Impact of Biologic Utilization Management Programs in Atopic Dermatitis

Treatment for atopic dermatitis (AD) has evolved from primarily topical and oral therapy (largely generic) to include subcutaneously injected biologicals. Despite biologics’ increased efficacy, their high cost leads health plans and pharmacy benefit managers to implement utilization management (UM) programs to control spending, with equal or improved overall outcomes. UM programs may include prior authorization (PA) for initial prescriptions, reauthorizations for dose changes or continued use, step therapy, and clinical and/or prescriber requirements. UM programs may manage costs but introduce unintended barriers to optimizing patient outcomes, such as administrative burdens on providers, delayed treatments, and increased health care resource use.¹ In an American Medical Association (AMA) survey, 93% of respondents indicated PAs lead to treatment delays, 82% stated PAs lead to treatment abandonment, and 29% indicated PAs lead to adverse events in their patients.¹ In an American Hospital Association survey,² most patients (62%) have had medical care delayed because of their insurance provider in the past 2 years, and 43% of those patients say their health has gotten worse as a result. A reevaluation of UM policies for AD is needed to address barriers, reduce costs, and maximize outcomes.

Clinical Management of AD

Treatment goals for AD are to prevent or relieve symptoms, achieve long-term disease control, and manage comorbidities and secondary AD complications.³ Currently, the foundation of AD care is the treatment of the disturbed skin barrier with daily use of emollients to hydrate the skin and the avoidance or reduction of triggers, such as food or chemical allergens.⁴ First-line antiinflammatory treatment includes topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) (eg, tacrolimus, pimecrolimus), as well as a topical PDE4 inhibitor (crisaborole). Phototherapy, as monotherapy or in combination with topical treatments, is considered if AD is uncontrolled topically.

The American Academy of Dermatology recently updated its guidelines for AD⁵ to include topical therapies, phototherapy, and systemic therapies, which include biologics, Janus kinase (JAK) inhibitors, and immunosuppressants.

Oral JAK inhibitors include upadacitinib (Rinvoq; AbbVie) and abrocitinib (Cibinqo; Pfizer), representing a new treatment approach that can provide rapid control of the disease and an oral route of administration. However, these have been associated with safety issues and the need for routine monitoring.⁶

Four biologic therapies for AD have been approved: dupilumab (Dupixent; Sanofi and Regeneron) and tralokinumab (Adbry; Leo Pharma), nemolizumab (Nemluvio; Galderma Laboratories) and lebrikizumab (Ebglyss; Eli Lilly).

Dupilumab, a human monoclonal IgG4 antibody, was approved by the US Food and Drug Administration (FDA) in 2017 for moderate to severe AD for patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are inadvisable.⁷

Tralokinumab-ldrm was approved by the FDA in 2021 for the treatment of moderate to severe AD in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those topical therapies are inadvisable.⁸ Tralokinumab is administered by subcutaneous injection.⁹

Nemolizumab is an IL-31 receptor antagonist approved for adults and pediatric patients aged 12 years and older with moderate to severe AD in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies and is administered by subcutaneous injection.¹⁰

Lebrikizumab is an IL-13 antagonist indicated for the treatment of adults and pediatric patients aged 12 years and older who weigh at least 40 kg with moderate to severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is administered by subcutaneous injection.¹¹

Perceptions of AD Treatments

The AMA states, “The (UM) requirements that gobble up physician and staff time while interrupting or delaying appropriate care need to be dramatically reshaped to ensure they are clinically valid and implemented in a way that is transparent, timely, efficient, flexible, and standardized.”¹² This statement is included in a comprehensive set of 21 principles to reform PA requirements that were endorsed by 16 additional organizations representing physicians, medical groups, hospitals, and patients. Key categories include clinical validity, continuity of care, transparency and fairness, timely access, and administrative efficiency, and provide alternatives and exemptions.¹²

Howell et al estimate that payers, manufacturers, physicians, and patients incur about $93.3 billion annually on UM. While payers spend approximately $6.0 billion on drug UM, manufacturers, physicians, and patients spend around $87.3 billion supporting patient access and navigating UM and on drug cost sharing. Decreasing UM could benefit all stakeholders by combining lower drug prices with easier patient access.¹³

