Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018 | Clinical Pharmacy and Pharmacology | JAMA | JAMA Network
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Figure.  Mean Medicaid Reimbursement Rate and Market Share of Long-Acting Insulin Products, 2005-2018
Mean Medicaid Reimbursement Rate and Market Share of Long-Acting Insulin Products, 2005-2018

The upper panel shows the mean reimbursement per 100 international units for each long-acting insulin product and quarter, before minimum statutory rebates, and expressed in nominal dollars. The lower panel shows the market share of each long-acting insulin product, which was defined as the proportion of international units for long-acting insulins reimbursed by Medicaid in each quarter for each insulin product. Lantus is insulin glargine; Basaglar, “biosimilar” for insulin glargine; Toujeo, highly concentrated insulin glargine; Levemir, insulin detemir; Tresiba, insulin degludec; and Soliqua, combination insulin glargine and lixisenatide.

Table.  Changes in Spending Associated With Use of Basaglar Instead of Lantus in Medicaida
Changes in Spending Associated With Use of Basaglar Instead of Lantus in Medicaida
1.
Luo  J, Avorn  J, Kesselheim  AS.  Trends in Medicaid reimbursements for insulin from 1991 through 2014.  JAMA Intern Med. 2015;175(10):1681-1686. doi:10.1001/jamainternmed.2015.4338PubMedGoogle ScholarCrossref
2.
Hua  X, Carvalho  N, Tew  M, Huang  ES, Herman  WH, Clarke  P.  Expenditures and prices of antihyperglycemic medications in the United States: 2002-2013.  JAMA. 2016;315(13):1400-1402. doi:10.1001/jama.2016.0126PubMedGoogle ScholarCrossref
3.
Greene  JA, Riggs  KR.  Why is there no generic insulin? historical origins of a modern problem.  N Engl J Med. 2015;372(12):1171-1175. doi:10.1056/NEJMms1411398PubMedGoogle ScholarCrossref
4.
US Food and Drug Administration Center for Drug Evaluation and Research. Approval package for Basaglar. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000Approv.pdf. Accessed January 7, 2019.
5.
Centers for Medicare & Medicaid Services. Medicaid drug rebate program. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html. Accessed September 25, 2018.
6.
San-Juan-Rodriguez  A, Prokopovich  MV, Shrank  WH, Good  CB, Hernandez  I.  Assessment of price changes of existing tumor necrosis factor inhibitors after the market entry of competitors.  JAMA Intern Med. 2019. doi:10.1001/jamainternmed.2018.7656PubMedGoogle Scholar
Research Letter
March 25, 2019

Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018

Author Affiliations
  • 1Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania
  • 2Insurance Services Division, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • 3Now with Humana, Louisville, Kentucky
  • 4Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
JAMA. 2019;321(16):1627-1629. doi:10.1001/jama.2019.2990

Insulin prices increased by 320% from 2001 to 2014,1,2 partly because of limited competition and barriers to generic entry.2,3 There were only 2 long-acting insulins available before 2015, insulin glargine (Lantus [Sanofi]), and insulin detemir (Levemir [Novo Nordisk]). In December 2015, a “biosimilar” for insulin glargine (Basaglar [Lilly]) gained US Food and Drug Administration approval. Although approved as a new drug rather than through the biosimilar pathway,4 it is the first substitute for Lantus. Basaglar’s approval coincided with approvals of highly concentrated insulin glargine (Toujeo [Sanofi]; February 2015), ultra long-acting insulin degludec (Tresiba [Novo Nordisk]; September 2015), and a combination of insulin glargine and lixisenatide (Soliqua [Sanofi]; November 2016).

We examined changes in reimbursement and market share of long-acting insulins in Medicaid following the approval of these new products. Additionally, we estimated savings associated with the use of Basaglar instead of Lantus.

Methods

Using Medicaid state drug utilization data, we extracted fee-for-service and managed care reimbursement records for long-acting insulins1 from quarter 1 (Q1) 2005 to Q2 2018, including insulin glargine, 100 international units (IU)/mL (Basaglar and Lantus); insulin detemir; insulin glargine–lixisenatide; insulin glargine, 300 IU/mL; and insulin degludec. For every product and quarter, we calculated the mean amount reimbursed per 100 IU and the market share, defined as the proportion of all long-acting IU reimbursed for the particular product. All outcomes were reported at the product level.

To estimate Medicaid savings associated with Basaglar, we multiplied the number of milliliters (100 IU) reimbursed for Basaglar each quarter by the lower reimbursement rate of Basaglar compared with Lantus (ie, the difference between postrebate reimbursement rates for Lantus and Basaglar). Because Basaglar was approved as a new drug,4 it receives the base rebate of 23.1% of average manufacturer price.5 Our estimates do not account for inflationary or supplemental rebates, which remain proprietary.

