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June 2020
@RichardCharter
linkedin.com/in/richardcharter
Richard.Charter@AliraHealth.com
Diagnostics
Digital
Health
Medical
Devices
The post-COVID Value Shift & How
MedTech Companies can Capitalize.
Richard Charter
Vice President, MedTech Market Access, Europe & Asia Pacific
2
Disclaimers
The views presented are those of the presenter, and do not necessarily reflect those of the affiliated organisations or their subsidiaries
1. Vice President, MedTech Market Access, Europe & Asia Pacific, Alira Health
2. Co-chair, ISPOR Medical Devices Special Interest Group
3. Co-chair, HTAi Medical Devices Interest Group
4. Industry Advisor: Horizon 2020 Funded COMED Initiative (grant agreement No 779306)
3
Background
For more content, please see the LinkedIn article: "Value will change in the post-COVID World": Value Based Healthcare and MedTech
solutions will benefit.
4
Todays Topics
The Pre-COVID Value Challenges
How healthcare systems have changed as a result of COVID
How these changes can benefit MedTech Companies
Aligning your organization to the ‘new normal’ of healthcare
Why Alira Health: Upon Request
5
Project Proposal Overview
Healthcare is Unique: This creates a ”Value challenge”
PROJECT GOALS
STRUCTURE
SCOPE OVERVIEW
HEALTHCARE IS UNIQUE § HEALTHCARE HAS STRUCTURAL CHALLENGES § HEALTHCARE HAS A SOLUTION
HEALTHCARE IS THE ONLY INDUSTRY WITH A
COMPLETELY DISTINCT SET OF DECISION
MAKERS AND USERS OF ‘HEALTHCARE’
THE CHALLENGES ARISING FROM THE UNIQUE
STRUCTURE OF HEALTHCARE IS COMPOUNDED
BY KEY MACROTRENDS
THE SOLUTION TO THESE CHALLENGES IS VERY
SIMPLE, BUT THE HEALTHCARE ECOSYSTEM
MAKES THINGS INCREDIBLY COMPLEX
Source: Porter M. Redefining Health Care. HBS Press, 2006
1. Provide the highest quality healthcare to
maximise population health outcomes
2. Paying for healthcare despite limited
budgets, & rapidly growing demand
3. Ensuring equality & universal healthcare
coverage
Value =
Health Outcome
Total Cost of Delivering Outcome
?Value?
Patient
PayerPhysician
HEALTHCARE NEEDS A TRANSFORMATION: COVID-19 HAS ACCELERATED THIS TRANSFORMATION
6
Working harder does not mean working smarter: Especially in a Pandemic
Sales people can be more productive and generate greater revenue per head, IF they adopt a clinical and economic sales approach that caters to ALL
stakeholders. But they have to be able to articulate multi-factorial benefit to multiple stakeholders. Commercial teams need a transformation.
Source: Google search, http://www.studysphere.com.au/productivity/no-thanks-were-
too-busy/ Accessed March 2019 Source: Google search, Accessed March 2019
Healthcare systems require a different type of engagement to 20 years ago. Successful medical technology companies are the ones that have
transformed their approach to one where they are ‘selling’ the health outcomes their products can deliver, and not the products that are created. The
shift from selling products, to selling health outcomes is one that every company should embrace. COVID 19 is a clear example of this.
7
Todays Topics
The Pre-COVID Value Challenges
How healthcare systems have changed as a result of COVID
How these changes can benefit MedTech Companies
Aligning your organization to the ‘new normal’ of healthcare
Why Alira Health: Upon Request
8
Source: Alira Health analysis; https://www.bruegel.org/publications/datasets/covid-national-dataset/
Pandemic Response: A Note on Willingness to Pay from government
With a surge in critical care admissions, there will need to be a commensurate increase in funding for healthcare
Intensive care = Expensive Care
Key Takeaway: Massive reprioritisation of funding means a complete shift in willingness to pay and budget allocations. MedTech companies CAN benefit, but it requires a
reprioritisation of resourcing to accommodate payer and hospital procurement value propositions
9
”As surge increases, the demand–resource imbalance worsens. With an increasing magnitude of pandemic surge, response strategies increasingly
depart from the usual standard of care until patient mortality increases and effective delivery of critical care is no longer possible.”
Intensive Care Surge Capacity: A Primer
Published in December 2019
CHALLENGING CONCEPTS IN CRITICL CARE Surge Capacity & the Role of MedTech
WHAT CRITICAL CARE EXPERTS SAY
Source: Gabriel L Farrar J. Challenging Concepts in Critical Care: Cases
with Expert Commentary. Oxford University Press, December 2019.
Available online.
§ The duration of patient isolation,
use of personal protective
equipment (PPE), and the risks
associated with cohorting of
patients with suspected /
confirmed infection are often
unknown, particularly in the early
phase of an emerging epidemic.
§ Critical care staff often accounts
for over 50% of Critical Care
resource consumption, and is
requisite for appropriate device
use and patient care
KEY CONSIDERATIONS
In a severe surge, staff illness and
fear of infection is likely to increase
absenteeism
Staff Stuff Space Systems
§ The opportunities for applying
mobile technologies have yet
to be fully explored. The
literature suggests that
implementing emergency
medical systems using mobile
technology is often given a low
priority. However, in the future
these will undoubtedly
enhance communication,
facilitate strategic mapping,
coordinate logistics, and
improve local and international
responses in a timely and cost-
effective manner.
KEY CONSIDERATIONS
Communication, Screening &
Diagnostics
§ PPE should be rationalized.
Simple surgical masks can be
used where patients’ lungs are
ventilated using closed circuits,
but N95 masks are required for
aerosol-generating procedures.
§ In the inter-pandemic period,
equipment, such as monitors
and ventilators, may be
standardized and stockpiled
where feasible.
KEY CONSIDERATIONS
Consumable & Equipment
Availability
§ A 300% expansion target for
bed capacity has been
suggested, but in practice few
facilities would reach this goal.
§ It is essential not to overlook
that patients requiring ICU care
for reasons unrelated to the
surge will continue to present
during the pandemic phase.
Planning must accommodate
these patients too.
KEY CONSIDERATIONS
Bed Availability
Authors:
• Dr Lucinda Gabriel: Kings Health Partners
• Dr Jeremy Farrar: Wellcome Trust
SHIFT TO DIGITAL
ALIGN TO CHANGED
HOSPITAL NEEDS
ENSURE SUPPLY
COMMUNICATE &
UNDERSTAND
10
The MedTech Pandemic
Eisenhower Matrix
The MedTech Pandemic Eisenhower Matrix
The MedTech Modified Eisenhower matrix indicates the urgency and importance of various manufacturers in their role in a pandemic response.
