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Fight looms over practice that forces patients to wait for better prescription drugs

Terri Eggeman, at her home in Valrico on Thursday, suffers from psoriatic arthritis and uses a medication called Enbrel. Before her insurer, Tricare, would cover the drug that eventually helped her, she had to try a cheaper option and prove it didn’t work.
Published Aug. 1, 2015

There were days Terri Eggeman didn't want to get out of bed.

Her back was too sore, her knees too stiff.

It was no surprise her prescription medication wasn't working. Her doctor had said it probably wouldn't. But before her health insurer would approve the more expensive drug her doctor preferred, Eggeman had to prove this one wasn't enough.

The process took five months.

"I still had a lot of pain," said Eggeman, a 58-year-old nurse from Valrico who suffers from psoriatic arthritis.

The experience was Eggeman's introduction to step therapy, a practice requiring patients to start with cost-effective treatments before "stepping up" to more expensive ones.

Step therapy isn't new to health insurance plans. Insurers say the protocols prevent unnecessary pharmacy costs, and ensure patients don't start with drugs that are too strong or risky.

But as prescription drug prices soar to new heights, physicians say the practice is becoming more prevalent, sometimes to the detriment of patients.

"There are more step-therapy protocols, more hoops to jump through," said Dr. Robert Levin, a rheumatologist who practices in Dunedin. "The reason for them is financial. It's for the insurance companies."

Advocates, doctors, drugmakers — and now lawmakers — are pushing back.

• • •

There are different types of step therapies. An insurer might require patients try a generic drug before a brand-name one, or a long-established drug before a new one.

The policies extend to a variety of medical conditions, including allergies, heart conditions and diabetes.

Natalie Blake, who lives in Broward County, ran into one last year when she tried refilling an asthma medication called Advair at a Walgreens pharmacy. She was told her insurer had changed its medication list and was no longer covering her prescription.

Blake's doctor later informed her she would have to "fail first" on a drug called Dulera.

"It was a little jarring," she said. "I had been on Advair for about five years. It was controlling my asthma."

Insurers cite multiple reasons for using step therapy. They say the practice helps prevent prescription drug abuse and fraud, and enhances patient safety by mandating proven medications before those that could be riskier.

"When used effectively, it benefits the entire system," said Yunus Meah, a clinical pharmacist for Humana.

It helps keep premiums low, too.

Robert P. Navarro, a pharmaceutical consultant and professor at the University of Florida College of Pharmacy, said insurers are under "enormous pressure" to manage costs, especially as drug prices rise.

Consider the latest statistics: The average price for generic, brand-name and specialty drugs spiked nearly 11 percent in 2014, according to the research firm Truveris.

What's more, some of the newest speciality drugs have come with unprecedented price tags. Sovaldi, a medication used to treat hepatitis C, costs an eye-popping $1,000 a pill.

"In today's world of biologic drugs that cost thousands of dollars, it is prudent for patients to try more cost effective, proven treatments first, especially when those treatments are proven to work just as well," the state's dominant health insurer Florida Blue said in a statement.

Meah, the clinical pharmacist from Humana, said most insurers have "exceptions" processes that enable physicians to make the case for a specific drug. And Navarro pointed out that patients can almost always elect to pay more for the more expensive treatment.

"Insurance is about what's covered, not what the doctor prescribes or what the patient can take," Navarro said.

But critics say the right medicine is sometimes out of the patient's reach.

• • •

Terri Eggeman's troubles started in 2007 with a persistent pain in her lower back.

She tried Aleve and bought a new mattress. Nothing helped.

Over the next several months, she started to experience stiffness in her joints, too.

"I'd get up in the morning and I'd be stiff for up to two hours," she recalled. "My knees were sore and swollen. My toes swelled. It was an effort to get through the day."

Eggeman finally decided to see a doctor after noticing a patch of flaky, red skin near her ankle. Her dermatologist referred her to a rheumatologist, who confirmed she had psoriatic arthritis, an autoimmune disease that affects the joints and skin.

The rheumatologist advised Eggeman to take Humira, which reduces inflammation by targeting a protein called TNF alpha. The drug is made from living cells and costs about $3,000 a month.

But Tricare, the health insurance program for members of the military and their families, wouldn't cover Humira unless Eggeman tried a cheaper drug called methotrexate first, she said.

The methotrexate cleared up Eggeman's skin. The pain and stiffness, however, persisted.

"I wasn't sleeping well," she said, adding that she struggled at work.

Tricare agreed to cover Humira five months later.

It took just three doses for Eggeman's pain to all but disappear.

"I could pretty much do whatever I wanted again," she said.

Eggeman is now on a different medication called Enbrel; she developed a resistance to Humira around 2012, she said. But she's been largely free of the pain that once kept her home from work. She and her husband even made a trip to Jordan, Turkey and the United Arab Emirates.

• • •

Sate Sen. Don Gaetz, R-Nice­ville, says stories like Eggeman's are not uncommon.

Earlier this year, he proposed legislation aimed at helping patients in her situation. The bill called for the creation of a new Florida Department of Health panel to review step therapy protocols submitted by health maintenance organizations, insurers and Medicaid managed care plans.

"The bill didn't say that insurance companies have to cover everything a doctor recommends," Gaetz said. "What the bill did say is if an insurance company wants to play doctor — and purports to know more about medical science than doctors do — then they should have to step into the arena, accept a burden of proof and make the case."

His proposal, dubbed the "Right Medicine, Right Time Act," was supported by a broad coalition, including the American Cancer Society-Cancer Action Network, the Parkinson's Action Network, the patient advocacy group Florida CHAIN, Florida Legal Services, the Florida Medical Association — and the pharmaceutical industry.

But it met strong resistance from the insurers, who argued it would lead to a spike in premiums.

"Health plans already work directly with providers through their own pharmaceutical and therapeutics committees to create formularies that meet the needs of their members for the best value," Florida Association of Health Plans president Audrey Brown told the Senate Health Policy Committee in March.

Business groups, including the powerful Associated Industries of Florida, fought against the proposal, too.

Like most of the other health care proposals filed during the last legislative session, Gaetz's bill died amid a tense standoff between the House and Senate over Medicaid expansion. But he said he plans to try again when the 2016 session begins in January.

While insurers are holding their ground, Gaetz says he is determined.

"I've got the bit in my teeth on this issue," he said. "I plan to either get the bill passed, or to go down fighting."

Contact Kathleen McGrory at kmcgrory@tampabay.com or (727) 893-8330. Follow @kmcgrory.

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