 15

Reviewer / Tariff Drug name Indication Status publication date excluded

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

NTAG Jun 15 Atypical bisphosphonate-induced Unlicensed Teriparatide Appraisal report YES fractures indication Recommendation

Locally advanced or metastatic Tertomotide Not launched NSRIC 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 NSRIC Aug 14

Complicated intra-abdominal, skin and soft tissue infections, excluding Tigecycline Launched SMC Sep 15 diabetic foot infections, in children aged over 8 years Prevention of thombotic events in Unlicensed patients with acute ischaemic stroke NSRIC Apr 15 indication or high risk transient ischaemic attack Ticagrelor Prevention of cardiovascular disease Unlicensed events in patients with prior NSRIC Jul 13 indication myocardial infarction

Tildrakizumab Moderate-to-severe plaque psoriasis Not launched NSRIC 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 AWMSG Dec 15 Tinzaparin thromboembolism in patients with New indication solid tumours SMC Jul 15

AWMSG due TBC

(In production)

SMC Aug 15 Tiotropium (Spiriva Asthma New indication Respimat) MTRAC Mar 15

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

Tocilizumab Juvenile idiopathic polyarthritis – New indication NSRIC Jan 16 YES subcutaneous second-line

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

AWMSG May 14 Juvenile idiopathic arthritis New indication SMC Jan 14

UKMi Dec 13

NICE Jan 16 Launched (Update)

LMEN Sep 14 Tocilizumab Rheumatoid arthritis YES (SC preparation) Launched 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 NSRIC Feb 14 line indication

Psoriatic arthritis – second or Not launched NSRIC Jul 15 subsequent line

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

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

Kidney disease, autosomal dominant Launched SMC Jan 16 Tolvaptan polycystic Launched NICE Oct 15

NICE due Apr 16 Topotecan Ovarian cancer – advanced, recurrent Launched (In production)

NICE due Apr 16 Trabectedin Ovarian cancer – advanced, recurrent Launched YES (In production)

HER2 positive metastatic adenocarcinoma of the stomach or SMC Oct 15 Trastuzumab gastro-oesophageal junction, in New indication YES (Resubmission) combination with capecitabine or 5- fluorouracil and cisplatin – first-line

HER2-positive, unresectable locally NICE Dec 15 Launched Trastuzumab advanced or metastatic breast cancer SMC Oct 14 YES emtansine (Kadcyla) HER2-positive locally advanced or Unlicensed NSRIC Nov 13 metastatic relapsed gastric cancer indication

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

Elevated intraocular pressure in AWMSG Nov 15 patients aged two months to <18 Travoprost New indication years with ocular hypertension or SMC Oct 15 paediatric glaucoma

Recurrent epithelial ovarian, fallopian Trebananib Not launched NSRIC 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

Reviewer / Tariff Drug name Indication Status publication date excluded

Triamcinolone Juvenile idiopathic arthritis Launched SMC Nov 15 hexacetonide

Premenopausal women with early Unlicensed NSRIC Jan 16 Triptorelin (Decapeptyl endocrine-responsive breast cancer indication SR) Prostate cancer New indication NICE-ES Jan 14

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 NSRIC Apr 13 first-line Post-coital contraception for patients NTAG Sep 14 - update Launched who present between 72 and 120 Appraisal report (ellaOne) hours Recommendation

AWMSG due TBC Intermittent treatment of moderate-to- Launched (In production) severe symptoms of uterine fibroids in (Esmya) Ulipristal adult women of reproductive age SMC due Feb 16 (In production)

Launched LMEN Jan 16 (Esmya) Pre-operative treatment of moderate- to-severe uterine fibroids Launched AWMSG Aug 13 (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

UKMi Sep 15

Chronic obstructive pulmonary NICE-ES Jan 15 Umeclidinium Launched disease AWMSG Jan 15

SMC Dec 14

Treatment of hepatobiliary disorders AWMSG due TBC associated with cystic fibrosis in Launched Ursodeoxycholic acid (In production) children aged 1 month to 18 years (Ursofalk) Primary biliary cirrhosis and for Launched SMC Aug 13 dissolution of gallstones

Reviewer / Tariff Drug name Indication Status publication date excluded Unlicensed Crohn’s disease NSRIC Oct 14 indication

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

AWMSG due TBC New indication (In production) Plaque psoriasis in adolescents New indication SMC Jan 16

New indication NSRIC 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 – NSRIC 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 NSRIC Jan 13 bullosa –second-line NICE Aug 15

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

NSRIC 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

NSRIC Apr 13

Velaglucerase alfa Type 1 Gaucher disease Launched AWMSG Jul 14 YES

Secondary hyperparathyroidism – Velcalcetide Not launched NSRIC Feb 14 first-line

Metastatic BRAF V600 mutation- Unlicensed positive melanoma in children and NSRIC Jul 15 indication Vemurafenib adolescents YES BRAF V600 mutation-positive SMC Dec 13 Launched unresectable or metastatic melanoma (Resubmission)

Chronic lymphocytic leukaemia with Venetoclax Not launched NSRIC Oct 15 17p deletion or TP53 mutation

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

Reviewer / Tariff Drug name Indication Status publication date excluded

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 Launched NICE Nov 15 combination with or without dasabuvir

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

Elderly patients with newly-diagnosed CD20 positive diffuse large B-cell Not launched NSRIC Oct 15 Vincristine liposomal lymphoma in combination with

(Marqibo) chemotherapy – first-line Relapsed or refractory acute Not launched NSRIC Oct 15 lymphoblastic leukaemia – third-line

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) Acute myeloid leukaemia in patients Volasertib ineligible for intensive induction Not launched NSRIC Apr 13 therapy – first-line

Reduce atherothrombotic events after NICE due TBC Voraxapar a myocardial infarction or in peripheral Not launched (In production) vascular disease

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

SMC due Jul 16 Vortioxetine Major depressive disorder Launched (In production) NICE Nov 15

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

Reviewer / Tariff Drug name Indication Status publication date excluded

AWMSG Nov 15

Xultophy (insulin SMC Oct 15 degludec and Type 2 diabetes mellitus Launched liraglutide) NICE-ES Jul 15

RDTC May 15

AWMSG due TBC Complicated intra-abdominal Zerbaxa (ceftolozane (In production) infections and Complicated urinary Launched and tazobactam) tract infections in adults SMC due May 16 (In production)

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 NSRIC 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]