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.