Patient Advocacy Groups in Biosimilars and Biomedical Industry with case studies

1. Patient
Advocacy
Groups

2. Table of Contents
Patient Advocacy Groups
01
Introduction
Types and How they
work
03
PAG - Industry
Partnership
02
Role of PAG
Scenario in India
04
PAG in Biosimilar
05
Examples & Case
Study

3. Introduction
01
Types and How they work

4. Patient Advocates?
A patient advocate helps patients communicate with their healthcare
providers so they get the information they need to make decisions about
their health care.
Patient advocates may also help patients set up appointments for doctor
visits and medical tests and get financial, legal, and social support.
They may also work with insurance companies, employers, case
managers, lawyers, and others who may have an effect on a patient’s
healthcare needs. Also called patient navigator.
Patient advocacy has its origins from the early days of cancer treatment
in the 1950s.

6. Types of Patient Advocates
Lay patient
advocate
Ask Questions
03
Professional individual
patient advocate
06
Patient advocacy within the
healthcare community
05
Nursing and
patient
advocacy
04
Governmental
agencies Patient Advocacy Group
02
01

7. CDC.Government ; Health Affairs A study by the Harvard University last
year showed that nearly 5,000,000
deaths occur in India annually due to
medical errors triggered by lack of
practical knowledge among the doctors
and nurses to handle patients when
brought to the hospital.
“More than 250000 people in the US die
every year because of medical mistakes,
making it the third-leading cause of death
after heart disease and cancer.”
Medical Error cause
2.6 million deaths
yearly: WHO

8. India : About 60.4% of the subjects had
low health literacy level, 29.4% average
and only 10.2% had high health literacy
levels.

9. Patient with high
literacy
● Understand prescription
● Understand Adverse drug reaction
● Understand when to take follow ups

11. Different Types Of PAG
Rare Disease PAGs come in different shapes and sizes

12. Patient Advocacy Example
A Patient Who Needs Cancer Treatment Asks About Fertility
A 20-year-old woman needs chemotherapy and does not have immediate plans to have a child. However, she
wants to ensure she will be fertile in the future. Her doctors tell her the treatment may damage her eggs,
make them infertile, or prompt premature menopause.
Patient Advocate Response
The patient advocate helps educate the client about potential treatment side effects. Then the advocate
consults with the client, helping her form in-depth questions for the doctor. Next, the advocate investigates
local fertility treatment centers and sets up an appointment for the client to learn about egg freezing and
other options for conceiving a child in the future.

13. Role of Patient Advocacy Groups
02
And scenario in India

14. Communication and collaboration
with patient and their families
● Help them understand about the disease
and alternative therapies
● Help achieve better patient outcomes by
providing guidance on diagnosis and
treatment adherence
● Help the patients manage their finance by
assisting them with insurance and
household accounting management.
● To generate funds for needy patients
Support healthcare research
● create awareness about research activity
● facilitate clinical trial participation.
Communication with media
● To sensitize media members
● Acting as a facilitator
Communication and collaboration
with government agencies
● healthcare system not merely profit
driven
● review of research protocol
● ensure that projects being
considered for funding by
government directly impacts
patient’s lives
● work with finance boards, analyze
cost constraints and act as a
proponent for best practices
● Make policies in favor of patients

15. A Harvard Business Review
analysis found that
52 percent of patients in
the U.S. cannot navigate
the healthcare system’s
complexity without help.

16. Services that PAG Offer
Medical Care
Navigation
01 02
Placement &
Medical Billing
Navigation
05
Legal
Navigation
04
Navigation of
Older Adult
Services
03
Health
Insurance
Navigation

17. Medical Care
Navigation
● Communicating with
healthcare providers
● Setting, coordinating, and
attending appointments
● Speaking up about patient
rights
● Identifying health resources
and making referrals
● Clarifying diagnoses and
conditions
● Coordinating care between
specialists
Placement & Medical Billing
Navigation
● Reviewing medical bills
for accuracy
● Negotiating bills with
providers
● Assisting patients getting
admitted into or
discharged from hospitals
● Coordinating patient
transfers to nursing
homes, assisted living, or
rehabilitation centers
Health Insurance
Navigation
● Figuring out the coverage
guaranteed by insurance
plans, Medicare benefits, and
veteran benefits
● Advising patients on
selecting health plans and
insurance policies
● Researching additional
potential benefits such as
long-term care insurance
● Informing patients about
wellness benefits
Services that PAG Offer Cont'd:

18. PAGs Engage with
Three Primary Rare Disease Stakeholders

19. OPPORTUNITY FOR PAG IN INDIA
● Helping hand for the right treatment to patients can help
patients take more informed decision in addition to getting
access to new treatments and cost benefits.
● Pharma companies can create more transparency about their
deeds and acts and also get indirect help to promote research
activities.
● Government agencies can get additional manpower to learn
about perceptions and needs of different stakeholders and take
balanced decisions in policy making, in development and
review of research documents, etc.
● Students can see this as an opportunity to pursue this field as a
career option.
● Educational institutions can see this as an opportunity to design
specific courses to supply talent pool for this upcoming field.

20. PAG & Industry Partnership
03

21. PAG
&
INDUSTRY
Better Outcomes for Patients
GOAL

22. WHY? - Industry & PAG
Collaboration
● Conquest of the disease
● Increased patient engagement
● Assuring that new medications
meet the need of the patients
● R&D- patient needs, formulation
● Trials- design, follow-up
● Logistics- packaging, distribution
● Market Access- personalized
reimbursement, education
● Post loss of exclusivity-
affordability, adherence programs
GOALS
Input
Access
Data
Partnership
Involvement
Respect
INDUSTRY
PAGs

23. INPUT
● Meaningful outcome
measures
● Minimize disease
burden
● Recruitment
strategies for trials
● Messaging theme &
content
ACCESS
● Qualified patients
● Key opinion leaders
● Appropriate sites
● Referral sites
● Awareness outlets:
1.Organization-specific
2. Disease- specific
3. Social media
DATA
● Prescreened patients
who pre-identified as
interested in clinical
research trials
● Data pertaining to
patient opinions and
disease
What PAG offers to the Healthcare Industry

24. INVOLVEMENT
● Direct inputs- product
development, medical
research, educational
events, and conferences
● Involvement in protocol
design
● Burden minimization
strategies
● Awareness campaigns
PARTNERSHIP
● Key Opinion Leader
relationships
● Support of advocacy
group relationship with
community
● cancer.com - Message
development
Transparent
communications
● Support for additional
community assistance
● Co-develop tools for
research and awareness
● Funding
RESPECT
● Understand how
advocacy group is
structured and
resourcing levels
● Compassion and true
commitment to
community
● Adhere to ethical
principles of
interaction with
advocacy groups
What Healthcare Industry offers PAGs

25. Mutual Benefits
Specific Rare Diseases
● R&D costs
● Scarcity and Geographical
dispersal of patients
Engagement
● Represents the patient
● Gatekeepers
● Unified communities
Information
● Holistic Perspective
● Healthcare journey
● Identify unmet needs
Keen on Research
● Influence rare disease
landscape
Voice of the patient is heard
● Access
● Innovations
● Healthcare Policies
Enrol patients in to Clinical Trials
● Also part take in
Market Research and
offer support

26. 34 million EUR
137 contributions

28. Boundaries & Challenges
PAG’s Perspective
Profits and Financial
Benefits
Imbalance of Perceived Power
PAGs reliant on Industry
Work On The Challenges
Patient-Centric Approach
Focus on the product?

29. “
● Transparency
● Identify Common Goals
● Ethical Boundaries
● Patient Advocacy Pre-launch and
launch
How to Manage PAG-Industry Relationships
84% patients believe collaboration is key (US, Europe)

31. The Perils
Financial Ties-
30-71%
Conflict of
Interest
Trustworthiness of
Testimonies

32. Patient Advocacy Groups in
Biosimilars
04

33. WHY ARE PAGs REQUIRED ?
Patient Education
“There is a greater need for prescriber and
patients regarding biosimilar’’
American Society of
Clinical Oncology (ASCO)

34. In one of the virtual panel discussions
hosted by Samsung Bioepis, Serena
Mingolla, Communications Consultant
at Associazione Nazionale Persone con
Malattie Reumatologiche e Rare
APMARR, highlighted an Italian survey
showing that
WHY ARE PAGs REQUIRED ?
Patient Education
Mercury is the closest planet to the Sun
and the smallest one in the Solar
System—it’s only a bit larger than our
Moon. The planet’s name has nothing
to do with the liquid metal, since it was
named after the Roman messenger god
Mercury

35. WHY ARE PAGs REQUIRED ?
Patient Education
An international study in 2016
on patient understanding of
biosimilars found that
Knowledge gaps were identified in
biosimilar safety, efficacy. Very
few had heard of biosimilars.
Those who were aware thought
biologics performed better.
Thus, it was concluded that
there was an immediate need
for patient education about
biosimilars & clinical trials.