Companies that are Highly Urgent, and of
Highly Important in Pandemic Response
URGENCY
IMPORTANCE
Companies that are Highly Important, but
Less Urgent in Pandemic Response
Companies that are Less Important, but
Highly Urgent in Pandemic Response
Companies that are Less Important, but
Less Urgent in Pandemic Response
Key Strategic Priorities
- ensure supply chains and production are
fully functional
- ensure internal teams are reallocated to
optimise supply of critical medical
technologies and diagnostics
- ensure new products to diagnose and
manage patients with COVID are rapidly
scaled up and ethically distributed
EXAMPLES: PPE suppliers, mechanical
ventilator companies, pumps, consumables
and diagnostics
Key Strategic Priorities
- ensure continuous supply of core
products. Eg. Glucose monitors and
insulin delivery systems
- create dedicated teams to remote-
manage HCP questions and responses.
Teams wont be allowed in facilities
– develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Chronic illness suppliers,
diabetes management, COPD
Key Strategic Priorities
- ensure support teams can manage
your installed base of existing equipment
- Shift to digital marketing and digital
engagement solutions
- develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Capital equipment, medical
imaging, and low priority elective
surgery
Key Strategic Priorities
- ensure a strategy for the rapid rebound
in pent up elective surgery demand
- ensure a digital framework and remote
consultations for patients that require
immediate interventions
- develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Cardiac interventions,
oncology interventions, orthopaedics and
the associated MedTech suppliers
Key Takeaway:
Develop forward looking value propositions to adjust to the necessary budget shifts going forward.
Increased funding will lead to opportunity, but it will also lead to budget reprioritisation
* Companies Listed are indicative on. Companies may be present in more than 1 quadrant given multiple business units, and multiple definitions of urgent and
important globally
11
The Primary Impact of COVID on healthcare systems: A System Perspective
COVID-19 has accelerated the transformation of healthcare, some changes will be temporary, some will be permanent, but COVID will will be a clear
demarcation point in how healthcare is provided, funded, and managed.
Patient pathway approach: COVID-19 is being holistically managed, from screening, to
diagnosis, to management to track and trace.
Aligned to VBHC
Transformation ?
Of benefit to
MedTech Industry
Block / bundled contracting: of key Medical Technologies through national purchasing which
means MedTech can articulate value at more holistic level – beyond procurement budgets
Shift to digital health: teleconferencing for appointments, mobile phones Apps, drones flying
PPE to isolated communities, remote monitoring of hospitalised patients
MedTech Value recognition: Massive shift in value recognition as demonstrated via budget and
resource allocation.
Integrated care systems: becoming the default system structure: health and social care are
inextricably linked centrally
Employee care: Companies revising health plans to ensure employees are looked after. Look
after employees, they look after your business.
Public health: moving to the fore of decision making: screening and diagnostic companies need
a rapid distribution strategy
12
Todays Topics
The Pre-COVID Value Challenges
How healthcare systems have changed as a result of COVID
How these changes can benefit MedTech Companies
Aligning your organization to the ‘new normal’ of healthcare
Why Alira Health: Upon Request
The Nuance of Evidence Generation & MedTech:
ALIRA HEALTH:
A LIFECYCLE APPROACH
Too early for solution to have
quantifiable value
Product fully adopted,
disinvestment challenges
REAL-WORLD
DATA COLLECTION
Initial Product
Adoption
Evidence of
Safety & Efficacy
Adaptative
RCT design
Adaptive RCT
Results
Time
Adapted from source: P. Armeni ISPOR Presentation, Boston 2017
Candidate for Value Based Access Programs (VBAP)
Value Based Procurement (tendering) criteria defined at provider level
Product Diffusion
Physician & User Learning Curve
HTA Decision,
Reimbursement,
Coding & Funding
Successful
Market
Access
Launch
(CE Mark)
Perception of
Market Access
We provide a variety of services under the same
umbrella and with a holistic approach and clear
vision: to support you and be of value to you at
every stage of your corporate and product
evolution.
A Product Life Cycle Approach beginning with the clinical unmet need of a solution triggers healthcare value
14
Source: Nature Reviews Neurology, 2019 July; Alira Health analysis.
Value Based Healthcare: Why it Applies MORE in a post-COVID world
The role of different stakeholders is crucial. Some changes are more easily implemented by MedTech companies than others.
1. Organise solutions around medical
conditions
2. Measure patient relevant outcomes
3. Measure total costs of delivering
outcomes
4. Move to government
reimbursement of medical
conditions – not products
Integrate multi-site treatment centres
Expand provider reach across urban
& rural care
Build enabling IT platforms to scale up
evidence & data driven decisions.
Source: Adapted from: https://www.isc.hbs.edu/health-care/vbhcd/Pages/default.aspx
(Accessed January 2019)
Porter M, Teisberg EO, Redefining Health Care, Harvard Business Review Press, 2006
15
Source: Nature Reviews Neurology, 2019 July; Alira Health analysis.
Value Based Procurement is an enabler of Value Based Healthcare
Value based procurement in of itself is not the end goal. It is a stepping-stone to a more holistic and patient-centric buying process in healthcare. The
MedTech companies that adapt the fastest will have a significant competitive advantage
Adapted from: Mangan, B Kelley T, McGough R, & Meehan J. Value Based Procurement An alternative approach to total cost reduction, improved efficiency and enhanced patient
outcomes in the NHS: A Framework for Delivery. NHS Northwest Procurement Development, 2018. University of Liverpool
Potential for Improved
Total Costs to System &
patient outcomes
Time, Complexity
& # of stakeholders
Unilateral decisions
made with Price only
contracts
Procurement based
NOT only on price,
but outcomes &
costs
Value & outcomes
quantified,
contracted, with risk
sharing
Price mainly
Individual Unit Value
Risk High Medium Low
Value Based
Procurement
Value Based
Healthcare
Timeline of Payer &
Procurement Savings
SHORT
(<3 years)
MEDIUM
(3-5 years)
LONG
(>5 years)
• Approximately 70% of all MedTech reaches the user
through some form of procurement.
Value Based Procurement
Enables Value Based Healthcare
• Traditionally tenders are conducted by stakeholders who
are measured on reducing costs associated with buying
materials, often not healthcare products.
• MedTech must align with stakeholders to ensure value-
based metrics are included in tenders
• Health outcomes: patient, physician,
system
• Total Costs: Acquisition & avoided costs
• Societal value and aggregate impact
• Value based procurement is a mid-term solution to
transforming health towards a value based system
16
Todays Topics
The Pre-COVID Value Challenges
How healthcare systems have changed as a result of COVID
How these changes can benefit MedTech Companies
Aligning your organization to the ‘new normal’ of healthcare
Why Alira Health: Upon Request
17
The MedTech Pandemic
Eisenhower Matrix
The MedTech Pandemic Eisenhower Matrix
The MedTech Modified Eisenhower matrix indicates the urgency and importance of various manufacturers in their role in a pandemic response.
Companies that are Highly Urgent, and of
Highly Important in Pandemic Response
URGENCY
IMPORTANCE
Companies that are Highly Important, but
Less Urgent in Pandemic Response
Companies that are Less Important, but
Highly Urgent in Pandemic Response
Companies that are Less Important, but
Less Urgent in Pandemic Response
Key Strategic Priorities
- ensure supply chains and production are
fully functional
- ensure internal teams are reallocated to
optimise supply of critical medical
technologies and diagnostics
- ensure new products to diagnose and
manage patients with COVID are rapidly
scaled up and ethically distributed
EXAMPLES: PPE suppliers, mechanical
ventilator companies, pumps, consumables
and diagnostics
Key Strategic Priorities
- ensure continuous supply of core
products. Eg. Glucose monitors and
insulin delivery systems
- create dedicated teams to remote-
manage HCP questions and responses.
