New medicines
RED IXEKIZUMAB solution for injection (Taltz®) for axial spondyloarthritis
Red statement in line with NICE TA718 that recommends ixekizumab as an option for treating active ankylosing spondylitis that is not controlled with conventional therapy, or active non-radiographic axial spondyloarthritis with objective signs of inflammation that is not controlled well enough with NSAIDs, in adults, only if TNF-alpha inhibitors are not suitable or do not control the condition well enough and ixekizumab is provided in accordance with the commercial arrangement.
PBR excluded high cost drug. NICE does not expect this guidance to have a significant impact on resources (less than £9,000 per 100,000 population) because ixekizumab is a further treatment option available at a similar price to the current treatment options.
RED SECUKINUMAB solution for injection (Cosentyx®) for non-radiographic axial spondyloarthritis
Red statement in line with NICE TA719 that recommends secukinumab as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation that is not controlled well enough with NSAIDs in adults. It is recommended when TNF-alpha inhibitors are not suitable or do not control the condition well enough and only if the company provides secukinumab according to the commercial arrangement.
PBR excluded high cost drug. NICE does not expect this guidance to have a significant impact on resources (less than £9,000 per 100,000 population) because secukinumab is a further treatment option available at a similar price to the current treatment options.
RED BIMEKIZUMAB solution for injection (Bimzelx®▼) for moderate to severe plaque psoriasis
Red statement in line with NICE TA719 that recommends bimekizumab as an option for treating plaque psoriasis in adults when the disease is severe, as defined by a total PASI of 10 or more and a DLQI of more than 10, the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and the company provides the drug according to the commercial arrangement.
PBR excluded high cost drug. NICE does not expect this guidance to have a significant impact on resources (less than £9,000 per 100,000 population) because secukinumab is a further treatment option available at a similar price to the current treatment options.
GREEN CANAGLIFLOZIN, DAPAGLIFLOZIN, EMPAGLIFLOZIN and ERTUGLIFLOZIN as COMBINATION THERAPIES in type 2 diabetes: a multiple prescribing statement
Routine review of existing green statement at expiry, that also incorporates erugliflozin to bring all advice regarding the use of SGLT-2 inhibitors as combination therapy in type 2 diabetes into a single multiple policy statement.
No additional financial impact as all four drugs are well established in clinical practice for type 2 diabetes.
GREEN CANAGLIFLOZIN, DAPAGLIFLOZIN, EMPAGLIFLOZIN and ERTUGLIFLOZIN as MONOTHERAPIES in type 2 diabetes: a multiple prescribing statement
Routine review of existing green statement at expiry, that also incorporates erugliflozin to bring all advice regarding the use of SGLT-2 inhibitors as monotherapy in type 2 diabetes into a single multiple policy statement.
No additional financial impact as all four drugs are well established in clinical practice for type 2 diabetes.
Formulary & Guidelines
AMBER INITIATED Melatonin prolonged-release tablets (Circadin® and Slenyto®) for the treatment of persistent chronic sleep disorders in adults and children
Melatonin prolonged-release recommended in selected indications in children (and continuation in these indications into adulthood or transition to adult services) and adults.
There is Prescribing Support Information and a flowchart to position use of melatonin after sleep hygiene, and also after referral to specialist sleep service (where this exists) or other specialist.
The recommendation is to use Circadin® where possible in all patients on cost grounds (off-label), except for restricted use of Slenyto® in its licensed indications (children and adolescents ages 2-18 with Autistic Spectrum Disorders (ASD) or Smith Magenis syndrome (SMS), or both), continuation for these into adulthood (off-label) or in other melatoninapproved uses where patients are unable to swallow Circadin® (off-label).
There is a significant cost implication, with some uncertainty depending on the number of patients not able to swallow Circadin®. There are commissioning implications in view of the fact that sleep services are not widely commissioned (only Alder Hey pilot service in children, no adult services).
Ongoing review by GPs to determine if melatonin needs to continue is proposed, i.e., treatment holidays, sleep diaries.
Estimated current total Pan Mersey spend per annum: £2,203,318.
Projected spend increased to between £3,772,729 and £5,835,505 plus cost of sleep behavioural intervention service per annum (excludes discount scheme). Higher cost assumes no children can swallow Circadin® which is unlikely.
Additional information included in line with NICE NG158. No further cost implication.
AMBER INITIATED Zonisamide 20mg in 1mL suspension - focal onset epilepsy (children)
Addition to Formulary. Zonisamide capsules are already included in formulary designated as Amber Initiated in paediatrics. This is a licensed product, is more cost effective and more concentrated than unlicensed special therefore less volume to be given to the child to improve adherence.
Removal from formulary. Product discontinued and superseded by alternatives.
Shared Care
Framework reviewed at its routine review-by date. No updates have been required and only small amendments to wording made.
Safety
Routine review at expiry date. Re-written for clarification but no major content changes. Core message remains the same. More emphasis on the need for at least one specialist review.
Recent third party publication covering the use of steroid emergency cards adopted to replace expired APC guidance. The safety subgroup will monitor implementation and develop a supplementary localised advice as the need arises.
New formulary addition with black status following concerns about the potential for significant inadvertent inappropriate dosing at 2 g, particularly if the patient was not aware.
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