Specialty Medical Benefit
Management of IG: Issues for
Consideration
Lauren Barnes
Senior Vice President
Avalere Health, LLC
Under Medicare, the Benefit Category Determines
Coverage, Coding and Payment
Pump
Coverage, Coding, and Payment
DME
“Incident to”
HyQ Drug
Coverage, Coding, and Payment
DME
“Incident to”
HyQ Administration
Coverage, Coding, and
Payment
DME
 E Code
 DME fee schedule
 N/A
 J Code
 95% AWP
 N/A
 N/A (patient selfadministers)
Home Health + DME
 E Code
 DME fee schedule
 N/A
 J Code
 95% AWP
 N/A
 Home Health PPS3
Physician Office
 E Code
 DME fee schedule
 Supply (no
payment)
 J Code
 95% AWP
 J Code
 ASP+6%1
 CPT Code
 MPFS
HOPD*
 E Code
 DME fee schedule
 Supply (no
payment)
 J Code
 95% AWP
 C/J Code
 ASP+X%2
 CPT Code/APC
 OPPS
1Reimbursement
will be at WAC+6% until ASP is available.
2Reimbursement will be at 95% of AWP until WAC is available and then will be WAC+6% until ASP is available. When eligible for passthrough payment, reimbursement will be ASP+6%; after pass-through status expires, reimbursement will be ASP+5% (CY2011).
3Patient must meet eligibility criteria for home health services (patient must be deemed “home bound”).
Medicare coverage and payment varies significantly by setting of care
*See Appendix
slides 60-61
PPS = Prospective Payment System
HOPD = Hospital Outpatient Department
CPT = Current Procedural Terminology
ASP = Average Sales Price
AWP = Average Wholesale Price
MPFS = Medicare Physician Fee Schedule
OPPS = Outpatient Prospective Payment System
APC = Ambulatory Payment Classification
Private Payer Coverage, Coding and Payment for IG
Varies By Setting of Care
Immune Globulin
Coverage and Coding
IG Administration
Coverage and Coding
DME
 Drug: J-code
 External Infusion Pump: E/S Code
 Home health or home infusion benefit1
 Coding & payment vary
Home Health +DME
 Drug: J-code
 External Infusion Pump: E/S Code
 Home health or home infusion benefit1
 Coding and payment vary
Physician Office
 Drug: J-code
 External Infusion Pump: E/S Code
 CPT Code
 Fee Schedule
HOPD
 Drug: J-code
 External Infusion Pump: E/S Code
 Coding and payment vary
 Private payers may use different reimbursement benchmarks for drug payments (e.g.
average sales price (ASP), wholesale acquisition cost [WAC]), and Average Wholesale Price
[AWP])
In all settings of care, other than the hospital inpatient setting, Immune Globulin is
paid for separate from the administration
CPT = Current Procedural Terminology
1Patient must meet private payer eligibility criteria for home health/home infusion benefit; these criteria are
generally much less stringent than Medicare’s criteria.
Private Payers Are Likely to Focus on Management of
Specialty Drug Spending, Including IG
Drug Spending Trend, 2006-2011
25%
20%
15%
10%
5%
0%
2006
2007
Specialty Drug Trend
2008
2009
Overall Drug Trend
2010
2011
Traditional Drug Trend
Specialty drugs, such as IG, are the fastest-growing segment of drug spend. This is
likely to lead to an increased focus on utilization management (UM) techniques for
expanded indications
Source: ESI Drug Trend Report, 2011
Most Private Plans Manage IG Through the Medical Benefit
Using a Specialty Pharmacy
In addition, 80
percent of
payers
managed IG
through
specialty
pharmacy in
2011
Source: EMD Sereno Specialty Digest, 2011
Private Payers Are Likely to Increase Their Focus
on Management of IG
Increase in Specialty Products
The prevalence of specialty products is
increasing in the market and these products
account for a large portion of total drug
spend making them a target for health plans
Pressures to Control Costs
Potential for Increased
Focus on Management
of IG through Specialty
Pharmacy
Due to the changing landscape, health plans
are likely to increase their focus on
management of specialty medical benefit
drugs through increased UM
40 percent of private payers indicated that within the next year they intended to limit
the number of subcutaneous IG agents on formulary based on favorable pricing or
rebates from manufacturers*
Source: *EMD Sereno Specialty Digest, 2011
Private Payers Increase Thresholds for IVIG
Coverage and Payment
Private Payer Perspective
 Private Payers may demand increased
