Ohio lawmakers are seeking greater transparency and a streamlined process for patients whose medications require step therapy — a process imposed by insurers that requires patients to try multiple approved drugs before they can access one prescribed by their doctor.
The step therapy process is intended to save insurers and patients money by steering patients to lower-cost prescription drugs unless a higher-priced one is absolutely necessary. But patients have complained for years that it’s caused them undue stress and at times medical complications.
Companion bills House Bill 72 and Senate Bill 56 were reintroduced this week from last legislative session. Neither bill would outlaw step therapy but aim to make the process more transparent and quicker for patients who have exceptions.
“SB 56 seeks to minimize barriers to treatment by improving the step therapy process also known as ‘fail first,’” said State Senator Peggy Lehner, R-Kettering, in her sponsorship testimony.
“Under step therapy, a patient must try one or more drugs chosen by their insurer — usually based on financial, not medical, considerations — before coverage is granted for the drug prescribed by the patient’s health care provider.”
This can mean patients are taking drugs that may not be the best therapy for them, said Dr. Shannon Trotter, a Springfield dermatologist and president of the Ohio Dermatological Association.
“It can be cheaper, but at the expense of not working for the patient,” she said.
The current process for getting around step therapy requirements is cumbersome and means doctors can spend hours on the phone only to have their patient still not be approved for an exception.
The bills require that an insurer’s process for requesting a step therapy override is transparent and available to the doctor and patient. They would also allow for automatic exceptions to step therapy requirements when a required drug could cause an adverse reaction, is expected to be ineffective, the patient has previously tried the drug and it was ineffective, the doctor deems the drug medically inappropriate, or the patient is stable on another medication.
Some insurers will currently accept such overrides if a doctor argues for it, but it’s not automatic and can take time to get approved, putting patients at risk.
“Step therapy protocols can be harmful to patients both financially and physically, causing an undue wait for the proper treatment and in some cases a worsening of a person’s medical condition,” the Ohioans for Step Therapy Reform coalition said in announcing the bills. The coalition is made up of 50 patient advocacy and physician organizations.
The bills also ensure that step therapy programs are based on clinical guidelines developed by independent experts. Pharmacy benefit managers, who develop step therapy protocols for health plans, say this is already the case. But the PBM industry has been criticized for favoring drug brands from which they get the biggest rebates, rather than those that are the most effective for patients.
“The perception is that PBMs and insurers are making those formulary decisions purely based on the economics and purely based on prices and rebate negotiations, rather than sort of looking at what’s the range of medications that we should have?,” said Bari Talente, executive vice president of advocacy for the National Multiple Sclerosis Society.
“Step therapy is a valuable tool to ensure patients get the most clinically appropriate and affordable treatment possible,” a spokesman the Pharmaceutical Care Management Association, a for PBM industry group, said in a statement. “Employers, unions, and public programs use tools like step therapy and prior authorization to reduce inappropriate drug use, lower costs, and improve quality.”
Eleven states have passed step therapy reforms, backers of the bills say.