By Zain Rizvi
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. 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. 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|
|Lantus||Insulin glargine||Interchangeable biosimilar (Semglee) and follow-on biologic (Basaglar)|
|Novolog||Insulin aspart||Mylan/Biocon biosimilar candidate subject to regulatory authorization|
|Humalog||Insulin lispro||Follow-on biologic approved (Admelog); biosimilars in clinical pipeline|
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)
|Brand Name||Part D Spending||Part D Total Claims||Part D Total Beneficiaries|
|Insulin Glargine (Lantus)|
|Insulin Aspart (Novolog)|
|Novolog Mix 70-30 Flexpen||$421,364,939||373,649||78,223|
|Insulin Aspart Flexpen||$30,872,498||126,542||56,064|
|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|
|Insulin Lispro Kwikpen U-100||$141,621,808||454,776||153,626|
|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 Kwikpen U-200||$49,352||41||26|
 Because insulin users may use multiple products in combination, the number of total Medicare beneficiaries using the three insulin products is not immediately clear.
 “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.
 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.
 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.