PBM Delays for Cancer Drugs May Risk Lives, Warn Oncologists

In In The News by Barbara Jacoby

By: Alicia Ault

From: medscape.com

The patient had metastatic kidney cancer, and his oncologist was seeking to treat him with sunitinib malate (Sutent, Pfizer), a preferred first-line oral therapy. But the patient’s pharmacy benefit manager (PBM) refused to cover the cost of the medication. The PBM told the oncologist that the patient’s kidney must first be removed.

However, the patient’s surgeon had already determined that the patient was not a surgical candidate, owing to the extent of his disease and to coexisting medical conditions.

For 3 months, the oncologist — in concert with the surgeon — attempted to win approval for the oral medication. For those 3 months, the patient with metastatic cancer did not receive treatment.

In the end, the PBM relented, and the patient received the medication.

It’s not clear in this case whether the delay altered the course of the patient’s disease, said Michael Diaz, MD, a medical oncologist at Florida Cancer Specialists and Research Institute, St. Petersburg, who is president of the Community Oncology Alliance (COA). But a 3-month delay when time is limited is concerning: a recent trial found that for patients with metastatic renal cell carcinoma who were not suitable candidates for surgery and who were taking sunitinib, the median overall survival was 18.4 months.

Not only was the 3-month delay an emotional strain for the patient, but the oncologist, the pharmacist, and other staff who were involved spent a lot of time on the appeal — time that could have been spent caring for patients, said Diaz.

More importantly, the PBM “made a medical decision without having seen the patient,” Diaz pointed out.

The PBM does not have the same liability as the physician on record. “They have no repercussions on their end — and yet they’re making medical decisions,” he noted.

The COA has been collecting similar stories from oncologists for several years, as it has become increasingly apparent that PBMs — who generally act as middlemen between insurers and healthcare providers — are having a major impact on cancer patients’ lives and on how oncologists deliver care. The PBMs are also making it more difficult for in-office pharmacies to survive.

Delays Can Be the Difference Between Life or Death

Prior authorization is the bane of many specialties, but in oncology, the delays can mean the difference between life or death. Turnaround times for authorizations are increasing, and the process has become more complicated, said Melissa Dillmon, MD, chair of the oncology division at the Harbin Clinic, a large multispecialty facility in Rome, Georgia.

It can take 2 to 3 weeks to get an oral medication to patients, she pointed out.

“From the patient’s perspective, the effects of the PBMs are dramatic,” she said.

A 3-week delay for a woman with metastatic breast cancer is “heartbreaking to watch,” she said, especially “when you know [the drug] is sitting on your pharmacy shelf down the hall and you can’t give it to her.”

Dillmon recounted the case of a patient with glioblastoma who needed temozolomide (Temodar, Merck). A lifelong sailing enthusiast, he’d been offered a berth on a trip from Catalina to the Panama Canal. Because of delays related to the PBM, his medication did not come before he was to leave for the trip. “He missed his trip of a lifetime,” she said.

Patient Was “Hoping to Die”

Fred Divers, MD, hematologist/oncologist with Genesis Cancer Center, Hot Springs, Arkansas, said that he has noticed an increase in delays.

He recounted the case of a patient with metastatic colorectal cancer who always received filgrastim (Neupogen, Amgen) with chemotherapy and who had been receiving self-inject syringes from the Genesis in-house pharmacy.

At some point, the PBM for the patient’s insurance company decided that prefilled syringes were not covered but that vials — the use of which involved the patient’s drawing her own blood — would be covered. But they still required preauthorization.

That change was not communicated to Divers, who ordered the usual prefilled syringes.

Five days later, the patient had still not received filgrastim. Her white blood cell count began to fall. Divers — who was notified of the PBM denial on day 6 — then ordered individual vials and syringes. But that order too was denied because that form of filgrastim also needed prior authorization.

Ten days after the patient received chemotherapy, she finally got the medication, but by then, her white blood cell count was 0.1 and she’d been lying on the floor at home with fever, diarrhea, and vomiting, said Divers.

The patient told him: “I was just hoping I would go ahead and die.”

PBM Defends Prior Authorization

When asked to respond to oncologists’ various concerns about PBMs, the industry — represented by the Pharmaceutical Care Management Association (PCMA) — said clinicians just didn’t like losing money. “Clearly, some oncologists prefer Medicare Part B’s fee-for-service approach to paying for prescription medications, which according to the Medicare Payment Advisory Commission (MedPAC) gives providers ‘incentives for use of higher-priced drugs when lower priced alternatives exist,’ ” Greg Lopes, a PCMA spokesman, told Medscape Medical News.

The PBM industry defends prior authorization. “When more affordable, clinically appropriate treatment options are available, employers, unions, and public programs choose to use prior authorization to lower costs and improve patient safety,” said Lopes, the PCMA spokesman. “Payers and pharmacy benefit managers use teams of doctors to develop prior authorization standards to ensure patient safety,” he said. “These standards determine which drugs are appropriate, with the ultimate objective of promoting the appropriate use of medications,” he said.

Change in Landscape

The change in landscape is being driven by several factors. The PBM market has been dominated by three heavyweights: CVS Caremark, Express Scripts, and OptumRX. Their monopolistic-like power will soon become even greater.

UnitedHealth Group owns OptumRx; CVS has merged with Aetna and already owns the PBM CVS/Caremark; Cigna owns Express Scripts; Anthem has developed its own PBM, IngenioRx; and Humana owns a PBM.

In 2019, five insurers — Anthem, Cigna, CVS Health, Humana, and UnitedHealth — will control both health insurance and pharmacy benefits for more than 125 million Americans in private insurance plans, Medicare, and Medicaid, according to a report published by Axios.

The rise of oral cancer drugs has given PBMs a new opportunity. In the past, when the majority of cancer treatments involved infusions, PBMs did not come into play. But with oral drugs — which are covered under drug plans, including for Medicare — PBMs are the go-to entity for payers trying to ensure the best bang for their buck.

PBMs say they are helping clients reduce drug costs. Express Scripts, for instance, reported that in 2018, its commercial clients’ drug spending rose 0.4%, the lowest increase in 25 years. This was accomplished in part by “guiding plan members to effective, lower-cost therapies and by securing deeper discounts from manufacturers and pharmacies,” the company said. Spending for Medicare Part D plans decreased by 0.3%. Unit costs declined by 1.4%, while utilization increased 1.1%, which means that Express Scripts made “medication more accessible for beneficiaries,” said the PBM.

Divers said he isn’t buying it. PBMs drive costs up by taking money from insurers and exacting rebates and fees from drugmakers and pharmacies, he said. “They basically extort both sides of the equation,” Divers told Medscape Medical News.

“I do not see any value that comes from the PBMs,” said Barbara McAneny, MD, president of the American Medical Association (AMA), who is a medical oncologist/hematologist in Albuquerque, New Mexico.

There’s often one drug that’s head and shoulders better than the other/ Dr Barbara McAneny

In oncology, “there’s often one drug that’s head and shoulders better than the other,” McAneny told Medscape Medical News. “Trying to negotiate which one we’re going to use is ridiculous and doesn’t add any benefit.”