36. PAGs can work with companies to
educate patients on the therapy
options available, including the price
advantage of biosimilars and the
long-term benefits of the medication
(and adherence to the regimen)
WHAT PAGs CAN DO ?
Advocacy groups, social organizations,
worker groups and physicians can also
help distribute patient education
material (which should be made easy
to read and understandable for
patients with limited education or
literacy
COMPANY COLLABORATION EDUCATIONAL EFFORTS

37. 01
50 to 60 online workshops a year on oncology
related topics
02
Publications department creates a publication
on the subject and fact sheets after workshops
03
Online education workshop on biosimilars in
2017 drew 543 participants

38. 01
Focuses on providing variety for patients
Also provide videos & e-books for younger
patients
02
Updating existing documents to include
biosimilars.
03
Not just adding brand name in lists but also
making sure the biosimilar is referenced in
trusted materials to increase credibility

39. The Biosimilars Council is a
division of
Association for Accessible
Medicines
Ensures a positive regulatory, reimbursement,
political & policy environment for biosimilars.

40. Signed by President Biden this year
BIOSIM ACT
Advancing Education on
Biosimilars Act of 2021

41. Examples & Case Study
05
● PAG Role in Meningitis Prevention
● PAG Role in HIV Prevention
● BMS with GRYT Health
● Roche with Thalassemia Patients Group in India
● Novartis Invisible Nation
● Sanofi Genezyme MS Trust (PAG) collaboration for
better patient outcomes in Multiple Sclerosis

42. Meningitis Vaccines
The hugely successful ‘Beat
it Now’ campaign by
Meningitis Now recently led
to the incorporation of a
free meningitis B vaccine
into the NHS immunisation
programme.

43. Social Media Presence & Content

46. HIV and Pre-exposure prophylaxis (PrEP)
● ‘Don’t Die of Ignorance’
campaign in the 1980s.
● Advocacy also led to a High
Court ruling to make the
life-changing preventative
intervention, pre-exposure
prophylaxis (PrEP) – a once
daily pill which prevents people
without HIV from getting HIV if
they are high risk – available to
those who need it and meet
the eligible criteria.

47. ● Live discussion sessions, with 24-7
on-demand access to recordings
● Collaborative working groups and chat
rooms to meet with peers and experts
● An exhibit hall highlighting patient
advocacy groups across the globe
● A newsroom filled with coverage on
the Advocacy Exchange
Pharmaceutical firm & digital oncology
company

48. Novartis Invisible Nation

49. Roche with Thalassemia Patients Group in India

50. Roche with Thalassemia Patients Group in India

51. Roche with Thalassemia Patients Group in India

52. Missing Pieces
Campaign, 2018

54. Missing Pieces Campaign
● The initial patient survey and report,
which were executed by Sanofi with
input from The MS Trust, were
successful, in reflecting on the activity,
the team at Sanofi felt there was a
piece missing- earlier stage strategic
partnership approach
● The MS Trust and Sanofi then
co-hosted a parliamentary event in
December 2018 to present
recommendations from the report to
policymakers.

55. Missing Pieces Campaign
● In this example, early industry-PAG collaborative
working resulted in public awareness raising
around the need to transform MS care and
improve the quality of life of people who are
affected by this complex condition.
● The Missing Pieces campaign aligned with the nine
consensus statements in the MS Trust’s MS Forward
View report, which set out the ambition for the
future of MS Services in England and presented a
shared view about the priority actions needed to
make MS care fair across the UK.

56. Collaborations to deliver better outcomes for patients
Patient first
Establishing and respecting expertise
Support each partners’ practical
requirements
Profile continuous improvement in
collaboration
Embedding the principles of each
partner
Where we are
Now
Calls to
ACTION
Sharing skills and resources
Articulating the patient voice
Complementing rather than
conflicting
Benefits of working
together

57. Conclusions
The pharmaceutical industry has made
great strides in changing its way of
working, moving to a model where
patient needs are considered at every
stage.Vision of future:-
-More impactful projects,
-opportunities for partnerships,
-Patients’ needs targeted and
addressed better than ever before.

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