Teams wont be allowed in facilities
– develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Chronic illness suppliers,
diabetes management, COPD
Key Strategic Priorities
- ensure support teams can manage
your installed base of existing equipment
- Shift to digital marketing and digital
engagement solutions
- develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Capital equipment, medical
imaging, and low priority elective
surgery
Key Strategic Priorities
- ensure a strategy for the rapid rebound
in pent up elective surgery demand
- ensure a digital framework and remote
consultations for patients that require
immediate interventions
- develop forward looking value
propositions to adjust to the necessary
budget shifts going forward
EXAMPLES: Cardiac interventions,
oncology interventions, orthopaedics and
the associated MedTech suppliers
Key Takeaway:
Develop forward looking value propositions to adjust to the necessary budget shifts going forward.
Increased funding will lead to opportunity, but it will also lead to budget reprioritisation
* Companies Listed are indicative on. Companies may be present in more than 1 quadrant given multiple business units, and multiple definitions of urgent and
important globally
18
5. Integrate multi-site treatment centres
6. Expand provider reach across urban & rural care
7. Enable IT platforms for evidence & data driven decisions
1. Organise around medical conditions
2. Measure patient relevant outcomes
3. Measure total costs of delivering outcomes
4. Move to reimbursement of medical conditions
Source: Porter M. Redefining Healthcare. 2006. Internal Alira Health research. Harvard Business School
Healthcare Transformation: System, Payers & MedTech
Health System Transformation to Value Based Health Care
Healthcare systems are adapting, and payers ask defined questions. MedTech can adapt via 7 steps.
Key Questions Payers will Ask
How MedTech Can support Systems & Payers
6. Determine
prospective outcomes
and cost improvement
This defines the
quantifiable benefit that
will drive pricing, volume
and access discussions
5. Quantify baseline
Outcomes & Costs for
each patient cohort
A baseline is critical for
cost benefit analysis for
payers outlining why is
this may be better than
the Standard of Care.
7. Develop a simple
business model.
A business model serves
two purposes:
1. internal and resourcing
2. viability of payer
investment
BusinessFundamentals
1. Patient Centric Therapeutic Areas
Identify the primary therapeutic areas for your MedTech solution. A PICO framework
can support this and define your core value proposition.
1. What is the unmet need?
2. What am I currently paying?
3. How is your solution better than the alternates?
4. How much is your device and why is it worth it?
5. Can I afford your device?
6. What are the consequences of NOT funding this?
7. Which patients should get this?
Patient&TherapeuticArea
2. Develop patient cohorts with risk adjusted criteria and protocols
This ensures similar patients to drive comparability of outcomes in the clinical trial. This
also helps to identify exactly where the value for a solution is derived from.
3. Define clear outcome measures for cohorted patients
The outcomes become the measurements for success, which define value, and set the
foundation of pricing a MedTech solution
4. Define a clear timeframe to achieving optimal outcomes: trial and RWE settings
Timeframes for patient outcomes, must align to economic savings to resonate with
payer budgets
19
Preparing your business for the 2nd Wave
Pandemics often have multiple waves of outbreaks. Without a vaccine, we could experience a second wave. Under the example of the Spanish Flu and
SARS, it would be prudent to hope for the best, yet plan for the worst in terms of a second wave of COVID-19
Spanish Flu: 1918 - 1919 SARS 2003 - Ontario, Canada
It would be prudent, yet hopefully unnecessary to have a strategic plan for a second wave of COVID-19
20
A final thought: Prof Dr Jeremy Farrar, OBE, Director Wellcome Trust
Deaths resulting from a new pandemic will be
regrettable. Those that result from insufficient
planning, inequitable allocation of resources, and
inadequate preparation will be especially tragic [7].
Source: Gabriel L Farrar J. Challenging Concepts in Critical Care: Cases with Expert Commentary. Oxford University Press, December 2019. Available online.
A comment on the role of leadership and planning during a pandemic
Experience with previous pandemics shows the critical role leadership plays in
addressing the challenges in delivering critical care. Leadership involves using existing
infrastructures and strengthening the capacity of national and international surveillance
systems, in ways that ensure accurate detection of suspected human cases, reliable
laboratory confirmation, effective field investigation, and complete reporting in a timely
manner. The ICU generates information about the evolving pandemic and has the
potential to communicate this in real time.
What We Believe In
Success through collaboration
We enable cross-functional, evidence-based teams within
MedTech organizations to engage in external collaborative
dialogue with Payers, Providers, Procurement, Policy
Makers, and Physicians.
Diagnostics
Digital Health
Medical Devices
Care Setting
Therapeutic Areas
Value Based Market Access
Solutions for MedTech
June 2020
@RichardCharter
linkedin.com/in/richardcharter
Richard.Charter@AliraHealth.com
Diagnostics
Digital
Health
Medical
Devices
The post-COVID Value Shift & How
MedTech Companies can Capitalize.
