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Updates to Most Cost-Effective Setting Program for injectable and infusion therapy drugs

October 3, 2016

Independence wants to ensure that our members receive injectable/infusion therapy drugs in a setting that is both safe and cost-effective for their clinical condition. Since 2012, Independence has been reviewing the most appropriate setting for commercial members to receive certain injectable and infusion therapy drugs as part of the precertification review process.

Effective January 1, 2017, four drugs (Exondys 51, Neulasta® , Neulasta® Onpro ®, and Sandostatin® LAR) will be added to the list of drugs that require review for setting as part of the precertification process for our commercial members. It is important to note that these drugs do not currently require precertification review, but all requests for these drugs (even those that have been covered as part of a member?s existing treatment regimen) will require precertification approval for dates of service on or after January 1, 2017.

The following are drugs that require precertification approval for setting:*

  • Aralast (alpha-1 proteinase inhibitor [human])
  • Berinert® (C1 esterase inhibitor [human])
  • Cerezyme® (imiglucerase)
  • Cinryze® (C1 esterase inhibitor [human])
  • Elelyso? (taliglucerase alfa)
  • Exondys 51 (eteplirsen) ? New for 2017
  • Fabrazyme® (agalsidase beta)
  • Glassia (alpha-1 proteinase inhibitor [human])
  • Intravenous/subcutaneous immunoglobulin (IVIG/SCIG)
  • Kalbitor® (ecallantide)
  • Lumizyme® (alglucosidase alfa)
  • Myozyme® (alglucosidase alfa)
  • Neulasta® (pegfilgrastim) ? New for 2017
  • Neulasta® (pegfilgrastim) Onpro® ? New for 2017
  • Prolastin® (alpha-1 proteinase inhibitor [human])
  • Prolia® (denosumab)
  • Sandostatin® LAR (octreotide acetate) ? New for 2017
  • Soliris® (eculizumab)
  • Stelara® (ustekinumab)
  • Synribo (omacetaxine mepesuccinate)
  • Vimizim® (elosulfase alfa)
  • VPRIV® (velaglucerase alfa)
  • Xolair® (omalizumab)
  • Zemaira® (alpha-1 proteinase inhibitor [human])
  • These drugs are covered by Independence for members who meet the clinical criteria outlined in our medical policy for each drug and receive the drug in the setting approved by Independence during precertification review.

    Precertification review

    During precertification review, each member?s medical needs and clinical history are evaluated to determine if the drug and setting requested by the provider are appropriate. Typically, the first administration of these drugs will be approved in the hospital outpatient facility. This allows the member to be monitored for any treatment-related adverse effects. If the member does not experience any adverse effects during treatment, subsequent drug administration will be approved in a more cost-effective setting, such as the member?s home, the provider?s office, or an ambulatory (freestanding) infusion suite. If there are circumstances that require a member to continue receiving the drug in the hospital outpatient facility, the provider must submit documentation to Independence that specifically addresses these circumstances when submitting a request for coverage.

    To review the medical policies for the drugs listed, visit our Medical Policy Portal and select Accept and go to Medical Policy Online. Select the Commercial tab, and then type the name of the drug in the Search box.

    * Any biosimilar to an originator product on this list that is approved by the U.S. Food and Drug Administration is subject to precertification review for most cost-effective setting.


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