Abstract
BACKGROUND:
It is unknown whether using pegfilgrastim biosimilars is cost saving in a real-world setting.
OBJECTIVE:
To compare medical costs including pegfilgrastim drug costs and febrile neutropenia (FN) treatment and management costs between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users for primary prophylaxis of febrile neutropenia.
METHODS:
A retrospective cohort study using 2019 IBM MarketScan Commercial and Medicare Supplemental databases was conducted in adult patients with cancer initiating myelosuppressive chemotherapy courses. At least 2 diagnoses of the same cancer (at least 7 days apart) were required within 30 days of the chemotherapy initiation date. Pegfilgrastim (excluding on-body injector) costs included drug costs only (excluding administration fees). FN-related costs included all FN-related health care utilizations that were defined as having neutropenia, fever, or infection diagnosis. Per-patient per-cycle (PPPC) out-of-pocket (OOP) costs, health plan costs, and total costs were compared between originator (excluding on-body injector) and biosimilars users in the first cycle. A generalized linear model and a 2-part model were used.
RESULTS:
A total of 1,930 patients were included, of whom 884 (45.8%) used pegfilgrastim originator, 427 (22.1%) used pegfilgrastim-jmdb, and 619 (32.1%) used pegfilgrastim-cbqv. Adjusted PPPC OOP pegfilgrastim costs in the first cycle were significantly lower for the biosimilars vs the originator ($182 for pegfilgrastim-jmdb and $159 for pegfilgrastim-cbqv vs $299 for originator, P < 0.0001 for both comparisons). However, there was no difference in health plan costs ($5,783 for pegfilgrastim-jmdb and $5,845 for pegfilgrastim-cbqv vs $5,618 for originator) and total costs. In addition, no difference was observed for adjusted PPPC FN treatment and management OOP costs, health plan costs, and total costs in the first cycle. FN treatment OOP costs were $192 for originator, $197 for pegfilgrastim-jmdb (P = 0.958), and $240 for pegfilgrastim-cbqv (P = 0.680). FN treatment health plan costs were $2,804 for originator, $2,970 for pegfilgrastim-jmdb (P = 0.692), and $2,745 for pegfilgrastim-cbqv (P = 0.879).
CONCLUSIONS:
In a commercially insured population, using pegfilgrastim biosimilars in the first cycle for primary prophylaxis of FN led to cost savings for patients but not payers. No difference in FN-related costs was observed.
Plain language summary
In this study, we found that among commercially insured patients with cancer receiving chemotherapy in the first cycle, using pegfilgrastim biosimilars instead of originator for primary prophylaxis of febrile neutropenia was associated with 47%-59% lower costs for patients. Using pegfilgrastim biosimilars was not associated with lower costs for payers.
Implications for managed care pharmacy
In the context of primary prophylaxis for febrile neutropenia, patient out-of-pocket costs were lower for pegfilgrastim biosimilar users compared with originator users, and 67%-83% of patients paid nothing for treatment in the first cycle. Although no difference in costs was observed for payers, rebates and discounts were not considered in the present analysis. For managed care pharmacies interested in adopting pegfilgrastim biosimilars, prices offered by the manufacturers after considering all discounts and rebates is a determining factor.
Granulocyte-colony stimulating factors (G-CSFs) are essential for oncology supportive care. They are used to reduce the duration of neutropenia and the incidence of febrile neutropenia (FN) for patients with cancer receiving myelosuppressive chemotherapy, allowing maintenance or increase of chemotherapy dose intensity.1 According to National Comprehensive Cancer Network (NCCN) guidelines,1 use of G-CSFs for primary prophylaxis is recommended when the overall FN risk is greater than 20% following myelosuppressive chemotherapy, and secondary prophylaxis is recommended following FN or a dose-limiting neutropenic event. Off-label use of G-CSFs for FN treatment is not recommended. G-CSFs are available in both short-acting (ie, filgrastim) and long-acting (ie, pegfilgrastim) products. For FN prophylaxis, filgrastim requires daily administration until the neutrophil level recovers, whereas pegfilgrastim is given once per cycle. Owing to its ease of use, pegfilgrastim has dominated the G-CSF market since its introduction, accounting for more than 97% of G-CSF use as recently as 2019.2 Although both agents are effective in reducing the risk of FN, the high costs make them significant drivers of expenses in oncology care, and lack of reimbursement to practice and concerns about insurance coverage are the main factors why high-risk patients may not receive prophylaxis with G-CSFs.3 The approval of biosimilars for G-CSF products presents a promising opportunity for expanded access to this therapy and cost savings for both patients and payers.
