Comparison of U.S. and International Prices for Top ...

Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures

October 25, 2018

Executive Summary

The prices charged by drug manufacturers to wholesalers and distributors (commonly referred to as exmanufacturers prices) in the United States are 1.8 times higher than in other countries for the top drugs by total expenditures separately paid under Medicare Part B. U.S. prices were higher for most of the drugs included in the analysis, and U.S. prices were more likely to be the highest prices paid among the countries in our study.

1. Introduction

Recently there has been increased interest in how U.S. drug prices compare to those of other developed countries. Much of this interest focuses on pricing for pharmacy-dispensed drugs, which account for about 72 percent of total prescription drug spending.1 This paper, instead, focuses on prices for non-retail drugs, which are generally physician-administered.

In the fee-for-service Medicare program, outpatient prescription pharmaceuticals are covered under two separate voluntary benefits. Drugs dispensed by retail and specialty pharmacies to patients for self-administration are typically covered under the Medicare Part D program. Part D is operated by commercial insurance companies that negotiate formulary placement and prices with drug manufacturers and payment rates with pharmacies. This

1 U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE). Observations on Trends in Prescription Drug Spending. March 2016. Available at g.pdf.

approach is one reason why spending growth under Part D has remained below its initial spending projections.

Drugs more typically administered to patients by healthcare practitioners, however, are covered and paid under Medicare Part B, which is part of the fee-for-service traditional Medicare benefit.2 Under Part B, providers and suppliers "buy and bill" these types of drugs. Since 2005 for physicians, and 2006 for hospital outpatient departments, Medicare has paid suppliers and providers based upon the Average Sales Price (ASP) for each product, as reported by manufacturers to the Centers for Medicare & Medicaid Services (CMS).3 Physician offices that buy and bill Part B drugs are paid 106% of the drug's ASP. Depending on a hospital outpatient department's participation in a safety

2 Medicare Part B covers some self-administered drugs that were added to the benefit by Congress prior to the creation of Part D. These self-administered drugs are not the subject of this paper. 3 Section 1847A of the Social Security Act governs payments to physicians for certain Part B drugs. Section 1833(t) governs payments to HOPDs, and allows the use of 1847A payment rates. By 2006, CMS cited this authority, and by 2014, was paying HOPDS based upon it.

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Comparison of U.S. and International Prices for Top Spending Medicare Part B Drugs U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation

net drug pricing program, hospitals are reimbursed either 106 or 77.5 percent of ASP.4

ASP is reported by manufacturers to CMS as the total sales to all purchasers minus the price concessions granted to these purchasers and eventual end users, i.e. physicians and hospitals, with certain exceptions. For example, manufacturers may offer a rebate to physician specialists to prescribe and administer their product over a competitor's. The sale of the product to a wholesaler and the price concession granted to the physician are both accounted for in the ASP. Purchases and price concessions or rebates offered under federal discount programs (such as the Veterans Health Administration, the Medicaid Drug Rebate Program and State Supplemental Rebate Agreements, and the 340B Drug Discount Program) are excluded from the ASP calculation.5

Unlike the situation with traditional, pharmacydispensed drugs, payers are not typically involved in the prescribing, purchasing, or dispensing decision for physician-administered drugs, and there is therefore more limited private-payer negotiation for formulary coverage. Specifically, the Medicare program has not applied the types of formulary management practices that are commonly used to achieve better value for self-administered drugs by commercial insurers, including those sponsoring Medicare Advantage or Part D plans, which were recently granted new authority by CMS to use formulary management practices such as step therapy for Part B drugs.6 However, this flexibility does not extend to the fee-for-service Medicare Part B. Many have

4 HOPDs and off-campus locations that participate in the 340B Drug Discount Program are reimbursed a lower rate to account for significantly reduced acquisition costs. See 82 Fed. Reg. 52356. 5 See SSA 1847A(c)(2) for exclusions. 6 Source: CMS, "Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage," available at: _HPMS_Memo_8_7_2018.pdf.

also suggested that the 6 percent add-on payment currently in place for physician offices and some hospitals may incentivize the use of the highest priced clinically beneficial product.

Differences in coverage for drugs under Part B compared to Part D may have contributed to an acceleration in spending for physicianadministered drugs, relative to spending growth under the approach taken under Part D. Specifically, spending for Part B drugs has doubled since 2006, despite overall low FFS enrollment growth.7 In Part D, although enrollment continues to grow, annual and perbeneficiary expenditure growth rates are lower than in Part B. Put another way, per-beneficiary spending under Part B rose 7 percent and then 11 percent annually over two five-year periods (2006-2011 and 2011-2016) while Part D perbeneficiary spending increased only 3 percent per year in the same five-year intervals. See Figure 1.

