Formulary Group Decisions May 2012
NICE (Multiple) Technology Appraisal Guidance
NICE (Multiple) Technology Appraisal Guidance No 246 Venom anaphylaxis - immunotherapy pharmalgen (TA246)
The Group noted NHS Healthcare Improvement Scotland's advice that the recommendations are as valid for Scotland as for England and Wales,
http://www.nice.org.uk/guidance/TA246.
The guidance states that Pharmalgen® is recommended as an option for the treatment of IgE-mediated bee and wasp venom allergy in people who have had a severe systemic reaction to bee or wasp venom, or a moderate reaction and other risk factors or anxiety about future stings. Treatment with Pharmalgen should be started and monitored in a specialist centre experienced in venom immunotherapy.
NICE (Multiple) Technology Appraisal Guidance No 251 - Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (part review of technology appraisal guidance 70) (TA251).
The Group noted NHS Healthcare Improvement Scotland's advice that the recommendations are as valid for Scotland as for England and Wales,
http://www.nice.org.uk/guidance/TA251.
This guidance states that:
- Standard-dose imatinib (400 mg per day for patients in chronic phase) is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive chronic myeloid leukaemia (CML).
- Nilotinib is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive CML if the manufacturer makes nilotinib available with the discount agreed as part of the patient access scheme (PAS).
- Dasatinib is not recommended for the first-line treatment of chronic phase Philadelphia-chromosome-positive CML.
- People currently receiving dasatinib in this indication should be able to continue treatment until they and their clinician consider it appropriate to stop.
This guidance should be read in conjunction with NICE technology appraisal guidance 70 (TA70) Guidance on the use of imatinib for chronic myeloid leukaemia. This guidance partially updates NICE technology appraisal guidance 70 (published October 2003)].
Approved for use in NHS Grampian
Adrenaline tartrate 150 and 300micrograms autoinjector (Jext®) SMC 687/11
Allergic emergencies, anaphylaxis, adrenaline intramuscular injection for self-administration BNF 3.4.3
Adrenaline tartrate 150 and 300 micrograms autoinjector (Jext®) is included on the Grampian Joint Formulary for the indication in question; included pending protocol (product assessment).
Indication under review: emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.
For patients at risk of anaphylaxis and requiring adrenaline, this is a new presentation of adrenaline for emergency use. It has an extended shelf life (24 months) compared with some existing products. Available for restricted use under specialist supervision and treatment may be initiated in either hospital or community. Inclusion is subject to product assessment by the Resuscitation Training team.
Caphosol® supersaturated calcium phosphate rinse is classified as a medical device.
Caphosol® supersaturated calcium phosphate rinse is included on the Grampian Joint Formulary for the indication in question; restricted use.
Indication under review: prevention of oral mucositis in patients undergoing radiotherapy for head and neck cancer.
Restriction: to be prescribed by radiologists. Available for restricted use under specialist supervision and treatment to be initiated prior to handover.
Imatinib 100mg, 400mg tablets (Glivec®) SMC 584/09
Other antineoplastic drugs, Protein kinase inhibitors BNF 8.1.5
Imatinib 100mg, 400mg tablets (Glivec®) is included on the Grampian Joint Formulary for the indication in question; restricted use.
Indication under review: adjuvant treatment of adult patients who are at significant risk of relapse following resection of a KIT (CD117) positive gastrointestinal stromal tumour (GIST). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Restriction: Imatinib is restricted to use in patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria).
Adjuvant imatinib therapy given for a period of three years compared to one year, significantly improved the recurrence free survival in adult patients at significant risk of relapse following resection of GIST.
The clinical and cost-effectiveness of three years adjuvant imatinib treatment was demonstrated.
Available for restricted use under specialist supervision and recommended for hospital use only.
Insulin detemir injection (Levemir®) SMC 780/12
Intermediate- and long-acting insulins BNF 6.1.1.2
Insulin detemir injection (Levemir®) is included on the Grampian Joint Formulary for the indication in question.
Indication under review: treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Restriction: in patients unable to achieve good glycaemic control with established insulins. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.
