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

Formulary News (August 2012)

Additions to Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on August 13th and added the following medicines/indications/ formulations to the GGC Formulary. Additions are to the Total Formulary unless specified otherwise.

Azacitidine (Vidaza®) is included in the Total Formulary for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).  It is restricted to specialist use in accordance with regional protocol, which excludes the routine use in chronic myelomonocytic leukaemia (CMML). 

For the relevant SMC advice click here

Eplerenone (Inspra®) for use in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%) is included in the Total Formulary.  It is restricted to prescribers working with specialised heart failure teams only for use in patients intolerant to spironolactone. 

For the relevant SMC advice click here 

Fidaxomicin (Dificlir®) for the treatment of adults with Clostridium difficile  infections also known as C. difficile- associated diarrhoea (CDAD) is included in the Total Formulary. It is restricted to use for the treatment of adults with microbiologically proven recurrence of Clostridium difficile infections (CDI) only on the advice of Consultant microbiologists or Consultants in Infectious Diseases. An Alert Antibiotic form must be completed prior to issue from pharmacy.

It is non-formulary for use in adults with first episodes of CDI or as empirical treatment in CDI.

Golimumab (Simponi®) is included in the Total Formulary for use alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. It is restricted to specialist use in patients whose disease has not responded to adequate trials of at least two standard DMARDs, administered either individually or in combination.  It is also restricted to use at a dose of 50mg only. 

For the relevant SMC advice click here

Mercaptopurine oral suspension (Xaluprine®) for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children is included in the Total Formulary.  It is restricted to specialist use. 

For the relevant SMC advice click here

Nilotinib (Tasigna®) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase is included in the Total Formulary restricted to specialist use in accordance with regional protocol.  

For the relevant SMC advice click here

Rufinamide oral suspension (Inovelon®) is  a new formulation which is included in the Total Formulary for the adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 4 years of age or older. It is restricted to specialist initiation in patients who have failed treatment with or are intolerant of other antiepileptic drugs.

For the relevant SMC advice click here

Tadalafil (Adcirca®) is included in the Total Formulary for the treatment of adults with pulmonary arterial hypertension (PAH) classified as World Health Organisation functional class (WHO-FC) II and III, to improve exercise capacity. It is restricted to prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists.

For the relevant SMC advice click here

Ticagrelor (Brilique®) is licensed for use in combination with aspirin for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). It is included in the Total Formulary restricted to specialist initiation only for patients who are either allergic or intolerant to clopidogrel or those who have a stent thrombosis on clopidogrel.  Use in other patient groups currently remains non-Formulary until regional / national position is clarified.

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 ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine or who are intolerant to or have medical contraindications for such therapies.

For the relevant SMC advice click here

Amifampridine (Firdapse ®) is not included in the Adult Formulary for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

For the relevant SMC advice click here

Azilsartan medoxomil (Edarbi®) is not included in the Adult Formulary for the treatment of essential hypertension in adults.

The relevant SMC advice is currently not available.

Azithromycin dehydrate eye drops (Azyter®) are not included in the Adult Formulary for the local antibacterial treatment of conjunctivitis.

The relevant SMC advice is currently not available

Rifaximin (Xifaxanta®) is not included in the Adult Formulary for the treatment of travellers' diarrhoea.

For the relevant SMC advice click here

Thiotepa powder (Tepadina®) is not included in the Adult Formulary for the use in combination with other chemotherapy for conditioning prior to haematopoietic progenitor cell transplantation (HPCT) in haematological diseases or the treatment of solid tumours when high dose chemotherapy with HPCT support is appropriate.

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.

Abiraterone acetate (Zytiga®) for use with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. (Regional Cancer Advisory Group)

For the relevant SMC advice click here

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

Pegylated interferon alfa-2b (Viraferon Pegol ®) in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA is not included in the Paediatric Formulary pending consultation /protocol.

For the relevant SMC advice click here

Other Formulary information

The following advice has been noted by ADTC.

NICE MTA241: Dasatinib, Nilotinib, Imatinib for the 2nd line treatment of chronic myeloid leukaemia (CML).  Following advice, dasatinib is to be removed from the Adult Formulary. No other changes to Formulary are required.

For the relevant NICE/NHS HIS advice click here

NICE MTA251: Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia.  Guidance is noted and no changes to Formulary are required

For the relevant NICE/NHS HIS advice click here

NICE MTA257: Lapatinib and trastuzumab for the 1st line treatment of metastatic hormone receptor positive breast cancer that overexpresses HER2 in combination with an aromatase inhibitor.  Guidance is noted and no changes to Formulary are required

For the relevant NICE/NHS HIS advice click here

Methotrexate pre-filled syringes (Metoject®) which is currently included in the Total Formulary has had its Formulary restriction amended to specialist initiation but suitable for continuation by GPs for the use in the management of severe active rheumatoid arthritis.

For the relevant SMC advice click here