evidence to differentiate IG products
Private Payer Tools
 Clinical policies (cover or noncover decisions)
» To date, limited evidence has
differentiated IG products
» Absent evidence, payers may view
products as interchangeable and
demand price concessions for
preferred positioning
» Increases pressure on medical versus
pharmacy benefit IG products
 Private Payers may have higher
thresholds for coverage of expanded
indications for IG
 Utilization management
» i.e., Step edits
 Guidelines and care pathways
 Formulary evaluations
 Pay-for-performance initiatives
 Value-based insurance designs
Payers are likely to demand increased evidence to differentiate IG Products and when
considering expanded indications
Panel Discussion
Specialty Medical Benefit
Management: Immunoglobulin
Michael Baldzicki, CRCM
Vice President
AxelaCare Health Solutions
A National Home Infusion Provider
Payer & Specialty Medical Benefit
Payer Insight Areas: Specialty Pharmacy
Data
Reimbursement
Site of Care
Benefit Design
•
•
•
Pharmacy claims system
Medical claims system
Specialty fulfillment system
•
•
•
•
Average wholesale price (AWP)
Average sales price (ASP)
Average manufacturer price (AMP)
Wholesale acquisition cost (WAC)
•
•
•
•
Home health
Physician office
Hospital (inpatient and outpatient)
Ancillary
•
•
•
•
•
Copayments
Coinsurance
Out-of-pocket (OOP) max/min
Deductibles
Doughnut hole
Site of Care: Shift of Reimbursement
Hospital Outpatient
Hospital Inpatient
Cost-effective for Member
MD Office – Buy & Bill
MD Office Specialty – Medical Benefit
MD Office Specialty – Pharmacy Benefit
Pharmacy Benefit
Home Infusion
Decrease Total Cost of Care
Expensive
Site of Care Options: Payers
Product Demand & Clinical Needs
IVIG & Subcutaneous Immune Globulin - United States
United States IVIG Forecast, 2009 – 2015
Percentage of Usage
Volume
Patients Growth
Per Year
Primary Immunodeficiencies
36.0%
2.1%
Neurology
25.1%
9.9%
Hematology / Oncology
25.7%
3.8%
Cardiology
1.5%
5.6%
Rheumatology / Nephrology
5.4%
11.5%
All Others*
6.3%
13.4%
100.0%
8.2%
TOTAL
MBaldzicki
A New, Proprietary Home Infusion Tool
• A new, proprietary iPAD home
infusion tool, tool functions
as an outcomes reporting and
medical management
resource for referring
physicians and payers.
14
Home Infusion Therapy Monitoring
Validated
Outcomes
Measures
Physician
Data Review
IVIg Patient
Data Collection
Physical Assessments
Disability / Activities of Daily Living
(ADL)
Quality of Life (QOL)
Outcomes
vs.
Dose Over Time
Careators
Care Support
CIDP/GBS/Peripheral Neuropathy
Myasthenia Gravis
Primary Immunodeficiency
Pharmacist
Data Review
Dose, Side Effect, Clinical
Monitoring
Administrators
Coordinators
Researchers
Case Study Example: Immune Therapy Monitoring
Case Study 1
New Neurology Patient – Response to Therapy
•
•
•
•
Peripheral neuropathy patient, new to IVIG,
receives recommended dosing of 2gm/kg
followed by 1gm/kg every three weeks.
Physical ability as measured by grip strength
increases over 20% after only three doses
(less than two months)
Outcomes tool shows physician that patient
has responded to therapy, confirming
diagnosis, and dramatic patient benefit.
A non-responsive patient would be identified
in this timeframe (2 mo.), and could come off
of drug, saving payer as much as 60% to
IVIG drug cost, as compared to typical 6 mo.
office visit decision. This would be
approximately $50k in savings for a nonresponder, and faster change to a more
effective therapy option.
16
IVIG – Alzheimer’s Indication
Alzheimer's
Indication
Alzheimer’s Prediction
GLOBAL DEMAND FOR IVIG/SCIG WITH/WITHOUT ALZHEIMER’S DISEASE - 2008 2018 (Metric Tons)
US source plasma collection forecast,
1996 -2013
IVIG & Alzheimer’s
• Currently, IVIG is not FDA approved for the
treatment of Alzheimer's disease, but physicians are
free to prescribe it if they believe it is warranted in a
particular case.
• Manufacturers are confident it will be approved in
the next few years.
• Some analysts estimate that as many as 2,000
Alzheimer's patients in the US have received IVIG
treatment.
Questions
References
•
•
•
•
•
•
•
•
•
•
•
International Blood & Plasma News
The Marketing Research Bureau, Inc.
