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Volume 37 Number 10 VOLUME 37 NUMBER 10 NOVEMBER 2019 Gates Foundation Plots A Fresh Metric From US To EU: Young Biotechs Early Dialogue: Getting The Most For Market Access: Lives Saved Going It Alone Out Of Advice From HTA Agencies PAGE LEFT BLANK INTENTIONALLY invivo.pharmaintelligence.informa.com STRATEGIC INSIGHTS FOR LIFE SCIENCES DECISION-MAKERS CONTENTS ❚ November 2019 MARKET ACCESS Balancing benefit and value against health care sustainability 10 16 22 In US Drug Pricing Debate, Market Access 2020: Gates Foundation Plots A ICER’s Voice Gets Louder Understanding US Payer Fresh Metric For Market Access: MELANIE SENIOR Expectations Lives Saved The Institute for Clinical and Economic WILLIAM LOONEY WILLIAM LOONEY Review's influence on drug pricing, and Big pharma is facing a difficult US In Vivo visits Gates Medical Research policy, is growing. Spotlighting the worst competitive landscape as its traditional Institute CEO Dr. Penny Heaton to review its drug price rises is one recent example. customers realign to build their own first pipeline of drugs and vaccines to Ten years ago, it would have seemed redoubts of size, scale and reach. attack four of the world’s biggest killers: unthinkable that an independent, Consolidation on the payer side is TB, malaria, enteric diseases and other non-profit organization with no statutory changing the dynamics of success in conditions affecting maternal, newborn power could influence the pricing health care. and child health, as well as highlight the behavior of the US pharmaceutical sector. unique business model of this latest Yet that is what ICER has achieved. 36 addition to the Bill & Melinda Gates Foundation and reveal more about the From US To EU: focus and aims of the Boston, US group. 30 Young Biotechs Going It Alone We Need To Talk – When To Get JO SHORTHOUSE 40 Early Scientific Advice Europe’s patchwork of reimbursement LEELA BARHAM agencies makes it a daunting place for a SMA Market: Hearing direct from HTA agencies on what small US biotech to do business. Assessing The Unknowns evidence they want to see is now an Traditionally large pharma partners or MARK RATNER option through early dialogue. With many CMSOs have provided an experienced The introductions of Spinraza and options for early dialogue available, it is hand to hold, but as a new wave of gene Zolgensma in SMA offer new insights hard for companies to know whether to therapies and orphan drugs gets the EMA into neuromuscular diseases. But more get advice, from which agency and how to green light, smaller drug developers are real-world evidence is needed. get the most out of the dialogue. choosing to go solo. ©2016 Informa Business Information, Inc., an Informa company November 2019 | In Vivo | 1 ❚ CONTENTS November 2019 DEPARTMENTS ❚ From The Editor AROUND THE INDUSTRY Today, market access as a function is an intricate 4 MHealth And Research beast that requires drug and device developers to In Oncology think creatively while acting within rigid systems. NIHARIKA DANDAMUDI This challenge is intensified in Europe, where the fragmented environment adds further layers of 6 Sony’s AV Tech Propels complexity and involves a greater number of Medical Unit stakeholders. Success appears to be the same for ASHLEY YEO all players: access for patients to the treatments they need, when they need them. But individual goals differ. INFOGRAPHIC: MARKET ACCESS It was an interesting experience this month to sit 8 LUCIE ELLIS, WILLIAM MASTERS in on a roundtable discussion with market access AND GAYLE REMBOLD FURBERT LUCIE ELLIS experts from mid and large pharma companies. There were some extreme ideas placed on the ta- ble about what the future of patient access should look like. A Netflix-like mod- 46 ON THE MOVE el was one suggestion, while government tenders, such as those used in the Recent executive appointments aerospace sector, was another. Huge change and disruption on this scale seems in the life sciences industry unlikely. Still, the systems in place today have gaps where efficiency can be REGINA PALESKI improved for the betterment of companies and the people they serve, and tech- nologies already exist that could be put to work for regulatory and reimburse- ment proceedings. 