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F5 Point-of-Care Assessment of
Response to High-Cost Specialty
Therapy: Real-World Experience
in Outcomes-Based Contracting
Nathan White, CPC
Sal Rafanelli, RPh
Fred Brownfield, RPh
Learning Objectives
1.) Explain the rationale and societal promise of outcomes-based
contracting programs to the health care industry as a whole, and the
specialty pharmaceutical industry specifically.
2.) Discuss the socioeconomic and business benefits to patients,
providers, payers, specialty pharmacies, and manufacturers of a
response-to-therapy innovative contracting program.
3.) Identify the clinical and economic considerations in designing an
outcomes-based contract as well as potential outcomes, and per
member per month or per member per year cost savings to a payer.
4.) Describe clinical algorithms and utilization management pathways
for automated non-responder risk assessment.
Continuing Pharmacy Education Credit
• Log-in to AMCP Learn at http://amcplearn.org/
– *PLEASE NOTE: USE THIS EXACT URL
• Follow instructions available on amcpmeetings.org
• Have available:
– NABP e-profile ID
– Birth month and birthday
– Session-specific attendance code
• Complete and submit session evaluation no later than
May 23, 2016 (5:00 PM ET)
• Information in CPE Monitor approximately 72 hours
after submission completion
Financial Relationship Disclosures
• Nathan White reports-
– eMAX Health: Employee
– NucleusX Market Access: Employee (Self) Salary ; is
employed by Company
• Sam Rafanelli reports-
– BiologicTx: Employee (Self) Salary
• Fred Brownfield reports having no financial
relationships with any commercial interests
during the past 12 months
AMCP Antitrust Guidelines
• AMCP’s policy is to comply fully and strictly with all
federal and state antitrust laws.
• This session will be monitored for any antitrust
violations and will be stopped by the session
monitor if any such violation occurs.
• Please refer to page 5 of the final program or
www.amcp.org/antitrust for more information.
Please Silence All Devices
PLEASE WRITE DOWN THIS
ATTENDANCE CODE:
[PLACEHOLDER CODE]
Faculty
Fred Brownfield, BSPharm
Strategic Consultant - Innovative
Contracting, Humana Pharmacy
Solutions
Humana Inc.
Louisville, Kentucky
Sal Rafanelli, RPh
Chief Operating Officer and
Co-Founder
BiologicTx
Totowa, New Jersey
Nathan White, CPC
Managing Director, Head of Market
Access, eMAX Health, White Plains,
New York
PRE-TEST
Demographic Question
What title best describes your current
position?
a. Payer
b. Manufacturer
c. Consultant
d. Retail, community or hospital pharmacist
e. Academic
f. Student
g. Other
TEXT
TO
22333
a. 320389
b. 320391
c. 320392
d. 320393
e. 320395
f. 320396
g. 320397
h. 320398
i. 320399
Learning Assessment Question #1
Out of the following disease categories,
which would benefit the most from
outcomes-based contracting?
a. Rheumatoid arthritis
b. Next-gen hepatitis C
c. Diabetes
d. Multiple sclerosis
e. Cholesterol management
f. Oncology
TEXT
TO
22333
a. 320400
b. 320403
c. 320404
d. 320405
e. 320411
f. 320412
Learning Assessment Question #2
Of the following, what is the greatest
challenge to implementing an outcomes-
based contract?
a. Parties averse to financial risk
b. Corporate structures get in the way
c. Difficulty in gathering and analyzing
clinical data
d. Parties don’t see true value in the
arrangement
TEXT
TO
22333
a. 320413
b. 320415
c. 320416
d. 320423
Learning Assessment Question #3
Outcomes-based contracting in the US
started in what year?
a. 2001
b. 2005
c. 2009
d. 2015
TEXT
TO
22333
a. 320431
b. 320456
c. 320460
d. 320461
Learning Assessment Question #4
Who has been more active in promoting
movement towards an outcomes-based
contracting environment?
a. Payers
b. Manufacturers
TEXT
TO
22333
a. 320462
b. 320463
BACKGROUND
Landscape of Outcomes-based Contracting
SOURCES:
http://www.ibj.com/blogs/12-the-dose/post/54074-obama-orders-hospitals-to-serve-full-meal-dealsand-sparks-a-health-care-revolution
WHY CHANGE THE STATUS QUO?
Healthcare Spending as a Percentage of GDP, 1960-2013
US
Trajectory
1982
The overall trend in healthcare spending over the past 35 years is not sustainable.
Rest of
First
World
1960 2013
2%
4%
6%
8%
10%
12%
14%
16%
18%
#1: UNSUSTAINABLE COSTS
Inappropriate healthcare resource utilization leads to high costs and poor quality of care.
SOURCES:
1Becher EC, Chassin MR. Improving the quality of healthcare: who will lead? Health Aff. 2001;20:68-81.
2ASPE analysis of IMS Health NPA data from October 2009 to September 2015.
US spent an estimated $128B on “non-retail” prescription drugs in 2015.
$2.729 Trillion
2015 Total Healthcare
Spending
$457 Billion 2015 RX Spend
72% Retail
Misuse of healthcare resources in the US amounts
to roughly 30% of all healthcare costs1
30%
$2.729 Trillion
2015 Total Healthcare
Spending
“Non-retail” prescription spending represented
28% of the $457B spent on prescription drugs
RX drug spending accounted for 17% of total
healthcare spend ($457 billion)2
17%
28% Non-retail
#2: DISPROPORTIONATE SPENDING
90%
100%
110%
120%
130%
140%
150%
2009 2010 2011 2012 2013 2014 2015
Relative Cumulative Growth in Retail Expenditures and Retail
Prescription Units, 2009 to 20151
Retail
Revenues
Retail
Prescription
Units
In six years, a nearly 30-point gap has arisen between
retail expenditures and retail prescription units.
The widening gap between RX revenues and RX volume is indicative of trends toward increasingly high-
cost treatments and continuing price increases.
SOURCES:
1ASPE analysis of IMS Health NPA data from October 2009 to September 2015.
#3: ACCESS BARRIERS
SOURCES:
1www.express-scripts.com; www.caremark.com
2http://khn.org/news/large-employers-look-to-tighten-control-of-costs-for-expensive-drugs/
Barriers to novel drug access will continue to grow with PBM exclusion lists and employer-driven cost
containment measures.
48
72
80
38
49
76
97
124
2012 2013 2014 2015 2016
Drug Exclusion Trends for CVS
Health and Express Scripts
ESI CVS
CVS and ESI grew their formulary exclusion lists by 67%
and 61% respectively from 2014 to 2016.
33%
29%
29%
29%
18%
55%
53%
35%
34%
32%
Mandatory SPP
Prior authorization
Supply limit
Personalized care management
Localized drug management
Employers Increasingly Take Steps
To Control Specialty
Pharmaceutical Costs2
2016 2015
Localized drug management
Personalized care management
Supply limit
Prior authorization
Mandatory SPP
#4: INTERNET OF THINGS (IoT)
Real-time, real-world data will become easily available as the IoT grows rapidly over the next decade.
