cummulative list april 2012 to present
TRANSCRIPT
Date Product/Manufacturer SMC Advice NHS Fife ADTC Decision Rationale
Not preferred.
Not preferred.
Not recommended
February 2012476/08
icatibant acetate, 30mg, solution for injection in pre-filled syringe (Firazyr®)Shire Human Genetic Therapies
icatibant acetate (Firazyr®) is accepted for use within NHS Scotland.
Indication under review: Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of icatibant. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland
Add to restricted list.
To be initiated by a specialist in immunology.
SMC Advice 476/08
February 2012 766/12
atorvastatin 10 and 20mg chewable tablets (Lipitor®)Pfizer Ltd
Atorvastatin chewable tablets (Lipitor®) is accepted for use in NHS Scotland
Indication under review: as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older.
Not included as medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary. Formulary choices are standard simvastatin tablets or standard atorvastatin tablets.
SMC Advice 766/12
February 2012 761/12
bupivacaine HCL 1.0mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2 microgram/mL solution for infusion (Bufyl®) Goldshield Pharmaceuticals Ltd
bupivacaine HCL 1.0mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2 microgram/mL solution for infusion (Bufyl®) is accepted for use in NHS Scotland.
Indication under review: epidural analgesia to relieve pain during labour and to control post operative pain.
Not included as medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary.
Choice in Fife for this indication would be levobupivacaine.
SMC Advice 761/12
February 2012 762/12
asenapine 5mg, 10mg sublingual tablet (Sycrest®)Lundbeck Ltd
asenapine (Sycrest®) is not recommended for use within NHS Scotland.
Indication under review: treatment of moderate to severe manic episodes associated with bipolar I disorder, in adults.
Lack of evidence of economic benefits.
SMC Advice 762/12
Not recommended
Not recommended Non-submission
Not recommended Non-submission
Not recommended Non-submission
March 2012 775/12
belimumab, 120mg and 400mg powder for concentrate for solution for infusion (Benlysta®)GlaxoSmithKline
belimumab (Benlysta®) is not recommended for use within NHS Scotland.
Indication under review: Add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity.
Lack of evidence of cost-effective benefits.
SMC Advice 775/12
March 2012 788/12
Catumaxomab (Removab®) 10 and 50 microgram concentrate for solution for infusionFresenius Biotech GmbH
catumaxomab (Removab ®) is not recommended for use within NHS Scotland.
Indication under review: Intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
SMC Advice 788/12
March 2012 787/12
everolimus (Votubia®) 2.5mg and 5mg tabletsNovartis Pharmaceuticals UK Ltd
everolimus (Votubia ®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of patients aged 3 years and older with subependymal giant cell astrocytoma.
SMC Advice 787/12
March 2012 789/12
fampridine 10mg prolonged-release tablets (Fampyra®)Biogen Idec Ltd
fampridine (Fampyra) ®) is not recommended for use within NHS Scotland.
Indication under review: Improvement of walking in adult patients with multiple sclerosis with walking disability.
SMC Advice 789/12
April 2012 777/12
everolimus, 5mg, 10mg tablets (Afinitor®)Novartis Pharmaceuticals UK Limited
everolimus (Afinitor®) is accepted for use within NHS Scotland.
Indication under review: Treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin (pNET) in adults with progressive disease.
Everolimus was superior to placebo in prolonging progression-free survival in adults with progressive, advanced pNET who were receiving best supportive care.
Approved. In addition to current treatment options.
Everolimus will be used in patients with pNETs of low-intermediate grade demonstrating either radiological or symptomatic progression over the previous 12 months. Patients should have good performance status and good organ function.
Scottish Medicines Consortium everolimus (Afinitor)
April2012 715/11
collagenase clostridium histolyticum 0.9mg powder and solvent for solution for injection (Xiapex®)Pfizer Ltd
collagenase clostridium histolyticum (Xiapex®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of Dupuytren’s contracture in adult patients with a palpable cord.
Included in the Formulary.
Alternative to limited fasciectomy in patients with moderately severe Duputyren’s Contracture.
Specialist hospital use only.
Scottish Medicines Consortium collagenase clostridium histolyticum (Xiapex)
April 2012 781/12
etanercept 10mg and 25mg powder and sterile water for solution for injection for paediatric use(Enbrel®)Pfizer Ltd
etanercept (Enbrel) is accepted for restricted use within NHS Scotland.
