Q&A: The Impact of Step Therapy on Patient Care

A recent study, sponsored by Eli Lilly and Company, found access restrictions to therapies, such as biologics, among patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) significantly impacted the odds of treatment effectiveness and adherence.¹ The retrospective study used data from the IBM MarketScan Claims Database to assess treatment effectiveness for 12 months among 3993 patients with RA and 1713 patients with PsA with one or more insurance claims for subcutaneous biologic disease-modifying antirheumatic therapies. In addition, they compared therapy adherence among those with and without access restrictions.

Natalie Boytsov, PhD, health economist and research advisor, of Eli Lilly and Company in Indianapolis, IN.

Among patients with RA and those with PsA, 34.2% and 35.1% had access restrictions, respectively. Of those with restrictions, 70.5% with RA and 78.9% with PsA had insurance plans with step therapy. The odds of treatment effectiveness were 19% and 27% lower among patients with RA and patients with PsA with insurance plans with step therapy compared with those without step therapy. According to the researchers, these differences were driven by differences in therapy adherence, which were 19% lower among patients with RA and 29% lower among patients with PsA with insurance plans including step therapy requirements compared with those without step therapy.

Lead study author Natalie Boytsov, PhD, of Eli Lilly and Company, discussed the study and implications of these findings for patients, dermatologists, and rheumatologists.

Q. Why did you and your team decide to do this study?

A. We conducted this study to expand our understanding of step therapy and its consequences among people with RA or PsA. In this study, we collected compelling data that support our hypothesis that step therapy, which delays people’s access to the full range of available therapies, is associated with worse treatment outcomes. We hope these data demonstrate the need for people to have access to the treatments they need when they need them.

Professional associations and patient advocacy organizations, including the American Academy of Dermatology and the National Psoriasis Foundation, have long pointed to the negative impacts that step therapy can have on people with immune-mediated diseases.^2,3 It is important to emphasize that individuals’ experiences with arthritis therapies varies and that a one-size-fits-all approach does not allow a provider to tailor a treatment plan to their patient’s individual needs. Delaying a person’s access to treatments with different mechanisms of action may delay bringing their disease under better control. We now have data to support this and to describe the additional burden of care that step therapy places on health care providers and payers.

Q. Could you elaborate more on these findings and their implications for how prior authorizations and step therapy impact disease, patient outcomes, and care?

A. We were primarily interested in treatment effectiveness during the 12-month period following the first observed prescription of a biologic or targeted synthetic disease-modifying antirheumatic drug (bDMARD or tsDMARD). We assessed treatment effectiveness using the claims-based algorithm that was defined and validated by Curtis et al.⁴ According to this algorithm, if a patient’s dose is increased, their treatment is changed, or their treatment is supplemented with the addition of a steroid, their treatment is considered “ineffective.”⁴

During this 12-month period, people with RA or PsA in insurance plans with step therapy had lower odds of treatment effectiveness.¹ In addition, more people with access restrictions filled prescriptions for nonsteroidal anti-inflammatory drugs, antidiabetics, antidepressants, glucocorticoids, and antihypertensives than patients without access restrictions. Likewise, some comorbidities, including depression, hypertension, and osteoarthritis, were found to be more common among patients with access restrictions than among people with no access restrictions.

These results¹ indicate an association between step therapy requirements and additional use of medicines and health care services, including hospital services, and this is most likely due to poorly managed disease. When insurance plans impose stringent controls over access to newer medicines and require people to try certain medicines first, patients’ disease may progress unnecessarily, with permanent joint damage leading to greater health care costs, before being brought under control. This also may negatively impact payers’ budgets, as they account for these additional costs.

