Doctors Oppose Step Therapy's Effect on Patients

“As a doctor, I am forced by insurance company requirements to let many of my patients fail on older, ineffective medicines before they become eligible for the treatments I know will make them better,” rheumatologist Paul Barton Brown, MD, wrote in a recent Seattle Times editorial. Brown was discussing step therapy, a policy introduced by managed care organizations in the 1980s as a way to control prescription drug costs. Insurance companies and pharmacy benefit managers (PBMs) use step-therapy policies to require doctors to prescribe older, less expensive drugs first, which patients must fail to respond to adequately before they become eligible for newer, more expensive treatments.

PBMs and insurers reason that patients may be helped by an older drug and not need the newer, more expensive one. Leanne Gassaway, Senior Vice President of State Affairs at America’s Health Insurance Providers (AHIP), explains that step therapy encourages physicians and patients to undertake a more evidence-based approach to treatment: “When you tailor a plan to the patient, you can gauge the patient’s response to medications before graduating to the more potent and higher-risk drugs.” Most large employers now offer employee health plans that require step therapy, according to the American Academy of Dermatology, 1 of several patient and physician organizations that opposes step therapy. According to the Coalition of State Rheumatology Organizations (CSRO), some health plans require that patients try up to 5 different medications with durations lasting up to 130 days per medication.

Opponents of step therapy refer to the policy as “Fail-First.” Brown said his patients must endure worsening health if they are forced to take a series of ineffective treatments. The problem is compounded when patients have to switch insurance companies and repeat the process of “failing” medications that they have already tried without success. Additionally, patients who receive such therapies may have skyrocketing out-of-pocket costs as they pay co-pays for numerous doctor’s visits and for drugs that fail to work.

Doctors decry step-therapy protocols that are not based on their medical assessments of the best treatment for a patient, and which undermine the doctor-patient relationship. “I have pledged first to do no harm,” says dermatologist Gil Yosipovitch, MD, of Temple University Health System in Philadelphia. “How can I be required to prescribe medicines to patients for whom they are inappropriate?”

The Lupus Foundation of America, and the National Psoriasis Foundation, along with provider groups, such as the American College of Rheumatology and the American Academy of Dermatology, are opposed to restrictive step therapy. Patients with rheumatoid arthritis (RA), psoriasis, and other chronic inflammatory conditions that can be effectively managed with newer biologic treatments are particularly affected by step-therapy protocols because newer biologics have proven particularly effective for these conditions, but many health insurers refuse to pay for expensive drugs until patients have tried less-expensive alternatives.

For patients living with rheumatic and autoimmune conditions, a delay getting a better treatment could experience pain, loss of movement, loss of independence, loss of work, and increased costs. Surprisingly, step therapy policies can also result in higher—not lower—drug costs. Robert Popovian, MD, Vice President of US Government Relations at Pfizer, and Sam Azoulay, MD, a Senior Vice President and CMO at Pfizer, recently wrote about insurance companies mandating that patients “fail” on a brand-name anti—tumor necrosis factor (anti-TNF) agent, used for treatment of RA and other diseases, before the plans will cover a lower-cost biosimilar.

According to one insurer, before a biosimilar can be reimbursed, a patient has to have tried the brand-name anti-TNF agent for at least 14 weeks, and the physician must attest that either the patients’ clinical response would be expected to be superior with a biosimilar, or the patient in question has a history of intolerance or an adverse event related to the brand-name anti-TNF agent (and the physician must attest that the same intolerance or adverse event would not be expected with the biosimilar).

“The notion that a physician should ever attempt treatment with a biosimilar of its original drug that has already failed to treat the patient’s symptoms is nonsensical, as by definition there are no significant differences between the biosimilar and the original drug,” Popovian and Azoulay note. “Patients deserve unobstructed access to the treatments they need, not to have their health outcomes determined by contractual restrictions designed to avoid competition.”

Research suggests that step therapy, while often shown to reduce the costs involved with covering prescription drugs, can result in unintended consequences. For example, step therapy protocols used for Medicaid patients with bipolar disorder in Maine resulted in a “trivial” cost reduction for certain drugs; savings were found to be due in large part to the fact that patients stopping taking their medications as opposed to having switched to cheaper alternatives.