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

Formulary Update (June 2015)

Additions to the GGC Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutic Committee (ADTC) met on 8th June 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.

Apixaban (Eliquis®) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults is included in the GGC Adult Formulary (Preferred List) for the indication in question.

For relevant SMC advice click here

Apremilast tablets (Otezla®) for active psoriatic arthritis (PsA) in adults is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in patients with active psoriatic athritis who have had an inadequate response with at least two prior disease modifying anti-rheumatics drugs (DMARDs) or who are intolerant to such therapies.

For relevant SMC advice click here

Apremilast tablets (Otezla®) for the treatment of severe chronic plaque psoriasis in adults who have failed to respond or have contraindications to, or are intolerant of other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) is included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use.

For relevant SMC advice click here

Budesonide capsules (Budenofalk®) for the treatment of autoimmune hepatitis is included in the GGC Adult Formulary for the indication in question.  It is restricted to specialist initiation in non-cirrhotic patients who are intolerant of conventional oral steroids (prednisolone) with severe corticosteroid-related side effects (actual or anticipated) such as psychosis, poorly controlled diabetes or osteoporosis.

For relevant SMC advice click here

Dexamethasone intravitreal implant (Ozurdex®) for treatment of adults with visual impairment due to diabetic macular oedema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid 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

Idelalisib tablets (Zydelig®) as monotherapy for treatment of adults with follicular lymphoma (FL) that is refractory to two prior lines of treatment is included in the GGC Adult Formulary pending protocol for the indication in questions.  It is restricted to specialist use in accordance with regional protocol (in development).

For relevant SMC advice click here

Levonorgestrel intrauterine delivery system (Levosert®) for use as contraception and for heavy menstrual bleeding is included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Linagliptin tablets (Trajenta®) for the treatment of type 2 diabetes mellitus to improve glycaemic control in adults in combination with insulin, with or without metformin. when this regimen alone, with diet and exercise, does not provide adequate glycaemic control is included in the GGC Adult Formulary (Preferred List) for the indication in question.

For relevant SMC advice click here

Linagliptin with metformin (Jentadueto®) for the treatment of adults with type 2 diabetes mellitus in combination with insulin (i.e. triple therapy) as an adjunct to diet and exercise when insulin and metformin alone 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 for whom a combination of linagliptin and metformin is an appropriate choice and these fixed-doses are considered appropriate and where there is demonstrable compliance issues with the separate constituents.

For relevant SMC advice click here

Liraglutide pre-filled pen (Victoza®) for the treatment of adults with type 2 diabetes mellitus in combination with basal insulin when this, together 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 specialist initiation.

For relevant SMC advice click here

Ofatumumab infusion (Arzerra®) in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy is included in the GGC Adult Formulary pending protocol for the indication in question. It is restricted to specialist use in accordance with regional protocol (in development) in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy.

For relevant SMC advice click here

Ombitasvir, paritaprevir and ritonavir (Viekirax®) with dasabuvir (Exviera®) with or without ribabvirin for the treatment of genotype 1 chronic hepatitis C (CHC) in adults are included in the GGC Adult Formulary for the indication in question. It is restricted to specialist use in accordance with local protocol.

For relevant SMC advice click here

Secukinumab pre-filled pen (Cosentyx®) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy is included in the GGC Formulary for the indication in question. It is restricted to specialist use in patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to or have contraindications to these treatments.

For relevant SMC advice click here

Vedolizumab infusion (Entyvio®) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist is included in the GGC Formulary for the indication in question.  It is restricted to specialist use in accordance with regional protocol (in development).

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.

Cangrelor infusion (Kengrexal®) for use with aspirin for the reduction of thrombotic cardiovascular events in adults with coronary artery disease undergoing percutaneous coronary intervention is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Collagenase clostridium histolyticum injection (Xiapex®) for the treatment of adult men with Peyronie's disease is not included in the GGC Adult Formulary for the indication in question.

For relevant SMC advice click here

Insulin Degludec injection (Tresiba®) for the treatment of diabetes mellitus is not included in the GGC Adult or Paediatric Formulary for the indication in question.

For relevant SMC advice click here

Paclitaxel Albumin infusion (Abraxane®) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adults who are not candidates for potentially curative surgery and/or radiation therapy 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 pre-filled syringe (Humira®) for the treatment of active enthesitis-related arthritis in patients 6 years and older, who have had an inadequate response to, or who are intolerant of conventional therapy.

For relevant SMC advice click here

Entecavir tablets and oral solution (Baraclude®) for chronic hepatitis B in patients age from 2 to <18 years (see SMC advice for full details of indication).

For relevant SMC advice click here

Other Formulary Decisions

NICE Technology Appraisal TA323: Erythropoesis stimulating agents. Following consultation with regional specialist services, this advice does not require any changes to the GGC Adult Formulary because clinicians do not support the formulary inclusion.

For the relevant NICE/HIS advice click here

GGC Adult Formulary Section Review: Respiratory Medicine. ADTC endorsed the recommendations made during the recent Formulary Section Review of medicines pertaining to respiratory medicine (Sections 3.1, 3.2 and 3.3).  Refer to the relevant sections of the GGC Adult Formulary.