New Product Evaluations - a Resource for Medicines Management
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August 2015 Number 152 New product evaluations - a resource for medicines management What this is: A list of new product evaluations that are freely available to NHS staff via the internet. The list is updated monthly. How to find the evaluation you want: Look at the table below. Products are listed in alphabetical order, by generic drug or device name. If a product contains two or more drugs it will be listed by brand name. If an evaluation has been produced in the last 31 months, it will say who did it and when. If an evaluation is currently ‘In production’ it will say who is doing it and when it is due. Evaluations that are highlighted in red are newly-produced evaluations that have been added to the list this month. To read the full-text evaluation: In most cases there is a direct link to the evaluation; these are available by clicking the blue hyperlink in the ‘reviewer / publication date’ column of the table. NICE: Technology appraisals are produced following a series of consultations. Information is published at specific stages of the appraisal process. If the final appraisal is not yet available, there will be a link to available interim documents. Please note that the publication date listed for these items is the anticipated publication date for the final appraisal. Who produces the evaluations? Groups included in this list that produce evaluations are: AWMSG – All Wales Medicines Strategy Group NICE – National Institute for Health and Care LCNDG – London Cancer New Drugs Group Excellence LNDG – London New Drugs Group NICE-ES – NICE Evidence Summary LMEN - London Medicines Evaluation Network NHSC – NIHR Horizon Scanning Research & MTRAC – Midland Therapeutic Review & Advisory Intelligence Centre Committee RDTC – Regional Drug & Therapeutics Centre NETAG / NTAG – North East / Northern Treatment SMC – Scottish Medicines Consortium Advisory Group UKMi – United Kingdom Medicines Information Status – what does this mean? Not launched – the product is not commercially available in the UK. Launched – the product has been launched in the UK and is licensed for the stated indication. New indication – the product has been launched in the UK and is licensed for the stated indication, but the indication stated is not the first indication for which the drug was initially licensed. Unlicensed indication – the product has been launched in the UK but is not licensed for the stated indication. Specified high cost drugs (tariff excluded) This column indicates which drugs appear on the 2015/16 list of high cost drugs exclusions or on the chemotherapy regimens list and consequently are ‘Tariff excluded’. The list is updated annually, with no in-year updates. The information in the table should be used as a guide only; drugs launched after publication of the lists may be Tariff excluded but do not appear in the list and would have to be negotiated locally. There may be drugs in this document which have yet to be launched and consequently may not appear on either list. This document does not give any indication as to potential Tariff position of new drugs. North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected] New product evaluations Number 152 The evaluations: Reviewer / Tariff Drug name Indication Status publication date excluded Postmenopausal osteoporosis – first- Abaloparatide Not launched NHSC Oct 14 and second-line Rheumatoid arthritis after failure of SMC Apr 13 conventional disease-modifying anti- Launched (Resubmission) rheumatic drugs NICE Apr 13 NICE due Oct 15 Rheumatoid arthritis Launched YES Abatacept (In production – update) Moderate-to-severe active polyarticular juvenile idiopathic New indication AWMSG Feb 14 arthritis in patients aged six years and older – second-line Abatacept (sub- Moderate-to-severe active rheumatoid Launched SMC Aug 13 YES cutaneous) arthritis in adults NICE due TBC (In production) Asymptomatic or mildly symptomatic SMC due Oct 15 prostate cancer, after failure of (In production) Abiraterone androgen deprivation therapy, when New indication YES chemotherapy is not yet clinically SMC Feb 15 indicated AWMSG Sep 14 LCNDG Jan 13 Non-small cell lung cancer in adults who are not candidates for potentially curative surgery and/or radiation New indication SMC Jun 15 therapy, in combination with carboplatin Breast cancer as a substitute for Unlicensed LCNDG Jan 13 docetaxel/paclitaxel indication Abraxane (nab- YES paclitaxel) NICE due TBC (In production) Metastatic pancreatic cancer – first- SMC Feb 