Abstract
BACKGROUND:
Ustekinumab, approved for the treatment of moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC), requires a clinic-administered intravenous (IV) induction infusion (loading dose) followed by transition to self-administered, subcutaneous (SC) injection for maintenance every 8 weeks. Many patients need subsequent dose escalations to obtain or maintain effectiveness. As an increasing number of CD and UC therapies require a similar dosing and escalation strategy, research evaluating care coordination requirements and clinical outcomes for patients prescribed ustekinumab can help guide best practices.
OBJECTIVE:
To describe the care coordination process and response to therapy from decision to treat with ustekinumab through the first 12 months of initiating SC injection and evaluate differences in SC shipment timing between patients filling at a health-system specialty pharmacy (HSSP) compared with a non-HSSP.
METHODS:
A single-center, retrospective cohort study was conducted. Patients prescribed ustekinumab for CD or UC between November 1, 2021, and March 31, 2022, were included. Patients were excluded if they never received an infusion or SC dose, received the SC dose at an infusion center, or became lost to follow-up. Outcomes included time between clinical events (decision to treat to IV infusion, prior authorization [PA] submission, PA approval, and SC shipment), the occurrence of SC shipments between 4 and 8 weeks after infusion (most appropriate time frame to prevent waste), and the occurrence of a dose escalation within the first 12 months of therapy. The occurrence of SC shipments within the 4- to 8-week window were analyzed using a multiple logistic regression with the following covariates: age, insurance type, and filling pharmacy type.
RESULTS:
In the 70 included patients, the median age was 36 (IQR, 28-44) years. Most patients had commercial insurance (79%), and approximately half filled SC doses external to the HSSP (53%). Median time between events was as follows: decision to treat to PA submission: 3 days (IQR, 1-8); decision to treat to PA approval: 6 days (IQR, 3-14); decision to treat to infusion date: 20 days (IQR, 13-25); and PA approval to medication shipment: 49 days (IQR, 34-73). In the 70 SC doses shipped, 64% (n = 45) occurred within the 4- to 8-week window. Prescriptions filled with the HSSP had 2.5 times higher odds of being shipped in the appropriate window compared with non-HSSP prescriptions (95% CI, 0.8-7.8; P = 0.126). Thirty-nine patients (56%) had dose escalations.
CONCLUSIONS:
Ustekinumab initiation and escalation within the first year can be a complex process requiring a high level of care coordination to ensure patients receive timely therapy while reducing potential waste.
Plain language summary
This study looked at how patients with Crohn’s disease and ulcerative colitis started a medicine called ustekinumab and whether patients needed a higher dose. The medicine is first given through an infusion and then a shot under the skin 4 to 8 weeks later. Most patients needed higher doses, and those who used a special pharmacy in the health system were more likely to get their shot when they needed it.
Implications for managed care pharmacy
This study found ustekinumab initiation and escalation within the first year of treatment requires a high level of care coordination to ensure patients receive timely therapy. Health-system specialty pharmacy prescriptions had 2.5 times higher likelihood of being shipped in the appropriate window compared with non–health-system specialty pharmacy prescriptions. Managed care pharmacy stakeholders should consider the impact of patients being dispensed and potentially administering a subcutaneous dose prior to the patient receiving their loading dose to reduce potential waste.
Moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC) is treated with advanced therapies including biologics (ustekinumab, adalimumab, certolizumab, risankizumab, golimumab, mirikizumab, vedolizumab, infliximab, and guselkumab) and small molecule agents (upadacitinib, tofacitinib, ozanimod, and etrasimod).1–8 Recently, 5 advanced therapies (risankizumab, mirikizumab, vedolizumab, infliximab, and guselkumab) have become available as a subcutaneous (SC) formulation for maintenance dosing after the induction intravenous (IV) infusions (loading doses).5–8 Although SC formulations offer a more convenient treatment solution for patients to administer at home, there is added complexity to coordinating care for medications that include both medical and pharmacy billing, which differ in their insurance approval processes and often in the pharmacy personnel involved in the billing.9 The process of initiating a medication requiring an IV induction, billed on the medical benefit, followed by SC maintenance dose, billed on the pharmacy benefit, necessitates care coordination among health care providers, clinic staff, medical and pharmacy billing, potentially multiple specialty pharmacies, and the infusion center.10–12 As UC and CD therapy options advance, care coordination efforts must advance as well to ensure patients can access and benefit from therapy.
