May 2013 Number 125 New product evaluations - a resource for medicines management North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]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 drug 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 12 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. NeLM: If the review is a ‘pre launch review’ you will be prompted to enter your NeLM username and password. If you do not have a NeLM username and password you can register by following this link: click here to register. Registration is free and available to NHS staff. 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 LCNDG – London Cancer New Drugs Group LNDG – London New Drugs Group MTRAC – Midland Therapeutic Review & Advisory Committee NETAG – North East Treatment Advisory Group NICE – National Institute for Health and Care Excellence NICE-MPC – NICE Medicines & Prescribing Centre NHSC – NIHR Horizon Scanning Centre RDTC – Regional Drug & Therapeutics Centre SMC – Scottish Medicines Consortium 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. PbR excluded drugs This column indicates which drugs appear on the 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.
Transcript
May 2013 Number 125
New product evaluations - a resource for medicines management
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
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 drug 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 12 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. NeLM: If the review is a ‘pre launch review’ you will be prompted to enter your NeLM username and password. If you do not have a NeLM username and password you can register by following this link: click here to register. Registration is free and available to NHS staff. 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 Excellence
NICE-MPC – NICE Medicines & Prescribing Centre
NHSC – NIHR Horizon Scanning Centre
RDTC – Regional Drug & Therapeutics Centre
SMC – Scottish Medicines Consortium
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. PbR excluded drugs This column indicates which drugs appear on the 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 8117 E-mail: [email protected]
Number 125
The evaluations:
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Abatacept Rheumatoid arthritis after failure of conventional disease-modifying anti-rheumatic drugs
Launched
SMC Apr 13 (Resubmission) YES
NICE Apr 13
Abatacept (sub-cutaneous)
Moderate to severe active rheumatoid arthritis in adults
Launched SMC due Aug 13
(In production) YES
Abiraterone
Asymptomatic or mildly symptomatic prostate cancer, after failure of androgen deprivation therapy, when chemotherapy is not yet clinically indicated
New indication SMC May 13
New indication LCNDG Jan 13
Metastatic, castration-resistant prostate cancer
Launched
SMC Aug 12 (Resubmission)
NICE Jun 12
Abraxane (nab-paclitaxel)
Breast cancer as a substitute for docetaxel/paclitaxel
Unlicensed indication
LCNDG Jan 13
YES
Metastatic pancreatic cancer – first-line in combination with gemcitabine
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Aflibercept
Metastatic colorectal cancer in adults that is resistant to, or has progressed after, an oxaliplatin-containing regimen
Launched SMC due Jul 13 (In production)
Age-related macular degeneration Launched
SMC Apr 13
YES
LNDG due TBC (In production)
NETAG Jan 13 Appraisal report
Recommendation
Alirocumab LDL-C reduction and/or treatment of hypercholesterolaemia
Not launched NHSC Nov 12
Alogliptin Type 2 diabetes Not launched NICE-MPC May 13
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Bevacizumab
In combination with paclitaxel for breast cancer
New indication LCNDG due TBC
(In production)
YES First-line treatment of metastatic breast cancer when other chemotherapy options are not considered appropriate – in combination with capecitabine
New indication
NICE Aug 12
SMC May 12
Diabetic macular oedema Unlicensed indication
