Medicaid Coverage and Utilization for Novel Therapies for Chronic Rhinosinusitis With Nasal Polyposis

Key Points

• Most state Medicaid programs granted omalizumab (91.4%) and dupilumab (59.5%) preferred drug status.

• Omalizumab was the most commonly prescribed therapy among Medicaid patients between 2015 and2024.

1. Introduction

The Food and Drug Administration (FDA) has recently approved novel treatments for chronic rhinosinusitis with nasal polyposis (CRSwNP), including an exhalation delivery system with fluticasone (EDS‐FLU [2017]) and biologic therapies (dupilumab [2019], omalizumab [2020], and mepolizumab [2021]). Recent work has demonstrated rapid adoption among Medicare beneficiaries [1]. However, little is known about utilization among Medicaid beneficiaries, who are primarily low‐income adults and children. Prior work demonstrates that these patients suffer from more severe sinonasal inflammatory disease, substantial barriers to rhinologic care, and worse outcomes following sinus surgery [2, 3, 4]. These inequities could be exacerbated by restrictive drug coverage policies, which state Medicaid programs may implement to reduce spending. We therefore sought to understand the extent to which state Medicaid programs cover novel treatments for CRSwNP and therapeutic uptake among this medically and socially vulnerable population.

2. Methods

We cross‐sectionally analyzed Medicaid coverage for EDS‐FLU and FDA‐approved biologics for CRSwNP (dupilumab/omalizumab/mepolizumab). We reviewed publicly available coverage policies specified in state Medicaid formularies and preferred Ddrug List (PDLs) in July 2025 in accordance with established methodology [5]. Though Medicaid covers nearly all drugs for FDA‐approved indications, most state programs steer patients and clinicians toward drugs on formularies and PDLs (i.e., “preferred” drugs) [6]. For example, states may lower co‐pay requirements for preferred drugs or stipulate that beneficiaries fail treatment with preferred drugs before authorizing coverage of non‐preferred alternatives. States select drugs based on both clinical and economic considerations; pharmaceutical manufacturers often negotiate substantial rebates to obtain preferred status.

We classified each drug by preference status (preferred/non‐preferred) in each state and determined whether prior authorization (yes/no) or step therapy (yes/no) was required. States may grant preferred status to more than one drug within the same class (e.g., omalizumab and dupilumab as respiratory biologics). For states with indication‐specific policies, we restricted analysis of preference status and coverage requirements to CRSwNP.

We extracted national utilization for each drug between 2015 and 2024 from public Medicaid State Drug Utilization database, which reports aggregate numbers of reimbursed prescriptions across indications. We excluded utilization prior to 2015, when omalizumab was the only FDA‐approved respiratory biologic available. We normalized annual utilization to the number of Medicaid beneficiaries enrolled in January of each year to account for program expansion during the study period.

We used descriptive statistics to characterize state coverage policies and Medicaid utilization. We performed all analyses using Microsoft Excel (version 16.97). This study was not considered human subjects research and therefore did not require exemption or approval from the institutional review board at The Ohio State University College of Medicine.

3. Results

Our analysis of coverage policies included 47 states with public formularies or PDLs, including 10 (21.3%) states with CRSwNP‐specific coverage policies; most included state (n = 37, 78.7%) coverage policies were indication‐agnostic. Preference status varied widely by drug (Figure 1). Omalizumab (n = 43 of 47; 91.4%) was preferred in nearly all states. Dupilumab (n = 28 of 47, 59.5%) and mepolizumab (n = 19 of 47, 40.4%) were preferred in approximately half. Few states granted preferred drug status to EDS‐FLU (n = 2 of 47, 4.25%). Most states imposed prior authorization or step therapy requirements for both preferred and non‐preferred drugs (Figure 1).

FIGURE 1.