15 New indication line in combination with gemcitabine (Resubmission) AWMSG Sep 14 NHSC Jan 13 Chronic obstructive pulmonary Aclidinium Launched NICE-ES Jan 13 disease Actikerall (5-fluorouracil Hyperkeratotic actinic keratosis Launched RDTC Apr 13 and salicylic acid) North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected] New product evaluations Number 152 Reviewer / Tariff Drug name Indication Status publication date excluded Active enthesitis-related arthritis in AWMSG Jun 15 New indication patients aged six years and older SMC May 15 Severe chronic plaque psoriasis in SMC Jul 15 children and adolescents – second- New indication line NHSC Dec 14 Ankylosing spondylitis and axial NICE due Oct 15 New indication spondyloarthritis (non-radiographic) (In production) Axial spondyloarthritis New indication SMC Apr 13 NICE due Oct 15 Rheumatoid arthritis Launched (In production – update) Adalimumab YES RDTC May 13 Juvenile idiopathic polyarticular AWMSG Aug 13 New indication arthritis SMC Jul 13 NICE Feb 15 Moderate-to-severe active ulcerative New indication NTAG Dec 14 colitis – second-line Appraisal report Recommendation Severe active Crohn's disease in AWMSG Aug 13 patients aged six to 17 years – New indication second-line SMC Jul 13 Cutaneous treatment of acne vulgaris Adapalene (Epiduo when comedones, papules and Launched SMC Apr 14 Gel) pustules are present Non-small cell lung cancer Launched SMC Mar 14 Locally-advanced, recurrent or Afatinib Unlicensed metastatic head and neck squamous NHSC Apr 13 indication cell carcinoma – second-line In combination with FOLFIRI AWMSG Jun 15 chemotherapy in adults with NICE Mar 14 metastatic colorectal cancer that is Launched resistant to, or has progressed after, SMC Mar 14 an oxaliplatin-containing regimen (Resubmission) LMEN Feb 15 LNDG Mar 13 Aflibercept NICE Jul 13 Age-related macular degeneration Launched SMC Apr 13 YES NETAG Jan 13 Appraisal report Recommendation Visual impairment due to macular SMC Apr 14 oedema secondary to central retinal Launched vein occlusion NICE Feb 14 North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected] New product evaluations Number 152 Reviewer / Tariff Drug name Indication Status publication date excluded Visual impairment due to macular SMC due Sep 15 oedema secondary to branch retinal New indication (In production) vein occlusion NHSC Dec 14 Aflibercept NICE Jul 15 YES Visual impairment due to diabetic LMEN Apr 15 New indication macular oedema SMC Nov 14 NHSC Jun 13 NETAG Apr 15 Airsonett laminar flow Treatment of uncontrolled allergic Launched Appraisal report device asthma Recommendation SMC due TBC Akynzeo (netupitant Chemotherapy-induced nausea and (In production) Launched and palonosetron) vomiting NICE-ES due Jan 16 (In production) SMC due TBC Albiglutide Type 2 diabetes Not launched (In production) Advanced ALK-positive, non-small Not launched NHSC Aug 15 cell lung cancer – first-line Alectinib Locally advanced or metastatic ALK- positive, non-small cell lung cancer Not launched NHSC Aug 15 following failure of crizotinib SMC Jul 14 Alemtuzumab Multiple sclerosis, relapsing-remitting Launched NICE May 14 Alicaforsen Pouchitis – second-line Not launched NHSC Nov 13 Relapsed or refractory peripheral T- Alisertib cell lymphoma – second and Not launched NHSC Mar 14 subsequent line AWMSG Oct 14 SMC Oct 14 Alogliptin Type 2 diabetes Launched (Resubmission) MTRAC May 14 NICE-ES May 13 Emphysema associated with alpha-1 Alpha-1 antitrypsin antitrypsin deficiency – maintenance Not launched NHSC Dec 14 YES (Respreeza) therapy Alpha-mannosidase, recombinant, human Alpha mannosidosis Not launched NHSC May 14 YES (Lamazym) Alprostadil cream Erectile dysfunction Launched NICE-ES Dec 14 Ameluz (5- Actinic keratosis of mild to moderate aminolaevulinic acid Launched AWMSG Dec 13 intensity on the face and scalp hydrochloride) Anorexia-cachexia in advanced non- Anamorelin Not launched NHSC Nov 13 small cell lung cancer North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8122; E-mail: [email protected] New product evaluations Number 152 Reviewer / Tariff Drug name Indication Status publication date excluded AWMSG Mar 15 Anoro Ellipta SMC Feb 15 Chronic obstructive pulmonary (umeclidinium and Launched (Resubmission) disease vilanterol) MTRAC Jan 15 NICE-ES Nov 14 NETAG Jan 13 Not launched – Anti-thymocyte globulin Appraisal report Aplastic anaemia – first-line named patient YES (horse) Recommendation only LCNDG Jan 13 Stroke prevention in patients with NICE Feb 13 New indication atrial fibrillation SMC Feb 13 Apixaban NICE Jun 15 Treatment and prevention