BUILDING TRUST IN RARE AND ORPHAN DISEASES. Insights from PA panel discussion with key stakeholders Eyeforpharma Barcelona 2016
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1 BUILDING TRUST IN RARE AND ORPHAN DISEASES Insights from PA panel discussion with key stakeholders Eyeforpharma Barcelona
2 Contributors Sir Andrew Dillon CEO, NICE Nigel Brooksby Chairman, UK Life Sciences Board Benedikt von Braunmühl Chairman of the Board of Directors, PathoQuest Germo Gericke Global Programme Head Oncology Development, Novartis Trevor Leighton Head of International Market Access, Shire Begoña Nafría Escalera Patient Advocacy Manager of Rare Commons, Hospital Sant Joan de de Déu of Barcelona Chris Isler Life sciences and integrated healthcare expert, PA Consulting Group 2
3 As the focus on improving outcomes and the pressure of pay-forperformance increases, survival in the shifting healthcare landscape requires the reshaping of traditional operating models. This reality is even more present and acute in rare and orphan diseases due to the high price of treatments, a small evidence base and often high engagement from patient and caregiver groups. Building trust in rare and orphan diseases As a result, pharma companies are increasingly seeking to shift from the traditional role of a supplier of medicines to becoming a more active, patient-centric partner in healthcare. Although the potential business benefits are extraordinary, this transition from a transactional mindset to a more solutions and services-oriented perspective is not without challenges, both internally and externally. Drawing on the discussions from an expert panel PA facilitated at the eyeforpharma conference in Barcelona, we explore how trust can be built in rare and orphan diseases. 3
4 Technology can help identify, measure and more clearly define outcomes in rare diseases Isolation is still a feature, with little patient advocacy in rare diseases. The outcomes are unknown and it is not clear how to measure efficacy, which makes them very difficult to prioritise. We are still trying to fix the broken watch with the tools of a car mechanic real world evidence is a critical challenge in rare and orphan diseases. Germo Gericke 4
5 Exploring the challenges and opportunities in rare and orphan diseases Rare and orphan diseases have increasingly become an area of interest for the pharma industry. These diseases affecting less than one in every 1,500-2,500 1 people offer a convergence of issues that provide a great business opportunity for the industry. Historically, both public and private payers have been slightly more accepting of a higher price point as each specific treatment (due to the small patient population) often does not have a great budgetary impact. Less than 10% of the approximately 7,000 known rare diseases have an effective treatment. By 2020, the market for rare and orphan disease treatments is estimated to grow to $178 billion 2, amounting to 20% of the total prescription drug sales which may affect pricing and reimbursement of rare diseases. 1 Depending on geography US: 1:1,500, EU: 1:2,000, JP:1:2,500. Wikipedia, 2 EvaluatePharma, Orphan Drug Report, 364/images/EPOD15.pdf 5 More holistic approaches encompass more than just medications Companion diagnostics can bring key value at the early stages of rare and orphan diseases. Benedict von Braunmühl
6 Stronger connections with patients, families and advocates bring benefits to all stakeholders Sometimes it is the families which are the most important drivers of research in rare and orphan diseases. We really need to develop a more effective task force to coordinate and accelerate research. Begoña Nafría Escalera Finally, there is a strong emotional element related to these diseases as 75% of cases affect children who often do not reach adulthood. Since many are genetic in nature, they can also affect multiple family members. Nonetheless, rare and orphan diseases offer two significant challenges to the pharma industry. On the clinical side, the biggest challenge of orphan drug development is robust evidence generation due to the inherent difficulties in identifying and diagnosing patients, as well as a lack of validated endpoints. To further fuel this challenge, endpoints have to be accepted by regulators, payers, physicians and patients. The second challenge is one of reputation and the industry s portrayal in the media as opportunistic mainly due to the high prices charged for orphan drugs. For an industry already suffering from a lack of trust, overcoming this negative perception is especially difficult. At the root of this lies the issue of transparency. To build trust and overcome a negative reputation in the public eye, the industry will have to work to become more transparent about outcomes, pricing and how the two link together. Integrated healthcare solutions can be a powerful tool in addressing both these issues. However, it is crucial to find a way of creating a virtuous circle, as selling solutions rather than pills often require more trust to begin with. 6
7 Some numbers on rare and orphan diseases There are 6,000-8,000 rare diseases At least 75% of rare diseases affect children It takes on average five years to diagnose a rare disease 30% of rare disease patient die before the age of five Since year 2000: 1,615 indications have been designated Only 134 designations have been implemented 1,273 are active designations The average time from designation to implementation is four years 7
8 Sometimes we invest in what we know is right, even if we don t see how we will make a return. This helps build trust. The current pharma / service provider model does not work for rare and orphan diseases. We need a different approach. Technology is part of the answer but the size and return is so uncertain we need to trust that if we start to solve the problem then we will find more and more patients to help. Nigel Brooksby 8
9 Areas for building trust As highlighted, the issue of trust is accentuated in rare and orphan diseases as they are often devastating to the affected patients and families, and the price point for treatments is often very high. This increases the importance of an integrated approach as this will ensure the health and life quality outcomes of the treatments are maximised. Four main areas emerge for the key industry stakeholders to focus on: collaboration, alignment, flexibility in innovation and a holistic and patient centric approach to care. 1. Collaboration between all stakeholder groups patients, healthcare providers, payers and the pharma/medical device/diagnostics companies is essential for building trust. Combining strengths and resources by working together can increase transparency and help address the issues of disease understanding that will inform diagnostic and clinical approaches. We all have to work together in partnership to deliver better outcomes in rare diseases. Sir Andrew Dillon, CEO, NICE We need to pool information, build links with regulators, encourage early dialogue, establish standards for preclinical models and create a foundation and centre of excellence. Nigel Brooksby, Chairman, UK Life Sciences Board 9