Competition from biosimilars has emerged for filgrastim and pegfilgrastim since 2015 and 2018, respectively. As of September 2021, there are 2 filgrastim biosimilars and 4 pegfilgrastim biosimilars on the market, including filgrastim-sndz and filgrastim-aafi for filgrastim as well as pegfilgrastim-jmdb, pegfilgrastim-cbqv, pegfilgrastimbmez, and pegfilgrastim-apgf for pegfilgrastim. Uptake of biosimilars has been rapid. In Q4/2019, biosimilars accounted for about 56% of filgrastim and 30% of pegfilgrastim use among commercially insured populations.2
Biosimilars should offer the same therapeutic benefits with lower prices for market competition. The prices of originators decreased following the entry of biosimilars, potentially narrowing the gap in price between the originator and biosimilar.4 Current economic evidence for the impact of biosimilars is thus far limited to filgrastim5-7 or other simulated data.8-12 One study evaluated the costs for a pegfilgrastim on-body injector (OBI).13 There are no real-world data focused on pegfilgrastim biosimilar medication costs from the patient and payer perspectives in addition to the costs for FN treatment and management. Thus, it is unknown whether cost savings are realized from adopting pegfilgrastim biosimilars. This study addresses this knowledge gap by analyzing and comparing pegfilgrastim costs to the patient and payer as well as the downstream costs associated with FN treatment and management for patients with cancer receiving myelosuppressive chemotherapy.
Methods
SETTING, PATIENT POPULATION, AND DATA SOURCE
A retrospective cohort study was conducted using 2019 IBM MarketScan Commercial and Medicare Supplemental databases. These databases were HIPAA-compliant, fully integrated, longitudinal data sources of inpatient, outpatient, and prescription drug claims for individuals covered under commercial health plans and Medicare supplemental insurance plans. Patients with cancer (breast, lung, colorectal, esophageal, gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphoma) who received selected myelosuppressive chemotherapy regimens (Supplementary Table 1 (408.5KB, pdf) , available in online article) and used any of the 3 pegfilgrastim products—pegfilgrastim originator (prefilled syringe), pegfilgrastim-jmdb, and pegfilgrastim-cbqv—for FN prophylaxis were included.
Adult patients aged 18 years and older were required to receive at least 1 chemotherapy agent. The date of the first chemotherapy administration was defined as the index date (day 1). The chemotherapy regimen was determined based on all chemotherapy agents a patient received from day 1 to day 7. Regimens were then categorized into high FN risk (≥ 20%), intermediate FN risk (10%-20%), and low FN risk (< 10%) according to NCCN guidelines1 and clinical expert opinion (Supplementary Table 2 (408.5KB, pdf) ).2 Patients were required to have 180 days of continuous enrollment and 90 days without any chemotherapy administered prior to the index date to identify the start of the chemotherapy courses. Furthermore, 2 or more cancer diagnoses at least 7 days apart within 30 days before or after the index date were required (Supplementary Table 3 (408.5KB, pdf) ). Patients who were on weekly chemotherapy regimens were excluded because use of pegfilgrastim with weekly chemotherapy is not recommended by NCCN guidelines.1
Other exclusion criteria included (1) evidence of 2 or more primary solid cancers or acute myeloid leukemia within ± 30 days of the index date; (2) evidence of autologous peripheral blood progenitor cell collection, bone marrow transplantation, or hematopoietic stem cell transplantation during the period beginning 30 days before the index date and ending 10 days after that; or (3) evidence of the use of more than one G-CSF product (including all filgrastim and pegfilgrastim products), pegfilgrastim-OBI, or pegfilgrastim with an unknown route. Codes for exclusion criteria are shown in Supplementary Table 4 (408.5KB, pdf) .