NETAG Jul 12 Appraisal report
Recommendation
Bicalutamide Prostate cancer Launched MTRAC Jul 12
(Update)
Bimatoprost solution in single-dose container (Lumigan UD)
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults
Launched SMC Mar 13
Bitopertin Schizophrenia Not launched NHSC Jun 12
Bortezomib
Newly-diagnosed mantle cell lymphoma
Unlicensed indication
NHSC Sep12
YES
Relapsed multiple myeloma in combination with dexamethasone or pegylated liposomal doxorubicin
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Cabazitaxel Hormone-refractory prostate cancer Launched NICE May 12 YES
Caffeine citrate (Peyona)
Primary apnoea of premature newborns
Launched SMC due Sep 13 (In production – resubmission)
Launched SMC Oct 12
Calcium polystyrene sulphonate (Sorbisterit)
Hyperkalaemia, in patients with acute and chronic renal insufficiency, including patients undergoing dialysis treatment
Launched SMC due Aug 13
(In production)
Cangrelor
Prevention of coronary thrombosis in patients undergoing cardiovascular surgery
Not launched NHSC Apr 13
To reduce platelet aggregation and thrombosis in patients undergoing percutaneous coronary intervention
Not launched NHSC Nov 12
Carfilzomib Multiple myeloma – third-line Not launched NHSC Sep 12
Ceftaroline
Complicated skin and soft tissue infections
Launched SMC Jan 13
Community-acquired bacterial pneumonia
Launched LNDG Sep 12
Certolizumab Rheumatoid arthritis Launched RDTC May 13 YES
Chloroprocaine hydrochloride (Ampres)
Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes
Not launched SMC due Aug 13
(In production)
Ciclosporin A (Cyclokat)
Keratoconjunctivitis sicca Not launched NHSC Jun 12
Cinryze (C1 inhibitor)
Treatment and prevention of angioedema attacks in adults and adolescents with hereditary angioedema
Launched AWMSG Feb 13
Cisplatin (liposomal)
Pancreatic cancer in combination with gemcitabine – first-line
Not launched NHSC Sep 12
(Lipoplatin) YES
Advanced non-small cell lung cancer – first-line
Not launched NHSC Sep 12 (Nanoplatin)
Clonidine Attention deficit hyperactivity disorder in children and young people
Unlicensed indication
NICE-MPC Mar 13
Clostridium botulinum toxin A (Dysport)
Treatment of focal spasticity, including arm symptoms, in conjunction with physiotherapy
Launched SMC Jan 13 YES
Colecalciferol Vitamin D insufficiency in adults and elderly
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Colestilan Hyperphosphataemia in adults with chronic kidney disease on dialysis
Not launched UKMi due TBC (In production)
Colistimethate Pseudomonas lung infection in cystic fibrosis
Launched NICE Mar 13 YES
Collagenase clostridium histolyticum
Dupuytren’s contracture Launched SMC May 12
(Resubmission) YES
Conestat Acute angioedema attacks in adults with hereditary angioedema due to C1 esterase inhibitor deficiency
Launched LNDG Jun 12 YES
Crizotinib Non-small cell lung cancer – second-line
Launched SMC May 13
Launched LCNDG Nov 12
Dabigatran Prevention of stroke and systemic embolism in adults with atrial fibrillation
New indication MTRAC May 12
Dacomitinib Advanced or metastatic non-small cell lung cancer – second- or third-line
Not launched NHSC Nov 12
Dapagliflozin Type 2 diabetes
Launched NICE due Jun 13
(In production)
Launched MTRAC Feb 13
Launched
SMC Jan 13
RDTC Dec 12
LNDG Nov 12
Dapoxetine Premature ejaculation Not launched RDTC Oct 12
Darunavir
HIV infection in adults and antiretroviral-experienced children aged at least three years and weighing at least 15kg
New indication SMC Apr 13
YES
HIV infection in antiretroviral therapy-experienced adults
Launched AWMSG Jul 12
Dasatinib Imatinib-resistant, Philadelphia positive acute lymphoblastic leukaemia
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Desmopressin Nocturia and nocturnal polyuria in men with lower urinary tract symptoms
Unlicensed indication
NICE-MPC Apr 13
Dexamethasone intravitreal implant (Ozurdex)
Diabetic macular oedema – first- or second-line
Unlicensed indication
