Middlemen make our complicated health care system even more difficult...

Middlemen make our complicated health care system even more difficult and create conditions that inflate prescription drug list prices. Credit: iStock

Congress is considering legislation that would address misaligned prescription drug cost incentives set by pharmacy benefit managers, or PBMs. I applaud Congress for acting on this pressing issue, because these middlemen make our complicated health care system even more difficult and create conditions that inflate prescription drug list prices. But not just any bill will do. Meaningful legislation must include step therapy reform to improve patient access to needed medications.
Given their leadership roles, Sen. Chuck Schumer and Rep. Hakeem Jeffries have an opportunity to address harmful step therapy by making sure a bill called the Safe Step Act is included in the final PBM reform package.

Step therapy — also known as “fail first” — is an increasingly prevalent practice in which insurers and PBMs force patients in need of medication to try one or more preferred therapies before they can access the drug their doctor prescribed. Only after the insurer-preferred medicines “fail,” usually after several months, will insurers agree to cover the physician-recommended treatment.
Step therapy may help PBMs maximize their own profits, but it can be deeply problematic for patients. It allows company bureaucrats — rather than doctors — to decide which medications a patient can take. And since PBMs make their decisions based on profits, rather than medical need, step therapy can have harmful health consequences.

I’ve seen the impact in my own practice. I specialize in diseases like psoriasis, a chronic, inherited disease that affects the skin, joints, and cardiovascular and immune systems and affects more than eight million people in the U.S. It not only can cause great physical pain and mental distress, but also irreversible heart and joint disease and disability due to systemic inflammation.

Psoriasis can be challenging to treat. There are multiple types, it can appear on many different parts of the body, and symptoms vary from skin type to skin type. And patients can have a simultaneous condition — like psoriatic arthritis, obesity, or a history of cancer — that affects what they should be prescribed.
In short, a great deal of expertise and nuance is required to diagnose and treat psoriasis. So imagine the frustration a physician feels when they apply all of their knowledge and training to choose the right medication, only to learn that their patient has been denied coverage and steered toward a medication that would be less effective or even dangerous.

This isn’t a theoretical concern. I’ve treated people with a history of skin cancer who were denied the medications I prescribed for their psoriasis and told to go on a medication known to increase the risk of skin cancer.
Thankfully, more than 36 states, including New York, have adopted some protections against step therapy, but it’s not enough. Current protections don’t apply to many employer-sponsored health plans, which some 153 million Americans — including over nine million New Yorkers — rely on. That’s 49% of insured people in New York and 54% nationwide who could be left vulnerable to significant delays and denials on their way to effective treatment.

We need federal action that ensures patients and physicians can easily seek exceptions for PBM’s step therapy rules when medically warranted. Schumer and his colleagues can do a great deal for patient health by making sure the Safe Step Act is included in the final PBM reform bill. It’s time to end the dangers caused by step therapy.

  

This guest essay reflects the views of Dr. Mark Lebwohl, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, and chair emeritus on the National Psoriasis Foundation Medical Board.

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