Pegfilgrastim product use was identified in medical claims using Healthcare Common Procedure Coding System and pharmacy claims using National Drug Code (Supplementary Table 5 (408.5KB, pdf) ). To be considered FN prophylaxis, patients were required to receive pegfilgrastim within 3 days from chemotherapy completion. Patients were followed from the index date (day 1) to the day prior to the next chemotherapy administered between day 12 and day 60 (end of cycle 1). If no chemotherapy was administered between day 12 and day 60, follow-up was considered censored on day 35, disenrollment, or the end of the study period, whichever occurred first. Patients whose followup ended because of disenrollment or the end of the study period were considered to have an incomplete cycle 1 and were excluded from the study. Pegfilgrastim and febrile neutropenia costs were only compared in cycle 1 because risks for FN are highest in the first cycle and we do not expect difference in costs between pegfilgrastim originator and biosimilars to change significantly across cycles. Study design diagrams are shown in Supplementary Figures 1 and 2 (408.5KB, pdf) .
COST OUTCOMES
Per-patient per-cycle (PPPC) pegfilgrastim costs, FN treatment costs, and FN management costs were estimated in cycle 1. Pegfilgrastim costs included medication costs only. FN treatment costs include all FN-related health care utilizations, including emergency visits, outpatient visits, and hospitalizations. FN management costs were calculated as the sum of pegfilgrastim costs and FN treatment costs. FN treatment–related health care utilizations were defined as having International Classification of Diseases, Tenth Revision diagnosis codes for neutropenia, fever, or infection in any position using algorithms for FN that were validated in administrative claims databases14 and have been widely used in previous studies.6,15,16 For all 3 cost outcomes (pegfilgrastim costs, FN treatment costs, and FN management costs), patient out-of-pocket (OOP) costs, health plan costs, and total costs were analyzed separately. Patient OOP costs were calculated as the sum of coinsurance, copayments, and deductibles.
STATISTICAL ANALYSES
Descriptive statistics were summarized for all study variables (mean and SD for continuous variables; frequencies and proportions for categorical variables). Patient characteristics were compared between biosimilar and originator users by the Student’s t-test for continuous variables and chi-square test for categorical variables.
Multivariable regression models were used to evaluate differences in all cost outcomes. Pegfilgrastim-jmdb and pegfilgrastim-cbqv were compared against the originator. The modified Park test was performed to determine the distributions of the cost data and to select the most appropriate regression model.17,18 PPPC costs were estimated using either a generalized linear model or 2-part model19 after adjusting for covariates presented in Table 1. For outcomes with 10% or more zero as value, the 2-part models were used where a logistic regression is fit for the probability of observing a positive-vs-zero outcome. Then, conditional on positive outcome, a generalized linear regression model is fit for the positive outcome. An a priori 2-tailed α level of 0.05 was used for all statistical tests. Analyses were performed with SAS version 9.4 (SAS Institute Inc) and STATA version 15.1 (Stata Corp).
TABLE 1.
