Side Effects

Cancer patient on PBMs: 'It's scary when you're in the hospital and they say, "denied" '

Pharmacy middlemen and the insurers they represent give themselves a lot of leeway in deciding when or whether they'll pay for expensive cancer drugs — leeway that patients and care providers say can cut lives short.

Take Charlotte Ortiz, 39. She was perfectly healthy in January, easily passing a fitness assessment for her job and going ice skating at Kings Island with her 8-year-old, Chloe. And on Feb. 11, when severe back pain sent her to the hospital at Wright-Patterson Air Force Base near Dayton, one thing she didn’t worry about was whether her insurance would cover her treatment.

As the assistant superintendent for recruiting at the Ohio Air National Guard, she was insured by Tricare, TRICARE,the plan that covers members of the active-duty military. Her husband, a former military recruiter, said his colleagues use the plan as a selling point to potential recruits: You might not get rich in the service, but you’ll serve your country and you'll have the best health care available while you do it.

Drug Look Up | Use our database to see if you're paying too much for your prescription drugs

But after Charlotte went to the hospital, her health collapsed. Back pain turned into paralysis from the waist down. Then she couldn’t swallow. She began to lose her ability to smell, speak and see.

"They couldn't get a diagnosis because her cancer was in her blood and in her brain," said Charlotte's husband, John Ortiz.

Other than a three-day sojourn, she hasn’t returned to their home near Enon, about 55 miles west of Columbus.

On Feb. 21, Charlotte was moved to Miami Valley Hospital in Dayton, where her doctors spent the next few weeks diagnosing her condition, which they determined was Extramedullany Granulocytic Sarcoma, an extremely rare cancer that was attacking her nerve endings. And that it was rapidly getting worse.

They scrambled the jets, so to speak.

Her pharmacologist thought he’d identified a type of drug that would flip off the chemical switch that was driving the uncontrolled cell production. Finding research on the topic from Memorial Sloan Kettering Hospital in New York, the pharmacologist, Josh Cox, sent Charlotte’s case to its author. That doctor agreed that the drug, Mekinist, was appropriate. The MD Anderson Cancer Center in Houston concurred, John Ortiz said.

Around March 20, Charlotte’s cancer doctor, Mark Romer of Dayton, wrote a prescription for it.

So with Charlotte’s health in a nosedive, her personal doctor and top experts in the United States had agreed on a diagnosis of a cancer that fewer than 50 people worldwide are known to suffer — and on a drug to help treat it.

Then a pharmacy middleman grounded the jets.

Express Scripts, the pharmacy benefit manager for Tricare, TRICARE,declined to pay for the $11,000-a-month prescription because it was for an “off-label” use — meaning its manufacturers didn’t have Charlotte’s type of cancer in mind when they made it.

"After reviewing the information provided, it has been determined that the request cannot be approved," Express Scripts' March 29 letter to Romer said.

The cancer doctor, who has 33 years of experience, appealed.

Cox said that because her cancer is exceedingly rare, there is no FDA-approved drug to specifically treat it. But despite how sick Charlotte was, Express Scripts said it could take 90 days to consider the appeal.

Charlotte was dumbfounded.

"It's scary when you're in the hospital and they say 'denied,'" she said last week from her bed at Miami Valley.

On May 1, more than a month after Express Scripts denied coverage of Charlotte's anti-cancer drug, the company reversed itself. But it took the intervention of U.S. Sen. Sherrod Brown, D-Ohio, to speed up the process, John Ortiz said.

Now, the Ortiz family is speaking out, hoping to keep corporate bureaucrats from needlessly interrupting others' cancer care.

“It’s for those people who don’t have the voice or the knowledge to do this,” Charlotte said. “If the doctors and the medical experts are telling you that you need a lifesaving drug, you should get it. (Express Scripts) is an insurance company. They’re not doctors.”

For its part, Express Scripts said that it "implements coverage review and prior authorization criteria established by the Defense Health Agency," which oversees Tricare.

"Generally speaking, off-label use of a medication is not approved on initial review," Jennifer Luddy, a spokeswoman, said in an email. "Typically, it requires a prescriber to engage in the appeals process, during which the prescriber provides additional information about a patient's clinical circumstances."

The Dispatch last year reported on delays in treatment caused by pharmacy benefit managers forcing cancer patients to get expensive drugs from PBMs' own mail-order specialty pharmacies. Charlotte wasn't faced with such a requirement. Her delay was caused by the requirement that she get a prior authorization for drug coverage from Express Scripts, the company's subsequent denial, and the elongated appeal process.

But whatever the cause of a holdup, it delays all other treatment of cancers that are complex and frequently fast-moving, said Cox, who is pharmacy director for the Dayton Physicians Network, a medium-sized oncology practice, and who sits on the Ohio Board of Pharmacy.

"There's a massive ripple effect if there's a delay of one medication," he said, adding that Charlotte's case was unusual only "because of the rarity of her cancer, but the fluidity and rapidity happens every day."

Luddy said her company tries to minimize delays in reviewing appealswhen it denies coverage.

"Express Scripts aims to resolve appeals as quickly as possible to ensure patients can get treatment in a timely manner," she said. "We turn around the majority of coverage appeals in under 30 days, and many of them under 14 days. We also have a process where a prescriber can request an expedited appeals process for serious and life-threatening circumstances, or for cancer surgery/radiation. In the expedited process, appeals are clinically reviewed within one business day."

But the Defense Health Agency "does allow Express Scripts up to 90 days to decide a coverage appeal, which allows us adequate time to work with the prescriber to acquire the information needed to make a decision based on DHA's criteria."

Cox said that when they're measured in weeks, delays for cancer patients can have the most-dire consequences.

"While it is difficult to definitively correlate a patient’s death to a delay in therapy, we have certainly seen patients who have died while waiting, including a man with lung cancer who was forced to wait seven weeks for his therapy,” he said in an email.

In fact, a 2017 study by the Cleveland Clinic found that delays in the start of treatment for cancer patients are getting longer and that people are dying as a result. It found an increased risk of mortality of 1.2% to 3.2% for each week of delay.

That has doctors frustrated.

"When I must tell a patient that she or he has cancer, that diagnosis comes with the explicit promise that I will provide timely treatment, including medicines aimed at curing cancer or extending life as long as possible," Jeff Vacirca, a New York oncologist and immediate past president of the Community Oncology Alliance, wrote Thursday in STAT News.

"But an insidious interloper now often comes between me and my patients. I’m talking about pharmacy benefit managers (PBMs), the middlemen that have introduced a bureaucratic and nightmarish system of delays and denials into filling prescriptions."

The oncology alliance maintains an archive of what it calls "horror stories" of cancer patients suffering at the hands of pharmacy benefit managers that essentially retain veto rights over doctors' treatment decisions.

For the Ortiz family, getting Charlotte's meds covered is just one part of a battle to get her better and back to work for the National Guard in Columbus.

"It's the unknown and the pain you go through, and not letting your mind go down rabbit holes," she said when she was having a tough day in the Miami Valley intensive-care unit this month. "That's where I've done really good."

Charlotte said a lot of things have enabled her to keep her strength in the face of so much discouragement. She credited her faith, the constant company and support she's gotten from a tight family, old friends from her hometown, and her coworkers in the Air National Guard — as well as the care she's received from her doctors and nurses— for getting this far.

"You can't let these people down," she said. "They're rooting for you."

Dispatch Reporter Catherine Candisky contributed to this story.