‘Nonsensical’ Limits on Support Drugs Complicate Cancer Care

A young woman with breast cancer was experiencing such intense hot flashes from her triplet chemotherapy regimen, AC-T, that she begged to stop treatment.

Her oncologist, Ramy Sedhom, MD, suggested she take oxybutynin, an inexpensive drug for overactive bladder that has been shown to help reduce hot flashes. But her insurer refused to pay for the drug, even after Sedhom had several peer-to-peer discussions with the insurer in which he emphasized the effectiveness and low cost of the medication.

Frustrated, Sedhom, a medical oncologist at the University of Pennsylvania Perelman School of Medicine in Philadelphia, suggested the patient buy oxybutynin directly from CostPlus Drug Company. The site sells the medication for $6.50 for 30 pills.

The oxybutynin was a game changer. It curbed the patient’s hot flashes and helped her remain on the chemotherapy regimen.

But the headache the patient experienced was “unfair,” said Sedhom, also medical director of oncology and palliative care at Penn Medicine Princeton Health.

Insurers and pharmacy benefit managers (PBMs) have traditionally used processes to evaluate the necessity of medical treatments and services on an individual patient basis — a practice called utilization management. But utilization management techniques, which include prior authorization, can also delay or flat out deny essential care for patients. Even if treatments are eventually approved, patients still may be on the hook for a large portion, sometimes all, of the cost.

Oncologists like Sedhom have been seeing more stringent insurer reviews for effective, often inexpensive supportive care medications, such as oxybutynin, and, in response, have increasingly been looking for ways around these barriers.

One solution is to tell patients to bypass insurance companies altogether and purchase the medications directly from discount pharmacies. Patients can, for instance, use coupons from GoodRX to get discounts at local pharmacies or buy directly from Mark Cuban’s CostPlus, which sells generic drugs at cost, plus a 15% markup and a $3 service fee. Amazon Prime also offers discounted pharmaceuticals delivered directly to buyers, as does Costco, which has members-only prices.

But some clinicians wonder if this is how patients with cancer should be getting much-needed medications that alleviate symptoms of the disease and cancer treatment.

Limited Access to Antiemetics

For many years, insurers tried to block access to the anti-nausea drug ondansetron (Zofran) because it was expensive, said Fumiko Chino, MD, an associate professor of radiation oncology at MD Anderson Cancer Center in Houston.

But ondansetron, approved by the US Food and Drug Administration (FDA) in 1991, has been available as a generic since 2007. GoodRx lists the medication for as low as $9.56 for 30 orally disintegrating 4-mg tablets. CostPlus sells the same number and dose of pills for $6.20.

Now, instead of preventing or delaying access through prior authorization requirements or coverage denials, insurers have largely shifted toward quantity limits for ondansetron, Chino told Medscape Medical News. Those limits are “a slightly different flavor of horribleness,” she said.

Chino said the limits could be a “hangover” from when the drug was more expensive.

But these limits extend to inexpensive antiemetics beyond ondansetron.

In a yet-to-be published study, Chino and colleague Michael Anne Kyle, RN, MPH, PhD, of the University of Pennsylvania Perelman School of Medicine, found that more than half of commercial insurers selling plans on the Affordable Care Act marketplace have pill limits on ondansetron. One third of these plans had limits on all anti-nausea drugs. Options can include granisetron, prochlorperazine, promethazine, dexamethasone, olanzapine, metoclopramide, and lorazepam, which are all available as less costly generics.

The restrictions miss the value of these drugs, Chino said.

If ondansetron or other antiemetics control nausea and allow the patient to tolerate and continue their cancer treatment, receiving these anti-nausea agents can improve quality of life, make cancer therapies more effective, and help keep the patient out of the hospital — an expensive proposition that insurers ultimately pay for, Chino said.

Arjun Gupta, MBBS, called such restrictions “nonsensical.” And like Chino, Gupta has seen an uptick in utilization management strategies to limit or prevent access to these drugs. In 2021, Gupta and colleagues reported that among 35 Medicare Part D plans in Texas, 29 required prior authorization for ondansetron and six had quantity limits.

In Gupta’s practice, even when his team can secure approval, he may then be told that the patient only gets eight pills for a 30-day period. Sometimes, he will administer two pills prophylactically during a chemotherapy infusion. The patient then only has six pills for the month when they might require 30-60 pills, said Gupta, assistant professor of medicine in the Division of Hematology, Oncology and Transplantation at the University of Minnesota Medical School, Minneapolis.

