Formulary Group Decisions March 2011
Approved for use in NHS Grampian
Capsaicin 179mg patches (Qutenza®)
Rubefacients, topical NSAIDs, capsaicin, and poultices BNF 10.3.2
Capsaicin 179mg patches (Qutenza®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of adults with post-herpetic neuralgia (PHN) who have not achieved adequate pain relief from, or who have not tolerated, conventional first- and second-line treatments. Treatment should be under the supervision of a specialist in pain management. Available for restricted use under specialist supervision and recommended for hospital use only.
Rubefacients, topical NSAIDs, capsaicin, and poultices BNF 10.3.2
Capsaicin 179mg patches (Qutenza®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of adults with post-herpetic neuralgia (PHN) who have not achieved adequate pain relief from, or who have not tolerated, conventional first- and second-line treatments. Treatment should be under the supervision of a specialist in pain management. Available for restricted use under specialist supervision and recommended for hospital use only.Nortriptyline tablets 10mg and 25mg
Tricyclic and related antidepressant drug BNF 4.3.1
Nortriptyline tablets 10mg and 25mg was approved for inclusion in the Grampian Joint Formulary for restricted use:
Tricyclic and related antidepressant drug BNF 4.3.1
Nortriptyline tablets 10mg and 25mg was approved for inclusion in the Grampian Joint Formulary for restricted use:
- as a treatment option in resistant depression in the elderly or patients unable to tolerate a range of other antidepressants due to side effects
- for post-stroke depression when other treatments have been ineffective.
Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.
Rituximab 10mg/mL concentrate for intravenous infusion (MabThera®)
Anti-lymphocyte monoclonal antibodies BNF 8.2.3
Rituximab 10mg/mL concentrate for intravenous infusion (MabThera®) was approved for inclusion in the Grampian Joint Formulary for restricted use for maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy. Available for restricted use under specialist supervision and recommended for hospital use only.
Anti-lymphocyte monoclonal antibodies BNF 8.2.3
Rituximab 10mg/mL concentrate for intravenous infusion (MabThera®) was approved for inclusion in the Grampian Joint Formulary for restricted use for maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy. Available for restricted use under specialist supervision and recommended for hospital use only.
Not approved for use in NHS Grampian
In the absence of a submission from the holder of the marketing authorisation
Bendamustine injection (Levact®)
8.1.1 Alkylating drugs
Bendamustine injection (Levact®) is not recommended for use within NHS Scotland [
SMC 700/11].
Indication under review: for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Bendamustine injection (Levact®)
8.1.1 Alkylating drugs
Bendamustine injection (Levact®)
is not recommended for use within NHS Scotland [
SMC 700/11].
Indication under review: for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
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.
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
Bendamustine injection (Levact®)
8.1.1 Alkylating drugs
Bendamustine injection (Levact®) is not recommended for use within NHS Scotland [
SMC 701/11].
Indication under review: for the front line treatment of indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Bendamustine injection (Levact®)
8.1.1 Alkylating drugs
Bendamustine injection (Levact®)
is not recommended for use within NHS Scotland [
SMC 701/11].
Indication under review: for the front line treatment of indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Botulinum toxin type A injection (Botox®)
Central nervous system BNF 4
Botulinum toxin type A injection (Botox®) is not recommended for use within NHS Scotland [SMC 692/11].
Indication under review: the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).
In pooled analysis of two phase III studies, botulinum toxin type A was superior to placebo for the primary endpoint, headache days. However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population.
Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Central nervous system BNF 4
Botulinum toxin type A injection (Botox®) is not recommended for use within NHS Scotland [
SMC 692/11].
Indication under review: the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).
In pooled analysis of two phase III studies, botulinum toxin type A was superior to placebo for the primary endpoint, headache days. However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population.
Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Calcium acetate 435mg/magnesium carbonate 235mg tablet (Osvaren®)
Phosphate-binding agents BNF 9.5.2.2
Calcium acetate 435mg/magnesium carbonate 235mg tablet (Osvaren®) is not recommended for use within NHS Scotland [SMC 693/11].
Indication under review: treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).
The combined preparation of calcium acetate/magnesium carbonate has been shown to reduce hyperphosphataemia associated with chronic renal disease.
However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Phosphate-binding agents BNF 9.5.2.2
Calcium acetate 435mg/magnesium carbonate 235mg tablet (Osvaren®) is not recommended for use within NHS Scotland [
SMC 693/11].
Indication under review: treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).
The combined preparation of calcium acetate/magnesium carbonate has been shown to reduce hyperphosphataemia associated with chronic renal disease.
However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
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
Cannabinoid oromucosal spray (Sativex®)
Skeletal muscle relaxants BNF 10.2.2
Cannabinoid oromucosal spray (Sativex®) is not recommended for use within NHS Scotland [
SMC 703/11].
Indication under review: as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Cannabinoid oromucosal spray (Sativex®)
Skeletal muscle relaxants BNF 10.2.2
Cannabinoid oromucosal spray (Sativex®)
is not recommended for use within NHS Scotland [
SMC 703/11].
Indication under review: as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Drospirenone/ethinylestradiol tablets (Yasmin®)
Combined hormonal contraceptives BNF 7.3.1
Drospirenone/ethinylestradiol tablets (Yasmin®) is not recommended for use within NHS Scotland [SMC 23/03].
Indication under review: oral contraception.
Drospirenone/ethinylestradiol has been shown to have similar contraceptive effectiveness to other combined oral contraceptives in routine use, with no significant differences in adverse event profile.
The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Combined hormonal contraceptives BNF 7.3.1
Drospirenone/ethinylestradiol tablets (Yasmin®) is not recommended for use within NHS Scotland [
SMC 23/03].
Indication under review: oral contraception.
Drospirenone/ethinylestradiol has been shown to have similar contraceptive effectiveness to other combined oral contraceptives in routine use, with no significant differences in adverse event profile.
The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Fesoterodine fumarate prolonged release tablets (Toviaz®)
Drugs for urinary frequency, enuresis, and incontinence BNF 7.4.2
Fesoterodine fumarate prolonged release tablets (Toviaz®) was not approved for use in NHS Grampian as a second-line choice in the treatment of the symptoms of overactive bladder.
Not recommended for use in NHS Grampian - will not be included in Grampian Joint Formulary for this indication.
Drugs for urinary frequency, enuresis, and incontinence BNF 7.4.2
Fesoterodine fumarate prolonged release tablets (Toviaz®) was not approved for use in NHS Grampian as a second-line choice in the treatment of the symptoms of overactive bladder.
Not recommended for use in NHS Grampian - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation
Paliperidone tablets (Invega®)
Antipsychotic drugs BNF 4.2.1
Paliperidone tablets (Invega®) is not recommended for use within NHS Scotland [
SMC 702/11].
Indication under review: For the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated.
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.
Paliperidone tablets (Invega®)
Antipsychotic drugs BNF 4.2.1
Paliperidone tablets (Invega®)
is not recommended for use within NHS Scotland [
SMC 702/11].
Indication under review: For the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated.
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.
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