Formulary Group Decisions January 2011
NICE (Multiple) Technology Appraisal Guidance
NICE (Multiple) Technology Appraisal Guidance No 187 -
Infliximab (review) and adalimumab for the treatment of Crohn's disease (including a review of technology appraisal guidance 40).The review and re-appraisal of infliximab for the treatment of severe active or active fistulising Crohn's disease has resulted in a change in the guidance. Specifically, infliximab should now be given as a planned course of treatment until treatment failure (including the need for surgery) or for 12 months, whichever is shorter. Treatment should then only be continued if there is clear evidence of ongoing active disease. Adalimumab is now also recommended as another treatment option for people with severe active Crohn's disease.
Infliximab (review) and adalimumab for the treatment of Crohn's disease (including a review of technology appraisal guidance 40).The review and re-appraisal of infliximab for the treatment of severe active or active fistulising Crohn's disease has resulted in a change in the guidance. Specifically, infliximab should now be given as a planned course of treatment until treatment failure (including the need for surgery) or for 12 months, whichever is shorter. Treatment should then only be continued if there is clear evidence of ongoing active disease. Adalimumab is now also recommended as another treatment option for people with severe active Crohn's disease.Approved for use in NHS Grampian
Adalimumab 40mg injection (Humira®)
Chronic bowel disorders BNF 1.5
Adalimumab 40mg injection (Humira®) was approved for inclusion in the Grampian Joint Formulary for restricted use as a treatment option for adults with severe active Crohn's disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. Adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. Available for restricted use under specialist supervision and recommended for hospital use only.
Adalimumab 40mg injection (Humira®)
was approved for inclusion in the Grampian Joint Formulary for restricted use as a treatment option for adults with severe active Crohn's disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. Adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. Available for restricted use under specialist supervision and recommended for hospital use only.Bio-Melatonin® 3mg tablets
Hypnotics and anxiolytics BNF 4.1
Bio-Melatonin® 3mg tablets [unlicensed product] was approved for inclusion in the Grampian Joint Formulary for restricted use for use in children over 3 years of age with neuro-developmental disorders (including ADHD), autism spectrum disorders (ASDs), visual impairment, or other neuropsychiatric disorders, and chronic sleep disturbance where:
Hypnotics and anxiolytics BNF 4.1
Bio-Melatonin® 3mg tablets [unlicensed product] was approved for inclusion in the Grampian Joint Formulary for restricted use for use in children over 3 years of age with neuro-developmental disorders (including ADHD), autism spectrum disorders (ASDs), visual impairment, or other neuropsychiatric disorders, and chronic sleep disturbance where:
- Sleep hygiene measures have not been effective,
- Symptoms of sleep disturbance have been present for at least six months,
- Sleep disturbance is associated with significant interference with daily functioning.
Available for restricted use under specialist supervision and treatment to be initiated in hospital prior to handover. Dose should be stable before handover to primary care.
Not approved for use in NHS Grampian
In the absence of a submission from the holder of the marketing authorisation
Botulinum toxin type A injection (Azzalure®)
Drugs used in essential tremor, chorea, tics, and related disorders BNF 4.9.3
Botulinum toxin type A injection (Azzalure®) is not recommended for use within NHS Scotland.
Indication under review: for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical 'frown' lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication due to its cosmetic nature. As a result we cannot recommend its use within NHS Scotland [SMC 679/11].
Indication under review: for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical 'frown' lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication due to its cosmetic nature. As a result we cannot recommend its use within NHS Scotland [
SMC 679/11]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation
Botulinum toxin Type A injection (Vistabel®)Drugs used in essential tremor, chorea, tics, and related disorders BNF 4.9.3
Botulinum toxin Type A injection (Vistabel®) is not recommended for use within NHS Scotland.
Indication under review: for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical "frown" lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication due to its cosmetic nature. As a result we cannot recommend its use within NHS Scotland [SMC 680/11].
