Prior authorization and step therapy can impact compliance and outcomes, according to a survey by the Pharmaceutical Research and Manufacturers of America.
Patients face barriers put in place by insurances companies when trying to access medications, according to a recent survey of 4,765 patients by the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents biopharma companies.
About 49% of insured patients said they faced prior authorization, fail first, and exclusions from a formulary in the three months prior. Nearly two-thirds (64%) of Hispanic Americans and more than half (55%) of Black Americans faced these barriers compared with 44% of white Americans.
In a study released last year, among the largest U.S. commercial plans, step therapy was applied to one-third of specialty drug coverage policies and half of those protocols were more stringent than treatment guidelines recommended by clinical organizations, according to a study published in the November 2021 issue of Health Affairs.
Cost savings generated by step-therapy protocols may be offset by additional costs associated with therapy that ends up being ineffective and may have a negative impact on patient outcomes, said investigators, led by Kelly L. Lenahan, associate director at ISPOR— the Professional Society for Health Economics and Outcomes Research. She was research associate in the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, when the majority of this research was conducted.
In the PhRMA survey, 75% of those respondents who experienced barriers reported not taking medications as prescribed, and many had worse health outcomes. In fact, 27% reported they skipped one of more doses, 21% did not fill or pick up medication from the pharmacy, 19% delayed picking up medications, and 16% cut pills in half.
Non-adherence can lead to adverse outcomes. Half (48%) of all those reporting one or more episodes of non-adherence say their health suffered.
This seems to support other research about the impact of prior authorization and step therapy, or fail first, policies.
For example, one study published in 2020 looked at prior authorization for infused biologics for rheumatoid conditions such as rheumatoid arthritis, osteoporosis, systemic lupus erythematosus, vasculitis, multiple sclerosis, and inflammatory bowel disease. Investigators found that prior authorization requirements for infusible medications introduce delays in treatment for rheumatology patients, especially for the about 20% of patients whose prior authorizations are initially denied.
Investigators in this study found that treatment delays and denials are associated with greater glucocorticoid exposure, which can lead to osteoporosis and factures.
In another study published in 2019, patients in insurance plans with step therapy had lower odds of treatment effectiveness, mainly due to lower odds of adhering to treatment. This retrospective study assessed the use of disease-modifying antirheumatic drugs among patients with rheumatoid arthritis and psoriatic arthritis.
There can also be negative impact on patient struggling with a mental health condition, where 65% of responds in the PhRMA survey said they had experienced access barriers, Lisa Joldersma, senior vice president of policy, research and membership at PhRMA, said recently in an interview.
“We know that in the mental health space, it's often an exercise in trial and error before doctors find the specific medication that treats an individual. The barriers to accessing the wide variety of medications here is making things harder for patients,” she said. “Even if a patient doesn't give up, that the physician is being burdened with additional time to address this.”
The PhRMA survey found that Americans spent an average of $1,568 out of pocket
on health care in the past year. One in five (22%) also report it’s difficult to afford the out-of-pocket expenses required by their health insurance. About 30% of patients said they had trouble paying hospital bills, and 16% said they would be very worried about paying for medications.