Medicaid coverage of novel CRSwNP therapies in states with formularies or Preferred Drug List in 2025. Caption: Among the 50 US states, 47 had public formularies or preferred drug lists and three (New Mexico, South Dakota, and Hawaii) did not. Initial FDA approval years for included drugs were omalizumab (2003; asthma), mepolizumab (2015; asthma), dupilumab (2017; atopic dermatitis), and EDS‐FLU (2017; chronic sinusitis with nasal polyposis).

Between 2015 and 2024, Medicaid utilization for these drugs increased per beneficiary (relative difference [RD]: 169.1%; compound annual growth rate [CAGR]: 11.6%; Figure 2) and overall (RD, 220.8%; CAGR, 13.8%; Figure S1). Omalizumab was the most commonly prescribed drug throughout the study period and accounted for 74.4% of the prescriptions in 2024. Dupilumab utilization increased substantially following FDA approval (CAGR 2017–2019: 141.7%) but precipitously declined thereafter (CAGR 2019–2024: −20.9%). Mepolizumab and EDS‐FLU utilization remained low following FDA approval. Drug prescription volumes were similar in states with and without CRSwNP‐specific coverage policies in 2024 (Figure S2).

FIGURE 2.

Reimbursed prescriptions per beneficiary for novel CRSwNP Therapies in Medicaid, 2015 ‐ 2024. Caption: Includes all reimbursed prescriptions in the 50 states, District of Columbia, and US territories (e.g., Puerto Rico) covered under fee‐for‐service or managed care organization programs. Utilization aggregated across all FDA‐approved indications. Initial FDA approval years for included drugs were omalizumab (2003; asthma), mepolizumab (2015; asthma), dupilumab (2017; atopic dermatitis), and EDS‐FLU (2017; chronic sinusitis with nasal polyposis).

4. Discussion

In this study of Medicaid coverage and utilization for novel CRSwNP therapies, we found that omalizumab had received preferred drug status in nearly all states and accounted for the majority of prescriptions. These findings contrast recent analysis of the Medicare population in which dupilumab utilization is rapidly growing and exceeds all other respiratory biologics [1]. State Medicaid programs may favor omalizumab for both historical and financial reasons. Omalizumab received initial FDA approval in 2003 and may therefore benefit from first‐mover advantage for both adult and pediatric indications; states may perceive less clinical need to grant preferred status to follow‐on drugs. Omalizumab is also substantially less expensive than other biologics; the annual cost per beneficiary of dupilumab is more than twice that of omalizumab to both Medicare Part D and commercial plans [7, 8].

The primary limitation of our study is that we were unable to stratify biologic utilization by indication using publicly available Medicaid data. Though manufacturers typically do not report indication‐level sales, the utilization trends we observed were likely driven by FDA‐approved treatment indications with larger market sizes, including asthma (omalizumab, dupilumab, mepolizumab) and atopic dermatitis (dupilumab). However, we expect that our results are directionally correct for the CRSwNP indication because our analysis of CRSwNP‐specific coverage policies (as applicable) demonstrated that omalizumab was preferred in a substantially higher proportion of states than other biologics.

Our findings have important implications for patient care. Though head‐to‐head trials have not been completed, indirect comparisons suggest that omalizumab is inferior for the treatment of both CRSwNP and asthma compared to other biologics [9, 10]. Medicaid coverage policies preferencing omalizumab therefore reflect an implicit tradeoff between fiscal sustainability and clinical effectiveness. Recently enacted reductions in Medicaid funding may further limit access to biologic therapy for disadvantaged patients.

Funding

The authors have nothing to report.

Conflicts of Interest

Zachary M. Soler is a consultant for Olympus, OptiNose, and Regeneron and is Medical Director for Healthy Humming. Rodney J. Schlosser is a consultant for OptiNose, Stryker, Medtronic, and Regeneron and is Medical Director for Healthy Humming. The remaining authors declare no conflicts of interest.

Supporting information

Supplemental Figure 1: Medicaid Reimbursement of Novel FDA‐Approved Therapies for CRSwNP, 2015 – 2024

Supplemental Figure 2: Reimbursed Prescriptions for Novel CRSwNP Therapies in Medicaid in 2024, Stratified by State Coverage Policy Type