Ustekinumab is an interleukin 12 and 23 inhibitor approved by the US Food and Drug Administration (FDA) for moderate to severe CD and UC in 2016 and 2019, respectively.8 Ustekinumab was the first advanced inflammatory bowel disease (IBD) therapy that required an initial IV induction dose followed by self-administered SC dosing every 8 weeks for maintenance treatment.8 Delays in initiating SC ustekinumab of approximately 12 or more weeks from the induction infusion may result in the need for reinduction, causing more health care spend and patient inconvenience.8,10 Because most patients do not achieve remission until they are on the SC maintenance dose, delayed initiation may delay or reverse a therapeutic response.13
In patients who fail to achieve a response or lose an initial response to therapy, providers may administer an ustekinumab reinduction IV dose or escalate ustekinumab doses beyond the current FDA-approved dose by shortening the maintenance SC dosing interval from every 8 weeks to every 4 or 6 weeks.14 Ustekinumab dose escalation because of inadequate response or loss of response has been shown to be an effective strategy, with a previous meta-analysis finding that 55% of patients achieved clinical response after escalation.14 The insurance prior authorization (PA) process required for ustekinumab can impact patient access to treatment at initial prescribing and when dose changes are needed. Patients who experience longer time to insurance approval of dose escalations have been shown to be less likely to have improvement in clinical outcomes such as C-reactive protein levels.15
Integrated health-system specialty pharmacies (HSSPs) have advanced care coordination capabilities such as access to the electronic health record (EHR) as well as proximity to patients and providers.9,16 HSSPs manage patients and specialty medications during transitions of care, including transitioning from a clinic-administered to self-administered specialty medication.9 Previous studies of integrated HSSPs have demonstrated that a designated team managing PAs and the medication access process can result in faster turnaround time for getting medication to patients,16 which has been shown to impact clinical outcomes in patients with IBD.11,12,17 Evaluating the care coordination care process and patient outcomes in the SC ustekinumab population can provide meaningful insights to promote a smooth transition between the initial infusion and maintenance SC dose with minimal delays.9–12,17 The objective of this study was to describe the care coordination process from decision to treat with ustekinumab through a follow-up of 12 months and corresponding clinical outcomes.
Methods
STUDY DESIGN
A single-center, retrospective cohort analysis was conducted in the IBD clinic at Vanderbilt University Medical Center (VUMC). This study was approved by the institution’s institutional review board.
SETTING
VUMC has an integrated HSSP wherein specialty pharmacists and pharmacy technicians are embedded into the IBD clinic to facilitate the comprehensive management of patients on specialty medications for IBD (Figure 1). After a provider chooses to start a patient on ustekinumab, the IBD clinic staff coordinate the initial IV induction dose, which is typically billed on the medical insurance benefit. HSSP pharmacists or pharmacy technicians in clinic submit the PA for the SC maintenance doses on the pharmacy insurance benefit on behalf of the provider regardless of whether the patient will fill at the HSSP or an external specialty pharmacy. If the SC PA is denied, HSSP pharmacists work through the appeal process or explore other potential options for coverage.
FIGURE 1.
Inflammatory Bowel Disease Clinic and Integrated Health-System Specialty Pharmacy Workflow
HSSP = health-system specialty pharmacy; IBD = inflammatory bowel disease; PharmD = pharmacist; RX = prescription; SC = subcutaneous.