PPTA (Plasma Protein Therapeutics Association)
NDDR=National Donor Deferral Registry
FFF - Plasma New Products and Development
Dermatology, Infectious diseases, Ophthalmology, Obstetrics/Gynecology, others
IVIG 2015: A Forecast of the Polyvalent Intravenous Immune Globulin (IVIG) Market in
the United States in 2015. Orange, CT
*AMR Patient Profile "Intravenous Immune Globulin Hospital Patient Profile Reports" United States Edition 2009
Axelacare Health Solutions Internal Data Analytics & Outcomes
Annual Reports of major pharmaceutical companies: Baxter, CSL, Grifols, Octapharma,
Telecris
U.S. Census Bureau’s released data
Specialty Medical
Benefit Management:
Immunoglobulin
Site of Service Implications on IVIG Cost to Treat
Michael T. Einodshofer, RPh, MBA
Director of Utilization Management, Walgreens Specialty Pharmacy Division
[email protected]
©2013 Walgreen Co. All rights reserved.
Site of Care Optimization – distribution of drugs covered in the medical
benefit generally reside in 3 main sites of service
• Site selection for infusion is largely
dictated by the prescribing
physician
• Each place of service may have
different fee schedules for
medications
Typical drug related medical
benefit costs by site of care*
Home
Infusion /
Infusion
Suite
~5%
~10%
• Each place of service may have
different benefit implications and
limitations
• Remicade, IVIG, Tysabri are the
most prevalent non-chemo drugs in
medical.
All Others
~40%
~45%
Physician
Office
Outpatient
Hospital
* Allowable amounts based on Walgreens
internal analysis, will vary by client
©2013 Walgreen Co. All rights
reserved.
Site of Care Optimization to manage medical pharmacy costs
Specialty Infusion Site of Care Optimization
• Move clinically appropriate patients from high cost of care
delivery settings to lower cost of care alternate treatment sites
(aka “ATS”)
Higher cost
(Outpatient
Hospital)
Lower cost, lower risk,
more convenient ATS
options
Home
Infusion
Physician
Office
Infusion
Suites
©2013 Walgreen Co. All rights
reserved.
Site of Care Optimization
• Each “dot” represents
the cost per 500mg per
immune globulin claim.
• Significant pricing
variability is observed
within hospital outpatient
site of service.
• Site of Care Optimization
lowers the average price
per unit and provides
more price consistency.
Walgreens client date on file. Dates of service 1/1/2011 – 12/31/2011 1.9 million commercial lives.
IVIG defined as J1459, J1557, J1561, J1566,J1567, J1568,J1569, J1572, J1599. Claims meeting
specified exclusion rules are not included herein.
©2013 Walgreen Co. All rights
reserved.
Much lower variance and lower average cost per unit at MD office and
Home Infusion / Infusion Suite
Walgreens client date on file. Dates of service 1/1/2011 –
12/31/2011 1.9 million commercial lives. IVIG defined as J1459,
J1557, J1561, J1566,J1567, J1568,J1569, J1572, J1599. Claims
meeting specified exclusion rules are not included herein.
©2013 Walgreen Co. All rights
reserved.
While home infusion offers the lowest cost per unit, majority
of patients are treated in the most costly place of service
Walgreens client date on file. Dates of service 1/1/2011 –
12/31/2011 1.9 million commercial lives. IVIG defined as
J1459, J1557, J1561, J1566,J1567, J1568,J1569, J1572,
J1599. Claims meeting specified exclusion rules are not
included herein.
©2013 Walgreen Co. All rights
reserved.
Questions?
©2013 Walgreen Co. All rights
reserved.
Specialty Medical Benefit
Management: Immunoglobulin
Ann Nguyen, PharmD
Staff Vice President
Immunoglobulins Challenges
IVIG Products
• Clinical mechanism of IVIG/SQIG action remains undetermined
• Lack of disease specificity, numerous FDA indications and many off label uses
Outcomes
• Clinical effectiveness and follow-up are often not documented
• Extended treatment length without clinical outcomes observed
Market
• Market consolidation, fewer manufacturers controlling distribution
channel and allocation
• Consumer demand and consumption continuing to grow
Immunoglobulins Mgmt Strategies
• Benefit alignment: Rx & Med
• In-Network incentives
Member
• Case Mgmt &
Coordination
• Robust
meaningful
analytics
Care
Mgmt
• Appropriate use
w/clinical outcomes &
length of therapy criteria
• Preferred product
selections
• Pre-cert required (med)
Physician
• In office
infusion
incentives
• Limit IVIG
distribution
channel to a
select few
Utilization
Mgmt
Ancillary
HIT & SPP
• Preferred HITs / SPPs
w/demonstrable outcomes
• Contract pricing
Specialty Medical Benefit Management:
Immunoglobulin
Alignment of the Patient, Provider, Plan
and SOC Continuum
Bruce Phelan
Compass BioPharma, LLC
Compass BioPharma, LLC- All Rights Reserved
Chronic Care Management
• 40% + of the US population has one or more chronic condition1
• 50% of working age Americans have at least one chronic
condition2
• The prevalence of chronic disease is increasing in the elderly and
non-elderly populations3,4
– A significant number of people have multiple chronic diseases
• Chronic conditions account for 75% of health spending in the US5
• By 2017, insurers will be spending an average of 32% more for
their individual members' medical claims6
[1] Chronic diseases are “conditions that last a year or more and require ongoing medical attention
and/or limit activities of daily living.”W. Hwang, et al., “Out of Pocket Medical Spending for Care for
Chronic Conditions.” Health Affairs. 20:2689 (2001).
