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Product-specific clinical information across all medications in sample for hepatitis C from Summary of all hepatitis C virus medications available in Medicare Part D claims from to Total prescriptions Rx adjusted by lowest regimen duration for one year. Question Which methodologic considerations affect drug price inflation estimates, and what may be a better approach to constructing a drug price index? Findings In this cross-sectional study of drug price indexes, including a case study of hepatitis C virus medications, a product-level index failed to capture high-cost drugs at launch compared with a class-level index approach. Additionally, adjusting for prescription duration and manufacturer rebates substantially affected inflation rate calculations. Meaning The findings of this cross-sectional study indicate that although the Inflation Reduction Act prevents prescription drug prices from outpacing the Consumer Price Index, it fails to address new drug launches for specific diseases, which can substantially increase the average cost of treatment for patients. Importance Measuring drug price inflation is challenging because new drugs continually enter the market, some drugs transition from branded to generic, and current inflation indexes do not account for these market basket changes. Instead, they measure the price increases after new drugs have been launched. Therefore, the public pays the higher costs of newer and usually more expensive drugs, but the inflation indexes do not reflect the increases over existing drugs previously used to treat the same conditions. Objective To assess how price index methods can affect estimates of drug price inflation using a case study of hepatitis C virus HCV medication and to explore other approaches for constructing a price index. Design, Setting, and Participants This cross-sectional study used data from outpatient pharmacies to compile a list of all HCV medications that were ever on the market brand and generic from to Alternative drug price indexes, including product-level vs class-level product and quantity definitions were developed in which gross vs net price definitions were used and an adjustment was created and applied to capture treatment duration because newer drugs often required a shorter duration. Main Outcomes and Measures Price index value and rate of inflation from to for each methodologic approach to constructing a drug pricing index. Conclusions and Relevance The findings of this cross-sectional study indicate that the current product-level methods to estimate drug price inflation underestimated price increases for HCV drugs by failing to include the high launch prices of new market entrants. Using a class-level approach, the index captured higher spending on new products at launch. Prescription-level analyses, which did not consider shorter durations of treatment, overestimated price increases. Drug price inflation has recently received substantial attention from patients, clinicians, researchers, and policy makers who are concerned with affordability of medications. The challenge in measuring the rate of inflation for drugs is that new drugs continually enter the market and drugs transition from branded to generic, yet the current inflation indexes do not account for these market basket changes. Current inflation indexes do not capture a new drug until it has at least 2 periods of data; therefore, the patient experiences the typically higher cost of a newer drug to treat the same condition, while the inflation indexes lag behind, not capturing the increase until they have additional data. Although this mechanism keeps drug prices below the rate of inflation, the public may still experience increases in drug costs that are greater than overall inflation. When new drugs enter the market at prices higher than the drugs they replace, these higher launch prices are not included in the current inflation indexes. The new drug price will not be reflected in the inflation index until after the launch and only then will the indexes measure price increases or decreases. That is, patients will pay a much higher price for a new drug, but the inflation index will not measure the increased cost to the patient; instead, it will measure any postlaunch fluctuations in price. Researchers and the government have developed multifarious ways to measure inflation broadly, in addition to the CPI approach. Calculating the rate of inflation for drugs is more methodologically difficult than calculating the rate of increase for most other medical services or goods and services overall. The US Bureau of Labor Statistics calculates an inflation rate for prescription and nonprescription drugs, 6 using a fixed sample of drugs. Numerous concerns have been expressed regarding the validity of this approach, including the small number of drugs in the sample and the point that the indexes do not reflect what patients pay. Bosworth and colleagues proposed an alternative method using actual dispensing data, an approach that demonstrated more rapid rates of price increases than shown by the Bureau of Labor Statistics approach. There are 3 main challenges to creating an inflation measure for drugs. First and most important is the continuously changing number and types of drugs available. This is a dynamic market where new drugs enter, others are withdrawn, and some formulations transition from being exclusively branded to having generic alternatives. Most health care inflation indexes use a fixed market basket of goods and services that does not change appreciably over time. For example, hospitals use approximately the same percentage of nursing staff, laboratory tests, and capital during a year period. As new drugs enter the market with substantially higher prices than existing drugs, overall drug expenditures increase. However, unless the market basket measures the higher prices of the new drugs, the inflation measure will underestimate the cost to the patient. When new drugs are incorporated into the market basket after launch, price increases are only measured postlaunch and the higher price of the new drug is not reflected by the inflation index. If the manufacturer of the new drug lowers its price postlaunch, the inflation index will go down even when patients and insurers are paying more for a new drug to treat the