Prescribing Outlook National Developments November 2015 A resource for the NHS to help with budget setting, prescribing planning and medicines optimisation Contents Foreword……………………………………………………………………………...3 Drug related exclusions in the 15/16 National Tariff……………………………..6 1. GASTROINTESTINAL SYSTEM 9 7. OBSTETRICS, GYNAECOLOGY AND URINARY Inflammatory Bowel disease (IBD) ................................ 9 TRACT DISORDERS Patent expiries ......................... 57 Diarrhoea and constipation .......................................... 11 Incontinence ................................................................ 57 Dyspepsia and gastro-oesophageal reflux disease Contraception .............................................................. 57 (GORD) ........................................................................ 12 Antenatal, intrapartum and postnatal care .................. 57 Other gastro-intestinal related conditions .................... 12 Endometriosis and menstrual disorders ...................... 58 2. CARDIOVASCULAR DISEASE 15 8. MALIGNANT DISEASE AND Patent expiries ............................................................. 15 IMMUNOSUPPRESSION Patent expiries ................. 59 Hypertension ................................................................ 15 Multiple sclerosis (MS) ................................................ 59 Lipid modification ......................................................... 15 Organ transplantation .................................................. 59 Acute coronary syndrome [ACS - unstable angina and Malignant disease ....................................................... 61 myocardial infarction (MI)] & chest pain ...................... 19 Breast cancer .............................................................. 61 Heart failure (HF) ......................................................... 21 Gastrointestinal (GI) cancer ........................................ 62 Ischaemic stroke & atrial fibrillation (AF) ..................... 22 Haematological cancers .............................................. 64 Venous thromboembolism (VTE) ................................. 23 NHL and other lymphomas .......................................... 67 3. Respiratory System ................................................. 24 Lung cancer ................................................................. 69 Patent expiries ............................................................. 24 Head and neck cancers ............................................... 71 Asthma ......................................................................... 24 Skin and connective tissue cancers ............................ 71 Chronic Obstructive Pulmonary Disease (COPD) ....... 25 Sarcoma ...................................................................... 73 Drug allergy .................................................................. 27 Urogenital and renal cancers ...................................... 74 Other respiratory conditions ......................................... 27 Ovarian cancer ............................................................ 75 4. CENTRAL NERVOUS SYSTEM 29 Bone cancers and metastases .................................... 75 Patent expiries ............................................................. 29 Prostate cancer ........................................................... 76 Psychosis and schizophrenia ...................................... 29 Brain cancer ................................................................ 77 Hypnotics and sedation ............................................... 30 9. NUTRITION AND BLOOD Patent expiries ............. 78 Bipolar disorder ............................................................ 31 Anaemia ...................................................................... 78 Depression ................................................................... 31 Nutrition ....................................................................... 79 Autism .......................................................................... 32 Renal ........................................................................... 79 Attention Deficit Disorder ............................................. 32 Metabolic disorders ..................................................... 80 Obesity ......................................................................... 32 10. MUSCULOSKELETAL AND JOINT DISEASES Pain .............................................................................. 34 Patent expiries ............................................................. 81 Substance dependence ............................................... 34 NSAIDs ........................................................................ 81 Alzheimer’s disease & dementia .................................. 37 Rheumatoid Arthritis (RA) ........................................... 81 Parkinson’s disease ..................................................... 37 Juvenile Idiopathic Arthritis (JIA) ................................. 83 Eating disorders ........................................................... 37 Ankylosing spondylitis (AS) ......................................... 83 Other mental health and CNS related guidance .......... 38 Psoriatic Arthritis (PsA) ............................................... 84 5. INFECTIONS 40 Systemic lupus erythematosus (SLE) ......................... 86 Patent expiries ............................................................. 40 Osteoarthritis (OA) ...................................................... 88 General strategy .......................................................... 40 Gout ............................................................................. 88 Infection in children ...................................................... 42 Spasticity ..................................................................... 88 Respiratory infections .................................................. 43 11. EYE Patent expiries .............................................. 90 Tuberculosis (TB)......................................................... 43 Macular oedema .......................................................... 90 Pneumonia ................................................................... 43 Age related macular degeneration (AMD) ................... 92 Hepatitis C ................................................................... 43 Cataracts ..................................................................... 92 Hepatic encephalopathy .............................................. 46 Dry eye disease ........................................................... 92 Infective endocarditis ................................................... 47 13. SKIN…………………………………………….94 Sepsis .......................................................................... 47 Psoriasis ...................................................................... 93 Other infection-related developments and guidance ... 47 Urticaria ....................................................................... 94 6. ENDOCRINE SYSTEM Patent expiries .................. 48 Wound care ................................................................. 95 Diabetes ....................................................................... 48 Extemporaneous Specials ........................................... 95 Osteoporosis ................................................................ 54 PATENT EXPIRIES…………………………………......96 Fertility ......................................................................... 55 Menopause .................................................................. 55 Autosomal dominant polycystic kidney disease (ADPKD) ..................................................................................... 56 2 Foreword Managing new medicines big financial impact in the NHS if used in a large number of patients. Prescribing Outlook includes such drugs but Underpinning the strategic direction for managing new quantifying their impact is difficult. However, there are other medicines is the Department of Health's (DH) report Innovation mechanisms in place at a national level to mitigate the financial Health and Wealth, Accelerating Adoption and Diffusion in the impact of such drugs. NHS. It sets out government support for the NHS to embrace innovation to meet current and future healthcare challenges, The mechanism agreed between the government and the and outlines the importance of early adoption and uptake of pharmaceutical industry for setting the NHS cost of new drugs clinically and cost effective innovative practices, including is known as the Pharmaceutical Price Regulation Scheme medicines. Horizon scanning is essential for this process at (PPRS). This scheme is negotiated every five years. The latest many organisational levels so new medicines that have been scheme PPRS 2014 is very different to previous schemes. A shown to improve patient outcomes can be planned for and question and answer document outlines how it operates. adopted. Increasing financial pressure facing the NHS means Pharmaceutical companies decide whether to join the PPRS it is even more important that the introduction of new scheme. If they decide not to join they are subject to the medicines is actively managed. alternative statutory scheme which imposes a price cut on individual medicines of 15% of their NHS list price. If they join Funding of medicines in the NHS is inextricably linked to the the scheme they are subject to an overall aim of limiting growth national