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Specialty Medical Benefit Management of IG: Issues for Consideration

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Presentation on theme: "Specialty Medical Benefit Management of IG: Issues for Consideration"— Presentation transcript:

1 Specialty Medical Benefit Management of IG: Issues for Consideration
Lauren Barnes Senior Vice President Avalere Health, LLC

2 Under Medicare, the Benefit Category Determines Coverage, Coding and Payment
Pump Coverage, Coding, and Payment HyQ Drug Coverage, Coding, and Payment HyQ Administration Coverage, Coding, and Payment DME “Incident to” E Code DME fee schedule N/A J Code 95% AWP N/A (patient self-administers) Home Health + DME Home Health PPS3 Physician Office Supply (no payment) ASP+6%1 CPT Code MPFS HOPD* 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 pass- through 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

3 Private Payer Coverage, Coding and Payment for IG Varies By Setting of Care
Immune Globulin Coverage and Coding IG Administration DME Drug: J-code External Infusion Pump: E/S Code Home health or home infusion benefit1 Coding & payment vary Home Health +DME Coding and payment vary Physician Office CPT Code Fee Schedule HOPD 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.

4 Private Payers Are Likely to Focus on Management of Specialty Drug Spending, Including IG
Drug Spending 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

5 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

6 Private Payers Are Likely to Increase Their Focus on Management of IG
Pressures to Control Costs Due to the changing landscape, health plans are likely to increase their focus on management of specialty medical benefit drugs through increased UM 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 Potential for Increased Focus on Management of IG through Specialty Pharmacy 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

7 Private Payers Increase Thresholds for IVIG Coverage and Payment
Private Payer Perspective Private Payers may demand increased evidence to differentiate IG products 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 Private Payer Tools Clinical policies (cover or non- cover decisions) 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

8 Panel Discussion

9 Specialty Medical Benefit Management: Immunoglobulin
Michael Baldzicki, CRCM Vice President AxelaCare Health Solutions A National Home Infusion Provider

10 Payer & Specialty Medical Benefit

11 Payer Insight Areas: Specialty Pharmacy
Pharmacy claims system Medical claims system Specialty fulfillment system Data Average wholesale price (AWP) Average sales price (ASP) Average manufacturer price (AMP) Wholesale acquisition cost (WAC) Reimbursement Home health Physician office Hospital (inpatient and outpatient) Ancillary Site of Care Copayments Coinsurance Out-of-pocket (OOP) max/min Deductibles Doughnut hole Benefit Design

12 Site of Care: Shift of Reimbursement
Site of Care Options: Payers Hospital Outpatient Expensive Hospital Inpatient MD Office – Buy & Bill Decrease Total Cost of Care MD Office Specialty – Medical Benefit MD Office Specialty – Pharmacy Benefit Cost-effective for Member Pharmacy Benefit Home Infusion

13 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% TOTAL 100.0% 8.2% IVIG products differ in regard to AE risk Risk of aggregation in products with PH over 6: Products w/ PH > 6 need to add stabizlers such as Sucrose, sorbitol, dextrose – diabetic or renal dysfunction (90% of IVIG associated renal adverse events occurred when products stabilized with sucrose were used) (of patients who experienced renal Aes 59% had one or more of the following - - prior renal insufficiency, diabetes, advanced age Osmolatity – High osmo may increase the risk of infusion related Aes in patients with cardiac impairment, renal dysfunction or high risk of thromboemolic event - high osmo should not be used in neo or elderly patients Formulation - fixed concentrations are ready to use - lyophilized can take up to 20 minutes to reconstitute and may not be reimbursed by Medicare Concentration Volume Load - impacts total volume and time of infusion – higher concentration will lower fluid and shorter infusion time – 10% requires half the infusion time of a 5% = time, money & convenience Infusion Rate - Patients may tolerate products differently Pathogen Safety- where products were sourced needs to taken into consideration Indications- Dose, Package Size and Storage - different indications require different doses – variety of doses is important to best meet prescribed dose to cut wastage 13 13

14 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. I-Pad based product wireless connectivity Physical assessments & questionnaires Patient management tool for physicians Nursing driven It is a web-based product with wireless connectivityEducation, Outcomes tracking, disease management, comparison of dosing strategies.

15 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 Administrators Coordinators Researchers Dose, Side Effect, Clinical Monitoring

16 Case Study 1 New Neurology Patient – Response to Therapy
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 non-responder, and faster change to a more effective therapy option.

17 IVIG – Alzheimer’s Indication

18 Alzheimer’s Prediction


20 US source plasma collection forecast, 1996 -2013

21 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.

22 Questions

23 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 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

24 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 ©2013 Walgreen Co. All rights reserved.

