The migraines began when Morgan Fitzgerald was around 12. They were frequent from the start, sometimes numbering 15 episodes a month. Then they became constant, tormenting Fitzgerald with not just searing pain, but also nausea, brain fog, dizziness, spots in her vision and difficulty forming words.
Eventually, Fitzgerald, now 25, could barely leave the bed in her darkened room. She had to drop out of school. Once a collegiate tennis player, it now took her five minutes to drag herself up a single flight of stairs in her family home in Encinitas, California. She tried multiple medicines, but they never helped much and often had side effects that were nearly as bad as the migraines themselves.
Finally, in 2018, Fitzgerald’s doctor gave her a prescription for the first migraine-specific medication to hit the market. But her insurance company wouldn’t pay for the new drug, insisting that she continue for months to try cheaper alternatives that had long failed her.
California had a law at the time that was meant to give doctors and patients like Fitzgerald a way to obtain exemptions from the so-called fail first or step therapy drug policies of their insurance companies.
But California’s law granting step therapy exemptions, and similar laws in many of the other 28 states that have them, are riddled with loopholes and lack enforcement mechanisms, patient advocate groups say. The laws, most of which passed in the past decade, also do not cover the vast majority of people with health insurance, because states only regulate certain types of plans.
Insurers and pharmacy benefit managers, which administer prescription drug programs on behalf of health plans, argue that step therapy prevents wasteful spending by directing patients to cheaper yet still effective treatments.
Patient advocacy groups and physicians counter that step therapy places financial considerations over clinical decisions, often imposing needless harm on patients by delaying their access to medicines their doctors think can best help them.
Those groups acknowledge that they were outgunned in state legislatures by far more powerful and wealthier opponents, chiefly the industries that represent health insurers and pharmacy benefit managers. The advocates were unable to prevent many of the bills from being watered down before passage.
They also concede that by the time they developed model legislation in 2016 to help more patients, many states had already passed flawed laws.
“Once passed, it’s hard to go back,” said Zoe Rothblatt, who co-authored a paper published last month in the journal Health Economics, Policy and Law that details the deficiencies of most state laws. She is a patient advocate and community outreach manager at the Global Healthy Living Foundation, which represents people with chronic illnesses such as autoimmune and cardiovascular disease.
Legislators have introduced bills in some states, including California and New York, that would strengthen existing laws, and in others, such as in Massachusetts and New Jersey, that would create policies. A bill with bipartisan support also has been filed in Congress, and if successful, would extend protections to far more Americans with health insurance, particularly employer-sponsored plans, which are beyond the reach of state laws.
Advocates acknowledge, however, that most states with existing measures have little appetite to revisit the issue.
Dozens of organizations, including the American Heart Association, the Arthritis Foundation and Mental Health America, have urged passage of federal legislation. Even so, supporters admit they are not hopeful that any measure can emerge from a gridlocked Congress, especially in the face of well-financed opposition.
“We don’t have a place at the table when it comes to issues like this,” said Louis Tharp, executive director of the Global Healthy Living Foundation and co-author of the journal article. “The reality is patients are not as powerful as lobbyists.”
Desperate after years with little relief, Morgan Fitzgerald decided to pay out of pocket for the drug her doctor prescribed, at a cost of $600 for a month’s supply.
Eventually, her insurance company relented, agreeing to reimburse her for the drug. She said her condition has improved 90%, enabling her to finish her degree with honors at the University of California, Santa Barbara, publish an award-winning research paper and get a job as a researcher at the University of California San Diego.
But she feels that she suffered needlessly.
“I think when there is a migraine-specific preventive medicine that is prescribed not just by a neurologist but a migraine specialist, an insurance company shouldn’t have the right to reject it,” said Fitzgerald.
Health insurers have used step therapy for decades, claiming it helps keep prescription drug prices low for consumers.
David Allen, a spokesperson for America’s Health Insurance Plans, an industry group, argued in an email that, “step therapy (ST) is used millions of times a year with no harm to patients.”
“In fact, the goal of ST is to use clinical evidence to develop guidelines (very similar to what the medical specialty societies do themselves) to help patients get the right medication at the lowest cost,” Allen wrote. “ST prioritizes the use of medications that consider both efficacy and cost in a way the maximizes the former and minimizes the latter where medically appropriate.”
Allen added that step therapy is used only with brand-name drugs, which he said represent only 15% of prescription drug volume.
The pushback against step therapy practices intensified in the 2000s with the advent of specialty drugs, called biologics, that are derived from living cells and are often far more expensive than conventionally manufactured medications. They are usually used to address complex, debilitating medical conditions such as cancers and autoimmune diseases.