Figure 1: Part B and D Per-Beneficiary Net Expenditures Growth Rates, 2006-20168

Administration of coverage and payment of Part B drugs is delegated to regional Medicare

7 While overall Medicare enrollment has grown, a growing proportion of beneficiaries have enrolled in Medicare Advantage plans, whose spending is not reflected in Figure 1. 8 Source: Medicare Trustees Report from 2016 (for 2006) and 2018 (for 2011 and 2016); Part B annual National Summary Files; OPPS Final Rules from 2008, 2013, and 2018. Percent changes reported are annually over the five-year periods shown. Net payments exclude beneficiary cost-sharing.

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Comparison of U.S. and International Prices for Top Spending Medicare Part B Drugs U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation

Administrative Contractors (MACs). Broad rulemaking by CMS and ASP-based payment limits are applicable at the national level, while each MAC can determine for each patient if a Part B drug claim is reasonable and necessary.

While the Medicare program and MACs do not use formulary decision-making to restrict the coverage and payment of Part B drugs, a number of other economically comparable countries do for these types of drugs. Though these countries use their national health systems to negotiate lower prices in exchange for market access, drug manufacturers retain the choice whether to offer price concessions beyond those available to payers in the United States. To better understand the effect of these negotiations on prices paid for physician-administered drugs, ASPE compares in this paper the prices paid for physician-administered drugs in the U.S. to other selected countries.

2. Background

The peer-reviewed literature assessing international drug prices has significant limitations, which we sought to address in our analysis. Namely, few of these analyses use data from after 2007, and there are no specific analyses of the exact set of drugs that we are interested in comparing.

Drug prices are generally higher in the U.S. based on price comparisons in the literature. In their recent systematic literature review, Kesselheim and Avorn (2016) estimate that U.S. prices were more than twice as high as those in other, similar countries. However, they include bilateral comparisons combined into a metaanalysis, which may overstate price differences.

Instead, below and in Figures 2 and 3, we compare seminal original research publications. Comparing sample baskets of branded and generic prescription drugs in the U.S., all compared countries except Japan and Mexico had prices that were at least 20 percent less than

those in the U.S. Prices in Japan were lower than U.S. prices in the 2004 Department of Commerce study but higher in Danzon and Furukawa (2003, 2005, 2006). This is likely due to methodological differences that result in different products being included in the study. For instance, package sizes in Japan differ significantly from elsewhere particularly because doses tend to be lower in Japan.

Figure 2: Reported Brand Drug Price Differentials from Price Index-Based Studies (U.S. = 100)

Narrowing to branded drugs, the literature demonstrates similar results, with prices higher in the U.S. than in all countries except Mexico among the three sources comparing branded drug prices. Two of the selected studies compared differences among biologics; these studies demonstrated mixed results for the drug class (Figure 3). We would note that Kanavos et al. (2013) compared a different price (average retail price per standard unit) than Danzon & Furukuwa (2006), which used ex-manufacturer prices, likely explaining the divergent results. Some of the variability may be related to product availability, per the authors' conclusions.

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Comparison of U.S. and International Prices for Top Spending Medicare Part B Drugs U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation

Figure 3: Reported Price Differentials from Studies Comparing Biologics (U.S. = 100)

There are important challenges in comparing drug prices across countries, including ambiguity in actual U.S. prices, assumptions and limitations related to available data on drugs sales and volume, and mismatches between drugs and dosage forms available in different markets. Despite these challenges, updated estimates of price differentials are needed.

3. Methods

In this paper, we calculate the price per gram of each included product in each selected country. We aggregate sales outside the U.S. and compare an average volume-weighted international price to the U.S. price. Below we describe each source underlying each aspect of this calculation in more detail.

Data Sources

International and Domestic Acquisition Cost Data. ASPE purchases licenses to several data products maintained by IQVIA (formerly known as Quintiles-IMS Institute for Healthcare Informatics or QIIHI). For this study, we used two products that contain acquisition pricing and volume information. First, MIDAS is IQVIA's international sales and volume database, which contains sales information (price and quantity) for more than 50 countries through the second quarter of 2018, from as early as 2013. Sales are stated in local and U.S.

currency, as of the transaction date or current date, as desired.

For our analysis, we use ex-manufacturer prices9 (sometimes called the ex-factory price) stated in U.S. currency on the transaction date. IQVIA also provides sales and volume information on U.S. domestic sales in its National Sales Perspective (NSP) database. We used this database to facilitate the accurate comparison of drug quantities in different package sizes and to account for how overfill is treated across the database. We describe how we make these corrections later in this section.

