Formulary Update (April 2015)
Additions to the GGC Adult Formulary
Greater Glasgow and Clyde Area Drug and Therapeutic Committee (ADTC) met on 20th April 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.
Aclidinium and Formoterol (Duaklir Genuair®) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) is included in the GGC Adult Formulary Preferred List.
For relevant SMC advice click here
Dabrafenib (Tafinlar®) as monotherapy treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use only in accordance with regional protocol for use in patients with unresectable or metatstatic BRAF V600 mutation-positive metastatic melanoma who have received no prior therapy.
For relevant SMC advice click here
Fingolimod (Gilenya®) as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for adult patients with high disease activity despite treatment with at least one disease modifying therapy is included in GGC Adult Formulary. It is restricted to specialist use only.
For relevant SMC advice click here
Fosfomycin IV infusion (Fomicyt®) is included in the GGC Adult Formulary for the treatment of the following infections in adults and children including neonates:
- Acute osteomyelitis
- Complicated urinary tract infections
- nosocomial lower respiratory tract infections
- bacterial meningitis
- bacteraemia that occurs with, or is suspected to be associated with, any of the infections listed above
It is restricted to specialist use only on the advice of a microbiologist or infectious disease physician for multi-resistant organisms and is classed as an 'Alert Antibiotic'.
For relevant SMC advice click here
Idelalisib (Zydelig®) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use in accordance with regional protocol (under development) in patients with relapsed CLL who are unsuitable for chemotherapy and treatment naive patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.
For relevant SMC advice click here
Infliximab (Inflectra® and Remsima®): Infliximab is already included in the GGC Adult Formulary and these new biosimilar preparations are acknowledged for the range of indications subject to local implementation. Inflximab is restricted to specialist use in accordance with existing formulary restrictions.
For relevant SMC advice click here and click here
Ledipasvir and sofosbuvir (Harvoni®) for the treatment of chronic hepatitis C (CHC) in adult patients is included in the GGC Adult Formulary. It is restricted to specialist use only in patients with genotype 1 and 4 chronic hepatitis C in accordance with local protocol and implementation plan.
For relevant SMC advice click here
Levonorgestrel IUD (Jaydess®) as contraception for up to 3 years duration is included in the GGC Adult Formulary.
For relevant SMC advice click here
Nintedanib (Vargatef®) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use only in accordance with regional protocol (under development).
For relevant SMC advice click here
Ponatinib (Iclusig®) for the treatment of:
- chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolreant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have theT215l mutation
- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or T315l mutation
is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use only in accordance with regional protocol (under development).
For relevant SMC advice click here
Regorafenib (Stivarga®) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use only in accordance with regional protocol (under development).
For relevant SMC advice click here
Ruxolitinib (Jakavi®) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (aslo know as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis is included in the GGC Adult Formulary pending protocol. It is restricted to specialist use only in accordance with regional protocol (under development).
For SMC advice click here
Sucroferric oxyhydroxide (Velphoro®) to control of serum phosphorus levels in adult chronic kideny disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD) is included in the GGCAdult Formulary. It is restricted to specialist initiation for second-line therapy where a non-calcium phosphate binder is required.
For relevant SMC advice click here
Tacrolimus monohydrate (Envarsus®) as prophylaxis of transplant rejection in adult kideny or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients is included in the GGC Adult Formulary. It is restricted to specialist initiation.
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.
Apixaban (Eliquis®) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults is not included in the GGC Adult Formulary (pending protocol) for the indication in question. Implementation plans will be considered at the next ADTC meeting and Formulary status will be updated.
For relevant SMC advice click here
Cabozantinib (Cometriq®) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma is not included in the GGC Adult Formulary for the indication in question.
For relevant SMC advice click here
Other Formulary Decisions
Infliximab, adalimumab and golimumab for the treatment of moderately to severely active ulcerative colitis in adults are included in the GGC Adult Formulary. Their use is restricted to specialist use in those patients whose disease has responded inadequately to conventional therapy including corticosteroids, mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for such therapies.
For relevant NICE/HIS advice click here
Trospium chloride for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder is included in the GGC Adult Total Formulary.