SOURCES:
1http://www.wallstreetdaily.com/2016/02/10/internet-of-things-big-data-healthcare/ (infographic above)
2http://www.lairdtech.com/solutions/embedded-wireless/what-connected-hospital/connected-hospital-infographic
3.7 Million
97%
10%
Medical
Devices in US2
WiFi Adoption Rate
in Hospitals
Medical Devices Enabled
With WiFI
318.9 Million (2014)
5,723
US Population
Improved
Patient Care
Objectives of
“eConnectivity”
Facilitation
of Data Flow
John Chambers, former CEO of Cisco, predicts
500 billion connected devices by 20251.
“eConnected”
hospitals
OUTCOMES-BASED CONTRACTING IN EUROPE
Outcomes guarantees have been established in European markets for more than a decade.
All outcomes-based contracts in Europe involve a
significant financial risk component.
SOURCES:
http://www.ispor.org/research_pdfs/35/pdffiles/PHP15.pdf
Patient Population
(or sub-population)Patient
Response
Dependent
Response
Assumed
Cost-
Effectiveness
Cash
refund
Replacement
stock
Pay for
consequence
Longer
treatment
required,
drug free
of charge
Higher
dose
required,
drug free
of charge
Pre-agreed
price
increase
Pre-agreed
price
decrease +/-
rebate
Price
adjusted +/-
cash transfer
variable
determined
by data
Failure
Maximum
treatment
cost/patient
Unit of
Analysis
Outcome
Measure
Terms of
Settlement
ESI excludes
atorvastatin
Novartis
ESI
sacubitril/valsartan
AbbVie
ESI
HepC
BCBS patient-centered
care program
MERCK
Cigna
sitagliptin/metformin
EMD Serono
Cigna
interferon b-1a
Gilead
Cigna & Catamaran
HepC
Amgen
Harvard Pilgrim & ESI
evolocumab
2005 20162010
OUTCOMES-BASED CONTRACTING IN THE US
Sanofi
Health Alliance
risedronic acid
Outcomes-based contracting in the US had a stalled start in 2009, and began in earnest in 2015.
Amgen, AbbVie, Novartis, and Gilead have publicly announced
outcomes-based contract discussions over the past 18 months.
SOURCES:
eMAX Health Research
OBJECTIVES AND METHODS
Primary Research With Payers and Manufacturers
RESEARCH OBJECTIVES
eMAX Health conducted research via a web survey with manufacturers and payers.
OBJECTIVE 3
Pinpoint contract
structures that have
greatest likelihood
of success
OBJECTIVE 2OBJECTIVE 1
Understand top
reasons why
outcomes-based
contracts are
challenging to
implement
Understand which
therapeutic
categories and drug
classes are
important for
outcomes-based
contracting
discussions
The principal goal is to better understand perceptions and opinions of the
current outcomes-based contracting landscape.
ABOUT THE SAMPLE
The research was conducted via an internet survey with representatives from both payers and
manufacturers who had a moderate to advanced topical knowledge of outcomes-based contracting.
Small R&D only
biotech/pharma
2%
Other
4%
Regional
managed
care
organization
9%
National
managed
care
organization
13%
Small commercial
biotech/pharma with
at least one
commercially
available product
13%
Midsize
commercial
biotech/pharma
with products in
multiple
therapeutics
areas
17%
Pharmacy benefit
manager
19%
Big pharma/biotech
23%
Combined Sample: Organization Types
n=46
Primary Research Sample
National and
regional
commercial
payers
n = 17
Pharmaceutical
Manufacturers
n = 29
Representatives of pharmacy benefit managers and large pharmaceutical/biotech
companies represent 42% of the experts surveyed.
External
relations
21%
Integrated Care
Management
4%
Pharmacy
71%
Specialty
4%
ABOUT THE SAMPLE
Within the manufacturer cohort, we obtained insights from stakeholders in HEOR, field managed markets,
and payer strategy; within the payer cohort, pharmacy and external relations were most prevalent.
Market
access/payer
strategy
31%
Managed
markets
28%
National
accounts
7%
Marketing /
Brand
3%
HEOR
28%
Other
3%
Manufacturer
Roles
n=29
Payer Roles
n=17
Of the payers surveyed, nearly a quarter were pharmacy directors; of the
manufacturers surveyed, HEOR, managed markets, and market access strategy
were evenly represented.
RESULTS
Primary Research With Payers and Manufacturers
FAMILIARITY
Question: How familiar are you with the topic of outcomes-based contracting?
Three quarters of the screened respondents had a moderate or higher familiarity
with the topic of outcomes-based contracting.
Not at all familiar,
8%
Slightly familiar,
16%
Moderately familiar,
40%
Very familiar, 27%
Extremely familiar,
8%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
n=73
HISTORICAL PERSPECTIVE
Question: Has your organization implemented an outcomes-based contract in the past five years?
All of the payers who participated had been involved in outcomes-based
contracting in the past five year, while most in the manufacturer sample had not.
21%
100%
79%
Manufacturer response
Payer response
n=42
YES
n=17
n=29
YES NO
PLAYERS
Question: Who has been more active in promoting the outcomes-based contracting movement?
The majority of respondents, both payer and manufacturer, believe
that payers are in the driver’s seat.
38%
24%
62%
77%
Manufacturer response
Payer response
n=46
Manufacturers Payers
n=17
n=29
DISEASE AREAS
Question: Outcomes-based contracting arrangements are most promising in what disease area?
No singular disease area was mentioned as significantly more important,
however, oncology led slightly as an area of interest.
Bone/muscle/joint
3%
Weight management
3%
Pain
6%
Immunology/inflammation
(i.e. RA, psoriasis,
Crohn's)
9%
Infectious
disease
12%Neuroscience
15%
CV
15%
Oncology
19%
Metabolic
disorders
18%
n=33
TYPES OF CONTRACTS
Question: Which type of contract has the most/least potential for success?
Both manufacturers and payers agree that clinical performance (or “pay-for-
performance”) contracts have the most potential for success; while a capitated
utilization model has the least potential for success.
13%
7%
19%
14%
31% 50%
19%
25%
19%
4%
PAYER MANUFACTURER
19% 14%
19%
7%
3%
31%
17%
31%
59%
PAYER MANUFACTURER
MOST LEAST
n=46
n=17 n=29 n=17 n=29
MANUFACTURER RISK
Question: What level of financial risk do you expect manufacturers
to take on in order to proceed with an outcomes-based contract?
Not surprisingly, payers said that a manufacturer should assume
a moderate level of financial risk.
3
12
1
0
2
4
6
8
10
12
14
Extreme risk High risk Moderate Risk Some risk No risk
n=17
EXCLUSIVITY
Question: How likely is it that your organization would have future interest
in an “exclusivity” outcomes-based contract?
Payers leaned towards a the possibility of a future
filled with exclusivity arrangements.
1
4
7
5
0
1
2
3
4
5
6
7
8
Not at all likely Slightly likely Moderately likely Very likely Completely likely
n=17
IMPLEMENTATION BARRIERS
Question: Please rate each of the following implementation barriers.
Although the corporate inertia exists to make outcomes-based contracting
happen, technical difficulties present as the most challenging barrier to
implementation.
