APC Monthly Update

AUGUST 2015

Due Published in last month st Leukaemia (chronic lymphocytic) – obinutuzumab (with chlorambucil, 1 line) What actions do you TA Atrial fibrillation (non- Crohn's disease (moderate to still need to take to valvular) - edoxaban tosylate severe) - vedolizumab ensure these pub- lished NICE guidances are implemented in Major depressive disorder - Deep vein thrombosis, pulmo- your locality or Trust? vortioxetine nary embolism (treatment, sec- What arrangements ondary prevention) - edoxaban are in place to plan tosylate for the introduction of Ovarian, fallopian tube or pri- the forthcoming guid- mary peritoneal cancer ances? (relapsed, platinum-resistant) - What barriers to im- bevacizumab—Terminated ap- plementation do you praisal foresee? CG Coeliac disease: recognition, Melanoma: assessment and Did you know that assessment and management management you can use this spreadsheet: http:// Diabetic foot problems wessexahsn.org/ahsn- Diabetes in children and young archive/formulary- people checklist/ to keep track of local imple- Type 1 Diabetes (update) mentation of TAs?

Antimicrobial stewardship: sys- tems and processes for effective antimicrobial medicine use

Drug Safety

The latest MHRA Drug Safety Update extends the previous warning on the use of some sofosbuvir combination therapy with amiodarone to simeprivir, warning of the risk of severe bradycardia and heart block with the combination of simeprevir with sofosbuvir and amiodarone.

The EMA is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorisation safety studies (PASS) for medicines. This voluntary, optional procedure will help to improve the design of studies meant to collect further information on a medicine's safety once it is on the market. The aim is assist the developers in putting together safety studies which are of high quality and can provide useful information on a medicine in a real-life setting, in the interest of patients.

PAGE 2 APC MONTHLY UPDATE

New medicines and major licence changes Changes to licensed indications of existing medicines in the UK: Adalimumab (Humira) injection for the treatment of moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional therapy

Medroxyprogesterone acetate (Sayana Press) suspension for injection is now licensed for self- administration with medical follow-up as necessary, for long term female contraception Fludarabine (generic, Hospira) injection/infusion for treatment of B-cell chronic lymphocytic leukaemia in patients with sufficient bone marrow reserves Pertuzumab (Perjeta) infusion for breast cancer, HER2-positive, locally advanced, inflammatory or early stage—neoadjuvant therapy in combination with trastuzumab and chemotherapy for adults at high risk of recurrence

Factor VII/von Willebrand factor (Voncento) injection/infusion for prophylaxis and treatment of haemorrhage or surgical bleeding in patients with von Willebrand disease, when desmopressin alone is ineffective or contraindicated, and for prophylaxis and treatment of bleeding in patients with haemophilia A

New medicines to the market in the UK: Insulin glargine 300units/ml (Toujeo) injection for treatment of type 1 and type 2 diabetes mellitus in adults

Edvolocumab (Repatha) injection for adults with primary hypercholesterolaemia (heterozygous familial and non-fanmilial) or mixed dyslipidaemia, as an adjunct to diet, and for adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia Ciclosporin (Ikervis) eye drops for treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes Tafluprost/timolol (Taptiqom) preservative-free eye drops for reduction of intraocular pressure in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative-free eye drops Nivolumab (Nivolumab BMS) infusion for treatment of locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in adults Pembrolizumab (Keytruda) infusion for advanced (unresectable or metastatic) malignant melanoma in adults—monotherapy Ethinylestradiol/drospirenone (ELOINE) tablets for contraception (lower-dose version of Yasmin) Cangrelor (Kengrexal) injection/infusion for reduction of thrombotic cardiovascular events in adults with coronary artery disease undergoing percutaneous coronary intervention Midodrine (Bramox) tablets for severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other treatments are inadequate Colecalciferol (Thorens) oral solution/drops for the prevention and treatment of vitamin D deficiency, osteomalacia and rickets

P AGE 3 APC MONTHLY UPDATE

The following have been given a positive opinion by the European Medicines Agency: Susoctocog alfa (Obizur) injection for treatment of bleeding episodes in adult patients with acquired haemophilia caused by antibodies to factor VIII Permetrexed Lilly (generic) infusion for malignant pleural mesothelioma and non-small cell lung cancer Isavucinazole (Cresemba) capsules/infusion for treatment of invasive aspergillosis or mucormycosis in patients for whom amphotericin B is inappropriate Ferric citrate coordination complex (Fexeric) for the control of hyperphosphataemia in adult patients with chronic kidney disease Ivabradine Anpharm (generic) tablets for chronic stable angina in coronary artery disease, or chronic heart failure NHYA II to IV with systolic dysfunction Sufentanil (Zalviso) sublingual tablets for acute moderate to severe post-operative pain in adults Ceftolozane/tazobactam (Zerbaxa) infusion for complicated intra-abdominal infections, acute pyelpnephritis, and complicated urinary tract infections Alirocumab (Praluent) injection for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet Guanfacine (Intuniv) prolonged-release tablets for treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Must be used as part of a comprehensive ADHD treatment programme

The following have been given a positive opinion for a new indication by the European Medicines Agency: Dabrafenib (Tafinlar) capsules now indicated as monotherapy or in combination with trametinib for treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mu- tation Trametinib (Mekinist) tablets now indicated as monotherapy or in combination with dabrafenib for treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mu- tation Capsaicin (Qutenza) cutaneous patch now indicated for the treatment of peripheral neuropathic pain in sdults either alone or in combination with other medicinal products for pain (previously indicated only in non-diabetic adults) Eltrombopag (Revolade) tablets now indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pre- treated and are unsuitable for haematopoietic stem cell transplantation

With thanks to the Regional Drug and Therapeutics Centre. Further information is available from http://rdtc.nhs.uk/publications/publication-type/monthly-horizon-scanning-reports