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

Formulary News (Feb 2013)

Additions to Adult Formulary

Greater Glasgow and Clyde Area Drug and Therapeutics Committee (ADTC) met on February 18th 2013 and added the following medicines/indications/ formulations to the GGC Formulary.  Additions are to the Total Formulary unless specified otherwise.

Apixaban tablets (Eliquis®) is included in the Total Formulary for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, with one or more risk factors. It is restricted to patients currently receiving warfarin who have poor INR control despite evidence that they are complying, patients with allergy or intolerable side effects from coumarin anticoagulants or for patients for whom warfarin has been clinically excluded as a therapeutic option but anticoagulation is deemed safe and appropriate. Preference over warfarin for practical rather than clinical reasons remains non-Formulary.  ADTC is committed to reviewing these restrictions following anticipated local/national advice.

For the relevant SMC advice click here

Budesonide gastro-resistant capsule (Budenofalk®) for the symptomatic relief of chronic diarrhoea due to collagenous colitis is included in the Total Formulary restricted to specialist initiation.

For the relevant SMC advice click here

Budesonide gastro-resistant granules (Budenofalk®) are included in the Total Formulary restricted to specialist initiation for the induction of remission in patients with active collagenous colitis

For the relevant SMC advice click here

Ceftaroline fosamil infusion (Zinforo®) for the treatment of complicated skin and soft tissue infections in adults in included in the Total Formulary.  It is restricted to specialist use on the advice of local microbiologists or specialists in infectious disease for patients with known or suspected meticillin resistant Staphylococcus aureus (MRSA) infection in the following settings:

  • For Gram-positive only infections where vancomycin iv is inappropriate/has not been tolerated or treatment modification is required; and daptomycin iv or linezolid iv is normally used.
  • For polymicrobial Gram-positive and common Gram-negative pathogens*, where vancomycin iv in combination with gentamicin iv is inappropriate/has not been tolerated or treatment modification is required; and daptomycin iv in combination with gentamicin iv, or linezolid iv in combination with gentamicin iv, or tigecycline iv is normally used.

Ceftaroline is also licensed for the treatment of community acquired pneumonia, but this indication has not been reviewed by SMC and is therefore non-Formulary.

For the relevant SMC advice click here

Clostridium botulinum type A toxin-haemagglutinin complex (Dysport®) for use in the focal spasticity of the upper limbs associated with stroke is included in the Total Formulary restricted to specialist use.

For the relevant SMC advice click here

Colecalciferol 800 units (20 micrograms vitamin D3) tablets (Desunin 800 IU®) are included in the Total Formulary.  Desunin® contains 800 units of colecalciferol. It should be noted that this preparation is double the daily recommended dose of Vitamin D for adults who are considered to be at risk of vitamin D deficiency as outlined in guidance issued from the Chief Medical Officer for Scotland in February 2012. Healthy Start vitamins contain 400 units of vitamin D and are available for eligible patient groups in NHSGGC and vitamin supplement preparations containing 400 units of vitamin D are readily available for purchase over the counter from pharmacies and health food shops.
Guidance on when to measure vitamin D levels and the subsequent management are currently in development by the GG&C Osteoporosis Group and Biochemistry Department

For the relevant SMC advice click here

Dapagliflozin tablets (Forxiga®) is included in the Total Formulary for adults with type 2 diabetes mellitus. It is restricted to initiation by clinicians experienced in the management of diabetes as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate.

For the relevant SMC advice click here

Dexamethasone implant (Ozurdex®) is included in the Total Formulary restricted to specialist use in adult patients with macular oedema (i) following central retinal vein occlusion (CRVO) and (ii) in patients with branch retinal vein occlusion (BRVO) who are not clinically suitable for laser treatment including patients with dense macular haemorrhage or patients who have received and failed on previous laser treatment in accordance with local protocol.

For the relevant SMC advice click here

Ferumoxytol injection (Rienso®) is included in the Total Formulary.  It is restricted to the treatment of iron deficiency anaemia in non-haemodialysis dependent adult patients with chronic kidney disease when oral iron preparations are ineffective or cannot be used and when standard IV iron is inappropriate due to its administration schedule.

For the relevant SMC advice click here

Glycopyrronium for inhalation (Seebri Breezhaler®) is included in the Total Formulary as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

For the relevant SMC advice click here

Linagliptin tablets (Trajenta®) for is included in the Total Formulary for the indication in question restricted to use:

  • as monotherapy in patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance.
  • as combination therapy with a sulphonylurea and metformin when diet and exercise plus dual therapy does not provide adequate glycaemic control.