Resistance to
Financial Risk
Least
Challenging
Most
Challenging
Corporate
Structure
Technical
Difficulty
Lack of Corporate
Inertia
Lack of Perceived
Value
IMPLEMENTATION BARRIERS
Question: What single barrier is most challenging to successful implementation of an
outcomes-based contract?
The sheer difficulty with the technical aspects of contract implementation ranks
as the most challenging barrier to outcomes-based contact implementation.
Resistance to
financial risk
17%
Corporate
structure
14%
Technical difficulty
45%
Lack of
corporate
inertia
10%
Lack of
perceived
value
10%
Other
4%
n=29
IMPLEMENTATION
Question: What is the likelihood you will implement an outcomes-based contract
over the following time periods?
Payers more strongly than manufacturers that they would implement outcomes-
based contracts in the near future.
Six Months
One Year
Two Years
Three Years
Very
Unlikely
Very
Likely
KEY LEARNINGS
Our research with payers and manufacturers on outcomes-based contracting yielded seven key learnings.
Payers are largely responsible for the push towards outcomes-based
contracting
Oncology, metabolic, cardiovascular, and CNS are four key disease areas of
interest to payers
Clinical performance agreements are believed to have the highest likelihood of
implementation success
Technical difficulties are largely responsible for implementation delays and
failures
Manufacturers expected to take on some level of financial risk in an outcomes-
based contract
Payers are open to the idea of formulary preference as part of an outcomes-
based contract arrangement
Outcomes-based contracting should become more common in the next few
years
1
2
3
4
5
6
7
CASE STUDIES
Constructs of Implemented Outcomes-based Contracts
CASE STUDY #1
sitagliptin/metforminMERCK CIGNA
Disease Area: Diabetes Implemented: 2009
AGREEMENT COMPONENTS GOALS/OUTCOMES
• CIGNA assesses the blood sugar levels (A1c lab
values) for patients on any oral antidiabetic
medications
• If the A1c values, in aggregate, improve by the end
of the agreement period, the discounts will decrease
by a pre-agreed amount
• CIGNA uses claims data to determine if patients are
taking the Merck drugs as prescribed
• Better placement on CIGNA’s formulary
• Lower copayment versus that for other branded
drugs
• In 2010, CIGNA announced positive outcomes from
the diabetes support program:
• Patients’ blood sugar levels were reduced by more
than 5%,
• Individuals who participated were more likely to
control their blood sugar than those who did not
participate in the program
• 87% of patients who took the Merck drugs took their
medications correctly
SOURCE:
http://www.ispor.org/meetings/montreal0614/presentations/IP9-AllSpeakers.pdf
Type: Clinical Performance
The MERCK-Cigna deal is one of the few to have publicly released results of the program.
CASE STUDY #2
Interferon beta-1aEMD SERONO CIGNA
Disease Area: MS Implemented: 2011
AGREEMENT COMPONENTS GOALS/OUTCOMES
• CIGNA tracks the percentage of hospitalizations
and ER visits avoided by people using EMD Serono
drug
• CIGNA uses medical claims in order to determine
whether a relapse was the cause for hospitalization
and/or ER visits
• CIGNA uses 2010 as a baseline, looking at data
from medical, pharmacy and lab claims, and
measuring members’ medication-possession ratio
(MPR)
• EMD Serono provides rebates based on adherence
outcomes and relapse-free patients
• Because MS eventually leads to a state of disability,
CIGNA helps to delay disease progression and
quick accumulation of irreversible neurological
damage by improving adherence
• Using experiences in MS, CIGNA extended its
monitoring strategies to other conditions through
the THERACARE program
SOURCE:
https://aishealth.com/archive/nspn0411-01
Type: Clinical Performance
The EMD Serono-Cigna deal is the only publicly acknowledged US OBC in MS.
CASE STUDY #3
evolocumabAMGEN HARVARD PILGRIM
Disease Area: CV Implemented: 2015
AGREEMENT COMPONENTS GOALS/OUTCOMES
• Amgen gained formulary preference as part of the
deal
• Harvard Pilgrim can also receive additional rebates
if utilization is above a pre-determined amount
• Amgen will be at risk financially if health plan
members’ cholesterol levels aren’t lowered enough
• The pay-for-performance element is in addition to
the discount
• Compare patient low-density lipoprotein cholesterol
levels to clinical trial outcomes
SOURCE:
http://www.modernhealthcare.com/article/20151109/NEWS/151109899
Type: Clinical Performance
Amgen implemented a highly innovative risk-based contract model focused on a population-health outcome.
APPROPRIATE CARE MODEL
Real-world Example of an Outcomes-based Contracting Program
Large % of patients on specialty drugs do not respond but stay on therapy
APPROPRIATE CARE MODEL
An appropriate care model identifies non-responders based on therapeutic response.
The single greatest opportunity to reduce aggregate claim dollars in specialty
is to identify patients that do not respond and take them off the drug.
SOURCES:
1eMAX Health claims analysis
2Adalimumab Full Prescribing Information
3Hughes et al., Lancet Neurol 2008; 7: 136–44
Inappropriate
Use
PROBLEM
OBJECTIVES
• Reduce treatment days with no response
• Integrate outcomes and authorizations
• Establish funding partnership for patient monitoring
46% of CIDP patients did not respond to
IVIG after 24 weeks, yet 75% of patients
are on treatment for more than 48
weeks1,3
Adalimumab showed only a 53%
response rate after 6 months2
Reimbursement decisions based
on actual response
Point of care drug assessment
mobile app
Utilization preference in
exchange for price
adjustment to offset
monitoring cost
Standardized Assessment Discounts/Rebates Response-linked Authorizations
SOLUTION
PROGRAM FLOW
The appropriate care model supplements current drug authorization process.
At PA/re-auth,
point, plan requires
enrollment in
program
Partner SPP
conducts
assessment on
behalf of plan in
case management
system
Software flags non-
responders
Program administrator
coordinates with SPP
and provider to identify
alternate care plans for
non-responders
Plan authorization
department makes
ultimate coverage
decision using
outcomes data
Program administrator
manages the rebate
between the
manufacturer sponsor
and healthplan
Program
administrator reports
on program savings
to healthplan and
manufacturer
sponsor
CASE STUDY: APPROPRIATE CARE
IGIVDE-IDENTIFIED DE-IDENTIFIED
Disease Area: Neurology Implemented: N/A
AGREEMENT COMPONENTS GOALS/OUTCOMES
• Real-time patient outcomes data monitored via point
of care assessment tool
• Appropriate site-of-care and treatment response
were monitored
• Non-responders were transitioned to alternate site-
of-care and/or alternate treatment
• Manufacturer sponsored monitoring program in
exchange for formulary preference
• Savings PMPM: $.22
• 26% reduction in drug spend for treated patients
Type: Appropriate Care
Manufacturer implemented an appropriate care model focused on identifying non-responders
in exchange for formulary preference.
