AbbVie bows to pressure to keep cheaper Imbruvica formula on the market

AbbVie and Janssen launched a single-tablet formulation of Imbruvica this year. (AbbVie)

When AbbVie introduced a single-tablet version of its blood cancer drug Imbruvica earlier this year, it pitched the new formula as easier and more convenient for patients who took the older version as often as four times a day.

But switching patients from several tablets to just one also turned out to be far more expensive for some. The new pills are priced at a flat $400 each, regardless of dose. For patients on the lowest dose of 140 milligrams per day, the cost of their Imbruvica therapy would triple if they switched to the new tablets—and like many drugmakers who introduce single pills, pen injectors and other more convenient dosing of older drug, the company planned to stop selling the old ones.

That didn’t go over well at a time when drug companies are under pressure from payers and politicians to keep a lid on high prices. So last week, AbbVie quietly announced it would keep the original 140 milligram tablet on the market, even though most patients, it said, have already switched to the new formulation.

The company, whose Pharmacyclics unit co-markets Imbruvica with Johnson & Johnson’s Janssen, said in the statement that it had received “feedback” about its Imbruvica plans that prompted its change in course.

“We are committed to exploring ways of providing Imbruvica in a form that works best for patients and healthcare professionals by continuing to listen to their insights and medication preferences by maintaining an ongoing dialogue,” the statement said.

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Some of that feedback was harsh, to say the least. In April, nine oncologists published a blistering analysis of AbbVie’s plans for Imbruvica in The Cancer Letter, which concluded that the company was erecting barriers to safe prescribing practices. The old tablets gave prescribers complete freedom to select dosages that were appropriate to individual patients, the oncologists wrote, and they could adjust those dosages as needed. For example, if a patient is prescribed a 14-day course of antibiotics, he or she may need to take fewer Imbruvica pills during that time.

The oncologists urged the FDA to review the safety of You&i, AbbVie’s patient-access program for Imbruvica. The Cancer Letter article suggests You&i is a “marketing scheme” for the new single-tablet product that creates “the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140 mg capsules.”

The FDA should consider “that the combination of the high price per pill and the flat pricing scheme are specific impediments to safe administration, and that ignoring the marketing approach for [Imbruvica] is antithetical to fostering optimally safe dosing and administration,” the oncologists wrote.

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AbbVie and Janssen published a response in The Cancer Letter stating that the prescribing information for the new formulation was approved by the FDA, and that the companies believed the single-tablet switch would benefit patients.

“Research demonstrates that better adherence to medicines can lead to improved outcomes and that one-pill, once-daily regimens can lead to improved adherence,” they wrote.

As for the price of the new formulation, it “is based on the most widely prescribed and lowest of the two FDA-approved standard starting doses,” the companies said.

But then President Donald Trump renewed his campaign vow to stop drug companies from “getting away with murder” on prices—a development that no doubt played into AbbVie’s decision to keep the older, less expensive formulation of Imbruvica on the market. Trump’s plan, unveiled the same day AbbVie released its announcement, was not as harsh as some industry insiders feared. But his administration is asking the FDA to consider forcing drugmakers to cite prices in ads for their products, an idea proposed by Department of Health and Human Services secretary Alex Azar.

On Monday, Azar ramped up his rhetoric aimed at the drug industry, suggesting in a speech that any company that doesn’t get on board with Trump’s proposals might find itself on the receiving end of the President’s temper.

“I can imagine he is going to be very interested in the next company that takes a price increase not justified by inflation or change in clinical benefit,” Azar said.