The Value of Integrated Care
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The document discusses the integration of care in healthcare systems, emphasizing timely patient access and effective pricing for drugs and medical devices. It outlines the approval process differences for drugs and devices, early access options in various regions, and implications for pricing and regulation. Additionally, it predicts the future of healthcare management and the need for innovative models to adapt to evolving technologies in health treatments.
The Value of Integrated Care
- 1. WPPMA 2019: INTEGRATING CARE TO SECURE EARLY ACCESS AND EFFECTIVE PRICING Andrea Mantovani, M.Sc., MBA Amsterdam, March 19th, 2019
- 2. 2 DISCLAIMER I have/ had the following relevant financial relationships in the products or services described, reviewed, evaluated or compared in this presentation: • Abbott, Amgen, Novartis, Sanofi: o Current or past employee All opinions expressed in the presentation are my own and do not necessarily reflect official current/ previous companies positions.
- 3. 3 With the ongoing technology revolution, will Healthcare Systems & Payers be ready to manage timely patients’ access and pricing?
- 4. 4 DRUGS VS. MEDICAL DEVICES APPROVAL PROCESS: DATA LOAD AND ACCELERATED PATHWAYS TOGETHER WITH RWE ACCEPTANCE KEY DIFFERENTIATORS • Centralized vs. Decentralized approach • Heavy load of registration data, with exceptions • Increased acceptance of RWE data • Accelerated approval pathways • Centralized vs. Decentralized approach • Light load of registration data • Higher acceptance of RWE data • No (need for) accelerated app. pathways
- 5. 5 EARLY ACCESS CASES FOR DRUGS IN US/ EUROPE: OPTIONS AVAILABLE TO GET FUNDING BEFORE MARKETING AUTHORISATION (MA) No Early Access options available for Medical Devices
- 6. 6 EARLY ACCESS CASES FOR DRUGS IN ITALY: OPTIONS AVAILABLE TO GET FUNDING BEFORE EU/ LOCAL MARKETING AUTHORISATION (MA) • Early Scientific Advice(s) possible with AIFA • No Early Access options available for Medical Devices
- 7. 7 AIFA NEW* INNOVATION ALGORITHM CLEARLY DEFINES WHICH DRUGS WOULD BENEFIT FROM DEDICATED FUNDS (€1B/ YEAR) HIGHIMPORTANT VERY LOW LOW MODERATE HIGH MODERATELOWVERYLOW VERY LOW LOW MODERATE IMPORTANT HIGH UNMETMEDICALNEED THERAPEUTIC VALUE ADDED QUALITY OF DATA (GRADE)** 1 2 3 INNOVATION GRANTED (FULL OR POTENTIAL) INNOVATION UNCERTAIN (FULL OR POTENTIAL) INNOVATION NOT GRANTED * Approved in AIFA in March 31.03.2017 ** Specialized GRADE Center: Technical Commision Emilia Romagna Region; GRADE Criteria do not apply to Orphan Drugs • No such process for any other (innovative) technology
- 8. 8 ITALY AS A PIONEER FOR INNOVATIVE P&R AGREEMENTS FOR DRUGS; REGISTRIES AS A KEY FEATURE OF THE NHS SYSTEM (SO FAR) No national price negotiations available for Medical Devices (only regional/ local)
- 9. 9 2019 KEY 6 PREDICTIONS FOR THE GLOBAL HEALTHCARE INDUSTRY Reference: Adapted from Frost & Sullivan, 2018 How is this revolution impacting the NHS Systems around the world?
- 10. 11 POPULATION HEALTH MANAGEMENT: A NEW VISION FOR THE NHS BY TURNING DATA INTO KNOWLEDGE, PEOPLE AND THEIR CARE PROVIDERS CAN WORK BETTER TOGETHER, CULTIVATING A MINDSET OF PROACTIVE HEALTH, RATHER THAN REACTIVE CARE Know your population in order to engage citizens to take an active role, and to actively manage each individual to improve their health and wellbeing Reference: Adapted from Cerner, 2019
- 11. 12 THE TRIPLE AIM AND THE KEY DIMENSIONS OF THE POPULATION HEALTH MANAGEMENT: OPPORTUNITY TO BUILD OUTCOMES BASED PRICING SOLUTIONS - Dimensions of population health management - - The Triple Aim - VALUE BASED HEALTHCARE OR OUTCOMES BASED PRICING Reference: How population health management will deliver a sustainable NHS, February 2018, Andrew Corbett-Nolan et Al. (GGI)
- 12. 13 THE INTEGRATED APPROACH FOR DIABETES: A VIRTUOUS EXAMPLE IN MANAGING INDIVIDUAL PATIENTS - THE 5D MODEL Reference: Adapted from Integrated Approaches in Diabetes Care – The 4Ds Author: Jochen Maas, Sanofi General Manager R&D Germany, Date: 24/05/2018 DTx - Digital Therapeutics • Utilizes digital technologies to treat a medical or psychological condition. • The treatment relies on behavioral and lifestyle changes usually spurred by a collection of digital impetuses.
- 13. 14 THE APPLE HEART STUDY: A PRECURSOR OF WHAT COULD BE NEXT Reference: Apple, released public information Methods The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants. The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1. Characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2. Estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants.