Patient Characteristics Between Pegfilgrastim Biosimilar and Originator Users Among Patients With Cancer Receiving Chemotherapy From 2019 IBM MarketScan
| Pegfilgrastim (Neulasta) | Pegfilgrastim-jmdb (Fulphila) | Pegfilgrastim-cbqv (Udenyca) | |
|---|---|---|---|
| Number of patients | 884 | 427 | 619 |
| Age, years | |||
| Mean (SD) | 56.3 (11.9) | 53.4 (10.1)a | 53.0 (10.8)a |
| Median (IQR) | 57.0 (14.0) | 55.0 (14.0)a | 54.0 (14.0)a |
| ≤ 50 | 264 (30.0) | 156 (36.5)a | 242 (39.1)a |
| 51-60 | 295 (33.4) | 176 (41.2)a | 232 (37.5)a |
| 61-70 | 215 (24.3) | 75 (17.6)a | 111 (17.9)a |
| ≥ 71 | 110 (12.4) | 20 (4.7)a | 34 (5.5)a |
| Sex | |||
| Male | 188 (21.3) | 72 (16.9) | 98 (15.8)b |
| Female | 696 (78.7) | 355 (83.1) | 521 (84.2)b |
| Region | |||
| Northeast | 177 (20.0) | 90 (21.1) | 88 (14.2)b |
| North Central | 198 (22.4) | 92 (21.6) | 163 (26.3)b |
| South | 387 (43.8) | 184 (43.1) | 280 (45.2)b |
| West | 122 (13.8) | 61 (14.3) | 85 (13.7)b |
| Unknown | 0 (0.0) | 0 (0.0) | 3 (0.5)b |
| Insurance type | |||
| Commercial | 707 (80.0) | 397 (93.0)a | 563 (91.0)a |
| Medicare supplementary | 177 (20.0) | 30 (7.0)a | 56 (9.1)a |
| Plan type | |||
| HMO | 103 (11.7) | 56 (13.1)b | 76 (12.3)a |
| PPO | 481 (54.4) | 197 (46.1)b | 273 (44.1)a |
| Others/unknown | 300 (33.9) | 174 (40.8)b | 270 (43.6)a |
| Provider type | |||
| Acute care hospital | 372 (42.1) | 153 (35.8)b | 353 (57.0)a |
| Hematology | 125 (14.1) | 89 (20.8)b | 76 (12.3)a |
| Oncology | 235 (26.6) | 116 (27.2)b | 130 (21.0)a |
| Others/unknown | 152 (17.2) | 69 (16.2)b | 60 (9.7)a |
| Place of service | |||
| Office-based outpatient | 450 (50.9) | 247 (57.9) | 231 (37.3)a |
| Institutional outpatient | 404 (45.7) | 166 (38.9) | 375 (60.6)a |
| Others/pharmacy | 30 (3.4) | 14 (3.3) | 13 (2.1)a |
| Cancer type | |||
| Breast | 572 (64.7) | 309 (72.4)b | 462 (74.6)a |
| Lung | 86 (9.7) | 37 (8.7)b | 34 (5.5)a |
| Non-Hodgkin lymphoma | 107 (12.1) | 43 (10.1)b | 69 (11.2)a |
| Others | 119 (13.5) | 38 (8.9)b | 54 (8.7)a |
| Regimen FN risk level | |||
| High | 637 (72.1) | 331 (77.5) | 499 (80.6)a |
| Intermediate | 170 (19.2) | 65 (15.2) | 88 (14.2)a |
| Low | 77 (8.7) | 31 (7.3) | 32 (5.2)a |
| Other FN risk factor | |||
| History of chemotherapy | 29 (3.3) | 6 (1.4)b | 12 (1.9) |
| History of radiation therapy | 52 (5.9) | 20 (4.7) | 31 (5.0) |
| Recent surgery | 361 (40.8) | 198 (46.4) | 247 (39.9) |
| History of infection | 229 (25.9) | 92 (21.6) | 125 (20.2)b |
| History of neutropenia | 170 (19.2) | 46 (10.8)a | 62 (10.0)a |
| Renal disease | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Liver disease | 121 (13.7) | 59 (13.8) | 95 (15.4) |
| CVD | 99 (11.2) | 41 (9.6) | 45 (7.3)b |
| Diabetes | 127 (14.4) | 57 (13.4) | 78 (12.6) |
| COPD | 101 (11.4) | 27 (6.3)b | 41 (6.6)b |
| HIV/AIDS | 4 (0.5) | 0 (0.0) | 3 (0.5) |
| Metastasis | 428 (48.4) | 222 (52.0) | 300 (48.5) |
| Metastatic cancer to bone | 57 (6.5) | 19 (4.5) | 29 (4.7) |
Data are shown as n (%) unless otherwise noted. Reference: Pegfilgrastim-PFS (Neulasta).
aP < 0.001.
bP < 0.05.
COPD = chronic obstructive pulmonary disease; CVD = cardiovascular diseases; FN = febrile neutropenia; HMO = health maintenance organization; IQR = interquartile range; PFS = prefilled syringe; PPO = preferred provider organization.
