Proponents of SB 56, told members of the Senate, Health, Human Services and Medicaid Committee, March 7, that step therapy can be a useful tool for controlling costs, but exemptions are necessary to protect patient safety and timely access to effective treatments.
Sarah Sams, MD, past president of the Ohio Academy of Family Physicians, said requiring patients to try less expensive drugs first can frustrate practices when requesting exemptions and can keep patients from getting the medications they need immediately.
“Step therapy requirements vary from insurer to insurer and change frequently even within the same insurance company,“ said Dr. Sams.
“The requirements result in physicians and other practice staff spending hours each week on the phone attempting to obtain permission to get appropriate, needed medications for patients.”
Dr. Sams cited one of her patients -- an 85-year-old who previously had a stroke. Dr. Sams said she had worked with a nephrologist on multiple medication adjustments to find the right combination of four drugs needed to control her blood pressure.
“I was concerned about any change in medication as an elevation of her blood pressure could put her at serious risk,” Dr. Sams said. “After spending 45 minutes on the phone, being transferred from department to department my request was denied because she had never tried and failed “their preferred medication.”
She also cited a young patient who was diagnosed with Attention Deficit Disorder. She said she wanted to prescribe Strattera because there was a family member in the household who was recovering from substance abuse: instead, she was required to prescribe an amphetamine instead, even after explaining the circumstances involved.
"I could tell you countless stories of where my medical judgment and the safety of the patient have been disregarded due to step therapy and formulary decisions," she said. "Every physician could write a book about the frustration and time wasted because of these requirements - requirements that often put the patient at risk."
Megan Testa, MD, speaking on behalf of the Ohio Psychiatric Physicians Association, said she always considers the cost of medications in her practice, since medications can be expensive and patients need to be able to afford the prescriptions she writes.
"Step therapy or fail first policies can be harmful to all patients," she said. "As a psychiatric physician, I can testify that I have seen these policies have devastating outcomes for my patients with mental illnesses. Research and experience show that treating mental illness at its earliest onset with the most effective medication produces the best results, not only for the patient but for the patient's family and the community."
She cited the following opinion from the Journal of the American Medical Association to make her point.
When conceived and implemented intelligently, step therapy can use evidence-based criteria, with clinically reasonable provisions for exceptions, to encourage more rational prescribing and help control medication costs, while ensuring that patients are receiving the most data-driven regimens. However, if based on poor evidence or implemented inflexibly, the approach can cause clinical problems, especially for patients forced to return to a medication class that was previously ineffective. But all policies that require patients to change medications risk negative consequences. Even switches between pharmacologically identical generic versions of the same medication can decrease adherence if the medication appearances differ.
Rachel Lichten, mother of a son with psoriasis and a volunteer with the National Psoriasis Foundation, said her son went through a number of therapies that didn't work before finding one that now allows him to live a normal life. She said when the family changed insurance companies she spent hours on the phone to obtain authorization for him to continue on the medication that worked.
Holly Pendell, representing the National Multiple Sclerosis Society of Ohio, said step therapy delays in treating patients with diseases like multiple sclerosis, can debilitating.