Section 2: Cumulative list of drugs and preparations NOT ...



A

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |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|Not recommended by SMC |

| | | |and pustules are present. | |

|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 |New medicine |Major depressive episodes in adults |Not recommended by SMC |

| |(Resub) | | | |

|Aliskiren (Rasilez®) |02/09 |New medicine |Treatment of essential hypertension |Not recommended for use in NHS Scotland |

|Aliskiren (Rasilez®) |02/10 |New medicine |Treatment of essential hypertension |Not recommended for use in NHS Scotland |

| |(Resub) | | | |

|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 |12/05 |New medicine |Treatment of postmenopausal osteoporosis in patients at risk|Insufficient advantages over existing therapy |

|(Fosavance®) | | |of vitamin D insufficiency | |

|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 |Not recommended by SMC |

| | | |conjunctivitis in adults | |

|Amifampridine (Firdapse®) |12/10 |New medicine |Treatment of Lambert-Easton Myasthenic Syndrome (LEMS) in |Not recommended by SMC |

| | | |adults | |

|Amifostine injection (Ethyol®) |07/95 |New medicine |To reduce neutropenia-related risk of infection in cancer |Insufficient information to determine place in therapy |

| | | |patients | |

|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 therapy |

|Apixaban (Eliquis®) |02/12 |New medicine |Prevention of venous thromboembolic events (VTE) in adult |Not included in the Formulary because the medicine does not represent |

| | | |patients who have undergone elective hip or knee replacement|sufficient added benefit to other comparator medicines already available in|

| | | |surgery. |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 |New indication |Treatment of moderate to severe manic episodes in bipolar 1 |Not recommended by SMC. |

| |06/09 | |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. | |

|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 |No requirement |

| | | |P falciparum malaria | |

|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 |Not recommended by SMC. |

| | | |to Pseudomonas aeruginosa in patients with cystic fibrosis | |

| | | |(CF) aged 18 years and older. | |

B

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |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 |No advantages over existing therapy. |

| | | |the bladder. | |

|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 |New medicine |Prevention of thromboembolic disease in patients undergoing |Not recommended by SMC |

| |10/05 | |general surgery (with a moderate risk of venous | |

| |08/07 | |thromboembolism) |Insufficient advantages over existing Formulary choices. |

| |12/09 | |Prevention of thromboembolic disease in patients undergoing | |

| |10/05 | |orthopaedic surgery (with a high risk of thromboembolism). |Not recommended by SMC |

| |10/05 | |Prevention of clotting in the extra-corporeal circuit during| |

| |08/07 | |haemodialysis. |Not recommended by SMC |

| | | |Treatment of established deep vein thrombosis, with or | |

| | | |without pulmonary embolism, during the acute phase | |

|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 |Not recommended by SMC |

| | | |respond to treatment wit less potent corticosteroids, such | |

| | | |as eczema, lichenification, lichen planus, granuloma | |

| | | |annulare, palmoplantar pustulosis and mycosis fungoides. | |

|Bevacizumab (Avastin() |02/06 |New medicine |In combination with intravenous 5-fluorouracil/folinic acid |Not recommended by SMC |

| |06/06 | |or intravenous 5-fluorouracil/folinic acid/irinotecan for |Not recommended by SMC |

| | | |first-line treatment of patients with metastatic carcinoma | |

| | | |of the colon or rectum. | |

|Bevacizumab 100mg/4ml and 400mg/16ml solution for |08/07 |New indication |First-line treatment of patients with metastatic breast |Not recommended by SMC (Non-submission) |

|intravenous infusion (Avastin() | | |cancer in combination with paclitaxel. | |

|Bevacizumab (Avastin() |12/07 |New indication |Treatment of patients with unresectable advanced, metastatic|Not recommended by SMC (Non-submission) |

| | | |or recurrent non-small cell lung cancer other than | |

| | | |predominantly squamous cell histology. | |

|Bevacizumab (Avastin®) |04/08 |New Indication |In combination with interferon alfa-2a for the first line |Not recommended by SMC (non-submission) |