Results
STUDY POPULATION
A total of 1,930 patients receiving chemotherapy in 2019 were identified, among whom 884 (45.8%) received pegfilgrastim originator, 427 (22.1%) received pegfilgrastim-jmdb, and 619 (32.1%) received pegfilgrastim-cbqv. Biosimilar users were significantly younger than the originator users (pegfilgrastim-jmdb: 53.4 years [P < 0.001]; pegfilgrastim-cbqv: 53.0 years [P < 0.001]; and pegfilgrastim originator: 56.3 years). They were also more likely to be commercially insured than covered by Medicare supplemental insurance (80.0% of pegfilgrastim originator users, 93.0% of pegfilgrastim-jmdb users [P < 0.001], and 91.0% of pegfilgrastim-cbqv users [P < 0.001] were commercially insured). More than 40% of patients resided in the South. Breast cancer was the most common cancer type. Originator users were more likely to have a preferred provider organization health plan type (54.4% for pegfilgrastim originator vs 46.1% for pegfilgrastim-jmdb and 44.1% pegfilgrastim-cbqv). Biosimilar users were less likely to have a history of neutropenia (10.8% of pegfilgrastim-jmdb users [P < 0.05] and 10.0% of pegfilgrastim-cbqv users [P < 0.001] had a history of neutropenia vs 19.2% of pegfilgrastim originator users; Table 1).
PEGFILGRASTIM COSTS
Adjusted PPPC OOP costs were significantly lower for biosimilars compared with originators. OOP costs were $299 USD (95% CI = 268-331) for the originator, $182 USD (95% CI = 157-207, P < 0.0001) for pegfilgrastim-jmdb, and $159 USD (95% CI = 133-185, P < 0.0001) for pegfilgrastim-cbqv (Figure 1A). There was no significant difference in adjusted PPPC health plan costs and total costs for pegfilgrastim in the first cycle between biosimilars and originator. Adjusted PPPC health plan costs for pegfilgrastim were $5,618 USD (95% CI = 5,332-5,903) for originator, $5,783 USD (95% CI = 5,374-6,191, P = 0.511) for pegfilgrastim-jmdb, and $5,845 USD (95% CI = 5,507-6,182, P = 0.316) for pegfilgrastim-cbqv (Figure 1B). Adjusted PPPC total costs for pegfilgrastim were $6,683 USD (95% CI = 6,411-6,955) for originator, $6,234 USD (95% CI = 5,877-6,591, P = 0.048) for pegfilgrastim-jmdb, and $6,412 USD (95% CI = 6,111-6,712, P = 0.198) for pegfilgrastim-cbqv in the first cycle (Figure 1B).
FIGURE 1.
Adjusted Pegfilgrastim Costs
FN TREATMENT AND MANAGEMENT COSTS
No significant differences were observed for FN treatment costs (OOP costs, health plan costs, and total costs) between patients who used pegfilgrastim originator and biosimilars in the first cycle. Adjusted PPPC OOP FN treatment costs were $192 (95% CI = 78-307) for pegfilgrastim originator, $197 (95% CI = 35-359, P = 0.958) for pegfilgrastim-jmdb, and $240 (95% CI = 49-432, P = 0.680) for pegfilgrastim-cbqv. Adjusted PPPC health plan FN treatment costs were $2,804 (95% CI = 2,314-3,295) for pegfilgrastim originator, $2,970 (95% CI = 2,285-3,655, P = 0.692) for pegfilgrastim-jmdb, and $2,745 (95% CI = 2,149-3,340, P = 0.879) for pegfilgrastim-cbqv. Adjusted PPPC total FN treatment costs were $3,085 USD (95% CI = 2,530-3,639) for pegfilgrastim originator, $3,162 USD (95% CI = 2,391-3,933, P = 0.871) for pegfilgrastim-jmdb, and $3,283 USD (95% CI = 2,526-4,041, P = 0.682) for pegfilgrastim-cbqv in the first cycle.
