1. Market Access in the Era of Specialty and
Biotech: An EBI Virtual Conference
December 13, 2011
Presented by
WE‟RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW THE WAY IN HEALTHCARE.™
WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
2. Introductions and Housekeeping
Nathan White, CPC
Executive Director
Access & Reimbursement
Sessions begin promptly at time listed on agenda
We‟ll break for lunch at 12:15 for one hour – please stay signed in!
Questions from listeners are welcome
To contact a panelist or presenter, please email
nwhite@inventivhealth.com
2 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
3. World’s leading provider of sales,
marketing, and communications The leading management
One of the industry’s consulting group specializing
top global CROs solutions for the healthcare industry
in biopharma
Services include: Services include: Consulting practices include:
Phase I-II Outsourced sales teams and Brand management
(FIH or bioequivalence studies) sales support Business development
Phase IIb – Phase IV studies Advertising, branding and PR
Clinical development
Strategic partnerships Digital and closed loop marketing
Medical affairs
Bioanalytical services Patient outcomes, REMS and
Pricing and market access
Clinical data services/technology
Rx access/adherence
Sales
Medical education
Staffing services
WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
4. Industry Megatrends
Specialty trend (spend) gaining lots of
attention
• By 2016, 8 of top 10 worldwide drugs will be specialty
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
4 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
5. Industry Megatrends
Specialty trend (spend) gaining lots of
attention
• By 2016, 8 of top 10 worldwide drugs will be specialty
Pharma companies will move toward
developing more targeted and tailored
therapies and more personalized medicine
• About 70% of current pipeline drugs have biomarkers associated with them.
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
5 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
6. Industry Megatrends
Specialty trend (spend) gaining lots of
attention
• By 2016, 8 of top 10 worldwide drugs will be specialty
Pharma companies will move toward
developing more targeted and tailored
therapies and more personalized medicine
• About 70% of current pipeline drugs have biomarkers associated with them.
Pipeline for specialty is substantial
• 600 new drugs in pipeline (40% oncology and 30% of these infused)
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
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7. Industry Megatrends
Legislative and regulatory activity will shape
our future
• Many of today‟s Indigent patients will become insured (underinsured)
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
7 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
8. Industry Megatrends
Legislative and regulatory activity will shape
our future
• Many of today‟s Indigent patients will become insured (underinsured)
The co-pay card tipping point
• The government has already restricted commercial co-pay activity and private payers are next
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
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9. The beginning of the end…
CVS Caremark Corp.'s pharmacy-benefit business is recommending
customers stop covering more than 30 drugs next year, including diabetes
treatments and an erectile-dysfunction pill, to save money and combat drug-
maker coupons that promote brand-name medicine over cheaper alternatives
WSJ, November 19th, 2011
Drug-company coupons that promote brand-name medicine over cheaper
alternatives could hike drug costs by $32 billion over the next
decade, according to a study from the industry that manages pharmacy
benefits WSJ, November 3rd, 2011
9 INVENTIV HEALTH > TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
10. Industry Megatrends
Legislative and regulatory activity will shape
our future
• Many of today‟s Indigent patients will become insured (underinsured)
The co-pay card tipping point
• The government has already restricted commercial co-pay activity and private payers may be next
The demonstration of value is becoming
more critical
• Payers are already demonstrating resistance to high cost specialty products w/o a value proposition
SOURCE: Accredo Keynote Address, Armada Summit, May 2011
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11. Who cares about value?
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12. PPACA Implementation
A Beltway Insider‟s Perspective
Jayson Slotnik, JD
Partner, Health Policy Strategies, LLC
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
13. Outline
• Recent Payment Developments Related to Specialty
– Accountable Care Organizations (ACOs)
– CMI Examples
– Comparative Effectiveness
• CMS Coverage Update
– New list of NCDs
– Parallel Review
– New Coverage with Evidence Development (CED) Process
• Miscellaneous Topics
– Medicaid Managed Care
– Drug Shortage
13
14. Physician Fee Schedule
• CMS projects that total payments in CY 2012 will be
approximately 80 billion dollars.
