WHEN SHE WAS 11, Anna Legassie was diagnosed with a rare type of juvenile arthritis. In the 26 years since, there have been 17 times that an insurance company tried to deny Legassie coverage for a drug her doctor prescribed until after she first tried a different, less-expensive drug.
The same procedure was followed recently when Legassie had a disease flare-up at work and collapsed. With few drugs left that she has not tried, her rheumatologist recommended a drug and was scheduling infusions when Legassie’s insurance denied her coverage. They wanted her to try two other drugs first, even though both had failed her in the past, and one gave her a seizure.
Legassie eventually got her appeal approved after bullying the company on social media, which she notes “is not an accessible appeal mechanism to most people who aren’t well known patient advocates who also work in health care and communications.”
While patient advocates and disease foundations have been pushing for years to limit the use of so-called step therapy – where an insurer requires patients to fail on one drug before trying a different, often more expensive drug – they are finally approaching a compromise with insurers that could result in legislation becoming law.
The Massachusetts Senate plans to vote Thursday on a bill placing additional guardrails around the use of step therapy and an amendment dealing with the practice is pending on a House health care bill that will also be considered this week. This would mark the first time in six years of advocacy that a step therapy bill is voted on by either body, although it remains to be seen whether a final bill can be agreed on by the Friday night end to formal legislative sessions.
“Directionally, we’re comfortable with the Senate bill,” said Lora Pellegrini, president of the Massachusetts Association of Health Plans, which has previously opposed attempts to curb the use of step therapy. She said there are some “technical areas” that still need work.
From an insurance perspective, step therapy is a way to control costs by having a patient try a less expensive drug before moving on to a more expensive one. Pellegrini said it also prevents patients from constantly seeking out the latest drug they see marketed on TV.
From a patient perspective, step therapy is a way for insurers to try to cut costs at the expense of patients getting medication they need. Advocates say this can increase costs, if a patient ends up in the emergency room or has flare-ups of their disease if the drug required by the insurer does not work.
Marc Hymovitz, director of government relations at the American Cancer Society Cancer Action Network, said telling a patient they have to “fail first” before getting the treatment recommended by their doctor “seems like a really backwards way of providing care to patients.”
Prior versions of the bill would have imposed so many restrictions on step therapy that insurer groups said it would have essentially banned the practice. For example, they would have required step therapy be based on clinical prescribing guidelines and medical evidence.
The latest version of the bill is more narrow. It lays out the circumstances under which a patient can receive an exemption from step therapy – if the drug the insurer prefers is expected to be ineffective, if it could be harmful based on their health condition, if the patient previously tried the required drug, if a patient is stable on a drug and switching would cause them harm, or if it is otherwise not in the patient’s best interest based on medical necessity.
An insurance company would have 72 hours after it receives the necessary information to grant or deny a request for an exemption, or 24 hours in an emergency.
If someone is already on a drug and switches insurers, the company would have to continue paying for the drug for 30 days while it gets the necessary information to consider whether to grant an exception.
The bill would apply to MassHealth and private insurers and would go into effect Jan. 1, 2022.
“It does not prevent insurers from using step therapy, its goal is just to make sure that any decisions are made with widely acceptable medical practices guiding it,” Hymovitz said. He noted that 29 other states have imposed some restrictions on step therapy.
Anecdotally, patient groups say step therapy is a big problem. Bill Murphy, director of advocacy and public policy for Epilepsy Foundation New England, said insurance requirements have forced epilepsy patients to switch medicines that they were stable on, resulting in seizures if the new medicine is ineffective. In that case, he said, “any cost savings goes out the window,” since a patient could face an ambulance ride, testing, or a hospital stay.
Legassie, who works at a hospital research center, said she faced step therapy requirements whenever she switched insurers or tried new drugs. “That’s been a consistent experience with every therapeutic I’ve been prescribed in the past 18 years,” she said. She has generally succeeded in appealing. But she said the issue has become a barrier for her whenever she considers switching jobs, because she has to look carefully at any insurer’s plans, and the information she needs is not often readily available.
“All that we’re looking to do is provide consistent access to patients that are on stable therapies and ensure there is a timely and transparent appeals process,” Legassie said.
Pellegrini said the campaign to limit step therapy is part of a national effort, and Massachusetts carriers have generally acted responsibly. She said the biggest problem, which insurers are willing to fix, is that when someone switches insurers, the new insurer might want a patient to undergo step therapy again, even if they did it with their old insurer. She said the Senate bill would solve that problem by requiring an insurer to cover a medication refill, while the company gets the necessary paperwork from their physician to keep them on the drug. “We believe this is an important patient safety feature while preserving step therapy,” she said.