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

Formulary News (June 2013)

Additions to the GGC Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on June 10th 2013 and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Aflibercept intravitreal injection (Eylea®) for the treatment of (wet) age-related macular degeneration in adults is included in the GGC Adult Formulary for the indication in question restricted to specialist use in accordance with NHSGGC protocol.

For the relevant SMC advice click here

Linaclotide hard capsules (Constella®) for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults is included in the GGC Adult Formulary pending protocol. It is restricted to use in patients with moderate to severe IBS-C who have not responded adequately to, or cannot tolerate all other suitable treatment options. A prescribing note within the Formulary entry outlines the other available options.

For the relevant SMC advice click here

Mirabegron prolonged-release tablets (Betmiga®) for the symptomatic treatment of urgency, increased micturition frequency and/or urge incontinence in adults with overactive bladder (OAB) syndrome is included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Ipilimumab infusion (Yervoy®) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy is included in the GGC Adult Formulary pending protocol for the indication in question restricted to specialist use.

For the relevant SMC advice click here

Ranibizumab intra-vitreal injection (Lucentis®) for the treatment of visual impairment due to macular oedema (MO) secondary to branch retinal vein occlusion (BRVO) in adults is included in the GGC Adult Formulary pending protocol for the indication in question restricted to specialist use.

For the relevant SMC advice click here

Saxagliptin with metformin tablets (Komboglyze®) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets is included in the GGC Adult Formulary for the indication in question. It is restricted to use in patients for whom a combination of saxagliptin and meformin is an appropriate choice of therapy and only when the addition of sulphonylureas to metformin monotherapy is not appropriate. It is also further restricted to use only in those patients who have demonstrable compliance issues with the separate constituents

For the relevant SMC advice click here

New medicines, indications and formulations not included in the GGC 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.

Abiraterone (Zytiga®) for use with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Canakinumab (Ilaris®) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 2 years and older is not included in the GGC Adult or Paediatric Formulary for the indication in question.

For the relevant SMC advice click here

Canakinumab (Ilaris®) for the symptomatic treatment of adult patients with frequent gouty arthritis attacks in whom NSAIDs and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate is not included in the GGC Adult Formulary for the indication in question. 

For the relevant SMC advice click here

Crizotinib hard capsules (Xalkori®) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Everolimus (Votubia®) for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Fluocinolone acetonide intravitreal implant (Iluvien®) for the treatment of vision impairment associated with chronic diabetic macular oedema, considered insufficiently responsive to available therapies is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Ivacaftor tablets (Kalydeco®) for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene is not included in the GGC Adult or Paediatric Formulary for the indication in question. Appropriate patients will receive this medicine under the arrangements defined within the Scottish Government Rare Conditions Medicines Fund.

For the relevant SMC advice click here

Rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride (Voractiv®) for the initial treatment of tuberculosis according to World Health Organisation (WHO) guidelines is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Tafamidis meglumine soft capsules (Vyndaqel®) for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Vildagliptin (Galvus®) for the treatment of type 2 diabetes mellitus in adults as triple therapy in combination with a sulphonylurea and metformin or for use in combination with insulin (with or without metformin) is not included in the GGC Adult Formulary for the indication in question.

For the relevant SMC advice click here

Vildagliptin/metformin hydrochloride film-coated tablets (Eucreas®) for treatment of type 2 diabetes mellitus in combination with a sulphonylurea (ie triple combination therapy) or in combination therapy with insulin is not included in the GGC Adult Formulary for the  indication in question.

For the 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 Decisions.

Lisdexamfetamine dimesylate capsules (Elvanse®) as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate is included in the GGC Paediatric Formulary for the indication in question restricted to specialist initiation.

For the relevant SMC advice click here

Pegylated interferon alfa-2a (Pegasys®) in combination with ribavirin, for the treatment of chronic hepatitis C (CHC) in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus ribonucleic acid (HCV-RNA) is included in the GGC Paediatric Formulary restricted to prescribing by specialists in paediatric infectious disease or paediatric gastroenterology.

For the relevant SMC advice click here

Other Formulary information               

The following change has been agreed by ADTC:

Tiotropium solution for inhalation (Spiriva Respimat®) for the Maintenance treatment of chronic obstructive pulmonary disease (COPD) is to be removed from the GGC Adult Formulary.  The dry powder inhaler device (Spiriva Handihaler®) remains a Formulary option.

Following a NICE Multiple Technology Appraisal:

Colistimethate dry powder inhaler (Colobreathe®) for Pseudomonas infection in cystic fibrosis is included in the GGC Adult Formulary (Total Formulary), restricted to specialist initiation where nebulised colistimethate is not tolerated and tobramycin is being considered. The TOBI Podhaler® was part of this appraisal, but no change to Formulary status was required.

For the relevant NICE/NHS HIS advice click here

Other changes to Formulary not directly related to SMC advice, NICE advice or Formulary appeals are noted below:

Beclomethasone/Formoterol for inhalation (Fostair®) prescribing notes updated to reflect the licensed use as maintenance and reliever therapy in asthama. The prescribing note states: In selected adult patients with asthma at step 3 who are poorly controlled or in selected adult patients at step 2 (above beclometasone 400micrograms/day or equivalent and poorly controlled), the use of beclomethasone and formoterol in a single inhaler as rescue medication instead of a short-acting beta2 agonist, in addition to its regular use as controller therapy, has been shown to be an effective treatment regime.

Cinacalcet (Mimpara®) for secondary hyperparathyroidism in end stage renal disease has been changed from specialist use only to specialist initiation in the GGC Adult Formulary to reflect current practice.  An updated prescribing note states: all monitoring and review related to this medicine is to be carried out at specialist renal clinics.

For the relevant NICE/NHS HIS advice click here

Piroxicam 0.5% gel for use as a topical non-steroidal anti-infammatory drug now replaces Movelat® cream/gel in the Preferred List of the GGC Adult Formulary.

Following a NICE/NHS HIS Multiple Technology Appraisal

Omalizumab (Xolair®) for the treatment of severe persistent allergic asthma. No changes to Formulary are required as a result of this advice.

For the relevant NICE/NHS HIS advice click here