西瓜视频

Object moved to here.

Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans | Health Care Economics, Insurance, Payment | JAMA | 西瓜视频

西瓜视频

[Skip to Navigation]
Sign In
Table 1. 聽Medicare Part D Plan Formulary Coverage of Adalimumab Products in 2024, Unweighted and Weighted by Plan Enrollment
Table 2. 聽Patterns of Medicare Part D Plan Formulary Coverage of Adalimumab Products in 2024, Unweighted and Weighted by Plan Enrollment
1.
Cubanski 聽J锘, Neuman 聽T锘. A small number of drugs account for a large share of Medicare Part D spending. KFF. Published July 12, 2023. Accessed February 22, 2024.
2.
Samsung Bioepis. Biosimilar market report: 4th edition, Q1 2024. Accessed April 10, 2024.
3.
Hakim 聽A锘, Ross 聽JS锘. 聽Obstacles to the adoption of biosimilars for chronic diseases.聽锘 听闯础惭础. 2017;317(21):2163-2164. doi:
4.
Centers for Medicare & Medicaid Services. Medicare Part D spending by drug. Accessed March 5, 2024.
5.
Tozzi 聽J锘. The bizarre pricing strategy for Humira鈥檚 new competition. Bloomberg. Published April 26, 2023. Accessed March 3, 2024.
6.
Silverman 聽E锘. Net prices for medicines fell considerably in 2023鈥檚 last quarter, mostly thanks to Humira biosimilars. STAT. Published April 1, 2024. Accessed April 10, 2024.
Research Letter
闯耻苍别听6, 2024

Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans

Author Affiliations
  • 1Division of General Internal Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia
  • 2Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia
  • 3The University of Texas MD Anderson Cancer Center, Houston
JAMA. Published online June 6, 2024. doi:10.1001/jama.2024.8917

Adalimumab (Humira) is a top-selling drug in Medicare Part D, representing $4.7 billion of Medicare spending in 2021.1 This anti-inflammatory biologic lost US patent protection in 2023, and a number of manufacturers introduced biosimilar competitors (eTable in Supplement 1). Biosimilars could help lower spending on biologics for Medicare, just as generics have done for small-molecule drugs. However, early use of adalimumab biosimilars is low: biosimilars captured 2% of market share in 2023.2 Narrow formulary coverage could limit adoption of these drugs.3 This study examined Part D formulary coverage of adalimumab biosimilars relative to Humira.

Methods

We analyzed formulary and enrollment files for all Medicare Part D plans in January 2024 (eMethods in Supplement 1). List price or wholesale acquisition cost (WAC) for a typical monthly supply of each drug was extracted from the Red Book (Merative). We described formulary coverage of high- and low-concentration products and determined whether each plan covered only Humira, only biosimilars, or both. For plans covering both, we calculated the percentage covering biosimilars more favorably through preferential tiering or less prior authorization or step therapy. Descriptive analysis was conducted at the plan and beneficiary levels (ie, weighted for enrollment) with Stata version 18.0 (StataCorp).

Results

Humira鈥檚 high- and low-concentration formulations were covered by 98.9% and 98.7% of 5609 plans, respectively (Table 1). Half of plans (53.4%) covered biosimilars (Table 2). The most frequently covered high-concentration biosimilar was adalimumab-adaz: 26.8% of plans covered the high-priced ($6576) branded version (Hyrimoz) and 13.0% covered the low-priced ($1315) unbranded version, with WACs 5% and 81% below Humira鈥檚 ($6923), respectively (Table 1). The most frequently covered low-concentration biosimilar (adalimumab-adbm, Cyltezo) was available in 50.7% of plans, with WAC ($6576) 5% below Humira鈥檚. Other biosimilars were covered by less than 5% of plans, and some had WACs greater than 80% below Humira鈥檚.

Plans varied in how they covered biosimilars relative to Humira: 46.5% covered only Humira, 1.1% covered only biosimilars, and 52.3% covered both (Table 2). Among plans covering both, 1.5% placed biosimilars on lower tiers, and none covered biosimilars with less prior authorization. No plans used step therapy for any adalimumab product. Beneficiary-weighted analyses showed similar patterns (Tables 1 and 2).