Likewise, there were no differences in FN management costs between pegfilgrastim originator and biosimilars users in the first cycle. Adjusted PPPC OOP FN management costs were $490 USD (95% CI = 323-656) for pegfilgrastim originator, $337 USD (95% CI = 165-510) for pegfilgrastim-jmdb (P = 0.186), and $426 USD (95% CI = 196-656) for pegfilgrastim-cbqv (P = 0.679). Adjusted PPPC health plan FN management costs were $8,469 (95% CI = 7,869-9,091) for pegfilgrastim originator, $8,854 (95% CI = 7,915-9,792, P = 0.499) for pegfilgrastim-jmdb, and $8,758 (95% CI = 7,985-9,530, P = 0.565) for pegfilgrastim-cbqv. Adjusted PPPC total FN management costs in cycle 1 were $9,830 USD (95% CI = 9,106-10,554) for pegfilgrastim originator, $9,397 USD (95% CI = 8,389-10,404, P = 0.493) for pegfilgrastim-jmdb, and $9,893 USD (95% CI = 9,008-10,777, P = 0.915) for pegfilgrastim-cbqv.
Discussion
This is the first study comparing economic outcomes including drug costs and FN-related costs between pegfilgrastim biosimilars and originator users. Using data from a commercially insured population, we found that OOP costs for pegfilgrastim biosimilars were significantly lower than those for the originator (59% lower for pegfilgrastim-jmdb and 47% lower for pegfilgrastim-cbqv). Although it is tempting to assume that lower OOP expenses could make pegfilgrastim more affordable to patients and payers could drive biosimilar adoption using differential cost sharing structure, 67%-83% of patients were paying zero OOP for the pegfilgrastim. This would limit the potential of using differential cost sharing structure to drive biosimilar adoption and expand pegfilgrastim use. One reason why a high proportion of patients are paying nothing for pegfilgrastim is likely because of the patient assistance program, such as Coherus COMPLETE and Amgen ASSIST 360, offered by the manufacturers. Another reason could be that pegfilgrastim users likely reached their OOP limits for the year because of chemotherapy treatment.
Although wholesale acquisition costs and average sale price are 33% and 6%-11% lower for pegfilgrastim biosimilars compared with the originator,20 we were unable to detect differences in health plan costs and total costs between the pegfilgrastim biosimilars and originator. This may be due to the small sample size of our analysis or the inability to capture rebates and discounts in the claims database. Future studies using larger samples will further address the saving potential of pegfilgrastim biosimilars. Regardless, our findings for pegfilgrastim costs align with previous studies comparing filgrastim costs between biosimilars and originator users showing modest to no difference in costs.6,7
Despite the absence of differences in total costs for pegfilgrastim between biosimilar and originator users, the availability of biosimilars may have other financial and clinical benefits to the health care system and patients through increased competition. Studies have shown that the net price (accounting for all concessions made by manufacturers, including rebates, coupon cards, 340B discount, prompt pay discounts, return provisions, and any other deductions) of both filgrastim and pegfilgrastim originator has dropped since the availability of biosimilars.4 Product differentiation strategy from the branded manufacturers in response to competition from biosimilars, such as development of OBI, can also benefit patients by reducing provider office time and patient travel burden, although several studies have shown that the pegfilgrastim-OBI device is subject to failure at a rate of 1%-6.9%.21-24 Proactively removing legal and regulatory barriers for biosimilars will help mitigate the problem of escalating costs for biologics and advanced technology.
