Abstract
This cross-sectional study uses Medicare Part D claims for high-utilization generic drugs to analyze gross profits accumulated by pharmacy benefit managers, pharmacies, wholesalers, and manufacturers in the pharmaceutical supply chain.
Introduction
The practice by pharmacy benefit managers (PBMs) of spread pricing—charging the client (ie, insurer) a higher amount than is reimbursed to the pharmacy—has garnered substantial attention from policymakers. The bipartisan proposals in the PBM Transparency Act1 and PBM Reform Act2 and numerous state laws3 prohibit spread pricing. However, others in the pharmaceutical supply chain, such as pharmacies and wholesalers, also rely on spread pricing to earn profits. The gross profit for each entity in the supply chain remains unexplored in the literature. Using Medicare Part D data, this study analyzed entity-level gross profit in the pharmaceutical supply chain for high-utilization generic drugs.
Methods
We conducted a cross-sectional study of generic drugs covered by Medicare Part D with more than 2 manufacturers, accounting for more than $100 million in total Part D spending and impacting more than 1 million Medicare beneficiaries. The Medicare Part D Dashboard was used to determine total spending, units dispensed, claims, and beneficiaries for these drugs in 2021.4 We followed the STROBE reporting guideline. Approval and informed consent were waived per the University of Utah institutional review board because we did not include human participants.
Pharmacy revenue was estimated by using the Federal Upper Payment Limit (FUL) for each drug in 2021.5 The FUL is a statutorily determined price for generic drugs with multiple competitors and approximates maximum allowable price limits paid by PBMs.5 Wholesaler revenue was estimated using National Average Drug Acquisition Cost (NADAC) in 2021,6 which is based on a national survey of a random sample of pharmacies from all states estimating the price pharmacies pay to acquire drugs. Manufacturer revenue was estimated using average manufacturer price (AMP) reported in 2021. Therefore, PBM gross profit was estimated as Medicare Part D spending minus pharmacy revenue (FUL); pharmacy gross profit equals pharmacy revenue (FUL) minus wholesaler revenue (NADAC) and wholesaler gross profit equals wholesaler revenue (NADAC) minus manufacturer revenue (AMP). The remainder is manufacturer revenue. Manufacturer gross profit was not estimated due to lack of information on ingredient cost and other manufacturing expenses. Spread pricing was calculated at claim level (total spending divided by total claims). Analyses used Microsoft Excel, version 16.
Results
In all, 45 drugs met inclusion criteria (Table 1). In 2021, Medicare Part D spent $11.8 billion for 690 million claims (mean, $22.50 per claim; 95% CI, $18.28-$26.72 per claim), representing 5.5% of all Part D spending ($216 billion) in 2021. The $22.50 was distributed as follows: $9.18 (40.8%) represents PBM gross profit; $3.87 (17.2%), pharmacy gross profit; $2.71 (12.0%), wholesaler gross profit; and $6.73 (29.9%), manufacturer revenue. Total intermediary gross profit (PBM, wholesaler, and pharmacy) ranged from −12.3% to 88.6% of Medicare Part D spending. Table 2 describes 2 case-study drugs with key sample data extracted.
Table 1. Medicare Part D Spending and Intermediary Gross Profit for High-Utilization Generic Drugs in 2021.
