Suboxone Strategy: Protecting Patients Or Profits?

I’m a little late on posting this one, but it still seems worth sharing.

Reckitt Benckiser has decided to pull Suboxone tablets from the market. Why? It’s an evidence-based decision and an expression of their desire to be a good corporate citizen and their concern for children.

Late last month, Reckitt Benckiser created a stir by unexpectedly announcing that its Suboxone tablet for treating opioid dependence will be withdrawn from the US market sometime over the next six months. The reason? The drugmaker, which is based in the UK and actually best known for household cleaning products, expressed concern that children could be accidentally harmed by easy access to tablets that are marketed in bottles.

In making its case, Reckitt cited specially commissioned data showing “consistently and significantly higher rates of accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. Specifically, the rates for Suboxone tablets were roughly eight times greater (read here).

What’s the big business picture?

To generic drug makers, some physicians and Wall Street analysts, however, the moves amounted to a transparent one-two punch designed to delay lower-cost generic tablets from reaching the market. The patent on Suboxone tablets, in fact, expired two years ago, while patent on Suboxone Film expires in 2022, according to the Reckitt spokesman. “If Reckitt is so concerned about safety,” says one industry source, who asked not to be named, “then why not take the tablets off the market right away? Their tablets are still on the market without blister packing, which they themselves say is unsafe.”

Meanwhile, Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients. The current wholesale average cost (WAC) for a bottle of 30 Suboxone Tablets is $161.70 for the 2 mg dose and $289.80 for the 8 mg dose, according to the Reckitt spokesman. In July, however, the same bottle of the 2 mg dose cost $140.00 and the 8 mg WAC was $252.00, industry sources say. Meanwhile, Suboxone film pricing has held steady: WAC pricing for a carton of 30 Suboxone Film strips remains $117.85 for the 2 mg dose and $211.15 for the 8 mg dose.

More recently, sales of Suboxone tablets fell 19 percent between August 2011 and August 2012, to $658.5 million, according to IMS Health, while sales of Suboxone film doubled to more than $764 million during the same period. “They are (removing the tablets) because generics are expected in 2013 on the tablet,” says Sanford Bernstein analyst Ronny Gal. “The critical question is whether their argument that film is always safer for children will convince FDA not to approve any oral solid generic.”

For these reasons, the back-to-back announcements have been met with outrage. “They have known for years that a generic tablet could destroy their golden calf — and Suboxone is Reckitt Benckiser, from an earnings standpoint. If they do not destroy the tablet, it destroys them,” Jeff Junig, a psychiatrist at the University of Wisconsin Oshkosh Student Health Service and an assistant clinical professor of Psychiatry at the Medical College of Wisconsin, wrote in a letter to Alcoholism & Drug Abuse Weekly.

“I’m sure I sound… paranoid? Cynical?,” wrote Junig, who also authors a blog about Suboxone. “But it is so frustrating when you see marketing trump science. This will discourage generics from making buprenorphine, which will keep the price high, which will cause deaths. Shame on them.”