GGC Formulary Formulary decisions from the meeting of ADTC in June 2014
NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Formulary Update

Formulary News (Apr 2014)

Additions to the GGC Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on 28th April 2014 and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Adapalene and benzoyl peroxide topical gel (Epiduo®) for the cutaneous treatment of acne vulgaris when comedones, papules and pustules are present is included in the GGC Adult Formulary for the indication in question. It is restricted to the treatment of mild to moderate facial acne when monotherapy with benzoyl peroxide or adapalene is not considered appropriate.

For relevant SMC advice click here

Afatinib tablets (Giotrif®), as monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s) is included in the GGC Adult Formulary for the indication in question pending protocol.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Aflibercept infusion (Zaltrap®) in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin containing regimen and is included in the GGC Adult Formulary for the indication in question pending protocol.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Aflibercept intravitreal injection (Eylea®) for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion in adults is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in accordance with local protocol.

For relevant SMC advice click here

Azithromycin infusion (Zedbac®) for the treatment of community acquired pneumonia (CAP) and pelvic inflammatory disease (PID) due to susceptible organisms in adult patients where initial intravenous therapy is required is included in the GGC Adult Formulary for the indication in question. It is restricted to use on the advice of a microbiologist or infectious disease physician when the oral route of administration is compromised.  It is considered an Alert Antimicrobial.

For relevant SMC advice click here

Dapagliflozin tablets (Forxiga®) for use in adults with type 2 diabetes mellitus to improve glycaemic control in combination with insulin is included in the GGC Adult Formulary.  It is restricted to use in combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.

For relevant SMC advice click here

Dimethyl fumerate (Tecfidera®) for the treatment of adult patients with relapsing remitting multiple sclerosis is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in accordance with local guidelines.

For relevant SMC advice click here

Fluticasone furoate and vilanterol dry powder inhaler (Relvar Ellipta®) for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with an exacerbation history despite regular bronchodilator therapy is included in the GGC Adult Formulary for the indication in question.  It is restricted to use in patients with severe COPD (FEV1 <50% predicted normal and two or more exacerbations in a year) in accordance with NHSGGC COPD Guidelines.

For relevant SMC advice click here

Lenalidomide hard capsules (Revlimid®) for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate is included in the GGC Adult Formulary for the indication in question pending protocol.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Lenalidomide hard capsules (Revlimid®) in combination with dexamethasone, for the treatment of multiple myeloma in adult patients who have received at least one prior therapy is included in the GGC Adult Formulary for the indication in question pending protocol.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Lipegfilgrastim injection (Longuex®) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Macitentan tablets (Opsumit®) as monotherapy or in combination is indicated for the long-term treatment of pulmonary arterial hypertension in adult patients of World Health Organisation Functional Class II to III and is included in the GGC Adult Formulary for the indication in question. It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists.

For relevant SMC advice click here

Rilpivirine, emtricitabine, tenofovir tablets (Eviplera®) for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with viral load ≤100,000 HIV-1 RNA copies/mL is included in the GGC Adult Formulary for the indication in question. It is restricted to use by HIV specialists.

For relevant SMC advice click here

Solifenacin and tamsulosin modified-release tablets (Vesomni®) for the treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia in men who are not adequately responding to treatment with monotherapy is included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Teriflunomide tablets (Aubagio®) for the treatment of adults with relapsing remitting multiple sclerosis (MS) is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use as an alternative to treatment with interferon beta or glatiramer acetate. Teriflunomide is not expected to be used for the treatment of patients with highly active disease.

For relevant SMC advice click here

Trastuzumab sub-cutaneous injection (Herceptin®) for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) and early breast cancer (EBC) in a range of settings is included the GGC Adult Formulary for the indication in question pending protocol.  It is restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Ustekinumab sub-cutaneous injection (Stelara®) for use alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate, is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in patients with active psoriatic arthritis who have failed on, or are unsuitable for, treatment with an anti-TNF drug.

For relevant SMC advice click here

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.

Alogliptin tablets (Vipidia®) for adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Insulin degludec (Tresiba®) for the treatment of diabetes mellitus in adults is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Saxagliptin tablets (Onglyza®) as monotherapy in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Additions to GGC Paediatric Formulary

The following new medicines, indications or formulations have been considered for the GGC Paediatric Formulary.

Darunavir tablets, oral suspension (Prezista®) when co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients 12 to 17 years of age and at least 40kg body weight who are: antiretroviral therapy (ART) naïve; or, ART-experienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥100 cells/mm3 is included in the GGC Paediatric Formulary for the indication in question. It is restricted to patients <18 years, to be prescribed under the supervision of specialists in paediatric HIV.

For relevant SMC advice click here

Zonisamide capsules (Zonegran®) as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents, and children aged 6 years and above, is included in the GGC Paediatric Formulary for the indication in question. It is restricted to initiation on advice from specialists (paediatric neurologists or paediatricians with an expertise in epilepsy.

For relevant SMC advice click here

Other Formulary Decisions

Following formulary appeals:

Ulipristal acetate tablets (Esmya®) for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist initiation with a restricted duration of treatment of 3 months.

Fosfomycin granules (Monuril®) for the treatment of extended-spectrum beta-lactamases (ESBL) lower urinary tract infection (LUTI) in non-septic men and non-pregnant women as an oral alternative to current intravenous treatments is included in the GGC Adult Formulary for the indication in question. It is restricted to use on the advice of microbiologists or infectious disease physicians when laboratory results indicate sensitivity and according to local primary care or acute sector treatment protocols.

Other changes to Formulary:

Trospium chloride modified-release capsules (Regurin XL®) for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder is now included in the Preferred List of the GGC Adult Formulary.

Diclofenac (oral preparations) have been moved from the Preferred List of the GGC Adult Formulary to the Total Formulary.

Apixaban tablets (Eliquis®) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors has had its Formulary status amended.  In addition to patients poorly controlled on warfarin, newly diagnosed patients will have this available as a treatment option.  Patients who are well controlled on warfarin should remain on warfarin therapy.

Dabigatran etexilate tablets (Pradaxa®) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, has had its Formulary status amended.  In addition to patients poorly controlled on warfarin, newly diagnosed patients will have this available as a treatment option.  Patients who are well controlled on warfarin should remain on warfarin therapy.