The Impact of Step Therapy on Individuals with Psoriatic Disease in the USA: Patient and Provider Perspectives

Abstract

The management of psoriatic disease has been revolutionized by biologic medications in recent years. Despite their efficacy and safety, patients are often required by insurance plans in the USA or national formulary guidelines in other countries to try and fail other treatments first, which is a strategy called step therapy. Originally designed to contain costs of specialty drugs, step therapy has a number of negative impacts on patients and providers, both personally and clinically. This article is coauthored by a patient with psoriasis and psoriatic arthritis who navigated step therapy. She describes her early experiences with psoriasis and achieving disease control with biologic medication, only to later be diagnosed with psoriatic arthritis and need to revise this treatment plan. She then explains how insurance denials and step therapy impact her life physically, emotionally, socially, and medically. This case is then discussed from the perspective of a dermatologist specializing in inflammatory skin disease. We highlight the psychosocial burden of psoriatic disease, as well as the burden of step therapy and its impacts on patients, providers, and the entire medical system.

Key Summary Points

Psoriatic disease has profound psychosocial impacts on patients.

Biologic medications are efficacious and safe treatments for psoriasis and psoriatic arthritis.

Many insurance providers implement step therapy plans, requiring patients to try and fail medications.

Step therapy is meant to contain costs for insurance providers; however, it can have negative impacts on patients and providers.

Commentary

Patient’s Perspective

As a medical student, I hoped I would have the knowledge and resources to successfully navigate the American healthcare system and access the clinically appropriate treatments that every patient deserves. While experiencing my first severe psoriatic arthritis (PsA) flare during my initial month at the Pritzker School of Medicine, I realized this hope was naïve, not capturing the extent of hoops I had to jump through to acquire proper treatment.

The road to finding an appropriate medication for many patients with chronic disease is a long one, made increasingly difficult by insurance utilization-management strategies such as step (fail-first) therapy. Intended to prevent overuse of high-cost medications, step therapy is a tiered insurance tactic in which patients must try and “fail” lower-tier treatments before receiving coverage for higher-tier (more expensive) treatments [1, 2].

This process often delays access to medically necessary treatments, with patients’ conditions potentially worsening each day. Declining physical health and accompanying feelings of powerlessness in turn erode mental health, with a significant percentage of patients (52%) and friends/family members (44%) who faced step therapy reporting extremely negative impacts on their mental health [3]. For me, delays in my treatment mean the possibility of irreversible joint damage and an increased future risk of cardiovascular disease [4].

Throughout the last 2 years, I have had insurance coverage for risankizumab, an injectable biologic medication (biologic) that has managed my moderate-to-severe psoriasis. This therapy has brought me from a full body covered in red scaly plaques to completely clear skin—a seemingly miraculous feat.

I still remember waking up anxious, scared to look in the mirror knowing that my psoriasis would likely have spread. The constant stares I received filled me with embarrassment, and activities I loved, like volleyball and weightlifting, became dreadful, as the sweat made my skin burn. I rarely slept well, as my skin was constantly irritated, and often had to lay surrounded by ice packs to alleviate the itching. At its worst, my psoriasis impacted my whole body, covering approximately 40% of my body surface area. Once I received my first biologic and achieved clear skin again, I thought that the fight was over, that I was allowed to be a normal 21-year-old again.

But my miraculous health was temporary, as I was diagnosed with both peripheral and axial PsA when I started medical school. What was supposed to symbolize a joyous milestone of my budding medical journey turned into weeks of grieving the end of a life without physical disability. Thus, I became part of the approximately one in three people with psoriasis who eventually develop PsA [5].

With this, I had to switch to a different biologic that could help manage my joint disease—and I needed to switch urgently. Each day, my body pain worsened; some days, I could not walk to class due to my debilitating back pain. I remember crying in my Dean’s office, wondering whether my diagnosis would prevent me from achieving my dream of becoming a physician.

Every aspect of my life worsened. No matter how exhausted I was, I rarely slept more than 3 h per night due to the pain, which drastically hurt my academic performance. No matter how excited I was to get make new friends, I did not have the capacity to socialize after class; I just needed to rush home, lay down, and turn on my heat pad.

Despite my declining quality of life, I remained optimistic. Bimekizumab, a highly efficacious biologic, had recently received Food and Drug Administration (FDA) approval for use in patients like myself with moderate-to-severe psoriasis and/or PsA. Unfortunately, the medication was not on my insurance plan’s formulary, its approved list of medications that could be covered. Although I thought I could leverage my resources as a medical student to request coverage for this medication, I was mistaken.

