Plans in showdown against high-cost drugs

Denise Marksberry, 47, of Ruther Glen, Virginia, said she couldn't find a drug that controlled the symptoms of her rheumatoid arthritis until 2012, when she started taking Johnson & Johnson's Simponi.

In late 2013, she said a letter from her insurer suggested it wouldn't pay for the drug in 2014, and that she had to switch to one of two alternatives. Operators for her insurer confirmed her understanding in two long phone calls, she said.

Off medication

"They said they wouldn't cover it," she said. Figuring an official application to stay on Simponi stood little chance, her doctor switched her to one of the other drugs.

After switching, she said she lost 10 pounds because she was queasy and had headaches after each weekly injection. She recently stopped therapy in hopes of getting back on Simponi next year.

Blue Cross Blue Shield Association, the umbrella group for Marksberry's insurance plan, said in an e-mailed statement that she is covered for Simponi but her doctor didn't return a required authorization form. It said the letter to Marksberry informed her about a new requirement that her doctor gain authorization for her to stay on the drug. The 2-page authorization form has 17 questions.

"There is never a period of time where I don't have some patient that is without medication" because of delays in getting insurance approval, said Peter Snyder, an endocrinologist at the University of Pennsylvania, who treats life-threatening pituitary disorders.

Prepared scripts

He said denials are issued by "low-level employees who are reading from prepared scripts" while his staff tracks down higher-ups to reverse the decision.

"It used to be the most important time was the time you spent actually speaking to the patient. Now it is the paperwork" to get drug approvals, said William Harvey, a rheumatologist at Tufts Medical Center. "The methodology is they hope you will get so tired that you will just give up."

A quarter of his patients who need expensive biologic drugs face treatment delays because of the bureaucracy, he said.

Rising costs have come as a jolt after a period of moderation brought about by new low-priced generics in the market. Federal data show annual cost increases averaging less than 2 percent for the four years through 2013, when $272 billion was spent on prescription drugs.

While drugs at upwards of $100,000 a year have been around for years, the conditions they treated were usually limited to rare disorders, including enzyme deficiencies and unusual cancers. Now such prices are spreading to more diseases, and are especially prominent for cancer.

Costly cancers

Sixteen of the 33 cancer drugs introduced since 2010 cost $10,000 a month or more and all were at least $5,000 a month, according to data compiled by Memorial Sloan Kettering Cancer Center, in New York. Only four of 44 cancer drugs introduced in the 1990s cost more than $5,000 monthly.

Sovaldi, which could be beneficial to 2.7 million Americans with hepatitis C, racked up $8.6 billion in sales in the first nine months of this year.

"Never before has a drug been priced so high to treat such a large population," Miller said.

In addition to hepatitis C, payers are closely monitoring a new class of injected cholesterol drugs in late-stage testing at companies including Sanofi and Amgen Inc.

Miller said the drugs could reach tens of billions in annual sales based on a price of $10,000 a year, which is comparable to other drugs engineered the same way, and a potential market of 10 million heart patients.

Futile calls

Initially, Express Scripts didn't restrict use of Sovaldi, other than verifying that patient had the disease and were being treated by appropriate specialists. Instead, it had its pharmacists call doctors' offices and ask whether they would be willing to postpone treating patients with earlier-stage disease until cheaper, more convenient regimens came out. The calls didn't have much impact, Miller said.

Some Illinois doctors say the state's Medicaid restrictions on Sovaldi, including limiting it to sicker hepatitis patients, aren't based on medical evidence.

"It is a bellwether moment in American medicine, where we have a disease that is known to cause significant morbidity and mortality that we basically are not treating because of cost," said Steven Flamm, chief of the liver-transplant program at Northwestern University Feinberg School of Medicine.

Gilead's Harvoni, a pill that combines Sovaldi with a second drug, reduces treatment time from Sovaldi's 12 weeks to eight weeks for some patients. Harvoni, approved by the U.S. in October, is priced at $63,000 for the shorter regimen.

Harvoni's cost to the health-care system "is significantly less" than other treatments, Gregg Alton, an executive vice president at Gilead, said in an e-mailed statement.

Although it's understandable that doctors want unfettered access to drugs for patients, Miller said sometimes decisions aren't based on the medical evidence or are influenced by pharmaceutical sales representatives.

Express Scripts "acts as a countermeasure" to this marketing, Miller said. "We can take billions out of the system by doing it."