• CMS continues with the third year of a four year phase-in
for practice expense RVU changes:
– CMS estimates that spending for radiation oncology procedures will
fall by 6% from CY 2011.
– Over next two years radiation oncology and radiation therapy
centers are slated for a cumulative cut of 10% and 11% respectively.
– Hem/Onc is only 1%
• Adjustments to quality reporting system, electronic
prescribing and electronic health records incentive program.
14
15. Accountable Care Organizations
• ACOs (Medicare Shared Savings Program)
are voluntary groups of physicians, hospitals
and other health care providers that have
collectively agreed to manage care for a
defined group of Medicare beneficiaries.
• Only includes Medicare Parts A and B.
• Effective January 1, 2012.
– First agreements will start on April 1,
2012 or July 1, 2012.
• First dollar savings to ACO.
15
16. Accountable Care Organizations
• Final Rule issued October 20, 2011 with significant changes
to make the structure more appealing to providers for a
three year commitment.
• Two tracks for providers to choose from, one is only upside.
– First dollar savings.
• Beneficiary assignment is prospective. 5,000 minimum per
ACO and measured against a FFS benchmark.
• Reduction in number of quality measures, four key domains
remain the same.
– Still an important part of financial model.
16
17. Other Shared Savings Models
• Advanced Payment ACO Model
– Three types of payment: (1) an upfront fixed payment; (2) an
upfront variable amount based on the number of its historically
assigned beneficiaries; (3) a monthly payment of varying amount
based on the number of its historically assigned beneficiaries.
– Only two types of organizations are eligible: ACOs that do not
include an inpatient facilities and have less than 50 million in total
annual revenue; or, ACOs is which the only inpatient facilities are
CAH and/ or Medicare low volume rural hospitals and have less than
80 million in revenue.
• Pioneer ACO
– Designed for health care organizations and providers that are
already experienced in coordinating care for patients.
17
18. Center for Medicare and
Medicaid Innovation (CMI)
• Created by Congress with 10 billion dollars over 10
years to “test innovative payment and service
delivery models to reduce program expenditures,
while preserving or enhancing the quality of care”
for those who get Medicare, Medicaid or CHIP
benefits.
• CMI will “test models of care that deliver better
healthcare, better health and reduced costs through
improvement.”
18
19. CMI Examples
• Bundled Payments for Care Improvements
– There are four broadly defined models of care.
– Three models involve a retrospective bundled payment arrangement,
and one model would pay providers prospectively.
– Applicants would propose the target price, which would be set by
applying a discount to total costs for a similar episode of care as
determined from historical data. Participants in these models would
be paid for their services under the traditional fee-for-service
system.
– At the end of the episode, the total payments would be compared
with the target price. Participating providers may then be able to
share in those savings.
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20. CMI Examples
• Comprehensive Primary Care Initiatives
– The CPC initiative will test two models simultaneously: a service
delivery model and a payment model to strengthen the role of
primary care.
• State Demonstrations to Integrate Care for Dually
Eligible beneficiaries
– Selected states will receive up to $1 million to design strategies for
implementing person-centered models that fully coordinate primary,
acute, behavioral and long-term supports and services for dual
eligible individuals.
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21. Comparative Effectiveness
• Funding: FY 2010 – 2012: Appropriations of $10M, $50M, and
$150M, respectively. 2013-2019: Mix of public and private funding.
• Scope: To inform coverage, findings cannot be construed as
coverage/payment recommendations, HHS Secretary can set co-pay
differentials based on effectiveness, however.
• Value proposition is no longer based solely on safety &
efficacy.
• Post-approval, stakeholders look for evidence that new therapies
are differentiated from existing treatment.
• Patients, payers, and prescribers want to know which patient
populations optimally respond to new treatments.
• Changing investment decisions.
21
22. Updated NCD List
• First list was issued in 2008.
– Many of the proposed NCDs were conducted.
– Not clear what will happen to the remaining list
• CMS issued notice on September 28, 2011, comment period closed.
• The Notice states that “Medicare may be paying for potentially
ineffective or harmful items and services, and there may be
potentially high value items and services that are being
underutilized” as a driver for this effort.
• Current Notice “introduces” “minimal benefit” concept.
