A
Medicine
/ ADTCDecision / Reason for consideration / Indication / Pharmacology / Decision
Abatacept (Orencia) / 06/10 / New medicine / Juvenile idiopathic arthritis / Not recommended by SMC
Aceclofenac tablets (Preservex®) / 06/96 / New medicine / NSAID / No advantages over existing therapy
Activated Charcoal (Charcodote®) / 4/00 / New formulation / Treatment of poisoning / Insufficient advantages over existing therapy
Adapalene gel (Differin®) / 05/97 / New medicine / Topical retinoid for acne / No advantages over existing therapy
Adapalene/ benzoyl peroxide (Epiduo®) / 05/11 / New medicine / Cuteanous treatment of acne vulgaris when comedones, papules and pustules are present. / Not recommended by SMC
Adenosine injection (Adenoscan®) / 10/95 / New indication / Pharmacological stress testing / No advantages over existing therapy
Agomelatine (Valdoxan®) / 12/09 / New medicine / Major depressive episodes in adults / Not recommended by SMC
Agomelatine (Valdoxan®) / 10/10
(Resub) / New medicine / Major depressive episodes in adults / Not recommended by SMC
Aliskiren (Rasilez®) / 02/09 / New medicine / Treatment of essential hypertension / Not recommended for use in NHS Scotland
Aliskiren (Rasilez®) / 02/10
(Resub) / New medicine / Treatment of essential hypertension / Not recommended for use in NHS Scotland
Alglucosidase alfa (Myozyme®) / 04/07 / New medicine / Treatment of Pompe disease / Not recommended by SMC
Agalsidase beta (Fabrazyme®) / 10/01 / New medicine / Fabry’s disease / Insufficient evidence of benefit.
Albendazole tablets (Eskazole®) / 06/93 / New medicine / Hydatid disease / Order for named patient as required
Alendronate 70mg, colecalciferol 2800iu tablet (Fosavance®) / 12/05 / New medicine / Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency / Insufficient advantages over existing therapy
Aliskiren (Rasilez®) / 06/08 / New medicine / Essential hypertension / Not recommended by SMC (non-submission)
Allergen extract of grass pollen (Grazax) / 02/08 / New medicine / Treatment of grass pollen induced rhinitis and conjunctivitis in adults / Not recommended by SMC
Amifampridine (Firdapse®) / 12/10 / New medicine / Treatment of Lambert-Easton Myasthenic Syndrome (LEMS) in adults / Not recommended by SMC
Amifostine injection (Ethyol®) / 07/95 / New medicine / To reduce neutropenia-related risk of infection in cancer patients / Insufficient information to determine place in therapy
Amisulpride (Solian®) / 02/98 / New medicine / Atypical antipsychotic for schizophrenic disorders / No advantages over existing therapy
Amlodipine & Valsartan (Exforge®) / 03/06 / New combination / Hypertension / No advantages over existing therapy
Amorolfine cream/ nail lacquer (Loceryl®) / 01/92 / New medicine / Topical antifungal / No advantages over existing therapy
Amprenavir (Agenerase®) / 12/00 / New medicine / Protease inhibitor for HIV / Insufficient advantages over existing therapy.
Anakinra (Kineret®)
/ 6/02, 8/02 / New medicine / Treatment of rheumatoid arthritis / Insufficient advantages over existing therapyApixaban (Eliquis®) / 02/12 / New medicine / Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. / Not included in the Formulary because the medicine does not represent sufficient added benefit to other comparator medicines already available in the Formulary.
Apraclonidine eye drops (Iopidine®) / 11/93 / New medicine / Control of intra-ocular pressure / No advantage, more expensive
Arbutamine injection (GenESA®) / 07/95 / New medicine / Pharmacological stress testing / No advantages over existing therapy
Aripiprazole (Abilify®) / 10/08
06/09 / New indication / Treatment of moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. / Not recommended by SMC.
