Abstract

The high and increasing expenditures for prescription medications in the US is a national problem. To explore the association of generic statin competition on relevant use and cost savings and to provide use and expenditure trends for all available statins for private and public payers and for out-of-pocket spending. This survey study evaluated data from the January 1, 2002, to December 31, 2018, Medical Expenditure Panel Survey by using a difference-in-differences analysis. Participants included noninstitutionalized individual statin users. Data were analyzed from November 1, 2020, to March 30, 2021. The market entry of 5 generic statin medications (atorvastatin, rosuvastatin, simvastatin, lovastatin, and pravastatin). National- and individual-level reductions in the annual number of statin purchases and total expenditures across private insurance, public insurance (Medicaid and Medicare), and out-of-pocket spending (presented in 2018 US dollars). Between January 1, 2002, and December 31, 2018, an average of 21.35 million statins (95% CI, 16.7-25.5 million) were purchased annually, with an average total annual cost of $24.5 billion (95% CI, $18.2-$28.8 billion). The number of brand-name statin purchases decreased by 90.9% (95% CI, 56%-98%) nationally and 27.4% (95% CI, 13%-40%) individually after the end of market exclusivity. Among major payers, the end of market exclusivity was associated with individual cost savings of $370.00 (95% CI, $430.70-$309.20) for private insurers, $281.00 (95% CI, $346.80-$215.30) for Medicare, $72.34 (95% CI, $95.22-$49.46) for Medicaid, and $211.90 (95% CI, $231.20-$192.50) for out-of-pocket spending. Combining all payers, the decrease translates to $925.60 (95% CI, $1005.00-$846.40) of annual savings per individual and $11.9 billion (95% CI, $10.9-$13.0 billion) for the US. Results of this survey study suggest that full generic competition of statins was associated with significant cost savings across all major payers within the US health care system.

Highlights

  • The high and increasing health care expenditure in the US is a national problem

  • The number of brand-name statin purchases decreased by 90.9% nationally and 27.4% individually after the end of market exclusivity

  • The end of market exclusivity was associated with individual cost savings of $370.00 for private insurers, $281.00 for Medicare, $72.34 for Medicaid, and $211.90 for out-of-pocket spending

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Summary

Introduction

The high and increasing health care expenditure in the US is a national problem. In 2019 alone, national health care spending increased 4.6%.1. Retail prescription drug spending reached $369.7 billion (10% of total health care spending),[1] resulting in immense public outcry.[2] Improving the affordability of prescription drugs has become a focus of both the scientific and policy communities.[3,4]. Generic competition is one important policy tool to stem rising prescription drug expenditures.[3] In the US, the entry of generic drugs into the market typically starts after the market exclusivity period of a brand-name drug ends.[4] A generic drug is a pharmaceutically equivalent alternative to a brand-name drug that is made by another manufacturer and is sold at a fraction of the cost.[7,8] According to the Center of Drug Evaluation and Research estimates, the average generic drug price is 49% of the corresponding brand-name drug.[9] When 6 or more generic competitors exist, the reduction is up to 95%.5

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