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

Formulary News (Dec 2013)

Additions to the GGC Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on 9th December 2013 and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Atomoxetine capsules (Strattera®) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults as part of a comprehensive treatment programme is included in the GGC Adult Formulary for the indication in question restricted to specialist initiation.

For relevant SMC advice click here

Axitinib (Inlyta®) for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine is included in the GGC Adult Formulary for the indication in question restricted to specialist use in accordance with regional protocol.

For relevant SMC advice click here

Eltrombopag film coated tablets (Revolade®) for the treatment of thrombocytopenia in adult patients with chronic hepatitis C virus infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy, is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use.

For relevant SMC advice click here

Enzalutamide soft capsules (Xtandi®) for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy 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

Mannitol inhaled (Bronchitol®) for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care is included in the GGC Adult Formulary for the indication in question. This preparation is restricted to specialist initiation for use in patients who are not currently using dornase alfa due to lack of response, intolerance or ineligibility and have rapidly declining lung function and in whom other osmotic agents are considered unsuitable.

For relevant SMC advice click here

Ondansetron orodispersible films (Setofilm®) for the following reviewed indications:

  • Prophylaxis of acute nausea and vomiting induced by moderately emetogenic chemotherapy.
  • Prophylaxis and treatment of delayed nausea and vomiting induced by moderately to highly emetogenic     chemotherapy.
  • Prophylaxis and treatment of acute and delayed nausea and vomiting induced by highly emetogenic radiotherapy.
  • Prophylaxis and treatment of post-operative nausea and vomiting (PONV).

is included in the GGC Adult Formulary (Total Formulary) for the indications in question.  Use of this formulation is restricted to specialist initiation in patients with an enhanced risk of aspiration or who experience difficulties in swallowing.

For relevant SMC advice click here

Ranibizumab (Lucentis®) for the treatment for visual impairment due to choroidal neovascularisation secondary to pathologic myopia in adults in included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use. 

For relevant SMC advice click here

Saxagliptin (Onglyza®) for the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as triple oral therapy in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control is included in the GGC Adult Formulary for the indication in question. It is restricted to use in patients who are inadequately controlled on their respective maximal tolerated doses of metformin and sulphonylurea.

For relevant SMC advice click here

Sodium phenylbutyrate (Pheburane®) granules for adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase is included in the GGC Adult Formulary for the indication in question restriced to specialist initiation. Available granule formulations are not dose equivalent and are not interchangeable and should be prescribed by brand name to avoid confusion.

For relevant SMC advice click here

Vemurafenib (Zelboraf®) as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is included in the GGC Adult Formulary for the indication in question restricted to specialist use for first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma pending regional protocol.

For relevant SMC advice click here

Vildagliptin (Galvus®) for the treatment of type 2 diabetes mellitus in adults as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control is included in the GGC Adult Formulary for the indication in question. It is restricted to use in patients who are inadequately controlled on their respective maximal tolerated doses of metformin and sulphonylurea.

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.

Azelastine hydrochloride plus fluticasone propionate (Dymista®) for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Botulinum toxin type A (Botox®) for the management of bladder dysfunctions in adult patients with overactive bladder with symptoms of urinary incontinence, urgency and frequency who are not adequately managed with anticholinergics is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Bosutinib film coated tablets (Bosulif®) for the treatment of adult patients with chronic phase, accelerated phase, and blast phase Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Canakinumab (Ilaris®) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged two years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids is not included in the GGC Paediatric Formulary for the indication in question. This applies to treatment either as monotherapy or in combination with methotrexate.

For relevant SMC advice click here

Cefuroxime sodium (Aprokam®) as antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Imiquimod (Zyclara®) as topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Lapatinib (Tyverb®) for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Micronized progesterone (Utrogestan® Vaginal) as supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles 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 Decisions

Ondansetron orodispersible films (Setofilm®) for the reviewed indications 

  • Management of chemotherapy-induced nausea and vomiting in children aged  ≥6 months.
  • Prophylaxis and treatment of post-operative nausea and vomiting (PONV) in children aged  ≥4 years.

is included in the GGC Paediatric Formulary for the indication in question.  Use of this formulation is restricted to specialist initiation in patients with an enhanced risk of aspiration or who experience difficulties in swallowing.

For relevant SMC advice click here

Sodium phenylbutyrate (Pheburane®) granules for adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase is included in the GGC Paediatric Formulary for the indication in question restricted to specialist initiation. Available granule formulations are not dose equivalent and are not interchangeable and should be prescribed by brand name to avoid confusion.

For relevant SMC advice click here