The U.S. Food and Drug Administration (FDA) recently approved a subcutaneous formulation of Benlysta (belimumab) for the treatment of active, autoantibody-positive systemic lupus erythematosus. This is the second formulation of Benlysta to receive FDA approval; the infusible formulation was approved in 2011. The new formulation allows members to self-administer the drug at home rather than go to a hospital outpatient facility for infusion. As a reminder, effective June 1, 2018, AmeriHealth will add the infusible formulation of Benlysta to our Most Cost-Effective Setting Program for AmeriHealth members. This formulation will remain eligible for coverage under the medical benefit, but the following changes will occur: - New requests for infusible Benlysta will require review for setting, as well as medical necessity, during the precertification process.
- Members who have received precertification approval for infusible Benlysta in a hospital outpatient facility may continue treatment in this setting until their current precertification approval expires. However, at the next precertification review, AmeriHealth will evaluate the requested setting and make a coverage determination.
Appropriate setting reviewDuring 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, AmeriHealth also reviews the requested treatment setting for certain drugs covered under the medical benefit to ensure that they are administered in settings that are both safe and cost-effective. Covered settings for infusible Benlysta 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 Benlysta or if there is a clinical rationale that requires the member to receive treatment in that setting. The provider must submit documentation to AmeriHealth 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. | Drugs included in the Most Cost-Effective Setting ProgramThe following is a complete list of drugs that will require precertification approval for medical necessity and setting as of June 1, 2018:* - Actemra® (tocilizumab)
- Aralast NP® (alpha-1 proteinase inhibitor [human])
- Benlysta® (belimumab) ? NEW FOR JUNE 1, 2018
- Cerezyme® (imiglucerase)
- ElelysoTM (taliglucerase alfa)
- Entyvio® (vedolizumab)
- Exondys-51TM (eteplirsen)
- Fabrazyme® (agalsidase beta)
- Glassia® (alpha-1 proteinase inhibitor [human])
- Inflectra® (infliximab-dyyb)
- Intravenous/subcutaneous immunoglobulin (IVIG/SCIG)
- IxifiTM (infliximab-qbtx)
- Lumizyme® (alglucosidase alfa)
- 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. |