– “CMS is inviting your input concerning any items and services you
believe may be inappropriately used (i.e., underused, overused, or
misused) or provide minimal benefit in hospitals, clinics, emergency
departments, doctors’ offices, or in other healthcare settings.”
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23. Parallel Review
• In joint Notice statement, the agencies state that “parallel review is
intended to reduce the time between FDA marketing approval and
CMS national coverage determinations, thereby improving the
quality of patient health care by facilitating earlier access to
innovative medical products for Medicare beneficiaries.”
• Agencies established a voluntary pilot program for devices that
does not change the existing separate and distinct review standards
for FDA device approval and CMS coverage determination.
• CMS is open for conducting parallel review for drugs/biotech
products???
– Good idea for currently non covered items or services
23
24. Changes to CED
• CMS issued Notice on November 7, 2011, comment period closes January 20,
2012.
• Coverage with Evidence Development (CED) is currently used by CMS to provide
conditional payment for items and services while generating clinical data to
demonstrate their impact on health outcomes.
– The goal is to improve health outcomes for Medicare beneficiaries
• CMS states that the “intended outcome is to mature CED so that it fulfills its
potential as a mechanism that simultaneously reduces barriers for innovation and
enables CMS to make better informed decisions that improve health outcomes for
Medicare beneficiaries.”
• Agency seeks comments on:
– Implementation of CED through the national coverage determination (NCD) or
other avenues under Part A and Part B;
– Potential impact of CED on the Medicare program and its beneficiaries.
– Suggested approach to CED to maximize benefit to Medicare beneficiaries
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25. Medicaid Managed Care
• Public insurance program for low income Americans
is single largest healthcare program in the US.
• In 2011, average monthly Medicaid enrollment is
projected to exceed 55 million.
• 17 states currently “carve out” prescription drugs.
• ACA will dramatically reduce this number due to
changes in rebate formula and state budgets
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26. Drug Shortage
• Number of prescription drug shortages nearly tripled between
2005 and 2010.
• More than 200 drugs are on the current shortage list kept by
the American Society of Health-System Pharmacists.
– Resulting from ASP system
• Changing reimbursement formula discussed, but no changes
proposed.
• FDA sent letter to manufacturers encouraging them to voluntarily
notify the agency of impending shortages.
– Pending legislation to mandate notification.
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27. Trends in Specialty Care
• Expansion of pharmacy benefit tools on specialty
products.
• Greater use of guidelines driving coverage.
• Outcomes based payment structures.
• Adherence—growth of programs at specialty level
• REMS
• Will Biosimilars make a difference?
– Guidance by year end
27
28. Specialty Industry Panel
Moderated by Michael McCaughan
Michael McCaughan
Founding Partner, Prevision Policy
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
29. Panelists
Steve Bloom, RPh
Vice President
ZIOPHARM Oncology
Kay Barry
Director, Government Accounts
Shire Human Genetic Therapies
Steve Bourke, RPh
Manager, Patient Support and Reimbursement Services
Celgene Corporation
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30. REMS Considerations in a
Market Access Strategy
Jeff Fetterman
President, ParagonRx
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
51. Presenters
Nathan White, CPC
Executive Director
Access & Reimbursement
Jeff Trotter
Executive Vice President
Phase IV Development
Lujing Wang, MD, MPH
SVP and Practice Area Lead
Pricing & Market Access
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52. The Global Payer Market:
Programs to Support Managed Markets Strategies
Nathan White, CPC
Executive Director, inVentiv Patient Access Solutions
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
53. European Landscape
• Coverage largely through government
sponsored/managed insurance
• Well-defined health technology assessment
(HTA) process
• HTA/Payer relationship is strong (i.e. UK‟s NHS
& NICE)
• Emphasis on medical innovation: “me too”
products are not favored in HTA process
• HIT is a critical part of coverage and
reimbursement systems
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54. US Landscape
• Complex evidence development and utilization
• Many national payers and PBMs have developed in-house HTA‟s
› Research could be viewed as subjective
› Rely heavily on claims data and chart review
• CMS coordinates to some degree with AHRQ on evidence needs
› AHRQ-sponsored review of evidence for colorectal screenings
› NCD for treatment of actinic keratoses
• “Me-too” products still have market potential
• National HIT standards implementation
still has room for improvement
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55. US Payers Likely To Use Patient Reported Outcomes
(PRO) In Future Decisions
How likely are you to use PRO to make
coverage and reimbursement policy
decisions in the future?