Indication under review: for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
SMC restriction: - The disease is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10;- The psoriasis has failed to respond to standard systemic therapies including ciclosporin,methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant to, or has a contraindication to, these treatments;- etanercept treatment should be discontinued in patients whose psoriasis has not responded adequately at 12 weeks.
Already included in the Fife Formulary.
New licensed indication noted.
Scottish Medicines Consortium etanercept (Enbrel) (Chronic Severe Psoriasis)
April 2012 782/12
etanercept 10mg and 25mg powder and sterile water for solution for injection for paediatric use (Enbrel®)Pfizer Ltd
etanercept (Enbrel®) is accepted for restricted use within NHS Scotland.
Indication under review: for the treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
SMC restriction: use within specialist rheumatology services (including those working within the network for paediatric rheumatology).
Already included in the Fife Formulary.
New licensed indication noted.
Scottish Medicines Consortium etanercept (Enbrel) (JIA)
Not Recommended
Not Recommended
April 2012 780/12
insulin detemir (Levemir®)NovoNordisk
insulin detemir (Levemir) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
SMC restriction: in patients unable to achieve good glycaemic control with established insulins.
Already included in the Fife Formulary.
New licensed indication noted.
Scottish Medicines Consortium insulin detemir (Levemir)
April 2012 778/12
bevacizumab, 25mg/mL, concentrate for solution for infusion (Avastin®)Roche Products Ltd
bevacizumab (Avastin®) is not recommended for use within NHS Scotland.
Indication under review: bevacizumab in combination with capecitabine is indicated for first-line treatment of patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.
Lack of benefits compared to cost, lack of robust economic analysis.
Scottish Medicines Consortium bevacizumab (Avastin)
April 2012 779/12
ipilimumab (Yervoy®) 5mg/mL concentrate for solution for infusionBristol-Myers Squibb
ipilimumab (Yervoy®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.
Lack of benefits compared to cost, lack of robust economic analysis.
Scottish Medicines Consortium ipilimumab (Yervoy)
May 2012 784/12
dexmedetomidine 100 micrograms/mL concentrate for solution for infusion (Dexdor®)Orion Pharma UK
dexmedetomidine (Dexdor®) is accepted for use within NHS Scotland.
Indication under review: for sedation in adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale [RASS] 0 to -3).
Included in the Formulary - Add to restricted list.
Restricted to use in patients who do not achieve adequate sedation with propofol.
Scottish Medicines Consortium dexmedetomidine hydrochloride (Dexdor)
May 2012 785/12
exenatide, 5 micrograms & 10 micrograms, solution for injection, prefilled pen (Byetta®)Eli Lilly and Company Limited
exenatide (Byetta®) is accepted for use within NHS Scotland.
Indication under review: as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults with type 2 diabetes who have not achieved adequate glycaemic control with these agents.
Already included in Fife Formulary.
New licensed indication noted.
Specialist initiation only.
Scottish Medicines Consortium exenatide (Byetta)
May 2012 783/12
tobramycin 28mg inhalation powder, hard capsules (TOBI Podhaler®)Novartis Pharmaceuticals UK Limited
tobramycin inhalation powder, hard capsules (TOBI Podhaler®) is accepted for use within NHS Scotland.
Indication under review: Suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tobramycin inhalation powder (TOBI Podhaler®). This SMC advice is contingent upon the continuing availability of the patient access scheme in Scotland.
Tobramycin already included in Fife Formulary.New formulation noted.
Use restricted to patients where tobramycin nebulised solution is unsuitable.
Hospital use only.
Scottish Medicines Consortium tobramycin inhalation powder 28mg (TOBI Podhaler)
May 2012714/11
alteplase, 10mg, 20mg, 50mg, powder and solvent for solution for injection and infusion (Actilyse®)Boehringer Ingelheim
alteplase (Actilyse®) is accepted for use within NHS Scotland.
Indication under review: the fibrinolytic treatment of acute ischaemic stroke. Treatment must be started as early as possible within 4.5 hours after onset of the stroke symptoms and after exclusion of intracranial haemorrhage.
New indication noted.
Hospital use only.
Scottish Medicines Consortium alteplase (Actilyse)
May 2012652/10
dexamethasone 700 microgram intravitreal implant (Ozurdex®)Allergan Ltd
dexamethasone intravitreal implant (Ozurdex®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion or central retinal vein occlusion.
SMC restriction: for use in adult patients with macular oedema (i) following central retinal vein occlusion (CRVO) and (ii) in patients with branch retinal vein occlusion (BRVO) who are not clinically suitable for laser treatment including patients with dense macular haemorrhage or patients who have received and failed on previous laser treatment.
