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ICER’s GIGO

2017-05-05 | Peter Pitts
ICER’s new report, to no one’s great surprise, has found abuse-deterrent opioids provide neither financial nor societal benefits.

GIGO. Garbage In. Garbage Out.

For example:

The ICER analysis specifically does not include diversion – even though the majority of the problem arises from this community.

ICER also changed its model at the last minute to be include all abuse-deterrent formulations (ADFs) and not just Oxycontin -- despite preliminary results that showed that, over 5 years, OxyContin ADF prevented 4,300 cases of abuse, >12,000 abuse years, saved $300 million in medical costs against $387 million in incremental pharmacy costs. These results alone are within the realm of cost effectiveness: $20,500 per abuser avoided, $7100 per abuse year avoided for the most successful ADO introduced into the market.

Societal costs are not included despite ICER’s promise they would be.

Heroin switching is included, despite the fact that it is an incident cohort. Per ICER, “We did not include the effects of increasing heroin use that might result from opioid abusers being switched to ADF opioid, as we are considering only incident and not prevalent opioid abuse in the model.” Hm.

ADF benefit is reduced by 25% because of the author of the original paper (Rossiter) conducted a sensitivity analysis to see how such a reduction would effect the model.

ICER is calling for ADFs to be “cost-neutral.” But how is this possible since the overwhelming cause of the problem are inexpensive, non-ADF generics?

What the ICER report ignores entirely is that one of the factors driving abuse and addiction is the inappropriate use of generic opioids for conditions that have non-opioid, on-label options. (52 percent of patients diagnosed with osteoarthritis receive an opioid pain medicine as first line treatment as do 43 percent of patients diagnosed with fibromyalgia and 42 percent of patients with diabetic peripheral neuropathy.)

Payers often implement barriers to the use of branded, on-label non-opioid medicines, relegating these treatments to second line options – along with new abuse-deterrent opioid formulations. The result is a gateway to abuse and addiction. An unintended consequence of the ICER analysis will be more of this inappropriate behavior.

According to Harvard health economist David Cutler, Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost.  But, as Aldous Huxley reminds us, ““Most human beings have an almost infinite capacity for taking things for granted.”

Abuse-deterrent opioids are precision medicines. They are not for everyone. As Dr. Charles Inturrisi, professor of pharmacology at the Weill Cornell Medical College, said at a 2013 Center for Medicine in the Public Interest Capitol Hill conference on opioids, “Personalized medicine can reduce the non-responder rate because you can focus in on individuals who are highly associated with being responders and you can eliminate the trial and error inefficiencies that inflate healthcare cost.”

One of the consequences of the ICER report is that it will deter investment in more and more creative abuse deterrent programs. The phrase, “strangling the baby in the crib” comes to mind.

Remember – ICER is the organization that found the new class of Hepatitis C therapeutics failing their cost/benefit litmus test -- another example of this organization being on the wrong side of history. Alas, it’s totally understandable considering that, on September 3, 2016, Dan Ollendorf (ICER Chief Scientific Officer) told the Pink Sheet, “It’s difficult to really understand how these [abuse deterrent opioids] are going to be of benefit if the non abuse-deterrent formulations are still out there.”

Talk about Confirmation Bias!