Prices for dermatologic medications have skyrocketed over the past decade due to an increase in demand and the development of new therapies. [1,2] As an example, the FDA recently approved OPZELURA™ (ruxolitinib) for vitiligo which can cost over $2,000 for a single tube. In the United States (US), psoriasis is one of the most common immune-mediated diseases affecting adults.[3,4] Psoriasis drugs are driving autoimmune market growth, with sales of over $40 billion expected by 2031.[1]

Due to the rising price of dermatology medications, payers are increasingly using prior authorization (PA or prior auth) to keep costs in check. Prior auth is a utilization management process requiring healthcare providers (HCPs) to obtain approval from payers before prescribing expensive medications such as biologics.[5,6]

However, PAs are often required for less expensive, commonly prescribed dermatologic drugs, such as clobetasol and isotretinoin.[5] Dermatologists are increasingly frustrated by the burden of PAs and their impact on patient care.[5]

This article provides an overview of prior authorizations in dermatology, current challenges, and solutions to improve the prior auth process for patients and HCPs.

Background

Since 2009, the retail price of 19 of the most commonly prescribed name-brand dermatology medications has increased by over 400%.[7] Even generic brands increased by 279% between 2011 and 2014.[7] Some medications, such as Carac cream and nystatin-triamcinolone, have existed for over a decade and experienced some of the highest price rises.[7]

Why are prices for common dermatology medications continuing to rise? According to some studies, limited manufacturing and anti-competitive activities among drug manufacturers are responsible for the continuous increase.[8]

Approximately 30% of the global population suffers from dermatologic conditions, and the demand for dermatologic medications will continue to rise as the population ages and skin cancer rates increase.[9] In particular, biologics for skin cancer and psoriasis are driving demand and prices for dermatologic medications.[1,7,9]

Biologics are medications made from living organisms and remain the most expensive on the market. Consequently, payers frequently utilize PAs or step therapy when HCPs prescribe biologics for dermatologic conditions. For example, 87% of patients require PAs for HUMIRA® (adalimumab), a common systemic biologic for patients with moderate to severe chronic plaque psoriasis.[5] PAs present challenges to HCPs, office managers, biologic coordinators, and patients.

Challenges

Dermatologists have been particularly affected by PA challenges because of the rising costs of dermatologic medications.[10,14] On average, dermatologists receive 420 PA requests annually.[10]. A 2020 survey of 252 dermatologists and dermatology office managers discovered the following: [5]

• 60% of dermatologists had to interrupt their patient visits to respond to PAs.

• 45% of PA approvals required over a week.

• 12% of PAs led to patients delaying or abandoning treatment.

• 17% of PAs forced patients to use less effective treatments.

PAs challenge dermatologists and patients by interfering with the physician-patient relationship, delaying patient care, and increasing physicians’ administrative burden. [5,6,10] Other challenges dermatologist face when prescribing drugs that require a PA include an outdated formulary, denials, and delays.[11,13]

1. Outdated formularies

Many dermatologists point to outdated formularies as a challenge when trying to obtain the best treatment for their patients.[11] Formulary decisions are typically made by payers and pharmacy benefit managers (PBMs) without insight from HCPs.[11] As a result, Tier 1 therapies are often outdated, have multiple black box warnings, or are ineffective for specific patients (i.e., lack of personalized medicine).[11] Restrictive formularies and off-label prescriptions force many patients to pay out of pocket for dermatologic medications.[14]

2. Delays

A study conducted in 2020 found that patients with complex dermatological conditions experience a median delay of 12 days.[14] Outdated formularies and step therapy can delay patients’ access to optimal treatment. Delays of only 5 days can lead to hospitalization, as one dermatologist cited for a patient with severe psoriasis flare.[10] The patient was unable to obtain a prescription for cyclosporine, a common medication dermatologists believe should not require a PA.[10] The delay resulted in an extended hospitalization and thousands of dollars in expenses for the insurer.[10]

3. Denials

The same 2020 study reported a 51% denial rate for patients with complex dermatological conditions.[14] When PAs are denied, HCPs and staff are forced to navigate the appeal process, which is often unclear and time-consuming.[11] Additionally, staff may not have the medical background necessary to navigate the PA process, resulting in miscommunication between office staff and payers.[6] This miscommunication leads to delays and denials.[6]

All of these challenges affect patients in multiple ways, including increasing medication costs and decreasing adherence to therapy.[14] About 20% of patients cite PAs for their inability to adhere to their acne medications.[14] PAs also cause downstream costs for patients and insurers when appropriate treatment is delayed or denied.[14] Multiple solutions are needed to improve the PA process in dermatology, along with collaboration among all participants.

Solutions

The American Academy of Dermatology (AAD) stated that greater transparency from payers and PBMs may improve patient access to medications.[16] The AAD also emphasizes the importance of communication, delegation, and streamlined processes.[15] Streamlining PA processes includes using automated PA tools and electronic prior authorizations (ePAs). Automated PA tools such as CoverMyMeds can reduce the time it takes for patients to reach therapy by 25%.