After receiving notice of a preliminary insurance denial, I was initially unphased. I knew insurance claims were regularly denied, with 250 million health claims denied by health insurance companies each year [6]. Channeling disappointment into action, I gathered heaps of medical records to show this treatment was medically necessary, and my rheumatologist submitted my records alongside a formal appeal.

Approximately 3 weeks later, I received yet another notice of denial, with a letter stating that I needed to try and fail three more of my insurance company’s preferred—but likely less effective—drugs before they would consider coverage. I closed my denial letter, heavy with disappointment. My insurance company insisted I must try, fail, or show contraindications for two or more of the following medications: ustekinumab, apremilast, guselkumab, etanercept, or adalimumab; this in addition to records proving 6 months of moderate benefit from secukinumab. Was the fact that I could not sleep, could not walk, could not cook, and could not function as a normal 24-year-old not enough?

Taken collectively, I would have to continue trying and failing different biologics for at least 12 more months before I could try the treatment my doctor thought was most medically appropriate, because biologics for PsA require 3–6 months of dosing to evaluate whether they are effective. All of the medications suggested by my insurance company are known to be less effective for psoriasis than risankizumab, and many of them are ineffective for axial PsA.

With my physician-recommended treatment retailing for approximately $20,000 per dose and $180,000 in year 1 of use, paying out-of-pocket was simply unfathomable. I was distraught.

All I wanted was to be a normal medical student and worry about my classes, but my biggest stressor was my health. I spent hours on end calling my insurance company, my specialty pharmacy, my school health center, my medical center financial office, the drug manufacturer, and support programs, desperate for help on how I can get my new treatment.

Eventually, I was able to receive the biologic I advocated for through a 2-year access program from the medication’s manufacturer, designed to support patients experiencing insurance denials. After 3 months in the access program, I received notice that the program staff worked with my insurance company to achieve approval, especially due to how remarkably my life has changed since starting my new biologic. Now, I rely on the manufacturer’s co-pay assistance program to ensure the biologic is affordable to me, bringing costs down from $40 per dose with insurance coverage to $5 per dose with co-pay assistance. Still, these programs operate only in the context of our broken healthcare system, existing to address large and persistent gaps in care—a small bandage on a much larger problem.

Step therapy was originally employed to promote clinically appropriate care while mitigating costs for both health plan and patient [7]. Unfortunately, the opposite is occurring—patients cannot access treatments their physicians recommend, health plans spend more on outpatient services, and patients recoil at the enormous retail cost of their necessary medications [2].

Although I am grateful for the care and kindness that I have received from my dermatology and rheumatology care team, I still live in fear of what the future may hold for my PsA. My entire health, and thus, my potential as a medical student and future physician, is dependent on the efficacy of one expensive biologic that I need to use for the rest of my life, one that I am not guaranteed access to.

Despite trying my best to maintain an internal locus of control, there are times where I catch myself thinking about the “what-if’s.” What if the co-pay assistance program loses funding and I cannot depend on that avenue to help me access the biologic anymore? What if I change insurance plans when I graduate medical school and am forced to start this process all over again? What if this particular biologic stops working?

Even so, I ground myself in the aspects of my life that I can control, and practice exercises of gratitude. I know I am not alone in this unfortunate experience and the encouragement of my loved ones helps me stay afloat. For now, I will appreciate my newly stable health, and live 1 day at a time.

Provider Perspective

It is a privilege to hear about Dayna’s experience with psoriatic disease, biologic medications, and step therapy, and her story highlights issues and barriers that many psoriatic disease patients encounter.

I was first struck by the impact of psoriasis (PsO) and PsA on Dayna’s life. Like many patients with PsO and PsA, Dayna recalls the emotional distress she experienced as a result of the disease. In fact, patients with PsO are at higher risk of developing depression, anxiety, and suicidal ideation compared to the general population [5]. Factors associated with greater risk of mental health comorbidities include younger age at diagnosis and more severe psoriasis [8]. Athletic hobbies worsened Dayna’s PsO, thus forcing her to give them up while her PsO was at its highest severity.

PsA further impacted Dayna’s life, as she shared not being able to sleep more than 3 h per night due to pain. A 2023 study investigating the relationship between PsA and sleep found that 63.15% of patients with PsA had poor sleep quality as assessed by the Pittsburgh Sleep Quality Index [9]. Pain, fatigue, and anxiety were found to be top contributors to this poor sleep [9]. In addition to PsA, PsO impacted Dayna’s sleep, which is unfortunately the case for many patients [10, 11]. Poor sleep further affected Dayna’s social life, as she felt unable to engage with her friends due to fatigue. Psoriatic disease contributes to social isolation in part due to its effect on sleep, but also because of stigma surrounding skin disease, patients’ feelings of embarrassment and low self-esteem [12]. Moreover, PsO and PsA may impact patient’s ability to engage in work and school, worsening social isolation and financial burden [12]. Results of the 2009–2011 National Psoriasis Foundation (NPF) survey showed that 49% of PsO patients reported missing work regularly due to disease symptoms [13]. Of the respondents who were not employed, 92% said PsO or PsA were the main reasons why were there not currently working [13]. From Dayna’s experience and current evidence, it is clear that PsO and PsA have significant negative effects on patient’s lives.

