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.

Dr Michael Diaz

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.

Dr Melissa Dillmon

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.

Dr Fred Divers

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.

Dr Barbara McAneny

"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."

Steering Patients to PBM Networks

Oncologists said PBMs are making it harder for patients to get medications, through a variety of tactics — including denying coverage of drugs dispensed through a practice's in-house pharmacy and instead requiring patients to go to a specialty pharmacy of the PBM's choice.

It is not just a matter of steering patients to their networks, commented several oncologists interviewed by Medscape Medical News. "The PBMs are very interested in getting rid of all of the physician office pharmacies," said McAneny.

Lisa Day, CPhT, a certified pharmacy technician with Ventura County Hematology Oncology Specialists in Ventura, California, said the use of outside pharmacies creates huge delays. In house, it might take 24 hours for a patient to receive a medication. But jumping through the hurdles required by the PBMs and using outside specialty pharmacies — a process that Day assists with — takes at least a week, and sometimes a month or longer.

"During that time, we've had patients say, 'Forget it, I'm going on hospice,' " Day told Medscape Medical News.

The five-physician Ventura practice opened its in-house pharmacy in 2007 so as to be more of a full-service provider. The practice belongs to a buying group and gets favorable pricing, but it only makes a tiny profit on the drugs it dispenses, said Day. The pharmacy staff can make sure that patients get medications in hand, answer questions, call before appointments to see whether they need a refill — all in a familiar, comfortable environment. "There's a lot more to it than a potential profit," said Day.

In oncology, patients "look toward us to be there for them, and ultimately, after years of chemotherapy and treatment, and sometimes seeing them every day or once a week, we become their family," Day said.

PBMs have been chipping away at the practice's dispensing ability since 2011, she said. That was when Express Scripts said Ventura could no longer dispense to non-Medicare patients who were clients of Tricare because it did not have a proper ratio of specialty to maintenance medications. Then, in 2016, CVS Caremark said it would not contract with Ventura because it did not meet Medicare Part D dispensing requirements. A team of lawyers got CVS to back off.

In October 2018, OptumRx notified the pharmacy that it would no longer be a contractor unless it modified its hours so as to be open 12 hours a day on weekdays and 4 hours each weekend day. It also had to be accredited by two organizations — URAC and the Accreditation Commission for Health Care (ACHC). There was a long list of additional requirements, including having 24-hour-a-day counseling available. Ventura was given a month to comply.

The oncology practice through its attorneys challenged the requirements. It was able to negotiate a deal that allows for single accreditation through ACHC and that enables Ventura to satisfy the hours and counseling requirements by having a physician on call. Ventura now has until June 2019 to comply.

"We are doing whatever it takes because we need to take care of our patients," said Day, who noted that her pharmacy now fills only 30% of patients' prescriptions, down from about 70%.

Wrong Medication, Wrong Dose

Divers and his colleagues in Arkansas essentially shut down the Genesis in-house pharmacy in the face of pressure — such as dual accreditation requirements — from PBMs. Genesis recently joined the American Oncology Network, an administrative services and contracting group that gives Genesis access to RX to Go, a specialty pharmacy at Florida Cancer Specialists.

RX to Go has jumped through all the PBM hoops but is within an oncology practice. It also has direct access to the Genesis patient records, said Divers. The PBM-favored specialty pharmacies "don't have access to the patient record, so they are in the dark," he said.

It also means that they do not keep up on changes in dosing or a switch to a different medication. A $14,000 bottle of pills sent to the patient might not ever be used, said Divers, adding, "This happens all day every day."

The RX to Go pharmacy lets the oncologist track how the pharmacy is serving the patient. "I can see when their drug is shipped," Divers said.

At the Harbin Clinic in Georgia, the oncology division started its in-office pharmacy in 2011, when oral cancer drugs started coming to the fore.

The revenue from the dispensing pharmacy lets the clinic cover the cost of back office staff, who educate and counsel patients, help with copay support, and navigate through insurance and reimbursement issues, explained Dillmon, chair of oncology for the clinic.

Harbin continues to operate its pharmacy, but usually loses the prescription to a PBM's chosen specialty pharmacy after the initial dispensing, she said. Even so, Harbin wants to continue its pharmacy operation, she said.

"Oral oncology drugs require almost more safeguards and oversight than intravenous therapies," said Dillmon, who is also chair-elect of the American Society of Clinical Oncology's Government Relations Committee.

AMA president McAneny agreed. Oral chemotherapy is still chemotherapy, and there is potential for significant side effects, she said. Patients may be more likely to skip doses or delay taking them because they are not in the clinic.

