The FDA and the Endo International plc reached an agreement on July 6, 2017 to voluntarily withdraw its reformulated Opana® ER (oxymorphone HCL extended release tablets) from the market after determining the benefits of its use in patients no longer outweighs the misuse and abuse risks. Endo plans an orderly transition for patients to minimize treatment disruption and to ensure patients have time to work with their prescribers. Optum expects prescribers will review their patients’ current therapy, evaluate the continued need for ongoing opioid therapy and then choose their course of action. This new treatment plan may include either implementation of an opiate weaning schedule as a plan to discontinue opioid therapy for or to continue opioid therapy and begin the process of migration to a new medication. Should a claimant require continued opioid therapy, alternatives exist including a generic non-abuse deterrent formulation of oxymorphone extended-release tablets.
At this time, Optum highly recommends awaiting change of therapy to an alternative medication prior to submission of any Medicare Set Aside (MSA) to The Centers for Medicare and Medicaid Service (CMS) to avoid the possibility of inclusion of Opana® ER in the approved MSA. We are proactively reviewing previously completed (MSA) reports and current referrals and will notify clients whose MSA contains Opana® ER. This voluntary withdrawl provides an opportunity to help the prescriber in weaning or transitioning the claimant to another opioid regimen.
We offer a variety of clinical products and have a staff of pharmacists and nurses to assist claimants with a plan to render the most cost-effective treatment for the claimant while allowing for the best therapeutic outcome.
Note, at this point other formulations of Opana® will remain on the market; the only formulation slated for removal is the Opana® ER. Click here to view the Endo news release in reference to this matter.