Site-of-
service
savings
72%
Discontinuation
savings
28%
90
95
100
105
110
115
Pre-program
plan spend
Post-program
plan spend
$111.9m
$99m
BENEFITS
The primary benefit of an appropriate care model contracting model is to improve overall health outcomes
by reducing inappropriate utilization of treatment, resulting in savings to the payer.
Improve and simplify health outcomes for chronic disorders
Simplify health outcomes monitoring for therapy
Reduce duration of treatment for non-responding patients
Provide medically-defensible coverage determination
Reduce specialty drug spend for non-responding patients
Reduce specialty drug spend by optimizing site of care
ROLE OF SPECIALTY PHARMACY
How does specialty pharmacy fit in?
ROLE OF SPECIALTY PHARMACY
Specialty and infusion pharmacies play an important role in the patient care and monitoring aspects of
outcomes-based contracting programs.
• In the high-cost specialty area, health plan’s provider networks can play an
important role in outcomes-based contracting
• Outcomes data must be conveyed quickly and efficiently to be actionable
Infusion Providers
Infusion pharmacies administer the
drug creating an opportunity to assess
patient status in real-time
Relying on claims data to review drug
performance only offers retrospective
price adjustment, but not a change in
appropriate care and coverage
Physically at the point-of-care Routinely interact with patients
HEALTH STATUS MONITORING
Specialty pharmacy disease programs provide opportunity for health status monitoring.
Specialty pharmacy and home infusion providers develop disease programs with
routine patient touch points.
• Key patient status parameters under disease programs
are captured at the point of care and reside in
pharmacy software
• Creates a unique global picture of therapeutic
impact and treatment efficacy
• Captures and reports
clinical profile, lab data,
adverse events,
medication history,
insurance information,
and general metrics
CONTRACTING PROGRAMS
Specialty pharmacies already reside in payer networks, allowing seamless participation
in contracting programs.
• Payer-directed patient volume provides incentives for patient monitoring and
data reporting
• Pharmacies can efficiently monitor patient status through data collection tools
provided under a program
Data Collection Methods
Nurse enter data into
pharmacy software which
can be relayed electronically
to data aggregator for use
by payer and prescriber
Paper Surveys
Efficient tools are deployed
in the field for ongoing
monitoring if there is
minimal training and data
integration requirements
Specialty pharmacies
maintain electronic medical
records for its patients -
data elements can be
incorporated into programs
to define outcomes
Electronic Application Medical Records
HOME INFUSION CASE STUDY
IGIVDE-IDENTIFIED DE-IDENTIFIED
Disease Area: Neurology Implemented: N/A
COMPONENTS
• BiologicTx negotiates reimbursement rates with payers to compensate for monitoring and reporting cost
• Manufactures offer brand preference agreements in the form of a rebate with health plans to offset the cost of
monitoring
• Manufactures may also offer discounted drug purchase agreements with pharmacies for participation in the
payer program
Type: Appropriate Care
BiologicTx participates as infusion pharmacy to deliver IGIV to patients with neurological disability.
Nurses nationally
trained on the use of
point-of-care
application to assess
patient neurological
status
Pharmacy on-boards
cases during prior
authorization process
and links the upcoming
patient encounter to a
nurse for monitoring
Infusion pharmacy
ships product along
with a hard copy of
disability survey as a
back-up to digital
application survey
Infusion nurse arrives
at the home and
conducts digital survey
on tablet or phone
through a secure URL,
to assess neurological
disability
Neurological status
data are relayed to the
program manager in
real-time and provided
to the health plan to
make coverage
decisions
PAYER PERSPECTIVE
Insights From a Leader in Outcomes-based Contracting
INNOVATIVE CONTRACTING
Drug Access
Real World
Evidence
Real World Data
Patient Response
Statistics
Therapeutic Response
Progression Free
Survival
Hospital Avoidance
Lower Discontinuation
Disease Cure
Assess Effectiveness
Measure Endpoints
Share Financial
Responsibility for
Failures/Successes Total Cost of Care
Pharmaceutical
Manufacturer
Humana
RECIPE FOR SUCCESS
• Keep it simple
• Senior level support/buy-in
• Being a captive PBM
• Dedicated HEOR analytical support staff
• Aligned incentives within the organization
• Be willing to share in risk
INNOVATIVE CONTRACTING TYPES
Toxicity Therapeutic
Response
New
Approaches
Relapse Discontinuation
Indication
Based
Hospital
Admission
Total Cost
of Care
Adverse
Events
Wastage
Duration
Progression
Quality
Of Life
CHALLENGES
• ASP pricing
• Medicaid Best Price
• Safe Harbor/Anti-kickback statute
• Willingness of pharma to participate
• Finding and funding the money from
pharma
CHALLENGES
• Data limitations and privacy concerns
• Fire wall within pharma
• Limited payer participation
• Lack of access to medical claims in PDP
LESSONS LEARNED
• HPS has contracts in place for CFI, MAPD and
both lines of business
• Understanding the data, what we have, who owns
it, where to find it
• Need to have access to experts in data
management and HEOR
• Usually an addendum to an existing rebate
contract
• The outcome or cost associated is paid as a
rebate
LESSONS LEARNED
• Revenue is DIR reportable
• Persistency and adherence are part of the
contract
• Most contracts are for one year
• Data submitted quarterly, bi-annual or annually
• Build 120 days into submissions due to medical
claim lag
• Average time to execute is 6-9 months
• ROI is knowledge gained, not revenue produced
POST-TEST
Learning Assessment Question #1
Out of the following disease categories,
which would benefit the most from
outcomes-based contracting?
a. Rheumatoid arthritis
b. Next-gen hepatitis C
c. Diabetes
d. Multiple sclerosis
e. Cholesterol management
f. Oncology
TEXT
TO
22333
a. 320492
b. 320514
c. 320521
d. 320522
e. 320531
f. 320544
Learning Assessment Question #2
Of the following, what is the greatest
challenge to implementing an outcomes-
based contract?
a. Parties averse to financial risk
b. Corporate structures get in the way
c. Difficulty in gathering and analyzing
clinical data
d. Parties don’t see true value in the
arrangement
TEXT
TO
22333
a. 320545
b. 320597
c. 320602
d. 320603
Learning Assessment Question #3
Outcomes-based contracting in the US
started in what year?
a. 2001
b. 2005
c. 2009
d. 2015
TEXT
TO
22333
a. 320605
b. 320619
c. 320630
d. 320631
Learning Assessment Question #4
Who has been more active in promoting
movement towards an outcomes-based
contracting environment?
a. Payers
b. Manufacturers
TEXT
TO
22333
a. 320632
b. 320633
QUESTIONS?
[PLACEHOLDER CODE]
DISCLAIMER
All Faculty in this education session have obtained the
appropriate permission to use Copy Righted materials.
Sources for all images are provided in citations.

