Formulary News (April 2013)
Additions to Adult Formulary
Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on April 8th 2013 and added the following medicines/indications/ formulations to the GGC Formulary. Additions are to the Total Formulary unless specified otherwise.
Abatacept infusion (Orencia®) for the use in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a TNF-alpha inhibitor is included in the Total Formulary restricted to specialist use in patients with active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
For the relevant SMC advice click here
Adalimumab injection (Humira®) for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs) is included in the Total Formulary restricted to specialist use in accordance with Assessment in Spondyloarthritis International Society (ASAS) guidance.
For the relevant SMC advice click here
Bimatoprost single-dose eye drops (Lumigan UD®) for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers) is included in the Total Formulary restricted to specialist initiation only in patients who have proven sensitivity to the preservative benzalkonium chloride.
For the relevant SMC advice click here
Darunavir oral suspension (Prezista®), co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients is included in the Total Formulary restricted to use by HIV specialists.
For the relevant SMC advice click here
Ingenol mebutate gel (Picato®) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults is included in the Total Formulary.
For the relevant SMC advice click here
Rivaroxaban tablets (Xarelto®) for the treatment of pulmonary embolism (PE), and prevention of recurrent deep vein thrombosis (DVT) and PE in adults is included in the Total Formulary restricted to use in accordance with local guidance for patients requiring anticoagulation where the intended duration of treatment is 3 to 6 months. Where indefinite duration is indicated, then the treatment of choice should be a low molecular weight heparin followed by warfarin.
For the relevant SMC advice click here
Tegafur / gimeracil / oteracil hard capsules (Teysuno®) for use in adults for the treatment of advanced gastric cancer when given in combination with cisplatin is included in the Total Formulary restricted to specialist use only in accordance with regional protocol.
For the relevant SMC advice click here
New medicines, indications and formulations not included in the Adult Formulary
The following are not included in the GGC Adult Formulary following the latest ADTC meeting. Where the reason is other than not recommended advice from SMC it is noted. NB: these medicines may be included in the Formulary for other indications or for other formulations. Please refer to Formulary.
Axitinib tablets (Inlyta®) for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine is not included in the GGC Formulary.
For the relevant SMC advice click here
Bevacizumab (Avastin®) in combination with carboplatin and gemcitabine for the treatment of adult patients with first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents is not included in the GGC Formulary.
For the relevant SMC advice click here
Botulinum toxin type A (Botox®) for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine) is not included in the GGC Formulary.
For the relevant SMC advice click here
Deferasirox dispersible tablets (Exjade®) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older is not included in the GGC Formulary.
For the relevant SMC advice click here
Insulin degludec (Tresiba®) for the treatment of diabetes mellitus in adults is not included in the GGC Formulary.
For the relevant SMC advice click here
Ruxolitinib tablets (Jakavi®) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis is not included in the GGC Formulary.
For the relevant SMC advice click here
Timothy grass pollen allergen (Grazax®) for the disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children (5 years or older), with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen is not included in the GGC Formulary.
For the relevant SMC advice click here
Ulipristal acetate tablets (Esmya®) for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age is not included in the GGC Formulary because clinicians do not support the Formulary inclusion. Alternative medicines are available in section 6.7.2 of the Formulary.
For the relevant SMC advice click here
New medicines, indications and formulations not included in the Adult Formulary pending protocol / consultation
The following new medicines, indications or formulations require the development of a protocol or further consultation before Formulary status can be concluded. Until this process is complete, these medicines, indications or formulations are not included in the Formulary.
Aflibercept intravitreal injection (Eylea®) for the treatment of neovascular (wet) age-related macular degeneration in adults is not included in the GGC Formulary pending protocol.
For the relevant SMC advice click here
Ipilimumab infusion (Yervoy®) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy is not included in the GGC Formulary pending protocol.
For the relevant SMC advice click here
Sugammadex injection (Bridion®) for the routine reversal of neuromuscular blockade induced by rocuronium or vecuronium in adult and paediatric patients is not included in the GGC Formulary pending protocol.
For the relevant SMC advice click here
Additions to Paediatric Formulary
The following new medicines, indications or formulations have been considered for the GGC Paediatric Formulary Decisions.
Darunavir oral suspension (Prezista®), co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced paediatric patients from the age of 3 years and at least 15 kg body weight, is included in the Paediatric Formulary restricted to use by HIV specialists.
For the relevant SMC advice click here
Infliximab (Remicade®) for the treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies is included in the GGC Paediatric Formulary. It is restricted to specialist use as an alternative to ciclosporin in patients with acute, severe paediatric ulcerative colitis (rescue therapy) who are steroid refractory.
For the relevant SMC advice click here
Insulin glargine (Lantus®, Clicstar®, Lantus® Solostar®) for the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above is included in the Total Formulary restricted to patients with type 1 diabetes who are at risk of or experience unacceptable frequency and/or severity of nocturnal hypoglycaemia on attempting to achieve better hypoglycaemic control during treatment with established insulins. It is also acceptable as a once daily insulin therapy for patients who require carer administration of their insulin. In patients with type 2 diabetes it should be restricted to those who suffer from recurrent episodes of hypoglycemia or require assistance with their insulin injections.
For the relevant SMC advice click here
Other Formulary information
Following Formulary Appeals, the following changes have been agreed by ADTC.
- Liquid paraffin 11% cream (Zerobase®) is included in the Preferred List.
- Light Liquid paraffin 12.6% cream (Zerocream®) is included in the Total Formulary.
- Light Liquid paraffin 40% ointment (Zeroderm®) is included in the Preferred List.
Other Formulary decisions:
Coal tar 6% and lecithin 0.4% cream (Psoriderm®) is included in the Preferred List for the treatment of psoriasis of the scalp. It replaces Alphosyl HC® which has been discontinued.
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