Bill targets ‘fail first’ medical swaps [Columbia Daily Tribune, Mo.]

Mar. 17--JEFFERSON CITY -- A bill introduced in the Missouri General Assembly is seeking to constrain the bureaucrats who stand between patients and doctors deciding which drugs will be paid for.

Pharmacy benefit managers, or PBMs, are the third-party intermediaries hired by insurers to administer prescription drug claims with an eye toward saving money. Often, PBMs require "step therapy," derided by critics as a "fail first" protocol asking patients to use an equivalent drug or treatment for a time before they can be given the drug their doctor first prescribed.

In a hearing yesterday, Sen. Kurt Schaefer, R-Columbia -- vice chairman of the Commerce, Consumer Protection, Energy and the Environment Committee -- said "fail first" is flawed and dangerous. He recounted a time two years ago when his 6-year-old son was diagnosed with acid-reflux disease and prescribed a "tab" medication by his pediatrician designed to dissolve in the mouth. Instead, Schaefer recalled, the PBM decided his son should first try a much larger pill nearly impossible for a child to swallow. "It was a horse pill. The thing was the size of my little finger," Schaefer said.

Instead of haggling with the PBM, Schaefer decided to pay for the original prescription out-of-pocket. The conflict was decided weeks later after an appeals process launched by Schaefer's pediatrician. That appeals process, physicians say, can be slow.

"Why on earth are we giving the PBMs the ability to interfere?" Schaefer asked.

Schaefer is not alone. The committee also heard from Tracey Joyce of Webb City, a legislative assistant for state Rep. Bryan Stevenson. Joyce told the committee that several years ago, her refill prescription of the anti-arthritis medication Celebrex was rejected by St. Louis-based PBM Express Scripts. Instead, Joyce was asked to try three months of Advil or Aleve.

Despite protests by Joyce and her physician that this "step therapy" ran the risk of aggravating her ulcers, Joyce tried the medication. After completing the three months' therapy, Joyce was rushed to the emergency room, and doctors discovered six ulcers. Her primary-care physician, Andrew Roudebush, later blamed "step therapy" for exacerbating her illness.

"This whole thing has just been a nightmare to me," Joyce said yesterday. "My little trip to the ER and spending the night and the scope and everything else cost the state $15,000, and the medication they turned down would have cost $70 per month."

But representatives of the PBM industry pushed back hard against the stories. They say all of the decisions on step therapy are made after extensive clinical research. They said most times they intervene, it is simply to ask patients to try a chemically identical but cheaper generic version of a prescribed drug.

Michael Harrold, state government affairs director at Express Scripts, testified that his company is hired by many of Missouri's largest employers who are looking to get a handle on health care costs. Contrary to popular belief, he said, it is not the job of PBMs to choose what drugs to cover. Rather, he said, PBMs simply enforce the health insurance plans selected by employers.

Harrold said that without someone keeping on eye on cost-benefit, the sole deciders would be doctors who are constantly approached by drug reps hawking products and patients who are bombarded with advertisements advocating the latest, greatest pill.

"I don't mind the way the drug manufacturers develop their product and promote it, but at the end of the day, you also need to" look out for "a plan's sponsor and payer," Harrold said. "And it isn't just the insurance companies which aren't very popular these days, but it's also an employer. It's also Enterprise Rent-A-Car, it's Edward Jones, it's Monsanto and Anheuser-Busch. And I don't think those companies just don't give a dang about their employees."

Schaefer's bill, SB 918, was not voted on yesterday by the committee. Similar legislation has been introduced in past years without success, but Schaefer is optimistic the bill will move forward this week.

Schaefer's bill requires that:

--Any time a PBM asks that a physician change a prescription, the PBM must send a "switch communication" explaining the financial incentives involved in the change and clinical effects of the medication that differ from the original prescription.

--A prescribing doctor has ability to override any step therapy recommendations made by a PBM if the doctor gives a clinical reason for doing so. The bill also caps the duration of step therapy at 14 days.

--PBMs do not discriminate between "in-network" pharmacies to fill a prescription based on certain criteria. PBMs will not reassign a prescription from one pharmacy to another.

Reach T.J. Greaney at 573-815-1719 or e-mail [email protected].

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