Biologic Therapies: Innovative Treatments Confront Real-World Challenges

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American healthcare excels at innovation yet falls short on access.¹ This tension is perfectly encapsulated in the rise of biologics—groundbreaking dermatological therapies that remain out of reach for countless patients and introduce new workplace inefficiencies within dermatology practices. On one hand, biologics represent the pinnacle of scientific progress, engineered to precisely target conditions previously deemed untreatable. However, any dermatology provider (MD, DO, PA, NP) who has prescribed one quickly learns of the immense barriers surrounding them—leading to underutilization and great hesitancy.¹

Biologic therapies, akin to the emergence of smartphones, signify a significant leap forward for medical science. These therapies, with their unique mechanisms of action, offer immense potential for treating some of the most challenging medical conditions. However, much like the unease we experience when confronted with our unexpectedly high weekly screen time, biologics bring their own set of challenges.

Biologics provide transformative treatments, excellent safety profiles, improved patient outcomes through personalized therapy, reduction in symptom severity, and potential long-term healthcare cost savings by preventing disease progression. However, they also introduce a complex array of new educational requirements and paperwork, disrupting clinical workflows and practices. 

These therapies, while promising, necessitate a deeper understanding and coordination within the healthcare system. This article aims to educate dermatology providers about the origins of biologics, the challenges in their implementation, and the potential for superior care with a renewed focus on biologic coordination.²

The Biologics Boom

Biologics are derived from living organisms such as microbes or animal cells, making them larger and more complex compared to traditional "small molecule" drugs. For instance, while aspirin is made up of 21 atoms, a monoclonal antibody biologic contains over 25,000 atoms, rendering it approximately 1000 times larger. Due to their size, biologics require administration through injection or infusion to ensure they reach the bloodstream or targeted tissues effectively, bypassing the digestive system where they could be degraded. Their precision in targeting specific components of the immune system leads to less frequent dosing and often superior effectiveness.³

The management of previously difficult-to-treat dermatology conditions such as psoriasis, psoriatic arthritis, atopic dermatitis, hidradenitis suppurativa, urticaria, and others has completely flipped. Where once there was an overarching sense of hopelessness, now dermatology providers are receiving hugs from patients who are in disbelief of their newfound life after starting a novel biologic.

Understanding the Hesitancy

In reality, the adoption of new technology varies among individuals, with some being slower to embrace it than others. This can be beneficial in certain scenarios. Can you imagine if all 8 million residents of New York City simultaneously started using Apple's new Vision Pro virtual reality headsets? It could lead to significant disruption. Therefore, a degree of hesitancy in adopting new technologies is not always detrimental.

Similarly, it is understandable that many dermatology providers are hesitant to prescribe biologic therapies. Factors contributing to this reluctance include comfort level with new therapies, motivation, fear of adverse effects, and logistical challenges. However, as Dr. George Han, a dermatologist at Mount Sinai, points out, concerns about safety and long-term unknown effects with novel treatments, as well as inexperience with these medicines, have been largely debunked. He states, "Safety-wise, we have had over 15 years of experience with biologics, which have never demonstrated any increased risk of internal malignancy. Some of the newer biologics used in treating psoriasis are even being considered as adjuvant treatments for cancer!"⁴

Biologics in Practice

Any prominent public figure will agree that it takes decades to go viral. So, despite biologics surging in specialties like dermatology, they only account for 2% of all US prescriptions as of 2022. In other words, we are still very early in their mass adoption. Specialties like dermatology, oncology, and recently others are not only getting used to this new world, we are paving the groundwork for subsequent providers.6

The United States is home to over 5000 dermatology practices, catering to a population that exceeds 335 million. With the rising demand for dermatological care coupled with a growing shortage of physicians across the nation, there will be a corresponding increase in the need for biologic medications. However, dermatology providers are acutely aware that the introduction of these advanced therapies places significant pressure on already strained practice workflows.⁵ 

