Independence seeks to ensure that our members receive injectable/infusion
therapy drugs in a setting that is both safe and cost-effective. 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.
Drugs included in the Most Cost-Effective
Setting Program
The following is a complete list of drugs that require precertification
approval for medical necessity and setting:*
- Actemra? (tocilizumab)
- Adagen? (pegademase bovine) ? NEW FOR OCTOBER 1, 2018
- Aralast NP? (alpha-1 proteinase inhibitor [human])
- Benlysta? (belimumab)
- Cerezyme? (imiglucerase)
- Crysvita? (burosumab-twza) ? NEW
FOR OCTOBER 1, 2018
- ElelysoTM (taliglucerase alfa)
- Entyvio? (vedolizumab)
- Exondys-51TM (eteplirsen)
- Fabrazyme? (agalsidase beta)
- FulphilaTM (pegfilgrastim-jmdb) ? NEW FOR JUNE 25, 2018
- Glassia? (alpha-1 proteinase inhibitor [human])
- Inflectra? (infliximab-dyyb)
- Intravenous/subcutaneous immunoglobulin (IVIG/SCIG)
- IxifiTM (infliximab-qbtx)
- Lumizyme? (alglucosidase alfa)
- Naglazyme? (galsulfase) ? NEW
FOR OCTOBER 1, 2018
- Neulasta? (pegfilgrastim)
- Neulasta? (pegfilgrastim) Onpro?
- Nucala? (mepolizumab)
- OcrevusTM (ocrelizumab)
- Orencia? (abatacept)
- Prolastin? (alpha-1 proteinase inhibitor [human])
- Prolia? (denosumab)
- RadicavaTM (edaravone)
- Remicade? (infliximab)
- Renflexis? (infliximab-abda)
- Sandostatin? LAR Depot (octreotide acetate)
- Simponi Aria? (golimumab)
- Soliris? (eculizumab)
- Somatuline? Depot (lanreotide)
- Stelara? (ustekinumab)
- Vimizim? (elosulfase alfa)
- VPRIV? (velaglucerase alfa)
- Xolair? (omalizumab)
- Zemaira? (alpha-1 proteinase inhibitor [human])
*This list of drugs is subject to change.
Note: All biosimilars to the originator products in this program are
subject to precertification review for most cost-effective setting.
As of June 25, 2018, Independence added the biosimilar
FulphilaTM (pegfilgrastim-jmdb) to our Most Cost-Effective
Setting Program for members enrolled in commercial products.
In addition, effective October 1, 2018, Independence will add the
following drugs to this program for members enrolled in commercial
products:
- Adagen? (pegademase bovine)
- Crysvita? (burosumab-twza)
- Naglazyme? (galsulfase)
New requests for these four drugs will require review for setting, as well
as medical necessity, during the precertification process.
Members who have precertification approval to receive these drugs in a
hospital outpatient facility may continue treatment in this setting until their
current precertification approval expires. At the next precertification review,
Independence will evaluate the requested setting and make a coverage
determination.
Appropriate setting review
During precertification review, each member?s medical needs and clinical
history are evaluated to determine if the drug requested by the provider is
appropriate. As part of our Most Cost-Effective Setting Program,
Independence also reviews the requested treatment setting for certain drugs
covered under the member?s medical benefit to ensure that they are administered
in settings that are both safe and cost-effective.
Covered settings for drugs in this program include:
- a physician's office;
- the member?s home, where the infusion is administered by an in-network home
infusion provider;
- an ambulatory (freestanding) infusion suite that is not owned by a hospital
or health system in our network.
A hospital outpatient facility setting will primarily be considered for
members who are receiving an initial dose of any drug in this program, or if
there is a clinical rationale that requires the member to receive treatment in
that setting. The provider must submit documentation to Independence to support
the request for coverage in the hospital outpatient facility. This information
will be reviewed and a coverage determination on setting will be made.
Medical policy information
You can find additional information about these drugs in the following
Independence commercial medical policies:
- #08.00.70c: Enzyme Replacement Therapy for Mucopolysaccharidosis
(e.g., Aldurazyme?, ElapraseTM, VimizimTM,
Naglazyme?, MepseviiTM, etc.)
- #08.01.26: Pegademase bovine (Adagen?)
Note: Medical policies for Crysvita and Fulphila are currently in
development. Until these policies are published, precertification review for
these drugs will be based on the U.S. Food and Drug Administration
(FDA)-approved indication.
To review the medical policies, visit our Medical Policy Portal.
Select Accept and Go to Medical Policy Online, then select Commercial
, and type the policy name or number in the Search field.