If oncologists are "pulled out of the loop" by the PBMs, "it makes a mess out of our ability to manage those patients," McAneny said. "It increases our burden in trying to figure out if the patient actually did get the drug, and it decreases the adherence for the drug, which is key in cancer therapy," she said.

DIR Fees — Pay to Play?

Oncologists are particularly mystified — and upset — about direct and indirect remuneration (DIR) fees.

Those fees exist only in Medicare Part D; the fees are paid to the PBM as a means of decreasing costs for the Part D plan sponsor. The fees can include rebates from drugmakers, subsidies, price concessions, or performance-based price concessions from pharmacies.

According to a PBM industry–commissioned report, DIR fees saved the Part D program and its beneficiaries $20.4 billion in 2017.

The fees helped reduce the federal government's costs in 2017 by $17 billion. Medicare beneficiaries may see premiums decrease by 30% during the next decade, thanks to the DIR fees, according to the report.

The pharmacy DIR fees — which is what oncology practices pay — accounted for a small portion of the total DIR fees in 2017, said the report. But "its impact on Part D program costs may be larger, in that it typically encourages pharmacies to meet contractual 'pay-for-performance' standards based on measures such as the generic dispensing rate."

These standards are often all but impossible to meet and frequently don't even pertain to oncology practice — such as rating the practice on how well it educates patients on diabetes or hyperlipidemia — said oncologists interviewed by Medscape Medical News.

"It has nothing to do with the service the pharmacy is providing," said Diaz.

DIR fees became more noticeable in 2016 when some PBMs and Part D plans began assessing retroactive fees on the basis of these largely irrelevant quality metrics, according to a COA report.

Specialty pharmacies — such as those in oncology practices — have a 2% to 5% profit margin on the medications they dispense, "with no additional reimbursement received for the comprehensive patient care services critical to ensuring optimal patient clinical outcomes," said the COA. The DIR fees can range from 3% to more than 5% of the drug's cost and "can thus wholly eradicate any profits" and "in many instances actually result in specialty pharmacies losing money when dispensing their medications," the COA pointed out.

"When you're talking about up to 12% of the cost of the transaction, that's making it more and more difficult for our pharmacies to provide these medications to our patients," Diaz, the COA president, told Medscape Medical News.

"They took $300,000 out of my practice last year that I cannot afford," said McAneny. The retroactive fees meant that for many of the drugs sold by her practice, reimbursement ended up being less than what was paid for the therapies. "This is not the best business model out there," McAneny told Medscape Medical News.

Day agreed, noting that in many cases, her pharmacy is not making any profit on PBM-controlled prescriptions.

The fees are ostensibly based on performance metrics, but many oncologists say they are a "pay-to-play" payment. The DIR fees are required to participate in a network, said Divers. "It's kind of like the mafia, where you pay Fat Tony for protection, but you get no protection," he told Medscape Medical News.

The fees aren't itemized, and there's no specific description of what they cover. The practice just receives a notice that the money will be withdrawn to cover the fees. "And they're all retroactive, so you have no idea how to plan for those ahead of time," he said.

His practice is still paying DIR fees from its now-shuttered in-house pharmacy. The latest notice was for $69,000 for June and July of 2018. He has estimated that with Genesis' previous volume of 100 to 200 prescriptions a month, that amounts to almost $2000 per prescription paid back to the PBM.

"How is that justifiable?" asks Divers.

Dillmon said DIR fees "make no sense." From what she can tell, they are payment to the PBM "for the privilege of providing medication to their patients." She, too, has had trouble planning around the DIR fees. Because they are retroactive, "it's hard to know whether you're winning or losing," said Dillmon.

Despite claims by PCMA that premiums are being reduced, Medicare beneficiaries may be harmed by the DIR fees. Day noted that beneficiaries' copay for medications is a percentage of the drug's cost. PBMs have been increasing the net price of the drug to include the DIR fees, which means ultimately, the patient copay is based on a higher price, said Day.

Dillmon said she worried about patients, too. "The Centers for Medicare & Medicaid Services has to look at whether the PBMs they are using are truly saving money and whether the Medicare beneficiaries are being harmed," she said.

Congress has been taking a closer look at drug pricing but may not specifically go after PBMs, said Diaz. However, he said, "I believe there is interest on both sides of the aisle in drafting legislation that will protect patients, not necessarily regulating PBMs," he said.

"It's all about the patients," Diaz said.

In the meantime, oncologists will be left trying to figure out how to operate in an increasingly PBM-dominated world.