Guiding principles in Hidradenitis Suppurativa (HS) care June 2016 GBL/HHS/0616/0728 This study was commissioned and solely funded by AbbVie AbbVie had no role in the design and conduct of the study, collection, management, analysis and interpretation of data, or preparation, review and approval of this report. © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 2 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. How to navigate through the report Executive Summary Goals Context Pages 6-18 Pages 19-20 Pages 21-25 Summary of the context, approach and Details on the aims and objectives of the Disease background, epidemiology key findings from the report project and clinical burden Approach Findings Appendix Pages 26-31 Pages 32-59 Pages 60-194 Information on how the research Compilation on the project findings, Detailed case studies from, was conducted and who was including the patient pathway in HS, and information on the visited involved key challenges and interventions to centres, including the overview help address them of the teams, their key strengths and challenges faced © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 3 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Foreword Prof Dr Christos C. Zouboulis President of the European Hidradenitis Suppurativa Foundation (EHSF) Hidradenitis suppurativa / acne inversa (HS) is a complex chronic disease which has a serious impact on patients. Currently, patients and physicians face significant challenges including ill-defined and fragmented care pathways, poor use of medical treatments, late diagnosis and late referral to specialist centres. There is wide variation in the quality of care patients receive, even within the same geographical locations. This study has been carried out to help understand how to deliver excellent HS treatment and care for patients and how to help improve care delivery across healthcare systems. A team of clinicians and research scientists visited eight reference centres. During these visits, the team observed HS care, collected data and interviewed healthcare professionals involved in the management of HS patients. © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 4 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. Contents 1.0 Executive summary 2.0 Goals 3.0 Context Page 5 Page 19 Page 21 4.0 Approach 5.0 Findings 6.0 Appendices Page 26 Page 32 Page 60 6.1 Case studies 6.2 Centre details Page 61 Page 161 © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 5 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. 1.0 Executive summary 1.0 Executive summary | 1.1 Goals 1.1 Goals This report aims to improve the quality of care for HS patients by identifying possible challenges and interventions in delivering care, raised by HS clinicians and patients. KPMG’s role in this report is to collect the views of HS clinicians and patients and to collate their opinions AbbVie sponsored as a guide for potential KPMG to produce an solutions for HS centres independent report on that may be facing similar hidradenitis suppurativa challenges. (HS) care in collaboration with the chair of the European Hidradenitis Suppurativa Foundation (EHSF), Prof. Christos Zouboulis In doing so, it aims to identify, document and share practices to help increase the awareness The aim of the project is of HS, promote timely to improve the quality and accurate diagnosis, and efficiency of care increase the consistency for HS patients globally of care and, ultimately, improve outcomes for patients with HS The report collates information and views on key initiatives to improve care from clinicians and patients in multiple worldwide centres © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 7 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. 1.0 Executive summary | 1.2 Context 1.2 Context HS is an inflammatory, systemic, recurrent skin disease that usually presents after puberty with painful, inflamed lesions in the apocrine gland-bearing areas of the body1 Symptoms range from single nodules to HS has several multiple abscesses associated connected by sinus tracts. comorbidities. Severe cases may require surgical intervention The estimated impact of The cause of HS is HS overall is 1% of the unclear, with many adult population believing it has multiple worldwide, but prevalence causal factors, namely numbers vary across genetic, environmental countries1. and endocrine As such, it is a highly under-diagnosed disease Notes: 1. Zouboulis et al, Hidradenitis Suppurativa / Acne Inversa: criteria for diagnosis, severity assessment, classification and disease evaluation, 2015 © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 8 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. 1.0 Executive summary | 1.3 Approach 1.3 Approach KPMG interviewed a range of HS experts and clinicians across 8 centres. This report collates the information and views shared by these experts and highlights interventions to improve HS care raised during the interviews. Note: the interventions identified are not considered to be exhaustive of best practice, but simply represent those identified from our data collection The EHSF Centres were KPMG engaged KPMG gathered Findings were president and picked to represent a with a range of views in key collated into a members selected variety of stakeholders areas: report which centres around geographies, including challenges, was reviewed by the world to healthcare systems, dermatologists, interventions to the participate care settings and surgeons, specialist address them, participating in this project different nurses and patient networks, patient– centres and access to specialties organisations centricity and their lead KOL to benefit creation ensure the validity Canada Canada France Denmark TORONTO ST. JOHN’S LYON ROSKILDE Sunnybrook NewLab Medical Clinique Val Roskilde Sygehus Medical Centre Research d’Ouest March 2016 February 2016 February 2016 March 2016 Spain Germany Italy UAE Valencia DESSAU PISA DUBAI Hospital Manises Städtisches Ospedale Santa Rashid Hospital February 2016 Klinikum Chiara May 2016 March 2016 May 2016 © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 9 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. 1.0 Executive summary | 1.4 Findings 1.4 Findings - challenges Through our 8 centre visits (and detailed case studies) interviewees identified a number of challenges faced in their respective centres, of which we have captured below: First symptoms – Delayed presentation to clinicians. – Patients discouraged when presenting with initial symptoms. Diagnosis – Low clinician awareness causing delays in diagnosis, and mis-diagnosis. Referral – Low clinician awareness causing lack of, and mis-directed referrals. – Delayed or limited patient information transfer. – Clinician reluctance to accept HS referrals. Treatment – Difficulty in accurately identifying disease extent. – Multiple patient needs / high comorbidity. – Variable quality of treatment between countries. – Variable funding for biologics, surgery and follow-up care across regions and payors. – Low patient concurrence with treatment plans, including lifestyle change plans. – Lack of robust, standardised outcome measures. Follow up and ongoing – Heavy time burden on patient. – Clinician capacity affected by follow-up demand. – Undetected symptom deterioration. – Physical, psychological and financial strain on patients. – Limited understanding of disease mechanism. – Professional siloes. © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 10 firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity. All rights reserved. 1.0 Executive summary | 1.4 Findings 1.4 Findings - interventions Through our 8 centre visits (and detailed case studies) interviewees identified possible solutions that they had recognised to be beneficial in tackling challenges stated, of which we captured below: First symptoms – Public awareness campaigns – HS awareness training for clinicians Diagnosis – HS awareness training for clinicians and nurses Referral – HS awareness training for clinicians and nurses – Information sharing systems – MDTs and strong networks Treatment – CO2 laser surgery – Lifestyle support – Ultrasound imaging – Laser imaging – Standardising staging and treatment across regions and settings – Patient education Follow up and ongoing – Follow-up care in the community – Patient association – Patient care meetings – Hyperbaric chamber therapy – HS registry – Physiotherapy – Global networks – Dermatology nurses – Topographic records © 2016 KPMG LLP, a UK limited liability partnership and a member firm of the KPMG network of independent member 11 firms affiliated