PRESENTED BY: Patrick Lupinetti, JD, Julie Suko, PharmD, Travis Johnson, Karl Matuszewski, PharmD IN SEARCH OF LOST COSTS:The Implications for Cost-Effectiveness Research When the Price Isn’t Right OBJECTIVES DEFINITIONS DRUG COST-EFFECTIVENESS ANALYSES HAVE TRADITIONALLY BEEN BASED ON TWO KEY COMPONENTS: efficacy, measured by clinical endpoints reported in product labeling or biomedical TRADITIONAL MEASURES OF COST HAVE RELIED ON PUBLISHED BENCHMARKS such as literature; and cost, obtained from available pricing sources. While the former is a relatively well-defined value derived from pivotal trials and subsequent studies, the latter has often not been well-defined or rigorously assessed and has frequently been based upon manufacturer-reported pricing information shown to be inaccurate and unreliable. This study examines existing benchmarks against newly available sources of pharmaceutical pricing, describes their interrelationships and assesses their relative reliability. Average Wholesale Price and Wholesale Acquisition Cost or on reimbursements based on them. However, as revealed in numerous government pricing investigations, these manufacturer-reported values are not accurate indicators of true market prices. Consequently, efforts have been undertaken to develop alternative pricing standards based on acquisition cost data obtained through pharmacy surveys. Wholesale Acquisition Cost (“WAC”) • Manufacturer-reported list price to wholesalers not including discounts Average Wholesale Price (“AWP”) • Generally reported as WAC + 20% METHODS Average Acquisition Cost (“state AAC” or “CMS NADAC”) USING PUBLICLY AVAILABLE COST DATA FOR A VARIETY OF PUBLISHED PRICE TYPES, pricing values were determined for a broad range of pharmaceuticals by trade classes (brand vs. generic), compared and analyzed for trend and consistency patterns. •B ased on pharmacy reports, generally voluntary, not volume-weighted, and exclusive of discount or rebates •D etermined by six state Medicaid programs and by the Centers for Medicare and Medicaid Services (National Average Drug Acquisition Cost or “NADAC”) New York Average Acquisition Cost (NYAAC) TRUE MARKET COSTS • Distinguished by a calculation methodology involving mandatory participation, volume-weighting and inclusion of discounts and rebates WACs Show No Consistent Pattern A comparison of manufacturer-reported WACs to pharmacy-reported acquisition cost pricing (in the following examples the CMS NADAC) exhibits a highly inconsistent correspondence. The differences are most notable for generic products, both among therapeutic equivalents and between different generic drugs, but brand products’ WACs also vary unevenly from their AACs. National Average Retail Prices (NARP) • Derived from electronic pharmacy claim and payment data, reported by payer class and as overall average (publication of NARP was suspended in June 2013) *O ther available prices exist, including Average Manufacturer Price and Average Sales Price, but issues of comprehensiveness and regularity render their application too limited for general use. No Identifiable Ratio Between WACs and Acquisition Costs — BETWEEN DIFFERENT GENERIC DRUGS OR WITHIN A GENERIC DRUG CLASS Comparison of Various WACs to NADAC Prices Comparison of Different Generic Amoxicillin WACs to NADAC Prices as of 2/28/2014 as of 2/28/2014 $0.20 Vit D2 1.25 mg (50,000 Unit) $0.18 Tramadol HCI 50 mg Tablet $0.16 Sulfamethoxazole-TMP DS Tablet $0.14 Mupirocin 2% Ointment $0.12 Ibuprofen 800 mg Tablet $0.10 Hydrocodone-Acetaminophen 5 mg-500 mg Tablet $0.08 Gabapentin 300 mg Capsule $0.06 Folic Acid 1 mg Tablet $0.04 Fluticasone Prop 50 mcg Spray WAC NADAC $0.02 Fluconazole 150 mg Tablet 0% 50% 100% 150% 200%250% 300%350% 400%450%500% $0.00 Each point represents one generic manufacturer of amoxicillin WAC/NADAC Brands are More Stable, but Still Show Variability NADAC Methodology Makes It Better than AWP/WAC, but Still Open to Question While the CMS form of AAC, NADAC, provides a more stable foundation than WAC, its underlying methodology raises questions about its reliability and future viability. The NADAC is based on voluntary responses, does not take purchase volumes