Patient advocates push for curbs on ‘step therapy’

JENNA GREEN, of Mansfield, was 31, active, and running a small business when she was diagnosed with multiple sclerosis. A neurologist prescribed a medication, but the day she scheduled an infusion, her insurance denied coverage. The insurer wanted her to try another drug first, and only if that failed to use the newer, more expensive therapy. 

“There’s no scientific data to measure the damage done to my mental and physical health when insurance originally denied treatment,” Green said on a Zoom call with reporters this week. “It was indescribable and terrifying.”

She is hardly alone in facing an insurance company’s “step therapy” requirement, in which lower-cost treatments must be tried first. Marissa Shackleton, the director of an infusion center that cares for multiple sclerosis patients, said her organization encounters step therapy requirements daily, and has two full-time employees whose job is to manage insurance authorization.

Patient advocates this year are taking another run at writing guidelines on step therapy into law. For around seven years, the bill has pitted patient groups against insurers. 

A version of the bill considered in 2019 included strict caveats on when an insurer could use step therapy that insurers said would essentially ban the practice. In 2020, the insurers and patient groups came close to agreeing on a compromise bill that would lay out clearly when a patient could obtain an exemption, and require insurers to adhere to a strict timeline for granting one. The Senate passed a version of the bill in 2020, but it never passed the House. Advocates blame COVID-19 for limiting the passage of non-pandemic-related bills.  

This year, advocates hope the time is right to get the bill to the finish line. Legislation under consideration would not ban step therapy but would establish rules regarding exemptions. The bill, as currently drafted, would require an exemption if the drug preferred by the insurer is expected to cause an adverse reaction or be ineffective to the patient, if the patient tried step therapy before with a different insurer, or if the patient is already stable on a drug. It requires decisions to be made within 72 hours.

Rep. Jeff Roy, a Franklin Democrat who sponsored the bill, said step therapy harms patients by delaying treatment, which results in more trips to the doctor when a medication doesn’t work. The bill, Roy said, “removes the barriers that interfere with sound medical judgment made within the confines of a physician-patient relationship.”

But the issue is not that simple. National reporting by the Kaiser Family Foundation has revealed that pharmaceutical companies make large donations to patient groups, and the groups often lobby for policies that benefit drug companies.

Here, the insurance companies argue that step therapy is valuable not only because it saves money – which reduces premiums – but also because it can require patients to try older drugs that are proven effective before trying the latest, most expensive drug, which may not be better. 

Generally, only a small number of drugs covered by insurance – the most expensive ones – are subject to step therapy. “Step therapy encourages prescribers to use prescription drugs that are safe, clinically appropriate, and cost effective before using drugs that could pose safety concerns or clinical concerns or have higher costs and is used in limited circumstances,” said Lora Pellegrini, president and CEO of the Massachusetts Association of Health Plans, in a statement.

Pellegrini said the insurers support eliminating the step therapy requirement and providing an immediate supply of medication in cases when a patient is stable on a drug, but switches insurance plans. But the group is still “working with the Legislature” on final language it can support.

SHIRA SCHOENBERG

FROM COMMONWEALTH

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OPINION

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