NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Formulary Update

Formulary News (June 2012)

Please note some of the indications have been summarised for brevity but complete details can be found by following the links to the SMC advice.

Additions to Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on June 11th and added the following medicines/indications/ formulations to the GGC Formulary. Additions are to the Total Formulary unless specified otherwise.

Alteplase (Actilyse®) is included in the Total Formulary for the fibrinolytic treatment of acute ischaemic stroke (administration extended up to 4.5hours post stroke). It is restricted to use only in specialist centres with adequate resources and appropriate expertise and in accordance with detailed protocols.

For the relevant SMC advice click here

Bee/Wasp venom immunotherapy (Pharmalgen®) for the treatment of IgE-mediated bee and wasp venom allergy in people with severe systemic reaction to bee or wasp venom is included in the Total Formulary. It is restricted to use by appropriate specialists only at specialist centres.

For the relevant NICE/NHS HIS advice click here

Erlotinib (Tarceva®) is included in the Total Formulary as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. It is restricted to specialist use in accordance with regional protocol.

For the relevant SMC advice click here

Exenatide (Byetta®) is included in the Total Formulary 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. It is restricted to specialist initiation.

For the relevant SMC advice click here

Icatibant acetate (Firazyr®) is included in the Total Formulary for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).  It is restricted to specialist use only on the advice of the Immunology Service

For the relevant SMC advice click here

Imatinib (Glivec®) is included in the Total Formulary as adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). It is restricted to specialist use in accordance with regional protocol.

For the relevant SMC advice click here

Pregabalin oral solution (Lyrica®) is included in the Total Formulary for the same Formulary-approved uses and restrictions as pregabalin tablets. However, the oral solution is also further restricted to those patients who find it difficult to or are unable to swallow tablets.

For the relevant SMC advice click here

Rivaroxaban (Xarelto®) is included on the Total Formulary for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE).  It is 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

Tobramycin powder for inhalation (TOBI Podhaler®) for suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis is included in the Total Formulary.   It is restricted to specialist initiation as second-line use after colistimethate (colistin).

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.

Belatacept (Nulojix ®) is not included in the Adult Formulary for use in combination with corticosteroids and a mycophenolic acid, is indicated for prophylaxis of graft rejection in adults receiving a renal transplant.

For the relevant SMC advice click here

Bevacizumab (Avastin ®) is not included in the Adult Formulary for use in combination with capecitabine as first-line treatment of patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.

For the relevant SMC advice click here

Ipilimumab (Yervoy ®) is not included in the Adult Formulary for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.

For the relevant SMC advice click here

Triptorelin (Salvacyl ®) is not included in the Adult Formulary for the reversible reduction of testosterone to castrate levels in order to decrease sexual drive in adult men with severe sexual deviations.

For the relevant SMC advice click here

Vandetanib (Caprelsa ®) is not included in the Adult Formulary for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

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.

Collagenase clostridium histolyticum (Xiapex ®) for the treatment of Dupuytren’s contracture in adult patients with a palpable cord is not included in the Adult Formulary pending protocol.

For the relevant SMC advice click here

Dexmedetomidine (Dexdor®) 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). is not included in the Adult Formulary pending protocol.

For the relevant SMC advice click here

Dexamethasone (Ozurdex ®) for the treatment of adult patients with macular oedema following either branch retinal vein occlusion or central retinal vein occlusion is not included in the Adult Formulary pending protocol.

For the relevant SMC advice click here

Everolimus (Afinitor®) for the treatment of unresectable or metastatic, well or moderately-differentiated neuroendocrine tumours of pancreatic origin (pNET) in adults with progressive disease is not included in the Adult 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.

Abatacept (Orencia ®) is included in the Paediatric Formulary for use in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other disease modifying antirheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor.  It is restricted to use specialist use within paediatric rheumatology.

For the relevant SMC advice click here

Adalimumab (Humira ®) is included in the Paediatric Formulary for use in combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).  It is restricted to specialist use within paediatric rheumatology.

For the relevant SMC advice click here

Etanercept (Enbrel ®) is included in the Paediatric Formulary 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.  It is restricted to specialist use within paediatric rheumatology.

For the relevant SMC advice click here

Insulin detemir (Levemir ®) is included in the Paediatric Formulary for treatment of diabetes mellitus in adolescents and children aged 2 years and above.  It is restricted to use in patients unable to achieve good glycaemic control with established insulins.

For the relevant SMC advice click here

Tocilizumab (RoActemra ®) is included in the Paediatric Formulary for treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.  It is restricted use within paediatric rheumatology.

For the relevant SMC advice click here

New medicines, indications and formulations not included in the Paediatric Formulary pending protocol / consultation

Etanercept (Enbrel ®) for chronic severe plaque psoriasis in children and adolescents from the age of 6 years is not included in the Paediatric Formulary pending consultation /protocol.

For the relevant SMC advice click here

Somatropin (saizen ®) for growth failure and disturbance in children and adolescents is not included in the Paediatric Formulary pending consultation / protocol.

For the relevant SMC advice click here

Other Formulary information

The following advice has been noted by ADTC.

NICE MTA242: Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy.  All three options are not recommended for use within this guidance.  No change in Formulary status is required.

For the relevant NICE/NHS HIS advice click here

NICE MTA251: Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia.  This guidance has been deferred for consideration by the Regional Cancer Advisory Group.

For the relevant NICE/NHS HIS advice click here