Richard Charter
Vice President, MedTech Market Access, Europe & Asia Pacific
FRANCE
26 rue de Navarin
75009 PARIS
FRANCE
+33 (0)1 44 54 96 23
USA
SAN FRANCISCO
88 Kearny Street, Suite 2100
SAN FRANCISCO
CA, 94104
USA
+1 (774) 777 5255
SPAIN
Carrer de Balmes, 206 (Atico 2)
08006 BARCELONA
SPAIN
+34 (93) 655 55 05
ITALY
Via Carlo Ottavio
Cornaggia 10,
20123 MILAN
ITALY
+39 (02) 36680198
GERMANY
Kurfürstenstraße 22,
80801 MUNICH
GERMANY
+49 (89) 416 14 22-0
SWITZERLAND
GENEVA
Campus Biotech Innovation Park
Avenue de Sécheron 15
1202 GENEVA
SWITZERLAND
+33 (7) 69677361
+41 (79) 5937886
SWITZERLAND
BASEL
Hochbergerstrasse 60B
CH 4057 Basel
SWITZERLAND
+41 (0)61 205 9669
USA
BOSTON
1 Grant Street,
Suite 400 Framingham
FRAMINGHAM, MA 01702
USA
+1 (774) 777 5255
www.alirahealth.com
24
Todays Topics
The Pre-COVID Value Challenges
How healthcare systems have changed as a result of COVID
How these changes can benefit MedTech Companies
Aligning your organization to the ‘new normal’ of healthcare
Why Alira Health: Upon Request
REGULATORY
Strategy and Roadmap
Development
Submission Management
FDA Liaison Officer For Non-US
Companies
PRODUCT
DEVELOPMENT LAB
New Product Development
IP Development
(StructuredIP™)
Incubation Of Breakthrough
Technologies
Discovery Development Plan
In-VITRO and In-VIVO Testing
CLINICAL
Study Design and Protocol
Writing
Site Selection and Feasibility
Investigator Training
Subject Recruitment &
Retention
Data Management and
Biostatistics
Trial Management and Clinical
Operations
Pharmacovigilance
STRATEGY CONSULTING
Market Opportunity
Assessment
Indication Prioritization
Portfolio Management
Commercial / Vendor Due
Diligence
Scientific and Clinical Due
Diligence
Asset and Company Valuations
Commercial Excellence
Corporate Strategy Planning
Commercial Strategy and Go-to-
Market Model Development
Integrated Launch Planning
Competitive Gaming
TRANSACTION
ADVISORY
Mergers & Acquisitions Sell/Buy
Side
In & Out Licensing
Strategic Partnerships
Capital Raise
Global Market Access, Pricing and
Reimbursement Strategy
Mock Negotiations and Payer
Consultations
Health Economics and Outcomes
Research Strategy
Real World Evidence Strategy and
Plan
Value Communication
Value Based Healthcare Pilots
Market Access Diagnostic MAP
MARKET ACCESS
Our Practice Areas
01
Clinical and Economic
KOL Mapping
02
03
04
0506
07
08
09
Clinical & Economic
Evidence Mapping:
Efficacy & Effectiveness
Reimbursement &
Procurement Approval
Shape Clinical & Payer
Guidelines
Adoption & Funding via
Value Based Access
Programs
Unmet Need & Patient Pathway
Mapping
Centre Specific Pilot
Programs
HCP Access & User
Training
Clinical & Economic
advocacy
Our 9-Step MedTech Market Access Process
Undertaking a Market Access
MAP Diagnostic ensures
integrated internal alignment,
to optimize external market
access processes.
It aligns sometimes
fragmented internal functions
around a core value
framework, activity cadence,
and external market access
process.
Market Access & Commercial Execution
MAP Diagnostics
Messaging
• Diagnostic of existing tools to
support a structured value
framework
• Cross functional workshops to align
product and commercial teams to
domains of value
• Gap Assessment of evidence
Activity
• Diagnostic of country stakeholder
maps and gap analysis for key
geographies
• Regional payer segmentation and
local provider engagement
assessment
• Alignment on external activity
cadence
Process
• Unmet need and patient pathway creation
• Clinical & economic KOL mapping
• Clinical & economic evidence strategy
• Reimbursement & procurement approval
• Centre specific pilot programs
• Value based access programs
• HCP access & user training
• Clinical & economic advocacy
• Optimise clinical & payer guidelines
A B
CD
Stakeholder
Segmentation
PURPOSEMARKET ACCESS & COMMERCIAL EXECUTION MAP DIAGNOSTICS
01
Clinical and
Economic KOL
Mapping
02
03
04
0506
07
08
09
Clinical & Economic
Evidence Mapping:
Efficacy &
Effectiveness
Reimbursement &
Procurement Approval
Shape Clinical &
Payer Guidelines
Adoption & Funding via
Value Based Access
Programs
Unmet Need & Patient
Pathway Mapping
Centre Specific Pilot
Programs
HCP Access & User
Training
Clinical & Economic
advocacy
Improved
Outcomes
Improved Patient Outcomes
Improved HCP Outcomes
Improved Provider Outcomes
Quality of Evidence
Support for Evidence Generation
Evidence Bases Compendium
Lower Total
Costs
Procurement of Products &
Solutions
Efficiency Care Deliver
Cost of Care Delivery
Fewer Complications
Patient Pathway Costing
Alignment
Non-
Outcomes
Benefits
Secondary Patient Benefits
Healthcare Worker Benefits
Provider Benefits
Healthcare System Benefits
Material non-outcomes benefits
for stakeholders
Broader
Impact on
Society
Innovation
Sustainability
Social Economic Impact
Universal Healthcare Benefits
The healthcare industry is undergoing
profound changes.
Every day, new ideas can lead to
promising breakthroughs.
But navigating the complex and rapidly
shifting road to commercialization is
challenging.
How do you into
efficient, safe, and economically viable
treatments and solutions that benefit
patients?
A Transforming Industry
At Alira Health,
our mission is to enable
healthcare transformation
We complement your expertise with a
full spectrum of advisory support to
uncover opportunity, accelerate
innovation, and improve outcomes for
patients around the world.
PRODUCT DEVELOPMENT
LAB
REGULATORY CLINICAL STRATEGY CONSULTING TRANSACTION ADVISORY
At Alira Health,
our mission is to enable
healthcare transformation
We complement your expertise with a
full spectrum of advisory support to
uncover opportunity, accelerate
innovation, and improve outcomes for
patients around the world.
PRODUCT DEVELOPMENT
LAB REGULATORY CLINICAL STRATEGY CONSULTING TRANSACTION ADVISORYMARKET ACCESS
“
Gabriele Brambilla, CEO.
Our clients are
disrupting healthcare.
They discover, create and bring to
market new devices, drugs and
treatments.
They are pioneering the new
standards of care, and we are their
accelerator.”
Local Insights,
Global Reach
of the Top 50
Medtech Companies
80% of the Top 100
Pharma Companies
50%
We advise
of serving clients
around the globe
20 Years
Boston (HQ), San Francisco,
Paris, Barcelona, Munich, Milan,
Geneva, Basel
8 Offices
Our clients are global, so are we. Our
local presence and global collaboration
allows us to deliver actionable business
insights.
Our integrated team of over 150
collaborate to
fully understand every aspect of your business
and offer an unmatched continuum of support
across your full corporate and
product lifecycle.
An Integrated Team
A Lifecycle Approach
We provide a variety of services
under the same umbrella and with a
holistic approach and clear vision:
to support you and be of value to
you at every stage of your corporate
and product evolution.
BACKED BY
DATA SCIENCE
REGULATORY
Strategy And Roadmap
Development
Submission Management
FDA Liaison Officer For Non-US
Companies
Our Practice Areas
PRODUCT
DEVELOPMENT LAB
New Product Development
IP Development
(StructuredIP™)
Incubation Of Breakthrough
Technologies
Discovery Development Plan
In-VITRO and In-VIVO Testing
CLINICAL
Study Design And Protocol
Writing
Site Selection And Feasibility
Investigator Training
Subject RecruPTCent &
Retention
Data Management and
Biostatistics
Trial Management And Clinical
Operations
Pharmacovigilance
STRATEGY CONSULTING
Market Opportunity
Assessment
Indication Prioritization
Portfolio Management
Commercial / Vendor Due
Diligence
Scientific And Clinical Due
Diligence
Asset And Company Valuations
Commercial Excellence
Corporate Strategy Planning
Commercial Strategy and Go-to-
Market Model Development
Integrated Launch Planning
Competitive Gaming
TRANSACTION
ADVISORY
Mergers & Acquisitions Sell/Buy
Side
In & Out Licensing
Strategic Partnerships
Capital Raise
Global Market Access, Pricing and
Reimbursement Strategy
Mock Negotiations and Payer
Consultations
Health Economics and Outcomes
Research Strategy
Real World Evidence Strategy and
Plan
Value Communication
Value Based Healthcare Pilots
Market Access Diagnostic MAP™
MARKET ACCESS
A Global Healthcare Perspective
Our expertise extends beyond the
walls of convention.
