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New Prior Authorization Requirements for Enzyme Replacement Medications

November 6, 2013

These requirements apply only to UnitedHealthcare integrated commercial members insured or administered by UnitedHealthcare, Mid-Atlantic Medical Services (MAMSI), Neighborhood Health Partnership, Oxford, and River Valley. They do not apply to direct commercial business (OptumRx direct business without UnitedHealthcare medical coverage or to the State of New York Empire Plan, UnitedHealthcare West, or UnitedHealthcare Community Plans.

As the cost of specialty medications continue to rise, we continue to look for ways to provide access to clinically appropriate health services and products while managing these escalating costs. Therefore, effective Feb. 1, 2014, we will implement prior authorization requirements for enzyme replacement medications, Cerezyme® and Elelyso®, used to treat Gaucher disease. These requirements will affect both new and existing members on therapy. 

Requests for coverage of Cerezyme and Elelyso may be subject to medical necessity review. Depending upon the results of that review where Cerezyme or Elelyso are not considered to be medically necessary, members may be required to switch to VPRIV®, a lower-cost clinically similar medication, in order to continue benefit coverage. Prior authorization will not be required for VPRIV. 

Although only approx. 131 UnitedHealthcare standard book of business members currently use the enzyme replacement medications for the treatment of Gaucher disease, use of these medications has a significant impact on pharmacy cost trends with the average cost of therapy ranging from $250,000 to $350,000 per patient, depending on the dose. 

What is medical necessity review?

  • Medical necessity review determines:
  • Whether the use of a health service is supported by published clinical evidence;
  • Whether it is clinically appropriate for the particular person for whom coverage is requested;
  • Whether it is cost-effective relative to other services that treat the same condition. 

Prior authorization requests will be reviewed:

  • Based on medical necessity criteria for:
    • Fully insured members with the 2011 Certificate of Coverage
    • Self-funded clients with updated Summary Plan Description language that includes a medical necessity definition
    • Based on approved or proven uses of the medications for all other members. 

All impacted members will be notified by Dec. 1, 2013. Network physicians are required to obtain prior authorization where appropriate and provide any supporting medical records before administering a targeted medication billed under the medical benefit.

If you have any additional questions, please contact your UnitedHealthcare or OptumRx representative.

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The following updates will take effect for the OptumRx direct Prescription Drug Lists (PDLs) on January 1, 2018. Learn more

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