Factors associated with target price status within the oncology care model population.

72 Background: The Oncology Care Model (OCM) is an alternative payment model put forth by the Centers for Medicare and Medicaid Services (CMS), which aims to improve quality of care for cancer beneficiaries, while reducing cost. One of the strategies implemented by CMS to achieve this goal was the development of an episode target price (TP), which uses historical data and episode specific adjusters to calculate a total cost of care goal for each episode. The goal of this analysis was to better understand how CMS risk adjustments could account for episode characteristics, as well as how these characteristics affect likelihood of meeting target price. Methods: OCM performance claims data were abstracted retrospectively from performance periods (PP) 1-6 (episodes initiated from 7/1/2016 – 12/31/2019), in which each episode captured 6 months of care. EHR data was linked to identify cancer staging for OCM Beneficiaries. Any OCM beneficiary with at least one episode in PP 1-6 was included. To assess odds of meeting TP, a logistic regression model with a generalized estimating equation was used to account for patients who contributed multiple episodes. Specific factors evaluated for their association with meeting TP included patient’s age and sex, cancer stage, cancer type, cancer related surgery, clinical trial participation, hospice status, inpatient admissions, observational stays, Medicare part B drug use and radiation therapy. Results: 4,612 episodes were included in analysis, which translated to 2,459 patients, who had an average age of 72 years old and were majority female (50.5%). 2,790 (60.5%) of the episodes met the TP set by OCM. When controlling for covariates, radiation treatment (OR = 1.75, 95%CI: 1.39-2.23), stage 2 compared to stage 4 cancers (OR = 1.86, 95%CI: 1.23-2.80), colorectal cancers (OR = 1.75, 95%CI: 1.11-2.77) and melanomas (OR = 4.35, 95%CI: 2.18-8.67) were significantly associated with increased odds of meeting TP. Novel therapies (OR = 0.19, 95%CI: 0.14-0.26), inpatient admissions (OR = 0.27, 95%CI: 0.22-0.33), observational stays (OR = 0.66, 95%CI: 0.51-0.87) and part B drug use (OR = 0.75, 95%CI: 0.60-0.93) were associated with significantly reduced odds of meeting TP. Conclusions: Our analysis suggests that radiation treatment, as well as selected cancer stage and types may contribute to increased likelihood of meeting TP, which may point to potential areas of cost savings. Conversely, specific resource utilizations such as novel therapy use, inpatient admissions, observational stays, and Medicare part B drug use may decrease the odds of meeting TP, despite being adjusted for in the OCM model. While CMS has recognized that late stage cancers require a more sensitive TP with the metastatic adjustment, other adjustments should also be considered to adequately account for episode characteristics. External validation at other OCM-participating practices is needed to corroborate these results.

Biosimilar uptake of filgrastim and impact on spending in Medicare Part D from 2015 to 2019.

67 Background: The introduction of a filgrastim biosimilar in 2014 was associated with substantial cost savings in Medicare Part B and Medicaid programs. However, Medicare Part D is unique since it is unable to directly negotiate prices with drug manufacturers. We sought to investigate the uptake of filgrastim biosimilars and impact on spending among Part D beneficiaries. Methods: We evaluated utilization trends for filgrastim (Neupogen), filgrastim-sndz (Zarxio), and tbo-filgrastim (Granix) using the 2015-2019 Medicare Part D Prescription Drug Event data. We conducted a retrospective cross-sectional review of annual spending, number of beneficiaries, number of claims, spending per beneficiary, and spending per dosage unit. We excluded filgrastim-aafi (Nivestym) due to recent approval and adjusted for inflation using 2019 dollars. Results: In 2019, total aggregate Part D spending on filgrastim products was $78 million. From 2015 to 2019, the biosimilar share of total aggregate spending increased from $1.8 million (2%) to $44 million (56%), with combined biosimilar spending (Zarxio and Granix) eclipsing originator Neupogen in 2018 (within 4 years of FDA approval of Zarxio). Total spending on Neupogen reduced 58% from 2015 to 2019. While biosimilar uptake progressively increased every year, total aggregate spending on all filgrastim forms reduced only 7% from 2015 to 2019 ($84 million to $78 million). For all 3 forms, from 2015 to 2019, trends in spending were: average spending per claim ($3193 to $2549, -20%), average spending per beneficiary ($5880 to $6722, +15%), and average spending per dosage unit of filgrastim ($583 vs $571, -2%). Detailed results in Table. Conclusions: We demonstrate that the significant uptake of biosimilar filgrastim products in Medicare Part D from 2015 to 2019 was associated with a small decrease in aggregate spending, essentially unchanged per unit spending, and increased spending per beneficiary on filgrastim products. Our findings contrast with experiences across Medicare Part B and Medicaid, that demonstrated significant cost savings with biosimilar filgrastim uptake. This may be due to inability of Medicare Part D to directly negotiate prices with manufacturers (in contrast to Medicare Part B and Medicaid), supporting ongoing Congressional policy being debated in the United States Senate (H.R. 3).[Table: see text]