10 We need to be more sensitive to the fact that there are more impacts on the patients quality of life than are typically included in our reporting on clinical trials. Begoña Nafría Escalera, Patient Advocacy Manager of Rare Commons, Hospital Sant Joan de de Déu of Barcelona A great example of collaboration is the efforts of the LouLou Foundation 3 which coalesced a group of stakeholders around a rare condition affecting the CDKL5 gene which is essential for normal brain development. This resulted in a disease registry being formed, opened dialogue with regulators and HTAs, and provided direction for clinical trial design, among other worthwhile achievements. From a pharma perspective, it is important to understand that this is an area where existing stakeholder groups, ie payers, providers and patients, do not collaborate to any great extent. However, there is an opportunity for pharma firms to become a coordinator or facilitator of collaboration. Related to this is the insight that educating patients and families on drug development, clinical trial design and regulation can bring in terms of making them more active and valuable partners
11 2. Alignment of the needs of all stakeholders is important to ensure everyone s requirements are met. A key role for pharma here is to devise approaches for delivering the best possible data and criteria. It will be these approaches that ensure payers give the right patients the correct medicines at a price that is fair to all. Our standard metrics need to take account of the special features of very rare conditions. We need to evolve new and better approaches. Sir Andrew Dillon 3. Flexibility and innovation are essential when it comes to tackling rare diseases where patients and evidence are scarce and prices are high. We can see some examples of this in risksharing agreements and conditional approvals 4 in the regulatory and reimbursement arenas. Conditional approvals could remove barriers for patients in the greatest need and allow an iterative approach to refining the definition of who benefits most from a particular therapy. Meanwhile, risk-sharing agreements could help build trust in the payer community especially when evidence is weak. 4. A holistic and patient centric approach is key for pharma. If the tension that arises from commercial interests is eased, real trust can be achieved. A holistic approach will change the nature of the conversations with payers and providers to be around their issues rather than just a pharmaceutical sale. Those conversations, in turn, will be the driver for growing trust. 4 In the US, the similar concept of provisional approval is used. 11
12 Closing the loop with integrated healthcare solutions Trust starts with transparency and this is the foundation of the areas we cover above. However, delivering this transparency will require more innovative approaches than pharma have traditionally used. Integrated Healthcare Solutions, when they are truly patient-centric, can deliver real value to patients and contribute to the body of evidence that will drive better outcomes and more informed clinical, regulatory and reimbursement decision making. By adding value for other stakeholders, pharma can simultaneously build business in rare diseases and help improve the industry s standing as a trusted healthcare partner. Customers should know exactly what they re getting and understand the interaction of treatment regime and patient behaviour. A few years ago, pharma companies didn t really understand how to go about this, but now some of their programmes are starting to do really well. They re moving from being manufacturers and developers of pills to providing healthcare solutions. Chris Isler, Life sciences and integrated healthcare expert, PA Consulting Group 12
13 Source This document is based on the panel discussion organized and facilitated by PA at Eyeforpharma Barcelona The panelists were: Sir Andrew Dillon, CEO, NICE Nigel Brooksby, Chairman, UK Life Sciences Board Benedikt von Braunmühl, Chairman of the Board of Directors, PathoQuest Germo Gericke, Global Programme Head Oncology Development, Novartis Trevor Leighton, Head of International Market Access, Shire Begoña Nafría Escalera, Patient Advocacy Manager of Rare Commons, Hospital Sant Joan de de Déu of Barcelona The discussion was chaired by Chris Isler, Life sciences and integrated healthcare expert at PA Consulting Group. 13
14 Get in touch At PA, we provide a full range of consulting approaches to help companies build their integrated and digital health tools, solutions and strategies. This includes: Strategy development and alignment with broader business goals Organisational architecture Processes for evaluating, developing and optimising solutions and services Care pathway mapping Stakeholders, customers, decision makers and influencers identification Decisions chain analysis Funding and resource flow mapping and analysis Patient journey mapping Roadblocks and pinch points identification Solution and technology scan and identification Innovative technology-based clinical trial endpoint design, development, validation Tools for customer engagement and engagement model design Service design Training, coaching and implementation support Change management and embedding new customer engagement approaches 14
15 To speak us about how we can help your organisation, please get in touch with one of our global life sciences experts. Chris Isler OBC, Aeschenvorstadt 71 Basel, Switzerland Telephone +41 (0) Callum Caldwell 123 Buckingham Palace Road London, UK Telephone +44 (0) Tina Boggiano OBC, Aeschenvorstadt 71 Basel, Switzerland Telephone +41 (0)
16 Corporate headquarters 123 Buckingham Palace Road London SW1W 9SR United Kingdom Tel: Switzerland OBC Suisse AG, Aeschenvorstadt 71, CH-4051, Basel Switzerland paconsulting.com We Make the Difference An independent firm of over 2,600 people, we operate globally from offices across the Americas, Europe, the Nordics, the Gulf and Asia Pacific. We are experts in consumer and manufacturing, defence and security, energy and utilities, financial services, government, healthcare, life sciences, and transport, travel and logistics. Our deep industry knowledge together with skills in management consulting, technology and innovation allow us to challenge conventional thinking and deliver exceptional results that have a lasting impact on business, governments and communities worldwide. Our clients choose us because we don t just believe in making a difference. We believe in making the difference. For more information about PA in Switzerland, please visit paconsulting.com/switzerland This document has been prepared by PA. The contents of this document do not constitute any form of commitment or recommendation on the part of PA and speak as at the date of their preparation. PA Knowledge Limited All rights reserved. No part of this documentation may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise without the written permission of PA Consulting Group
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