| | | |treatment of patients with advanced and/or metastatic renal | |

| | | |cell cancer. | |

|Bevacizumab (Avastin®) |06/08 |New indication |Treatment of patients with metastatic carcinoma of the colon|Not recommended by SMC |

| | | |or rectum in combination with fluoropyrimidine-based | |

| | | |chemotherapy | |

|Bexarotene (Targretin®) |04/02 |New medicine |Treatment of skin manifestations of advanced stage cutaneous|Orphan product for use in a small number of patients under protocol as |

| | | |T-cell lymphoma (CTCL). |required. |

|Bilastine (Ilaxten®)1 |08/11 |New indication |Symptomatic treatment of allergic rhino-conjunctivitis |Not recommended by SMC |

| | | |(seasonal and perennial) and urticaria | |

|Bisoprolol and hydrochlorothiazide (Monozide 10®) |03/94 |New formulation |Hypertension |Inappropriate combination |

|Bivalirudin (Angiox®) |02/05 |New medicine |Anticoagulant in patients undergoing percutaneous coronary |Not added after consultation with cardiologists |

| | | |intervention (PCI). | |

|Bivalirudin (Angiox®) |12/08 |New indication |Treatment of adult patients with acute coronary syndromes |Not added to Formulary. |

| | | |(unstable angina/non-ST segment elevation myocardial |Following consultation with the Cardiology MCN |

| | | |infarction) planned for urgent or early intervention. | |

| | | | | |

|Bivalirudin (Angiox®) |10/10 |New indication |As an anticoagulant in adult patients undergoing |Not added to Formulary. No current clinical demand. |

| | | |percutaneous coronary intervention (PCI), including patients| |

| | | |with ST-segment elevation myocardial infarction (STEMI) | |

| | | |undergoing primary PCI. Bivalirudin should be administered | |

| | | |with aspirin and clopidogrel. | |

|Bosentan (Tracleer®) |06/08 |New indication |Reduction of the number of new digital ulcers in patients |Not recommended by SMC (non-submission) |

| | | |with systemic sclerosis and ongoing digital ulcer disease. | |

|Bosentan (Tracleer®) |12/08 |New indication |Treatment of pulmonary arterial hypertension (PAH) WHO |Not recommended by SMC |

| | | |functional class II. |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 |Not recommended by SMC (non-submission) |

| | | |to severe glabellar lines | |

|Botulinum ToxinType A (Vistabel®) |02/11 |New indication |For the temporary improvement in the appearance of moderate |Not recommended by SMC (non-submission) |

| | | |to severe glabellar lines | |

|Botulinum toxin type A (Bocouture®) |05/11 |New indication |Temporary improvement in appearance of moderate to severe |Not recommended by SMC (non-submission) |

| | | |glabellar lines in adults | |

|Bromfenac eye drops (Yellox®) |11/10 |New medicine |Treatment of post-operative ocular inflammation following |Not recommended by SMC |

| | | |cataract surgery | |

|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 therapy |

|Budesonide 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 |No advantages over existing therapy |

| | | |the rectum and the sigmoid colon | |

|Buprenorphine transdermal patch (Transtec®) |8/02 |New formulation |Moderate to severe cancer pain and severe pain which does |Insufficient advantages |

| | | |not respond to non- opioids |over existing therapy |

|Buprenorphine transdermal patch |02/06 |New formulation |Treatment of severe opioid responsive pain conditions which |Not recommended by SMC |

|(BuTrans() |04/07 | |are not adequately responding to non-opioid analgesics. |Not recommended by SMC |

| |08/08 | | |Not recommended by SMC |

| |02/09 | | |Not recommended by SMC |

C

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |Decision | | | |

|Calcitonin (salmon recombinant) |6/00 |New medicine |Hypercalcaemia of malignancy and treatment |No advantages over |

|(Forcaltonin 100®) | | |of Paget’s disease |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 |Not recommended by SMC |

| | | |renal insufficiency in dialysis patients | |

|Calcium carbonate and cholecalciferol |06/11 |New formulation |Vitamin D and calcium supplement for deficiency in the |After consultation with the GGC osteoporosis group |