NHSC Jun 12
YES Macular oedema secondary to central or branch retinal vein occlusion
Launched SMC Jun 12
(Resubmission)
Dexamethasone intraocular injection (Verisome)
Prevention and treatment of post-ocular surgery inflammation
Not launched NHSC Jan 13
Dexmedetomidine
Sedation of adult ICU patients requiring a sedation level not deeper than arousal in response to verbal stimulation
Launched
AWMSG Jul 12
SMC Jun 12
Dexpramipexole Amyotrophic lateral sclerosis Not launched NHSC Jul 12
Diltiazem 2% topical Chronic anal fissure Not launched NICE-MPC Jan 13
Dimethyl fumarate (Tecfidera)
Relapsing remitting multiple sclerosis Not launched SMC due Aug 13
(In production) YES
Dovitinib Metastatic renal cell carcinoma Not launched NHSC Nov 12
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Erlotinib
Non-small cell lung cancer – third- or fourth-line re-challenge
Unlicensed indication
LCNDG Sep 12
YES
Locally advanced or metastatic non-small cell lung cancer with activating EGFR mutations
New indication NICE Jun 12
Adjuvant treatment of EGFR-positive non-small cell lung cancer
Unlicensed indication
NHSC Jan 13
Eslicarbazepine Partial-onset seizures in adults Launched AWMSG Oct 12
Etanercept
Polyarthritis and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate
New indication SMC Feb 13
YES
Psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate
New indication SMC Feb 13
Enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy
New indication SMC Feb 13
Active polyarticular juvenile idiopathic arthritis in children and adolescents aged 2+ years who have had an inadequate response to, or who have proved intolerant of, methotrexate
New indication SMC May 12
Chronic severe plaque psoriasis in children and adolescents aged 6+ years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies
New indication SMC May 12
Rheumatoid arthritis Launched RDTC May 13
Etoricoxib Pain associated with dental surgery New indication SMC Jan 13
Etravirine HIV-1 infection in antiretroviral treatment-experienced patients aged six years upwards
New indication SMC due TBC (In production)
YES
Excreas (vildagliptin and metformin)
Type 2 diabetes mellitus – second-line adjunct
New indication SMC May 13
Eurartesim (dihydroartemisinin and piperaquine phosphate)
Treatment of uncomplicated Plasmodium falciparum malaria in
patients aged six months and over and weighing 5 kg or more
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Everolimus
In combination with an aromatase inhibitor for HER2 negative, oestrogen receptor positive locally advanced or metastatic breast cancer – second-line
New indication
SMC due Jul 13 (In production)
YES
NICE due Jul 13 (In production)
LCNDG Aug 12
Advanced pancreatic neuroendocrine tumours
New indication AWMSG Jul 12
SMC May 12
Advanced unresectable or metastatic neuroendocrine tumours of gastrointestinal or lung origin
Unlicensed indication
NHSC Nov 12
Eviplera (emtricitabine,
tenofovir and rilpivirine) HIV infection in adults Launched AWMSG Jul 12 YES
Exenatide twice-daily (Byetta)
Type 2 diabetes mellitus in combination with basal insulin
New indication SMC Jun 12
Faldaprevir Chronic hepatitis C infection, genotype 1, in combination with BI 207127
Not launched NHSC Nov 12 YES
Fampridine Improving walking ability in adults with multiple sclerosis
Launched MTRAC May 12 YES
Ferumoxytol
Anaemia in chronic renal disease Launched SMC Feb 13
LNDG Oct 12
Iron deficiency anaemia not associated with chronic kidney disease – first- or second-line
Not launched NHSC Jul 12
Fidaxomicin Treatment of Clostridium difficile infection
Launched
AWMSG Nov 12
SMC Jul 12
NICE-MPC Jun 12
LNDG Jun 12
Fingolimod Relapsing-remitting and primary-progressive multiple sclerosis
Launched SMC Sep 12
(Resubmission) YES
Fluocinolone intravitreal implant
Diabetic macular oedema Launched
SMC due Jun 13 (In production)
YES
NICE Jan 13
Flutiform (fluticasone and formoterol inhaler)
Treatment of asthma Launched
NICE-MPC Oct 12
SMC Oct 12
MTRAC Sep 12