Aspirin MR tablets (Disprin CV®) / 06/93 / New formulation / Antiplatelet / No advantage, more expensive
Atosiban (Tractocile®) / 8/00 / New medicine / To delay imminent pre-term birth / Insufficient advantages over existing therapy.
Atovaquone and proquanil (Malarone®) / 02/98 / New formulation / Combination product for the treatment of
P falciparum malaria / No requirement
Azelastine eye drops (Optilast®) / 6/98 / New formulation / Antihistamine for allergic conjunctivitis / No advantages over existing therapy
Aztreonam for nebulisation (Cayston®) / 02/12 / New formulation / The suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 18 years and older. / Not recommended by SMC.
B
Medicine
/ ADTCDecision / Reason for consideration / Indication / Pharmacology / Decision
Balsalazide (Colazide®) / 10/99 / New indication / Maintenance of remission in ulcerative colitis / No advantages over existing therapy
Bambuterol tablets (Bambec®) / 06/93 / New medicine / Asthma / No advantages over existing therapy
BCG (Tice Strain)(OncoTice®)
/ 06/03 / Therapeutic review / Prophylaxis and treatment of CIS and papillary tumours of the bladder. / No advantages over existing therapy.Becaplermin Gel (Regranex®) / 10/99 / New medicine / To promote granulation and healing of diabetic ulcers / Insufficient evidence of benefit
Beclometasone dipropionate 5mg tablets (Clipper) / 10/07 / New formulation / Ulcerative colitis / Not recommended by SMC
Bemiparin (Zibor®) / 10/05
10/05
08/07
12/09
10/05
10/05
08/07 / New medicine / -Prevention of thromboembolic disease in patients undergoing general surgery (with a moderate risk of venous thromboembolism)
-Prevention of thromboembolic disease in patients undergoing orthopaedic surgery (with a high risk of thromboembolism).
-Prevention of clotting in the extra-corporeal circuit during haemodialysis.
-Treatment of established deep vein thrombosis, with or without pulmonary embolism, during the acute phase / Not recommended by SMC
Insufficient advantages over existing Formulary choices.
Not recommended by SMC
Not recommended by SMC
Bendamustine (Levact®) / 05/11 / New indication / Front line treatment for multiple myeloma / Not recommended by SMC
Bendamustine (Levact®) / 05/11 / New indication / Front line treatment for indolent non-Hodgkin’s lymphoma / Not recommended by SMC
Benzoyl peroxide (Brevoxyl®) / 10/00 / New formulation / For moderate acne vulgaris / Insufficient advantages over existing therapy.
Betamethasone valerate mousse (Bettamousse®) / 08/96 / New formulation / Steroid mousse for scalp application / No advantages over existing therapy
Betamethasone valerate plaster (Betesil®)
/ 08/10 / New formulation / Treatment of inflammatory skin disorders which do not respond to treatment wit less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides. / Not recommended by SMCBevacizumab (Avastin)
/ 02/0606/06 / New medicine / In combination with intravenous 5fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan for first-line treatment of patients with metastatic carcinoma of the colon or rectum. / Not recommended by SMC
Not recommended by SMC
Bevacizumab 100mg/4ml and 400mg/16ml solution for intravenous infusion (Avastin)
/ 08/07 / New indication / First-line treatment of patients with metastatic breast cancer in combination with paclitaxel. / Not recommended by SMC (Non-submission)Bevacizumab (Avastin)
/ 12/07 / New indication / Treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. / Not recommended by SMC (Non-submission)Bevacizumab (Avastin®) / 04/08 / New Indication / In combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer. / Not recommended by SMC (non-submission)
Bevacizumab (Avastin®)
/ 06/08 / New indication / Treatment of patients with metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine-based chemotherapy / Not recommended by SMCBexarotene (Targretin®)
/ 04/02 / New medicine / Treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL). / Orphan product for use in a small number of patients under protocol as required.Bilastine (Ilaxten®)1 / 08/11 / New indication / Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria / Not recommended by SMC
Bisoprolol and hydrochlorothiazide (Monozide 10®) / 03/94 / New formulation / Hypertension / Inappropriate combination
Bivalirudin (Angiox®) / 02/05 / New medicine / Anticoagulant in patients undergoing percutaneous coronary intervention (PCI). / Not added after consultation with cardiologists
Bivalirudin (Angiox®) / 12/08 / New indication / Treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction) planned for urgent or early intervention. / Not added to Formulary.