“There are many levels of this stupidity,” Gupta said.

Part of the problem, Gupta noted, is that insurers and PBMs might not be considering the differences between the use of antiemetics during chemotherapy infusions and take-home medications. Anti-nausea drugs given during infusions are usually, but not always, delivered via IV and tend to be more expensive, while take-home medications are usually oral and tend to be less expensive.

These antiemetics are more important than ever given that newer oral anticancer drugs are often associated with more constant nausea and vomiting, which may mean a need for daily anti-nausea medications, wrote Gupta and colleagues in the 2021 study.

Limits on Other Supportive Meds

Insurers and PBMs erect the highest barriers for opioids, said Sedhom. Pain “is a symptom for about 50% of patients with advanced cancers,” he said.

If Sedhom does not prescribe the opioid that’s preferred on the insurer’s formulary, patients may arrive at the pharmacy only to discover the prescription was rejected. If patients get to the pharmacy late in the day, they may have to wait until the practice opens the next day to get a new prescription.

Pharmacies are increasingly out of stock of certain opioids as well, said Sedhom. Lining up additional rides or going without pain medications for a few days increases the burden for these patients, he said.

Chino explained that she has also encountered limits on the anesthetic viscous lidocaine 2%, which she prescribes to ease throat pain from radiation therapy. The generic is available for as little as $9.75 with a GoodRx coupon.

A quantity limit “is just bananas,” said Chino, explaining that the drug is “really hard to abuse.” She sometimes can only dispense 200 ccs of the medication. If a patient needs it to eat, “they’ll run out of that pretty quickly,” she said.

Sedhom said he has run into barriers or outright denials for “magic mouthwash,” which contains viscous lidocaine 2%, to treat mouth sores.

“It’s not out of the ordinary that avoidable hospitalizations happen because people don’t have the medications they need, whether they’re nausea medicines, whether they’re pain medicines or whether they’re other supportive care medicines,” Sedhom said. “It’s unfortunate because cancer is a disease of older patients, and oftentimes, you are balancing many different comorbidities.”

When asked about restrictions on supportive care medications, a spokesman for CVS Caremark, one of the nation’s largest PBMs, said that the company provides clients with a wide range of tools to manage drug costs.

“Prior authorization and/or quantity limits are evidence-based and typically align with the product’s FDA labeling,” the spokesman, Phil Blando, told Medscape Medical News. “Additional quantities may be available beyond FDA guidelines if there is evidence-based, compendial support,” he added.

Two other large PBMs, OptumRx and Express Scripts, did not answer Medscape Medical News’s queries by press time.

Downsides to Discount Sites?

Although discount pharmacies like GoodRx or CostPlus can fill a gap, these options will not replace insurance, said Chino. Some patients have a lifelong relationship with a pharmacy and don’t want to go elsewhere, she said.

There can also be unintended consequences to referring patients to discount sites.

It takes time and effort to guide a patient through enrolling in CostPlus or GoodRx, Chino said.

To get the best price at GoodRx, patients may need to shop around at multiple pharmacies. A study from Gupta and colleagues looking at 24 drugs for nausea and vomiting and 19 for anorexia/cachexia offered through GoodRx found that no single pharmacy consistently offered the lowest price for all the formulations.

If a patient needs five supportive care medications, they might “end up driving around for 2 hours,” Chino explained.

And whatever patients pay out of pocket at a discount pharmacy is not counted toward a deductible. Delays and pill restrictions can save insurers money in the short term, especially if patients buy over-the-counter medications or go to discount sites, said Chino.

There’s also potential for duplicate prescriptions or medication interactions that would not be captured adequately in a patient’s electronic medical record, Gupta noted, though Chino said she has not encountered any patient safety issues.

Turning to GoodRx and CostPlus when insurers balk at or place limits on prescriptions helps patients in the short term, but long term, “it creates a breakdown in trust,” Gupta said. Patients are told they need chemotherapy urgently and are then referred to an alternative system to access necessary supportive care medications because the standard insurance process has failed them.

But because insurance company restrictions on supportive care medications are increasing, it can force oncologists and patients to go this alternate route.

“It’s a lot for a patient and their loved ones to handle,” said Gupta. “It’s a lot for our staff to handle.”

Sedhom, Chino, and Gupta reported no relevant financial relationships.

Alicia Ault is a St Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on X: @aliciaault.