into account and excludes any off-invoice discounts or rebates. Contrasted with the New York Medicaid AAC, which is based on a mandatory, volume-weighted and net-of-discount calculation, the NADAC also shows strong variability. Comparison of Various Brand WACs to NADAC Prices as of 2/28/2014 Zetia 10 mg Tablet Zestril 10 mg Tablet Comparison of Various NADACs to NYAAC Prices Xanax 1 mg Tablet as of 10/31/2013 Selzentry 300 mg Tablet Paxil 20 mg Tablet Symbicort 160-4.5 mgc Inhaler Imitrex 20 mg Nasal Spray Pentasa 500 mg Capsule Gleevec 100 mg Tablet Omeprazole Dr 20 mg Capsule Depo-Medrol 80 mg/mL Vial Nilandron 150 mg Tablet Cardizem CD 180 mg Capsule Eliquis 2.5 mg Tablet Bactroban 2% Cream Doxazosin Mesylate 8 mg Tab Avapro 300 mg Tablet Amoxicillin 400 mg/5 mL Susp Aricept 5 mg Tablet 0% 0% 20% 40% 60% 80% 100% 120% 20% 40% 140% 60% 80% 100% 120% NYAAC/NADAC VALID STANDARD FOR COMPARISON Use of AWP/WAC Benchmarks Can Skew Comparisons Drug comparisons incorporating a financial component may lead to misleading conclusions when the chosen price benchmark does not reflect true costs. However, it is also true that some benchmarks inflate or reduce the relative costs of drugs more than others. The choice between a standard that represents Drug X to be several times the price of Drug Y, and one that represents them as much closer in cost, can materially change the assessment of their relative value. Irbesartan 150 mg to Diovan 80 mg Simvastatin 20 mg to Atorvastatin 10 mg Tablet as of 10/31/2013 20 ...or six times? ...or eighteen times? 18 6 16 5 Diovan / Irbesartan Atorvastatin / Simvastatin 7 as of 10/31/2013 Is Atorvastatin two times the price of Simvastatin…? 4 3 2 14 Is Diovan eight times the price of Irbesartan…? 12 10 8 6 4 1 WAC 0 NYAAC 2 WAC 0 NYAAC Payment Amounts Fluctuate Substantially Among Different Payers Through April 2013, CMS published “National Average Retail Prices” (“NARPs”), values derived from electronic pharmacy claim and payment data, both as overall averages and in values broken down by payer class. Such reimbursement figures can be affected by a variety of factors, e.g., preferred formulary rules, and do not include any rebates or discounts provided outside the claims transaction. Atorvastatin 10 mg as of 4/30/2013 $1.20 Simvastatin 20 mg $0.50 $0.45 $1.00 $0.80 NDC 1 $0.40 NDC 2 $0.35 NDC 3 $0.30 $0.60 as of 4/30/2013 MFR 1 MFR 2 MFR 3 $0.25 $0.20 $0.40 $0.15 $0.10 $0.20 $0.05 $0.00 NARPNARP-NARP-NARP- WACNYAAC Medicaid Third Party Cash $0.00 NARP NARP- Medicaid NARP- Third Party NARP- Cash WAC NYAAC CONCLUSIONS Average acquisition cost pricing has presented the first generally available means of testing existing drug pricing benchmarks. Both manufacturer-reported values and data derived from reimbursement prices provide inconsistent measures of actual cost when compared to AAC data. Manufacturer reported AWPs or WACs that vary by highly different percentages from AACs, and payer reimbursement models influenced by formulary standards, plan coverage and payer class, exhibit similar disparities. Given its underlying basis—surveys of pharmacy purchases by government agencies—the AAC model presents stronger indicia of reliability, and by its design, provides a closer relationship to actual market transactions. Consequently, to ensure that a fair comparison of true costs is made in relative value assessments, researchers should look to publicly available AAC-based prices, particularly those that employ a well-designed statistical methodology. REFERENCES: Centers for Medicare and Medicaid Services (CMS, formerly HCFA) supplied National Average Drug Acquisition Cost (NADAC) prices. http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Survey-of-Retail-Prices.html DISCLOSURES: Authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: Patrick Lupinetti: Employee, First Databank, Inc.; Julie Suko: Employee, First Databank, Inc.; Travis Johnson: Employee, First Databank, Inc.; Karl Matuszewski: Employee, First Databank, Inc. © 2014 First Databank, Inc. Part of the Hearst Health network. All trademarks mentioned herein belong to their respective holders.
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