Whereas others may have a narrow focus,
we embrace the whole healthcare
ecosystem by taking into account all
involved stakeholders to ensure a
successful outcome for patients, providers,
payers, and suppliers.
PAT I E N T S
P A Y E R SS U P P L I E R S
P R O V I D E R S
A 360° Approach
for Value
at Every Turn
We support you from
concept ideation to
commercial realization;
from innovation to
implementation.
Weare

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The post-COVID Value Shift & How MedTech Companies can Capitalize

  • 1. June 2020 @RichardCharter linkedin.com/in/richardcharter Richard.Charter@AliraHealth.com Diagnostics Digital Health Medical Devices The post-COVID Value Shift & How MedTech Companies can Capitalize. Richard Charter Vice President, MedTech Market Access, Europe & Asia Pacific
  • 2. 2 Disclaimers The views presented are those of the presenter, and do not necessarily reflect those of the affiliated organisations or their subsidiaries 1. Vice President, MedTech Market Access, Europe & Asia Pacific, Alira Health 2. Co-chair, ISPOR Medical Devices Special Interest Group 3. Co-chair, HTAi Medical Devices Interest Group 4. Industry Advisor: Horizon 2020 Funded COMED Initiative (grant agreement No 779306)
  • 3. 3 Background For more content, please see the LinkedIn article: "Value will change in the post-COVID World": Value Based Healthcare and MedTech solutions will benefit.
  • 4. 4 Todays Topics The Pre-COVID Value Challenges How healthcare systems have changed as a result of COVID How these changes can benefit MedTech Companies Aligning your organization to the ‘new normal’ of healthcare Why Alira Health: Upon Request
  • 5. 5 Project Proposal Overview Healthcare is Unique: This creates a ”Value challenge” PROJECT GOALS STRUCTURE SCOPE OVERVIEW HEALTHCARE IS UNIQUE § HEALTHCARE HAS STRUCTURAL CHALLENGES § HEALTHCARE HAS A SOLUTION HEALTHCARE IS THE ONLY INDUSTRY WITH A COMPLETELY DISTINCT SET OF DECISION MAKERS AND USERS OF ‘HEALTHCARE’ THE CHALLENGES ARISING FROM THE UNIQUE STRUCTURE OF HEALTHCARE IS COMPOUNDED BY KEY MACROTRENDS THE SOLUTION TO THESE CHALLENGES IS VERY SIMPLE, BUT THE HEALTHCARE ECOSYSTEM MAKES THINGS INCREDIBLY COMPLEX Source: Porter M. Redefining Health Care. HBS Press, 2006 1. Provide the highest quality healthcare to maximise population health outcomes 2. Paying for healthcare despite limited budgets, & rapidly growing demand 3. Ensuring equality & universal healthcare coverage Value = Health Outcome Total Cost of Delivering Outcome ?Value? Patient PayerPhysician HEALTHCARE NEEDS A TRANSFORMATION: COVID-19 HAS ACCELERATED THIS TRANSFORMATION
  • 6. 6 Working harder does not mean working smarter: Especially in a Pandemic Sales people can be more productive and generate greater revenue per head, IF they adopt a clinical and economic sales approach that caters to ALL stakeholders. But they have to be able to articulate multi-factorial benefit to multiple stakeholders. Commercial teams need a transformation. Source: Google search, http://www.studysphere.com.au/productivity/no-thanks-were- too-busy/ Accessed March 2019 Source: Google search, Accessed March 2019 Healthcare systems require a different type of engagement to 20 years ago. Successful medical technology companies are the ones that have transformed their approach to one where they are ‘selling’ the health outcomes their products can deliver, and not the products that are created. The shift from selling products, to selling health outcomes is one that every company should embrace. COVID 19 is a clear example of this.
  • 7. 7 Todays Topics The Pre-COVID Value Challenges How healthcare systems have changed as a result of COVID How these changes can benefit MedTech Companies Aligning your organization to the ‘new normal’ of healthcare Why Alira Health: Upon Request
  • 8. 8 Source: Alira Health analysis; https://www.bruegel.org/publications/datasets/covid-national-dataset/ Pandemic Response: A Note on Willingness to Pay from government With a surge in critical care admissions, there will need to be a commensurate increase in funding for healthcare Intensive care = Expensive Care Key Takeaway: Massive reprioritisation of funding means a complete shift in willingness to pay and budget allocations. MedTech companies CAN benefit, but it requires a reprioritisation of resourcing to accommodate payer and hospital procurement value propositions
  • 9. 9 ”As surge increases, the demand–resource imbalance worsens. With an increasing magnitude of pandemic surge, response strategies increasingly depart from the usual standard of care until patient mortality increases and effective delivery of critical care is no longer possible.” Intensive Care Surge Capacity: A Primer Published in December 2019 CHALLENGING CONCEPTS IN CRITICL CARE Surge Capacity & the Role of MedTech WHAT CRITICAL CARE EXPERTS SAY Source: Gabriel L Farrar J. Challenging Concepts in Critical Care: Cases with Expert Commentary. Oxford University Press, December 2019. Available online. § The duration of patient isolation, use of personal protective equipment (PPE), and the risks associated with cohorting of patients with suspected / confirmed infection are often unknown, particularly in the early phase of an emerging epidemic. § Critical care staff often accounts for over 50% of Critical Care resource consumption, and is requisite for appropriate device use and patient care KEY CONSIDERATIONS In a severe surge, staff illness and fear of infection is likely to increase absenteeism Staff Stuff Space Systems § The opportunities for applying mobile technologies have yet to be fully explored. The literature suggests that implementing emergency medical systems using mobile technology is often given a low priority. However, in the future these will undoubtedly enhance communication, facilitate strategic mapping, coordinate logistics, and improve local and international responses in a timely and cost- effective manner. KEY CONSIDERATIONS Communication, Screening & Diagnostics § PPE should be rationalized. Simple surgical masks can be used where patients’ lungs are ventilated using closed circuits, but N95 masks are required for aerosol-generating procedures. § In the inter-pandemic period, equipment, such as monitors and ventilators, may be standardized and stockpiled where feasible. KEY CONSIDERATIONS Consumable & Equipment Availability § A 300% expansion target for bed capacity has been suggested, but in practice few facilities would reach this goal. § It is essential not to overlook that patients requiring ICU care for reasons unrelated to the surge will continue to present during the pandemic phase. Planning must accommodate these patients too. KEY CONSIDERATIONS Bed Availability Authors: • Dr Lucinda Gabriel: Kings Health Partners • Dr Jeremy Farrar: Wellcome Trust SHIFT TO DIGITAL ALIGN TO CHANGED HOSPITAL NEEDS ENSURE SUPPLY COMMUNICATE & UNDERSTAND