Following consultation with the Cardiology MCN
Bivalirudin (Angiox®) / 10/10 / New indication / As an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Bivalirudin should be administered with aspirin and clopidogrel. / Not added to Formulary. No current clinical demand.
Bosentan (Tracleer®) / 06/08 / New indication / Reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. / Not recommended by SMC (non-submission)
Bosentan (Tracleer®) / 12/08 / New indication / Treatment of pulmonary arterial hypertension (PAH) WHO functional class II. / Not recommended by SMC
Due to non-submission
Botulinum Type A (Botox®) / 05/11 / New indication / Prophylaxis of headaches in adults with chronic migraines / Not recommended by SMC (non-submission)
Botulinum ToxinType A (Azzalure®) / 02/11 / New indication / For the temporary improvement in the appearance of moderate to severe glabellar lines / Not recommended by SMC (non-submission)
Botulinum ToxinType A (Vistabel®) / 02/11 / New indication / For the temporary improvement in the appearance of moderate to severe glabellar lines / Not recommended by SMC (non-submission)
Botulinum toxin type A (Bocouture®) / 05/11 / New indication / Temporary improvement in appearance of moderate to severe glabellar lines in adults / Not recommended by SMC (non-submission)
Bromfenac eye drops (Yellox®) / 11/10 / New medicine / Treatment of post-operative ocular inflammation following cataract surgery / Not recommended by SMC
BSS Plus irrigating solution / 03/95 / New formulation / Use during intra-ocular surgery / No advantages over existing therapy
Budesonide capsules (Budenofalk®) / 04/99 /
New formulation
/Induction of remission in Crohn’s disease
/Insufficient evidence of benefit
Budesonide CR caps (Entocort CR®) / 04/96 / New medicine / Mild to moderate Crohn’s disease / No advantages over existing therapyBudesonide enema (Entocort®) / 05/97 / New formulation / Steroid enema for ulcerative colitis / No advantages over existing therapy
Budesonide 2mg rectal foam (Budenofalk®) / 10/07 / New formulation / Treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon / No advantages over existing therapy
Buprenorphine transdermal patch (Transtec®)
/ 8/02 / New formulation / Moderate to severe cancer pain and severe pain which does not respond to non- opioids / Insufficient advantagesover existing therapy
Buprenorphine transdermal patch
(BuTrans) / 02/06
04/07
08/08
02/09 / New formulation / Treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics. / Not recommended by SMC
Not recommended by SMC
Not recommended by SMC
Not recommended by SMC
C
Medicine
/ ADTCDecision / Reason for consideration / Indication / Pharmacology / Decision
Calcitonin (salmon recombinant)
(Forcaltonin 100®) / 6/00 / New medicine / Hypercalcaemia of malignancy and treatment
of Paget’s disease / No advantages over
existing therapy
Calcitonin/ Salcalcitonin (Miacalcic®) / 02/06 / Formulary review / Treatment of osteoporosis / Removed as part of section review
Calcitriol capsules (Rocaltrol®) / 12/95 / New indication / For postmenopausal osteoporosis / No advantages over existing therapy
Calcitriol injection (Calcijex®) / 11/94 / New medicine / Vitamin D analogue for use in severe renal failure / No advantages over existing therapy
Calcium acetate/ magnesium carbonate (Osvaren®) / 05/11 / New combination / Treatemtn of hyperphosphataemia associated with chronic renal insufficiency in dialysis patients / Not recommended by SMC
Calcium carbonate and cholecalciferol
(Cacit D3®sachets) / 06/11 / New formulation / Vitamin D and calcium supplement for deficiency in the elderly / After consultation with the GGC osteoporosis group
Canakinumab (Ilaris®) / 12/10 / New medicine / Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg. / Not recommended by SMC
Cannabinoid (Sativex®) / 05/11 / New medicine / As add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis. / Not recommended by SMC (non-submission)
