Abstract

Pharmaceutical manufacturers rarely reduce drug list prices, but 3 expensive treatments for hepatitis C experienced significant list price reductions in 2018. Understanding the impetus for these price reductions could inform policies to reduce drug spending. To estimate the differences in manufacturer and health care organization revenue from the Medicare Part D program following list price reductions for hepatitis C treatments, accounting for manufacturer discounts to eligible health care organizations under the 340B drug discount program and manufacturer rebates to pharmacy benefit managers. A cross-sectional analysis of Medicare Part D claims for hepatitis C treatments in 2016 was conducted. Data analysis was performed in February 2019. Using the observed price changes from 2018, manufacturer and 340B health care facility net revenues for each drug were estimated before and after the price change based on 2016 use, adjusting for estimated 340B health care organization discounts and pharmacy benefit manager rebates. The 340B health care organizations include hospitals, clinics, and other organizations that meet federal standards to participate in the 340B program and were actively enrolled in the 340B program from January 1 to December 31, 2016. Manufacturer discounts to 340B health care organizations are based on the price of a drug before rebates to pharmacy benefit managers, and a reduced list price would reduce discounts to 340B health care organizations. Health care organization-level claims data were obtained from the Medicare Part D Provider Utilization File, and health care organizations were matched to Health Resources and Services Administration Office of Pharmacy Affairs Information System to identify 340B-eligible health care organizations. Eligible claims included claims for ledipasvir with sofosbuvir (Harvoni; Gilead Sciences Inc), sofosbuvir with velpatasvir (Epclusa; Gilead Sciences Inc), and elbasvir with grazoprevir (Zepatier; Merck). Health care organizations were considered 340B eligible if their practice address was a registered 340B entity for the entirety of 2016. Discounts to 340B health care organizations and pharmacy benefit managers for each drug before and after the price change were the primary outcomes. Other outcomes included per-treatment and aggregate manufacturer and 340B health care organization net revenues for each drug before and after the price change and the share of claims prescribed by 340B health care organizations for each drug. Per-treatment manufacturer net revenues were estimated for 340B health care organizations, non-340B health care organizations, and a weighted average revenue across health care organization types. The 3 hepatitis C treatments evaluated had 30% to 41% of claims prescribed by 340B-eligible health care organizations, greater than the 14% 340B prescribing rate for all Medicare Part D drugs. Based on use data from 2016, list price reductions for hepatitis C treatments in 2018 were estimated to have increased aggregate manufacturer net revenues for 3 treatments by $181.9 million-a 28% increase. Aggregate 340B health care organization net revenues were estimated to have been $181.9 million lower-a 74% decrease. List price reductions for hepatitis C treatments may have increased drug manufacturer net revenues, owing in part to lower discounts provided under the 340B program and the high share of sales subject to those discounts. Policymakers should consider the role of 340B discounts when evaluating policies to reduce drug spending.

Highlights

  • Three hepatitis C (HCV) direct-acting antiviral curative treatments experienced price reductions of 60% or more in the second half of 2018.1,2 Price decreases for brand-name drugs are rare; even after generic competition, manufacturers of brand-name drugs increase the prices.[3]

  • The 3 hepatitis C treatments evaluated had 30% to 41% of claims prescribed by 340Beligible health care organizations, greater than the 14% 340B prescribing rate for all Medicare Part D drugs

  • List price reductions for hepatitis C treatments may have increased drug manufacturer net revenues, owing in part to lower discounts provided under the 340B program and the high share of sales subject to those discounts

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Summary

Introduction

Three hepatitis C (HCV) direct-acting antiviral curative treatments (ledipasvir with sofosbuvir [Harvoni; Gilead Sciences Inc], sofosbuvir with velpatasvir [Epclusa; Gilead Sciences Inc], and elbasvir with grazoprevir [Zepatier; Merck]) experienced price reductions of 60% or more in the second half of 2018.1,2 Price decreases for brand-name drugs are rare; even after generic competition, manufacturers of brand-name drugs increase the prices.[3]. The 340B program was established in 1992 following changes in the drug market after the establishment of the Medicaid Drug Rebate Program.[6] The Medicaid Drug Rebate Program uses a formula to determine the net price of drugs for the Medicaid program, and that formula requires drug manufacturers to extend the best price offered to any commercial purchaser to the Medicaid program.[7] Following the introduction of the Medicaid Drug Rebate Program, manufacturers were less willing to provide discounts to safety-net institutions and government purchasers because a single discount to one health care organization could reduce the manufacturer’s net revenue for all Medicaid purchases.[8] To fix this unintended consequence, in 1992, Congress passed a series of exclusions from the best price requirement, identifying a variety of health care organizations and government agencies to which manufacturers could extend discounted pricing without triggering best price As part of this carve-out, Congress required manufacturers to extend net Medicaid pricing (340B discount) to these identified 340B health care organizations (separate discounts were established for government purchasers). These discounts are at least 23.1% of a brand-name drug’s average manufacturer price,[9] which approximates the list price for brand-name drugs[10]; these discounts are greater if the manufacturer has increased prices higher than the rate of inflation.[11]

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