25 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 Each place of service may have different benefit implications and limitations Remicade, IVIG, Tysabri are the most prevalent non-chemo drugs in medical. Typical drug related medical benefit costs by site of care* Home Infusion / Infusion Suite All Others ~5% ~10% ~40% ~45% Maximize savings by focusing on opportunities at the outpatient hospital site of care where infusion drug costs are often 2x the cost at other places of services. Move patients from high cost/high risk setting to low cost/low risk setting Patient’s drug, dose, frequency and prescribing physician typically remain unchanged. Savings from physician office place of service must be evaluated independently Managing specialty drug utilization at the site of care has become critical to health plans. Each site of care within the medical benefit presents its own challenges, and not all strategies can be applied uniformly across the various sites of service We help payers identify areas of inefficient and wasteful spend—and provide actionable recommendations specific to each medical site of care. The first focus of the program is to drive down the costs associated with non-self administered specialty drugs to the most cost-effective site of care It is not uncommon for some drugs to be reimbursed 100% - 200% higher at the Outpatient Hospital site of care vs. other sites of care Walgreens Specialty Care centers help clients lower the cost to treat patients requiring infusion services without compromising quality—high-touch experience and higher member satisfaction scores Patients continue to receive their medications uninterrupted, providers can continue to prescribe as they have without any new administrative burden Costs typically decrease significantly from the payer though simply shifting site of care Alternative care sites include Walgreens Specialty Care Centers as well as patients’ homes and places of employment. Members’ satisfaction improves based on better access, more convenience and greater affordability. Physician Office Outpatient Hospital Allowable amounts based on Walgreens internal analysis, will vary by client ©2013 Walgreen Co. All rights reserved.

26 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”) Home Infusion Higher cost (Outpatient Hospital) Lower cost, lower risk, more convenient ATS options Physician Office Infusion Suites A somewhat unique lever to manage drug spend No perfect parallel to traditional pharmacy spend management ©2013 Walgreen Co. All rights reserved.

27 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. An emerging cost-saving discipline that leverages cost variance within different healthcare locations that provide essentially the same healthcare services. Typically, $20-$40 PMPY saved through specialty infusion/injection site of care optimization. $10-$20 PMPY on non-chemotherapy products. Walgreens client date on file. Dates of service 1/1/2011 – 12/31/ million commercial lives. IVIG defined as J1459, J1557, J1561, J1566,J1567, J1568,J1569, J1572, J Claims meeting specified exclusion rules are not included herein. ©2013 Walgreen Co. All rights reserved.

28 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/ million commercial lives. IVIG defined as J1459, J1557, J1561, J1566,J1567, J1568,J1569, J1572, J Claims meeting specified exclusion rules are not included herein. ©2013 Walgreen Co. All rights reserved.

29 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/ million commercial lives. IVIG defined as J1459, J1557, J1561, J1566,J1567, J1568,J1569, J1572, J Claims meeting specified exclusion rules are not included herein. ©2013 Walgreen Co. All rights reserved.

30 Questions? ©2013 Walgreen Co. All rights reserved.

31 Specialty Medical Benefit Management: Immunoglobulin
Ann Nguyen, PharmD Staff Vice President

32 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

33 Immunoglobulins Mgmt Strategies
Benefit alignment: Rx & Med In-Network incentives Member Physician Ancillary HIT & SPP Utilization Mgmt Care Mgmt Case Mgmt & Coordination Robust meaningful analytics In office infusion incentives Limit IVIG distribution channel to a select few Appropriate use w/clinical outcomes & length of therapy criteria Preferred product selections Pre-cert required (med) Preferred HITs / SPPs w/demonstrable outcomes Contract pricing

34 Bruce Phelan Compass BioPharma, LLC
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

35 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 Increases in disease state patient populations are driving increased Immunoglobulin utilization to address disease state needs – not the cost of Ig products [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

36 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 Although SCIg has experienced significant growth, Allergy/Imn continue to utilize IVIg for PI patients Neurological Patients: ~70% of Dx and Trx in Ambulatory Care setting, 30% Institutional (In-patient and OPIC) High awareness of potential Alzheimer’s Disease treatment Compass BioPharma, LLC- All Rights Reserved

37 Ig Ambulatory Variables
Opportunity To Adapt MCO AWP to ASP Methodology Appropriate Patient Cost Containment HC Reform? Reimbursement Compression M&A Specialty Infusion/Pharmacy Consolidation Competition Cost of Goods (acquisition / procurement) Labor Costs (Fixed/Variable Clinical/Op’s/Corporate) Infrastructure (IT, Logistics, DMP’s) Compass BioPharma, LLC- All rights reserved

38 Moving from Volume to Value
Medical and Pharmacy Benefit Designs that encourage benefit and SOC migration IVIg SCIg SCIg Med Benefit Med Benefit SOC significantly influences Ig “Total Cost of Care” under the medical benefit Pharmacy Benefit 2 Homecare Homecare 4 5 Homecare Hospital 1 Pharmacy Pharmacy Pharmacy IVIg PI Patient Medical Benefit (1-2X) 60-65% of all IVIg grams still administered in a hospital setting 3 IVIg IVIg IVIg Med Benefit Med Benefit Med Benefit AIS Phys Office Amb Clinic AIS Phys Office Amb Clinic AIS Phys Office Amb Clinic Compass BioPharma, LLC- All Rights Reserved

39 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

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