Prices for Leading Insulins Will Likely Not Be Negotiated Under New Drug Pricing Package

By Zain Rizvi

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The prices for leading insulins used by hundreds of thousands, if not millions, of Medicare beneficiaries are unlikely to be negotiated in the mechanism outlined in the new reconciliation drug price reform package.[1] Unlike the Build Back Better Act, the new package excludes insulin-specific negotiation requirements and, instead, treats insulin like other drugs.

Under the new bill, negotiations are limited to single-source drugs that do not have generic or biosimilar competition.[2]  Three popular insulins—insulin glargine (Lantus); insulin aspart (Novolog); and insulin lispro (Humalog)—either already have or are expected to have biosimilar competition before the negotiation mechanism is set to apply (Table 1). All three insulins would thus likely fail to qualify as single source drugs eligible for negotiation.

Table 1: Competition for leading insulin brands

Brand Name Insulin Name Competitive Landscape[3]
Lantus Insulin glargine Interchangeable biosimilar (Semglee)[4] and follow-on biologic (Basaglar)
Novolog Insulin aspart Mylan/Biocon biosimilar candidate subject to regulatory authorization[5]
Humalog Insulin lispro Follow-on biologic approved (Admelog); biosimilars in clinical pipeline[6]

While competition is helpful, the limited competition expected (one or two competitors) may not deliver the significant price reductions typically associated with more competitors. Further, in the case of insulin, both prescription drug corporations and pharmacy benefit managers have incentives to keep prices high. A combination of biosimilar competition and price negotiation would be more effective in delivering significant price reductions.

In 2020, Medicare spent billions of dollars before rebates purchasing huge volumes of these leading insulins for many beneficiaries (Table 2). To protect insulin users, Congress can restore the requirement to negotiate insulin product prices in the reconciliation drug price reform package.

Table 2: Spending and use of leading insulin brands (2020)[7]

Brand Name Part D Spending Part D Total Claims Part D Total Beneficiaries
Insulin Glargine (Lantus)
Lantus Solostar $2,663,360,231.80 4,583,923 1,002,500
Lantus $1,055,722,607.00 1,821,215 378,001
Insulin Aspart (Novolog)
Novolog Flexpen $1,844,084,368 2,265,569 585,300
Novolog $595,182,275 851,731 202,965
Novolog Mix 70-30 Flexpen $421,364,939 373,649 78,223
Insulin Aspart Flexpen $30,872,498 126,542 56,064
Insulin Aspart $11,784,405 53,350 24,803
Novolog Mix 70-30 $112,025,124 120,938 24,734
Insulin Aspart Prot-Insuln Asp $5,499,159 14,916 5,805
Insulin Aspart Penfill $136,607 381 241
Insulin Lispro (Humalog)
Humalog Kwikpen U-100 $1,053,915,810 1,276,804 384,871
Humalog $449,251,292 759,810 192,852
Insulin Lispro Kwikpen U-100 $141,621,808 454,776 153,626
Insulin Lispro $55,755,528 194,851 66,303
Humalog Mix 75-25 Kwikpen $277,054,166 258,489 53,831
Humalog Kwikpen U-200 $154,533,157 116,218 30,870
Humalog Mix 75-25 $89,208,218 103,461 19,228
Insulin Lispro Protamine Mix $9,342,252 18,372 6,802
Humalog Mix 50-50 Kwikpen $24,113,084 20,412 4,241
Humalog Junior Kwikpen $6,145,479 10,392 3,832
Humalog Mix 50-50 $10,144,997 11,129 1,932
Insulin Lispro Junior Kwikpen $325,269 1,167 664
Lyumjev Kwikpen U-100 $326,193 390 299
Lyumjev $193,210 196 123
Lyumjev Kwikpen U-200 $49,352 41 26

 

[1] Because insulin users may use multiple products in combination, the number of total Medicare beneficiaries using the three insulin products is not immediately clear.

[2] “A qualifying single source drug” must be a biologic that is not “not the reference product for any biological product that is licensed and marketed under section 351(k).” There are also other eligibility restrictions.

[3] The bill excludes negotiations for products with biosimilars licensed using a 351(k) application. Whether and how CMS will interpret the introduction of follow-on biologics (which represent 351(a) applications) remains unclear.

[4] https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes

[5] https://www.cnbctv18.com/healthcare/us-fda-asking-for-more-data-on-insulin-aspart-see-no-commercial-impact-of-application-rejection-biocon-12069932.htm

[6] https://www.amerisourcebergen.com/-/media/assets/amerisourcebergen/biosimilars-page/sgs-biosimilars-usmarketlandscape-053122.pdf

[7] https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug/data. We categorize products based on brand name, but CMS may interpret products in a different way.