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 BarnesSenior Vice PresidentAvalere Health, LLC
2 Under Medicare, the Benefit Category Determines Coverage, Coding and Payment Pump Coverage, Coding, and PaymentHyQ DrugCoverage, Coding, and PaymentHyQ Administration Coverage, Coding, and PaymentDME“Incident to”E CodeDME fee scheduleN/AJ Code95% AWPN/A (patient self-administers)Home Health + DMEHome Health PPS3Physician OfficeSupply (no payment)ASP+6%1CPT CodeMPFSHOPD*C/J CodeASP+X%2CPT Code/APCOPPS1Reimbursement 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 60-61PPS = Prospective Payment SystemHOPD = Hospital Outpatient DepartmentCPT = Current Procedural TerminologyASP = Average Sales PriceAWP = Average Wholesale PriceMPFS = Medicare Physician Fee ScheduleOPPS = Outpatient Prospective Payment SystemAPC = Ambulatory Payment Classification
3 Private Payer Coverage, Coding and Payment for IG Varies By Setting of Care Immune GlobulinCoverage and CodingIG AdministrationDMEDrug: J-codeExternal Infusion Pump: E/S CodeHome health or home infusion benefit1Coding & payment varyHome Health +DMECoding and payment varyPhysician OfficeCPT CodeFee ScheduleHOPDPrivate 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 administrationCPT = Current Procedural Terminology1Patient 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 indicationsSource: 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 2011Source: EMD Sereno Specialty Digest, 2011
6 Private Payers Are Likely to Increase Their Focus on Management of IG Pressures to Control CostsDue to the changing landscape, health plans are likely to increase their focus on management of specialty medical benefit drugs through increased UMIncrease in Specialty ProductsThe 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 plansPotential for Increased Focus on Management of IG through Specialty Pharmacy40 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 PerspectivePrivate Payers may demand increased evidence to differentiate IG productsTo date, limited evidence has differentiated IG productsAbsent evidence, payers may view products as interchangeable and demand price concessions for preferred positioningIncreases pressure on medical versus pharmacy benefit IG productsPrivate Payers may have higher thresholds for coverage of expanded indications for IGPrivate Payer ToolsClinical policies (cover or non- cover decisions)Utilization managementi.e., Step editsGuidelines and care pathwaysFormulary evaluationsPay-for-performance initiativesValue-based insurance designsPayers are likely to demand increased evidence to differentiate IG Products and when considering expanded indications
12 Site of Care: Shift of Reimbursement Site of Care Options: PayersHospital OutpatientExpensiveHospital InpatientMD Office – Buy & BillDecrease Total Cost of CareMD Office Specialty – Medical BenefitMD Office Specialty – Pharmacy BenefitCost-effective for MemberPharmacy BenefitHome Infusion
13 Product Demand & Clinical Needs IVIG & Subcutaneous Immune Globulin - United StatesUnited States IVIG Forecast, 2009 – 2015Percentage of Usage VolumePatients Growth Per YearPrimary Immunodeficiencies36.0%2.1%Neurology25.1%9.9%Hematology / Oncology25.7%3.8%Cardiology1.5%5.6%Rheumatology / Nephrology5.4%11.5%All Others*6.3%13.4%TOTAL100.0%8.2%IVIG products differ in regard to AE riskRisk 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 ageOsmolatity – 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 patientsFormulation - fixed concentrations are ready to use - lyophilized can take up to 20 minutes to reconstitute and may not be reimbursed by MedicareConcentration 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 & convenienceInfusion Rate - Patients may tolerate products differentlyPathogen Safety- where products were sourced needs to taken into considerationIndications-Dose, Package Size and Storage - different indications require different doses – variety of doses is important to best meet prescribed dose to cut wastage1313
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 connectivityPhysical assessments & questionnairesPatient management tool for physiciansNursing drivenIt is a web-based product with wireless connectivityEducation, Outcomes tracking, disease management, comparison of dosing strategies.
15 Home Infusion Therapy Monitoring ValidatedOutcomesMeasuresPhysician Data ReviewIVIg Patient Data CollectionPhysical Assessments Disability / Activities of Daily Living (ADL) Quality of Life (QOL)Outcomes vs. Dose Over TimeCareatorsCare SupportCIDP/GBS/Peripheral NeuropathyMyasthenia GravisPrimary ImmunodeficiencyPharmacist Data ReviewAdministrators CoordinatorsResearchersDose, Side Effect, Clinical Monitoring
16 Case Study 1 New Neurology Patient – Response to Therapy Case Study Example: Immune Therapy MonitoringCase Study 1 New Neurology Patient – Response to TherapyPeripheral 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.
