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Pharmacy benefit managers (PBMs) create unnecessary barriers between patients and the medicine they need, experts explained during a Nov. 25 virtual “Patient Advocacy Coffee Chat” organized by the Biotechnology Innovation Organization (BIO).
Discussion centered on the real-life negative impact on patients from several PBM practices, like abusive step therapy or prior authorization protocols—as well as hope for legislation to reform PBMs.
Moderated by Michele Oshman, BIO’s SVP, External Affairs, & Head, Patient Advocacy Center of Excellence (pictured, top left), the panel included:
- Anna Hyde, VP, Advocacy and Access, Arthritis Foundation (pictured, lower left).
- Brian Connell, VP Federal Affairs, Leukemia & Lymphoma Society (pictured, lower right).
- Patrick Wildman, SVP Advocacy & Government Relations, Lupus Foundation of America (pictured, top right).
Problems with consolidation
In her introduction to the challenges, Oshman noted the market power PBMs gain through consolidation with insurers, pharmacies, and other healthcare actors.
“I just scanned the Fortune 500 companies here in the U.S., and in the top 50 are all three of the primary PBMs in the country that cover about 80% of our market,” she said.
Panelists explained why that matters to patients.
“I think one thing we’re seeing with that consolidation is you have your PBM potentially owning your specialty pharmacy and owning your Part D plan,” said Connell. This creates a conflict when patients seek information on drugs and payments from their specialty pharmacy—“who is also owned by the PBM, who actually loses money if patients adhere to their therapy as would be clinically appropriate.”
For lupus patients, who take an average of eight different medications, obstacles to obtaining their prescriptions can be harmful, according to Wildman.
“The consolidation in the industry and the vertical integration presents challenges,” he said. “Whether it’s step therapy, whether it’s choice of pharmacy—which is one of the challenges with PBMs. The many barriers to care can lead to worse outcomes.”
Step therapy and prior authorization
Panelists discussed the process of step therapy, when PBMs seek to save money by requiring patients to try one or more other drugs, and prove those drugs do not work for them, before the patient can take the drug their doctor prescribed. The resulting treatment delay often harms the patient and the healthcare provider. The same is true for prior authorization, when insurers and PBMs must approve a prescription from a doctor before it’s filled.
“We know from talking to rheumatologists over many years now that the burden of managing prior authorization and step therapy is very intense—that a lot of practices are having to hire office staff just to manage prior authorization and step therapy,” Hyde said. “We know that it is one of the top administrative burdens that rheumatologists face.”
For conditions such as pediatric cancer, patients can’t afford delays in treatment caused by waiting for PBM approval of a doctor’s preferred prescription. Connell described a scenario of parents taking their child home after a doctor’s visit.
“They get the call from the pediatrician or pediatric oncologist who says, you can’t even go home yet, turn around. You need to get back as we need to get your child on therapy in the next hour or two hours. That’s how time-sensitive the initiation of therapy can be,” he said. “Across a lot of our diseases, every hour wasted is an hour that really impacts the patient’s quality of life and ability to keep fighting.”
Wildman said step therapy is often prescribed for lupus patients whose doctors want to give them the latest breakthrough medicines, which are really improving therapy.
“We have two new medications on the market, and the requirements that you have to fail on standard of care before you can get to one of these medications—that creates real-life problems in terms of outcomes,” he said. “People’s disease can progress to significant organ involvement.”
Hope for legislative action
Hyde agreed that the time people spend taking drugs that don’t help them because of step therapy is harmful.
“That’s one reason that we really support the Safe Step Act,” she said. The Safe Step Act is proposed federal legislation that would allow people to gain exemption from step therapy in certain instances.
“It doesn’t really do away with step therapy,” Hyde explained, “but there should be appropriate guardrails to make sure that we don’t see those adverse health outcomes.”
According to Hyde, there are several state regulations allowing exemptions, and there is progress toward getting Congress to approve federal Safe Step protection. “We’ve built a lot of support over the last few years,” she said. “We have over half of the House co-sponsored on it and a number of members of the Senate.”
Other legislative reforms to increase PBM transparency for the benefit of patients have broad support.
While she said it may be late to try to pass major reform bills before the current Congress ends, Hyde maintained that the appetite for PBM reform remains strong, even if proposals might be changed somewhat by the next Congress.
“I would anticipate that the incoming majority in both houses are going to want to put their own stamp on it,” she said.
Connell said bringing attention to the issue during the current Congress will be helpful in getting it passed during the next one.
“I think there’s no wasted effort in this time where we’re trying to get Congress to act now, and we’ll hopefully have a lot of successes next year if we don’t see it in December,” he said.