  • 10. 10 The MedTech Pandemic Eisenhower Matrix The MedTech Pandemic Eisenhower Matrix The MedTech Modified Eisenhower matrix indicates the urgency and importance of various manufacturers in their role in a pandemic response. Companies that are Highly Urgent, and of Highly Important in Pandemic Response URGENCY IMPORTANCE Companies that are Highly Important, but Less Urgent in Pandemic Response Companies that are Less Important, but Highly Urgent in Pandemic Response Companies that are Less Important, but Less Urgent in Pandemic Response Key Strategic Priorities - ensure supply chains and production are fully functional - ensure internal teams are reallocated to optimise supply of critical medical technologies and diagnostics - ensure new products to diagnose and manage patients with COVID are rapidly scaled up and ethically distributed EXAMPLES: PPE suppliers, mechanical ventilator companies, pumps, consumables and diagnostics Key Strategic Priorities - ensure continuous supply of core products. Eg. Glucose monitors and insulin delivery systems - create dedicated teams to remote- manage HCP questions and responses. Teams wont be allowed in facilities – develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Chronic illness suppliers, diabetes management, COPD Key Strategic Priorities - ensure support teams can manage your installed base of existing equipment - Shift to digital marketing and digital engagement solutions - develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Capital equipment, medical imaging, and low priority elective surgery Key Strategic Priorities - ensure a strategy for the rapid rebound in pent up elective surgery demand - ensure a digital framework and remote consultations for patients that require immediate interventions - develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Cardiac interventions, oncology interventions, orthopaedics and the associated MedTech suppliers Key Takeaway: Develop forward looking value propositions to adjust to the necessary budget shifts going forward. Increased funding will lead to opportunity, but it will also lead to budget reprioritisation * Companies Listed are indicative on. Companies may be present in more than 1 quadrant given multiple business units, and multiple definitions of urgent and important globally
  • 11. 11 The Primary Impact of COVID on healthcare systems: A System Perspective COVID-19 has accelerated the transformation of healthcare, some changes will be temporary, some will be permanent, but COVID will will be a clear demarcation point in how healthcare is provided, funded, and managed. Patient pathway approach: COVID-19 is being holistically managed, from screening, to diagnosis, to management to track and trace. Aligned to VBHC Transformation ? Of benefit to MedTech Industry Block / bundled contracting: of key Medical Technologies through national purchasing which means MedTech can articulate value at more holistic level – beyond procurement budgets Shift to digital health: teleconferencing for appointments, mobile phones Apps, drones flying PPE to isolated communities, remote monitoring of hospitalised patients MedTech Value recognition: Massive shift in value recognition as demonstrated via budget and resource allocation. Integrated care systems: becoming the default system structure: health and social care are inextricably linked centrally Employee care: Companies revising health plans to ensure employees are looked after. Look after employees, they look after your business. Public health: moving to the fore of decision making: screening and diagnostic companies need a rapid distribution strategy
  • 12. 12 Todays Topics The Pre-COVID Value Challenges How healthcare systems have changed as a result of COVID How these changes can benefit MedTech Companies Aligning your organization to the ‘new normal’ of healthcare Why Alira Health: Upon Request
  • 13. The Nuance of Evidence Generation & MedTech: ALIRA HEALTH: A LIFECYCLE APPROACH Too early for solution to have quantifiable value Product fully adopted, disinvestment challenges REAL-WORLD DATA COLLECTION Initial Product Adoption Evidence of Safety & Efficacy Adaptative RCT design Adaptive RCT Results Time Adapted from source: P. Armeni ISPOR Presentation, Boston 2017 Candidate for Value Based Access Programs (VBAP) Value Based Procurement (tendering) criteria defined at provider level Product Diffusion Physician & User Learning Curve HTA Decision, Reimbursement, Coding & Funding Successful Market Access Launch (CE Mark) Perception of Market Access We provide a variety of services under the same umbrella and with a holistic approach and clear vision: to support you and be of value to you at every stage of your corporate and product evolution. A Product Life Cycle Approach beginning with the clinical unmet need of a solution triggers healthcare value
  • 14. 14 Source: Nature Reviews Neurology, 2019 July; Alira Health analysis. Value Based Healthcare: Why it Applies MORE in a post-COVID world The role of different stakeholders is crucial. Some changes are more easily implemented by MedTech companies than others. 1. Organise solutions around medical conditions 2. Measure patient relevant outcomes 3. Measure total costs of delivering outcomes 4. Move to government reimbursement of medical conditions – not products Integrate multi-site treatment centres Expand provider reach across urban & rural care Build enabling IT platforms to scale up evidence & data driven decisions. Source: Adapted from: https://www.isc.hbs.edu/health-care/vbhcd/Pages/default.aspx (Accessed January 2019) Porter M, Teisberg EO, Redefining Health Care, Harvard Business Review Press, 2006
  • 15. 15 Source: Nature Reviews Neurology, 2019 July; Alira Health analysis. Value Based Procurement is an enabler of Value Based Healthcare Value based procurement in of itself is not the end goal. It is a stepping-stone to a more holistic and patient-centric buying process in healthcare. The MedTech companies that adapt the fastest will have a significant competitive advantage Adapted from: Mangan, B Kelley T, McGough R, & Meehan J. Value Based Procurement An alternative approach to total cost reduction, improved efficiency and enhanced patient outcomes in the NHS: A Framework for Delivery. NHS Northwest Procurement Development, 2018. University of Liverpool Potential for Improved Total Costs to System & patient outcomes Time, Complexity & # of stakeholders Unilateral decisions made with Price only contracts Procurement based NOT only on price, but outcomes & costs Value & outcomes quantified, contracted, with risk sharing Price mainly Individual Unit Value Risk High Medium Low Value Based Procurement Value Based Healthcare Timeline of Payer & Procurement Savings SHORT (<3 years) MEDIUM (3-5 years) LONG (>5 years) • Approximately 70% of all MedTech reaches the user through some form of procurement. Value Based Procurement Enables Value Based Healthcare • Traditionally tenders are conducted by stakeholders who are measured on reducing costs associated with buying materials, often not healthcare products. • MedTech must align with stakeholders to ensure value- based metrics are included in tenders • Health outcomes: patient, physician, system • Total Costs: Acquisition & avoided costs • Societal value and aggregate impact • Value based procurement is a mid-term solution to transforming health towards a value based system
  • 16. 16 Todays Topics The Pre-COVID Value Challenges How healthcare systems have changed as a result of COVID How these changes can benefit MedTech Companies Aligning your organization to the ‘new normal’ of healthcare Why Alira Health: Upon Request