Once the PA is approved, HSSP pharmacists coordinate sending the prescription to the insurance or patient-preferred specialty pharmacy. If the prescription is sent to the HSSP dispensing pharmacy, the integrated HSSP pharmacist communicates with the patient, clinic staff, and dispensing HSSP pharmacy team to coordinate timely shipment based on the patient’s IV induction dose date. For prescriptions filled at an external pharmacy, the integrated HSSP pharmacists ensure that the SC prescription is approved on insurance and that financial assistance is in place if needed before having the prescription sent to the external specialty pharmacy. After the prescription is sent to the external pharmacy, the HSSP pharmacist does not intervene to impact shipment times. However, pharmacists will assist if patients reach out to the clinic or HSSP to report issues with the external pharmacy.
PATIENT POPULATION
Patients were included if newly prescribed ustekinumab for CD or UC by a VUMC IBD clinic provider between November 1, 2021, and March 31, 2022. Patients were excluded if they never received an infusion, received the SC dose at an infusion center, never received the first SC dose, or were lost to follow-up after infusion prior to receiving an SC dose (Figure 2). All patients were observed for 12 months.
FIGURE 2.
Study Attrition
HSSP = health-system specialty pharmacy; SC = subcutaneous.
DATA COLLECTION
Patient data were collected from the EHR, specialty pharmacy management system, and dispensing system. Prescription fill dates for patients who did not fill their ustekinumab SC dose at the HSSP were confirmed by calling the external specialty pharmacy. External specialty pharmacies were located across the United States—not only in 1 geographic location. Data were managed using REDCap (Research Electronic Data Capture) hosted at VUMC. REDCap is a Health Insurance Portability and Accountability Act of 1996–secure, web-based software platform designed to support data capture for research studies.18,19
OUTCOMES
The primary outcomes were the number of days between events in the patient journey from decision to treat (defined as date the prescriber decided to initiate treatment with ustekinumab and requested to start the medication access process) to SC shipment including IV infusion, PA submission and approval, and SC shipment. The secondary outcome was the occurrence of SC shipments in an appropriate window defined as between 4 and 8 weeks after infusion. The 4- to 8-week period was considered the most appropriate time for patients to receive their SC dose to prevent waste as patients receiving the SC formulation prior to 4 weeks may need to waste it because of an infusion reaction or other reason to not continue therapy and therefore not require the SC dose; those receiving the SC formulation after 8 weeks may require a reinduction. Additional outcomes included (1) reasons for first PA submission denial; (2) the occurrence of a dose escalation (defined as an increase in frequency from every 8 weeks to every 4 or 6 weeks) within the first 12 months of therapy; (3) reasons for dose escalation (defined as the prescriber changing maintenance dosing to more frequent than every 8 weeks); and (4) time from infusion and SC shipment to dose escalation.
ANALYSIS
Data were summarized using descriptive statistics such as median and IQR for continuous variables and frequencies and percentages for categorical variables. A multiple logistic regression model was used to test for associations between shipment of SC ustekinumab within the appropriate window and the covariates: age, insurance type (commercial vs not commercial), and filling pharmacy type (internal HSSP vs external specialty pharmacy).
Results
There were 75 patients prescribed ustekinumab for CD or UC by a VUMC provider during the study time frame. Of those 75 patients, 5 were excluded for meeting 1 or more exclusion criteria (Figure 2). In the 70 included patients (Table 1), the median age was 36 (IQR, 28-44) years. Patients were predominantly White (n = 63, 90%) and female (n = 42, 60%) with a CD diagnosis (n = 46, 66%). Most patients had commercial insurance (n = 55, 79%), with 64% (n = 45) receiving their infusion outside of VUMC and 53% (n = 37) of patients having SC doses filled at an external specialty pharmacy.
TABLE 1.