Q. What are some of your hypotheses for why step therapy negatively impacts these outcomes?

A. The symptoms and treatment needs of people with immune-mediated diseases like RA and PsA can vary widely from person to person. Step therapy tends to disregard this heterogeneity and takes a one-size-fits-all approach that requires patients to first try and fail with an insurance plan’s preferred treatments regardless of their individual medical history, extent of disease, or needs. When patients are forced to try therapies not recommended by their health care providers, they may not see the symptom relief or disease management they need but rather potential side effects without benefit, and dissatisfaction with their outcomes may play a role in the lower treatment adherence seen with these groups.

Q. How does step therapy conflict with current changes in guidelines, specifically the recent American College of Rheumatology/National Psoriasis Foundation guidelines for PsA, and shifts towards introducing disease-modifying therapies, such as biologics, to patients early to prevent disease progression?

A. The latest American College of Rheumatology and National Psoriasis Foundation guidelines for the treatment of people with PsA recommend that health care providers treat to target.⁵ This means they should work with their patients to determine a personalized, measurable treatment goal and start their patients with the treatment that is most likely to help them reach this goal. Step therapy requirements imposed by insurers ultimately impede the ability of health care providers to make personalized treatment decisions with their patients and can impact the patient reaching treatment goals.

Guidelines from organizations like the American College of Rheumatologists and the National Psoriasis Foundation are a great resource designed to guide physicians in their decisions, whereas step therapy requirements prevent health care providers from making optimal decisions. Overall, our data¹ show that people who have RA or PsA experience worse treatment outcomes when their insurance plans impose more stringent control over their access to newer therapies. This is bad for people, because their disease may progress and they may have more comorbidities to treat, and it’s bad for payers, because they incur greater expenses managing more frequent complications.

Q. Is there anything providers can do now to combat these restrictions and improve patients’ access to treatments? 

A. It’s important to note that the study¹ doesn’t just confirm that step therapy impacts the health outcomes of people with RA or PsA—it shows that among insurance plans with access restrictions, step therapy is a common practice. Overall, one-third of patients with RA or PsA in our study had plans that restricted their access to at least one bDMARD or tsDMARD. Among those, 71% of people with RA and 79% of people with PsA were in insurance plans that required step therapy. These data illustrate the prevalence of this practice in rheumatology as well as its consequences.

Health care providers can start by sharing their experiences and concerns with their colleagues and professional organizations. By exchanging best practices for navigating step therapy requirements and requesting exceptions, health care providers can expedite their patients’ access to the full range of treatments and improve their chances for successful treatment outcomes.

Likewise, there are several policy initiatives, at both the state and federal level, that aim to reform the step therapy process and guidelines; health care providers who are politically inclined could engage on those initiatives and call the attention of their elected officials to this issue.

Note: Providers can support patient advocacy organizations such as the National Psoriasis Foundation in their mission to help patients access appropriate treatments. The Foundation is leading the way against step therapy by creating a network of patients, doctors, and advocacy groups seeking to introduce legislation that outlines appropriate step therapy guidelines based on current clinical data and provides clear and concise exceptions to step therapy protocols based on medical necessity. Providers can see which 25 states currently have step therapy legislation in effect and get involved by visiting www.steptherapy.com. 

References

1. Boytsov N, Zhang X, Evans KA, Johnson BH. Impact of plan-level access restrictions on effectiveness of biologics among patients with rheumatoid or psoriatic arthritis [published June 8, 2019]. Pharmacoecon Open. doi:10.1007/s41669-019-0152-1

2. Step therapy legislation. American Academy of Dermatology. https://www.aad.org/advocacy/state-policy/step-therapy-legislation. Accessed August 26, 2019.

3. Stand against step therapy. National Psoriasis Foundation. https://www.steptherapy.com/. Accessed August 26, 2019.

4. Curtis JR, Baddley JW, Yang S, et al. Derivation and preliminary validation of an administrative claims-based algorithm for the effectiveness of medications for rheumatoid arthritis. Arthritis Res Ther. 2011;13(5):R155. doi:10.1186/ar3471

5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5–32. doi:10.1002/art.40726

This article was published in the October 2019 issue of The Dermatologist.