1. Connect. Engage. Simplify.
with inVentiv Patient Access Solutions
The New Decade Of Healthcare: Enhancing Commercial Tools For Better Value
Nathan White, CPC, Executive Director, Access and Reimbursement
12th Annual Patient Assistance & Access Programs • Baltimore, MD • March 1-2, 2011

2. Connect. Engage. Simplify.
with inVentiv Patient Access Solutions

3. A global provider of results-driven
Clinical, Consulting and Commercial
services to the biopharmaceutical and healthcare industries

4. Client Roster
350
Leading pharmaceutical, biotech,
and life sciences companies.
A global provider of results-driven
Clinical, Consulting and Commercial
services to the biopharmaceutical and healthcare industries

5. Client Roster
350
Leading pharmaceutical, biotech,
and life sciences companies.

6. A leader in global management consulting
Client Roster
 Brand Management Consulting
350
 Business Development Consulting
 Managed Markets Consulting
Leading pharmaceutical, biotech,
 Trade and Distribution Consulting
and life sciences companies.
 Clinical Development Consulting
 Medical Affairs Consulting
 Sales Force Effectiveness
 Market Research
 Education and Training

7. A global contract research organization
 Clinical Trial Outsourcing
 Clinical Staffing
 Data Management
 Biostatistics
 Medical Writing and Scientific Communications
 Investigator Recruitment
 Patient Recruitment
 REMS Consulting and Planning

8. inVentiv Patient Access Solutions:
A leading provider of a customizable patient-centric solutions
Access and Education Programs
Strategic Consulting
(REMS, Reimbursement, Managed Markets and Health Policy)
Integrated, Field-Based Clinical and Reimbursement Support
Integrated Payer Communications

9. Powered by the best minds from inVentiv Health’s Clinical,
Consulting and Commercial divisions.
COMMERCIAL CLINICAL CONSULTING

10. The heart
of inVentiv Patient
Access Solutions:
guiding providers
and patients
through the difficult
process of securing
coverage for therapies
that keep patients well.

11. We develop
strategies that
resonate with
payers and, by
doing so, build
market share
for your brand.

12. Connect. Engage. Simplify.
with inVentiv Patient Access Solutions

13. The pharmaceutical industry is embarking on a perilous journey,
bracing itself for the perfect storm
What does the perfect storm look like
The uncertainties of healthcare reform
The complexities of proving
value to payers
The inefficiencies of managing
vendor and consultant relationships

14. Increasing premiums and cost sharing
Medicare and Medicaid expansion Comparative Effectiveness Research
Access to affordable coverage Safety Doughnut hole rebates
Outcomes
Quality
Premium subsidies Insurance exchanges

15. Patient Protection and Affordable Care Act
Uncertainties with new Congress
Future legislative changes
Expansion of coverage
Cost Containment
Quality and outcomes

16. The Value Equation:
Safety + Efficacy + Comparative Cost/Clinical Effectiveness
Industry
AHRQ NIH
PCORI Payers Patients and providers
(CMS & Private)
Who’s Responsibility Is It?

17. Patient Centered Outcomes Research Institute
 Patient Centered Outcomes Research Institute
− Non-profit corporation
− Not “an agency or establishment of the federal government”
 Assists in making informed healthcare decisions
− Comparative clinical effectiveness research
− Health outcomes, clinical effectiveness, and appropriateness of treatment
 Governed by stakeholders in AHRQ and NIH in addition to other
healthcare leaders (appointed in late 2010)
 Methodology Committee appointed in Jan. 2010

18. SOURCES:
National Pharmaceutical Council, PCORI Methodology Committee: Resource Guide, February 2011

19. Patient Centered Outcomes Research Institute
 Administer funds for research from:
− Trust (PCORTF)
− Private insurance
− Appropriations and other federal Trust Funds
 Who can participate in PCORTF funded research?
− NIH
− AHRQ
− Hospitals and other institutions
− Commercial organizations (CRO’s)
− Pharmaceutical companies
 Identify “national priorities” for research (similar to IOM’s priority list
released Summer 2009)

20. Let’s focus on the Patient… Patient Reported Outcomes (PRO)
 Helps to develop evidence of effectiveness outside an artificial
controlled environment (RCT)
 “Self-reports” by a patient
 Data collected through self-administered questionnaires or
interviews (ex. EQ-5D or SF-36)
− Generic
− Disease specific
 Attempts to assess:
− Impairments to well-being
− Disabilities
− Health perceptions
− Quality of Life (QoL)
− Other healthcare ratings