In particular, PAs can be costly to dermatology practices. A University of Utah Department of Dermatology study itemized all PA-related encounters over a 30-day period in September 2016. Across 9512 patient encounters, 626 PAs (6.58%) were generated, roughly 20 PAs daily. At a cost of $15.80 each, biologic PAs took up to 31 business days to complete, causing delayed treatment and decreased patient adherence and deterring providers from advocating for their patients. The study concluded that PAs are costly to dermatology practices, and their value appears limited for some requests. Fewer unnecessary PAs and appeals might increase practice efficiency and improve patient outcomes.¹⁴

Patients and health care providers (HCPs) report treatment challenges that impact patients’ physical, emotional, and mental well-being. HCPs indicate biologics provide symptom improvement, offering many patients a near-normal quality of life; demonstrate rapid onset, good efficacy, and tolerability over the long term; and are a viable option for patients who have exhausted all other available treatment options.¹⁵

Poor adherence, a significant problem in AD, leads to poor outcomes.¹⁶ Although adherence to topical AD treatments may be more than 90% at treatment initiation, that decreases with extended use (30% at 8 weeks). Patients’ resistance to complex topical treatment regimens and fears about steroid use contribute to poor adherence.¹⁷

Off-label treatments may face significant insurance barriers, as many health plans have automatic PAs for off-label prescribed drugs. The University of Pennsylvania evaluated the impact of PAs in patients with complex dermatological conditions seen by a dermatologist over 5 months. Of 51 PAs, 51% were initially denied, with systemic medications more likely to be denied than topical medications (P < 0.0001). Total administrative time spent on 50 PAs tracked was 62.5 hours, and the median delay to treatment was 12 days across all treatments.¹⁸This suggests that UM programs increase workload and costs in dermatology practices. An Academy of Dermatology survey concluded that PA burden remains high and consumes substantial clinical resources, potentially impacting patient care negatively.¹⁹

Coverage and Benefit Design

To optimize patient outcomes at the lowest overall cost, many health plans implement UM policies. With a goal to prevent unnecessary or inappropriate care, these UM policies restrict the use of certain (usually more expensive) therapies to patients.²⁰ The effectiveness of biological therapies for moderate to severe AD is proven.⁷ If results in general therapy are similar to results in AD therapy, with increases in treatment delays, treatment abandonment, and additional adverse events, such UM policies may be overly limiting, leading to delayed treatment response and higher costs.¹

In 2017, UM policies for dupilumab largely focused on clinical and prescriber requirements and step-therapy protocols. An analysis by the Tufts Medical Center’s Specialty Drug Evidence and Coverage (SPEC) Database of US commercial health plans’ coverage policies for specialty drugs observed changes in coverage policies for dupilumab, including PA requirements, over time (Figure).²¹ For example, in 2017, 10% of health plans required an Investigator Global Assessment score of 3 to 4 for coverage, but by 2020, that number dropped to 0%. Meanwhile, the percentage of plans requiring patients to have greater than or equal to 10% body surface area affected increased from 30% in 2017 to 57% in 2021 and has now leveled off at just under 50%.

Although prescriber or step-therapy requirements may be managed electronically at the point of service, a PA requires the provider to gain approval from the health plan before providing a particular therapy. The health plan often uses the original study’s clinical requirements as initial PA criteria. Development of criteria and subsequent reauthorization as new data becomes available place substantial burdens on payers and providers. Delays in obtaining safe and effective treatment may be a burden to patients as well.

Tralokinumab is approved with a potential reduction in dose every 4 weeks at 16 weeks in patients whose disease is being adequately controlled. When a patient who has been successfully down-titrated to a less frequent dose (every 4 weeks) of tralokinumab experiences a flare, the initial management typically involves adding TCS or TCI. If this approach is insufficient, the prescriber may need to escalate back to the more frequent dose (every 2 weeks). However, the requirement for a new PA for this dose increase can cause a delay in implementing the necessary treatment escalation, potentially extending the duration of the patient’s flare beyond what is clinically optimal. With step therapy, requiring a series of less-effective and less-cost-effective medications to be used prior to introducing AD biologics may lead to long-term increased cost and potential negative outcomes due to restricted access to more effective treatments. While this may lead to cost reductions and provide less burden to patients, UM programs requiring a reauthorization for potential flares may counteract both the clinical benefit and cost savings to the plan.