|(Cacit D3®sachets) | | |elderly | |

|Canakinumab (Ilaris®) |12/10 |New medicine |Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, |Not recommended by SMC |

| | | |adolescents and children aged 4 years and older with body | |

| | | |weight above 15 kg. | |

|Cannabinoid (Sativex®) |05/11 |New medicine |As add-on treatment for symptom improvement in patients with|Not recommended by SMC (non-submission) |

| | | |moderate to severe spasticity due to multiple sclerosis. | |

|Carbetocin (Pabal() |08/06 |New medicine |Prevention of uterine atony and excessive bleeding following|Not recommended by SMC |

| | | |delivery of the infant by Caesarean section under epidural | |

| | | |or spinal anaesthesia | |

|Carbomer 0.25% gel (Liquivisc®) |10/05 |New medicine |Symptomatic treatment of dry eye syndrome where a carbomer |Not added after consultation with ophthalmologists |

| | | |product is the treatment of choice. | |

|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 SMC |

|Celiprolol 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 |New medicine |Treatment of epidermal growth factor receptor-expressing |Not recommended by SMC |

| |10/05 | |metastatic colorectal cancer (in combination with | |

| | | |irinotecan) | |

|Cetuximab (Erbitux() |04/09 |New indication |Treatment of patients with EGFR-expressing, KRAS wild-type |Not recommended by SMC |

| | | |metastatic colorectal cancer in combination with | |

| | | |chemotherapy | |

|Cetuximab (Erbitux() |04/09 |New indication |Treatment of patients with squamous cell cancer of the head |Not recommended by SMC |

| | | |and neck in combination with platinum-based chemotherapy for| |

| | | |recurrent and/or metastatic disease | |

|Ciclesonide (Alvesco®) |12/05 |New Medicine |Prophylactic treatment of persistent asthma in adults (18 |Not added following a review of inhaled corticosteroid section of Formulary|

| | | |years and older) |by a multidisciplinary panel |

|Ciclesonide (Alvesco() |06/06 |New Indication |Treatment to control persistent asthma in adults and |Not added |

| | | |adolescents .This submission concerns use in adolescents | |

| | | |(aged at least 12 years and 70 years) |Not added to Formulary |

| | | | |No evidence of improved tolerability over existing Formulary choices to |

| | | | |justify the increased cost. |

|Nedocromil sodium eye drops (Rapitil®) |07/95 |New formulation |Allergic conjunctivitis |No advantages over |

| | | | |existing therapy |

|Nedocromil sodium nasal spray (Tilarin®) |12/95 |New formulation |Nasal allergy |No advantages over existing therapy |

|Nepafenac (Nevanac®) |12/09 |New medicine |Prevention and treatment of postoperative pain and |Not recommended by SMC |

| | | |inflammation associated with cataract surgery | |

|Nicardipine MR (Cardene SR®) |06/93 |New formulation |Hypertension |No advantages over existing therapy |

|Nicotinamide Gel (Papulex®) |10/95 |New formulation |Topical anti-inflammatory for acne vulgaris |No advantages over existing therapy |

|Nicotinic acid MR tablets (Niaspan®) |04/04 |New formulation |Adjunct to exercise and diet for the treatment of |Insufficient evidence of benefit; |

| |and |and |hyperlipidaemia and mixed dyslipidaemia | |

| | | | |Not recommended by SMC |

| |02/05 |Resubmission | |Not recommended by SMC |

| |02/06 |Resubmission | | |

|Nicotinic acid/ laropiprant (Tredaptive®) |05/11 |New medicine |Monotherapy of dyslipidaemia in patients in whom HMG-CoA |Not adde to Formulary following consultation wit Heart MCN. |

| | | |reductase inhibitors are considered inappropriate or not | |

| | | |tolerated. | |

|Nifedipine MR tablets (Angiopine®) |02/95 |New formulation |Modified release nifedipine preparation |No advantages over existing therapy |