(on a scale of 1 to 7 where # of lives = 4,353,435
1=Not likely, 7= Very likely)
5% # of lives = 19,701,655
26%
n=22
68%
Very Likely
# of lives = 51,127,435
Likely
Mean 4.5
Not Likely
SOURCE: 2011 inVentiv Health Payer Study
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56. US Payers Likely To Follow CMS Lead
If CMS publicly leverages the results
of these studies, how likely are you to
follow CMS’ lead in utilizing PRO to
guide your coverage decisions?
(on a scale of 1 to 7 where
1=Not likely, 7= Very likely)
1%
14%
n=22
Very Likely
Likely
Not Likely
86%
SOURCE: 2011 inVentiv Health Payer Study
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57. Evidence Development: Pre- and Post-Approval
• Prospective
› Clinical study data
• May include PRO endpoints and cost-benefit analysis
› FDA approved label
• Retrospective
› Pharmacy claims analysis
› Chart review
› Budget impact modeling
› Cost effectiveness analysis (limited use in US)
› Registry
› Phase IV outcomes study with PRO
› Commercial marketing programs
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58. What Is This Evidence Used For?
• Determining relevant “access barrier” criteria
› Step therapy
› Prior authorization
› Quantity limits
• Deciding which benefit the therapy is placed in (medical v.
pharmacy v. specialty)
• Reimbursing at an appropriate rate
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59. Reimbursement Support Programs
TODAY TOMORROW?
Focused on helping patients Managed markets data could
with reimbursement access be used to better guide NAM
barriers 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?
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60. 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
could be valuable to managed bias, misclassification)?
markets teams
Would patient advocates
Typically doesn‟t capture PRO object to muddying the waters of
a free drug program?
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61. 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
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62. Patient Support Programs:
The “Package” Approach
• Post-approval RCT sought to demonstrate superior effectiveness
of buprenorphine medication-assisted therapy paired with
interventional coaching (in opioid dependent patients)
• CAC and trained registered nurses conducted telephonic
interventions designed to encourage appropriate compliance &
persistency
• The study concluded that patients were more likely to take their
therapy every day and less likely to abuse, compared to controls
What can we learn from this example?
• Better patient support leads to better patient outcomes, reducing
overall payer spend
• Additional messaging to payers on total value of package (product
+ program)
Source: Supplement to Journal of Managed Care Pharmacy, Feb 2010
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63. Role of Commercial Programs In Evidence
Development
• The primary direct link to patients after approval
• Types of programs:
› Reimbursement
› Patient assistance
› Adherence
• Control arms could be added with a non-interventional survey or
interventional care coordination to demonstrate therapy or
therapy/program effectiveness to payers
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64. Observational Studies &
Registries:
Strategic and Operational Considerations
Jeff Trotter
Executive Vice President, PharmaNet/i3
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
65. Post-approval Research Today – Safety & Value
• Requirement
› In some countries, „real world‟ post-approval experience data must be
submitted to maintain market approval.
› Increasingly, some form of safety surveillance / risk management program
will be mandated and enforced.
• Responsibility
› Corporate accountability for post-approval safety is increasingly expected
by various constituencies.
› Documentation of clinical / economic / humanistic value is critical for
commercial acceptance and accelerated product uptake.
• Opportunity
› If managed proactively, safety surveillance obligation can be controlled.
› An observational study can be a cost-effective, high ROI mechanism for
fulfilling the post-approval obligation for both safety and effectiveness
data.
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66. Real World Perspectives, Real World Research
“The conditions under which products are
examined for regulatory approval are
generally not the conditions under which
they are actually used…”
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67. Who Needs Real World Data?
