Formulary News (Oct 2013)
Additions to the GGC Adult Formulary
Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on October 21st 2013 and added the following medicines/indications/ formulations to the GGC Formulary. Additions are to the Total Formulary unless specified otherwise.
Bimatoprost and Timolol eye drops (Ganfort® Unit Dose Preservative Free) For the reduction of intraocular pressure in adults with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues is included in the GGC Adult Formulary for the indication in question. This preparation is restricted to specialist initiation and for use only in patients who have proven sensitivity to preservatives.
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Botulinum toxin type A (Botox®) for the management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to subcervical spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who are not adequately managed with anticholinergics is included in the GGC Adult Formulary for the indication in question restricted to specialist use.
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Carglumic Acid (Carbaglu®) for hyperammonaemia due to isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia.
Included in the GGC Adult Formulary for the indication in question restricted to specialist use.
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Crizotinib, hard capsule (Xalkori®) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) is included in the GGC Total Formulary for the indication in question pending protocol. It is restricted to specialist use only.
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Granisetron transdermal patch (Sancuso®) for use in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist initiation only in accordance with regional anti-emetic protocol.
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Lixisenatide pre-filled disposable pen (Lyxumia®) for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist initiation as a third-line agent, either in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione, or as adjunctive therapy to basal insulin in patients for whom a glucagon-like protein 1 (GLP-1) agonist is appropriate.
for relevant SMC advice click here
Medroxyprogesterone acetate subcutaneous depot injection (Sayana® Press) for long-term female contraception is included in the GGC Adult Formulary (Preferred List) for the indication in question.
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Nalmefene (Selincro®) for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification is included in the GGC Adult Formulary. Nalmefene should only be prescribed as part of a full package of care including the provision of continuous psychosocial support by appropriate NHS personnel if DRL remains high two weeks after the initial assessment. It should also be reviewed regularly.
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Rifaximin (Targaxan®) for the reduction in recurrence of episodes of overt hepatic encephalopathy (HE) in patients ≥18 years of age is included in the GGC Adult Formulary for the indication in question restricted to initiation by a consultant gastroenterologist. Rifaximin is considered to be most useful in a highly selective group of patients with hepatic encephalopathy who are resistant to other standard therapies such as lactulose and dietary measures.
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Rituximab (MabThera®) for use in combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA) in included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in patients who have relapsed following treatment with cyclophosphamide or who are intolerant to or unable to receive cyclophosphamide.
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New medicines, indications and formulations not included in the GGC Adult Formulary or GGC Paediatric 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.
Eculizumab (Soliris®) for use in children for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) is not included in the GGC Paediatric Formulary.
For relevant SMC advice click here
Imatinib (Glivec®) for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy is not included in the GGC Paediatric Formulary
For relevant SMC advice click here
Ocriplasmin (Jetrea®) for the treatment of vitreomacular traction in adults is not included in the GGC Adult Formulary
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Pertuzumab (Perjeta®) for use in combination with trastuzumab and docetaxel in adult patients with human epidermal growth factor-2 (HER2)-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease, is not included in the GGC Adult Formulary.
For relevant SMC advice click here
Vismodegib (Erivedge®) for symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy is not included in the GGC Adult Formulary
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Additions to GGC Paediatric Formulary
The following new medicines, indications or formulations have been considered for the GGC Paediatric Formulary Decisions.
Aripiprazole (Abilify®) for treatment up to 12 weeks of moderate to severe maniac episodes in Bipolar Disorder I in adolescents aged 13 years and older is included in the GGC Paediatric Formulary for the indication in question. It is restricted to specialist initiation and management under the supervision of a child/ adolescent psychiatrist.
For relevant SMC advice click here
Caffeine Citrate (Peyona®) for the treatment of primary apnoea of premature newborns is included in the GGC Paediatric Formulary for the indication in question restricted to specialist use.
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Etravirine (Intelence®) for use in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced paediatric patients from 6 years to less than 18 years of age is included in the GGC Paediatric Formulary for the indication in question restricted to use by paediatric HIV specialists.
For relevant SMC advice click here
Raltegravir (Isentress®) in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adolescents and children aged 2 to 17 years is included in the GGC Paediatric Formulary for the indication in question. It is restricted to specialist use by paediatric HIV specialists in patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions.
For relevant SMC advice click here
Tenofovir Disoproxil (as fumarate) tablets (Viread®) for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infected paediatric and adolescent patients aged 6 to < 12 years, with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line agents is included in the GGC Paediatric Formulary for the indication in question. It is restricted to use by paediatric HIV specialists.
For relevant SMC advice click here
Tenofovir Disoproxil (as fumarate) tablets (Viread®) for:
- HIV-1 infection - in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infected paediatric and adolescent patients aged 12 to < 18 years, with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line agents.
- Hepatitis B infection - for the treatment of chronic hepatitis B in adolescents aged 12 to <18 years of age with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
Is included in the GGC Paediatric Formulary for the indication in question. Restricted to use by paediatric HIV specialists or specialists in paediatric infectious diseases.
For relevant SMC advice click here
Tenofovir Disoproxil (as fumarate) oral granules (Viread®) for:
- HIV-1 infection - in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate; and, in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults for whom a solid dosage form is not appropriate.
- Hepatitis B infection - for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease; and, for the treatment of chronic hepatitis B in adolescents 12 to <18 years of age for whom a solid dosage form is not appropriate with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
Is included in the GGC Paediatric Formulary for the indication in question. Restricted to use by paediatric HIV specialists or specialists in paediatric infectious diseases.
For relevant SMC advice click here