Patient Demographics
| Characteristic | HSSP (N = 33) | Non-HSSP (N = 37) | Overall (N = 70) |
|---|---|---|---|
| Age (at time of SC), median (IQR), years | 44 (29-60) | 32 (27-39) | 36 (28-44) |
| Gender | |||
| Female | 20 (61) | 22 (59) | 42 (60) |
| Male | 13 (39) | 15 (41) | 28 (40) |
| Race | |||
| White | 31 (94) | 32 (87) | 63 (90) |
| Black or African American | 1 (3) | 3 (8) | 4 (6) |
| Asian | 1 (3) | 0 (0) | 1 (1) |
| Other | 0 (0) | 1 (3) | 1 (1) |
| Unknown | 0 (0) | 1 (3) | 1 (1) |
| Ethnicity | |||
| Not Hispanic, Latino/a, or Spanish origin | 31 (94) | 32 (87) | 63 (90) |
| Unknown | 1 (3) | 3 (8) | 4 (6) |
| Cuban | 0 (0) | 1 (3) | 1 (1) |
| Other Hispanic, Latino/a, or Spanish origin | 1 (3) | 1 (3) | 2 (3) |
| Diagnosis | |||
| Crohn’s disease | 24 (73) | 22 (59) | 46 (66) |
| Ulcerative colitis | 9 (27) | 15 (41) | 24 (34) |
| Medical insurance type | |||
| Medicare | 8 (24) | 1 (3) | 9 (13) |
| Medicaid | 3 (9) | 0 (0) | 3 (4) |
| Tricare | 0 (0) | 1 (3) | 1 (1) |
| Commercial | 21 (64) | 34 (92) | 55 (79) |
| None | 1 (3) | 0 (0) | 1 (1) |
| Other | 0 (0) | 1 (3) | 1 (1) |
| Pharmacy insurance type | |||
| Medicare | 5 (15) | 1 (3) | 6 (9) |
| Medicaid | 5 (15) | 0 (0) | 5 (7) |
| Tricare | 0 (0) | 1 (3) | 1 (1) |
| Commercial | 22 (67) | 33 (89) | 55 (79) |
| None | 1 (3) | 0 (0) | 1 (1) |
| Other | 0 (0) | 2 (5) | 2 (3) |
All values reported are listed as n (%).
HSSP = health-system specialty pharmacy; SC = subcutaneous.
PATIENT JOURNEY STEPS
Figure 3 shows the time between events in the patient journey. The median time from decision to treat to infusion date was 20 days (IQR, 13-25). SC PA submission occurred a median of 3 days (IQR, 1-8) from decision to treat, and PA approval occurred a median of 6 days (IQR, 3-14) from decision to treat. Decision to treat with ustekinumab to SC shipment was a median of 67 days (IQR, 48-82). The median time from PA approval to medication shipment was 49 days (IQR, 34-73). The median time from infusion to SC medication shipment was 48 days (IQR, 27-54).
FIGURE 3.
Patient Journey on Ustekinumab
All values reported are listed as median (IQR).
PA = prior authorization; SC = subcutaneous.
SHIPPING IN 4- TO 8-WEEK WINDOW
Shipment times relative to the 4- to 8-week window are shown in Figure 4. For all patients, 63% (n = 45) of shipments were sent in the 4- to 8-week window (79% HSSP vs 51% non-HSSP). Prescriptions filled with the integrated HSSP had 2.5 times higher odds of being shipped 4 to 8 weeks after infusion as compared with non-HSSP prescriptions (odds ratio [OR], 2.5; 95% CI, 0.8-7.8; P = 0.126). Neither age nor insurance type was significantly associated with shipments being sent within the 4- to 8-week window (age [per 1 year] OR, 1.03; 95% CI, 0.98-1.07; noncommercial insurance OR, 1.4; 95% CI, 0.3-6.4).
FIGURE 4.
Time to Receiving Ustekinumab Subcutaneous Dose Within 4 to 8 Weeks After Infusion
HSSP = health-system specialty pharmacy.
PA DENIALS
Of the initial SC PAs, 11% (n = 8) were denied. Reasons for initial PA denials were formulary alternative required (n = 6), patient did not meet criteria (n = 1), and infusion completion required prior to SC approval (n = 1).