Fostamatinib Rheumatoid arthritis – second-line Not launched NHSC Jun 12
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Insulin degludec Diabetes mellitus
Launched SMC Apr 13
Launched MTRAC Feb 13
Launched
NICE-MPC Nov 12 (Type 1 diabetes)
NICE-MPC Nov 12 (Type 2 diabetes)
RDTC Aug 12
Insulin detemir Diabetes mellitus in adults, adolescents and children aged two years and above
New indication (children aged 2
to 5 years) AWMSG Nov 12
New indication (children aged 2
to 5 years) SMC May 12
Insulin glargine Diabetes mellitus in adults, adolescents and children aged 2 years to less than 6 years
Launched SMC Apr 13
AWMSG Feb 13
Interferon beta-1a (Rebif)
Single demyelinating event with an active inflammatory process in patients at high risk of developing clinically definite multiple sclerosis
New indication SMC Nov 12 YES
Ipilimumab
Malignant melanoma – first-line adjuvant therapy
Unlicensed indication
NHSC Jun 12
YES
Advanced melanoma in adults who have received prior therapy
Launched
SMC Apr 13 (Resubmission)
SMC May 12
NICE Dec 12
Irinotecan (nanoliposomal)
Metastatic pancreatic cancer in patients who have progressed on prior gemcitabine-based therapy
Not launched NHSC Nov 12 YES
Ivabradine Chronic heart failure Launched NICE Nov 12
SMC Oct 12
Ivacaftor Cystic fibrosis in patients aged six years and older who have a G551D mutation in the CFTR gene
Launched
SMC due Jun 13 (In production – resubmission) YES
SMC Jan 13
Jentadueto (linagliptin
and metformin) Type 2 diabetes mellitus Launched SMC Feb 13
Lanthanum carbonate Hyperphosphataemia in chronic renal failure patients
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Lapatinib
Stage I to III HER2-positive breast cancer – adjuvant therapy in combination with, or following, trastuzumab
Unlicensed indication
NHSC Apr 13
YES
Metastatic hormone receptor-positive breast cancer which over-expresses HER2 in combination with an aromatase inhibitor – first-line
Launched NICE Jun 12
Latanoprost solution in single-dose container (Monopost)
Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension
Launched SMC due Jul 13 (In production)
Lenalidomide
Multiple myeloma after bortezomib Launched LCNDG Dec 12
YES Myelodysplastic syndromes – first-line
Unlicensed indication
LCNDG Jan 13
Lesinurad Gout Not launched NHSC Jan 13
Linaclotide Irritable bowel syndrome with constipation
Launched
SMC due Jun 13 (In production)
NICE-MPC Apr 13
RDTC Mar 13
Linagliptin Type 2 diabetes mellitus Launched AWMSG Mar 13
Launched SMC Feb 13
Lisdexamfetamine Attention deficit/hyperactivity disorder in children aged six years and over
Launched NICE-MPC May 13
Launched SMC May 13
Lixisenatide Type 2 diabetes Launched
SMC due Sep 13 (In production)
NICE-MPC Jan 13
Loxapine Acute agitation and disturbed behaviours associated with schizophrenia or bipolar disorder
Not launched LNDG Feb 13
(Link unavailable)
Not launched NICE May 13
(Terminated appraisal)
Lubiprostone
Opioid-induced constipation in patients with chronic non-cancer pain
Not launched NHSC Jul 12
Chronic idiopathic constipation Not launched NHSC Jul 12
Lurasidone Schizophrenia Not launched NICE-MPC Apr 13
Lutetium177
octreotide Neuroendocrine tumours Not launched LCNDG May 12
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Masitinib
Severe asthma Not launched NHSC Sep 12
Mastocytosis – second or subsequent line
Not launched NHSC Apr 13
Gastrointestinal stromal tumours – second-line
Not launched NHSC Jun 12
Medroxyprogesterone acetate
Long-term female contraception Launched SMC due Sep 13
(In production)
Melatonin Sleep disorders in children and young people with attention deficit hyperactivity disorder
Unlicensed indication
NICE-MPC Jan 13
Mercaptopurine oral suspension (Xaluprine)
Acute lymphoblastic leukaemia in adults, adolescents and children
Launched AWMSG Sep 12
YES
SMC Aug 12
Metformin Polycystic ovary syndrome in women not planning pregnancy
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Obinutuzumab Chronic lymphocytic leukaemia with chlorambucil – first-line