19 GLOBAL DEMAND FOR IVIG/SCIG WITH/WITHOUT ALZHEIMER’S DISEASE - 2008 - 2018 (Metric Tons)
20 US source plasma collection forecast, 1996 -2013
21 IVIG & Alzheimer’sCurrently, 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.
23 References International Blood & Plasma News The Marketing Research Bureau, Inc.PPTA (Plasma Protein Therapeutics Association)NDDR=National Donor Deferral RegistryFFF - Plasma New Products and DevelopmentDermatology, Infectious diseases, Ophthalmology, Obstetrics/Gynecology, othersIVIG 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 2009Axelacare Health Solutions Internal Data Analytics & OutcomesAnnual Reports of major pharmaceutical companies: Baxter, CSL, Grifols, Octapharma, TelecrisU.S. Census Bureau’s released data
31 Specialty Medical Benefit Management: Immunoglobulin Ann Nguyen, PharmDStaff Vice President
32 Immunoglobulins Challenges IVIG ProductsClinical mechanism of IVIG/SQIG action remains undeterminedLack of disease specificity, numerous FDA indications and many off label usesOutcomesClinical effectiveness and follow-up are often not documentedExtended treatment length without clinical outcomes observedMarketMarket consolidation, fewer manufacturers controlling distribution channel and allocationConsumer demand and consumption continuing to grow
33 Immunoglobulins Mgmt Strategies Benefit alignment: Rx & MedIn-Network incentivesMemberPhysicianAncillary HIT & SPPUtilization MgmtCare MgmtCase Mgmt & CoordinationRobust meaningful analyticsIn office infusion incentivesLimit IVIG distribution channel to a select fewAppropriate use w/clinical outcomes & length of therapy criteriaPreferred product selectionsPre-cert required (med)Preferred HITs / SPPs w/demonstrable outcomesContract pricing
34 Bruce Phelan Compass BioPharma, LLC Specialty Medical Benefit Management: Immunoglobulin Alignment of the Patient, Provider, Plan and SOC ContinuumBruce PhelanCompass BioPharma, LLCCompass BioPharma, LLC- All Rights Reserved
35 Chronic Care Management 40% + of the US population has one or more chronic condition150% of working age Americans have at least one chronic condition2The prevalence of chronic disease is increasing in the elderly and non-elderly populations3,4A significant number of people have multiple chronic diseasesChronic conditions account for 75% of health spending in the US5By 2017, insurers will be spending an average of 32% more for their individual members' medical claims6Increases in disease state patient populations are driving increased Immunoglobulin utilization to address disease state needs – not the cost of Ig products Chronic diseases are “conditions that last a year or more and require ongoing medical attentionand/or limit activities of daily living.”W. Hwang, et al., “Out of Pocket Medical Spending for Care forChronic Conditions.” Health Affairs. 20:2689 (2001). C. Hoffman and K. Schwartz. “Eroding Access Among Nonelderly U.S. Adults with Chronic Conditions: Ten Years of Change.”Health Affairs. 27:w340 w348 (2008). K. A. Paez, L. Zhao, W. Hwang. Rising Out Of Pocket Spending for Chronic Conditions: A TenYear Trend. Health Affaris. 28:1525 (2009). K. E. Thorpe, Lydia L. Ogden, K. Galactionova. Chronic Conditions Account for Rise in MedicareAdapted from Health ReformGPS, L. Cartwright-Smith, 2011 H.Tecco, Rock Health, HIT Consultant, February2013Cost of the Future Newly Insured under the Affordable Care Act (ACA), Society of Actuaries, March 2013Compass BioPharma, LLC- All Rights Reserved
36 Immunoglobulin Dynamics Primary Immunodeficiency (PI) – 300K patient population10% ~ 28,000-30,000 patients receive Ig therapyNeurologists have demonstrated a growing acceptance of IVIg for patients with Neurological conditionsSafety, 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 supplyDisease state awareness and educationDistribution and service models to provide access to careAlthough SCIg has experienced significant growth, Allergy/Imn continue to utilize IVIg for PI patientsNeurological Patients: ~70% of Dx and Trx in Ambulatory Care setting, 30% Institutional (In-patient and OPIC)High awareness of potential Alzheimer’s Disease treatmentCompass BioPharma, LLC- All Rights Reserved
37 Ig Ambulatory Variables Opportunity To AdaptMCOAWP to ASPMethodologyAppropriate PatientCost ContainmentHC Reform?ReimbursementCompressionM&ASpecialty Infusion/PharmacyConsolidationCompetitionCost of Goods(acquisition / procurement)Labor Costs(Fixed/VariableClinical/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 migrationIVIgSCIgSCIgMed BenefitMed BenefitSOC significantly influences Ig “Total Cost of Care” under the medical benefitPharmacy Benefit2HomecareHomecare45HomecareHospital1PharmacyPharmacyPharmacyIVIgPIPatientMedicalBenefit(1-2X)60-65% of all IVIg grams stilladministered in a hospital setting3IVIgIVIgIVIgMed BenefitMed BenefitMed BenefitAISPhys OfficeAmb ClinicAISPhys OfficeAmb ClinicAISPhys OfficeAmb ClinicCompass 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 acceptanceLeads to inefficient/experimental Ig dosing patternsOpportunity for Clinical / Medical treatment algorithms (IVIg /SCIg)Medical Benefit data barriers exist to track, monitor, and manageIT / data management enhancement- integrated EMR/EHR transferenceMedical Benefit Data Stratification (Hospital, OPIC, HIT, AIS, Phys Office)New models of care represent an effort to solve deeplyembedded Healthcare delivery problems experiencedby organizations of all sizes and SOC’sGE Health, 2011, 01-Elhauge-Chap-01.indd, Oxford Press, 2010Compass BioPharma, LLC- All Rights Reserved