Endo Pharmaceuticals Voluntarily Withdraws Opana ER From the Market: What Does This Mean For Your Cases?

CMS, Medicare Set-Aside Blog, MSP News, Opioids, Re-Review Process on July 11, 2017 | Posted by Erin O'Neill, PA-C, JD

On July 6, 2017, Endo Pharmaceuticals issued a statement indicating it would voluntarily withdraw the opioid pain medication, Opana ER, from the market, in response to the Food and Drug Administration’s request one month earlier. As noted in our prior blog post, the FDA requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of ongoing misuse and abuse of the drug. This move is not surprising given the fact that the FDA had advised that if Endo Pharmaceuticals did not remove the product voluntarily, the agency planned to pursue withdrawal of the drug approval. Endo steadfastly stands by their claims regarding the drug’s safety, citing that “neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed.”

As also noted in our prior blog post, Opana ER is widely utilized in workers’ compensation cases, and consequently was included in many Medicare-Set-Aside Allocations (MSAs). The medication is very expensive, with Average Wholesale Pricing (AWP) ranging from $2.26 per pill for the 5mg dose up to $15.69 per pill for the 40mg dose. Inclusion of Opana ER in an MSA represents a huge expense. So what will happen with all of those MSAs previously approved by CMS that contain Opana ER? Will CMS be issuing refunds? We surely don’t think so. Most likely CMS will just assume that Opana ER will be replaced with another pricey abuse-deterrent opioid; however,  with the increased emphasis on curbing opioid prescribing, particularly in workers’ compensation claims,  this possibility seems much less likely. A recently released study by the Workers’ Compensation Research Institute (WCRI) noted significant decreases in the number of opioid prescriptions being provided, particularly to workers’ compensation Claimants. With the ongoing focus on opioid abuse and enacting legislation to combat the opioid epidemic, it is likely the number of opioid prescriptions will continue to decrease.

Perhaps, these recent developments might present an opportunity to request a Re-Review under the new “Amended Review” process CMS quietly snuck in just yesterday, in the revised Workers’ Compensation Medicare Set-Aside Portal (WCMSAP) User Guide, which can be found here, as announced in our blog post from 07/10/2017.  If you believe you have a case that may fall within the parameters for an Amended Review, or may be affected by the FDA’s latest development, feel free to reach out to our team to discuss your options.