Another important aspect of Dayna’s story was her journey getting diagnosed with PsA. As Dayna points out, about one in three patients with PsO will be diagnosed with PsA at some point in their lives [5]. However, unlike Dayna’s experience of developing PsA and receiving a diagnosis within 2 years of her PsO diagnosis, on average PsA is diagnosed 7 years after PsO [14]. Factors contributing to this delay include the lack of available diagnostic tests and inconsistent screening for PsA [14]. In conversation with Dayna, she said she was never given a Psoriatic Epidemiology Screening Tool (PEST), which screens for PsA, throughout her disease course. She also described feeling like her early joint symptoms and pain were due to inactivity and sitting for long periods of time, as she was studying for exams at the time. Dayna’s experience highlights a unique aspect of PsA compared to PsO: in its early stages, it is an invisible disease. For this reason, Dayna said she was not convinced she had PsA. She knew she had a skin disease when she first started experiencing PsO because it was clearly visible, but the lack of visual findings associated with PsA made her question her symptoms. In a study investigating predictors of mental health difficulties in patients with autoimmune arthritis, feeling like one’s disease was invisible was a significant predictor of mental health postmorbidities [15].

Other challenges of PsA include difficulty of accessing multispecialty care. In order to receive a diagnosis of PsA, Dayna had to be seen by a rheumatologist. However, the available biologics have different effects in treating PsA and PsO [16], so working with both rheumatology and dermatology providers enables effective and pragmatic treatment plans. Primary care is also critically important in the care of PsO and PsA patients in order to address cardiac and metabolic comorbidities [5].

Dayna’s experience navigating step therapy is perhaps the most powerful part of her story. Unfortunately, the challenges and barriers that Dayna faced are not unique to her; these same difficulties affect millions of PsO and PsA patients in the USA. Step therapy is a strategy employed by insurance plans to limit the cost of medications and prevent overuse of expensive therapies. In summary, they require patients to try therapies in a tiered fashion; they must fail a therapy before the insurance plan will pay for the subsequent therapy. Step therapy impacts patients on a personal level, as well as clinically.

Dayna highlights the ways step therapy impacted her life. Her insurance plan required her to try and fail three other therapies before she would be able to try the biologic preferred by her rheumatologist. Three of these medications (ustekinumab, apremilast, and guselkumab) are not proven as effective for axial PsA, which is one of Dayna’s chief concerns. Despite submitting a formal appeal, she was denied this medication twice. Dayna estimates that between August and October 2024, which happened to be her first quarter of medical school, she spent about 1–3 h each day researching medication options and insurance appeals and calling her insurance provider, specialty pharmacy, and medical providers. In fact, the American Medical Association (AMA) estimates patients and providers spend cumulatively 14.6 h per week working on prior authorizations, which are often required for therapies to be paid for by insurance providers [17]. Of all physicians surveyed by the AMA, 84% viewed prior authorizations as a high burden to their jobs [17]. In addition to the time spent, dealing with insurance coverage denials is associated with increased incidence of frustration and depression amongst patients [18].

Step therapy has important implications for patients’ clinical courses as well. It dictates the order in which patients can receive therapies, although these plans are not always in agreement with current clinical guidelines. One study analyzing 194 step therapy protocols for PsO found that none were consistent with current clinical treatment guidelines and that 99.4% were more stringent than current treatment guidelines [19]. In that same study, of 202 PsA step therapy plans, 1.9% were consistent with clinical treatment guidelines, and 68.4% were more stringent [19]. Despite the American Academy of Dermatology (AAD), National Psoriasis Foundation (NPF), and American College of Rheumatology (ACR) recommending biologic medications as first-line treatment for PsA, step therapy requires patients to first try and fail topical, oral systemics, and phototherapy protocols [20]. Notably, quality of evidence for treatments was more important than cost of the treatment when creating ACR treatment guidelines for PsA [21]. The reasons step therapy protocols may differ from clinical guidelines are multifactorial, but may in part be due to the tactics adopted by insurance companies when negotiating with drug manufacturers.