50 DEAL-MAKING The willingness to improve access to medicines is there, but the ability to act Deals Shaping The Medical Industry, and the tools for true disruption are not. It was a fitting experience to hear October 2019 speakers on this topic while working on In Vivo’s Market Access issue. THE STRATEGIC TRANSACTIONS TEAM This month Melanie Senior explores the impact of ICER in the US, a group that is having an unexpected impact on the sector and society’s expectations of drug manufacturers. EXCLUSIVE ONLINE CONTENT With another view on access, Jo Shorthouse looks at how smaller US compa- invivo.pharmaintelligence.informa.com nies can launch in Europe without a partner. Small and medium biopharmas that are targeting the US first with their new or first products have historically ❚ linked up with larger or local players to launch in Europe. However, a trend is Welcome To Alexion 2.0 emerging that has put the spotlight on some biotechs that have chosen to go it JO SHORTHOUSE alone with their drugs in the European market. Exploring the topic of “access for all,” in an exclusive interview, the CEO of the ❚ Biopharma Quarterly Deal-Making Gates Medical Research Institute (MRI), Penny Heaton, talks about the group’s Statistics, Q3 2019 plan to have 20 product candidates in the pipeline by 2023. The Bill and Melinda AMANDA MICKLUS AND Gates Foundation established the Gates MRI in 2018 to develop drugs and vaccines targeting major neglected diseases of poverty like tuberculosis and malaria. MAUREEN RIORDAN ❚ The Future Of AI Use In Endoscopy In Vivo: Always Online First Don’t have an online user account? CATHERINE LONGWORTH Quickly and easily create one Relevant and exclusive online-only by clicking on the “Create your content at your fingertips 24/7. ❚ Deals In Depth, September 2019 account” link at the top of the page. Full access to our 36-year archive. AMANDA MICKLUS Contact: Access your subscription by visiting: [email protected] invivo.pharmaintelligence.informa. or call: (888) 670-8900 or +1 (908) com and log in. 748-1221 for additional information. All stock images in this publication courtesy of /invivo @invivo /invivo www.shutterstock.com unless otherwise stated. 2 | | November 2019 invivo.pharmamedtechbi.com In Vivo invivo.pharmaintelligence.informa.com invivo.pharmaintelligence.informa.com CONTENTS ❚ ❚ Up-Front SNAPSHOTS FROM NOVEMBER’S CONTENT In the last decade, the health sector has seen a substantial rise “ 3D is clinically proven to in the number of mHealth apps, many of which are designed to increase surgical speed assist users in weight reduction and diabetes management. In and confidence and allows 2016, there were 79,000 apps available in the Health & Fitness certain operations with a category in the Google and Apple stores. However, the lot of intricate suturing to implementation of mHealth in oncology is lagging. be completed far quicker. PAGE 4 With the latest 4K EVIDENCE-FREE US DRUG PRICE HIKES, 2017-2018 PAGE 10 resolution 3D imaging, Rituxan Lyrica Sony can provide the most (Genentech) (Pfizer) advanced realistic Humira pictures available for (AbbVie) surgeons to utilize.” * – John Herman, 15.9% 23.6% 22.2% PMM for Sony Europe ESTIMATED AVERAGE Healthcare Solutions NET PRICE PAGE 6 INCREASE Stiff price competition is “We are at a special time in history, with coming in all US therapeutic new science that has enormous categories, including potential in saving and extending protected classes like lives. The tools are within our cancer and rare diseases. grasp to confront the pathogenic and immunologic roots of For the industry to thrive in infectious diseases that have this environment, plagued humankind since the innovations in pricing will dawn of civilization.” be as much, if not more, – Dr. Penny Heaton, CEO important than a product Gates Medical Research Institute and the science itself. PAGE 22 PAGE 16 ©2016 Informa Business Information, Inc., an Informa company November 2019 | In Vivo | 3 ❚ Around The Industry MHealth And Research In Oncology The World Health Organization defines mobile health (mHealth) as a “medical and public promote better patient-doctor commu- health practice supported by mobile devices, such as mobile phones, patient monitoring nication and encourage shared decision- devices, personal digital assistants, and other wireless devices.” making during treatment. After treatment, apps can ease follow-up care and help In the last decade, the health sector patients deal with side effects or make has seen a substantial rise in the number behavioral changes to improve their qual- of mHealth apps, many of which are de- ity of life. signed to assist users in weight reduction There is a need There are several apps on the market and diabetes management. In 2016, there and in development aimed at providing were 79,000 apps available in the Health & for app developers cancer patients with more personal- Fitness category in the Google and Apple ized care by tracking symptoms, patient stores. However, the implementation of and organizations journeys, treatment side effects and suc- mHealth in oncology is lagging. working with cesses. Select examples include: There is a need for the development of more mHealth apps in oncology set- health data to RESEARCH ON USER BEHAVIOR AND tings, considering the increasing disease USEFULNESS OF APPS burden and potential clinical benefit. Ac- build trust to A US-based consumer survey, conducted cording to Cancer Research UK, there were by Deloitte and published in 2018, report- 17 million cases of cancer and 9.6 million encourage users ed findings on attitudes and behaviors deaths globally in 2018.
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