Formulary Group Decisions October 2010
Approved for use in NHS Grampian
Lactobacillus acidophilus plus bifidobacterium bifidum (Infloran®)
Unlicensed product - advice subject to positive QA risk assessment
Lactobacillus acidophilus plus bifidobacterium bifidum (Infloran®) was provisionally approved for restricted use to reduce the incidence of necrotising entercolitis in pre-term very low birth weight infant. Unlicensed product available for restricted hospital use only. Use is restricted to the Neonal Unit ARI, subject to development of a unit guideline and maintaining and auditing records of key outcomes.
Unlicensed product - advice subject to positive QA risk assessment
Lactobacillus acidophilus plus bifidobacterium bifidum (Infloran®) was provisionally approved for restricted use to reduce the incidence of necrotising entercolitis in pre-term very low birth weight infant. Unlicensed product available for restricted hospital use only. Use is restricted to the Neonal Unit ARI, subject to development of a unit guideline and maintaining and auditing records of key outcomes.
Nexplanon®
(subdermal implant containing etonogestrel 68mg)
(subdermal implant containing etonogestrel 68mg)Parenteral progestogen-only contraceptives, BNF 7.3.2.2
Nexplanon®
(subdermal implant containing etonogestrel 68mg) was approved for inclusion in the Grampian Joint Formulary as a long-acting (up to 3 years) progestogen-only contraceptive available for patients for whom a long-acting etonogestrel implant is an appropriate choice of contraception. This formulation of etonogestrel implant is X-ray opaque, allowing verification of presence. Available for restricted use and treatment may be initiated in either hospital or community. Insertion and removal must be carried out by a person who has received the appropriate training.
(subdermal implant containing etonogestrel 68mg) was approved for inclusion in the Grampian Joint Formulary as a long-acting (up to 3 years) progestogen-only contraceptive available for patients for whom a long-acting etonogestrel implant is an appropriate choice of contraception. This formulation of etonogestrel implant is X-ray opaque, allowing verification of presence. Available for restricted use and treatment may be initiated in either hospital or community. Insertion and removal must be carried out by a person who has received the appropriate training.Tacrolimus 0.03% ointment (Protopic®)
Drugs affecting the immune response BNF 13.5.3
Tacrolimus 0.1% ointment (Protopic®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in adult patients (≥16 years) experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.
After 12 months, a review of the patient's condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a specialist. Use is restricted to initiation by doctors with a specialist interest and experience in treating atopic dermatitis using immunomodulatory therapy (this can include General Practitioners).
Drugs affecting the immune response BNF 13.5.3
Tacrolimus 0.1% ointment (Protopic®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in adult patients (≥16 years) experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.
After 12 months, a review of the patient's condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a specialist. Use is restricted to initiation by doctors with a specialist interest and experience in treating atopic dermatitis using immunomodulatory therapy (this can include General Practitioners).
Not approved for use in NHS Grampian
In the absence of a submission from the holder of the marketing authorisation
Amifampridine tablets (Firdapse®)
Drugs that enhance neuromuscular transmission BNF 10.2.1
Amifampridine tablets (Firdapse® ) is not recommended for use within NHSScotland.
Indication under review: for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHSScotland [
SMC 660/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Amifampridine tablets (Firdapse®
)
Drugs that enhance neuromuscular transmission BNF 10.2.1
Amifampridine tablets (Firdapse®
) is not recommended for use within NHSScotland.
Indication under review: for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHSScotland [
SMC 660/10].
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
Canakinumab 150 mg/mL, powder for solution for injection (Ilaris®)
Other immunomodulating drugs BNF 8.2.4
Canakinumab 150 mg/mL, powder for solution for injection (Ilaris®) is not recommended for use within NHSScotland.
Indication under review: Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHSScotland [SMC 658/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Canakinumab 150 mg/mL, powder for solution for injection (Ilaris®)
Other immunomodulating drugs BNF 8.2.4
Canakinumab 150 mg/mL, powder for solution for injection (Ilaris®)
is not recommended for use within NHSScotland.
Indication under review: Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHSScotland [
SMC 658/10].
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
Docetaxel Concentrate for intravenous infusion (Taxotere®)
Other antineoplastic drugs BNF 8.1.5
Docetaxel Concentrate for intravenous infusion (Taxotere®) in combination with doxorubicin and cyclophosphamide is not recommended for use within NHS Scotland.
Indication under review: adjuvant treatment of patients with operable node-negative breast cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHS Scotland [SMC 659/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Docetaxel Concentrate for intravenous infusion (Taxotere®)
Other antineoplastic drugs BNF 8.1.5
Docetaxel Concentrate for intravenous infusion (Taxotere®) in combination with doxorubicin and cyclophosphamide is not recommended for use within NHS Scotland.
