Formulary Update (August 2015)
Additions to the GGC Adult Formulary
Greater Glasgow and Clyde Area Drug and Therapeutic Committee (ADTC) met on 17th August 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.
Ceftobiprole (Zevtera®) for the treatment of pneumonia in adults is included in the GGC Adult Formulary (Total Formulary) for the indication in question. It is restricted to use only on the advice of a Microbiologist or Infectious Disease specialist for use in the treatment of HAP (excluding VAP) when activity is required against suspected methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens (including Pseudomona aeruginosa, Escherichia coli and Klebsiella pneumoniae) and when combination treatment that includes vancomycin or teicoplanin is inappropriate or has not been tolerated, or when treatment modification is required, i.e. as an alternative to linezolid-based regimen. This wil be managed as an Alert Antimicrobial.
For relevant SMC advice click here
Darunavir and Cobicistat tablets (Rezolsta®) for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older is included in the GGC Formulary for the indication in question. It is restricted to use by HIV specialists.
For relevant SMC advice click here
Magnesium aspartate dihydrate sachets (Magnaspartate®) for the treatment and prevention of magnesium deficiency, as diagnosed by a doctor is included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Posaconazole infusion (Noxafil®) for the treatment of specific fungal infections in adults and prophylaxis of invasive fungal infections in specific patient groups (see SMC advice for full details of the indication) is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use only in patients when the oral route of administration is compromised.
For relevant SMC advice click here
Riociguat tablets (Adempas®) for the treatment of adults with pulmonary arterial hypertension (PAH) is included in the GGC Adult Formulary. It is restricted to use as a PAH-specific monotherapy as an alternative treatment option to endothelin receptor antagonist (ERA) monotherapy in adult patients with PAH of WHO FC II to III. It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or by similar specialists.
For relevant SMC advice click here
Sorafenib tablets (Nexavar®) for the treatment of patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma, refractory to radioactive iodine is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use in accordance with regional protocol (in development).
For relevant SMC advice click here
Tedizolid phosphate tablets and infusion (Sivextro®) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults is included in the GGC Adult Formulary for the indication in question. It is restricted to use only on the advice of microbiologists and specialists in infectious diseases for use in patients with ABSSSI caused by Gram-positive Staphylococcus aureus (specifically methicillin-resistant Staphylococcus aureus [MRSA] isolates) as an alternative oxazolidinone antibacterial. This will be managed as an Alert Antimicrobial.
For relevant SMC advice click here
Tinzaparin pre-filled syringe (Innohep®) for extended treatment of symptomatic venous thrombo-embolism (VTE) and prevention of its recurrence in patients with solid tumours is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist initiation.
For relevant SMC advice click here
Vedolizumab infusion (Entyvio®) for the treatment of adult patients with moderately to severely active Crohn's disease is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use in accordance with local protocol (in development) for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a TNFα antagonist.
For relevant SMC advice click here
Deferred Formulary Decisions
ADTC has deferred Formulary decisions for the following SMC advice:
Tiotropium solution for inhalation (Spiriva Respimat) as add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 micrograms budesonide/day or equivalent) and long-acting beta2 agonists and who experienced one or more severe exacerbations in the previous year. Addition to the Formulary is deferred to allow the development of guidance and an implementation plan.
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 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.
Eribulin injection (Halaven®) for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Enzalutamide capsules (Xtandi®) for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) 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 relevant SMC advice click here
Olaparib capsules (Lynparza®) as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Panitumumab infusion (Vectibix®) for the treatment of adult patients with wild-type RAS metastatic colorectal cancer first-line in combination with FOLFIRI is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Rivaroxaban tablets (Xarelto®) in combination with aspiring or with aspirin and clopidogrel or ticlopidine for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Vinflunine infusion (Javlor®) as monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Formulary decisions relating to the GGC Paediatric Formulary
The following SMC advice is still awaiting consideration by the Paediatric D&T for inclusion in the GGC Paediatric Formulary.
Adalimumab injection (Humira®) for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
For relevant SMC advice click here
Darunavir tablets. suspension (Prezista®) for use with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in paediatric patients aged 3 - 12 years (see SMC advice for full indication)
For relevant SMC advice click here
Palonosetron injection (Aloxi®) for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in paediatric patients 1 month of age and older.
For relevant SMC advice click here
Other Formulary Decisions
Calcium and Vitamin D chewable tablets (TheiCal-D3®) for the prevention and treatment of vitamin D and calcium deficiency in the elderl and as a vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency is included in the GGC Adult Formulary (Preferred List).