|Nifedipine MR tablets (Cardilate®) |10/94 |New formulation |Modified release nifedipine preparation |No advantages over existing therapy |

|Nifedipine MR tablets (Nifelease®) |02/95 |New formulation |Modified release nifedipine preparation |No advantages over existing therapy |

|Nifedipine SR (Nifensar XL®) |06/92 |New formulation |Modified release nifedipine preparation |No advantages over existing therapy |

|Nifedipine SR (Slofedipine XL®) |02/99 |New formulation |Hypertension prophylaxis of chronic stable angina |No advantage over existing therapy |

|Nifedipine SR capsules (Coracten XL®) |04/99 |New formulation |Hypertension, prophylaxis of chronic stable angina |No advantage over existing therapy |

|Nifedipine SR tablets (Adipine MR®) |04/96 |New formulation |Modified release nifedipine preparation |No advantages over existing therapy |

|Nisoldipine SR tablets (Syscor MR®) |12/96 |New medicine |Management of hypertension and angina pectoris |No advantages over existing therapy |

|Normal immunoglobulin (Alphaglobulin®) |10/94 |New formulation |New formulation for intravenous use |No advantages over existing therapy |

|Normal immunoglobulin (Vigram S®) |06/96 |New formulation |New formulation for intravenous use |No advantages over existing therapy |

O

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |Decision | | | |

|Ofatumumab (Arzerra®) |08/10 |New medicine |Treatment of CLL in patients who are reftarctory to |Not recommended by SMC |

| | | |fludarabine and alemtuzumab. | |

|Ofloxacin eye drops (Exocin®) |04/94 |New formulation |Bacterial eye infections |No advantages over existing therapy |

|Olanzapine long ating injection (ZypAdhera®) |08/10 |New formulation |Maintenance treatment of adult patients with schizophrenia |Not recommended by SMC |

| | | |sufficiently stabilised during acute treatment with oral | |

| | | |olanzapine. | |

|Olmesartan (Olmetec®) |12/03 |New medicine |Treatment of essential hypertension. |Insufficient advantages over existing formulary choices |

|Olmesartan/ hydrochlorothiazide 20mg/12.5mg or |06/06 |New Formulation |Treatment of hypertension. |Not added |

|20mg/25 mg tablets (Olmetec Plus®) | | | | |

|Olmesartan medoximil/ amlodipine besilate |10/09 |New combination |Treatment of essential hypertension in patients whose blood |Not added to Formulary |

|(Sevikar®) | | |pressure is not adequately controlled on olmesartan | |

| | | |medoxomil or amlodipine monotherapy | |

|Olmesartan medoximil/ amlodipine besilate/ |1110 |New combination |Hypertension for patients controlled on these constituents |Not added to Formulary |

|hydrochlorothiazide (Sevikar HCT®) | | | | |

|Omega-3-acid ethyl esters (Omacor®) |10/02 |New medicine/ SMC decision |Treatment of endogenous hypertriglyceridaemia |No advantages over existing therapy. |

|Omega-3-acid ethyl esters (Omacor®) |08/09 |Formulary appeal |Secondary prevention following myocardial infraction |Unsuccessful appeal |

|Oxcarbazepine liquid (Trileptal®) |04/03 |New formulation |Epilepsy |Expensive compared with tablet. Small use expected |

|Oxycodone (Oxycontin® tablets and Oxynorm® |12/06 |Formulary appeal |Post-operative pain |No new evidence. |

|caps/liq) | | | | |

|Oxycodone and oxycodone SR |/00 |New medicine |Moderate to severe post operative pain |No advantages over existing therapy |

|(Oxynorm and Oxycontin®) | | | | |

|Oxycodone (OxyNorm®) injection |06/06 |New Indication |Treatment of post-operative pain. |Not recommended by SMC |

|Oxycodone/naloxone prolonged release tablets |04/09 |New combination |Treatment of severe pain which can be adequately managed |Not recommended by SMC |