Included in the Fife Formulary.
Specialist, hospital use only.
In CRVO Patients Alternative to ranibizumab in patients who would prefer less frequent administration.
In BRVO PatientsFor use in patients where laser therapy has failed or in patients where laser therapy is inappropriate i.e. patients with dense macular haemorrhage.
Scottish Medicines Consortium dexamethasone (Ozurdex)
May 2012 765/12
pregabalin oral solution (Lyrica®)Pfizer Ltd
pregabalin oral solution (Lyrica®) is accepted for restricted use in NHS Scotland
Indication under review: for the treatment of peripheral and central neuropathic pain in adults, as adjunctive therapy in adults with partial seizures with or without secondary generalization and the treatment of Generalised Anxiety Disorder (GAD) in adults.
SMC restriction: pregabalin oral solution should be prescribed only for patients who find it difficult to or are unable to swallow tablets.
The following SMC restrictions to the use of pregabalin apply: • Pregabalin is restricted to use in patients with peripheral neuropathic pain who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. Treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose.• Pregabalin is restricted to use as adjunctive therapy in adults with partial seizures with or without secondary generalisation. It should be initiated only by physicians who have appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug such as carbamazepine or sodium valproate, or for whom these drugs are unsuitable because of contra-indications, interaction or poor tolerance.
Pregabalin is not recommended for use in the treatment of Generalised Anxiety Disorder in adults as the company have not made a submission to SMC for use in this indication.
Pregabalin oral solution has been shown to be bioequivalent to pregabalin capsules.
New formulation noted.
Pregabalin is already in the Fife Formulary for use as a 3rd line option in the treatment of peripheral neuropathic pain.(after TCA, gabapentin).
The oral solution can be used as an alternative to capsules in patients with swallowing problems.
The oral solution can be considered 2nd line only in patients unable to swallow gabapentin tablets/capsules
Scottish Medicines Consortium pregabalin oral solution (Lyrica)
Not recommended.
Not recommended.
Not recommended. Non-submission by manufacturer
May 2012 786/12
belatacept powder for concentrate for solution for infusion 250mg vial and disposable syringe (Nulojix®)Bristol-Myers Squibb
belatacept (Nulojix®) is not recommended for use within NHS Scotland.
Indication under review: Belatacept, in combination with corticosteroids and a mycophenolic acid, is indicated for prophylaxis of graft rejection in adults receiving a renal transplant.
Lack of clinical benefits compared to the cost.
Lack of robust economic case.
Scottish Medicines Consortium belatacept (Nulojix)
May 2012 796/12
triptorelin pamoate (Salvacyl®) 11.25mg powder and solvent for suspension for injection Ipsen Ltd
triptorelin pamoate (Salvacyl®) is not recommended for use within NHS Scotland.
Indication under review: reversible reduction of testosterone to castrate levels in order to decrease sexual drive in adult men with severe sexual deviations.
Non-submission by manufacturer.
Scottish Medicines Consortium triptorelin pamoate (Salvacyl)
May 2012 797/12
vandetanib (Caprelsa®) 100 mg / 300mg film coated tabletsAstraZeneca UK Limited
vandetanib (Caprelsa®) is not recommended for use within NHS Scotland.
Indication under review: treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Scottish Medicines Consortium vandetanib (Caprelsa)
June 2012793/12
eplerenone 25, 50mg film-coated tablets (Inspra®)Pfizer Ltd
eplerenone (Inspra®) is accepted for use within NHS Scotland.
Indication under review: in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%).
Included in the NHS Fife Formulary - 2nd line choice in patients who are intolerant of spironolactone.
NHS Fife preferred option for this indication is spironolactone (off-label use).
Scottish Medicines Consortium eplerenone (Inspra)
June 2012 710/11
tadalafil 20mg tablets (Adcirca®)Eli Lilly and Company Limited
tadalafil (Adcirca®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adults with pulmonary arterial hypertension (PAH) classified as World Health Organisation functional class (WHO-FC) II and III, to improve exercise capacity.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tadalafil. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland
Included in the NHS Fife Formulary - restricted list.
Specialist use only by specialists working in the Scottish Pulmonary Vascular Unit.
Scottish Medicines Consortium tadalafil oral 20mg film coated tablets (Adcirca)
June 2012 791/12
fidaxomicin 200mg film-coated tablets (Dificlir®)Astellas Pharma Ltd
fidaxomicin (Dificlir®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adults with Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).