  • 17. 17 The MedTech Pandemic Eisenhower Matrix The MedTech Pandemic Eisenhower Matrix The MedTech Modified Eisenhower matrix indicates the urgency and importance of various manufacturers in their role in a pandemic response. Companies that are Highly Urgent, and of Highly Important in Pandemic Response URGENCY IMPORTANCE Companies that are Highly Important, but Less Urgent in Pandemic Response Companies that are Less Important, but Highly Urgent in Pandemic Response Companies that are Less Important, but Less Urgent in Pandemic Response Key Strategic Priorities - ensure supply chains and production are fully functional - ensure internal teams are reallocated to optimise supply of critical medical technologies and diagnostics - ensure new products to diagnose and manage patients with COVID are rapidly scaled up and ethically distributed EXAMPLES: PPE suppliers, mechanical ventilator companies, pumps, consumables and diagnostics Key Strategic Priorities - ensure continuous supply of core products. Eg. Glucose monitors and insulin delivery systems - create dedicated teams to remote- manage HCP questions and responses. Teams wont be allowed in facilities – develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Chronic illness suppliers, diabetes management, COPD Key Strategic Priorities - ensure support teams can manage your installed base of existing equipment - Shift to digital marketing and digital engagement solutions - develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Capital equipment, medical imaging, and low priority elective surgery Key Strategic Priorities - ensure a strategy for the rapid rebound in pent up elective surgery demand - ensure a digital framework and remote consultations for patients that require immediate interventions - develop forward looking value propositions to adjust to the necessary budget shifts going forward EXAMPLES: Cardiac interventions, oncology interventions, orthopaedics and the associated MedTech suppliers Key Takeaway: Develop forward looking value propositions to adjust to the necessary budget shifts going forward. Increased funding will lead to opportunity, but it will also lead to budget reprioritisation * Companies Listed are indicative on. Companies may be present in more than 1 quadrant given multiple business units, and multiple definitions of urgent and important globally
  • 18. 18 5. Integrate multi-site treatment centres 6. Expand provider reach across urban & rural care 7. Enable IT platforms for evidence & data driven decisions 1. Organise around medical conditions 2. Measure patient relevant outcomes 3. Measure total costs of delivering outcomes 4. Move to reimbursement of medical conditions Source: Porter M. Redefining Healthcare. 2006. Internal Alira Health research. Harvard Business School Healthcare Transformation: System, Payers & MedTech Health System Transformation to Value Based Health Care Healthcare systems are adapting, and payers ask defined questions. MedTech can adapt via 7 steps. Key Questions Payers will Ask How MedTech Can support Systems & Payers 6. Determine prospective outcomes and cost improvement This defines the quantifiable benefit that will drive pricing, volume and access discussions 5. Quantify baseline Outcomes & Costs for each patient cohort A baseline is critical for cost benefit analysis for payers outlining why is this may be better than the Standard of Care. 7. Develop a simple business model. A business model serves two purposes: 1. internal and resourcing 2. viability of payer investment BusinessFundamentals 1. Patient Centric Therapeutic Areas Identify the primary therapeutic areas for your MedTech solution. A PICO framework can support this and define your core value proposition. 1. What is the unmet need? 2. What am I currently paying? 3. How is your solution better than the alternates? 4. How much is your device and why is it worth it? 5. Can I afford your device? 6. What are the consequences of NOT funding this? 7. Which patients should get this? Patient&TherapeuticArea 2. Develop patient cohorts with risk adjusted criteria and protocols This ensures similar patients to drive comparability of outcomes in the clinical trial. This also helps to identify exactly where the value for a solution is derived from. 3. Define clear outcome measures for cohorted patients The outcomes become the measurements for success, which define value, and set the foundation of pricing a MedTech solution 4. Define a clear timeframe to achieving optimal outcomes: trial and RWE settings Timeframes for patient outcomes, must align to economic savings to resonate with payer budgets
  • 19. 19 Preparing your business for the 2nd Wave Pandemics often have multiple waves of outbreaks. Without a vaccine, we could experience a second wave. Under the example of the Spanish Flu and SARS, it would be prudent to hope for the best, yet plan for the worst in terms of a second wave of COVID-19 Spanish Flu: 1918 - 1919 SARS 2003 - Ontario, Canada It would be prudent, yet hopefully unnecessary to have a strategic plan for a second wave of COVID-19
  • 20. 20 A final thought: Prof Dr Jeremy Farrar, OBE, Director Wellcome Trust Deaths resulting from a new pandemic will be regrettable. Those that result from insufficient planning, inequitable allocation of resources, and inadequate preparation will be especially tragic [7]. Source: Gabriel L Farrar J. Challenging Concepts in Critical Care: Cases with Expert Commentary. Oxford University Press, December 2019. Available online. A comment on the role of leadership and planning during a pandemic Experience with previous pandemics shows the critical role leadership plays in addressing the challenges in delivering critical care. Leadership involves using existing infrastructures and strengthening the capacity of national and international surveillance systems, in ways that ensure accurate detection of suspected human cases, reliable laboratory confirmation, effective field investigation, and complete reporting in a timely manner. The ICU generates information about the evolving pandemic and has the potential to communicate this in real time.
  • 21. What We Believe In Success through collaboration We enable cross-functional, evidence-based teams within MedTech organizations to engage in external collaborative dialogue with Payers, Providers, Procurement, Policy Makers, and Physicians. Diagnostics Digital Health Medical Devices Care Setting Therapeutic Areas Value Based Market Access Solutions for MedTech
  • 22. June 2020 @RichardCharter linkedin.com/in/richardcharter Richard.Charter@AliraHealth.com Diagnostics Digital Health Medical Devices The post-COVID Value Shift & How MedTech Companies can Capitalize. Richard Charter Vice President, MedTech Market Access, Europe & Asia Pacific
  • 23. FRANCE 26 rue de Navarin 75009 PARIS FRANCE +33 (0)1 44 54 96 23 USA SAN FRANCISCO 88 Kearny Street, Suite 2100 SAN FRANCISCO CA, 94104 USA +1 (774) 777 5255 SPAIN Carrer de Balmes, 206 (Atico 2) 08006 BARCELONA SPAIN +34 (93) 655 55 05 ITALY Via Carlo Ottavio Cornaggia 10, 20123 MILAN ITALY +39 (02) 36680198 GERMANY Kurfürstenstraße 22, 80801 MUNICH GERMANY +49 (89) 416 14 22-0 SWITZERLAND GENEVA Campus Biotech Innovation Park Avenue de Sécheron 15 1202 GENEVA SWITZERLAND +33 (7) 69677361 +41 (79) 5937886 SWITZERLAND BASEL Hochbergerstrasse 60B CH 4057 Basel SWITZERLAND +41 (0)61 205 9669 USA BOSTON 1 Grant Street, Suite 400 Framingham FRAMINGHAM, MA 01702 USA +1 (774) 777 5255 www.alirahealth.com
  • 24. 24 Todays Topics The Pre-COVID Value Challenges How healthcare systems have changed as a result of COVID How these changes can benefit MedTech Companies Aligning your organization to the ‘new normal’ of healthcare Why Alira Health: Upon Request