Other large-scale solutions to enhance the PA process for HCPs and patients include improving outdated formularies, increasing pharmacy substitution, and incorporating PAs into electronic health records (EHRs).[11,15-18]

1. Improving outdated and restrictive formularies

Many formularies exclude or place targeted dermatologic medications at the bottom of the formulary list, potentially compromising patient safety. [11] Formularies often ignore the heterogeneity of symptoms and conditions among patients.[16] In particular, this is true for people with complex dermatologic conditions, for whom the PA process is more likely to delay or deny appropriate therapy.[14] Payers need to ensure formularies remain flexible enough to accommodate individualized patient care.[16]

Additionally, formularies differ between plans, further complicating the PA process.[11] Although payers insist the information is readily available, dermatologists say the information is not accessible at the point of care (POC).[11] Increasing transparency, clarifying the appeals process, improving insight from HCPs, and emphasizing medication safety and efficacy can improve formulary development and implementation.[11,14,16]

2. Increasing automatic therapeutic exchange

Automatic therapeutic exchange or pharmacy-level substitution refers to the ability of pharmacists to substitute a generic or a biosimilar (less expensive versions of biologics) for a brand-name drug without consulting the prescriber. Dermatologists generally support the automatic substitution of equivalent drugs.[17] Additionally, the AAD advocates reducing barriers that prevent generics from reaching the marketplace.[16]

Drug substitution can reduce pharmaceutical costs and improve healthcare efficiency. As a result of the interchangeability of all biosimilars in Europe, the overall cost of drugs has decreased in Europe. The first interchangeable biosimilar for HUMIRA®, Cyltezo® (adalimumab-adbm), will enter the market in 2023, reducing therapy costs for patients with moderate to severe psoriasis. A switching clinical trial of Cyltezo was conducted called the Voltaire-X trial [NCT03210259] and demonstrated the same safety and clinical outcomes as HUMIRA®. Drug substitutions can reduce drug costs and patients’ waiting time for treatment.

3. Incorporating prior authorizations into the electronic health record

Incorporating the PA process into the EHR can also speed up a patient’s access to medication. With the PA process integrated into the EHR, HCPs, and staff can stay informed about patient therapy delays.[13] Currently, EPIC is working with payers to incorporate a PA workflow into every patient’s EHR.

Integrating the PA process into HCPs and staff’s normal workflow can reduce the administrative burn and the burnout rate for clinicians, who often cite the heavy documentation burden as a reason for their burnout.[13] While not the only possible solutions, the solutions discussed here represent potential steps toward improving medication access, enhancing patient outcomes, and reducing HCP burnout.

To learn more about becoming a certified prior authorization or board-certified biologics specialist, visit the ACMA marketplace.

Author: Dr. Theresa Vuskovich, University of Florida Master of Pharmacy in Precision Medicine and Master of Public Health student (class of 2023)

References

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Market Growth. Iqvia.com. Accessed January 21, 2023.https://www.iqvia.com/-/media/iqvia/pdfs/library/articles/iqvia-forecast-link-autoimmune-market-article.pdf

2. IQVIA Institute for Human Data Science. Global Use of Medicines 2023. Iqvia.com. Accessed January 21, 2023. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicines-2023/iqvia-institute-global-use-of-medicines-2023-report-01-23-forweb.pdf

3. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021;157(8):940-946. doi:10.1001/jamadermatol.2021.2007.

4. Laughter MR, Maymone MBC, Karimkhani C, et al.The Burden of Skin and Subcutaneous Diseases in the United States From 1990 to 2017. JAMA Dermatology. 2020;156(8):874. doi:10.1001/jamadermatol.2020.1573.

5. 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. Published 2021 Jan 15.

6. Psotka MA, Singletary EA, Bleser WK, et al. Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative’s Prior Authorization Learning Collaborative. Circulation: Cardiovascular Quality and Outcomes. 2020;13(7). doi:10.1161/circoutcomes.120.006564.

7. Rosenberg ME, Rosenberg SP. Changes in Retail Prices of Prescription Dermatologic Drugs From 2009 to 2015. JAMA Dermatol. 2016;152(2):158-163. doi:10.1001/jamadermatol.2015.3897.

8. Li DG, Joyce C, Mostaghimi A. Association Between Market Competition and Prices of Generic Topical Dermatology Drugs. JAMA Dermatol. 2018;154(12):1441-1446. doi:10.1001/jamadermatol.2018.3798.

9. IQVIA Institute for Human Data Science. Biologics-The Key to Next Generation Dermatology R&D? Iqvia.com. Accessed January 21, 2023. https://www.iqviabiotech.com/library/white-papers/biologics-the-key-to-next-generation-dermatology-rd

10. 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.

11. Darves B. Dealing with prescription prior authorization in dermatology – practical dermatology. Accessed January 21, 2023. https://practicaldermatology.com/articles/2019-mar/dealing-with-prescription-prior-authorization-in-dermatology

12. Gavidia M. Dr Jason Ezra Hawkes on prior authorization, clinical documentation issues limiting atopic dermatitis treatment access. AJMC. Published October 26, 2022. Accessed January 21, 2023. https://www.ajmc.com/view/dr-jason-ezra-hawkes-on-prior-authorization-clinical-documentation-issues-limiting-atopic-dermatitis-treatment-access.

13. Digital innovation to the rescue: The future of electronic prior authorization in dermatology – practical dermatology. Accessed January 21, 2023. https://practicaldermatology.com/articles/2018-june/digital-innovation-to-the-rescue-the-future-of-electronic-prior-authorization-in-dermatology

14. 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.

15. Bhatia S. Optimizing prior authorization documentation. Aad.org. Accessed January 21, 2023. https://www.aad.org/dw/monthly/2020/december/answers-in-practice-optimizing-pa-documentation

16. Albrecht J, Lebwohl M, Asgari MM, et al. The state and consequences of dermatology drug prices in the United States. J Am Acad Dermatol. 2016;75(3):603-605. doi:10.1016/j.jaad.2016.03.053.

17. Kassamali B, Faletsky A, Han JJ, et al. Physician Perspectives on the Effect of Topical Steroid Costs on Patients and Proposed Solutions. JAMA Dermatol. 2022;158(1):79-83. doi:10.1001/jamadermatol.2021.414018. Johansen ME, Richardson C. Estimation of Potential Savings Through Therapeutic Substitution. JAMA Internal Medicine. 2016;176(6):769. doi:10.1001/jamainternmed.2016.1704.