[2] C. Hoffman and K. Schwartz. “Eroding Access Among Nonelderly U.S. Adults with Ch
ronic Conditions: Ten Years of Change.”Health Affairs. 27:w340 w348 (2008).
[3] K. A. Paez, L. Zhao, W. Hwang. Rising Out Of Pocket Spending for Chronic Conditions: A Ten
Year Trend. Health Affaris. 28:1525 (2009).
[4] K. E. Thorpe, Lydia L. Ogden, K. Galactionova. Chronic Conditions Account for Rise in Medicare
Adapted from Health ReformGPS, L. Cartwright-Smith, 2011
[5] H.Tecco, Rock Health, HIT Consultant, February2013
Cost of the Future Newly Insured under the Affordable Care Act (ACA), Society of Actuaries, March 2013
Compass BioPharma, LLC- All Rights Reserved
Immunoglobulin Dynamics
• Primary Immunodeficiency (PI) – 300K patient population
– 10% ~ 28,000-30,000 patients receive Ig therapy
• Neurologists have demonstrated a growing acceptance of IVIg for
patients with Neurological conditions
– Safety, Efficacy, Supply, and Outcomes (CIDP, MNN, MG, GB, and AD)
• Ig Manufacturers' have leveraged significant investments to
ensure:
– Expanded donation, efficient Ig fractionation, and adequate Ig supply
– Disease state awareness and education
– Distribution and service models to provide access to care
Compass BioPharma, LLC- All Rights Reserved
Ig Ambulatory Variables
Opportunity To Adapt
Reimbursement
Compression
MCO
AWP to ASP
Methodology
Appropriate Patient
Cost Containment
HC Reform?
M&A
Specialty Infusion/Pharmacy
Consolidation
Competition
Cost of Goods
Labor Costs
Infrastructure
(acquisition / procurement)
(Fixed/Variable
Clinical/Op’s/Corporate)
(IT, Logistics, DMP’s)
Compass BioPharma, LLC- All rights reserved
Moving from Volume to Value
Medical and Pharmacy Benefit Designs that encourage benefit and SOC migration
SOC significantly influences
Ig “Total Cost of Care”
under the medical benefit
2
IVIg
Med Benefit
Homecare
4
SCIg
Med Benefit
Homecare
5
SCIg
Pharmacy Benefit
Homecare
Hospital
1
IVIg
PI
Patien
t
Pharmacy
Pharmacy
Medical
Benefit
(1-2X)
60-65% of all IVIg grams still
administered in a hospital setting
3
IVIg
Med Benefit
IVIg
Med Benefit
IVIg
Med Benefit
AIS
Phys Office
Amb Clinic
AIS
Phys Office
Amb Clinic
AIS
Phys Office
Amb Clinic
Compass BioPharma, LLC- All Rights Reserved
Ig Efficiency Considerations
• Although only 7 FDA approved indications, 100+ ICD-9 codes
support Ig through proven clinical data and historical acceptance
– Leads to inefficient/experimental Ig dosing patterns
– Opportunity for Clinical / Medical treatment algorithms (IVIg /SCIg)
• Medical Benefit data barriers exist to track, monitor, and manage
– IT / data management enhancement- integrated EMR/EHR transference
– Medical Benefit Data Stratification (Hospital, OPIC, HIT, AIS, Phys Office)
New models of care represent an effort to solve deeply
embedded Healthcare delivery problems experienced
by organizations of all sizes and SOC’s
GE Health, 2011, 01-Elhauge-Chap-01.indd, Oxford Press, 2010
Compass BioPharma, LLC- All Rights Reserved