AARDA’s Randy Rutta Talks Step Therapy

The following reflects the views of AARDA.

People living with autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, and lupus, rely on individualized care regimens and treatment that reflect their unique immune systems. Their bodies’ responses to treatments and subsequent health can and do vary significantly. Being on a stable treatment helps them to slow or stop the progression of their illness, and maintain their current level of health. Yet step therapy, which requires a person to try and fail on therapies before accessing a preferred, but potentially more expensive medicine can thwart those efforts.

That’s why the American Autoimmune Related Disorder Association (AARDA), a leading voice for people living with autoimmune conditions, is raising awareness about step therapy, its challenges and opportunities for patient-centered reform.

Many treatments for autoimmune conditions involve biologics and other specialty medicines. The differences in health plan coverage place a significant burden on health care providers, who need to document that a patient has tried and failed to benefit from one or more preferred treatments. Studies estimate that meeting step therapy and other insurance prior authorization requirements can take physicians and their staff two business days each week, and one-third of all physicians have staff who work exclusively on prior authorization issues. Those costs and the provider time spent on administrative matters led the American Medical Association, the American Academy of Family Physicians, and other provider and stakeholder groups to develop and endorse principles for reforms, and more than 20 states have passed legislation to limit step therapy.  

NPC had an opportunity to talk with Randy Rutta, AARDA’s President and CEO, about his organization’s efforts to raise awareness about step therapy and opportunities for patient-centered reforms.

NPC: Thanks for talking with us, Randy. People living with autoimmune conditions face many challenges when it comes to diagnosis, finding the right treatment and getting coverage.  How are those challenges unique to someone living with one or more autoimmune conditions? How did those experiences lead AARDA to work on issues with step therapy?

AARDA: It is not uncommon for people with autoimmune disease to spend 3 to 5 to 7 years or more seeking a diagnosis, going to multiple specialists, enduring countless tests, and just suffering, before their disease is confirmed and they secure a treatment that works for them.  Each person is different, what works for one person may not work for another in quite the same way. So patients who finally understand their illness and are prescribed medicines that support better quality of life and reconnect them to family, work, school and community – are the last people who should be asked to arbitrarily switch therapies to meet one-size-fits-all insurance requirements. AARDA hears from these people every day - they are afraid, they are angry, and they are being forced from treatments prescribed by their physicians. Their lives are at risk, and AARDA comes to their defense to push back on step therapy. 

NPC: Is step therapy a problem that is unique to people living with autoimmune conditions?  What are the risks associated with step therapy for these patients?

AARDA: Many people experience step therapy, and for many it is not an issue. But for people with chronic conditions, mental illness, and health issues that require finely-tuned treatment regimens to maintain health and function, step therapy is a disaster.  The consequences of step therapy when the best treatment is denied or deferred can be devastating, sometimes irreversible. Patients forced to wait six months to access a medicine that could work well for them can experience severe pain, loss of work, and frequently permanent joint or other tissue damage.

NPC: Are there times when step therapy is appropriate? If so, what’s the difference?  

AARDA: Doctors often apply step therapy to newly diagnosed persons to test the efficacy of medicines with fewer side effects or that are less expensive before prescribing other medicines, eventually hitting on exactly the right treatment for that patient at that time. Step therapy is not appropriate in situations where the physician, though backed by available clinical evidence, is prohibited from prescribing the best option for treatment. And is certainly not appropriate in cases where a patient is stable and successful on a certain regimen and, due to a change in their insurance status – they change jobs, their employer changes insurance companies, or a formulary shifts – they are forced by step therapy to switch treatments, often with dire negative effects.  Ironically, it is not unusual for step therapy to push patients back onto medicines that have failed them in the past.

NPC: What about the burden on providers?  What do they experience and what are the associated costs?  How are provider groups working with AARDA in raising awareness of the problems and identifying solutions?

AARDA: Doctors, nurses, and medical office staff spend nearly two days a week responding to requirements in making a case, submitting an appeal to navigate step therapy requirements to secure the most effective treatment for their patients.  They face burnout and serious financial loss as they invest inordinate, unnecessary, and too often futile effort advocating on behalf of their patients’ health. Provider groups, including the American Gastroenterological Association, Dermatology Nurses Association, and the National Organization of Rheumatology Managers, have joined with patient groups to promote awareness and reform of step therapy for just this reason under the banner of Let My Doctors Decide.

NPC: Tell me more about AARDA’s efforts in launching Let My Doctors Decide and how that led to you to develop an interactive experience relating to step therapy. 

AARDA: AARDA piloted Let My Doctors Decide in Michigan several years ago to educate and engage patients, providers, and decisionmakers in understanding the harmful effects of step therapy and the need for change. Since then, Let My Doctors Decide (LMDD) has grown into a nationwide campaign to tackle this issue, raising awareness through patient and physician stories, facts and statistics, and an array of resources and tools that interpret the harsh realities of step therapy and its undermining effects of patient health and well-being.  We wanted the truths of step therapy to transcend words on a page to literally be experienced as a twisting, difficult maze of real world requirements and barriers that may or may not lead to needed treatment. That is what led us to develop the “Escape the System” step therapy experience available both as an in-person exhibit and online.

NPC: What are the main features of the experience? Why did you think it was important to actually demonstrate what patients and providers are experiencing?  What has the feedback been so far?  How can people participate?

AARDA: We created an interactive experience to demonstrate obstacles encountered in step therapy, including a highly engaging virtual version, that takes the participants past the red tape, to confront face- to-face the unfilled prescriptions, impossible bureaucracy, and a system that feels rigged to prevent actual access to needed treatments.  Everyone participating in our interactive presentation recognizes the frustrations of step therapy.  Many patients coming through the exhibit actually cried as they relived the pain of the step therapy that they encountered and its harmful impact on their health. Our experience ends on a hopeful note, with opportunities to endorse LMDD patient principles and a petition promoting step therapy reform. And a national map charting the progress of state efforts to reform step therapy, meant to inform and engage participants in home-state advocacy and advance passage of the Step Therapy Act by the U.S. Congress.

NPC: Has COVID-19 changed what patients and providers are experiencing with step therapy? What changes are patients and providers experiencing that you hope will continue when the crisis abates?

AARDA: The coronavirus pandemic has exacerbated the difficulties already confronting people with chronic conditions and has created some flexibility that, if continued, may prove beneficial. Over the past several months, patients experienced severe shortages of critical medicines, disruptions caused by limitations or closure of treatment sites due to COVID-19 related patient care, testing, or precautions for at-risk persons with underlying conditions, and elevated stress leading to worsened health status.  Federal and state policymakers responding to COVID-19, called on insurance plans to make changes that ameliorate some barriers typically found in step therapy, such as offering additional refills, and authorized expanding coverage for telehealth, and home-based therapies.

The impact of COVID-19 has been dramatic and devastating, particularly for persons with chronic health conditions who are routinely disadvantaged by step therapy and other impediments to needed care. It is my hope that the horror of this pandemic and revelation of health disparity in treatment and outcomes will drive recognition and lasting change so that patients and their doctors can, together, determine and secure the right treatments at the right time for optimal, lifetime health and well-being. 

NPC: Thanks for your time, Randy.