Indication under review: for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical "frown" lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication due to its cosmetic nature. As a result we cannot recommend its use within NHS Scotland [
SMC 680/11]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Erlotinib tablets (Tarceva®)
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Erlotinib tablets (Tarceva®) is not recommended for use within NHS Scotland.Indication under review: as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy.
Erlotinib maintenance treatment provided a statistically significant increase in progression free survival and overall survival in patients treated with standard first-line platinum-based chemotherapy, both in the whole study population and in a post hoc analysis in patients with stable disease. In the whole study population the changes in these outcomes were considered to be of modest size.
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC [
SMC 664/10].
SMC 664/10]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Ferric carboxymaltose injection (Ferinject®)
Parenteral iron BNF 9.1.1.2
Ferric carboxymaltose injection (Ferinject®) is not recommended for use within NHS Scotland.
Indication under review: the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.
Ferric carboxymaltose was superior to oral ferrous sulphate in raising haemoglobin levels in non-dialysis-dependent patients with chronic kidney disease and iron deficiency anaemia. It has also shown similar efficacy to standard intravenous iron therapy in haemodialysed patients.
However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC
[
SMC 463/08].
SMC 463/08]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Golimumab injection (Simponi®)
Drugs that suppress the rheumatic disease process, cytokine modulators BNF 10.1.3
Golimumab injection (Simponi®)
is not recommended for use within NHS Scotland.
is not recommended for use within NHS Scotland.Indication under review: 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.
Golimumab has demonstrated efficacy compared with placebo in patients with active psoriatic arthritis who have had an inadequate response to DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs).
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Golimumab is also licensed for use, in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to DMARD therapy including methotrexate has been inadequate and in the treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. SMC cannot recommend the use of golimumab in these indications as they were not included in the manufacturer?s submission to SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Histamine dihydrochloride injection (Ceplene®)
Other immunomodulating drugs BNF 8.2.4
Histamine dihydrochloride injection (Ceplene®) is not recommended for use within NHS Scotland.
Indication under review: maintenance therapy for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2. The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60 years.
In a randomised open-label study, histamine plus interleukin-2 was superior to no treatment for the endpoint of leukaemia free survival (LFS) in a sub-group of patients in first complete remission. In post hoc analysis of patients in first complete remission and aged less than 60 years, LFS rates at 36 months were 50% versus 30%. Overall the manufacturer did not present a sufficiently robust clinical or economic case to gain acceptance by SMC [
SMC 482/08].
SMC 482/08]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Miconazole muco-adhesive buccal tablet (Loramyc®)
Oropharyngeal anti-infective drugs BNF 12.3.2
Miconazole muco-adhesive buccal tablet (Loramyc®) is not recommended for use within NHS Scotland.
Indication under review: The treatment of oropharyngeal candidiasis (OPC) in immunocompromised patients.
Miconazole muco-adhesive buccal tablets were shown to be non-inferior in the treatment of OPC to another locally-acting miconazole preparation in patients with cancer of the head and neck who had received radiotherapy, and to another locally-acting anti-fungal in HIV-positive patients. There are no data comparing miconazole buccal tablets to treatments currently used in practice in Scotland in this patient group.
Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC [
SMC 517/08].
SMC 517/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Sorafenib tablets (Nexavar®)
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Sorafenib tablets (Nexavar®) is not recommended for use within NHS Scotland.
Indication under review: the treatment of hepatocellular carcinoma.
In one study in patients with advanced hepatocellular carcinoma, sorafenib was superior to placebo in terms of overall survival, but not for the time to symptomatic progression.
The manufacturer did not present a sufficiently robust economic analysis and in addition, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC [
SMC 482/08].
SMC 482/08]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation:
Velaglucerase intravenous infusion(Vpriv®)
Drugs used in metabolic disorders BNF 9.8.1
Velaglucerase intravenous infusion(Vpriv®) is not recommended for use within NHS Scotland.
Indication under review: for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease .
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland [SMC 681/11].
Velaglucerase intravenous infusion(Vpriv®) is not recommended for use within NHS Scotland.
Indication under review: for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease .
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland [
SMC 681/11].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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