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Cancer patients are suffering serious health consequences because step therapy practices enforced by pharmacy benefit managers (PBMs) are preventing timely access to essential medicines, a Florida oncologist writes in a piece published in the Orlando Sentinel earlier this month.
Under step therapy, insurers and PBMs refuse to cover the initial drug that a doctor prescribes until the patient tries one or more less-expensive drugs to see if they achieve the desired result. Patients’ health suffers as they “fail” on alternatives while hoping to be approved for the drug their doctor prescribes. The Biotechnology Innovation Organization (BIO) opposes the process and urges PBM reform.
“They call it step therapy or therapeutic substitution. I call it practicing medicine without a license,” writes Martin F. Dietrich, MD.
“Instead of the FDA-approved, guideline-supported medicine I chose, they insist the patient ‘try and fail’ or demonstrate intolerance to a different drug, one that may carry greater risks,” he explains.
Forcing patients into step therapy is a financial decision by PBMs, “putting profits ahead of clinical evidence and the treatment plans chosen by a doctor and patient,” according to Deitrich.
“These policies have crossed a dangerous line. Each forced ‘step,’ where a suboptimal treatment is required first, gives cancer cells another chance to adapt and grow stronger,” Deitrich warns.
He describes one case involving mantle cell lymphoma (MCL), “a rare, aggressive blood cancer,” where an insurer insisted the patient take an older drug despite known side effects that were dangerous for the patient. The step therapies are common, according to Deitrich, who complains of being “overruled by insurers several times each week.”
The problem he writes is “a system that feels more like loan-sharking than health care,” driven purely by profit motives.
“PBMs, the middlemen controlling drug formularies and prices, skim hidden cuts of nearly every prescription filled in America,” says Deitrich. “They steer patients toward drugs that offer them the biggest rebate, not the best outcome.”
The chance for PBM reform
Congress has shown a bipartisan appetite for PBM reform, though legislation has yet to be passed. Deitrich urges passage of overall reform to put PBMs in check. He also promotes the Safe Step Act.
The Safe Step Act was re-introduced in the House Sept. 19 with co-sponsorship from Reps. Lucy McBath (D-GA), Rick W. Allen (R-GA), Mariannette Miller-Meeks (R-IA), Raul Ruiz, M.D. (D-CA), and Bob Onder (R-MO-03). It would allow exceptions for step therapy, requiring coverage of the initial drug a doctor prescribes in specific cases, including when the alternative treatment is expected to: cause harm by delaying care; cause an adverse reaction; prevent a patient from performing daily activities.
BIO advocates further PBM reform.
“PBM ‘middlemen’ abuse across the health care system has driven patients toward higher-cost drugs, inflating the price of medicines that should be affordable, and siphoning off billions through hidden fees. Strong PBM reform can begin to break the link between PBM fees and drug prices,” according to BIO.
In a Bio.News piece regarding step therapy, BIO writes: “Those battling illness should never be railroaded into inefficient treatments or delays in receiving the care they need. Such considerations are a natural extension of other PBM reform efforts and should be considered in any broad PBM legislation.”
Deitrich, a medical oncologist at Cancer Care Centers of Brevard and an assistant professor of internal medicine at UCF College of Medicine, has been battling cancer for his whole career. But the battle recently became more personal, he explains, with his mother facing lung cancer and his father melanoma.
“Cancer already demands every ounce of expertise, courage, patience and hope a person has. No one should have to fight their insurer, too,” he writes. “Behind every denial or delay is a family waiting, worrying, losing precious time. Florida families deserve a system that trusts the doctors dedicated to saving lives. Let doctors treat. Let patients heal.”
