When Samantha Espinosa was 23 years old, 80 percent of her body was covered with psoriasis plaques — itchy, painful lesions that caused her severe pain and made her feel like an "ugly mutant of a person."
After six years of using topical treatments and occlusion therapy with the help of her husband, applying topical medications before bed and wrapping herself in plastic wrap to allow the treatment to penetrate more deeply in an "excruciating" and "degrading" process, Espinosa, now 30, returned to her dermatologist at one of her lowest points.
She felt like she was "living in hell." Her skin cracked and bled when she moved. It burned. She was in pain, and she was humiliated.
Her dermatologist recommended biologic injections — specifically, a medication called Stelara. But her insurance company wouldn't cover the expensive treatment, instead requiring her to go through a process known as step therapy.
Through step therapy, an insurance company can require a patient to first try less expensive treatment options — and if those don't work, the patient will "step" his or her way up toward the more expensive medication originally prescribed by the doctor.
Insurance companies argue this program works to keep costs in check for patients, by requiring them to try less costly and, at times, less risky options first.
The U.S. Centers for Medicare and Medicaid Services describes it this way: "Step therapy is a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions."
But opponents of the practice tend to focus on another way it's been described: "fail-first."
"It’s expensive to do this, to have to fail at a drug. It costs not only dollars, but costs the patient in terms of progress with health care," said Sen. Alberta Darling, R-River Hills, who, with Rep. John Nygren, R-Marinette, is proposing legislation that would establish a set of criteria to allow doctors and patients to override step therapy protocols in some circumstances.
Darling's and Nygren's bill would create five exemptions that would allow doctors and patients to override the standard step therapy protocol:
- The patient has already tried the drug required by the insurance company (or another prescription drug in the same pharmacologic class or with the same mechanism of action that has been "discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event").
- The drug required by the insurance company is "expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen."
- The drug required by the insurance company is not deemed to be in the best medical interest of the patient.
- The patient is "currently stable on a prescription drug selected by their health care provider for the medical condition under consideration."
- The patient has a condition or is on another medication that would make it likely that the drug required by the insurance company would cause an adverse reaction or "physical or mental harm" to the patient.
The bill would require insurance companies to respond to the override request within 72 hours in non-emergency situations and within 24 hours in emergency situations. It creates a "clear and expeditious process" for everyone involved, Darling said.
The proposal doesn't impose a mandate on insurers, Nygren said, because they can still decline to cover the drug the doctor prescribed and, as under current law, a doctor or patient can appeal that denial. But it provides more transparency, he said.
At least 18 states have enacted similar legislation to establish override protocols or expedite the timeline for insurance companies to respond, according to organizations that advocate for such changes, like the National Psoriasis Foundation and the Global Healthy Living Foundation.
Espinosa said she thinks her experience would have been different had such a law been on the books when her doctor prescribed her Stelara.
When her insurance company declined to cover Stelara, it laid out a set of steps: she had to first try photo therapy, then a chemotherapy drug, before moving up to the biologic treatment. Espinosa, who lives in New Lisbon, was about an hour-and-a-half from the closest photo therapy provider — which made multiple treatments in a week unfeasible. Her dermatologist prescribed a home unit for her, but after going through prior authorization, her insurance company declined to cover the cost and said she could instead try the less expensive option: a chemotherapy drug called methotrexate. Because she was overweight at the time, her doctor recommended against methotrexate due to its potential to cause liver damage.
After working with a pharmaceutical representative, Espinosa's doctor received a year's worth of Stelara samples for her. The drug worked, and within a few months, Espinosa's psoriasis coverage was down to about 30 percent.
Her dermatologist sent a testimonial — with photographic proof — to the insurance company, and this time, it approved the request. Sort of. Once Espinosa was almost out of Stelara samples, her insurance company approved a different biologic treatment called Humira.
Humira worked at first, but it soon backfired as her psoriasis returned with new symptoms. After another letter from her doctor, with more photos, Espinosa was approved for Stelara coverage.
Espinosa has been on Stelara for three years now — although her doctor first prescribed it in 2012. It's still working.
"At my worst, before this medication, I was at 80 percent coverage," she said. "Currently, I am about 1 percent, maybe 2 percent. I no longer live with pain and can function as a regular human being. The medication gave me my life back."
As lawmakers consider the issue, Espinosa said she wants them to understand that "people literally suffer through this process and go without the medications they need to lead normal, healthy, productive lives."
Darling had her own experience with step therapy last year, when she had a sudden change in her osteoporosis diagnosis and her doctor prescribed a medication to address the issue quickly. Her insurance company denied coverage, requiring her to try another drug for six months before moving to the one her doctor had chosen.
After about three or four months of repeated appeals from Darling and her doctor, the insurance company eventually approved the original prescription. But many patients aren't aware they can appeal these decisions, Darling said, and the appeal process can be intimidating.
"This puts the patient and the doctor in the driver’s seat to do a better job of their health care," Darling said. "Why should this insurance company make a decision on a drug that your doctor knows is not going to work for you? That doesn’t make any sense."
Nygren, who is an insurance agent and has spearheaded legislative efforts to combat opioid and heroin addiction, said he thinks the bill follows the approach lawmakers have taken on the bipartisan HOPE (Heroin, Opiate Prevention and Education) Agenda, "not to think that either the government or the insurer knows better than the patient or the doctor."
Step therapy sometimes comes into play when treating addiction, too, Nygren said, noting that medication-assisted treatment can not only be offered through different varieties of drugs, like Suboxone, Vivitrol or methadone, but in different forms, like strips, pills and injections. Treating addiction, like many other medical issues, requires different efforts for different patients, he said.
"Should the insurance company be in the middle making the decision of what’s right for the patient?" Nygren asked.
It's the hope of both Nygren and Darling that the bill will receive bipartisan support. A spokeswoman for Gov. Tony Evers did not immediately respond to an email seeking his position on the legislation.
It's the hope of Espinosa that lawmakers will listen to her story and act on it.
"Had I not received this medication, I would have more than likely become disabled. I would have needed disability, a home nurse, and I would have to rely on government benefits to make ends meet in my household," Espinosa, who is married with two children, said. "Now, with the medication I needed, I am able to work full time paying into taxes, giving back to the community, and being a productive member of society. When you consider the cost versus the gain, I think that I am worth it, and I think that everyone else in our communities is worth it as well."