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F5 Outcomes based contracting 040416 ARSmm

  • 1. F5 Point-of-Care Assessment of Response to High-Cost Specialty Therapy: Real-World Experience in Outcomes-Based Contracting Nathan White, CPC Sal Rafanelli, RPh Fred Brownfield, RPh
  • 2. Learning Objectives 1.) Explain the rationale and societal promise of outcomes-based contracting programs to the health care industry as a whole, and the specialty pharmaceutical industry specifically. 2.) Discuss the socioeconomic and business benefits to patients, providers, payers, specialty pharmacies, and manufacturers of a response-to-therapy innovative contracting program. 3.) Identify the clinical and economic considerations in designing an outcomes-based contract as well as potential outcomes, and per member per month or per member per year cost savings to a payer. 4.) Describe clinical algorithms and utilization management pathways for automated non-responder risk assessment.
  • 3. Continuing Pharmacy Education Credit • Log-in to AMCP Learn at http://amcplearn.org/ – *PLEASE NOTE: USE THIS EXACT URL • Follow instructions available on amcpmeetings.org • Have available: – NABP e-profile ID – Birth month and birthday – Session-specific attendance code • Complete and submit session evaluation no later than May 23, 2016 (5:00 PM ET) • Information in CPE Monitor approximately 72 hours after submission completion
  • 4. Financial Relationship Disclosures • Nathan White reports- – eMAX Health: Employee – NucleusX Market Access: Employee (Self) Salary ; is employed by Company • Sam Rafanelli reports- – BiologicTx: Employee (Self) Salary • Fred Brownfield reports having no financial relationships with any commercial interests during the past 12 months
  • 5. AMCP Antitrust Guidelines • AMCP’s policy is to comply fully and strictly with all federal and state antitrust laws. • This session will be monitored for any antitrust violations and will be stopped by the session monitor if any such violation occurs. • Please refer to page 5 of the final program or www.amcp.org/antitrust for more information.
  • 7. PLEASE WRITE DOWN THIS ATTENDANCE CODE: [PLACEHOLDER CODE]
  • 8. Faculty Fred Brownfield, BSPharm Strategic Consultant - Innovative Contracting, Humana Pharmacy Solutions Humana Inc. Louisville, Kentucky Sal Rafanelli, RPh Chief Operating Officer and Co-Founder BiologicTx Totowa, New Jersey Nathan White, CPC Managing Director, Head of Market Access, eMAX Health, White Plains, New York
  • 10. Demographic Question What title best describes your current position? a. Payer b. Manufacturer c. Consultant d. Retail, community or hospital pharmacist e. Academic f. Student g. Other TEXT TO 22333 a. 320389 b. 320391 c. 320392 d. 320393 e. 320395 f. 320396 g. 320397 h. 320398 i. 320399
  • 11.
  • 12. Learning Assessment Question #1 Out of the following disease categories, which would benefit the most from outcomes-based contracting? a. Rheumatoid arthritis b. Next-gen hepatitis C c. Diabetes d. Multiple sclerosis e. Cholesterol management f. Oncology TEXT TO 22333 a. 320400 b. 320403 c. 320404 d. 320405 e. 320411 f. 320412
  • 13.
  • 14. Learning Assessment Question #2 Of the following, what is the greatest challenge to implementing an outcomes- based contract? a. Parties averse to financial risk b. Corporate structures get in the way c. Difficulty in gathering and analyzing clinical data d. Parties don’t see true value in the arrangement TEXT TO 22333 a. 320413 b. 320415 c. 320416 d. 320423
  • 15.
  • 16. Learning Assessment Question #3 Outcomes-based contracting in the US started in what year? a. 2001 b. 2005 c. 2009 d. 2015 TEXT TO 22333 a. 320431 b. 320456 c. 320460 d. 320461
  • 17.
  • 18. Learning Assessment Question #4 Who has been more active in promoting movement towards an outcomes-based contracting environment? a. Payers b. Manufacturers TEXT TO 22333 a. 320462 b. 320463
  • 19.
  • 21. SOURCES: http://www.ibj.com/blogs/12-the-dose/post/54074-obama-orders-hospitals-to-serve-full-meal-dealsand-sparks-a-health-care-revolution WHY CHANGE THE STATUS QUO? Healthcare Spending as a Percentage of GDP, 1960-2013 US Trajectory 1982 The overall trend in healthcare spending over the past 35 years is not sustainable. Rest of First World 1960 2013 2% 4% 6% 8% 10% 12% 14% 16% 18%
  • 22. #1: UNSUSTAINABLE COSTS Inappropriate healthcare resource utilization leads to high costs and poor quality of care. SOURCES: 1Becher EC, Chassin MR. Improving the quality of healthcare: who will lead? Health Aff. 2001;20:68-81. 2ASPE analysis of IMS Health NPA data from October 2009 to September 2015. US spent an estimated $128B on “non-retail” prescription drugs in 2015. $2.729 Trillion 2015 Total Healthcare Spending $457 Billion 2015 RX Spend 72% Retail Misuse of healthcare resources in the US amounts to roughly 30% of all healthcare costs1 30% $2.729 Trillion 2015 Total Healthcare Spending “Non-retail” prescription spending represented 28% of the $457B spent on prescription drugs RX drug spending accounted for 17% of total healthcare spend ($457 billion)2 17% 28% Non-retail
  • 23. #2: DISPROPORTIONATE SPENDING 90% 100% 110% 120% 130% 140% 150% 2009 2010 2011 2012 2013 2014 2015 Relative Cumulative Growth in Retail Expenditures and Retail Prescription Units, 2009 to 20151 Retail Revenues Retail Prescription Units In six years, a nearly 30-point gap has arisen between retail expenditures and retail prescription units. The widening gap between RX revenues and RX volume is indicative of trends toward increasingly high- cost treatments and continuing price increases. SOURCES: 1ASPE analysis of IMS Health NPA data from October 2009 to September 2015.