Generic drug | Total spending, $ | Total claims, No. | Spending per claim, $ | Intermediary gross profit | Proportion of spending, % |
---|---|---|---|---|---|
Ezetimibe | 285 698 641 | 5 008 626 | 57.04 | 47.56 | 83.4 |
Clobetasol propionate | 118 407 665 | 1 875 448 | 63.14 | 43.55 | 69.0 |
Celecoxib | 198 447 520 | 3 965 182 | 50.05 | 38.34 | 76.6 |
Valacyclovir HCl | 112 298 507 | 2 540 155 | 44.21 | 32.51 | 73.5 |
Pregabalin | 307 562 067 | 5 638 407 | 54.55 | 30.51 | 55.9 |
Duloxetine HCl | 414 557 638 | 11 009 950 | 37.65 | 29.08 | 77.2 |
Baclofen | 140 461 448 | 4 830 105 | 29.08 | 25.03 | 86.1 |
Rosuvastatin calcium | 564 466 206 | 18 199 685 | 31.02 | 24.76 | 79.8 |
Diclofenac sodium | 258 978 903 | 8 379 385 | 30.91 | 24.73 | 80.0 |
Potassium chloride | 433 439 766 | 14 210 545 | 30.50 | 23.98 | 78.6 |
Doxycycline hyclate | 108 947 882 | 4 328 095 | 25.17 | 22.31 | 88.6 |
Losartan and hydrochlorothiazide | 122 708 535 | 4 675 200 | 26.25 | 21.56 | 82.1 |
Bupropion HCl | 226 430 273 | 5 275 658 | 42.92 | 19.86 | 46.3 |
Mirtazapine | 167 528 216 | 7 311 127 | 22.91 | 18.64 | 81.4 |
Oxycodone HCl and acetaminophena | 240 010 057 | 8 667 327 | 27.69 | 17.03 | 61.5 |
Metoprolol succinate | 587 427 283 | 26 215 995 | 22.41 | 17.00 | 75.8 |
Finasteride | 122 402 257 | 6 476 445 | 18.90 | 15.66 | 82.8 |
Buspirone HCl | 113 534 416 | 5 976 927 | 19.00 | 15.00 | 78.9 |
Quetiapine fumarate | 202 983 398 | 8 475 019 | 23.95 | 14.79 | 61.7 |
Pravastatin sodium | 188 695 359 | 10 559 760 | 17.87 | 14.75 | 82.5 |
Pantoprazole sodium | 375 326 098 | 20 999 275 | 17.87 | 14.72 | 82.3 |
Gabapentin | 622 195 038 | 32 996 186 | 18.86 | 12.06 | 64.0 |
Montelukast sodium | 163 129 688 | 11 318 679 | 14.41 | 11.71 | 81.3 |
Levothyroxine sodium | 728 257 030 | 38 443 070 | 18.94 | 11.54 | 60.9 |
Hydrocodone and acetaminophen | 458 937 357 | 21 200 893 | 21.65 | 11.47 | 53.0 |
Omeprazole | 439 420 730 | 28 270 377 | 15.54 | 11.24 | 72.3 |
Escitalopram oxalate | 152 321 907 | 10 603 618 | 14.37 | 11.19 | 77.9 |
Allopurinol | 135 198 663 | 8 988 289 | 15.04 | 10.47 | 69.6 |
Famotidine | 200 951 499 | 10 633 240 | 18.90 | 10.40 | 55.0 |
Donepezil HCl | 110 126 466 | 7 374 685 | 14.93 | 9.99 | 66.9 |
Atorvastatin calcium | 836 195 879 | 61 100 574 | 13.69 | 9.42 | 68.9 |
Carvedilol | 162 600 636 | 14 728 517 | 11.04 | 9.19 | 83.2 |
Losartan potassium | 392 886 345 | 29 424 165 | 13.35 | 8.63 | 64.6 |
Clopidogrel bisulfate | 158 314 799 | 12 930 126 | 12.24 | 8.59 | 70.2 |
Fluoxetine HCl | 100 275 333 | 6 920 559 | 14.49 | 8.41 | 58.0 |
Alprazolam | 118 722 365 | 11 930 537 | 9.95 | 7.91 | 79.5 |
Sertraline HCl | 159 175 693 | 14 268 296 | 11.16 | 7.55 | 67.7 |
Trazodone HCl | 188 771 115 | 15 158 326 | 12.45 | 6.75 | 54.2 |
Simvastatin | 163 875 183 | 18 748 527 | 8.74 | 6.71 | 76.7 |
Metoprolol tartrate | 137 111 040 | 17 454 387 | 7.86 | 6.47 | 82.4 |
Amlodipine besylate | 310 021 008 | 44 200 206 | 7.01 | 6.07 | 86.6 |
Lisinopril | 259 836 409 | 36 125 959 | 7.19 | 5.78 | 80.4 |
Metformin HCl | 181 651 525 | 24 245 215 | 7.49 | 5.18 | 69.2 |
Furosemide | 140 004 950 | 23 438 082 | 5.97 | 4.48 | 75.0 |
Oxycodone HCla | 180 530 233 | 7 486 820 | 24.11 | –2.96 | −12.3 |
Abbreviation: HCl, hydrochloride.
Immediate-release oxycodone HCl is available in 5 different tablet strengths and as a capsule with wide variation in unit-level pricing. The average manufacturer price reported was higher than the reported Medicare Part D spending per unit, potentially reflecting increased utilization of the lowest-price strength and dose form.
Table 2. Product-Specific Case Studies for Donepezil Hydrochloride and Oxycodone and Acetaminophen Using 2021 Data.
