Step Therapy Reform Advocates Seek to Spread Awareness of Proposed Law

Fifteen years after Louisiana became the first state to pass step therapy reform legislation, health plans nationwide could have been required to establish an exception to step therapy in specified cases as the Safe Step Act (S.652) passed out of the Senate Committee on Health, Education, Labor and Pensions (HELP), but the 118th Congress ultimately did not sign it into law.

Even if the bill—which now must be reintroduced in the 119th Congress—passes, advocates say there is still work to be done, and that the ball will be firmly in physicians’ court.

“Doctors do not have a magic wand, but they have so much knowledge that they can communicate to try to help a patient get to the right point,” said Susan Kaine, a patient who was first diagnosed with psoriasis in 2005 and recently began working as an advocate. “If a doctor can explain to a patient the availability of a safer, more efficacious option from the outset, then it is really valuable.”

Thirty-seven more states adopted similar legislation after Louisiana. While states such as Michigan, South Carolina, and New Jersey still have not passed their own, when Sen. Lisa Murkowski introduced the Safe Step Act on the federal level in March 2023, it garnered bipartisan support. The legislation would require group health plans to establish exceptions to medication step-therapy protocols in specified cases.

Support from the NSF

The act has been almost a decade in the making. Leah Howard, JD, President and CEO of the National Psoriasis Foundation (NPF), was among the people who initially conceptualized what it could entail.

“The science has gotten better and the treatment options have really progressed, and yet more patients are challenged to actually get those treatments, so that was what caused a group of us from the patient and provider community, almost 10 years ago now, to start discussing what we were seeing across all of our different communities and whether we could develop a piece of legislation that would support patients and providers navigating this increasingly complex system,” Howard said.  “It began with sharing stories. What were those situations when patients and providers felt most frustrated about these policies? From that grew these five circumstances that are outlined in the bill as those times when an exception should really be granted.”

Step Therapy Risks

While step therapy can pose dangers in a variety of diseases across the medical spectrum, the NPF has been at the forefront of the movement largely because of the importance of preventing psoriatic arthritis with early, effective treatment. Howard said an NPF survey indicated that approximately 70% of people with psoriatic disease who now take a biologic have experienced step therapy.

“The two most frequent consequences are: 1) patients being exposed to more risk with an older drug that has more potential side effects, and 2) patients not getting better as quickly or rapidly as they could because they are using something substantially less effective,” said Colby Evans, MD, FAAD, a former chair of the NPF Board of Directors. “The third consequence, less common than the first two but still very common, is that patients suffer permanent damage. Many diseases—not only psoriatic arthritis but cancer, multiple sclerosis, and more—when left untreated for too long can create permanent, often disabling, and sometimes even lethal consequences.”

In 2005, Kaine was offered only topical solutions, such as coal tar and topical corticosteroids. It was not until 2016 that she was offered disease-modifying antirheumatic drugs (DMARD), and it was 3 more years before she was given a biologic that served her best.

“In the meantime, I had to keep failing medicines,” Kaine says. “The irony of step therapy is you’re trying to move forward, but you’re really not taking steps forward at all.”

Even since discovering the biologic that worked best, Kaine has had to change medications with changes to her insurance. She recently had to come off the biologic to be treated for cancer but hopes to go straight back to it once her cancer treatments are finished.

“I can say very strongly that the biologic was really pulling a heavy load for me,” she said.

More Challenges in Getting Biologics

Another patient, Melissa Leeolou, was diagnosed with psoriasis as an infant, and when she reached the age at which her doctor wanted to prescribe a biologic approximately 8 years ago, her insurance company mandated that she try non-equivalent and lower-cost prescriptions first. One of those alternatives was contraindicated due to her medical history, and it took several weeks of back and forth just to get the insurance company to allow another alternative that still was not the preferred biologic.

“At the time, it felt like a small victory, but when I tried that medication for a few months, I had a bad reaction and it actually worsened my psoriasis,” said Leeolou, who was living at the time in New York, which had not yet passed its step therapy reform legislation. 