  • 24. #3: ACCESS BARRIERS SOURCES: 1www.express-scripts.com; www.caremark.com 2http://khn.org/news/large-employers-look-to-tighten-control-of-costs-for-expensive-drugs/ Barriers to novel drug access will continue to grow with PBM exclusion lists and employer-driven cost containment measures. 48 72 80 38 49 76 97 124 2012 2013 2014 2015 2016 Drug Exclusion Trends for CVS Health and Express Scripts ESI CVS CVS and ESI grew their formulary exclusion lists by 67% and 61% respectively from 2014 to 2016. 33% 29% 29% 29% 18% 55% 53% 35% 34% 32% Mandatory SPP Prior authorization Supply limit Personalized care management Localized drug management Employers Increasingly Take Steps To Control Specialty Pharmaceutical Costs2 2016 2015 Localized drug management Personalized care management Supply limit Prior authorization Mandatory SPP
  • 25. #4: INTERNET OF THINGS (IoT) Real-time, real-world data will become easily available as the IoT grows rapidly over the next decade. SOURCES: 1http://www.wallstreetdaily.com/2016/02/10/internet-of-things-big-data-healthcare/ (infographic above) 2http://www.lairdtech.com/solutions/embedded-wireless/what-connected-hospital/connected-hospital-infographic 3.7 Million 97% 10% Medical Devices in US2 WiFi Adoption Rate in Hospitals Medical Devices Enabled With WiFI 318.9 Million (2014) 5,723 US Population Improved Patient Care Objectives of “eConnectivity” Facilitation of Data Flow John Chambers, former CEO of Cisco, predicts 500 billion connected devices by 20251. “eConnected” hospitals
  • 26. OUTCOMES-BASED CONTRACTING IN EUROPE Outcomes guarantees have been established in European markets for more than a decade. All outcomes-based contracts in Europe involve a significant financial risk component. SOURCES: http://www.ispor.org/research_pdfs/35/pdffiles/PHP15.pdf Patient Population (or sub-population)Patient Response Dependent Response Assumed Cost- Effectiveness Cash refund Replacement stock Pay for consequence Longer treatment required, drug free of charge Higher dose required, drug free of charge Pre-agreed price increase Pre-agreed price decrease +/- rebate Price adjusted +/- cash transfer variable determined by data Failure Maximum treatment cost/patient Unit of Analysis Outcome Measure Terms of Settlement
  • 27. ESI excludes atorvastatin Novartis ESI sacubitril/valsartan AbbVie ESI HepC BCBS patient-centered care program MERCK Cigna sitagliptin/metformin EMD Serono Cigna interferon b-1a Gilead Cigna & Catamaran HepC Amgen Harvard Pilgrim & ESI evolocumab 2005 20162010 OUTCOMES-BASED CONTRACTING IN THE US Sanofi Health Alliance risedronic acid Outcomes-based contracting in the US had a stalled start in 2009, and began in earnest in 2015. Amgen, AbbVie, Novartis, and Gilead have publicly announced outcomes-based contract discussions over the past 18 months. SOURCES: eMAX Health Research
  • 28. OBJECTIVES AND METHODS Primary Research With Payers and Manufacturers
  • 29. RESEARCH OBJECTIVES eMAX Health conducted research via a web survey with manufacturers and payers. OBJECTIVE 3 Pinpoint contract structures that have greatest likelihood of success OBJECTIVE 2OBJECTIVE 1 Understand top reasons why outcomes-based contracts are challenging to implement Understand which therapeutic categories and drug classes are important for outcomes-based contracting discussions The principal goal is to better understand perceptions and opinions of the current outcomes-based contracting landscape.
  • 30. ABOUT THE SAMPLE The research was conducted via an internet survey with representatives from both payers and manufacturers who had a moderate to advanced topical knowledge of outcomes-based contracting. Small R&D only biotech/pharma 2% Other 4% Regional managed care organization 9% National managed care organization 13% Small commercial biotech/pharma with at least one commercially available product 13% Midsize commercial biotech/pharma with products in multiple therapeutics areas 17% Pharmacy benefit manager 19% Big pharma/biotech 23% Combined Sample: Organization Types n=46 Primary Research Sample National and regional commercial payers n = 17 Pharmaceutical Manufacturers n = 29 Representatives of pharmacy benefit managers and large pharmaceutical/biotech companies represent 42% of the experts surveyed.
  • 31. External relations 21% Integrated Care Management 4% Pharmacy 71% Specialty 4% ABOUT THE SAMPLE Within the manufacturer cohort, we obtained insights from stakeholders in HEOR, field managed markets, and payer strategy; within the payer cohort, pharmacy and external relations were most prevalent. Market access/payer strategy 31% Managed markets 28% National accounts 7% Marketing / Brand 3% HEOR 28% Other 3% Manufacturer Roles n=29 Payer Roles n=17 Of the payers surveyed, nearly a quarter were pharmacy directors; of the manufacturers surveyed, HEOR, managed markets, and market access strategy were evenly represented.
  • 32. RESULTS Primary Research With Payers and Manufacturers
  • 33. FAMILIARITY Question: How familiar are you with the topic of outcomes-based contracting? Three quarters of the screened respondents had a moderate or higher familiarity with the topic of outcomes-based contracting. Not at all familiar, 8% Slightly familiar, 16% Moderately familiar, 40% Very familiar, 27% Extremely familiar, 8% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% n=73
  • 34. HISTORICAL PERSPECTIVE Question: Has your organization implemented an outcomes-based contract in the past five years? All of the payers who participated had been involved in outcomes-based contracting in the past five year, while most in the manufacturer sample had not. 21% 100% 79% Manufacturer response Payer response n=42 YES n=17 n=29 YES NO
  • 35. PLAYERS Question: Who has been more active in promoting the outcomes-based contracting movement? The majority of respondents, both payer and manufacturer, believe that payers are in the driver’s seat. 38% 24% 62% 77% Manufacturer response Payer response n=46 Manufacturers Payers n=17 n=29
  • 36. DISEASE AREAS Question: Outcomes-based contracting arrangements are most promising in what disease area? No singular disease area was mentioned as significantly more important, however, oncology led slightly as an area of interest. Bone/muscle/joint 3% Weight management 3% Pain 6% Immunology/inflammation (i.e. RA, psoriasis, Crohn's) 9% Infectious disease 12%Neuroscience 15% CV 15% Oncology 19% Metabolic disorders 18% n=33
  • 37. TYPES OF CONTRACTS Question: Which type of contract has the most/least potential for success? Both manufacturers and payers agree that clinical performance (or “pay-for- performance”) contracts have the most potential for success; while a capitated utilization model has the least potential for success. 13% 7% 19% 14% 31% 50% 19% 25% 19% 4% PAYER MANUFACTURER 19% 14% 19% 7% 3% 31% 17% 31% 59% PAYER MANUFACTURER MOST LEAST n=46 n=17 n=29 n=17 n=29
  • 38. MANUFACTURER RISK Question: What level of financial risk do you expect manufacturers to take on in order to proceed with an outcomes-based contract? Not surprisingly, payers said that a manufacturer should assume a moderate level of financial risk. 3 12 1 0 2 4 6 8 10 12 14 Extreme risk High risk Moderate Risk Some risk No risk n=17
  • 39. EXCLUSIVITY Question: How likely is it that your organization would have future interest in an “exclusivity” outcomes-based contract? Payers leaned towards a the possibility of a future filled with exclusivity arrangements. 1 4 7 5 0 1 2 3 4 5 6 7 8 Not at all likely Slightly likely Moderately likely Very likely Completely likely n=17
  • 40. IMPLEMENTATION BARRIERS Question: Please rate each of the following implementation barriers. Although the corporate inertia exists to make outcomes-based contracting happen, technical difficulties present as the most challenging barrier to implementation. Resistance to Financial Risk Least Challenging Most Challenging Corporate Structure Technical Difficulty Lack of Corporate Inertia Lack of Perceived Value
  • 41. IMPLEMENTATION BARRIERS Question: What single barrier is most challenging to successful implementation of an outcomes-based contract? The sheer difficulty with the technical aspects of contract implementation ranks as the most challenging barrier to outcomes-based contact implementation. Resistance to financial risk 17% Corporate structure 14% Technical difficulty 45% Lack of corporate inertia 10% Lack of perceived value 10% Other 4% n=29
  • 42. IMPLEMENTATION Question: What is the likelihood you will implement an outcomes-based contract over the following time periods? Payers more strongly than manufacturers that they would implement outcomes- based contracts in the near future. Six Months One Year Two Years Three Years Very Unlikely Very Likely
  • 43. KEY LEARNINGS Our research with payers and manufacturers on outcomes-based contracting yielded seven key learnings. Payers are largely responsible for the push towards outcomes-based contracting Oncology, metabolic, cardiovascular, and CNS are four key disease areas of interest to payers Clinical performance agreements are believed to have the highest likelihood of implementation success Technical difficulties are largely responsible for implementation delays and failures Manufacturers expected to take on some level of financial risk in an outcomes- based contract Payers are open to the idea of formulary preference as part of an outcomes- based contract arrangement Outcomes-based contracting should become more common in the next few years 1 2 3 4 5 6 7
  • 44. CASE STUDIES Constructs of Implemented Outcomes-based Contracts
  • 45. CASE STUDY #1 sitagliptin/metforminMERCK CIGNA Disease Area: Diabetes Implemented: 2009 AGREEMENT COMPONENTS GOALS/OUTCOMES • CIGNA assesses the blood sugar levels (A1c lab values) for patients on any oral antidiabetic medications • If the A1c values, in aggregate, improve by the end of the agreement period, the discounts will decrease by a pre-agreed amount • CIGNA uses claims data to determine if patients are taking the Merck drugs as prescribed • Better placement on CIGNA’s formulary • Lower copayment versus that for other branded drugs • In 2010, CIGNA announced positive outcomes from the diabetes support program: • Patients’ blood sugar levels were reduced by more than 5%, • Individuals who participated were more likely to control their blood sugar than those who did not participate in the program • 87% of patients who took the Merck drugs took their medications correctly SOURCE: http://www.ispor.org/meetings/montreal0614/presentations/IP9-AllSpeakers.pdf Type: Clinical Performance The MERCK-Cigna deal is one of the few to have publicly released results of the program.