Pharmacist Provider-Status Legislation Returns

The Pharmacy and Medically Underserved Areas Enhancement Act, better known as the pharmacist provider status act, has been introduced in Congress in both the House of Representatives and the Senate The bill would reimburse pharmacists for Medicare Part B-covered services within their state authorized scope of practice if performed in areas recognized as being medically underserved. Paul Baldwin debates the likeliness of the bill's passage.

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices, but his administration also introduced ambitious reform policies that had previously lacked acceptance among Republican policymakers. President Trump appears to have been successful in developing a new, populist form of rhetoric that Republicans can use in support of novel drug pricing reforms like the ones his administration considered. From a policy perspective, however, the Trump administration failed to implement any of their more ambitious reform ideas. This article considers three of the Trump Administration’s signature policies—state-sponsored prescription drug importation, Medicare Part B international reference pricing, and reforms to the Medicare Part D rebate system—and explores how they represent both the political ambitions and policy failures of the Trump Administration. The fate of the Trump administration’s prescription drug proposals also reveals lessons about innovation and access which will be important to ongoing drug pricing reform efforts.

U.S. budget impactanalysis of body surface area (BSA)dosing for a rituximab biosimilar vsflat-fixed-dosing for subcutaneous rituximab in non-Hodgkin lymphoma (NHL)and chronic lymphocytic leukemia (CLL).

e18822 Background: The first rituximab biosimilar approved in the US, rituximab-abbs, is a CD20-directed monoclonal antibody that is expected to significantly reduce drug acquisition costs. This economic analysis evaluated budgetary impact of BSA-based rituximab-abbs (IV-R-BIOSIM) vs flat-fixed rituximab/hyaluronidase human subcutaneous injection (SC-R) dosing in NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL. The objective was to project incremental cost differences per patient between IV-R-BIOSIM and SC-R from a US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated 1-year costs for IV-R-BIOSIM and SC-R. The model assumed equal efficacy and safety between products. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Costs for the first infused rituximab (IV-R) dose were excluded for appropriate comparison. IV-R-BIOSIM doses used BSAs of 1.6 m2, 1.8 m2, infusion duration was 3 hours. Annual dose counts of IV-R-BIOSIM or SC-R were: 9 untreated FL with maintenance; 7 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 5 CLL. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was 2020 Medicare Part B 20% cost-share for office visits and drugs. A scenario analysis was also performed to estimate FL maintenance costs for 2-year dosing. Results: Estimated 1-year savings with IV-R-BIOSIM for 1.8 m2 BSA dosing were $1,067–$6,893 with variability between indications (Table). For 1.6 m2 BSA dosing, estimated 1-year savings with IV-R-BIOSIM were $3,819–$10,856. Estimated 2-year savings with IV-R-BIOSIM for FL maintenance dosing were $9,191 for 1.8 m2 BSA dosing and $14,475 for 1.6 m2 BSA dosing. Savings of up to $1,900 were seen for higher-than-average BSA dosing, regardless of regimen. Conclusions: These findings demonstrate the potential economic benefits of replacing a proportion of SC-R use with BSA-based IV-R-BIOSIM from a US payer perspective, especially when lower BSA dosing is used. Savings are driven by drug costs and may increase with IV-R-BIOSIM as patient BSA decreases due to static costs with SC-R doses. These data also suggest that drug wastage may occur with SC-R in lower BSA patients.[Table: see text]