“It was about a year before I could receive the medication that my doctor had originally prescribed. I have now been in remission for more than 7 years, but I do believe I have joint disease progression from that year that the treatment was delayed. That is especially concerning for a young person like myself with hopefully many years ahead to manage the disease.”

A medical student at Stanford with aspirations of becoming a pediatric dermatologist as a result of her experience—she also lobbied for New York’s legislation in 2016—Leeolou noted that if the Safe Step Act does not pass and she goes into practice in a state like New Jersey after residency, then her new insurance could force her off the medication that has worked for more than 7 years.

For her part, Kaine became an advocate for step therapy reform recently because she realized that sharing her journey could help others. She recalls being confused by psoriasis or psoriatic arthritis drug commercials showing patients rowing boats or on ballet barres when she could not lift her coffee cup without pain with the treatments she was being prescribed at the time.

“It’s sad that patients today still are in a whirlwind similar to what I faced in 2005,” she said. “They are still confused. They are still trying to figure out their diagnoses. They are still looking for the right doctor to give them clarity.”

The Need for Personalized Care

Kaine and others noted that the recent influx of new biologics into the dermatology space has made bypassing step therapy much more favorable in many cases.

“It’s unbelievable,” Howard said. “When you look at the psoriatic disease community, the progress that’s happened in recent years and from the first systemics in our space just over 20 years ago to the options that we have available today, it’s been an amazing 20 years. That’s why it is particularly frustrating when patients are forced to go through a step therapy protocol knowing that newer treatments are safer and more effective.”

Dr. Evans noted that the diversity of treatment options available today is also an important factor.

“The best medicine should be personalized and individualized to the patient,” Dr. Evans said. “If they have a medical problem that would make one drug less effective or more dangerous, we have other choices. However, when you are forced to just choose one drug to start—such as methotrexate for psoriasis—you are removing the best part of medicine. The other thing is that the newer drugs undoubtedly are more targeted, so in addition to better efficacy, but they do not affect a bunch of pathways in the body that don’t need to be affected. Methotrexate and cyclosporine can make psoriasis better, but they do it by driving down the entire immune system in the patient’s body, which can make them more prone to a variety of other consequences.”

Education is Key

In practice, advocates say, the legislation should not be difficult for patients and providers to use. The documentation is similar to what step therapy itself requires, but instead of proving that other treatments were attempted, it details why they should not be.

“The vast majority of the information that’s needed is within that patient’s electronic medical record,” Howard said. “If, for example, a patient has already tried and failed on one drug, the provider should be able to look back pretty quickly in their record and see that or have a conversation with that patient about whether they’ve utilized that therapy before. Our experience has been that it is not contributing to the paperwork burden.”

The key is physicians making patients aware of this option and both parties choosing to take advantage of it.

“In Texas, some participants definitely chose to sort of ignore it and just see what happened, and we had to write them letters or put stickers on authorization forms reminding them of the law that passed,” Dr. Evans said. “Once we did that and everybody became aware of the law and the guidelines, it became easier to get them followed. This did not mean step therapy did not happen or that some patients did not have to step through certain drugs. It just meant if there were specific reasons that that drug was not appropriate for that patient, the payer or the person requiring step therapy had to respond in a certain amount of time and had to respond within guidelines as to what appropriate decisions were and what information went into appropriate decisions.”

Incorporating Advocacy Organizations

Howard emphasized the role that the NPF and other advocacy organizations can play. More information can be found at saimcoalition.org/state-access-to-innovative-medicines/step-therapy.

“Like everything else, you need to do a lot of education,” Howard said. “Once these protections exist, both patients and providers need to know that this is now law. Our organization and a number of others have been sharing the successes at the state level with patients and providers so that they know how to navigate the process and know that it is available to them should they have a patient for whom this process is appropriate.”

Kaine said ensuring that every dermatologist keeps top of mind the impact that expeditious treatment with today’s biologics can have on each individual patient.

“It is important for providers to help patients like me understand that the decision-making tree can be complex and that there is not always a simple answer,” Kaine said. “That is where the Safe Step Act can help because once we have negotiated the decision tree, we can proceed to the optimal treatment options much quicker than in the past. And time matters.” -by Jason Mazda