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Need a new drug? You may be asked to ‘fail’ an old drug first

New laws target a health insurance practice called “step therapy,” which is used to control costs, but can also delay needed treatment


Many patients seeking better drug treatments are being rejected by their insurance companies. The reason: Patients must first “fail” at typically older, cheaper medications, including those they’ve tried before. The policy, which is known as “step therapy,” is touted by insurers as a way to control runaway prescription drug costs and help patients find the most appropriate treatments. But critics say it can delay symptom relief and allow medical conditions to irreversibly worsen.


One patient, suffering from painful and excessive itching due to severe eczema, became suicidal when his insurer wouldn’t allow a new treatment. A seventh-grader in Arizona was denied a drug shown to slow the progression of juvenile rheumatoid arthritis; now the disease has spread to the joints in her ribs.


Lawmakers in 36 states have passed laws that attempt to solve the biggest problems with step therapy — offering more clarity on the rules and a process for patients and their doctors to seek exceptions. While the new laws may help some patients, they don’t fully eliminate “fail first” requirements.


Proposed federal legislation called the Safe Step Act, which has bipartisan support in the Senate and the House, would go further, creating more transparency about step therapy rules and covering more patients, notably those who have employer-based health insurance plans regulated by the Labor Department, including self-insured employer plans.


Both the state and federal legislation speed up the exception process for patients who have already tried and “failed” on a required drug or if delays in treatment would lead to severe or irreversible consequences.


The laws would also address another big concern with step therapy protocols. Sometimes patients who have been stable on their medication are asked by insurers to interrupt their successful treatment plans and “fail” on a different medication before being allowed to renew their prescriptions. The new law would also allow those patients to file for exceptions and more quickly resolve the issue.


James Chambers, researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, created a database that tracks practices at the nation’s largest insurers.

In a study that looked at specialty drugs for a range of disorders that are often subject to step therapy requirements, Chambers found that nearly 40 percent of drug coverage policies were subject to step therapy rules that often varied dramatically from plan to plan, even for the same condition. For patients, he said, that means access to particular medications “can be highly dependent on who your insurer is.”


The study also found that insurance company protocols are often at odds with what is recommended by the medical community.


Step protocols for psoriasis, for instance, were more stringent than the clinical treatment guidelines 99.4 percent of the time. Insurance protocols for psoriatic arthritis, hepatitis C, and multiple sclerosis were more stringent than the clinical guidelines 50 percent of the time or more.


How insurance rules can delay needed treatment


When Cassidy Middleton, a seventh-grader from Tucson who has suffered from juvenile rheumatoid arthritis since early childhood, found no relief from the drug methotrexate, her physician prescribed a biologic medication called Humira.


But the family’s insurer required that Cassidy “fail” at another drug, Enbrel, first, said her mother, Kari Middleton. Cassidy stayed on Enbrel for three months, with no improvement. When the family tried to fill the new prescription, their insurer required that the young girl stay on the failing medication for another three months.


During this time, Kari Middleton said, her daughter’s symptoms worsened, and in one instance Cassidy had to be rushed to the emergency room because the arthritis had spread to the joints in her rib cage.


Cassidy testified before Arizona lawmakers in support of a bill reforming step therapy. She explained in an interview the impact that “fail first” policies had on her:


“It made my arthritis worse and go to more places in my body because the medicines they wanted me to take didn’t work,” she said. Asked about her current health status, Cassidy said: “I hurt.”


Insurers make the case that step therapy protocols encourage “prescribers to use medications that are safe and cost-effective before moving to more complex, costlier, or riskier drugs or drug combinations,” said David Allen, a spokesperson for America’s Health Insurance Plans, the major insurer lobby group.


Still, more than 200 organizations, from the National Psoriasis Foundation to the American Society of Clinical Oncology, have been advocating for a nationwide step therapy reform law that would apply to more health plans and cover more patients compared to the patchwork of state-by-state laws.


The groups argue that insurance-mandated step therapy treatment delays can lead to dangerous outcomes. They cite studies showing the harms of delaying breast cancer treatment, for instance; and that for people with depression, step therapy can reduce medication adherence and increase mental health inpatient, outpatient and emergency room visits.



A debilitating itch, left untreated


Dr. Bruce Brod, a dermatologist on the faculty at the University of Pennsylvania School of Medicine, said about 1 in 5 of his patients, many with severe, debilitating skin conditions, must undergo step therapy.


“Not a day goes by when I don’t open my already flooded inbox to several messages on step therapy protocol, saying your patient needs to fail on A or B medication,” he said.


Brod described a patient with severe eczema over his entire body, with open cracks, redness, raw, broken skin and an all-consuming itch. “In many patients, the itch is worse than the pain, it’s insufferable,” Brod said.


Before gaining access to an effective injectable medication, Brod said, the patient’s insurer required him to try a topical steroid cream he’d already found to be useless. When that failed, the insurer told the patient to undergo phototherapy three times a week for six to 12 weeks, which was not practical since the man lives alone in rural Pennsylvania more than 75 miles from the nearest dermatology office and is unable to drive that distance due to his condition.


“The severity of the illness and the frustration over lack of treatment became so severe, the patient became suicidal,” Brod said. His office urged the patient to connect with a suicide hotline and arranged for emergency responders go to his home to check in.


Finally, Brod said, he was able to schedule a “peer-to-peer” review with an insurance administrator and argue on behalf of his patient, who eventually received effective treatment.


A proposed law would speed the exception process


The Safe Step Act, sponsored by Sen. Lisa Murkowski (R-Alaska) and Rep. Raul Ruiz (D-Calif.), is expected to be reintroduced in the House and Senate early this year. Advocates are hopeful that current committee assignments will be favorable to getting the legislation moving.


It appears to have widespread bipartisan support, At the end of the last Congress, the proposal had garnered 197 co-sponsors in the House, including 62 Republicans and 135 Democrats, and 36 co-sponsors in the Senate, including 22 Democrats, 13 Republicans and Sen. Kyrsten Sinema (I-Ariz.).


“When a patient’s health is on the line, insurance companies should not require patients to take medications that might have severe side effects or make their condition worse, especially when a proven treatment is available,” Sen. Maggie Hassan, (D-N.H.), a sponsor of the Safe Step Act of 2021, said in a statement.


Patients also can find out whether their state has passed legislation related to step therapy by going to the StepTherapy.com website.


Brod noted that not only do treatment delays created by step therapy protocols cause unnecessary patient suffering, the process affects everyone in the medical system.


“To go through this process as doctors and as an office team requires so much extra work and it takes time away from patient care,” Brod said. “It wastes time and clinical experience.”


WP Reporter: Rachel Zimmerman

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