DOSE ESCALATIONS
Thirty-nine patients (56%) were prescribed a dose escalation (increase in frequency from every 8 weeks to every 4 or 6 weeks) in the first year of therapy. The (non–mutually exclusive) reasons for dose escalation included ustekinumab levels being too low (n = 28, 72%), worsening symptoms (n = 11, 28%), and symptoms not improving since initiation of ustekinumab (n = 15, 39%). The median time from infusion to dose escalation was 130 days (IQR, 110-181).
Discussion
This study found that there are many steps in the ustekinumab IV infusion to SC patient journey that require appropriate timing and can lead to lengthy efforts to coordinate care. Using an integrated HSSP for SC prescription fulfillment after an IV induction dose may help reduce unnecessary medication fulfillment or the need for reinduction by shipping the SC dose within a 4- to 8-week window after infusion. Integrated HSSPs have the unique capability to provide continuity of care for medicines that have complicated IV and SC dosing regimens because of integration with the EHR and communication with clinic staff.9–11
By coordinating the shipment of the ustekinumab SC dose with the administration of the infusion to ship within an appropriate time frame, there could be an opportunity for savings to the payer through avoided waste. Receiving an SC shipment prior to infusion may lead to waste, and financial burden to the patient and/or payer, if the patient does not tolerate the infusion and is unable to continue therapy or if the patient mistakenly injects the SC dose prior to receiving the infusion. Improper dispensing of a 1-month supply of 90 mg/mL SC dose would cost approximately $23,347.04 USD (2025 National Average Drug Acquisition Cost pricing).20 Recent studies have shown that HSSPs significantly outperform non-HSSPs in shortening the time from approval to dispensing specialty medications. However, for medications such as SC maintenance doses, it is not speed but timeliness (receiving the SC dose within the 4- to 8-week window following the IV induction dose) that is of critical importance. This study adds to the current body of literature demonstrating HSSP efforts to reduce waste by showcasing HSSP efforts to fill medications judiciously filling based on appropriate timing.21,22
The potential for delays abound throughout the IV to SC patient journey, which can lead to suboptimal clinical outcomes or medication waste. Among these include initial PA denial (11% within the current study) or lapses in communication among the patient’s health care team. Because of the complex process and growing number of advanced therapies for IBD that require an IV induction dose followed by SC maintenance therapy, the clinic in which this study was performed developed a flowsheet in the EHR to document each step in the patient journey from decision to treat through the patient receiving the SC dose.23 The flowsheet sends pertinent alerts to either the infusion or specialty pharmacist when the next step in the patient journey is due (eg, infusion has been administered, SC PA is needed) to reduce potential gaps in care. The flowsheet is visible to all clinic staff, which provides clinic staff transparency into the patient journey and promotes collaboration between the infusion and specialty pharmacy teams. Clear communication is necessary to ensure that patients initiating ustekinumab are routed in an appropriate and timely manner. Non-HSSP pharmacies must rely on documentation on the prescription or direct patient communication to know if or when an infusion has been administered, if the PA is approved, and when the SC dose should be shipped. Pharmacies without EHR access should develop similar tracking mechanisms to reduce potential gaps and ensure appropriate timing of delivery.
Dose escalations are common with SC ustekinumab administration, and previous literature supports their clinical effectiveness.14,24–28 Approximately half of the patients in this study were prescribed a dose escalation within 12 months of initiating ustekinumab, for reasons including low ustekinumab levels, worsening symptoms, or symptoms not improving since starting therapy.29 Additional reasons for dose escalation supported by the literature include low drug level, continued symptoms or symptoms prior to the next injection, and active disease or inflammation found on imaging.14,24–28 Specialty pharmacists are often responsible for completing PAs and appeals to help patients access escalated doses of advanced therapies. Because the timeliness of PA approvals can affect clinical outcomes in patients with moderate to severe CD or UC, managed care stakeholders should work to reduce potential delays for patients demonstrating clinical need.15 Further studies are needed to determine the impact of dose escalations on patient outcomes.