SMC restriction: Treatment of adults with a first CDI recurrence only. On the advice of local microbiologists or specialists in infectious diseases.
The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC for first-line use in adults with severe CDI.
Included in the NHS Fife Formulary - restricted list.
Use restricted to patients with a 1st recurrence of CDI only on the advice of local microbiologists or specialists in infectious disease.
Scottish Medicines Consortium fidaxomicin (Dificlir)
June 2012674/11
golimumab, 50mg, solution for injection in pre-filled pen (auto-injector) or pre-filled syringe (Simponi®)Merch Sharp & Dohme Limited
golimumab (Simponi®) is accepted for restricted use within NHS Scotland.
Indication under review: Alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Included in the NHS Fife Formulary - Add to the restricted list
Restricted to patients who have failed with Adalimumab or Etanercept and/or where the use of a once monthly injection would be advantageous to the patient/ service provider.
Hospital specialist use only.
Scottish Medicines Consortium golimumab (Simponi)
June 2012795/12
rufinamide 40mg/mL oral suspension (Inovelon®)Eisai Ltd
rufinamide 40mg/mL oral suspension (Inovelon®) is accepted for restricted use within NHS Scotland.
Indication under review: adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 4 years of age or older.
SMC restriction: restricted to use in patients who have failed treatment with or are intolerant of other antiepileptic drugs.
Included in the NHS Fife Formulary as a 3rd line treatment option for patients with swallowing problems with the tablets.
Hospital specialist initiation only.
Scottish Medicines Consortium rufinamide (Inovelon)
June 2012794/12
pegylated interferon alfa-2b 50, 80, 100, 120 or 150 micrograms powder for solution for injection in pre-filled pen (ViraferonPeg®)MSD Ltd
pegylated interferon alfa-2b (ViraferonPeg®) is accepted for use within NHS Scotland.
Indication under review: in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA.
Not included on the NHS Fife Formulary because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine
Scottish Medicines Consortium pegylated interferon alfa-2b (Viraferon Peg)
Not recommended
Not recommended Non- submission for this indication
Not recommended Non- submission
Not recommended Non- submission
June 2012 790/12
thiotepa 15mg and 100mg powder for concentrate for solution for infusion (Tepadina®)Adienne S.r.l.
thiotepa (Tepadina) is not recommended for use within NHS Scotland.
Indication under review: In combination with other chemotherapy medicinal products: 1) with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;2) when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Lack of evidence of clinical and economic benefits
Scottish Medicines Consortium thiotepa (Tepadina)
June 2012800/12
adalimumab (Humira ®) Pre-filled Pen, Pre-filled Syringe and VialAbbott Laboratories Limited
Adalimumab (Humira ®) is not recommended for use within NHS Scotland.
Indication under review: treatment of moderately active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Scottish Medicines Consortium adalimumab (Humira)
June 2012803/12
azilsartan medoxomil (Edarbi®) 20mg, 40 mg and 80mg tabletsTakeda
Azilsartan medoxomil (Edarbi®) is not recommended for use within NHS Scotland.
Indication under review: treatment of essential hypertension in adults.
Scottish Medicines Consortium azilsartan medoxomil (Edarbi)
June 2012804/12
azithromycin dihydrate (Azyter ®) 15 mg/g, eye drops, solution in single-dose containerSpectrum Thea Pharmaceuticals Limited
Azithromycin dihydrate (Azyter®) is not recommended for use within NHS Scotland.
Indication under review: Local antibacterial treatment of conjunctivitis caused by susceptible strains.
Scottish Medicines Consortium azithromycin dihydrate (Azyter)
Decision deferred
Not recommended
July 2012 764/12
abiraterone acetate 250mg tablets (Zytiga®) Janssen-Cilag Ltd
abiraterone acetate (Zytiga®) is accepted for restricted use within NHS Scotland.
Indication under review: with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
SMC restriction: abiraterone is accepted for use in patients who have received only one prior chemotherapy regimen.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of abiraterone. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Approved. Will be used in patients who have received only one prior standard docetaxel containing chemotherapy regimen.
Each patient will require LFTs and U+Es to be monitored on avg. 11 times over 8 montnhs. Vast majority will not require additional scans to monitor response as this will be measure don clinical and PSA grounds.
