Step therapy bill moving in informal sessions

Passage still uncertain as insurer concerns remain

FOR NEARLY EIGHT years, patient advocate groups have been battling insurers to limit the use of step therapy, a policy requiring patients to try one treatment before accessing a different one. Could 2022 be the year a bill finally becomes law?

Advocates saw hopeful signs Thursday, as lawmakers started moving a bill in informal sessions. But whether it becomes law remains an open question since it still faces some opposition.

Marc Hymovitz, director of government relations in Massachusetts for the American Cancer Society Cancer Action Network, said the bill is a compromise between the House and the Senate. He said patient groups and insurers have continued talking for years to try to get all interested parties on the same page. “It’s a good example of all the stakeholders continuing to talk and continuing to try to get to yes,” Hymovitz said. “It took awhile, probably longer than patient groups wanted, but that’s what happened.”

However, while the House and Senate may agree, not all stakeholders do. Lora Pellegrini, president and CEO of the Massachusetts Association of Health Plans, said she appreciates that the bill would not ban step therapy, as earlier versions would have. She said her tassociation agrees people should not be required to repeat a medication that is unsafe or ineffective if they change health plans. But she said the bill moving through the Legislature “goes beyond that and impacts the health plans’ ability to lower prescription drug costs and ensure patient safety.”

Step therapy, sometimes called “fail first” therapy, a a policy of insurers requiring a patient to try one drug – often a cheaper, older one – before switching to a different drug. Insurers say this limits costs and improves patient safety by not automatically approving access to the newest, most expensive drug.

But patient advocates say insurers should not stand in the way of a doctor’s clinical judgment, and the practice harms patients by requiring them to fail on treatments that are unlikely to work. Curbs on step therapy have been supported by the pharmaceutical industry, since step therapy limits access to expensive drugs.

Patient groups have been pushing for step therapy limits for years. In July 2020, CommonWealth reported that patient groups and insurers were nearing a compromise. The Senate voted that year for the first time on a bill limiting step therapy’s use. But the House never took it up. Separate bills passed both the House and Senate this session, but no agreement was reached between the two branches before formal sessions ended in July.

On Thursday, the State House News Service reported that Rep. John Lawn, House chair of the Health Care Financing Committee, introduced and got passed an amendment with a compromise on the final difference between the House and Senate, related to how long insurers have to respond to patient appeals. The House gave the insurer three business days, and one business day in case of emergency. The Senate gave the insurer 72 hours, or 24 hours in an emergency. The compromise was three business days normally, but 24 hours in emergencies.

Generally, the bill says, patients cannot be required to try a drug that is unlikely to succeed because of clinical characteristics of the patient or characteristics of the drug. It would eliminate step therapy when someone switches insurers if the patient already tried a drug under a prior insurer or if they are stable on a medication.

Stephen Acosta, a spokesperson for Health Care Financing Senate chair Cindy Friedman, said the bills that passed each chamber had “very minor differences,” and Friedman was glad to work with Lawn to reach a final agreement. He said Friedman “will be strongly pushing for the bill to pass during informal session.”

However, the down side of passing a bill during informal sessions is a single member’s opposition can derail the bill, as can opposition from Gov. Charlie Baker, since it takes a roll call vote to override a gubernatorial veto.

There is likely to be some lobbying against the bill. Insurers have raised concerns about language enabling members to obtain an exemption from step therapy if they tried and failed with a drug that is in the same pharmacologic class or acts in a similar way. Insurers say this runs counter to clinical guidelines. For example, Lipitor and Zocor work similarly to lower cholesterol but Lipitor is more potent, so failing with one drug does not mean a patient will fail with the other. Insurers also raise cost concerns in cases when a patient fails on a brand drug, then a generic is released, since the bill would forbid the insurer from requiring the patient to try the cheaper generic.

Baker has not taken a position. Baker spokesperson Terry MacCormack said, “The administration will carefully review any legislation that reaches the governor’s desk.”