In May, the governor of Texas signed a bill that will bring down barriers for patients to access timely, consistent and evidence-based medical care. With that signature, the National Psoriasis Foundation (NPF) scored a major win for people living with psoriasis, psoriatic arthritis and other chronic health diseases.
The passage of the Texas bill adds momentum to NPF’s nationwide efforts to put important limits on insurers’ use of step therapy, or “fail-first,” policies. Step therapy requires patients who are prescribed certain medications by their doctors to try a different, lower-cost drug or sequence of drugs first, and allow them to possibly fail — meaning either the drugs don’t treat the disease adequately or they cause side effects the patient can’t tolerate. So far, 12 states targeted by NPF for step therapy reform have passed legislation curbing the practice.
“At NPF, we are committed to dramatically improving the health outcomes of individuals living with psoriasis and psoriatic arthritis. Approximately five years ago, we identified that significant opportunities existed for us on the state level to influence insurance design through legislation and regulatory reforms,” said Leah M. Howard, J.D. Howard served as NPF’s vice president of government relations and advocacy until October 2017 when she assumed the role of chief operating officer. “Just as we work directly with individuals facing access challenges through our Patient Navigation Center, we also work to change policies by bringing forward real solutions to the barriers that keep individuals from treating their disease appropriately.”
For patients, step therapy often means delayed treatment, and sometimes no treatment, said Colby Evans, M.D., an Austin dermatologist who took part in the Texas advocacy efforts by meeting with legislators and writing letters explaining how step therapy harms patients.
Evans said he has seen the devastating impact step therapy can have on patients with long-term psoriasis and psoriatic arthritis. “In most cases, I have the tools available to make those patients dramatically better, but with step therapy, that tool is being taken from me and them.”
Patients typically have to take the drugs required by their insurer’s step therapy policies for about three months before the payer will authorize another drug. In addition, said Evans, in some circumstances, insurers can ask patients to repeat the step therapy they’ve already gone through when their prescription for the drug is renewed.
“It can delay treatment, but it also really can deny treatment because the patient may give up because they feel they can’t get the medications they need,” said Evans, who is the immediate past chair of NPF’s Board of Directors.
“The other serious practical effect is that patients get put on drugs that aren’t the right choice for them or have a risk of serious side effects,” he said. “In the last 15 years, an array of drugs for psoriatic disease has been developed, and some are better for a given patient than others because of efficacy or an individual’s risk profile. As a physician, it’s very frustrating not to be able to treat your patient with the medication that’s best for him.”
Success in the Lone Star State
NPF led the effort in Texas, which began only two years ago, to success by harnessing multiple avenues for its message, from letter writing to in-person meetings with legislators to social media advocacy. It also enlisted a host of voices explaining the real-world harms of step therapy, said NPF’s State Government Relations Manager Amy Prentice, who focuses on the Southeast region.
Michael Wood, the 16-year-old NPF National Youth Ambassador who lives in San Antonio, was one of those patients whose voice made a difference. Wood, along with his mother,
Jodi Wood, 16 other patients, NPF staff and health care providers like Evans, met in February 2017 with 25 elected officials at the Texas state capitol for the NPF-hosted Step Therapy Lobby Day.
Wood, who was diagnosed with psoriatic arthritis when he was 12, told legislators about his experience with the harmful effects of step therapy.
“I told them how difficult it was for me to get the drugs I needed, that during the long period it took to get me what I needed, I was going downhill sharply,” he said. “I tried to do everything I normally did, but I had difficulty walking and I couldn’t run anymore. My doctor told me I couldn’t play lacrosse and football, my two favorite sports.”
His mother recounted her battle for her son’s health.
“Every time a medication was prescribed, it was an argument with the insurance company. I was so tired and angry about fighting with insurance companies on every single thing,” she said. “I spent hours on the phone, our doctor’s office spent hours on the phone. We had friends who were doctors who could advise us, and still it was so difficult and stressful. I realized how hard it must be for others and wanted to help, which is why I got involved.”
Wood said he developed lupus-like side effects to TNF inhibitors, but his insurance company asked him to see multiple doctors to confirm this before it would allow him to switch to an appropriate class of drugs.
“It was clear I could not take any more, but still I had to go to more doctors and wait months and months,” he said. About a month after testifying during Lobby Day, Wood spoke to a committee considering the bill.
He could tell his testimony made a difference.
“Most of the legislators probably didn’t know much about the issue, and it opened their eyes as to how difficult and challenging step therapy can be and, particularly, how dangerous it can be for patients when they need medicine and can’t get it,” he said.