• Health authorities WellPoint's CER Guide Describes How It Will Determine
Usefulness Of Studies
• Pricing commissions Observational Studies Of "Real-World" Questions
The guidelines state that, "while randomized, controlled clinical trials remain the gold
• Payers standard for producing reliable efficacy and safety data, WellPoint recognizes that there
are circumstances in which RCTs alone may not be sufficient for decision-making.
Accordingly, a well-conducted CER or observational study may complement RCT-
• Regulatory based information by providing effectiveness data, or data on outcomes achieved
in a 'real-world' setting.“
authorities
• Physicians / German Pharma Law Require Firms to Prove Drugs' Value
providers Within a Year /
Germany's Comparative Effectiveness Debate Concludes;
Dossier Refinement Begins
• Policy makers
The holder of the marketing authorization will be required to hand in a comprehensive
• Patients dossier to the G-BA, which needs to contain information on:
• the authorized indications;
• the actual medical benefit of the product;
• the additional medical benefit of the product compared with existing therapies;
• the number of patients and patient groups for which the product is relevant;
• the cost of the therapy to the statutory health insurance funds; and
• requirements for quality-assured use of the product.
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68. Real World Studies & Registries Are Needed
Because…
►…RCTs can be too artificial in intent and design, and
therefore poorly reflective of actual medical practice
► Tight inclusion criteria
► Experimental protocol
► Tight procedural control
► Randomization, blinding, placebo, etc.
► Short in duration
► Homogeneous sites
►We need to know how a product is used and how it
“performs” under real world conditions
► Safety
► Clinical outcomes (CER)
► Economic value
► Humanistic value
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69. But The Real World Can Be Really Messy!
►What are we trying to prove?
►What can we prove?
►Should we be trying to “prove” anything?
►Considering…
►Not typically testing a hypothesis
►Potentially shaky statistical foundation
►Inexperienced research sites
►Liberal inclusion criteria
►Strong likelihood of various biases
►Imperfect ability to identify all confounders
►Hawthorne effect
►Inconsistent understanding of observational research
…is there a “perfect” observational study? Probably not…
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71. Key Components
RCT Component Observational Study
Support for approval Strategic Goal Support for “real world” data
Efficacy Measures Safety, effectiveness, value
Randomization, Controls Inclusion/exclusion
inclusion/exclusion criteria,
protocol, monitored
Sample size based on Statistical Power Possibly, based on expected
hypothesis event rate, but often lacking
Investigators, subjects Participants Practitioners, patients
Consent, EC/IRB, privacy Approval Consent, EC/IRB, privacy
(notification)
As short as necessary Timeframe Longer-term (“sustain
and maintain”)
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72. Operational Issues & Challenges
• Site selection • Data management
• Site training and start-up › Accommodating multiple
measures
• Site “interaction”
› EDC issues
(monitoring) and
management › Data quality
• SDV
› Site motivation
› Protocol “adherence” • Analysis
• Inclusion › Biases, etc.
• Procedures › Findings
› Reporting (communications
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73. Observational Studies Are A Different Animal
So, who “owns” it…?
• HEOR
• Epidemiology
• Medical Affairs
• Marketing / Product Management
• Clinical Operations
• Development
• Safety / PV
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74. Highlights From Study On Observational Research
• Motivation: “Schizophrenic” RFPs
› i.e., uncertainty, inconsistency, imprecision, over-engineering, etc.
• Many functional areas have some involvement in observational research
studies
• Many different purposes underlie these studies
• “Observational research” goes by many names
• Sponsors have varying levels of “comfort” with observational research
• Most sponsors do not have defined processes for observational studies
› Design, Procurement, Operational, Analytical, etc.
• Sponsors have varying expectations for the “conclusiveness” of findings from
observational studies
• Sponsors are concerned that regulatory/health authorities “don‟t get it”
• Sponsors plan to become increasingly involved in observational research
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75. Operational Planning:
Building The Study From The Ground Up
PUBLICATIONS ABSTRACTS, PRESENTATIONS
• What are the strategic REPORTS
goals underlying the ANALYSES
study?