|(Targinact®) | | |only with opioid analgesics | |

P

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |Decision | | | |

|Paclitaxel (Paxene®) |06/00 |New indication |Treatment of AIDS related Kaposi sarcoma |No advantages over existing therapy |

|Paclitaxel (Paxene®) |06/09 |New indication |Treatment of metastatic breast cancer in patients who have |Not recommended by SMC |

| | | |failed first-line treatment for metastatic disease and for | |

| |05/11 |New formulation |whom standard anthracycline containing therapy is not |Not added to Formulary following advice of the Regional Cancer Advisory |

| | | |indicated. |Group. |

|Palifermin (Kepivance®) |06/06 |New medicine |Treatment of oral mucositis in bone marrow transplantation. | |

|Paliperidone 3, 6 and 9mg prolonged release tablets|04/08 |New medicine |Treatment of schizophrenia |Not recommended by SMC |

|(Invega() | | | | |

|Paliperidone (Invega() |05/11 |New medicine |Treatment of psychotic or manic symptoms of schizoaffective |Not recommended by SMC (non-submission) |

| | | |disorder. | |

|Paliperidone (Xeplion®) |08/11 |New medicine |Maintenance treatment of schizophrenia in adult patients |Not recommended by SMC |

| | | |stabilised with paliperidone or risperidone. | |

|Pancreatin (Panzytrat®) |11/93 |New formulation |Pancreatin replacement therapy |No advantages over existing therapy |

|Panitumumab (Vectibix®) |06/08 |New medicine |Monotherapy for the treatment of EGFR expressing metatstatic|Not recommended SMC |

| | | |colorectal carcinoma |Due to non-submission |

|Panitumumab (Vectibix®) |02/12 |New medicine |Treatment of patients with wild-type KRAS metastatic |Not recommended by SMC |

| | | |colorectal cancer (mCRC) in first-line in combination with | |

| | | |FOLFOX; in second-line in combination with FOLFIRI for | |

| | | |patients who have received first-line fluoropyrimidine-based| |

| | | |chemotherapy (excluding irinotecan). | |

|Pantoprazole (Protium IV®) |04/99 |New formulation |Treatment of DU, benign GU, moderate and severe reflux |Insufficient evidence of benefit |

| | | |oesophagitis | |

|Pantoprazole tablets (Protium®) |12/96 |New medicine |Treatment of gastric and peptic ulcer |No advantages over existing therapy |

|Paracetamol and domperidone tablets |04/98 |New formulation |Combination product for the acute treatment of migraine |New formulation |

|(Domperamol®) | | | | |

|Parecoxib (Dynastat®) |2/03 |New medicine /SMC decision |Treatment of post-op pain (max 2 days) |Insufficient evidence of benefit over standard therapy. |

|Paricalcitol Injection (Zemplar() |08/06 |New medicine |Prevention and treatment of secondary hyper-parathyroidism |Not recommended by SMC |

| | | |in patients with chronic renal failure undergoing | |

| | | |haemodialysis. | |

|Paricalcitol capsules (Zemplar®) |08/08 |New formulation |Prevention and treatment of secondary hyperparathyroidism |Not recommended by SMC |

| | | |associated with chronic renal insufficiency (chronic kidney | |

| | | |disease States 3 and 4) patients and chronic renal failure |The benefits and adverse effects of paricalcitol capsules compared to other|

| | | |(CKD Stage 5) patients on haemodialysis or peritoneal |vitamin D analogues have not directly been assessed. The manufacturer did |

| | | |dialysis |not present a sufficiently robust economic analysis to gain acceptance by |

| | | | |SMC. |

|Paricalcitol injection (Zemplar®) |08/08 |New medicine |Prevention and treatment of secondary hyperparathyroidism in|Not recommended by SMC |

| | | |patients with chronic renal failure undergoing | |

| | | |haemodialysis. |The benefits and adverse effects of paricalcitol are similar to another |

| | | | |vitamin D analogue with which it has been compared. The manufacturer did |

| | | | |not present a sufficiently robust economic case to gain acceptance by SMC. |