LIMITATIONS
This study had several limitations. This study was a single-center analysis with a small sample size, and the majority of patients were commercially insured. This sample may not be representative of patient populations in other health care settings. A larger sample size may be warranted to expand upon the findings of the current study. Second, this study only included 1 IV infusion to SC medication although there are several on the market. Future studies may be needed to evaluate the impact of dose escalations on patient outcomes and the ability to dose deescalate when appropriate. Next, this study did not quantify pharmacist time spent on coordinating care between the transition from IV to SC. Further studies are warranted to quantify pharmacist and pharmacy technician time spent on coordinating care for medications that require billing both medical and pharmacy benefit. Lastly, ustekinumab biosimilars have been approved since the completion of this study and might require additional studies to determine whether these findings are generalizable once ustekinumab biosimilars are available.
Conclusions
This study highlights the complexity of care coordination between multiple health care providers upon initiation of ustekinumab for CD or UC. Patients transitioning from ustekinumab IV induction infusion to SC maintenance dosing are at risk of delayed therapeutic response or incurring unnecessary costs if not managed properly. SC prescriptions from the integrated HSSP were more likely to ship in the 4- to 8-week window after infusion. These results support the use of HSSPs when possible to ensure continuity of care. Ustekinumab dose escalation is common and often occurs within 6 months of initiation. Further studies are warranted to determine the impact of dose escalations on clinical outcomes and to better understand the role that HSSPs may have in coordinating care to improve health outcomes.
ACKNOWLEDGMENTS
The project described used REDCap for data management, which is supported by CTSA award No. UL1 TR000445 from the National Center for Advancing Translational Sciences. Its contents are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.
REFERENCES
- 1.Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113(4):481-517. doi: 10.1038/ajg.2018.27 [DOI] [PubMed] [Google Scholar]
- 2.Feuerstein JD, Isaacs KL, Schneider Y, et al. ; AGA Institute Clinical Guidelines Committee. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-61. doi: 10.1053/j.gastro.2020.01.006 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Rinvoq (upadacitinib) . Package insert. AbbVie Inc.; 2024. [Google Scholar]
- 4.Velsipity (etrasimod) . Package insert. Pfizer Labs; 2024.
- 5.Omvoh (mirikizumab-mrkz) . Package insert. Eli Lilly and Co; 2024.
- 6.Tremfya (guselkumab) . Package insert. Janssen Biotech, Inc.; 2025. [Google Scholar]
- 7.Skyrizi (risankizumab-rzaa) . Package insert. AbbVie Inc.; 2024. [Google Scholar]
- 8.Stelara (ustekinumab) . Package insert. Janssen Biotech, Inc.; 2020. [Google Scholar]
- 9.Zuckerman AD, Carver A, Cooper K, et al. An integrated health-system specialty pharmacy model for coordinating transitions of care: Specialty medication challenges and specialty pharmacist opportunities. Pharmacy (Basel). 2019;7(4):163. doi: 10.3390/pharmacy7040163 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Peterson J, Budlong H, Tisthammer B, Paine T, McNamara A, Simonson D. Ensuring continuity of care for patients transitioning from intravenous to subcutaneous therapy at a health system owned specialty pharmacy. J Drug Assess. 2018;7(suppl 1):19. doi: 10.1080/21556660.2018.1521080 [DOI] [Google Scholar]
- 11.Choi DK, Rubin DT, Puangampai A, Lach M. Role and impact of a clinical pharmacy team at an inflammatory bowel disease center. Crohns Colitis 360. 2023;5(2):otad018. doi: 10.1093/crocol/otad018 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Choi DK, Cohen NA, Choden T, Cohen RD, Rubin DT. Delays in therapy associated with current prior authorization process for the treatment of inflammatory bowel disease. Inflamm Bowel Dis. 2023;29(10):1658-61. doi: 10.1093/ibd/izad012 [DOI] [PubMed] [Google Scholar]