Discussion

Humira had nearly universal Part D formulary coverage despite market entry of numerous biosimilars. In contrast, only half of plans covered any biosimilar, and biosimilars with high concentration鈥攖he concentration of Humira鈥檚 most frequently used formulation4鈥攚ere covered even less often. The biosimilar with broadest coverage was adalimumab-adbm (Cyltezo), which may appeal to payers owing to its 鈥渋nterchangeable鈥 designation, enabling pharmacist substitution for Humira. However, it is interchangeable only with rarely used low-concentration Humira.4 Furthermore, formularies did not promote biosimilar use through preferential tiering or utilization management.

Although some adalimumab biosimilars had low list prices, the most frequently covered biosimilars were priced nearly equal to Humira. In addition, several biosimilar manufacturers offered high鈥 and low鈥搇ist price versions of the same drug鈥攖o appeal to pharmacy benefit managers seeking large rebates and payers willing to cover lower-priced drugs5鈥攁nd this study showed that higher-priced versions received greater formulary coverage. Ultimately, biosimilars鈥 true effect on spending will depend not on their list price but rather on their net price (after rebates) and their influence on originator biologics鈥 net price. By the end of 2023, Humira鈥檚 annual net price decreased to $29鈥800, a 38% drop compared with $48鈥000 1 year prior, likely due to biosimilar competition.6 Despite this price decrease, biosimilars offer far greater potential savings: several adalimumab biosimilars have list prices that are less than half of Humira鈥檚 net price.

Limitations include lack of net price data for each product. Nonetheless, this study of formulary coverage helps explain limited uptake of adalimumab biosimilars. Subpar biosimilar adoption will not only undermine their potential to reduce spending but also may deter investments in biosimilar development. Policymakers should consider mandating Part D formulary coverage of biosimilars with substantially lower prices than originator biologics.

Section Editors: Kristin Walter, MD, and Jody W. Zylke, MD, Deputy Editors; Karen Lasser, MD, MPH, Senior Editor.
Back to top
Article Information

Accepted for Publication: April 26, 2024.

Published Online: June 6, 2024. doi:10.1001/jama.2024.8917

Corresponding Author: Matthew J. Klebanoff, MD, Blockley Hall, 423 Guardian Dr, 13th Floor, Philadelphia, PA 19104 (matthew.klebanoff@pennmedicine.upenn.edu).

Author Contributions: Drs Klebanoff and Doshi 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.

Concept and design: Klebanoff, Li, Doshi.

Acquisition, analysis, or interpretation of data: Klebanoff, Lin, Doshi.

Drafting of the manuscript: Klebanoff, Lin, Doshi.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Klebanoff, Li.

Administrative, technical, or material support: Klebanoff, Doshi.

Supervision: Li, Doshi.

Conflict of Interest Disclosures: Dr Li reported receiving consulting fees from SKB Consulting Inc and Cobbs Creek Healthcare outside the submitted work. Dr Doshi reported receiving grants from Janssen, Merck, and Spark Therapeutics; and consulting fees from AbbVie, Acadia, Janssen, Merck, Otsuka, and Takeda outside the submitted work. No other disclosures were reported.

Funding/Support: Dr Klebanoff was supported by grant T32-HP46118 from the Health Resources and Services Administration. Drs Doshi and Li were supported by grant R21AG068726 from the National Institute on Aging.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2.

References
1.
Cubanski 聽J锘, Neuman 聽T锘. A small number of drugs account for a large share of Medicare Part D spending. KFF. Published July 12, 2023. Accessed February 22, 2024.
2.
Samsung Bioepis. Biosimilar market report: 4th edition, Q1 2024. Accessed April 10, 2024.
3.
Hakim 聽A锘, Ross 聽JS锘. 聽Obstacles to the adoption of biosimilars for chronic diseases.聽锘 听闯础惭础. 2017;317(21):2163-2164. doi:
4.
Centers for Medicare & Medicaid Services. Medicare Part D spending by drug. Accessed March 5, 2024.
5.
Tozzi 聽J锘. The bizarre pricing strategy for Humira鈥檚 new competition. Bloomberg. Published April 26, 2023. Accessed March 3, 2024.
6.
Silverman 聽E锘. Net prices for medicines fell considerably in 2023鈥檚 last quarter, mostly thanks to Humira biosimilars. STAT. Published April 1, 2024. Accessed April 10, 2024.
×