Step therapy affects many patients with chronic diseases in addition to those with psoriasis and psoriatic arthritis. NPF, as it is doing nationwide, partnered in Texas with other advocacy groups, notably Multiple Sclerosis Texas. It was NPF’s leadership, however, that brought the bill across the finish line, said Prentice.
“NPF was the driving force behind the effort through the entire legislative process, from finding bill sponsors and going through four committee hearings in the Texas House and Senate to helping finalize the bill’s language and getting the governor’s signature,” said Prentice. “We led a diverse coalition of patients and providers who were crucial in supporting the bill all along the way.”
Wood was eventually able to begin taking the drug his rheumatologist prescribed. While his mom said it seems to be keeping him stable, he’s not in remission. His rheumatologist is considering switching him to another medication, and Wood is hopeful the success of step therapy reform in Texas will make his next medication transition easier.
What the bill does
The Texas bill, which becomes state law in January 2018, does three things, said Patrick Stone, NPF vice president of government relations and advocacy.
“First, it ensures that the step therapy protocols insurance companies are using are built on the most current clinical evidence available, and that annual decisions about which drugs are included in formularies are based on science, not cost,” he said.
Second, the bill ends long waits patients have had to endure while insurance companies considered “exception requests,” which are made by physicians and patients when a doctor prescribes a drug that doesn’t conform to the company’s step therapy policies.
Prior to this legislation, insurers had 30 calendar days to consider exception requests after denying coverage for a prescription. With the legislation, companies now must respond within 72 hours of the exemption request and in 24 hours in urgent circumstances.
Before the bill’s passage, said Prentice, there were no laws requiring a quick response by the health insurer in urgent situations.
“In such cases, a provider would previously have had to spend a lot of staff hours on the phone with or completing forms for the health insurance company to explain the situation. With this legislation, the process will be much more efficient and compel quick responses,” she said.
The third component, and the heart of the bill, said Stone, also deals with the exceptions process.
“It says an exception request shall be granted — not may, not if you feel like it — if the prescribing physician can show one of five things, all of which center on meeting the medical needs of the patient,” he said.
In Texas, these reasons include, but aren’t limited to, the patient already being stable on the drug the physician is prescribing; the patient having a contraindication to the drug or drugs required by step therapy, including a previous adverse reaction to the class of drugs in the step therapy protocol (this requirement would have applied to Michael Wood); or the physician’s judgment that the drug is not in the best interest of the patient.
“Consistent care and care at an appropriate level are often casualties of step therapy,” said Stone. “We know that about half of patients with psoriatic disease are not being treated at appropriate levels, and barriers to access and cost are two main reasons for that. Bills like this will affect hundreds of thousands of people living in Texas with psoriasis, psoriatic arthritis and other chronic conditions by creating better access to the care they need.”
A bipartisan issue
NPF’s efforts to reform step therapy are continuing across the nation. In 2018, it will lead efforts in Washington, Minnesota, Georgia and Maine and will work in a dozen other states targeted for reform.
“We’re not stopping until we pass it in all 50 states,” said Stone, who noted that much progress has been made very quickly relative to the usual, far slower trajectory of many legislative efforts. In part, he said, this is because step therapy reform is a bipartisan issue.
“This is a common-sense issue that’s already been passed in both the reddest and bluest of states,” he said. “Patient and provider voices dramatically increase our chances of success because legislators want to hear from their constituents, the people who are going to impacted by the bill.”
NPF’s Howard agreed, noting, “In a very short time, we have had incredible success in passing legislation to address the burdens of step therapy and high patient out-of-pocket cost. None of this success, though, would be possible without individuals like Michael Wood who have shared their story with their state lawmakers.”
Wood encourages others with psoriatic disease to get involved. “You might not think one person can do anything, but I saw how even I was able to open [legislators’] eyes to this issue. It really can make a huge difference,” he said.
Join the battle!
Step therapy is a complicated subject, and our efforts to stop it take different forms in different states. You can keep up with our progress — and learn how you can help the psoriatic disease community — by following along on the new-and-improved steptherapy.com.
Steptherapy.com gives you information on how NPF is actively working to ensure patients have access to the treatments prescribed. The site also provides a rundown on the news and a scoreboard of our progress. NPF’s Government Relations and Advocacy team will blog about their activities, and you can watch webinars about our work in states from Maine to Iowa and places in between.
If you agree that you and your doctor — not your insurance company — should decide what medications you get, we hope you’ll get involved. And if you’re experiencing these problems with your health insurer, contact our Patient Navigation Center for personalized support.