|Pegaptanib (Macugen®) |10/09 |NICE MTA155 |Neovascular (wet) age-related macular degeneration |To be removed from Formulary following QIS and NICE recommendations |

|Pegvisomant 10mg, 15mg, 20mg powder and solvent for|04/05 |New medicine |Treatment of acromegaly |Not recommended by SMC |

|injection (Somavert®) | | | | |

|Pegvisomant 10mg, 15mg, 20mg powder and solvent for|06/06 |Resubmission |Treatment of patients with acromegaly who have had an |Not recommended by SMC |

|injection (Somavert() | | |inadequate response to surgery and/or radiation therapy. | |

|Pegylated liposomal doxorubicin (Caelyx®) |12/03 |New formulation |Metastatic breast cancer. |Insufficient advantages over existing therapy |

|Pegylated liposomal doxorubicin (Caelyx®) |10/08 |New indication |Treatment of progressive multiple myeloma in patients who |Not recommended for use in NHS Scotland |

| |08/09 | |have received at least one prior therapy and who have |The manufacturer did not present a sufficiently robust economic analysis to|

| | | |already undergone or are unsuitable for bone marrow |gain acceptance by SMC. |

| | | |transplant in combination with bortezomib. | |

|Pemetrexed (Alimta®) |06/06 |New Medicine |Treatment of patients with locally advanced or metastatic |Not recommended by SMC |

| |02/08 | |non-small cell lung cancer after prior chemotherapy. | |

|Pemetrexed (Alimta®) |10/10 |New indication |Monotherapy for the maintenance treatment of locally |Not recommended by SMC |

| | | |advanced or metastatic non-small cell lung cancer (NSCLC) | |

| | | |other than predominantly squamous cell histology in patients| |

| | | |whose disease has | |

| | | |not progressed immediately following platinum-based | |

| | | |chemotherapy. | |

| | | |First-line treatment should be a platinum doublet with | |

| | | |gemcitabine, paclitaxel or docetaxel. | |

|Pemetrexed (Alimta®) |02/12 |New indication |Monotherapy for the maintenance treatment of locally |Not recommended by SMC |

| | | |advanced or metastatic non-small cell lung cancer other than| |

| | | |predominantly squamous cell histology in patients whose | |

| | | |disease has not progressed immediately following | |

| | | |platinum-based chemotherapy. | |

|Perindopril /indapamide (Coversyl Plus®) |04/03 |New formulation |Hypertension |No advantages over existing therapy. Suitable formulary choices available |

|Perindopril arginine (Coversyl Arginine®) |06/08 |New presentation |Treatment of essential hypertension and the treatment of |Not added to the Formulary |

| | | |symptomatic heart failure |Generic preparations of the tert-butylamine salt are available at a lower |

| | | | |cost than the proprietary preparations of perindopril and there is a risk |

| | | | |of confusion associated with two salts of the same drug that are non-dose |

| | | | |equivalent being on the Formulary |

|Perindopril arginine/indapamide (Coversyl Arginine |06/08 |New presentation |Treatment of essential hypertension |Not added to the Formulary |

|Plus®) | | | |This combination has not been added because both of the constituents |

| | | | |(indapamide and perindopril arginine) are not on the Formulary. |

|Pilocarpine (Salagen®) |10/00 |New indication |For symptoms of dry eyes and mouth associated with Sjogren’s|Insufficient advantages over existing therapy. |

| | | |Syndrome | |

|Pilocarpine tablets (Salagen®) |05/95 |New medicine |Dry mouth after irradiation in head and neck cancer |No advantages over existing therapy |

|Pimecrolimus cream (Elidel®) |04/03 |New medicine/ |Treatment of mild to moderate atopic dermatitis |Insufficient evidence of benefit. |

| | |SMC decision | | |

|Pimecrolimus cream (Elidel®) |12/03 |New medicine |Short term treatment of signs and symptoms and intermittent |Not recommended by SMC |

| |08/04 |(resubmission and |long term treatment for prevention of flares of mild – | |

| | |independent panel |moderate atopic dermatitis (eczema) in patients aged 2 years| |

