November 27, 2017 at 5:00 am ET
Those who are addicted to opioids need help. They need appropriate insurance coverage for it — and without stigma. Worthy goals all. But what about the Food and Drug Administration’s efforts toward bringing new, better pain-mitigating alternatives to the tens of millions of Americans who suffer from both acute and chronic pain?
When the president gets around to considering additional resources to battle opioid abuse and addiction, he must also realize it must include resources for more expeditious FDA review of both abuse-deterrent formulations and non-opioid programs because the best way to treat addiction is to eliminate the opportunity.
At the most recent meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, Dr. Jim Campbell, the president of Centrexion Therapeutics, professor emeritus of neurosurgery at Johns Hopkins University School of Medicine and a past president of the American Pain Society offered some FDA-specific recommendations that are worth sharing:
1. Create a non-opioid drug priority review voucher to reward sponsors of new non-opioid pain drug
2. Allow waivers of FDA filing fees for new non-opioid pain drugs
3. Provide significant tax credits for investment in new non-opioid drug clinical development
In addition, there are some existing FDA mechanisms that could be adapted to prioritize the development and FDA review of new non-opioid drugs. For example:
Create a Non-Opioid Drug Designation: Establish a new designation scheme similar to that of the existing Orphan Drug designation but with 10 years market exclusivity,
Mandate a Breakthrough Non-Opioid Drug Designation: Designating new non-opioid pain drugs, as a priority category would substantially enhance the prospect for investment and successful development.
“Value-based” is the new, hot prefix. Value-based medicine, value-based insurance design, value-based contracting. It seems that everyone agrees that everything should be based on “value.” But do we – really? Do we really all agree that “value” is the denominator” rather than “price?” Clearly not considering that the “price of medicine” is still very much driving the media and political conversation. But “value” is what patients care about, because “value” means clinical outcomes. It’s what the FDA cares about.
Now let’s consider last month’s announcement by Cigna that it is going to stop covering “most” prescriptions for Oxycontin in favor of Collegium’s Xtampza.
Cigna has signed a value-based contract with Collegium Pharmaceutical for the drug Xtampza ER, an oxycodone equivalent with abuse-deterrent properties. According to Cigna’s Chief Pharmacy Officer Jon Maesner: “Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse.”
That’s fine, but there’s one fact that’s strangely absent – both drugs are equally “abuse-deterrent.” It’s important to understand that both products are formulated with properties designed to deter intranasal (snorting) and intravenous (injection) abuse, but that neither is abuse proof — and one isn’t “better” than the other.
Here’s another important fact – OxyContin was reformulated in 2013 and became the first opioid with FDA-approved labeling describing abuse-deterrent characteristics. Once the poster-child for abuse, Oxycontin is now at or near the bottom of the “junkie-preferred” chart. The ADF version of OxyContin, has led to a 65-percent reduction in snorting, a 56-percent decrease in smoking, and a 51-percent decrease in injection among patients with a history of abusing the drug. I mention this because there is real world data to support the product’s abuse-deterrent label. These aren’t any such data to support the Collegium claim – at least not yet.
So, why the switch from Oxycontin to Xtampza? Could it be that Cigna negotiated a better deal with Collegium than it had with Purdue? This decision appears to be more about pharmaceutical rebates than “guarding against opioid misuse.” Alas, Cigna’s hyperbole has been met with silence when it comes to pricing transparency.
It’s a simple “find x” algebra problem. If the co-pay for the medicine isn’t changing, the abuse deterrent labeling is the same, and the only variable is a new manufacturer, then the only reason for Cigna to make the change is because they got a better price via value-based contracting – that the manufacturer now has “skin in the game.”
That’s okay. We live in a free market economy – but it’s not mentioned in the Cigna press release. What is mentioned is that the switch will guard against opioid abuse. How? Nobody seems to know. And what’s more frightening is that nobody is asking.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
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