same condition. Second, drugs have a myriad of prices. Each price measures a different phase in the supply chain. Third, although an index can be constructed to adjust for improvements in convenience or quality of goods or services—as hedonic price indexes do—the most common inflation indexes do not make these adjustments. Because drugs vary in effectiveness, comparing drugs from with drugs in presents challenges. In addition, most measures of drug price inflation tend to incorrectly assume that the duration of treatment and the quality of the product or service has not changed over time. The aim of this study was to understand how these 3 challenges typically affect the rate of drug price inflation and to apply 5 methodologic considerations that are key to constructing a price index. We performed a case study using hepatitis C virus HCV treatment because it had undergone major therapeutic breakthroughs from to , and its new HCV drugs entered the market at prices much higher than those previous drugs. We also aimed to provide recommendations for developing class-based indexes that reflect the actual price increases experienced by patients who are prescribed new drugs. The study was exempted from review because it did not use human participants and data were deidentified; informed consent was waived for the same reasons. This study considered the various options for measuring drug inflation and 5 methodologic considerations important to constructing a price index: 1 product definition and substitution effects, 2 price definition, 3 quantity definition, 4 calculation approach, and 5 adjustment for quality improvements Table 1. We also created multiple drug price indexes, including product- vs class-level product and quantity definitions, gross vs net price definitions, and an adjustment to capture data on the duration of each HCV drug regimen, thereby accounting for the better quality and shorter treatment requirements of newer drugs. A list of all hepatitis C medications that were ever on the market from to , including brand and generic drugs, was compiled. This list was based on HCV clinical guidelines eTable 1 in Supplement 1 , clinical practices procedures, and pharmacy expertise. All data sets were deidentified before analyses. For each relevant claim, drug quantity and payment amount were recorded. The price measure was Medicare prerebate spending for each product identified in the Medicare Part D claims database as the plan paid amount. Different drugs have different treatment duration requirements that are based on clinical guidelines eTable 1 in Supplement 1. For each product, we determined an appropriate annualized utilization quantity to reflect the month duration needed for some drugs vs 2-month duration for others. By determining an annualized prescription number for our quantity definition, newer products requiring only 2 to 3 months of therapy would be appropriately compared with older month therapies. Medicare receives confidential drug rebates. We used the gross-to-net discount rate derived from the SSR Health pricing tool 21 to estimate postrebate net prices. First, the standard product-level approach was used. With this approach, new drugs were not included because the market basket is fixed in the first year annually. The prices and quantities at the beginning of the study period were fixed, and the price changes were measured in A common modification to this approach is called a chained index, in which new drugs are incorporated as they enter the market. However, when a new drug enters the market, there is no change in the index for that period. The reason for this is that both a simple Laspeyres and chained-Laspeyres method use the quantity of a product from the prior period to weight the price in the current quarter. The first potentially very high launch price does not enter the index until the second period. Second, to be able to include the launch prices of new drugs in the index, a class-level approach using a chained-Laspeyres method was used. This approach combines all HCV products into a single class, and it is critical to capture the prices of the new product launches as well as all generic products available for consumers throughout the period. This class-based imputation method recognizes within-class substitution. Third, to address changes in the duration of treatment, we calculated the indexes using both the actual prescriptions observed in the data along with an annualized prescription adjustment based on recommended durations per the clinical guidelines eTable 1 in Supplement 1. Additional information is also available from the eReferences in Supplement 1. However, this is before accounting for the changes in prescription duration. When we applied gross-to-net discount rates for HCV products using SSR Health data for the same period, the inflation rates were lower in both unadjusted and adjusted prescription models because rebate levels increased Table 3. In this case, the price was lower when rebates and duration were considered. This article evaluates 3 concerns regarding existing price indexes for pharmaceuticals: 1 accounting for new drugs entering the market, 2 adjusting for manufacturer rebates and discounts to compare gross price changes with net price changes, and 3 adjusting product quantity definitions to account for treatment duration. With the increased focus on drug price inflation after the passage of the IRA, it is imperative that more sophisticated methods of measuring increases in drug prices be developed. Using gross prices for drugs ie, wholesale acquisition cost or list price may be inappropriate or misleading considering the substantial reductions obtained through rebate and discount negotiations by payers for brand products and by wholesalers and group purchasing organizations for generic products. When gross prices are used, net spending amounts should be assessed simultaneously to better understand inflation in the context of manufacturer rebates and discounts. In the case of HCV treatment, the rate of net spending was considerably lower than gross spending, probably representing net price declines. In our analysis, annualizing the prescription definition better reflected the course of treatment a patient would receive from the different products within the data set. Currently, the IRA requires that prices for individual drug products