Carbetocin (Pabal) / 08/06 / New medicine / Prevention of uterine atony and excessive bleeding following delivery of the infant by Caesarean section under epidural or spinal anaesthesia / Not recommended by SMC
Carbomer 0.25% gel (Liquivisc®) / 10/05 / New medicine / Symptomatic treatment of dry eye syndrome where a carbomer product is the treatment of choice. / Not added after consultation with ophthalmologists
Carmellose sodium eye drops (Oprive®) / 06/11 / Formulary appeal / Treatmend for dry eyes / Removed from following a successful appeal for alternative preparation
Carvedilol (Eucardic®) / 2/98 / New indication / For unstable angina / No advantages over existing
therapy
Cefpirome injection (Cefrom®) / 07/95 /
New medicine
/Cephalosporin
/No advantages over existing therapy
Cefpodoxime (Orelox®) / 6/93 /New medicine
/Cephalosporin
/No advantages over existing therapy
Cefprozil (Cefzil®) / 10/98 /New medicine
/Community-acquired infection + skin infections
/No advantage over existing therapy
Celecoxib (Celebrex®) / 10/07 / New indication / ankylosing spondylitis / Not recommended by SMCCeliprolol tablets (Celectol®) / 01/92 / New medicine / -selective antagonist with mild vasodilator properties / No advantages over existing therapy
Cerivastatin tablets (Lipobay®) / 06/97 / New medicine / HMG-Co A reductase inhibitor / No advantages over existing therapy
Certoparin injection (Alphaparin®) / 06/98 / New medicine / New low molecular weight heparin / No advantages over existing therapy
Cetuximab (Erbutix®) / 02/05
10/05 / New medicine / Treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer (in combination with irinotecan) / Not recommended by SMC
Cetuximab (Erbitux) / 04/09 / New indication / Treatment of patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy / Not recommended by SMC
Cetuximab (Erbitux) / 04/09 / New indication / Treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease / Not recommended by SMC
Ciclesonide (Alvesco®) / 12/05 / New Medicine / Prophylactic treatment of persistent asthma in adults (18 years and older) / Not added following a review of inhaled corticosteroid section of Formulary by a multidisciplinary panel
Ciclesonide (Alvesco) / 06/06 / New Indication / Treatment to control persistent asthma in adults and adolescents .This submission concerns use in adolescents (aged at least 12 years and <18 years). / Not added
Ciclesonide (Alvesco®) / 12/07 / Product update / Change in license to enable use at high doses (up to 640mcg daily for up to 12 weeks) to control persistent asthma in adolescents and adults (12 years and older). / No advantages over existing therapy
Cilostazol (Pletal®) / 06/02
02/04
12/05 / New medicine / Improvement of the maximal and pain free walking distance in patients with intermittent claudication, / Insufficient advantages over existing therapy
Cinacalcet (Mimpara®) / 06/05
04/06 / New medicine / Treatment of secondary hyperparathyroidism / Not recommended by SMC
Not recommended by SMC
Cinacalcet (Mimpara®) / 10/08 / New indication / Reduction of hypercalcaemia in patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. / Not recommended by SMC (Non-submission)
Ciprofloxacin 0.3% eye drops (Ciloxan®) / 10/94 / New formulation / Superficial bacterial infections / No advantages over existing therapy
Ciprofloxacin 100mg Tablets (Ciproxin 100®) / 10/97 / New formulation / For uncomplicated urinary tract infections / Inappropriate strength and indication
Clarithromycin granules for oral suspension
(ClaroSip®) / 02/06 / New formulation / Treatment of acute and chronic infections caused by clarithromycin susceptible organisms. / Not recommended by SMC
Clindamycin vaginal cream (Dalacin®) / 3/94 / New formulation / For bacterial vaginosis / No advantages over existing therapy
Clobetasol propionate 0.05% shampoo (Etrivex®) / 02/08 / New formulation / Topical treatment of moderate scalp psoriasis in adults. / Not recommended by SMC
