The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abiraterone (Zytiga®) has been rejected for use in the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. The manufacturer failed to make a submission but plan to submit a case in December 2013.
Lisdexamfetamine dimesylate (Elvanse®) has been accepted for as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Mirabegron (Betmiga®) has been accepted for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. It is noted that alternative treatments are available at a lower drug acquisition cost.
A combination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride (Voractiv®) has been rejected for initial treatment of tuberculosis. The manufacturer failed to make a submission.
Vildagliptin (Galvus®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with metformin and a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Vildagliptin and metformin (Eucreas®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
MTRAC issued two new Commissioning Support reviews in February 2013. The reviews cover dapagliflozin and insulin degludec for the treatment of diabetes.
The dapagliflozin (Forxiga®) summary advises that this drug is suitable for prescribing in primary care following initiation by a practitioner with a special interest in diabetes. Although the evidence is relatively strong it is suggested that this treatment should occupy a lower place in therapy as there are no longer-term outcome data.
The insulin degludec (Tresiba®) summary advises that this drug is suitable for prescribing in primary care following initiation and stabilisation of dose in secondary care. The evidence was considered to be relatively weak as the trials to date have been short in duration and only made comparisons with insulin glargine. The product is also more expensive and has demonstrated no clinical advantage over current therapies. It is therefore suggested that this treatment should occupy a lower place in therapy
Action: Clinicians should be aware of these reviews and compare current practice to the recommendations, making changes where appropriate.
The Department of Health has announced several changes to the national vaccination programme to include protection against flu, shingles and diarrhoea.
The JCVI has previously recommended the addition of rotavirus vaccine to the childhood vaccination schedule. This infection currently causes around 140,000 cases of diarrhoea in the under 5s each year with 10% of these cases being admitted to a hospital. Use of this vaccine is expected to start from July 2013.
The shingles vaccine will be offered to people aged 70 years from September 2013. A catch up campaign will also be operated which will offer vaccination to anyone aged up to 79 years old. Shingles affects 30,000 people aged over 70 each year and it is hoped that this vaccine will prevent 40% of those cases.
A nasal influenza vaccine will be offered to 2 year old children from September 2013. The following year the programme will be rolled out to include all pre-school and primary school children and the year after that the programme will be extended again to include secondary school children.
Additionally, the current meningitis C booster vaccine given at 4 months old will be replaced with a vaccine given to those aged 12 and 13 years old.
Action: Clinicians should be aware of these changes to the national vaccination programme. Anyone involved with the delivery of the vaccination programme should ensure they familiar with the changes and the new vaccines.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2013 (PDF).
This issue contains drug safety advice informing clinicians of the potential risk of error with insulin degludec (Tresiba®) due to it being available in two strengths. Clinicians are urged to ensure that the correct insulin product and strength is prescribed and pharmacists should check again when the product is dispensed. It is also advised that patients are trained on how to use the device in particular they should always visually verify the dialled units on the dose counter.
This section also warns of the risk of cardiovascular and bleeding events associated with use of cilostazol (Pletal®). This drug is licensed for use to improve walking distances in patients with intermittent claudication. A recent safety review has concluded that the benefits of treatment are worthwhile in some, but not all patients. It is recommended that cilostazol is now used as second line treatment to lifestyle interventions and that it should not be use in patients with:
- Unstable angina, recent myocardial infarction or coronary intervention (within 6 months)
- A history of severe tachyarrhythmia
- A prescription for two or more other antiplatelet or anticoagulant treatments
The hot topic section advises that clinicians remain vigilant to the potential for errors to occur as a result of drug name confusion. Recent examples of medicine names that have been confused resulting in medication errors include:
- Mercaptamine and Mercaptopurine
- Sulfadiazine and Sulfasalazine
- Risperidone and Ropinirole
- Zuclopenthixol decanoate and Zuclopenthixol acetate
Finally, the stop press section advises of emerging cardiovascular safety concerns related to strontium ranelate (Protelos®). This drug is already associated with an increased risk of venous thromboembolism but recent analysis of randomised controlled trial data has identified an increased risk of cardiovascular events including myocardial infarctions. A full assessment of the risks and benefits will be carried out. In the meantime it is recommended that use of this drug is restricted to cases of severe osteoporosis, it should be avoided in patients who already have a cardiovascular disease and should only be used after careful consideration in those with risk factors for cardiovascular disease.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of April 2013. This month there are four technology appraisals that impact upon primary care.
The Asthma (severe, persistent, patients aged 6+, adults) - omalizumab (Xolair®) technology appraisal recommends this treatment as an option for treating severe persistent confirmed allergic IgE‑mediated asthma in individuals who need continuous or frequent treatment with oral corticosteroids. This recommendation is made provided the treatment is made available with the discount agreed in the patient access scheme.
The Gout - canakinumab (Ilaris®) technology appraisal was terminated because no evidence submission was received from the manufacturer. As such the treatment cannot be recommended.
The Idiopathic pulmonary fibrosis - pirfenidone (Esbriet®) technology appraisal is recommended for patients with a predicted FVC between 50% and 80% and provided the treatment is made available with the discount agreed in the patient access scheme. Treatment should be stopped if the predicted FVC decline by more than 10% in 12 months.
The Rheumatoid arthritis - abatacept (2nd line) (Orencia®) technology appraisal recommends this treatment in combination with methotrexate as an option for treating rheumatoid arthritis in adults whose disease has responded inadequately to two conventional DMARDs. This recommendation is based upon it being used in accordance with the recommendations for other biological DMARDs as defined in TA130 and provided the treatment is made available with the discount agreed in the patient access scheme.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.