| | |assessment) |and over | |

|Piracetam tablets (Nootropil®) |07/93 |New medicine |Adjunctive treatment of cortical myoclonus |No evidence of major benefit |

|Piroxicam injection (Feldene®) |06/94 |New formulation |NSAID |No advantages over existing therapy |

|Piroxicam-B-cyclodextrin (Brexidol®) |08/99 |New formulation |Rheumatic and inflammatory conditions |No advantages over existing therapy |

|Porfimer sodium (Photofrin®) |10/01 |New medicine |Palliative treatment of obstructive endo-bronchial nsclc and|Insufficient evidence of benefit. |

| | | |oesophageal cancer | |

|Povidone (Oculotect®) |04/99 |New formulation |Symptomatic treatment of dry eyes |Insufficient advantages over existing therapy. |

|Prasugrel tablets (Efient®) |12/09 |New medicine |Co-administered with aspirin for the prevention of |Insufficient advantages over existing Formulary choices |

| | | |atherothrombotic events in patients with acute coronary | |

| | | |syndrome undergoing primary or delayed percutaneous coronary| |

| | | |intervention | |

|Prednisone modified-release tablets (Lodotra®) |02/12 |New formulation |Treatment of moderate to severe, active rheumatoid arthritis|Not recommended by SMC |

| | | |in adults particularly when accompanied by morning | |

| | | |stiffness. | |

|Pregabalin tablets (Lyrica®) |12/06 |New indication |Generalised Anxiety disorder | |

| | | | |Not recommended by SMC |

|Prepared coal tar 1% w/w (Exorex Lotion®) |12/98 |New formulation |Psoriasis and eczema of the skin and scalp |Insufficient advantages over existing therapy. |

|Progesterone vaginal gel (Crinone®) |02/98 |New formulation |Gel for treatment of disorders caused by progesterone |No advantages over existing therapy |

| | | |deficiency | |

|Propiverine tablets (Detrunorm®) |10/98 |New medicine |Bladder instability |No advantage over existing therapy |

|Propiverine XL (Detrunorm XL®) |06/07 |New formulation |Urinary frequency, urgency and incontinence |No advantage over existing therapy following Formulary review |

|Propofol 1% emulsion (Propofol Lipuro®) |12/03 |New formulation |Induction and maintenance of anaesthesia, alone or in |Cost benefit ratio not completely convincing. Local specialist opinion |

| | | |combination. |sought |

|Prucalopride (Resolor®) |12/10 |New medicine |Symptomatic treatment of chronic constipation in women in |Not recommended by SMC |

| |08/11 | |whom laxatives fail to provide adequate relief. | |

Q

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |Decision | | | |

|Quetiapine tablets (Seroquel®) |10/09 |New indication |Treatment of major depressive episodes in the framework of |Not recommended for use in NHS Scotland |

| | | |bipolar disorder | |

|Quetiapine tablets (Seroquel®/ Seroquel®XL) |06/11 |SMC resubmission |Treatment of major depressive episodes in bipolar disorder |Not recommended by SMC |

|Quetiapine tablets (Seroquel®XL) |11/10 |New indication |Add-on treatment of major depressive episodes in patients |Not recommended by SMC |

| | | |with Major Depressive Disorder | |

| | | | | |

|Quinapril/hydrochloro-thiazide (Accuretic®) |06/93 |New formulation |Hypertension |Fixed dose combination |

R

|Medicine |ADTC |Reason for consideration |Indication / Pharmacology |Decision |

| |Decision | | | |

|Rabeprazole (Pariet®) |02/01 |New indication |H pylori eradication |Insufficient advantages over existing therapy. |

|Rabeprazole tablets (Pariet®) |10/98 |New medicine |Treatment of active GU and DU |No advantage over existing therapy |

| |10/04 |New indication |and on demand therapy in symptomatic GORD | |

|Rabeprazole (Pariet®) |02/06 |New indication |Treatment of Zollinger-Ellison syndrome. |Not added as non-formulary drug |