Requiring patients to fail therapies before trying subsequent therapies has a number of clinical consequences. A 2019 study investigating treatment outcomes among patients with rheumatoid arthritis and PsA found that patients who had restrictions on available treatments due to step therapy had 27% lower odds of treatment effectiveness compared with all other patients [22]. Additionally, the odds of medication adherence were 29% lower among PsA patients with step therapy requirements compared with all other patients [22]. In one survey, 78% of physicians reported that prior authorizations often lead to patients stopping their current treatment, with 92% of physicians reporting that prior authorizations have an overall negative impact on patients’ clinical outcomes [17]. In a recently published study, Florenzo et al. [23] analyzed treatment delays as a result of step therapy in using dupilumab to treat atopic dermatitis [23]. These authors found that step therapy caused an average treatment delay of over 4 months and an average of 1.4 additional appointments before treatment could be initiated [23]. Patients with step therapy insurance plans required an additional 112 days of treatment for symptom improvement compared to patients without these restrictions [23]. Time is critical in the treatment of PsO and PsA. As Dayna shared, being forced to try several therapies before getting an effective biologic approved risked irreversible joint damage.

Understanding the US pharmaceutical and drug industry is the key to understanding why step therapy is a common strategy amongst insurance providers. Many other countries utilize international reference pricing (IRP) to set the price of drugs or to limit how much insurers can spend on drugs [24, 25]. In the USA, however, drug manufacturers set prices themselves, and insurers must negotiate these costs for plan members via pharmacy benefit management companies. Insurers implemented step therapy plans to contain costs, especially as the price of specialty drugs have increased in recent years. However, several studies have shown that this strategy does not actually reduce medical spending overall, but rather shifts the cost to other entities, including patients and pharmacies [26–29]. A 2020 economic analysis projected that step therapy could even increase costs for insurers in the case of treating Crohn’s disease [30]. The cost savings of step therapy is theoretical, as there are no studies showing it definitively reduces spending. If patients and providers choose a treatment plan that includes a medication outside of the step therapy, as Dayna did, they face steep out-of-pocket costs that are often prohibitory.

Dayna’s story navigating PsO and PsA illustrates a scenario in which step therapy may not be in the best interest of the patient. Her symptoms were debilitating and interfered with her social and academic life because her insurance plan denied the use of a disease-modifying medication due to its step therapy protocol. Although Dayna eventually gained access to this medication, she could lose access to it if she were to change insurance providers or plans. Patients switching health insurance plans due to changes in employment may have to start over with step therapy. Many step therapy protocols require patients to fail each therapy, even it is a therapy they have tried and failed in the past [31]. It is also possible that patients may be required to try a therapy even if it is contraindicated [2].

Step therapy, while theoretically a strategy to reduce and contain high medication costs, has serious impacts on both patients and providers. Currently, 38 states have enacted legislation to protect patients on step therapy protocols [32]. Some of these protections state an override request will be granted if the step therapy drug is contraindicated or likely to cause and adverse reaction, if the step therapy drug likely to be ineffective, if the patient has tried and failed the step therapy drug previously, if the patient is currently stable on a different drug, or if the drug is not in best interest of patient [32]. However, not all 38 states have this complete list of protections, and 12 states have no protections at all. The Safe Step Act is a federal bill that ensures that all group health plans, including employer plans, offer patients and their providers a step therapy exception request process, requires plans to respond to exception requests within 24–72 h, and establishes circumstances when a patient should be granted exceptions by their health plan [2]. Passage of the Safe Step Act through Congress would offer protections to a much larger group of patients than current state legislation, as the majority of people in the USA receive health insurance through their employers.

While Dayna’s story is deeply personal, her experience is one shared by millions of patients in the USA. As dermatology providers, we must take these stories in mind as we help patients navigate chronic disease, prior authorizations, and step therapy.

Author Contributions

Patient perspective preparation was completed by Dayna Pham and Melissa C. Leeolou. Provider perspective preparation was completed by Georgia Marquez-Grap. First draft of the manuscript was written by Georgia Marquez-Grap and Dayna Pham and all authors (Georgia Marquez-Grap, Dayna L. Pham, Andrea Leung, Melissa C. Leeolou, Allison Kranyak and Wilson Liao) commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Funding

No funding or sponsorship was received for this study or publication of this article.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analyzed.

Declarations

Conflict of Interest

Wilson Liao has received research grant funding from Amgen, Janssen, Leo, and Novartis. Wilson Liao is an Editorial Board member of Dermatology and Therapy. Wilson Liao was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Georgia Marquez-Grap, Dayna Pham, Andrea Leung, Melissa C. Leeolou, and Allison Kranyak have no disclosures to declare.

Ethical Approval

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.