Scottish Medicines Consortium abiraterone (Zytiga) Resubmission
July 2012 798/12
Mercaptopurine 20mg/mL oral suspension (Xaluprine®)Nova Laboratories Limited
mercaptopurine 20mg/mL oral suspension (Xaluprine®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Mercaptopurine dosing is governed by cautiously monitoring haematotoxicity. The oral suspension and tablet formulations are not bioequivalent in terms of peak plasma concentrations and therefore careful haematological monitoring of the patient is advised on switching formulations.
Mercaptopurine oral suspension is more expensive than the tablet formulation.
Included in the Fife Formulary as an alternative to tablets in patients who are unable to swallow the tablets.
Specialist use only.
Scottish Medicines Consortium mercaptopurine (Xaluprine)
July 2012 660/10
amifampridine 10mg tablet, as phosphate (Firdapse®)BioMarin UK Ltd
amifampridine phosphate (Firdapse®) is not recommended for use within NHS Scotland.
Indication under review: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Lack of evidence of clinical benefits compared to cost of treatment
Scottish Medicines Consortium amifampridine (Firdapse)
Not recommended Non-submissionJuly 2012808/12
Rifaximin 200 mg film-coated tablets (Xifaxanta®)Norgine Limited
rifaximin 200 mg film coated tablets (Xifaxanta®) is not recommended for use within NHS Scotland.
Indication under review: treatment of travellers' diarrhoea.
Scottish Medicines Consortium rifaximin (Xifaxanta)
August 2012 801/12
colecalciferol 800 international units (equivalent to 20 micrograms vitamin D3) capsules (Fultium-D3®)Internis Pharmaceuticals Limited
colecalciferol (Fultium-D3®) is accepted for use within NHS Scotland.
Indication under review: In adults, the elderly and adolescents for the prevention and treatment of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
Included in the Fife Formulary.
Vitamin D Deficiency1st line choice for all causes of vitamin D deficiency.
Primary Hyperparathyroidism1st line choice for vitamin D insufficiency in symptomatic patients with primary hyperparathyroidism.
OsteoporosisRestricted use when calcium + vit. D products are considered unsuitable, ineffective due to non-compliance or are not tolerated.
Fife Formulary choice for calcium + vit. D products is Adcal D3®.
Scottish Medicines Consortium colecalciferol (Fultium-D3)
August 2012 763/12
fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®)Novartis Pharmaceuticals UK Ltd
fingolimod (Gilenya®) is accepted for restricted use within NHS Scotland.
Indication under review: As single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS). This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fingolimod. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Included in the Fife Formulary for restricted use only - restricted to use as single disease modifying therapy in highly active RRMS in adult patients with high disease activity despite treatment with a beta-interferon with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
Neurologist use only.
Advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland
Scottish Medicines Consortium fingolimod (Gilenya)
Not recommended.
August 2012774/12
tocilizumab, 20mg/mL, concentrate for solution for infusion (RoActemra®)Roche Products Limited
tocilizumab (RoActemra®) is accepted for restricted use within NHS Scotland.
Indication under review: Tocilizumab monotherapy is indicated in patients who are intolerant to methotrexate or where continued treatment with methotrexate is inappropriate, for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
SMC restriction: tocilizumab is restricted for use in accordance with British Society for Rheumatology guidance on prescribing TNFα blockers in adults with rheumatoid arthritis (2005).
This SMC advice takes account of the benefits of a Patient Access Scheme that improves the cost-effectiveness of tocilizumab. This SMC advice is contingent upon the availability of the Patient Access Scheme in NHS Scotland.
Included in the Fife Formulary as a 2nd/3rd line biologic option for this indication.
Specialist hospital use only.
Advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland
Scottish Medicines Consortium tocilizumab (RoActemra)
August 2012 802/12
tegafur/gimeracil/oteracil 15mg/4.35mg/11.8mg and 20mg/5.8mg/15.8mg hard capsules (Teysuno®)Nordic Pharma Ltd
tegafur/gimeracil/oteracil (Teysuno®) is accepted for restricted use within NHS Scotland.
Indication under review: tegafur/gimeracil/oteracil is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.
SMC restriction: tegafur/gimeracil/oteracil is restricted to use in patients with advanced gastric cancer who are unsuitable for an anthracycline, fluorouracil and platinum triplet first-line regimen.
Not included in the Fife Formulary
Clinicians do not support formulary inclusion.
Preferred treatment would be capecitabine + cisplatin.