Results

In 2005-2007, Lantus was the predominant long-acting insulin (Figure). From 2008-2014, Lantus accounted for approximately 80% of IU reimbursed for long-acting insulins, and insulin detemir accounted for the remaining 20%. Following the approval of new products, the market shares of Lantus and insulin detemir decreased to 42% and 14%, respectively. By Q1 2018, the market share of Basaglar reached 34% of all IU for long-acting insulins, or 44% of all IU for insulin glargine, 100 IU/mL (Table). In Q1 2018, insulin glargine, 300 IU/mL, and insulin degludec each accounted for 5% of IU for long-acting insulins and insulin glargine–lixisenatide for 0.1%.

Reimbursement rates for Lantus and insulin determir increased in parallel in 2006-2014 by an average of 13% annually but stabilized following new product entry. Without accounting for inflationary or supplemental rebates, Basaglar reimbursement rates have been 15% to 16% lower than those of Lantus since its entry. From Q4 2016 to Q2 2018, Basaglar entry resulted in savings of more than $70 million to Medicaid, or around 4.4% of expenditures on insulin glargine, 100 IU/mL.

Discussion

In the long-acting insulin market, new product entry was associated with a halt in increases in reimbursement levels for incumbent products. The first biosimilar insulin had a large uptake and was associated with modest reductions in insulin expenditures for Medicaid.

The present analysis has important limitations, including the unavailability of inflationary and supplemental rebate data and the potential effect on prices of external forces such as public pressure. Savings associated with Basaglar would be lower if supplemental rebates were larger for Lantus than for Basaglar. Additionally, it is not possible to determine whether the slowing of price increases for incumbent products was a result of Basaglar entry or due to the approval of branded competitors, which has not been shown to lower inflation in other therapeutic classes.6

Nevertheless, these findings suggest that increased competition in the long-acting insulin market was associated with lower per-milliliter reimbursements in Medicaid, lending support to policies that expedite biosimilar approval and market entry. More savings should be expected once biosimilars are labeled as “interchangeable” and can be automatically substituted at the pharmacy, which is not currently the case for Basaglar.

Section Editor: Jody W. Zylke, MD, Deputy Editor.
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Article Information

Accepted for Publication: March 1, 2019.

Corresponding Author: Inmaculada Hernandez, PharmD, PhD, Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, 3609 Forbes Ave, Room 103, Pittsburgh, PA 15261 (inh3@pitt.edu).

Published Online: March 25, 2019. doi:10.1001/jama.2019.2990

Author Contributions: Dr Hernandez had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Hernandez, Shrank, Gellad.

Drafting of the manuscript: Hernandez, Good.

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

Statistical analysis: Hernandez.

Administrative, technical, or material support: Hernandez, Shrank, Gellad.

Supervision: Shrank, Gellad.

Conflict of Interest Disclosures: None reported.

Funding/Support: Dr Hernandez is funded by the National Heart, Lung, and Blood Institute (grant K01HL142847).

Role of the Funder/Sponsor: The National Heart, Lung, and Blood Institute 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; or decision to submit the manuscript for publication.

References
1.
Luo  J, Avorn  J, Kesselheim  AS.  Trends in Medicaid reimbursements for insulin from 1991 through 2014.  JAMA Intern Med. 2015;175(10):1681-1686. doi:10.1001/jamainternmed.2015.4338PubMedGoogle ScholarCrossref
2.
Hua  X, Carvalho  N, Tew  M, Huang  ES, Herman  WH, Clarke  P.  Expenditures and prices of antihyperglycemic medications in the United States: 2002-2013.  JAMA. 2016;315(13):1400-1402. doi:10.1001/jama.2016.0126PubMedGoogle ScholarCrossref
3.
Greene  JA, Riggs  KR.  Why is there no generic insulin? historical origins of a modern problem.  N Engl J Med. 2015;372(12):1171-1175. doi:10.1056/NEJMms1411398PubMedGoogle ScholarCrossref
4.
US Food and Drug Administration Center for Drug Evaluation and Research. Approval package for Basaglar. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000Approv.pdf. Accessed January 7, 2019.
5.
Centers for Medicare & Medicaid Services. Medicaid drug rebate program. https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html. Accessed September 25, 2018.
6.
San-Juan-Rodriguez  A, Prokopovich  MV, Shrank  WH, Good  CB, Hernandez  I.  Assessment of price changes of existing tumor necrosis factor inhibitors after the market entry of competitors.  JAMA Intern Med. 2019. doi:10.1001/jamainternmed.2018.7656PubMedGoogle Scholar
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