Not launched NHSC Jun 12
Ocriplasmin Vitreomacular traction Launched SMC due Sep 13
(In production) YES
Ofatumumab
Relapsed diffuse large B-cell lymphoma
Unlicensed indication
NHSC Apr 13
YES Maintenance of relapsed chronic lymphocytic leukaemia in patients responding to induction therapy
Unlicensed indication
NHSC Nov 12
Omalizumab
Severe persistent allergic asthma in patients aged six years and over
Launched NICE Apr 13
YES
Chronic spontaneous urticaria – second-line
Unlicensed indication
NHSC Sep 12
Orteronel Prostate cancer, metastatic hormone-relapsed, following chemotherapy
Not launched NHSC Apr 13
Ospemifene Vulvo-vaginal atrophy in postmenopausal women
Not launched NHSC Jan 13
Paclitaxel Locally advanced or metastatic bladder cancer with cisplatin and gemcitabine
Unlicensed indication
LCNDG Mar 13 YES
Paliperidone palmitate injection
Schizophrenia Launched AWMSG Oct 12
Palifosfamide tromethamine
Advanced soft tissue sarcoma – first-line
Not launched NHSC Jul 12
Palonosetron capsules
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults
Launched SMC Feb 13
Panitumumab Metastatic colorectal cancer – second-line
New indication LCNDG May 12 YES
Pasireotide Cushing’s disease Launched
SMC Oct 12
YES NETAG Jun 12 Appraisal report
Recommendation
Pazopanib Soft tissue sarcoma – second or subsequent line
New indication SMC Dec 12
YES
LCNDG Dec 12
Peginesatide Anaemia in chronic kidney disease – first- and second-line
Not launched NHSC Jun 12
Pegloticase Gout Not launched NICE due Jun 13
(In production) YES
Pegylated interferon alfa-2a (Pegasys)
Chronic hepatitis C in treatment-naïve children and adolescents aged five years and above
Unlicensed indication
SMC due Jun 13 (In production)
YES
Pegylated interferon alfa-2b (ViraferonPeg)
Chronic hepatitis C in children and adolescents aged three years and above
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Pemetrexed Lung cancer (non-small cell, non-squamous) - maintenance following pemetrexed and cisplatin
New indication NICE due Jul 13 (In production)
YES
Perampanel
Partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
Launched
NICE-MPC Dec 12
SMC Dec 12
NETAG Nov 12 Appraisal report
Recommendation
Pertuzumab
With docetaxel and trastuzumab for first-line HER2 positive metastatic or locally recurrent unresectable breast cancer, in patients previously untreated or who have relapsed post adjuvant treatment
Launched LCNDG Mar 13 YES
Pirfenidone Idiopathic pulmonary fibrosis Not launched
SMC due Aug 13 (In production)
YES
NICE Apr 13
Pitolisant Hypersomnia and narcolepsy in patients with Parkinson’s disease
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Raltegravir HIV-1 infections in adolescents and children from the age of 2 years
Launched SMC due TBC (In production)
YES
Ramipril oral solution Multiple indications Launched AWMSG Oct 12
Ranibizumab
Diabetic macular oedema New indication
NICE Feb 13
YES
SMC Dec 12 (Resubmission)
Macular oedema secondary to retinal vein occlusion
New indication NICE May 13
New indication SMC May 13
(Resubmission)
Ranolazine Stable angina Launched SMC Nov 12
(Independent review)
Recombinant human N-acetyl-galactosamine-6-sulfatase (rhGALNS)
Mucopolysaccharidosis type IVA – first-line
Not launched NHSC Jun 12
Resperate device Hypertension Launched UKMi May 13
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Ruxolitinib
Polycythaemia vera – second-line Unlicensed indication
NHSC Apr 13
YES
Myelofibrosis Launched
NICE due Jun 13 (In production)
SMC Apr 13
RDTC Jan 13
LCNDG Jun 12
Saxagliptin Type 2 diabetes mellitus in adults in combination with insulin (with or without metformin)
New indication AWMSG Jul 12
Sebelipase alfa Lysosomal acid lipase deficiency Not launched NHSC Jun 12
Secukinumab
Ankylosing spondylitis – second-line Not launched NHSC Nov 12
Psoriatic arthritis, active and progressive
Not launched NHSC Nov 12
Moderate to severe, active rheumatoid arthritis
