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

Formulary Update (Oct 2015)

Additions to the GGC Adult Medicines Formulary

Greater Glasgow and Clyde Area Drug and Therapeutic Committee (ADTC) met on 19th October 2015 and added the following medicines/indications/formulations to the GGC Adult Formulary. Additions are to the Total Formulary unless specified otherwise. For brevity, some indications may be shortened. For the full detail of the indications and SMC restrictions (where applicable) see the relevant SMC advice.

Abiraterone acetate tablets (Zytiga) with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated is included in the GGC Adult Formulary pending protocol for the indication in question.  It is restricted to specialist use in accordance with regional protocol (in development)

For the relevant SMC advice click here

Aflibercept injection (Eylea) for the treatment of adult patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion is included in the GGC Adult Formulary, pending protocol, for the indication in question. It is restricted to specialist use in accordance with local protocol (in development)

For the relevant SMC advice click here

Bevacizumab infusion (Avastin) in combination with paclitaxel for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents is included in the GGC Adult Formulary, pending protocol, for the indication in question. It is restricted to specialist use only in combination with paclitaxel in accordance with regional protocol (in development).

For the relevant SMC advice click here

Bortezomib injection (Velcade) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation is included in the GGC Adult Formulary, pending protocol, for the indication in question. It is restricted to specialist use in accordance with regional protocol (in development).

For the relevant SMC advice click here

Ciclosporin eye drops (Ikervis) for the treatment of severe keratitis in adult patients with dry eye disease is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist initiation (Ophthalmologist) for the treatment of severe keratitis in adults with dry eye disease whcih has not improved despite treatment with tear substitutes.

For the relevant SMC advice click here

Empagliflozin plus metformin (Synjardy) for type 2 diabetes mellitus is included in the GGC Adult Formulary for the indication in question.  It is restricted to initiation by clinicians experienced in the management of diabetes for use in patients for whom this fixed dose combination is considered appropriate or for use as duel therapy when a sulphonylurea is inappropriate.  Additionally, it is restricted to patients who have demonstrated compliance issues with the separate constituents.

For the relevant SMC advice click here

Ledipasvir and sofosbuvir tablets (Harvoni) for the treatment of genotype 3 chronic hepatitis C in adults is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist use only.  Treatment choices will continue to be directed by national guidance.

For the relevant SMC advice click here

Lisdexamfetamine dimesylate (Elvance Adult) as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist initiation.

For the relevant SMC advice click here

Midodrine hydrochloride tablets (Bramox) for the treatment of severe orthostatic hypotension in adults due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist initiation.

For the relevant SMC advice click here

Nintedanib (Ofev) for the treament of adults with idiopathic pulmonary fibrosis (IPF) is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist use only in patients with a predicted forced vital capacity (FVC) less than or equal to 80% where an Interstitial Lung Disease Multidisciplanary Team has agreed it is appropriate.

For the relevant SMC advice click here

Pasireotide (Signifor) for the treatment of adults with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist use only.

For the relevant SMC advice click here

Radium-223 dichloride (Xofigo) for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases is included in the GGC Adult Formulary, pending protool, for the indication in question. It is restricted to specialist use in accordance with regional protocol (in development) when the service infrastructure is in place to support the safe delivery of this treatment.

For the relevant SMC advice click here

Sitagliptin (Januvia) for the treatment of type 2 diabetes mellitus as an add-on to insulin (with or without metformin) is included in the GGC Adult Formulary (Preferred List) for the indication in question.

For the relevant SMC advice click here

Tafluprost and timolol preservative-free eye drops (Taptiqom) for the reduction of intraocular pressure in adults with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers. It is restricted to specialist intiation for use in patients who have proven sensitivity to preservatives.

For the relevant SMC advice click here

Tiotropium solution for inhalation (Spiriva Respimat) as add-on maintenance bronchodilator treatment in adult patients with asthma is included in the GGC Formulary for the indication in question. It is restricted to initiation only by clinicians experienced in the management of asthma as add-on treatment in adults at step 4 with poorly controlled asthma (at least one course of oral steroids for a severe exacerbation in the last year) who have persistent airflow obstruction (post-bronchodilator FEV1 of less than 80% predicted).

For the relevant SMC advice click here

Trastuzumab (Herceptin), in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received  prior anti-cancer treatment for their metastatic disease is included in the GGC Adult Formulary pending protocol for the indication in question. It is restricted to specialist use in patient whose tumours have HER2 overexpression defined by immunohistochemistry (IHC) 3+ ("HER2 high expresser") in accordance with regional protocol (in development).

For the 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 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 as other formulations. Please refer to Formulary.

Avanafil tablets (Spedra) for erectile dysfunction is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Budesonide MR tablets (Cortiment) for mild to moderate active ulcerative colitis where 5-ASA treatment is not sufficient is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Elosulfase alfa (Vimizim) for the treatment of mucopolysaccharidosis type IVA (Morquio A Syndrome, MPS IVA) is not included in the GGC Adult or Paediatric Formulary for the indication in question.

For the relevant SMC advice click here

Everolimus (Afinitor) for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer in combination with exemestane is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Insulin glargine 300 units/ml (Toujeo) for the treatment of type 1 or type 2 diabetes mellitus in adults is not included in the GGC Adult Formulary for the indication in question as clinicians do not support inclusion.

For the relevant SMC advice click here

Ketoconazole tablets (Ketoconazole HRA) for the treatment of endogenous Cushing's syndrome in adult and adolescents above the age of 12 years is not included in the GGC Adult or Paediatric Formulary for the indication in question.

For the relevant SMC advice click here

Tigecycline infusion (Tygacil) for the treatment of complicated skin, soft-tissue and intra-abdominal infections in children from the age of 8 years is not included in the GGC Paediatric Formulary for the indication in question.

For the relevant SMC advice click here

Deferred Formulary decisions

ADTC has deferred Formulary decisions for the following SMC advice:

Insulin degludec and liraglutide (Xultophy) for the treatment of type 2 diabetes (Deferred to allow further consultation with the Diabetes MCN).

For the relevant SMC advice click here

Additions to the GGC Paediatric Formulary

Entecavir (Baraclude) for the treatment of chronic hepatitis B virus infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum alanine aminotransferase levels, or histological evidence of moderate to severe inflammation and/or fibrosis is included in the GGC Paediatric Formulary. It is restricted to specialist use by specialists in paediatric infectious diseases.

For the relevant SMC advice click here

Adalimumab (Humira) for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy is included in the GGC Paediatric Formulary. It is restricted to specialist use within specialist rheumatology services (including those working within the network for paediatric rheumatology).

For the relevant SMC advice click here

Paediatric Formulary decisions pending

Travoprost eye drops (Travatan) for the treatment of elevated intraocular pressure in children aged 2 month to 18 years (Referred to the Paediatric D&T).

For the relevant SMC advice click here