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

Formulary News (December 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 December 10th and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Aclidinium bromide (Eklira Genuair®) is included in the Total Formulary for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

For the relevant SMC advice click here

5-aminolaevulinic acid (as hydrochloride) (Ameluz®) is included in the Total Formulary for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2). It is restricted to use by consultant dermatologists.

For the relevant SMC advice click here

Bortezomib subcutaneous injection (Velcade®) is included in the Total Formulary in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant. It is restricted to specialist use according to regional protocol.

For the relevant SMC advice click here

Dexmedetomidine (Dexdor®) is included in the Total Formulary 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). It is restricted to specialist use in accordance with local protocol.

For the relevant SMC advice click here

Ferric Carboxymaltose (Ferinject®) is included in the Total Formulary for the treatment of iron deficiency (diagnosis based on laboratory tests) when oral preparations are ineffective or cannot be used and standard IV iron is inappropriate due to its administration schedule. It is restricted to specialist use.
These preparations are considerably more expensive than many other IV iron preparations. Use in patients on haemodialysis or use as a bolus injection was not recommended by SMC and remains non-Formulary.

For the relevant SMC advice click here

Iron isomaltoside 1000, 100mg/ml solution (Monofer®) is included in the Total Formulary for the treatment of iron deficiency anaemia when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.  It is restricted to specialist use. These preparations are considerably more expensive than many other IV iron preparations. Use in patients on haemodialysis or use as a bolus injection was not recommended by SMC and remains non-Formulary.

For the relevant SMC advice click here

Lanthanum carbonate (Fosrenol®) is included in the Total Formulary as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Lanthanum is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels  1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. It is restricted to initiation as second line agent in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or CAPD where a non-aluminium, non-calcium phosphate binder is required.

For the relevant SMC advice click here

Nepafenac (Nevanac®) is included in the Total Formulary for the reduction of postoperative macular oedema associated with cataract surgery in diabetic patients. It is restricted to specialist initiation in diabetic patients with retinopathy.  Initial supply should be obtained from the specialist centre with GP prescribing only necessary where the specialist considers extending the course of treatment to a total duration of 60 days.

For the relevant SMC advice click here

Perampanel film coated tablets (Fycompa®) is included in the Total Formulary as adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. It is restricted to initiation by specialists in epilepsy.

For the relevant SMC advice click here

Ticagrelor tablets (Brilique®) is included in the Total Formulary for co-administration with aspirin for the prevention of atherothrombotic events in adult patients with non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI].  Implementation plans to support prescribing are currently in development.

For the relevant SMC advice click here

Ustekinumab injection (Stelara®) is included in the Total Formulary for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA). It is restricted to specialist use. Continued  treatment should be restricted to patients who achieve a PASI 75% response within 16 weeks.  Formulary status (and SMC advice) is contingent upon the continuing availability of the patient access scheme.

For the relevant SMC advice click here

Ranibizumab (Lucentis®) is included in the Total Formulary for the treatment of visual impairment due to macular oedema (MO) secondary to central retinal vein occlusion (CRVO) adults. It is restricted to specialist use in accordance with GGC Protocol.  Use in patients with branch RVO was not recommended by SMC and remains non-Formulary 
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.

Adalimumab (Humira®) is not included in the Adult Formulary for the treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies

For the relevant SMC advice click here

Argatroban (Exembol®) is not included in the Adult Formulary for anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral antithrombotic therapy.

For the relevant SMC advice click here

Interferon beta-1a (Rebif®) is not included in the Adult Formulary for the treatment of Patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

For the relevant SMC advice click here

Olmesartan medoxomil/ amlodipine besilate/ hydrochlorothiazide (Sevikar HCT®) is not included in the Adult Formulary for the treatment of adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation because the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary (see below).


For the relevant SMC advice click here

Pazopanib (Votrient®) is not included in the Adult Formulary for the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.  Efficacy and safety has only been established in certain STS histological tumour subtypes.

For the relevant SMC advice click here

Racecadodril (Hidrasec®) is not included in the Adult Formulary for the treatment of symptomatic treatment of acute diarrhoea in adults when casual treatment is not possible.

For the relevant SMC advice click here

Ranolazine (Ranexa®) is not included in the Adult Formulary as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

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.

Ranibizumab (Lucentis®) for the treatment of visual impairment due to diabetic macular oedema (DMO) in adults 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.

Perampanel film coated tablets (Fycompa®) is included in the Total Formulary as adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. It is restricted to initiation by specialists in epilepsy.

For the relevant SMC advice click here

Sildenafil (as citrate) (Revatio®) is included in the Paediatric Formulary for the treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart  disease. It is restricted to specialist use only.

For the relevant SMC advice click here

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

Racecadodril (Hidrasec Infants®) is not included in the Paediatric Formulary  for the complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition.

For the relevant SMC advice click here

Other Formulary information

The following advice has been noted by ADTC.

Calcium 300mg and colecalciferol 200 unit tablets (Adcal D3® Caplets) is included in the Total Formulary as an adjunct to specific therapy for osteoporosis and in situations requiring therapeutic supplementation of malnutrition e.g. in pregnancy and established vitamin D dependent osteomalacia and the prevention and treatment of calcium deficiency/vitamin D deficiency especially in the housebound and institutionalised elderly subjects. It is restricted to patients who cannot tolerate the chewable tablet formulation of Calcium and VitaminD3®

Temazepam 10mg, 20mg tablets were moved from the Preferred List to the Total Formulary for the short-term treatment of insomnia.

Trospium modified-release (Regurin XL®) is included in the Total Formulary for the relief of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with an overactive bladder. 

Zopiclone 3.75mg, 7.5mg tablets replace temazepam tablets in the Preferred List for the short-term treatment of insomnia.

Calcium 500mg and colecalciferol 800 unit chewable tablets (Kalcipos-D3®) is not included in the Adult Formulary for the Prevention and treatment of calcium and vitamin D deficiency in the elderly or as vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency because the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary. 

For the relevant SMC advice click here

NICE MTA265: Denosumab (Xgeva®) for the Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. This guidance has been deferred for protocol development by the Regional Cancer Advisory Group.

For the relevant NICE/NHS HIS advice click here