A Frequent Occurrence
“This comes up every single day,” said Dr. Michael Schweitz, one of seven rheumatologists in a West Palm Beach, Florida, practice.
Schweitz said he often prescribes medicines that he does not think will work because he knows insurance companies will not approve his first choice until he can document that the cheaper alternatives approved by the insurer didn’t help the patient.
Patients with rheumatoid arthritis, osteoarthritis, lupus and other autoimmune diseases often endure worsened symptoms as a result of step therapy.
“The longer you delay appropriate treatment for rheumatoid arthritis, the worse the outcomes and the less chance you have to avoid deformity and disability,” he said.
Yaideliz Acevedo, a 24-year-old receptionist and technician at a veterinary practice in Newark, New Jersey, feels she suffered because of step therapy. At 21, she was diagnosed with rheumatoid arthritis, which left her with swollen and painful joints. Just squeezing her 2-year-old son Liam’s hand could shoot excruciating pain through her arm. Some days she couldn’t brush her hair.
She said she tried at least a half dozen autoimmune medicines. Some didn’t work at all; others worked temporarily. Many of them caused side effects, especially extreme nausea.
By last fall, her doctor wanted to put her on the medicine Orencia, which she would have to take at an infusion clinic. But she said her Medicaid plan wanted her to remain on a higher dose of a medicine that already had proven ineffective. Finally, in March, after no improvement in her condition, she said she was approved for Orencia. Her symptoms have largely abated.
“It was very frustrating, but on the other hand, what else could I do?” she said. “Paying out of pocket would have been impossible.”
Doctors and organizations that represent them have complained for years that step therapy interferes with the doctor-patient relationship and pushes patients toward drugs that align with financial agreements insurers have reached with drugmakers.
Some lawmakers agree. “As I see it, the challenges with the law we have is that it puts profits of insurers and drug companies ahead of the patients’ health,” said New York Democratic state Sen. Elijah Reichlin-Melnick, co-sponsor of a bill intended to strengthen New York’s law.
Weaknesses in Laws
Most state laws specify reasons that insurance carriers should grant exemptions from step therapy, such as that the patient failed on a drug under a previous insurance plan or the patient’s doctor thinks the medication will have an adverse impact.
The Global Healthy Living Foundation recommends six such reasons, but says that in its survey of 29 states with step therapy laws, only Delaware and Oklahoma specify all six. California and Oregon don’t specify any reasons exemptions can be granted, a gap the foundation argues doesn’t give the patients grounds to make a case.
Some states give insurers a deadline for responding to an exemption request. But nine states—Colorado, Connecticut, Kentucky, Maryland, Mississippi, Missouri, Oregon, Wisconsin and West Virginia—impose no time limit, forcing patients to go through step therapy in the interim.
A few states specify how long a patient must try an ineffective drug. In California, it’s 60 days; in Mississippi 30 days. But to critics, that provision simply forces patients to go through step therapy for that period. Kentucky, Maryland, Missouri and some other states don’t allow patients to file an appeal when insurers deny their exemption request.
The Global Healthy Living Foundation found few states with an enforcement mechanism to compel insurers. And no state laws have carryover requirements, which means that patients who receive exemptions from step therapy requirements one year may have to repeat the process the next. There also are no laws allowing carryovers if a patient switches insurers.
The foundation argues that step therapy can lead to greater costs for insurers if patients are being prescribed ineffective medicines and their symptoms worsen.
A bill in the California Assembly would address some of the issues the foundation raised. It details multiple exemptions and sets tight deadlines for insurers to respond to exemption requests.
“The existing law is insufficient,” said California Assembly Member Joaquin Arambula, the sponsor of the bill and an emergency room physician, who said he treated numerous patients who ended up in the hospital as a result of ineffective medicines.
“Making medical decisions solely on the basis of cost can lead to irreversible damage in the patient’s condition. Because of those delays, this bill was absolutely necessary.”
Arambula’s bill cannot tackle what the foundation regards as the greatest shortcoming of state laws: States regulate only a portion of the health plan market, mainly fully insured, group and individual health plans. States also can limit step therapy in their Medicaid programs, but they can’t regulate self-funded health insurance, which is the coverage most medium and large employers offer their workers.
According to the foundation’s analysis, in the 29 states with step therapy laws, at most 55% of the population is covered by the laws, depending on whether Medicaid is included under the law and how much of the commercial health insurance market is regulated by the state.