PAs and reauthorizations may limit payer cost savings across AD biologics. Delaying treatment with biologics may lead to the unintended increased use of health care resources such as emergency visits, as well as patients’ time off work due to repeated phone calls and follow-up physician visits to obtain access to biologic therapy or to discuss and implement alternative treatment pathways. In patients with AD, requiring reauthorization after specified periods, as opposed to allowing ongoing refills, may further increase unintended resource use and costs. Many patients with AD may remain clear for extended periods posttreatment and, therefore, under current UM policies may require reauthorization to restart therapy when their symptoms return.

Changes to UM Policies

New thinking is warranted around access management of biologics in AD. Researchers developed an automated substitution program for the least expensive TCS for AD that reduces delays in treatment initiation and alleviates the administrative burden of PAs.²² The same principle could be applied for biological therapies, where the more cost-effective biologic would be covered without a PA. To encourage dose reduction where appropriate with biologics, neither therapy, once initiated, should require reauthorization.

Conclusion

The goals of AD treatment are to prevent or relieve symptoms, achieve long-term disease control, and manage comorbidities and secondary AD complications. Recent advances using biologicals such as tralokinumab and dupilumab have resulted in improved outcomes in patients with AD. To optimize outcomes at the lowest cost, health plans have implemented UM programs, which may delay treatment with biologicals, burden providers and patients, and increase costs to health plans. UM programs should not worsen outcomes in AD patients, and health plans should follow AMA principles for UM, including clinical validity, continuity of care, transparency and fairness, timely access, and administrative efficiency, and provide alternatives and exemptions. Restructuring PA and reauthorizations will hopefully result in better results for providers, patients, and payers.

Diana Brixner, PhD, BPharm, is a professor emeritus in the Department of Pharmacotherapy, founder of the Pharmacotherapy Outcomes Research Center at the University of Utah, and principal of the Millcreek Outcomes Group, LLC, in Salt Lake City.

Joseph Biskupiak, PhD, MBA, is an emeritus research professor in the Department of Pharmacotherapy and former director of the Pharmacotherapy Outcomes Research Center at the University of Utah in Salt Lake City.

Gary Oderda, PharmD, MPH, is a professor emeritus in the Department of Pharmacotherapy, former director of the Pharmacotherapy Outcomes Research Center at the University of Utah, and a principal of the Millcreek Outcomes Group, LLC, in Salt Lake City.

Jeffrey D. Dunn, PharmD, MBA, is the president and CEO of Cooperative Benefits Group in Salt Lake City, Utah.

Acknowledgements

The authors acknowledge James Chambers of Tufts Medical Center for providing and updating the Figure specifically for this report and Kelley J. P. Lindberg for her technical editing of the manuscript.

Study Funding Disclosure Statement

This study was funded by Leo Pharma. Leo Pharma provided input into the initial study concept and design, but had no influence over the study execution and the decision to publish.

Potential Conflicts of Interest Statement

Dr Brixner, Dr Biskupiak, and Dr Oderda report financial support through an unrestricted educational grant from Leo Pharma to Millcreek Outcomes Group, LLC, where they are principals. Dr Dunn reports no potential conflicts of interest.