SITE
› Direct impact on how the SUPPORT MEETINGS
PATIENT ENROLLMENT,
project/study should be
OUTCOMES TRACKING,
„operationalized‟
DATA COLLECTION
NEWSLETTERS
• Direct impact on budget
and ROI
• Work backwards from MATERIALS PRODUCTION AND DISTRIBUTION SITE RECRUITMENT AND TRAINING
the deliverable LEGAL, REGULATORY, IRB REVIEW
• Don‟t consider any DATA COLLECTION FORMS,
SCIENTIFIC ADVISORY PANEL
SITE IDENTIFICATION (FIELD
PROCESSES, AND LOGISTICS INVOLVEMENT)
individual component in
a vacuum ANALYSIS PLAN COMMUNICATIONS PLAN
STRATEGY
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76. Observational Research & Registries: Best Practices
• Be realistic in study planning
• Set appropriate expectations (internally and externally)
› Observational study as part of overall “portfolio”
• Strive for organizational inclusiveness and consensus
• Develop guidelines addressing study design and SOPs addressing unique
operational requirements
• Interact with stakeholders during planning stages (and concurrently)
• Maintain a collaborative stance with research partners
› Minimize operational constraints
• Expect change: “shift” happens
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77. Payer Utilization of Value Evidence
Lujing Wang, MD, MPH
SVP & Practice Area Lead, Campbell Alliance
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™
78. Pros and Cons of Late Stage Evidence Generation
Late-stage evidence generation should aim to demonstrate how a product can provide meaningful
benefits to fulfill a justifiable need, at a reasonable and predictable cost
Evidence Analysis
Very
Evidence
X
Generation
Relevance
Slight Very
Pros Cons
Real-world data with Intuitive suspicion of
balanced demographics manufacturer-
Y Long-term outcomes sponsored studies
Slight
Repositioning in a large population Lack of credible
Ability to address adjudication of
Credibility payers‟ concerns methodology
Ability to define specific Perceived subjectivity
What to generate: patient (sub)population of patient-reported
study endpoints outcomes measures
Partnership to boost
credibility of results Limited actionability of
How to generate: study results
study design
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79. Payer Communication of Value Evidence
Successful communication with payers requires following three principles.
Principles of Payer Communication
I Simplicity II Transparency III Credibility
A complete story that Avoidance of “black Well-accepted
can be told in a box” design and methodology and
definite time window subjective validated design
assumptions
Concise and crisp Third-party
takeaways that can Key foundations for endorsement and
stay in memory audience to interpret KOL partnership
study results
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80. Stakeholder Engagement
The right value evidence needs to be delivered to the right audience at the right time by the right
people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently
and effectively.
Potential Access
Stakeholder Groups Stakeholder Profiles Engagement Plan
PULL
THROUGH
Pharmacy
Stakeholders
Roles and What messages to
responsibilities communicate
Provider Stakeholders
Evolving interests How to deliver the
and incentives messages
Financial Stakeholders
Interaction and Who to own the
Operational
influence relationship
Stakeholders
Attitudes and When to engage
Key Opinion Leaders
perceptions PUSH the stakeholders
THROUGH
Societies and
Advocacies
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81. Organizational Requirements
The right value evidence needs to be delivered to the right audience at the right time by the right
people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently
and effectively.
Hypothesis Evidence Value
Validation Generation Communication
Strategic Visionary Rigorous Scientist Credible Ambassador
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82. Session Contact Information
Nathan White, CPC
Executive Director, Access & Reimbursement
inVentiv Patient Access Solutions
(703) 662-1851
nwhite@inventivhealth.com
Website: www.inventivhealth.com/patientaccess
Jeff Trotter
Executive Vice President, Phase IV Development
PharmaNet / i3
(847) 943-2508
jtrotter@pharmanet.com
Website: www.pharmanet.com
Lujing Wang, MD, MPH
Practice Area Leader, Pricing & Market Access
Campbell Alliance
(973) 967-2300 ext. 2343
lwang@campbellalliance.com
Website: www.campbellalliance.com
WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
83. Innovative Contracting: A Peek
Behind the Curtain
Katya Svoboda, MPH, MBA
Sr. Practice Executive, Campbell Alliance
TRANSFORMING PROMISING IDEAS INTO COMMERCIAL REALITY™