  • 46. CASE STUDY #2 Interferon beta-1aEMD SERONO CIGNA Disease Area: MS Implemented: 2011 AGREEMENT COMPONENTS GOALS/OUTCOMES • CIGNA tracks the percentage of hospitalizations and ER visits avoided by people using EMD Serono drug • CIGNA uses medical claims in order to determine whether a relapse was the cause for hospitalization and/or ER visits • CIGNA uses 2010 as a baseline, looking at data from medical, pharmacy and lab claims, and measuring members’ medication-possession ratio (MPR) • EMD Serono provides rebates based on adherence outcomes and relapse-free patients • Because MS eventually leads to a state of disability, CIGNA helps to delay disease progression and quick accumulation of irreversible neurological damage by improving adherence • Using experiences in MS, CIGNA extended its monitoring strategies to other conditions through the THERACARE program SOURCE: https://aishealth.com/archive/nspn0411-01 Type: Clinical Performance The EMD Serono-Cigna deal is the only publicly acknowledged US OBC in MS.
  • 47. CASE STUDY #3 evolocumabAMGEN HARVARD PILGRIM Disease Area: CV Implemented: 2015 AGREEMENT COMPONENTS GOALS/OUTCOMES • Amgen gained formulary preference as part of the deal • Harvard Pilgrim can also receive additional rebates if utilization is above a pre-determined amount • Amgen will be at risk financially if health plan members’ cholesterol levels aren’t lowered enough • The pay-for-performance element is in addition to the discount • Compare patient low-density lipoprotein cholesterol levels to clinical trial outcomes SOURCE: http://www.modernhealthcare.com/article/20151109/NEWS/151109899 Type: Clinical Performance Amgen implemented a highly innovative risk-based contract model focused on a population-health outcome.
  • 48. APPROPRIATE CARE MODEL Real-world Example of an Outcomes-based Contracting Program
  • 49. Large % of patients on specialty drugs do not respond but stay on therapy APPROPRIATE CARE MODEL An appropriate care model identifies non-responders based on therapeutic response. The single greatest opportunity to reduce aggregate claim dollars in specialty is to identify patients that do not respond and take them off the drug. SOURCES: 1eMAX Health claims analysis 2Adalimumab Full Prescribing Information 3Hughes et al., Lancet Neurol 2008; 7: 136–44 Inappropriate Use PROBLEM OBJECTIVES • Reduce treatment days with no response • Integrate outcomes and authorizations • Establish funding partnership for patient monitoring 46% of CIDP patients did not respond to IVIG after 24 weeks, yet 75% of patients are on treatment for more than 48 weeks1,3 Adalimumab showed only a 53% response rate after 6 months2 Reimbursement decisions based on actual response Point of care drug assessment mobile app Utilization preference in exchange for price adjustment to offset monitoring cost Standardized Assessment Discounts/Rebates Response-linked Authorizations SOLUTION
  • 50. PROGRAM FLOW The appropriate care model supplements current drug authorization process. At PA/re-auth, point, plan requires enrollment in program Partner SPP conducts assessment on behalf of plan in case management system Software flags non- responders Program administrator coordinates with SPP and provider to identify alternate care plans for non-responders Plan authorization department makes ultimate coverage decision using outcomes data Program administrator manages the rebate between the manufacturer sponsor and healthplan Program administrator reports on program savings to healthplan and manufacturer sponsor
  • 51. CASE STUDY: APPROPRIATE CARE IGIVDE-IDENTIFIED DE-IDENTIFIED Disease Area: Neurology Implemented: N/A AGREEMENT COMPONENTS GOALS/OUTCOMES • Real-time patient outcomes data monitored via point of care assessment tool • Appropriate site-of-care and treatment response were monitored • Non-responders were transitioned to alternate site- of-care and/or alternate treatment • Manufacturer sponsored monitoring program in exchange for formulary preference • Savings PMPM: $.22 • 26% reduction in drug spend for treated patients Type: Appropriate Care Manufacturer implemented an appropriate care model focused on identifying non-responders in exchange for formulary preference. Site-of- service savings 72% Discontinuation savings 28% 90 95 100 105 110 115 Pre-program plan spend Post-program plan spend $111.9m $99m
  • 52. BENEFITS The primary benefit of an appropriate care model contracting model is to improve overall health outcomes by reducing inappropriate utilization of treatment, resulting in savings to the payer. Improve and simplify health outcomes for chronic disorders Simplify health outcomes monitoring for therapy Reduce duration of treatment for non-responding patients Provide medically-defensible coverage determination Reduce specialty drug spend for non-responding patients Reduce specialty drug spend by optimizing site of care
  • 53. ROLE OF SPECIALTY PHARMACY How does specialty pharmacy fit in?
