Formulary News (December 2011)
Please note: All these changes will be reflected in the Formulary database
Additions to Formulary
Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on December 12th and added the following medicines/indications/ formulations to the GGC Formulary. Additions are to the Total Formulary unless specified otherwise.
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.
Bendamustine hydrochloride (Levact®) for first-line treatment of chronic lymphocytic leukaemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate. Restricted to specialist use in accordance with regional protocol.
For the relevant SMC advice click here
Capecitabine (Xeloda®) for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer in combination with oxaliplatin was acknowledged as a new indication for specialist use in accordance with regional protocol.
For the relevant SMC advice click here
Dabigatran (Pradaxa®) for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors was acknowledged as a new indication. Use is restricted to patients currently receiving warfarin who have poor INR control despite evidence that they are complying, or patients with allergy or intolerable side effects from coumarin anticoagulants. Use in other patient groups remains non-Formulary. Further information regarding dabigatran can be found in the National Consensus Statement on the NHS HIS website (link here).
For the relevant SMC advice click here
Golimumab (Simponi®) for use in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients was added to Formulary. It is restricted to specialist use in accordance with the British Society for Rheumatology (BSR) guidelines (2005). Only the 50mg dose was accepted by SMC and therefore the 100mg dose remains non-Formulary.
For the relevant SMC advice click here
Mifamurtide (Mepact®) for use in combination with other chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. Restricted to specialist use in accordance with regional protocol.
For the relevant SMC advice click here
Paliperidone Palmitate (Xeplion®) for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. It is restricted to specialist use only under the overall supervision of a psychiatrist.
For the relevant SMC advice click here
Rituximab (MabThera®) for treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy was acknowledged as a new indication. It is restricted to specialist use in accordance with regional protocol.
For the relevant SMC advice click here
Somatropin (Saizen®) for growth failure or growth disturbance in children and adolescents and growth hormone replacement in adults with pronounced deficiency (see SMC advice for full indication details). This new formulation was acknowledged restricted to specialist initiation.
For the relevant SMC advice click here
New medicines, indications and formulations not added to Formulary
The following were not added to Formulary following the latest ADTC meeting (it should be noted that these medicines may be included in the Formulary for other indications or for other formulations. Please refer to Formulary for full information):
Aprepitant (Emend®) for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
For the relevant SMC advice click here
Cabazitaxel (Jevtana®) for the combination treatment of patients with hormone refractory metastatic prostate cancer.
For the relevant SMC advice click here
Denosumab (Xgeva®) for the prevention of skeletal related events in adults with bone metastases from solid tumours.
For the relevant SMC advice click here
Dexamethasone intravitreal implant (Ozurdex®) for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
For the relevant SMC advice click here
Naproxen and Esomeprazole (Vimovo®) for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
For the relevant SMC advice click here
Other Formulary decisions
Bortezomib (Velcade®) for first-line treatment of multiple myeloma in combination with an alkylating agent and a corticosteroid was added as a new indication following advice from NICE TA228. It is restricted to specialist use in accordance with regional protocol.
For the relevant NICE advice click here
Formulary decisions still to be made
The following new medicines, indications or formulations have had a decision on Formulary status deferred to allow further consultation, protocol development or implementation plans. Until a decision is made, these medicines, indications or formulations are non-Formulary.
? Apixaban (Eliquis®) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery (Orthopaedic Surgeons)
? Boceprevir (Victrelis®) for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (Hepatitis MCN)
? Ranibizumab (Lucentis®) for treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) (branch RVO or central RVO) in adults (Clinical Director of Ophthalmology)
? Telaprevir (Incivo®) for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (Hepatitis MCN)
Formulary reviews
A multidisciplinary group representing both primary care and the acute sector has recently reviewed much of chapter 13: Skin of the GGC Formulary. The recommendations of this group have been approved by the Formulary and New Drugs Subcommittee of ADTC and the subsequent changes to Formulary have been implemented in the online database.
The asthma and COPD sections of Chapter 3 have also recently been reviewed. These recommendations are still to be considered by Formulary and New Drugs Subcommittee and it is expected that the subsequent changes to Formulary content will take place in February 2012.
Also, a review of the contraception section of the Formulary is currently in progress, again with expected changes to Formulary content expected to be reviewed and implemented in February 2012.