Pharmalgen® (bee venom extract and wasp venom extract) NICE MTA 246
Allergen immunotherapy BNF 3.4.2
Pharmalgen® powder and solvent for solution for injection (bee venom extract (Apis mellifera) and wasp venom extract (Vespula spp.)) is included on the Grampian Joint Formulary for the indication in question; restricted use.
Indication under review: as an option for the treatment of IgE-mediated bee and wasp venom allergy in people who have had:
- a severe systemic reaction to bee or wasp venom OR
- a moderate systemic reaction to bee or wasp venom and who have one or more of the following: a raised baseline serum tryptase, a high risk of future stings or anxiety about future stings.
Restriction: Treatment as per NICE MTA 246, and Pharmalgen® should be initiated and monitored in a specialist centre experienced in venom immunotherapy. Available for restricted use under specialist supervision and recommended for hospital use only (immunology department).
Rivaroxaban 15mg and 20mg tablets (Xarelto®) SMC 756/12, HIS April 2012
Oral anticoagulants BNF 2.8.2
Rivaroxaban 15mg and 20mg tablets (Xarelto®) is included on the Grampian Joint Formulary for the indication in question; restricted use.
Indication under review: the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Restriction: for moderate or high risk atrial fibrillation patients (CHA2DS2-VASc ≥ 2) with poor INR control despite evidence that they are complying with coumarin anticoagulants, or allergy to or intolerable side effects from coumarin anticoagulants. Available for general use, under restrictions above, and treatment may be initiated in either hospital or community.
Rivaroxaban 15mg and 20mg tablets (Xarelto®) SMC 755/12
Oral anticoagulants BNF 2.8.2
Rivaroxaban 15mg and 20mg tablets (Xarelto®) is included on the Grampian Joint Formulary for the indication in question; included pending protocol.
Indication under review: treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Rivaroxaban has been shown to be non-inferior to standard anticoagulant therapy including a low molecular weight heparin in combination with a vitamin K antagonist for the treatment of proximal DVT and prevention of recurrence.
Experience with rivaroxaban in this indication for more than 12 months is limited therefore the cost-effectiveness of indefinite treatment has not been demonstrated. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendatio of a consultant/specialist. Inclusion pending protocol.
Not approved for use in NHS Grampian
Bevacizumab concentrate for intravenous infusion (Avastin®)
Other antineoplastic drugs BNF 8.1.5 - GJF
Bevacizumab concentrate for intravenous infusion (Avastin®) is not recommended for use within NHS Scotland.
Indication under review: bevacizumab in combination with capecitabine is indicated for first-line treatment of patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.
In a double-blind, multicentre, randomised, placebo-controlled phase III study in patients with locally recurrent or metastatic breast cancer, treatment with bevacizumab plus capecitabine was associated with an extended median progression-free survival of 2.9 months compared with capecitabine monotherapy. However, there was no overall significant improvement in survival.
The submitting company did not present a sufficiently robust economic analysis and, in addition, their justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by the SMC [
SMC 778/12].
Not recommended by SMC for use within NHS Scotland - will not be included in NHS Grampian Joint Formulary for the indication in question.
Fentanyl single dose nasal spray (Instanyl®)
Opioid analgesics BNF 4.7.2 - GJF
Fentanyl single dose nasal spray (Instanyl®) is not included on the Grampian Joint Formulary because clinicians do not support the formulary inclusion.
Indication under review: for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
SMC restriction: to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication [
SMC 750/11].
Not included on the Grampian Joint Formulary because clinicians do not support formulary inclusion.
Ipilimumab concentrate for intravenous infusion (Yervoy®)
Other antineoplastic drugs BNF 8.1.5 - GJF
Ipilimumab concentrate for intravenous infusion (Yervoy®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.
Ipilimumab demonstrated a survival benefit over an investigational gp100 peptide vaccine in previously treated patients with advanced melanoma.
The submitting company's justification of the treatment's cost in relation to its health benefits was not sufficient and, in addition, the submitting company did not present a sufficiently robust economic case to gain acceptance by SMC [
SMC 779/12].
Not recommended by SMC for use within NHS Scotland - will not be included in NHS Grampian Joint Formulary for the indication in question.
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