A revealing 2019 study on the prescribing patterns associated with biologic therapies for psoriasis conducted by researchers from the University of Pennsylvania retroactively analyzed a cohort of 34,714 eligible patients with psoriasis. The findings underscore the necessity for a more streamlined approach to biologic patient selection, medication access, and follow-up care. These are major pain points that dermatology providers face in daily practice.⁵ 

Choosing a systemic therapy for a patient with psoriasis involves a complex decision-making process, taking into account factors such as the severity of psoriasis, existing comorbid health conditions, accessibility to healthcare services, and the preferences of both the patient and the healthcare provider. The evidence also confirms that prescriptions for biologic treatments often face restrictive coverage policies or high out-of-pocket costs, leading to insurance denials or the patient forgoing the medication. Moreover, it was found that up to 50% of patients prescribed a biologic therapy did not receive a second prescription for the same medication, highlighting significant barriers to continuity and effectiveness of care.⁶

Biologic Coordination as a Solution

To navigate the complex challenges of administering innovative biologic therapies, many dermatology practices have embraced biologic coordination.

These specialists handle the administrative burdens, from securing financial support to streamlining approval processes, thus enabling more patients to access treatments without directly affecting costs. Janelle Ball, CEO of BC Educators and host of the "That's Derm Good" podcast, highlights the benefits: “When we provide a dedicated biologic coordinator, we not only streamline the process for accessing medication but also significantly enhance patient education and compliance.” Their expertise saves healthcare providers significant time by reducing bureaucracy.

Ball continues, “This dedicated support ensures patients are well-informed about their treatment, understand the steps involved, and have a direct contact for any questions or concerns. It's about making the journey as smooth as possible for them, ensuring they are not just receiving a prescription but are fully supported throughout their treatment. This approach fundamentally changes patient outcomes, making them more likely to stick with their treatment and, ultimately, improving their quality of life.”

Conclusion 

The challenges in biologic therapy access highlight an urgent need for further research. It's crucial to deepen our understanding of biologic coordination, assessing its impact, pinpointing improvements, and finding new ways to improve patient access. This call for research extends beyond academic circles to all healthcare stakeholders. Through focused studies, we have more research to better streamline biologic delivery, ensuring these pivotal treatments reach those in need. Enhancing biologic coordination can connect scientific breakthroughs more effectively with patient care, bridging the gap between innovation and real-world outcomes.

Michael Rubio, PA-C, is a dermatology physician assistant at Infinity Dermatology in Brooklyn, NY. He is the vice co-chair of the Society of Dermatology PAs Communication Committee and a contributor to the National Commission on Certification of Physician Assistants development of the Certificate of Added Qualifications in Dermatology. He is also a co-founder of Plait (plaithealth.com), an innovative communication platform that helps dermatology practices communicate better and work more efficiently.

References

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2. Del Bono M. Best practices for the 2023 biologic coordinator. Practical Dermatology. December 2022. Accessed January 26, 2024. https://practicaldermatology.com/articles/2022-dec/best-practices-for-the-2023-biologic-coordinator/pdf.
3. Kesik-Brodacka M. Progress in biopharmaceutical development. Biotechnol Appl Biochem. 2018 May;65(3):306-322. doi: 10.1002/bab.1617. Epub 2017 Nov 2.
4. Bhatia N, Alexis AA, Del Rosso JQ, et al. Why are dermatologists not writing biologics? Practical Dermatology. January 2021. Accessed January 26, 2024. https://practicaldermatology.com/articles/2021-jan/why-are-dermatologists-inoti-writing-biologics
5. Noe MH, Shin DB, Doshi JA, Margolis DJ, Gelfand JM. Prescribing patterns associated with biologic therapies for psoriasis from a United States medical records database. J Drugs Dermatol. 2019 Aug 1;18(8):745-750.
6. Dodson J, Lio PA. Biologics and small molecule inhibitors: an update in therapies for allergic and immunologic skin diseases. Curr Allergy Asthma Rep. 2022 Dec;22(12):183-193. doi: 10.1007/s11882-022-01047-w. Epub 2022 Nov 8.