  • 54. ROLE OF SPECIALTY PHARMACY Specialty and infusion pharmacies play an important role in the patient care and monitoring aspects of outcomes-based contracting programs. • In the high-cost specialty area, health plan’s provider networks can play an important role in outcomes-based contracting • Outcomes data must be conveyed quickly and efficiently to be actionable Infusion Providers Infusion pharmacies administer the drug creating an opportunity to assess patient status in real-time Relying on claims data to review drug performance only offers retrospective price adjustment, but not a change in appropriate care and coverage Physically at the point-of-care Routinely interact with patients
  • 55. HEALTH STATUS MONITORING Specialty pharmacy disease programs provide opportunity for health status monitoring. Specialty pharmacy and home infusion providers develop disease programs with routine patient touch points. • Key patient status parameters under disease programs are captured at the point of care and reside in pharmacy software • Creates a unique global picture of therapeutic impact and treatment efficacy • Captures and reports clinical profile, lab data, adverse events, medication history, insurance information, and general metrics
  • 56. CONTRACTING PROGRAMS Specialty pharmacies already reside in payer networks, allowing seamless participation in contracting programs. • Payer-directed patient volume provides incentives for patient monitoring and data reporting • Pharmacies can efficiently monitor patient status through data collection tools provided under a program Data Collection Methods Nurse enter data into pharmacy software which can be relayed electronically to data aggregator for use by payer and prescriber Paper Surveys Efficient tools are deployed in the field for ongoing monitoring if there is minimal training and data integration requirements Specialty pharmacies maintain electronic medical records for its patients - data elements can be incorporated into programs to define outcomes Electronic Application Medical Records
  • 57. HOME INFUSION CASE STUDY IGIVDE-IDENTIFIED DE-IDENTIFIED Disease Area: Neurology Implemented: N/A COMPONENTS • BiologicTx negotiates reimbursement rates with payers to compensate for monitoring and reporting cost • Manufactures offer brand preference agreements in the form of a rebate with health plans to offset the cost of monitoring • Manufactures may also offer discounted drug purchase agreements with pharmacies for participation in the payer program Type: Appropriate Care BiologicTx participates as infusion pharmacy to deliver IGIV to patients with neurological disability. Nurses nationally trained on the use of point-of-care application to assess patient neurological status Pharmacy on-boards cases during prior authorization process and links the upcoming patient encounter to a nurse for monitoring Infusion pharmacy ships product along with a hard copy of disability survey as a back-up to digital application survey Infusion nurse arrives at the home and conducts digital survey on tablet or phone through a secure URL, to assess neurological disability Neurological status data are relayed to the program manager in real-time and provided to the health plan to make coverage decisions
  • 58. PAYER PERSPECTIVE Insights From a Leader in Outcomes-based Contracting
  • 59. INNOVATIVE CONTRACTING Drug Access Real World Evidence Real World Data Patient Response Statistics Therapeutic Response Progression Free Survival Hospital Avoidance Lower Discontinuation Disease Cure Assess Effectiveness Measure Endpoints Share Financial Responsibility for Failures/Successes Total Cost of Care Pharmaceutical Manufacturer Humana
  • 60. RECIPE FOR SUCCESS • Keep it simple • Senior level support/buy-in • Being a captive PBM • Dedicated HEOR analytical support staff • Aligned incentives within the organization • Be willing to share in risk
  • 61. INNOVATIVE CONTRACTING TYPES Toxicity Therapeutic Response New Approaches Relapse Discontinuation Indication Based Hospital Admission Total Cost of Care Adverse Events Wastage Duration Progression Quality Of Life
  • 62. CHALLENGES • ASP pricing • Medicaid Best Price • Safe Harbor/Anti-kickback statute • Willingness of pharma to participate • Finding and funding the money from pharma
  • 63. CHALLENGES • Data limitations and privacy concerns • Fire wall within pharma • Limited payer participation • Lack of access to medical claims in PDP
  • 64. LESSONS LEARNED • HPS has contracts in place for CFI, MAPD and both lines of business • Understanding the data, what we have, who owns it, where to find it • Need to have access to experts in data management and HEOR • Usually an addendum to an existing rebate contract • The outcome or cost associated is paid as a rebate
  • 65. LESSONS LEARNED • Revenue is DIR reportable • Persistency and adherence are part of the contract • Most contracts are for one year • Data submitted quarterly, bi-annual or annually • Build 120 days into submissions due to medical claim lag • Average time to execute is 6-9 months • ROI is knowledge gained, not revenue produced
  • 67. Learning Assessment Question #1 Out of the following disease categories, which would benefit the most from outcomes-based contracting? a. Rheumatoid arthritis b. Next-gen hepatitis C c. Diabetes d. Multiple sclerosis e. Cholesterol management f. Oncology TEXT TO 22333 a. 320492 b. 320514 c. 320521 d. 320522 e. 320531 f. 320544
  • 68.
  • 69. Learning Assessment Question #2 Of the following, what is the greatest challenge to implementing an outcomes- based contract? a. Parties averse to financial risk b. Corporate structures get in the way c. Difficulty in gathering and analyzing clinical data d. Parties don’t see true value in the arrangement TEXT TO 22333 a. 320545 b. 320597 c. 320602 d. 320603
  • 70.
  • 71. Learning Assessment Question #3 Outcomes-based contracting in the US started in what year? a. 2001 b. 2005 c. 2009 d. 2015 TEXT TO 22333 a. 320605 b. 320619 c. 320630 d. 320631
  • 72.
  • 73. Learning Assessment Question #4 Who has been more active in promoting movement towards an outcomes-based contracting environment? a. Payers b. Manufacturers TEXT TO 22333 a. 320632 b. 320633
  • 74.
  • 76. DISCLAIMER All Faculty in this education session have obtained the appropriate permission to use Copy Righted materials. Sources for all images are provided in citations.

Editor's Notes

  1. Should we add specialty pharmacy provider?
  2. Poll Title: Demographic Question: What title best describes your current position? https://www.polleverywhere.com/multiple_choice_polls/1tpELxOVHRoAFEi
  3. Poll Title: Learning Assessment Question #1: Out of the following disease categories, which would benefit the most from outcomes-based contracting? https://www.polleverywhere.com/multiple_choice_polls/CCTEhfgJAIhiHV7
  4. Poll Title: Learning Assessment Question #2: Of the following, what is the greatest challenge to implementing an outcomes-based contract? https://www.polleverywhere.com/multiple_choice_polls/F7bEbt4z9YjAiv5
  5. Switch choice c and d order
  6. Poll Title: Learning Assessment Question #3: Outcomes-based contracting in the US started in what year? https://www.polleverywhere.com/multiple_choice_polls/D0NH8jCWbAkA9yh
  7. Poll Title: Learning Assessment Question #4: Who has been more active in promoting movement towards an outcomes-based contracting environment? https://www.polleverywhere.com/multiple_choice_polls/upoLTkLnusTRq7o
  8. Labels in pie seem unnecessarily long
  9. Poll Title: Learning Assessment Question #1: Out of the following disease categories which would benefit the most from outcomes-based contracting? https://www.polleverywhere.com/multiple_choice_polls/YXWg7pmHtQKacaR
  10. Poll Title: Learning Assessment Question #2.b: Of the following, what is the greatest challenge to implementing an outcomes-based contract? https://www.polleverywhere.com/multiple_choice_polls/Tlx50m0BXDjCaCp
  11. Switch choice c and d order
  12. Poll Title: Learning Assessment Question #3.b: Outcomes-based contracting in the US started in what year? https://www.polleverywhere.com/multiple_choice_polls/lRSBkW8KxG7623s
  13. Poll Title: Learning Assessment Question #4.b: Who has been more active in promoting movement towards an outcomes-based contracting environment? https://www.polleverywhere.com/multiple_choice_polls/NDui6b2mdPLI1uh