Use of linagliptin in combination with insulin is not recommended by SMC and is non-Formulary.

For the relevant SMC advice click here

Linagliptin plus metformin tablets (Jentadueto®) for the Treatment of adult patients with type 2 diabetes mellitus:

  • as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.
  • in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

Is included in the Total Formulary. It is restricted to use in patients for whom a combination of linagliptin and metformin is an appropriate choice of therapy and these fixed-doses are considered appropriate and where there is demonstrable compliance issues with the separate constituents

For the relevant SMC advice click here

Vildagliptin tablets (Galvus®) for the treatment of type 2 diabetes mellitus in adults as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance is included in the Total Formulary restricted to use in patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance

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.

Brentuximab vedotin infusion (Adcetris®) for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):

  • following autologous stem cell transplant (ASCT) or
  • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

For the relevant SMC advice click here

Decitabine infusion (Dacogen®) for Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

For the relevant SMC advice click here

Etoricoxib tablets (Arcoxia®) for the short-term treatment of moderate pain associated with dental surgery.

For the relevant SMC advice click here

Hydrocortisone modified-release tablets (Plenadren®) for the treatment of adrenal insufficiency in adults.

For the relevant SMC advice click here

Ivacaftor tablets (Kalydeco®) for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.  In response to advice from the Scottish Government, access to this medicine for suitable patients is available via the Group Patient Request process (requires NHS Network access).

For the relevant SMC advice click here

Mannitol inhalation powder hard capsule (Bronchitol®) for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care

For the relevant SMC advice click here

Palonosetron capsules (Aloxi®) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults is not included in the GGC Adult Formulary because the NHS GGC decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question.

For the relevant SMC advice click here

Tadalafil tablets (Cialis®) for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males

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.

Additions to Paediatric Formulary

The following new medicines, indications or formulations have been considered for the GGC Paediatric Formulary Decisions.

Etanercept injection (Enbrel®) For the treatment of:

  • polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate;
  • psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate;
  • enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Is included in the GGC Paediatric Formulary restricted to use within specialist rheumatology services (including those working within the network for paediatric rheumatology).

For the relevant SMC advice click here

Etanercept injection (Enbrel®) for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies in included in the GGC Paediatric Formulary. It is restricted to specialist use in patient where:

  • The disease is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10;
  • the psoriasis has failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant to, or has a contraindication to, these treatments;

Etanercept treatment should be discontinued in patients whose psoriasis has not responded adequately at 12 weeks

For the relevant SMC advice click here

Pegylated interferon alfa-2b pre-filled pen (ViraferonPegol®) for use 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 included in the Paediatric Formulary restricted to specialist use.

For the relevant SMC advice click here

Somatropin (Saizen®) is included in the Paediatric Formulary for the treatment of growth failure and disturbance in children and adolescents is restricted to initiation and monitoring by a paediatrician with expertise in managing childhood growth disorders and growth hormone therapy.

For the relevant SMC advice click here

Other Formulary information               

The following advice has been noted by ADTC.

Following advice outlined in NICE TA243:
Rituximab (MabThera®) in combination with:

  • cyclophosphamide, vincristine and prednisolone (CVP)
  • cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)
  • mitoxantrone, chlorambucil and prednisolone (MCP)
    cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-α (CHVPi) or
  • chlorambucil

is recommended as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated people. 

The advice means that no changes are required to the GGC Adult Formulary or regional protocols.

For the relevant NICE advice click here

Following a New Drug Assessment:
Desogestrel 75microgram tablets (Cerelle®) is Included in the GGC Total Formulary for use as an oral contraceptive restricted to use in patients in whom oestrogen containing contraceptives are not tolerated or are contra-indicated

Following a Formulary Appeal:
Micafungin infusion (Mycamine®) is included in the Total Formulary for the treatment of invasive candidiasis in adults, elderly, and children (including neonates) where other treatment options are unsuccessful or inappropriate. It is restricted to specialist use only on the advice of a consultant microbiologist or infectious disease physician.

Use for the treatment of oesophageal candidiasis, or for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have for 10 or more days is not recommended by SMC and is non-Formulary.

For the relevant SMC advice click here

Following a Formulary Appeal:
Temocillin injection (Negaban®) is included in the Total Formulary restricted to specialist use only on the advice of a microbiologist or an infectious disease physician as second line therapy in severely-ill patients with confirmed ESBL- or AmpC related infections.