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.

As of June 25, 2018, Independence added the biosimilar Fulphila^TM (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^?, Elaprase^TM, Vimizim^TM, Naglazyme^?, Mepsevii^TM, 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.