Variable | Donepezil hydrochloride | Oxycodone and acetaminophen | Sources and notes |
---|---|---|---|
Medicare Part D spending, $ | 110 126 466 | 240 010 057 | 2021 Medicare Part D Dashboard figures are based on gross drug costs including all spending on claims, plan, and beneficiary payments. These figures do not include manufacturers’ rebates or other price concessions that CMS is prohibited from disclosing. |
Total prescription claims, No. | 7 374 685 | 8 667 327 | |
Part D spending per prescription, $ | 14.93 | 27.69 | |
Total dose units, No. | 362 157 114 | 680 757 903 | |
FUL per unit, $ | 0.2044 | 0.2376 | The FUL is a statutorily determined price for generic drugs that have multiple competitors. These data are available per dose unit, and the average payment for the prescription can be calculated based on the mean units in each claim. |
FUL per prescription, $ | 10.04 | 18.66 | |
NADAC per unit, $ | 0.1673 | 0.1908 | NADAC data provide weekly reference data on drug prices at the product unit level, and the average payment for the prescription can be calculated based on the average units in each claim. These prices are based on a national survey of a random sample of pharmacies from all states estimating the price pharmacies pay to acquire drugs. |
NADAC per prescription, $ | 8.22 | 14.99 | |
AMP per unit, $ | 0.1006 | 0.1358 | The AMP is reported by manufacturers to CMS quarterly and is available at the product unit level. The average payment for the prescription can be calculated based on the average units in each claim. The AMP may not include prompt pay discounts to wholesalers and excludes direct sales to nursing homes. |
AMP per prescription, $ | 4.94 | 10.67 | |
PBM financials | |||
Revenue per prescription, $ | 14.93 | 27.69 | We estimated PBM revenue from Medicare Part D spending. |
COGS per prescription, $ | 10.04 | 18.66 | PBM COGS was estimated based on the prescription-level FUL as a proxy for the payment to the pharmacy. |
Gross profit per prescription, $ | 4.89 | 9.03 | The difference represents an estimated gross profit amount for the PBM that may factor into administrative fees, premiums, etc. |
Pharmacy financials | |||
Revenue per prescription, $ | 10.04 | 18.66 | We estimated pharmacy revenue using the prescription-level FUL as a proxy for payment from the PBM, as most multisourced generics may be on PBM MAC lists. |
COGS per prescription, $ | 8.22 | 14.99 | Pharmacy COGS was estimated based on the prescription-level NADAC survey reported by a national sample of pharmacies. |
Gross profit per prescription, $ | 1.82 | 3.67 | The difference represents an estimated gross profit amount for the pharmacy prior to paying for operating expenses. |
Wholesaler financials | |||
Revenue per prescription, $ | 8.22 | 14.99 | We estimated the wholesaler revenue based on the prescription-level NADAC paid by the pharmacy to acquire the product. |
Cost of goods sold per prescription, $ | 4.94 | 10.67 | Wholesaler COGS was estimated from the manufacturer-reported AMP. |
Gross profit per prescription, $ | 3.82 | 4.32 | The difference represents an estimated gross profit amount for the wholesaler prior to paying for operating expenses. |
Manufacturer financials | |||
Revenue per prescription, $ | 4.94 | 10.67 | Manufacturer revenue was estimated using prescription-level AMP. |
Abbreviations: AMP, average manufacturer price; CMS, Centers for Medicare & Medicaid Services; COGS, cost of goods sold; FUL, federal upper payment limit; MAC, maximum allowable cost; NADAC, National Average Drug Acquisition Cost; PBM, pharmacy benefit manager.
Discussion
In 2021, all but 29.9% of Medicare Part D dollars spent on 45 high-utilization generic drugs went to intermediary gross profit. This study was limited by the lack of information on direct and indirect remuneration offered by manufacturers or pharmacies. Without data on operating expenses, we were unable to estimate net profits generated. Additionally, without access to the proprietary agreements between the Centers for Medicare & Medicaid Services (CMS) and PBMs or plan sponsors, we were unable to determine what proportion of gross profits earned on these generic drug transactions was returned to CMS or used to reduce premiums. To the extent that the FUL exceeds actual pharmacy revenue for certain drugs in Medicare Part D, our estimated PBM spread pricing may be underestimated.
Policy efforts prohibiting spread pricing practices of PBMs may lower claim-level revenue retained by PBMs for generic drugs. However, absent sufficient market competition, PBMs may raise administrative fees to sustain revenue. Therefore, it remains unclear how much spread pricing reform focused on PBMs alone would lower drug spending or strengthen the generic pharmaceutical supply chain.
Data Sharing Statement
References
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Supplementary Materials
Data Sharing Statement