  • 25. REGULATORY Strategy and Roadmap Development Submission Management FDA Liaison Officer For Non-US Companies PRODUCT DEVELOPMENT LAB New Product Development IP Development (StructuredIP™) Incubation Of Breakthrough Technologies Discovery Development Plan In-VITRO and In-VIVO Testing CLINICAL Study Design and Protocol Writing Site Selection and Feasibility Investigator Training Subject Recruitment & Retention Data Management and Biostatistics Trial Management and Clinical Operations Pharmacovigilance STRATEGY CONSULTING Market Opportunity Assessment Indication Prioritization Portfolio Management Commercial / Vendor Due Diligence Scientific and Clinical Due Diligence Asset and Company Valuations Commercial Excellence Corporate Strategy Planning Commercial Strategy and Go-to- Market Model Development Integrated Launch Planning Competitive Gaming TRANSACTION ADVISORY Mergers & Acquisitions Sell/Buy Side In & Out Licensing Strategic Partnerships Capital Raise Global Market Access, Pricing and Reimbursement Strategy Mock Negotiations and Payer Consultations Health Economics and Outcomes Research Strategy Real World Evidence Strategy and Plan Value Communication Value Based Healthcare Pilots Market Access Diagnostic MAP MARKET ACCESS Our Practice Areas
  • 26. 01 Clinical and Economic KOL Mapping 02 03 04 0506 07 08 09 Clinical & Economic Evidence Mapping: Efficacy & Effectiveness Reimbursement & Procurement Approval Shape Clinical & Payer Guidelines Adoption & Funding via Value Based Access Programs Unmet Need & Patient Pathway Mapping Centre Specific Pilot Programs HCP Access & User Training Clinical & Economic advocacy Our 9-Step MedTech Market Access Process
  • 27. Undertaking a Market Access MAP Diagnostic ensures integrated internal alignment, to optimize external market access processes. It aligns sometimes fragmented internal functions around a core value framework, activity cadence, and external market access process. Market Access & Commercial Execution MAP Diagnostics Messaging • Diagnostic of existing tools to support a structured value framework • Cross functional workshops to align product and commercial teams to domains of value • Gap Assessment of evidence Activity • Diagnostic of country stakeholder maps and gap analysis for key geographies • Regional payer segmentation and local provider engagement assessment • Alignment on external activity cadence Process • Unmet need and patient pathway creation • Clinical & economic KOL mapping • Clinical & economic evidence strategy • Reimbursement & procurement approval • Centre specific pilot programs • Value based access programs • HCP access & user training • Clinical & economic advocacy • Optimise clinical & payer guidelines A B CD Stakeholder Segmentation PURPOSEMARKET ACCESS & COMMERCIAL EXECUTION MAP DIAGNOSTICS 01 Clinical and Economic KOL Mapping 02 03 04 0506 07 08 09 Clinical & Economic Evidence Mapping: Efficacy & Effectiveness Reimbursement & Procurement Approval Shape Clinical & Payer Guidelines Adoption & Funding via Value Based Access Programs Unmet Need & Patient Pathway Mapping Centre Specific Pilot Programs HCP Access & User Training Clinical & Economic advocacy Improved Outcomes Improved Patient Outcomes Improved HCP Outcomes Improved Provider Outcomes Quality of Evidence Support for Evidence Generation Evidence Bases Compendium Lower Total Costs Procurement of Products & Solutions Efficiency Care Deliver Cost of Care Delivery Fewer Complications Patient Pathway Costing Alignment Non- Outcomes Benefits Secondary Patient Benefits Healthcare Worker Benefits Provider Benefits Healthcare System Benefits Material non-outcomes benefits for stakeholders Broader Impact on Society Innovation Sustainability Social Economic Impact Universal Healthcare Benefits
  • 28. The healthcare industry is undergoing profound changes. Every day, new ideas can lead to promising breakthroughs. But navigating the complex and rapidly shifting road to commercialization is challenging. How do you into efficient, safe, and economically viable treatments and solutions that benefit patients? A Transforming Industry
  • 29. At Alira Health, our mission is to enable healthcare transformation We complement your expertise with a full spectrum of advisory support to uncover opportunity, accelerate innovation, and improve outcomes for patients around the world. PRODUCT DEVELOPMENT LAB REGULATORY CLINICAL STRATEGY CONSULTING TRANSACTION ADVISORY
  • 30. At Alira Health, our mission is to enable healthcare transformation We complement your expertise with a full spectrum of advisory support to uncover opportunity, accelerate innovation, and improve outcomes for patients around the world. PRODUCT DEVELOPMENT LAB REGULATORY CLINICAL STRATEGY CONSULTING TRANSACTION ADVISORYMARKET ACCESS
  • 31. “ Gabriele Brambilla, CEO. Our clients are disrupting healthcare. They discover, create and bring to market new devices, drugs and treatments. They are pioneering the new standards of care, and we are their accelerator.”
  • 32. Local Insights, Global Reach of the Top 50 Medtech Companies 80% of the Top 100 Pharma Companies 50% We advise of serving clients around the globe 20 Years Boston (HQ), San Francisco, Paris, Barcelona, Munich, Milan, Geneva, Basel 8 Offices Our clients are global, so are we. Our local presence and global collaboration allows us to deliver actionable business insights.
  • 33. Our integrated team of over 150 collaborate to fully understand every aspect of your business and offer an unmatched continuum of support across your full corporate and product lifecycle. An Integrated Team
  • 34. A Lifecycle Approach We provide a variety of services under the same umbrella and with a holistic approach and clear vision: to support you and be of value to you at every stage of your corporate and product evolution. BACKED BY DATA SCIENCE
  • 35. REGULATORY Strategy And Roadmap Development Submission Management FDA Liaison Officer For Non-US Companies Our Practice Areas PRODUCT DEVELOPMENT LAB New Product Development IP Development (StructuredIP™) Incubation Of Breakthrough Technologies Discovery Development Plan In-VITRO and In-VIVO Testing CLINICAL Study Design And Protocol Writing Site Selection And Feasibility Investigator Training Subject RecruPTCent & Retention Data Management and Biostatistics Trial Management And Clinical Operations Pharmacovigilance STRATEGY CONSULTING Market Opportunity Assessment Indication Prioritization Portfolio Management Commercial / Vendor Due Diligence Scientific And Clinical Due Diligence Asset And Company Valuations Commercial Excellence Corporate Strategy Planning Commercial Strategy and Go-to- Market Model Development Integrated Launch Planning Competitive Gaming TRANSACTION ADVISORY Mergers & Acquisitions Sell/Buy Side In & Out Licensing Strategic Partnerships Capital Raise Global Market Access, Pricing and Reimbursement Strategy Mock Negotiations and Payer Consultations Health Economics and Outcomes Research Strategy Real World Evidence Strategy and Plan Value Communication Value Based Healthcare Pilots Market Access Diagnostic MAP™ MARKET ACCESS
  • 36. A Global Healthcare Perspective Our expertise extends beyond the walls of convention. Whereas others may have a narrow focus, we embrace the whole healthcare ecosystem by taking into account all involved stakeholders to ensure a successful outcome for patients, providers, payers, and suppliers. PAT I E N T S P A Y E R SS U P P L I E R S P R O V I D E R S
  • 37. A 360° Approach for Value at Every Turn We support you from concept ideation to commercial realization; from innovation to implementation. Weare