LIMITATIONS
Our study has limitations. First, using a claims database has inherent limitations. For example, because measuring chemotherapy dose is unreliable in claims data, regimens were categorized into 3 FN risk categories based only on the chemotherapy agents received and the cycle length. The possibility of FN risk level misclassification cannot be ruled out. Moreover, although we used a nationally representative commercial claims database, we limited our study sample to patients with certain cancer types, predominately breast, lung, and non-Hodgkin lymphoma, who received selected chemotherapy regimens. Our findings can only be generalized to these patients. We were also unable to capture rebates in claims database, which would result in overestimation of the pegfilgrastim health plan and total costs. Next, we assessed costs in the first cycle only, because we believe this is the most straightforward way of comparing both pegfilgrastim costs and FN treatment costs between biosimilars and originator; it is unclear how the costs incurred later differ from those in the first cycle. Moreover, our analysis was performed in a study population comprising newly and previously diagnosed patients, which may influence the risk of FN and the pegfilgrastim product choice. Although we measured multiple FN risk factors and adjusted for them (some are indicators of previously diagnosed cancer, for example, history of chemotherapy and radiation therapy), residual confounding cannot be ruled out. Lastly, we excluded patients who used pegfilgrastim-OBI in the present analysis because we believe that the benefits OBI brought to patients and providers makes it incomparable to pegfilgrastim prefilled syringe, either biosimilar or originator. Regardless, a previous study found that there is no significant difference in costs between pegfilgrastim-OBI and pegfilgrastim originator.13 As pegfilgrastim biosimilars gain a larger market share, comparisons on specific cancer type and chemotherapy regimen as well as in the context of secondary prophylaxis are needed to advance our understanding on the cost-saving benefits of using biosimilars.
Conclusions
Use of pegfilgrastim biosimilars was associated with lower patient OOP costs but not lower health plan costs. No significant differences in FN treatment and management costs between biosimilars and originator were found. These findings are only applicable to patients with cancer types and selected chemotherapy regimens included in this study.
REFERENCES
- 1.Crawford J, Becker PS, Armitage JO, et al. Myeloid growth factors, version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017;15(12):1520-41. doi: 10.6004/jnccn.2017.0175 [DOI] [PubMed] [Google Scholar]
- 2.Wang CY, Heldermon CD, Vouri SM, et al. Trends in use of granulocyte colony-stimulating factor following introduction of biosimilars among adults with cancer and commercial or Medicare insurance from 2014 to 2019. JAMA Netw Open. 2021;4(11):e2133474. doi: 10.1001/jamanetworkopen.2021.33474 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Hawkins A, Murphy A, McNamara M, Gawade PL, Belani R, Kelsh MA. A survey of oncologists’ perceptions and opinions regarding the use of granulocyte colony-stimulating factors. J Cancer Educ. 2020;35(1):178-86. doi: 10.1007/s13187-019-01638-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.San-Juan-Rodriguez A, Gellad WF, Good CB, Hernandez I. Trends in list prices, net prices, and discounts for originator biologics facing biosimilar competition. JAMA Netw Open. 2019:2(12):e1917379. doi: 10.1001/jamanetworkopen.2019.17379 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Karaca-Mandic P, Chang J, Go R, Schondelmeyer S, Weisdorf D, Jeffery MM. Biosimilar filgrastim uptake and costs among commercially insured, Medicare Advantage. Health Aff (Millwood). 2019;38(11):1887-92. doi: 10.1377/hlthaff.2019.00253 [DOI] [PubMed] [Google Scholar]
- 6.Chen X, Agiro A, Barron J, Debono D, Fisch M. Early adoption of biosimilar growth factors in supportive cancer care. JAMA Oncol. 2018;4(12):1779-81. doi: 10.1001/jamaoncol.2018.5090 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Chen X, Barron J, Agiro A, Debono DJ, Fisch MJ. Real-world comparison of biosimilar filgrastim and reference filgrastim in cancer patients receiving chemotherapy. J Clin Oncol. 2018;36(30_suppl):85. doi: 10.1200/JCO.2018.36.30_suppl.85 [DOI] [Google Scholar]