not outpace the growth of the Consumer Price Index. In this HCV case study, we observed price inflation soon after the launch of novel products in ; however, we subsequently observed deflation across multiple calculation methods from to as these new expensive drugs lowered their prices. Policy makers should consider alternatives to price benchmarking, potentially focusing each analysis on a single class or disease area. Otherwise, the public will experience price increases, but the indexes will show the opposite. Innovation in the pharmaceutical market produces new products and the discontinuation of previous products. Federal regulations move some drugs from more expensive branded status to much less expensive generic formulations. When a new therapy offers a clinical cure over a shorter regimen duration, as was the case with HCV therapy, the change in clinical practice must be considered. The study analysis shows that adjustments to capture prescription duration can substantially affect price index estimates. Different data sources to measure quantity can also affect inflation indexes as can different price measures. The goal should be to create an index that reflects the prices that people pay to treat that condition. The benefits of new drugs were measured as a reduction in treatment duration, which is an inadequate measure of clinical efficacy. The new HCV drugs are associated with an important clinical improvement over previous drugs. Dunn and colleagues 24 and Cutler and colleagues 25 have both proposed utility-based quality adjustments for assessing drug price inflation that could be combined with our class-based, prescription-adjusted approach. However, this is a separate topic requiring a separate analysis. Another limitation was the sample selection using to Medicare data for these products, which failed to capture spending before multiple direct-acting antiviral launches, including boceprevir, telaprevir, and sofosbuvir. By including pre data, we may have observed more substantial overall price changes that accounted for these product launches. The focus on a single therapeutic area, such as HCV, limits the generalizability to other conditions because HCV treatment is relatively straightforward, and these products are not typically used for multiple conditions. When applying this approach to products approved for different diseases eg, pembrolizumab indicated for multiple cancers, semaglutide indicated for diabetes and for long-term weight management , researchers may need to use data containing patient-level diagnosis codes to map spending appropriately. The classification level ie, therapeutic use, pharmacologic activity, anatomic system used for the price index will affect the selection of products and generalizability of findings. This study did not assess patient out-of-pocket costs. To assess drug price inflation for patients, out-of-pocket expenses may be useful for understanding how patients are affected at the pharmacy counter. This cross-sectional study found that existing product-level methods to estimate drug price inflation are likely underestimating price increases within a given disease area by failing to account for high launch prices of new market entrants. Using a class-level approach, the index can better capture any higher spending on new products at launch. Other therapeutic areas should be reviewed and assessed for necessary adjustments needed for accurate price comparisons. The ultimate goal is to have an inflation index that includes all drugs and incorporates improvements in outcomes. Published: June 9, Corresponding Author: T. Author Contributions: Drs Mattingly and Levy had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Critical revision of the manuscript for important intellectual content: All authors. No other disclosures were reported. Data Sharing Statement: See Supplement 2. Download PDF Comment. Figure 1. View Large Download. Figure 2. Table 1. Table 2. Table 3. Supplement 1. Supplement 2. Data Sharing Statement. Inflation Reduction Act of Public Law No. HR th Congress. Accessed August 21, Published February 9, Accessed March 8, US Bureau of Labor Statistics. Published Accessed September 22, International price comparisons for pharmaceuticals: measurement and policy issues. Oxford Academic; Accessed July 1, An evaluation of the CPI indexes for prescription drugs. Estimating drug costs: how do manufacturer net prices compare with other common US price references? Hedonic price functions. The expanding role of Hedonic methods in the official statistics of the United States. Bureau of Economic Analysis. US Department of Commerce. Accessed May 3, Adjusting health expenditures for inflation: a review of measures for health services research in the United States. Abandoning list prices in Medicaid drug reimbursement did not affect spending. The price to consumers of generic pharmaceuticals: beyond the headlines. International Business Machines. IBM Micromedex. Accessed September 1, Diagnosis, management, and treatment of hepatitis C: an update. Boceprevir and telaprevir in the management of hepatitis C virus-infected patients. Merative Micromedex. Red Book Online. Accessed December 8, SSR Health. US brand Rx net pricing tool. Accessed October 23, Price Increases for Prescription Drugs, Accessed December 29, Preferences for antiviral therapy of chronic hepatitis C: a discrete choice experiment. Are medical care prices still declining? Are medical prices declining? Health Affairs Forefront. Published March 10, Accessed May 5, Changes associated with the entry of a biosimilar in the insulin glargine market. Branded price variation in the United States drug market, to Select Your Interests. Save Preferences. Privacy Policy Terms of Use. This Issue. Views 3, Citations 1. View Metrics. X Facebook More LinkedIn. Original Investigation. June 9, Anderson, PhD 2 ; Joseph F. Levy, PhD 2. Key Points Question Which methodologic considerations affect drug price inflation estimates, and what may be a better approach to constructing a drug price index? Study Data and Population. Measures and Outcomes. Back to top Article Information. Access your subscriptions. Access through your institution. Add or change institution. Rent article Rent this article from DeepDyve. Sign in to access free PDF. Save your search. Customize your interests. Privacy Policy. Make a comment.