- 14. 15 REGULATORY IMPLICATIONS: DIAGNOSTIC/ DRUG/ DEVICE/ DIGITAL THERAPIES COMBINATIONS – HOW TO SPEED UP SAFELY THE APPROVAL PROCESS? NOW THEN PS: Impact of EU Regulation 2017/745 on Medical Devices starting on May 26th, 2020
- 15. 16 IMPLICATIONS FOR THE REGULATORS: EMA IS DRAFTING A PLAN TO CHANGE THE OVERALL APPROACH BY 2025. TOO LATE?
- 16. 17 IMPLICATIONS FOR THE INDUSTRY: CAN THE INDUSTRY BE A RELIABLE AND KNOWLEDGEABLE PARTNER OF THE INSTITUTIONS? INDUSTRY PARTNERSHIPS AS THE ONLY VIABLE OPTION? “Integrated Care” Models (device, drugs, digital) “Evolving” Traditional Pharma Model (Focus on drugs) “Enlightened” Medical Devices Companies “Emerging” Digital Health Companies… 1 2 3 4
- 17. 18 IMPLICATIONS FOR THE INDUSTRY: THE ROLE OF THE START UPS
- 18. 19 CONCLUSIONS - IMPLICATIONS FOR PRICING AND EARLY ACCESS: ARE EU COUNTRIES READY TO MANAGE THE UPCOMING REVOLUTION IN HEALTHCARE? 1. Typical reimbursement and pricing process follows different pathways for drugs and devices; in some countries apps and digital tools are not even prescribed/ reimbursed/ paid for: How will EMA ensure a common vision? 2. The Value of a multiple D is very different from the simple sum of them: maybe 5xD = D5 ; How will Value be defined/ measured in the future? 3. With current combinations of Medical Devices + Drugs (impact of EU Regulation 2017/ 745 on Medical Devices starting on May 26th, 2020), will Early Access approaches as we know them still be valid in the future? 4. What kind of Innovative Pricing Models can be envisioned for the D5 approach? Will finally the Outcomes Based Pricing become a reality everywhere in Europe? 5. What kind of collaboration can be envisioned between all the organizations involved in the «Population Health Management»?
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- 20. 21Mantovani.andrea@gmail.com, @MANTO71 Pamphlet: What is Market Access?
- 21. 22 BACK UP
- 22. 23 THE REGULATORY CONTEXT: US & EU DEVICES CLASSIFICATION 2 3
- 23. 24 MAIN DIFFERENCES BETWEEN DRUGS AND MEDICAL DEVICES: PHARMA P&R PATHWAY
- 24. 25 MAIN DIFFERENCES BETWEEN DRUGS AND MEDICAL DEVICES: MED TECH P&R PATHWAY
- 25. 26 MAIN DIFFERENCES BETWEEN DRUGS A MEDICAL DEVICES: A DIRECT FINAL COMPARISON (1 OF 3) Feature Devices Pharmaceuticals Concept to commercialization Average 3–5 years. Average 8–10 years. Development milestones Product development in medical devices is focused on milestones such as prototype development, design validation, and manufacturing scale-up. Drug development is focused on health care milestones such as clinical indications and reimbursement Nature of product Medical devices are typically based on mechanical, electrical, information technology, and systems engineering, and stem from ideas typically generated in a clinician’s practice. Pharmaceuticals are based on chemistry, biotechnology, and genetics, originating in an R&D laboratory. Patent coverage Multiple fields of art contribute to the development of a medical device as compared to a pharmaceutical drug. Medical device patents are typically directed to the structure, function, and methods of using the device. As a result, many more patents are used to cover a medical device than a pharmaceutical. Since there are a finite number of molecules that may be used to elicit a desired biological response and clinical outcome, a single patent covering the class of molecules that comprise the pharmaceutical product is sufficient (However, Humira case).
- 26. 27 MAIN DIFFERENCES BETWEEN DRUGS A MEDICAL DEVICES: A DIRECT FINAL COMPARISON (1 OF 3) Feature Devices Pharmaceuticals Patent types The ultimate effectiveness and benefit of a medical device is dependent in part on the skill of the clinician using or implanting the device. In this regard, medical device patents may cover method of implant, installation, surgical navigation, placement, adjustment, calibration, and adaptation to particular patients. Specifically, medical device patents may also have method claims such as method of manufacturing, implanting, operating and initiating. Most pharmaceutical products are either ingested or introduced into the body directly and therefore constitute therapies themselves. Accordingly, with very few exceptions, pharmaceutical patents do not have method claims regarding delivery mechanisms. Further, pharmaceutical product patents are usually directed to the structure of the molecules themselves or methods of manufacturing or purifying that compound. Alternate designs “Design-arounds” are common for medical devices. The prevalence of alternate medical device designs typically precludes an exclusive position in the marketplace. Pharmaceutical products generally do not lend themselves to “designaround” efforts and do not require several patents covering variations or alternate designs. Once a key pharmaceutical patent has expired, it will be possible for other manufacturers to make “generic” versions of the same pharmaceutical.
- 27. 28 MAIN DIFFERENCES BETWEEN DRUGS A MEDICAL DEVICES: A DIRECT FINAL COMPARISON (1 OF 3) Feature Devices Pharmaceuticals Improvements and product life cycle As new technologies continue to develop, each field of art may implement these new technologies, which make frequent iterative improvements possible. As a result, medical devices have a short commercial life cycle, typically 18–24 months. Each new component or improvement (with the new technology implemented in the product) may be individually patentable. Pharmaceuticals typically have a long commercial life cycle (10 to 20+ years), during which they do not undergo significant changes. Number of patents A single medical device may be covered by hundreds of patents. A single drug can have a maximum of 2 patents (but, Humira case).