- 13.Lamb YN, Duggan ST. Ustekinumab: A review in moderate to severe Crohn’s disease. Drugs. 2017;77(10):1105-14. doi: 10.1007/s40265-017-0765-6 [DOI] [PubMed] [Google Scholar]
- 14.Meserve J, Ma C, Dulai PS, Jairath V, Singh S. Effectiveness of reinduction and/or dose escalation of ustekinumab in Crohn’s disease: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2022;20(12):2728-40.e1. doi: 10.1016/j.cgh.2021.10.002 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Shah NB, Zuckerman AD, Hosteng KR, et al. Insurance approval delay of biologic therapy dose escalation associated with disease activity in patients with inflammatory bowel disease. Dig Dis Sci. 2023;68(12):4331-8. doi: 10.1007/s10620-023-08098-7 [DOI] [PubMed] [Google Scholar]
- 16.Zuckerman AD, Whelchel K, Kozlicki M, et al. Health-system specialty pharmacy role and outcomes: A review of current literature. Am J Health Syst Pharm. 2022;79(21):1906-18. doi: 10.1093/ajhp/zxac212 [DOI] [PubMed] [Google Scholar]
- 17.Bhat S, Zahorian T, Robert R, Farraye FA. Advocating for patients with inflammatory bowel disease: How to navigate the prior authorization process. Inflamm Bowel Dis. 2019;25(10):1621-8. doi: 10.1093/ibd/izz013 [DOI] [PubMed] [Google Scholar]
- 18.Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Harris PA, Taylor R, Minor BL, et al. ; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208. doi: 10.1016/j.jbi.2019.103208 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Centers for Medicare & Medicaid Services . NADAC (National Average Drug Acquisition Cost) 2025. Updated April 16, 2025. Accessed April 16, 2025. https://www.medicaid.gov/medicaid/nadac
- 21.Looney B, Crumb J, White S, et al. Financial impact of integrated specialty pharmacy efforts to avoid oral anticancer medication waste. J Manag Care Spec Pharm. 2024;30(5):465-74. doi: 10.18553/jmcp.2024.30.5.465 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Zuckerman AD, Mourani J, Smith A, et al. 2022 ASHP survey of health-system specialty pharmacy practice: Clinical services. Am J Health Syst Pharm. 2023;80(13):827-41. doi: 10.1093/ajhp/zxad064 [DOI] [PubMed] [Google Scholar]
- 23.Fann J, Kozlicki M, Nichols P, et al. Implementation of a flowsheet to track patients with inflammatory bowel disease initiating a biologic with complex dosing regimens. J Manag Care Spec Pharm. 2023;29(10-a)(suppl):s1-s138.38051146 [Google Scholar]
- 24.Bennett A, Evers Carlini L, Duley C, et al. A single center experience with long-term ustekinumab use and reinduction in patients with refractory Crohn disease. Crohns Colitis 360. 2020;2(1):otaa013. doi: 10.1093/crocol/otaa013 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Ollech JE, Normatov I, Peleg N, et al. Effectiveness of ustekinumab dose escalation in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2021;19(1):104-10. doi: 10.1016/j.cgh.2020.02.035 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Fumery M, Peyrin-Biroulet L, Nancey S, et al. Effectiveness and safety of ustekinumab intensification at 90 mg every four weeks in Crohn’s disease: A multicenter study. J Crohns Colitis. 2020;jjaa177. doi: 10.1093/ecco-jcc/jjaa177 [DOI] [PubMed] [Google Scholar]
- 27.Haider SA, Yadav A, Perry C, et al. Ustekinumab dose escalation improves clinical responses in refractory Crohn’s disease. Therap Adv Gastroenterol. 2020;13:1756284820959245. doi: 10.1177/1756284820959245 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Kopylov U, Hanzel J, Liefferinckx C, et al. Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous maintenance therapy. Aliment Pharmacol Ther. 2020;52(1):135-42. doi: 10.1111/apt.15784 [DOI] [PubMed] [Google Scholar]
- 29.Petrov JC, Al-Bawardy B, Alzahrani R, Mohamed G, Fine S. Rates, predictors, and outcomes of ustekinumab dose escalation in inflammatory bowel disease. J Clin Gastroenterol. 2025;59(3):232-6. doi: 10.1097/MCG.0000000000002003 [DOI] [PubMed] [Google Scholar]