Indication under review: adjuvant treatment of patients with operable node-negative breast cancer.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result SMC cannot recommend its use within NHS Scotland [
SMC 659/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Eculizumab concentrate for intravenous infusion (Soliris®)
Drugs used in hypoplastic, haemolytic, and renal anaemias, paroxysmal nocturnal haemoglobinuria BNF 9.1.3
Eculizumab concentrate for intravenous infusion (Soliris®) is not recommended for use within NHS Scotland.
Indication under review: for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit of eculizumab in the treatment of patients with PNH is limited to patients with a history of transfusions.
In a controlled study in patients with transfusion-dependent PNH, eculizumab reduced the rate of haemolysis and improved anaemia compared to placebo. Uncontrolled data suggest that eculizumab reduces the incidence of thrombosis in patients with PNH [SMC 436/07].
The manufacturer did not supply any economic analysis and therefore eculizumab cannot be recommended for use within NHS Scotland.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Drugs used in hypoplastic, haemolytic, and renal anaemias, paroxysmal nocturnal haemoglobinuria BNF 9.1.3
Eculizumab concentrate for intravenous infusion (Soliris®)
is not recommended for use within NHS Scotland.
Indication under review: for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit of eculizumab in the treatment of patients with PNH is limited to patients with a history of transfusions.
In a controlled study in patients with transfusion-dependent PNH, eculizumab reduced the rate of haemolysis and improved anaemia compared to placebo. Uncontrolled data suggest that eculizumab reduces the incidence of thrombosis in patients with PNH [
SMC 436/07].
The manufacturer did not supply any economic analysis and therefore eculizumab cannot be recommended for use within NHS Scotland.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Glucosamine sulphate 1500mg powder for oral solution (Glusartel®)
Musculoskeletal and joint diseases BNF 10
Glucosamine sulphate 1500mg powder for oral solution (Glusartel®) is not recommended for use within NHS Scotland.
Indication under review: relief of symptoms in mild to moderate osteoarthritis (OA) of the knee.
In an active-comparator study, glucosamine sulphate 1,500mg once daily was superior to placebo in the treatment of symptoms associated with osteoarthritis of the knee [SMC 647/10].
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.
Musculoskeletal and joint diseases BNF 10
Glucosamine sulphate 1500mg powder for oral solution (Glusartel®)
is not recommended for use within NHS Scotland.
Indication under review: relief of symptoms in mild to moderate osteoarthritis (OA) of the knee.
In an active-comparator study, glucosamine sulphate 1,500mg once daily was superior to placebo in the treatment of symptoms associated with osteoarthritis of the knee [
SMC 647/10].
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.
Sevelamer carbonate tablets
Phosphate-binding agents BNF 9.5.2.2
Sevelamer carbonate tablets (Renvela®) is not recommended for use within NHS Scotland.
Indication under review: the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride for the control of hyperphosphataemia in adult haemodialysis patients.
The manufacturer presented an economic case based on sevelamer carbonate being used as a first-line treatment as an alternative to calcium-based binders in patients new to dialysis. The case was not sufficiently robust to gain acceptance by the SMC [SMC 641/10].
Sevelamer carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/L. The manufacturer's submission related only to the control of hyperphosphataemia in adult patients receiving dialysis. SMC cannot recommend the use of sevelamer carbonate in pre-dialysis patients.
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.
Phosphate-binding agents BNF 9.5.2.2
Sevelamer carbonate tablets (Renvela®) is not recommended for use within NHS Scotland.
Indication under review: the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride for the control of hyperphosphataemia in adult haemodialysis patients.
The manufacturer presented an economic case based on sevelamer carbonate being used as a first-line treatment as an alternative to calcium-based binders in patients new to dialysis. The case was not sufficiently robust to gain acceptance by the SMC [
SMC 641/10].
Sevelamer carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/L. The manufacturer's submission related only to the control of hyperphosphataemia in adult patients receiving dialysis. SMC cannot recommend the use of sevelamer carbonate in pre-dialysis patients.
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.
Trabectedin injection (Yondelis®)
Other antineoplastic drugs BNF 8.1.5
Trabectedin injection (Yondelis®) is not recommended for use within NHS Scotland.
Indication under review: the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were used, the licensed 3-weekly schedule was superior to the alternative one for the primary endpoint, time to progression [SMC 452/08].
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, 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.
Other antineoplastic drugs BNF 8.1.5
Trabectedin injection (Yondelis®)
is not recommended for use within NHS Scotland.
Indication under review: the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were used, the licensed 3-weekly schedule was superior to the alternative one for the primary endpoint, time to progression [
SMC 452/08].
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, 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.
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