Clofarabine (Evoltra®) / 03/06 / New medicine / Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients / No advantages over existing therapy
Co-amoxiclav susp (Augmentin Duo®) / 02/96 / New formulation / Twice daily formulation of co-amoxiclav / No advantages over existing therapy
Cocaine Hydrochloride 10% w/v solution / 10/99 / New formulation / Local anaesthesia prior to ENT procedures / No advantages over existing therapy
Co-careldopa intestinal gel (Duodopa®) / 10/06 / New formulation / Parkinson’s disease / Not recommended by SMC
Co-codamol 15/500 (Codipar®) / 08/09 / Formulary appeal / Mild to moderate pain / Insufficient benefit over existing formulary options
Colazide capsules (Balsalazide®) / 12/97 / New medicine / 5-ASA for acute treatment of ulcerative colitis / No advantages over existing therapy
Colesevelam hydrochloride (Cholestagel) / 02/08 / New medicine / Treatment of
-primary hypercholesterolaemia, co-administered with an HMG-CoA reductase inhibitor (statin), as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients not adequately controlled with a statin alone
- as monotherapy as adjunctive therapy to diet for
reduction of elevated total and LDL- cholesterol in
patients with isolated primary
hypercholesterolaemia, in whom a statin is
considered inappropriate or is not well tolerated. / Not recommended by SMC
Colesevelam (Cholestagel®) / 02/11 / New indication / In combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia. / Not recommended by SMC (non-submission)
Conestat alfa (Ruconest®) / 10/11 / New medicine / Treatment of angioedema attacks in adults with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency / Not recommended by SMC (non-submission)
Corifollitropin alfa (Elonva®) / 08/10 / New medicine / Treatment of Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. / Not recommended by SMC
Cytarabine 50mg liposomal suspension for injection (DepoCyte®) / 06/05
08/07 / New formulation / Intrathecal treatment of lymphomatous meningitis / Not recommended by SMC
D
Medicine
/ ADTCDecision / Reason for consideration / Indication / Pharmacology / Decision
Dabigatran (Pradaxa®) / 02/12 / New indication / Prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors. See SMC review for full details. / Not included in theFormulary because the medicine does not represent sufficient added benefit to other comparator medicines already available in the Formulary.
Danaparoid sodium injection (Orgaran®) / 11/93 / New medicine / Heparanoid for prophylaxis of DVT / More expensive than LMWH
Dasatinib, 20 mg, 50 mg, 70 mg, tablets (Sprycel®) / 06/07 / New medicine / Treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. / Not recommended by SMC
Darbepoetin alfa (Aranesp®) / 06/06 / New Indication / Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. / Not recommended by SMC
Darbepoetin alfa (Aranesp®) SureClick / 06/06 / New Indication / Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. / Not recommended by SMC
Darbepoetin / 08/08 / NICE TA 142 / Cancer treatment-induced anaemia / TA142 stated that these agents should not be used for routine use for this indication except in line with the circumstances documented in the guidance
Darifenacin (Emselex®) / 1008 / Section revew / Urge incontinence / Removed from formulary following section review
Deferiprone (Ferriprox®) / 12/00 / New medicine / Iron overload in thalassaemia major when desferrioxamine is contraindicated / Insufficient evidence of benefit.
Deflazacort tablets (Calcort®) / 03/97 / New medicine / Conditions requiring treatment with glucocorticosteroids / No advantages over existing therapy
Denosumab (Prolia®) / 12/10 / New indication / Bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. / Not recommended by SMC
Dermamist® / 02/96 / New formulation / Topical emollient / No advantages over existing therapy
Desirudin (Revasc®) / 02/99 /
New medicine