References

1. 2024 AMA prior authorization physician survey. American Medical Association. Accessed August 6, 2025. https://www.ama-assn.org/system/files/prior-authorization-survey.pdf
2. New surveys find majority of patients, doctors & nurses say health insurer policies reduce access to care. News release. American Hospital Association. July 11, 2023. Accessed August 6, 2025. https://www.aha.org/press-releases/2023-07-11-new-surveys-find-majority-patients-doctors-nurses-say-health-insurer-policies-reduce-access-care
3. Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(suppl 8):S115-S123.
4. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140-6736(20)31286-1
5. Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. J Am Acad Dermatol. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102
6. Olivera PA, Lasa JS, Bonovas S, Danese S, Peyrin-Biroulet L. Safety of Janus kinase inhibitors in patients with inflammatory bowel diseases or other immune-mediated diseases: a systematic review and meta-analysis. Gastroenterology. 2020;158(6):1554-1573.e12. doi:10.1053/j.gastro.2020.01.001
7. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303. doi:10.1016/S0140-6736(17)31191-1
8. Adbry. Prescribing information. Leo Pharma A/S; 2024. Accessed August 6, 2025. https://mc-df05ef79-e68e-4c65-8ea2-953494-cdn-endpoint.azureedge.net/-/media/corporatecommunications/us/therapeutic-expertise/our-product/adbrypi.pdf?rev=d8ced7cbd6874a6997427ab88a2093e0
9. Duggan S. Tralokinumab: first approval. Drugs. 2021;81(14):1657-1663. doi: 10.1007/s40265-021-01583-1
10. Nemluvio. Prescribing information. US Food and Drug Administration. Accessed August 6, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf
11. Ebglyss. Prescribing information. Eli Lilly and Company. Accessed August 6, 2025. https://pi.lilly.com/us/ebglyss-uspi.pdf
12. O’Reilly KB. 21 principles to reform prior-authorization requirements. American Medical Association. January 25, 2017. Accessed August 6, 2025. https://www.ama-assn.org/practice-management/prior-authorization/21-principles-reform-prior-authorization-requirements
13. Howell S, Yin PT, Robinson JC. Quantifying the economic burden of drug utilization management on payers, manufacturers, physicians, and patients. Health Aff (Millwood). 2021;40(8):1206-1214. doi:10.1377/hlthaff.2021.00036
14. Carlisle RP, Flint ND, Hopkins ZH, Eliason MJ, Duffin KC, Secrest AM. Administrative burden and costs of prior authorizations in a dermatology department. JAMA Dermatol. 2020;156(10):1074-1078. doi:10.1001/jamadermatol.2020.1852
15. Ameen M, Meller S, Pinter A, Shear NH, Soria A; the BADEL Study Group. Perception and experience of biologic therapy in atopic dermatitis: a qualitative focus group study of physicians and patients in Europe and Canada. Dermatol Ther (Heidelb). 2021;11(6):2159-2177. doi:10.1007/s13555-021-00631-8
16. Feldman SR, Cox LS, Strowd LC, et al. The challenge of managing atopic dermatitis in the United States. Am Health Drug Benefits. 2019;12(2):83-93.
17. Snyder A, Farhangian M, Feldman SR. A review of patient adherence to topical therapies for treatment of atopic dermatitis. Cutis. 2015;96(6):397-401.
18. Jew OS, Okawa J, Barbieri JS, McCaffrey J, Hayward E, Werth VP. Evaluating the effect of prior authorizations in patients with complex dermatologic conditions. J Am Acad Dermatol. 2020;83(6):1674-1680. doi:10.1016/j.jaad.2020.06.998
19. Petitt CE, Kiracofe E, Adamson A, Barbieri JS. Prior authorizations in dermatology and impact on patient care: an updated survey of US dermatology providers and staff by the American Academy of Dermatology. Dermatol Online J. 2021;27(1):13030/qt990631n9.
20. Utilization management. SummaCare. Accessed August 6, 2025. https://www.summacare.com/providers/utilization-management
21. Chambers J, Jenkins N. US commercial payer coverage of dupilumab varies widely. Tufts Medical Center, Center for the Evaluation of Value and Risk in Health. September 24, 2021. Accessed August 6, 2025. https://cevr.tuftsmedicalcenter.org/news/2021/dupilumab
22. Omar D, Brown-Korsah JB, Taylor SC, Mollanazar N. Automated pharmacy substitution for medications not covered by Medicaid: a model for reducing the burden of prior authorizations in dermatology. J Am Acad Dermatol. 2023;88(1):258-260. doi:10.1016/j.jaad.2022.09.039