The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of May 2016. This month there are three clinical guidelines and two technology appraisals that impact upon primary care.
The Dementia clinical guideline covers preventing, diagnosing, assessing and managing dementia in health and social care. The recommendation on prescribing medicines for Alzheimer’s disease was reviewed and partially updated.
The Crohn's Disease clinical guideline covers the management of Crohn’s disease in children, young people and adults. In this update a new recommendation on inducing remission was added.
The Psychosis and schizophrenia in children and young people clinical guideline covers recognising and managing psychosis and schizophrenia in children and young people. In this update a new recommendation was added on providing information about olanzapine when choosing antipsychotic medication for children and young people with a first episode of psychosis.
The Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease technology appraisal has been updated to include references to the Dementia clinical guideline.
The Canagliflozin, dapagliflozin and empagliflozin technology appraisal recommends these drugs as monotherapy treatment as an option for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if:
- a dipeptidyl peptidase‑4 (DPP‑4) inhibitor would otherwise be prescribed and
- a sulfonylurea or pioglitazone is not appropriate
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of exenatide once weekly (Bydureon®) has written to healthcare providers advising that the original 'vial and syringe' kit is being replaced by a pre-filled pen.
The pen has been available for several months and is designed to make administration easier for patients. According to the letter, the older formulation will be phased out later this year. Any patient who is starting this treatment should be supplied with the pen device. This is indicated as 'pre-filled pen' or 'pre-filled disposable device' in the item description on clinical systems. Patients who are currently prescribed the vials should be moved to the new device.
Patient information about the switch is available at talkingtype2.co.uk [acceptance of legal, privacy and cookie terms required] and the Patient Information Leaflet describes how to use the new device.
Action: Clinicians should be aware that the vial and syringe kit is being replaced. It would be prudent to run clinical system searches to identify any patients who are currently prescribed the vials so prescriptions can be updated.
The manufacturer of canagliflozin has written to healthcare professionals, in agreement with the European Medicines Agency, advising of an increased risk of lower limb amputations seen in the CANVAS study.
Canagliflozin (Invokana®, Vokanamet®) is licensed for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. The CANVAS study is a long-term study investigating cardiovascular outcomes. Adverse event monitoring in this study has observed a two-fold increase in the risk of a lower limb amputation, primarily the toe.
The risk rate in study participants taking canagliflozin is 6 lower limb amputations per 1,000 patient years compared to a risk of 3 per 1,000 patient years in patients taking placebo. No dose response had been noted.
Healthcare professionals are advised that:
- Routine preventative foot care management remains important
- Patients with other risk factors for amputation, such as peripheral vascular disease or peripheral neuropathy should be carefully monitored
- Consideration should be given to suspending treatment in patients who develop significant lower limb complications such as ulcers, osteomyelitis or gangrene
- Patients should be advised to maintain adequate hydration and monitored for signs or symptoms of volume depletion, especially those who are also taking diuretics
Regulatory agencies will continue to monitor and investigate this issue.
Action: Clinicians should be aware of this new safety information. Risk factors for amputation should be considered before starting new treatment and consideration given to stopping treatment if complications develop during treatment.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide (Genvoya®) has been accepted for use in the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Ivacaftor (Kalydeco®) has been rejected for use in the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25kg who have a specified gating mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Lumacaftor and ivacaftor (Orkambi®) has been rejected for use in the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Department of Health announced in March that the price for an NHS prescription in England will increase by 20p to £8.40 with effect from April 2016.
The prices for 3 and 12 month pre-payment certificates have remained the same at £29.10 and £104 respectively. For anyone requiring more than 3 items in 3 months or more than 12 in a year these certificates can provide significant savings.
Other NHS charges such as for dental work, wigs and fabric supports are also being increased.
Action: Clinicians should be aware of the current prescription charge and also the value for money represented by pre-payment certificates.