Scottish Medicines Consortium tegafur/gimeracil/oteracil (Teysuno)
August 2012 792/12
vemurafenib 240mg film-coated tablet (Zelboraf®)Roche Products Ltd
vemurafenib (Zelboraf®) is not recommended for use within NHS Scotland.
Indication under review: as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Lack of evidence of economic benefits
Scottish Medicines Consortium vemurafenib_Zelboraf
September 2012 681/11
velaglucerase alfa 400 units powder for solution for infusion (VPRIV®)Shire Pharmaceuticals Limited
velaglucerase alfa (VPRIV®) is accepted for use within NHS Scotland.
Indication under review: Long-term enzyme replacement therapy in patients with type 1 Gaucher disease.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of velaglucerase. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland
Included in the Fife Formulary.
Specialist hospital use only.
Advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
Scottish Medicines Consortium velaglucerase (Vpriv)
September 2012 805/12
ivabradine 5 and 7.5mg film-coated tablets (Procoralan®)Servier Laboratories Ltd
ivabradine (Procoralan®) is accepted for restricted use within NHS Scotland.
Indication under review: Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.
SMC restriction: for initiation only in patients whose resting heart rate remains ≥75 beats per minute despite optimal standard therapy.
Included in the Fife Formulary for chronic heart failure when heart rate remains >75bpm and 1. Patient is taking optimal standard therapy
Or
2. Beta-blockers are contra-indicated or not tolerated
Scottish Medicines Consortium ivabradine (Procoralan)
September 2012 736/11
fluticasone proprionate and formoterol fumarate metered dose inhaler, 50microgram/5microgram, 125microgram/5 microgram 250microgram/10 microgram (flutiform®)Napp Pharmaceuticals Ltd
fluticasone proprionate and formoterol fumarate metered dose inhaler (flutiform®) is accepted for use in NHS Scotland.
Indication under review: in the regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA)] is appropriate.
Included in the Fife Formulary as a 2nd line treatment option at Step 3 for asthma in patients where the use of a combination MDI containing fluticasone and formoterol is considered suitable
Scottish Medicines Consortium fluticasone/formoterol (Flutiform)
Not recommended
Not recommended
Not recommended Non-submission
Not recommended Non-submission
Not recommended Non-submission
Not recommended Non-submission
September2012 806/12
bevacizumab, 25mg/mL, concentrate for solution for infusion (Avastin®)Roche Products Ltd
bevacizumab (Avastin®) is not recommended for use within NHS Scotland.
Indication under review: bevacizumab in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Lack of evidence of economic benefits
Scottish Medicines Consortium bevacizumab (Avastin)
September 2012696/11
tocofersolan, 50mg/mL (corresponding to 74.5 IU tocopherol) oral solution (Vedrop®)Orphan Europe UK
tocofersolan oral solution (Vedrop®) is not recommended for use within NHS Scotland.
Indication under review: vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
Lack of evidence of economic benefits.
Scottish Medicines Consortium tocofersolan (Vedrop)
September 2012 814/12
caffeine citrate (Peyona®) 20mg/ml solution for infusion and oral solution Chiesi Farmaceutica SpA
caffeine citrate (Peyona®) is not recommended for use within NHS Scotland.
Indication under review: treatment of primary apnoea of premature newborns.
Scottish Medicines Consortium caffeine citrate (Peyona)
September 2012 815/12
pasireotide (Signifor®) 0.3mg, 0.6 mg and 0.9 mg solution for injectionNovartis Pharmaceuticals Limited
pasireotide (Signifor®) is not recommended for use within NHS Scotland.
Indication under review: treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
Scottish Medicines Consortium pasireotide (Signifor)
September 2012816/12
strontium ranelate (Protelos®) 2g granules for oral suspensionServier Laboratories Limited
strontium ranelate (Protelos ®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of osteoporosis in men at increased risk of fracture.
Scottish Medicines Consortium strontium ranelate (Protelos)
September 2012 817/12
zonisamide (Zonegran ®) 25, 50, 100mg Hard CapsulesEisai Ltd
Non SMC Submission
zonisamide (Zonegran ®) is not recommended for use within NHS Scotland.
Indication under review: monotherapy for the treatment of partial seizures (with or without secondary generalization) in adults with newly diagnosed epilepsy.
Scottish Medicines Consortium zonisamide (Zonegran)
Rationale
http://www.fifeadtc.scot.nhs.uk/formulary/sections/2%20Cardiovascular.pdf
http://www.fifeadtc.scot.nhs.uk/formulary/sections/15%20Anaesthesia.pdf