21. Federal Initiatives Using PRO
AHRQ DEcIDE Network
Group of Principal Investigators, working through 13 Research Centers,
conducts studies on outcomes, effectiveness, safety and usefulness of medical
treatments
PROMIS®: Patient Reported Outcomes Measurement System
NIH-funded development of PRO tools through primary research sites &
coordinating centers
SOURCES:
www.nihpromis.org;
http://effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-the-decide-network/

22. Patient Focused Initiatives May Be Generating Data Valuable To Payers…
• Registries/REMS
• Reimbursement/Patient Assistance
• Adherence
MANUFACTURER
PAYER STRATEGIES BRAND
?
Exchange of Dialogue PROVIDER
MANAGED
CMS STRATEGIES
MARKETS
Exchange of Dialogue
PATIENT
FDA STRATEGIES
GOVERNMENT
AFFAIRS
MANUFACTURER
…But HOW or IS it being used by decision makers?

23. Patient Access Programs
TODAY TOMORROW?
 Focused on helping patients  Managed markets data could
with reimbursement access be used to better guide NAM
barriers (RB) and assisting the tactics
underinsured
 Could this program type be
 Used primarily as marketing integrated into a Phase IV study
initiative to reduce sponsor cost?
 Captures some data which  CHALLENGE: How do we get
could be valuable to managed all the stakeholders
markets and brand teams (vendor, brand teams, managed
markets, etc) to share the same
 Typically doesn’t capture PRO vision?

24. Patient Assistance Programs
TODAY TOMORROW?
 Focused on assisting the  PAPs could begin to collect
uninsured (PAP) adherence/compliance data
(especially IPAPs)
 Used primarily as corporate
awareness to the public  What confounding factors
would inhibit such an evolution
 Captures some data which (ex. IRS, study population bias)?
could be valuable to managed
markets teams  Would patient advocates
object to muddying the waters of
 Typically doesn’t capture PRO a free drug program?

25. Adherence Programs
TODAY TOMORROW?
 Focused on changing patient  Would patients be willing to
behavior and improving patient respond to PRO questionnaires
health outcomes in an opt-out program?
 Opt-out programs typically  How can manufacturers
administered through 3rd party partner with payers and
and use claims data to manufacturers to utilize PRO
intelligently message patients more effectively?
 High touch programs use a
clinical case management
approach

26. Registries/REMS Programs
TODAY TOMORROW?
 Historically, registries were  Does patient education have
marketing tools but have evolved an impact on outcomes?
(ad-hoc -> RiskMAP -> REMS)
 Could measurements of
 Most focused on safety in the effectiveness of patient education
confines of REMS be useful to payers?
 Results of ETASU, MedGuides
 Could PRO instruments could
and HCP Communications used
be adapted to measure
principally by FDA
effectiveness of education?
 2010 Kaiser Permanente study
found registries play an important  Genzyme’s Gaucher Registry
role in CER is model for the future

27. Thoughts from REMS Expert Jeff Fetterman…
 REMS enables management of risks that otherwise would prevent
commercialization of products that could help specific patient
populations
− Thalidomide (leprosy and certain malignancies)
− Clozapine for psychoses
 REMS creates interesting challenges for payers and managed
markets
− Possibly interferes with the care management process of the integrated health
system model
− Increases complexity and burden of pharmaceutical care
 REMS offers intriguing opportunities for payers and managed
markets
− Reducing total cost of care by improving outcomes and costly adverse events
− Possibly could reduce the need for payer medication management and control
when access is carefully integrated with REMS
Jeff Fetterman is President, ParagonRx, an inVentiv Health company
ParagonRx is a recognized leader in REMS consulting, design and implementation.

28. Final Thoughts…
 Commercial programs have an enormous potential to be integrated
with evidence based medicine demonstration initiatives, both private
and public
− Elise Berliner, Director of Technology Assessment Program at AHRQ says that
AHRQ is looking for more innovative and external partnerships to do comparative
effectiveness research (manufacturers, institutions, CRO’s)
 Adherence and Access programs with multiple messaging mediums
are key to an intelligent PRO collection strategy
 Payers (federal, state and private) will need to weigh in on how PRO
data will be integrated into their coverage decision making practices
 Strategic, long-term partnerships amongst manufacturers, payers,
facilities/systems, vendors, and federal agencies are critical to the
success of healthcare reform

29. THANK YOU FROM INVENTIV PATIENT ACCESS SOLUTIONS!
Contact:
Nathan White
nwhite@inventivhealth.com