- 8.Wang W, Li E, Campbell K, McBride A, D’Amato S. Economic analysis on adoption of biosimilar granulocyte colony-stimulating factors in patients with nonmyeloid cancer at risk of febrile neutropenia within the Oncology Care Model framework. JCO Oncol Pract. 2021;17(8):e1139-49. doi: 10.1200/OP.20.00994 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.McBride A, MacDonald K, Fuentes-Alburo A, Abraham I. Conversion from pegfilgrastim with on-body injector to pegfilgrastim-jmdb: cost-efficiency analysis and budget-neutral expanded access to prophylaxis and treatment. J Med Econ. 2021;24(1):598-606. doi: 10.1080/13696998.2021.1916863 [DOI] [PubMed] [Google Scholar]
- 10.McBride A, MacDonald K, Abraham I. Conversion to supportive care with biosimilar pegfilgrastim-cbqv enables budget-neutral expanded access to R-CHOP treatment in non-Hodgkin lymphoma. Leuk Res. 2021;106:106591. doi: 10.1016/j.leukres.2021.106591 [DOI] [PubMed] [Google Scholar]
- 11.Tilleul PR, Rodgers-Gray BS, Edwards JO. Introduction of biosimilar pegfilgrastim in France: Economic analysis of switching from originator. J Oncol Pharm Pract. 2021;27(7):1604-15. doi: 10.1177/1078155220962208 [DOI] [PubMed] [Google Scholar]
- 12.Sun D, Andayani TM, Altyar A, MacDonald K, Abraham I. Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European Union G5 countries: a simulation study. Clin Ther. 2015;37(4):842-57. doi: 10.1016/j.clinthera.2015.01.011 [DOI] [PubMed] [Google Scholar]
- 13.McBride A, Campbell K, Li E, Schroader B, Campbell D, Wang W. Economic and clinical outcomes of pegfilgrastim via prefilled syringe vs on-body injector: a real-world data analysis. J Manag Care Spec Pharm. 2021;27(9):1230-38. doi: 10.18553/jmcp.2021.21010 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Weycker D, Sofrygin O, Seefeld K, Deeter RG, Legg J, Edelsberg J. Technical evaluation of methods for identifying chemotherapy-induced febrile neutropenia in healthcare claims databases. BMC Health Serv Res. 2013;13:60. doi: 10.1186/1472-6963-13-60 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Douglas AG, Schwab P, Lane D, Kennedy K, Slabaugh SL, Bowe A. A comparison of brand and biosimilar granulocyte-colony stimulating factors for prophylaxis of chemotherapy-induced febrile neutropenia. J Manag Care Spec Pharm. 2017;23(12):1221-26. doi: 10.18553/jmcp.2017.23.12.1221 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Li S, Liu J, Guo H, et al. Trends in the use of primary prophylactic colony-stimulating factors and neutropenia-related hospitalization in elderly cancer patients receiving myelosuppressive chemotherapy in the USA: 1995-2015. Support Care Cancer. 2020;28(6):2637-49. doi: 10.1007/s00520-019-05080-w [DOI] [PubMed] [Google Scholar]
- 17.Park RE. Estimation with heteroscedastic error terms. Econometrica. 1966;34(4):888. doi: 10.2307/1910108 [DOI] [Google Scholar]
- 18.Deb P, Norton EC. Modeling health care expenditures and use. Annu Rev Public Health. 2018;39:489-505. doi: 10.1146/annurev-publhealth-040617-013517 [DOI] [PubMed] [Google Scholar]
- 19.Belotti F, Deb P, Manning WG, Norton EC. Twopm: Two-Part Models. Stata J. 2015;15(1):3-20. [Google Scholar]
- 20.Center for Medicare & Medicaid Services. 2019. ASP Drug Pricing Files.
- 21.Mahler LJ, DiBlasi R, Perez A, Gaspard J, McCauley D. On-body injector: an administration device for pegfilgrastim. Clin J Oncol Nurs. 2017;21(1):121-22. doi: 10.1188/17.CJON.121-122 [DOI] [PubMed] [Google Scholar]
- 22.Joshi RS, Egbuna OI, Cairns AS, et al. Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers. Curr Med Res Opin. 2017;33(2):379-84. doi: 10.1080/03007995.2016.1257980 [DOI] [PubMed] [Google Scholar]
- 23.Stuessy P, Sanchez FA, Schober M. Retrospective review of pegfilgrastim on-body injector delivery rates in a large health system. J Clin Oncol. 2017;35(15_suppl):e18273. doi: 10.1200/JCO.2017.35.15_suppl.e18273 [DOI] [Google Scholar]
- 24.McMullen N, PharmD BCOP. Comparing grade 4 neutropenia associated with pegfilgrastim administered via the Onpro device versus manual injection with a prefilled syringe. J Hematol Oncol Pharm. 2018;8(3). [Google Scholar]