Not launched NHSC Sep 12
Serelaxin Acute decompensated heart failure – in addition to IV diuretics
Not launched NHSC Jul 12
Sevikar (olmesartan and amlodipine)
Adults whose blood pressure is not adequately controlled on olmesartan and amlodipinace taken as dual-component formulation
New indication SMC Dec 12
Sildenafil Pulmonary arterial hypertension in patients aged one to 17 years
New indication AWMSG Dec 12
YES
SMC Dec 12
Simeprevir Chronic hepatitis C – first-line Not launched NHSC Sep 12
YES
Chronic hepatitis C – second-line Not launched NHSC Sep 12
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Sugammadex
Reversal of neuromuscular blockade induced by rocuronium or vecuronium (only rocuronium-induced blockade in children and adolescents)
Launched SMC Mar 13
(Resubmission)
Tadalafil
Benign prostatic hyperplasia New indication
NICE-MPC Apr 13
RDTC Apr 13
SMC Jan 13
Pulmonary arterial hypertension in adults
Launched SMC Jul 12 YES
Tafamidis
Transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment
Launched SMC May 13
Teduglutide Short bowel syndrome Not launched LNDG due TBC (In production)
YES
Tenofovir granules HIV 1 infection in paediatric patients and chronic hepatitis B infection in adolescents
Launched SMC due TBC (In production)
YES
Tertomotide Locally advanced or metastatic pancreatic cancer
Not launched NHSC Jan 13
Teysuno (tegafur, gimeracil and oteracil)
Advanced gastric cancer in combination with cisplatin
Launched LCNDG Jan 13
YES
SMC Sep 12
Thiotepa
Conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Launched SMC Jul 12 YES
Thymosin beta-4 Dry eye syndrome Not launched NHSC Jun 12
Tobramycin inhalation powder
Suppression of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children
aged six years and older with cystic fibrosis
Launched
NICE Mar 13
YES
SMC Jun 12
Tocilizumab
Rheumatoid arthritis Launched SMC Sep 12
(Resubmission) YES
Active polyarticular juvenile idiopathic arthritis – second-line
Unlicensed indication
NHSC Jul 12
Tocofersolan Vitamin E deficiency due to digestive malabsorption
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Tofacitinib
Chronic plaque psoriasis – second-line
Not launched NHSC Nov 12
YES
Rheumatoid arthritis Not launched LNDG due TBC (In production)
Trametinib V600 BRAF-positive advanced malignant melanoma in combination with dabrafenib – first-line
Not launched NHSC Sep 12
Tranexamic acid Significant haemorrhage following trauma
Unlicensed indication
NICE-MPC Oct 12
Trastuzumab
HER2-positive early breast cancer – two year regimen
Unlicensed indication
NHSC Jul 12
YES
HER2-positive early breast cancer following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Launched AWMSG May 12
HER2-positive early breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab for locally advanced (including inflammatory) disease or tumours >2cm in diameter
New indication AWMSG Sep 12
Metastatic hormone-receptor positive breast cancer which over-expresses HER2 in combination with an aromatase inhibitor – first-line
Launched NICE Jun 12
Trastuzumab emtansine
HER2-positive metastatic breast cancer in combination with pertuzumab – first-line
Unlicensed formulation
NHSC Jun 12 YES
Trastuzumab subcutaneous
Breast cancer – early and metastatic Not launched NICE-MPC Mar 13 YES
Trebananib Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
Not launched NHSC Jan 13
Triptorelin
Reversible reduction of testosterone to castrate levels in order to decrease sexual drive in adult men with severe sexual deviations
North West Medicines Information Centre, The Pharmacy Practice Unit, 70 Pembroke Place, Liverpool, L69 3GF. Editor: Justine Howard, Telephone: 0151 794 8117 E-mail: [email protected]
Number 125
Drug name Indication Status Reviewer /
publication date Tariff
excluded
Ursodeoxycholic acid (Ursofalk)
Primary biliary cirrhosis and for the dissolution of gallstones
Launched SMC due Aug 13
(In production)
Ustekinumab Psoriatic arthritis Not launched NHSC Sep 12 YES