|Rabbit anti-human thymocyte immunoglobulin |08/08 |New medicine |Prevention of graft rejection in renal transplantation |Not recommended by SMC |

|(Thymoglobuline®) | | | | |

|Ramipril and Felodipine (Triapin®, Triapin Mite®) |10/99 |New formulation |Hypertension |No advantages over existing therapy |

|Ranitidine bismuth citrate (Pylorid®) |10/95 |New medicine |Ulcer healing medicine |No advantages over existing therapy |

|Ranolazine (Ranexa®) |10/09 |New medicine |Add-on therapy for the symptomatic treatment of patients |Not recommended for use in NHS Scotland |

| | | |with stable angina pectoris who are inadequately controlled | |

| | | |or intolerant to first-line antianginal therapies (such as | |

| | | |beta blockers and/or calcium antagonists) | |

|Ranolazine (Ranexa®) |12/10 |New medicine |Add-on therapy for the symptomatic treatment of patients |Not recommended for use in NHS Scotland |

| | | |with stable angina pectoris who are inadequately controlled | |

| | | |or intolerant to first-line antianginal therapies (such as | |

| | | |beta blockers and/or calcium antagonists) | |

|Ranolazine (Ranexa®) |02/12 |New medicine |As add-on therapy for the symptomatic treatment of patients |Not recommended by SMC |

| | | |with stable angina pectoris who are inadequately controlled | |

| | | |or intolerant to first-line antianginal therapies (such as | |

| | | |beta-blockers and/or calcium antagonists). | |

|Rasagiline 1mg tablet (Azilect®) |04/06 |New medicine |Treatment of idiopathic Parkinson’s disease as monotherapy |Not added |

| | |New medicine (resubmission) |(without levodopa) |Not recommended by SMC |

| |12/06 | |Parkinson’s disease (monotherapy) & (adjunct therapy) | |

|Rasagiline 1mg tablet (Azilect®) |04/06 |New medicine |Treatment of idiopathic Parkinson’s disease as adjunct |Not added |

| | | |therapy (with levodopa) in patients with end of dose | |

| | | |fluctuations | |

|Reboxetine tablets (Edronax®) |08/97 |New medicine |Noradrenaline re-uptake inhibitor for depression |Insufficient information to determine place in therapy. |

|Recombinant human interferon (Immukin®) |06/93 |New medicine |Reduce frequency of serious infection in chronic |Expensive palliative therapy |

| | | |granulomatous disease | |

|Recombinant somatropin (Genotropin®) |08/96 |New indication |Recombinant growth hormone for adults with deficiency |Insufficient information at present |

|Repaglinide (NovoNorm®) |12/98 |New medicine |Treatment of type 2 diabetes |No advantage over existing therapy |

|Retapamulin (Altargo®) |04/08 |New medicine |Short term treatment of the following superficial skin |Not recommended by SMC |

| | | |infections: | |

| | | |Impetigo | |

| | | |Infected small lacerations, abrasions or sutured wounds | |

|Reviparin (Clivarine®) |04/00 |New medicine |Low molecular weight heparin |No advantages over existing therapy |

|Rimexolone eye drops (Vexol®) |02/00 |New medicine |Treatment of ocular inflammation |No advantage over existing therapy |

|Risedronate sodium (Actonel() |12/07 |New indication |Treatment of osteoporosis in men at high risk of fractures. |Not recommended by SMC (Non-submission) |

|Risedronate/ calcium carbonate & vitamin D (Actonel|06/08 |New combination |Treatment of postmenopausal osteoporosis |Not evaluated by SMC |

|Combi®) | | | | |

|Rivastigmine (Exelon() |08/06 |New indication |Treatment of mild to moderately severe dementia in patients |Not recommended by SMC |

| | | |with idiopathic Parkinson’s disease. | |

|Roflumilast (Daxas®) |10/10 |New medicine |Maintenance treatment of severe chronic obstructive |Not recommended by SMC |

| | | |pulmonary disease (COPD) (forced expiratory volume in 1 | |

| | | |second [FEV1] postbronchodilator | |

| | | | ................
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