With the ongoing technology revolution, will EU Healthcare Systems & Payers be ready to manage timely patients’ access and innovative pricing?

1. WPPMA 2019: INTEGRATING CARE TO SECURE
EARLY ACCESS AND EFFECTIVE PRICING
Andrea Mantovani, M.Sc., MBA
Amsterdam, March 19th, 2019

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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.

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With the ongoing technology
revolution, will Healthcare Systems
& Payers be ready to manage
timely patients’ access and pricing?

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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

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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

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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

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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

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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)

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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?

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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

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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)

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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.

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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.

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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

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IMPLICATIONS FOR THE REGULATORS: EMA IS DRAFTING A PLAN TO
CHANGE THE OVERALL APPROACH BY 2025. TOO LATE?

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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

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IMPLICATIONS FOR THE INDUSTRY: THE ROLE OF THE START UPS

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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?

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BACK UP

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THE REGULATORY CONTEXT: US & EU DEVICES
CLASSIFICATION
2
3

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MAIN DIFFERENCES BETWEEN DRUGS AND MEDICAL DEVICES:
PHARMA P&R PATHWAY

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MAIN DIFFERENCES BETWEEN DRUGS AND MEDICAL DEVICES:
MED TECH P&R PATHWAY

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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).

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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.

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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).