Medicare Program Data. In order to identify study drugs, we used two files that summarized Medicare program spending on Part B drugs. First, for physician offices, we used the Part B National Summary File for 2016, summing allowable charges and payments across all Health Care Procedural Coding System (HCPCS) J-codes and select Q-codes as appropriate. Second, for hospital outpatient departments, we used the CY 2018 Medicare Hospital Outpatient Prospective System's underlying cost statistics files to identify utilization and spending for separately payable drugs in 2016, and applied the listed payment rates to these. From each file we identified the 20 highest-spending products. Further discussion regarding drug selection is below.

We use Medicare's quarterly HCPCS ASP payment allowances for the third quarter of 2018 to compare prices paid in the U.S. and abroad through the first quarter of 2018. Since ASP is calculated based on the most recently available quarter's manufacturer's sales and is associated with a two quarter lag, third-quarter

9 Ex-manufacturer price is the price received by manufacturers of a product, including discounts applied at the point of sale. In comparison, invoice price is the price paid by the dispenser of a product, including on-invoice discounts. To the extent that a product is sold through wholesalers, this price will differ by the wholesaler's markup.

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Comparison of U.S. and International Prices for Top Spending Medicare Part B Drugs U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation

2018 ASP is the best temporal approximation to the actual purchase prices paid in the first quarter of 2018. We also use these quarterly files to identify exactly which products are included in each selected drug's HCPCS code, which we describe in the section to follow. In all cases, the Medicare ASP payment files we use are publicly available. No manufacturer confidential information was collected for use in these analyses.

Drug Selection

ASPE compiled data on the top 20 drugs based on total Medicare reimbursement to either physician offices, hospital outpatient departments (HOPDs), or overall under Medicare Part B in 2016, which is the most recently available publicly accessible data (as described above). Drugs are defined in this study as each unique HCPCS code assigned by CMS. We included only U.S. single source10 drugs11 (as of July 1, 2018), biologicals, and biosimilars in our initial screening, and we specifically excluded vaccines and blood products, neither of which are paid under the ASP system. We also excluded contrast agents.

We compiled our list based upon the top 20 drugs by total spending from each segment-- physicians and suppliers from the National Summary File and HOPDs using Final Rule data--because there are differences in patient conditions and acuity that may affect treatment patterns when aggregating total 2016 spending. These steps ensured there were at least 20 drugs

10 In this paper, the single source status of a product was determined by the existence of a marketed product approved under an Abbreviated New Drug Application (ANDA). Some of the HCPCS codes included in this analysis contain multiple branded products marketed by different manufacturers. In addition, Velcade (bortezomib) is included in the analysis despite the recent approval of a generically named product that was approved under a New Drug Application (NDA) using the 505(b)2 pathway. 11 Elsewhere and throughout this paper the term "drug" includes biological products and biosimilar products. Here we separate "drug" from "biological" to ensure clarity with statutory definitions.

for the comparison after any exclusions, such as those above. We also totaled spending across the two settings to include additional drugs that may not be in the top 20 in either segment, but were in the top 20 overall. We cross-checked this list against a 2017 publication from the U.S. Department of Health and Human Services Office of Inspector General (OIG) that compared price-inflation rates for top Part B drugs12 to ensure that drugs the department has otherwise flagged with concerns about pricing were also included. No drugs needed to be added based upon the OIG report.

Appendix A lists all 32 products identified using this protocol. Among the 32 drugs identified in each payment system, we dropped Brovana (arformoterol tartrate) and Pulmicort (budesonide), because they are not physicianadministered products. We also excluded Botox (onabotulinim toxin A) and Epogen (epoetin alfa) from the main analysis because within the IQVIA data they are not characterized as being sold using such mass-based measures such as milligrams or grams. However, we have included Epogen and Botox in the table examining prices per standard unit in Appendix C, since they are physician-administered.

To select products for comparison in other markets, we matched the HCPCS codes with National Drug Codes (NDCs) using the July 2018 ASP NDC-HCPCS Crosswalk file.13 Using the identified NDCs, we examined which formulations of each product were included for each HCPCS code using IQVIA's NSP (described earlier) to identify other formulations of the same molecule. Based on this examination, we included formulations available in other countries that are not available

12 See HHS OIG, Calculation of Potential Inflation-Indexed Rebates for Medicare Part B Drugs 2017, available at . 13 Crosswalk file available at: .

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