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Step therapy hurts America’s sickest patients — reasonable parameters are needed now


When he was just seven years old, Lorenzo started to experience frequent pain and swelling in his joints that grew worse until it was an everyday occurrence. When the swelling in his knees and ankles became so severe that he was unable to walk, Lorenzo was referred to a pediatric rheumatologist and diagnosed with juvenile arthritis —a condition that can be managed when treated with the right therapies.

But instead of seeing him get the treatment he needed, Lorenzo’s parents had to watch in agony as their son was forced to try — and fail — numerous treatments preferred by their insurance company before being allowed to receive the medication his doctor originally prescribed. During this time, Lorenzo’s condition deteriorated. Once an active kid who played Little League baseball, he began to rely on a cane, walker and wheelchair; needed his parents to feed and dress him; and, ultimately suffered permanent damage to his spine.

It’s a horrific situation that has become all too common for Americans who live with juvenile idiopathic arthritis, rheumatoid arthritis, lupus, and more than a hundred other autoinflammatory and degenerative rheumatic diseases that affect a person’s joints, muscles, bones and organs.

More than 54 million Americans (including an estimated 300,000 children) live with a rheumatic disease — which can be debilitating and life-threatening if not properly treated.

Proper treatment does exist: Remarkable biologic drugs and therapies can slow the progression of disease and allow patients to maintain mobility, ease pain and improve quality of life. But, too often, those therapies are rendered useless when insurance plans strip physicians of the ability to prescribe the most appropriate treatment without first forcing patients to try the therapies preferred by the insurance companies — a process known as “step therapy.”

Ultimately, it’s patients like Lorenzo who pay the price.

Step therapy delays timely access to clinically appropriate treatment and endangers the health and well-being of patients whose conditions can deteriorate beyond repair if they are not able to receive prompt care. It’s incredibly frustrating and frightening for Americans whose lives and bodies depend on very specific treatments. And it’s no less infuriating for health care providers who find their care and clinical decision-making undermined by insurance companies with no first-hand knowledge of their patients’ individual circumstances.

Simply put, step therapy does not work — not for the 47 percent of rheumatic disease patients who have been subjected to it, nor for the thousands of rheumatologists across the country responsible for their care. Providers and patients are desperate to end this needless suffering. Fortunately, members of Congress are stepping up to protect Americans from this dangerous practice.

The bipartisan Safe Step Act (S. 464) would place reasonable limits on insurers’ use of step therapy and create a clear and transparent process for patients and physicians to seek exceptions from it. Specifically, the legislation outlines five situations in which a patient could bypass step therapy: 1) if he or she has already tried and failed the insurer-preferred drug; 2) if delayed treatment will cause irreversible consequences; 3) if requiring the insurer-preferred drug will cause harm to the patient; 4) if the required drug will prevent a patient from working or fulfilling activities such as eating, grooming, dressing, bathing; or 5) if the patient is stable on the prescription drug selected by their provider and that drug has been covered by their previous insurance plan.

For children like Lorenzo, and countless other Americans of all ages, the Safe Step Act would offer long-needed protections without dangerous delays — since plans would be required to respond to all exception requests within 72 hours, or 24 hours if the patient’s life is at risk. The legislation would also build on existing reforms passed in dozens of states in recent years to rein in step therapy. While these state-led efforts to limit overuse of step therapy are welcome, only Congress can address the use of step therapy in employer-provided plans, which are regulated by federal law under the Employee Retirement Income Security Act (ERISA).

No American should have to go without treatment, simply because health plan policies fail to put patients first. And no health care provider should have to stand idly by while an insurer or pharmacy benefit manager makes decisions that have lasting impacts on their patients’ lives and wellbeing. With 136 million Americans receiving health care through ERISA-regulated plans, it is long past time to rein in an insurer practice that causes great harm to patients in need of clinically appropriate treatments.

It’s time for Congress to pass the Safe Step Act.

David R. Karp, MD, PhD is a practicing rheumatologist and President of the American College of Rheumatology. Ann M. Palmer is the President & Chief Executive Officer of the Arthritis Foundation.

Tags Step therapy

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