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HealthPartners

Coverage criteria policies

Pegfilgrastim (Neulasta®, Fulphila™, Udenyca™)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Neulasta, Neulasta Onpro, Fulphila, and Udenyca require prior authorization from HealthPartners Pharmacy Administration for hospital outpatient administration and home IV administration.

No prior authorization is required when pegfilgrastim (Neulasta, Neulasta Onpro, Fulphila, Udenyca) is given in a clinic office.

No prior authorization is required for biosimilars (Fulphila, Udenyca) when dispensed through a pharmacy. Retail pharmacy dispensing is available for biosimilars (ie, not restricted to specialty pharmacy dispensing). Prior authorization is required for Neulasta and Neulasta Onpro when dispensed through a pharmacy.

The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Pegfilgrastim (Neulasta, Neulasta Onpro, Fulphila, Udenyca) are generally covered when all of the following criteria are met, and per member plan documents.

Clinic office

No prior authorization is required for pegfilgrastim (Neulasta, Neulasta Onpro, Fulphila, Udenyca) when used at a clinic office.

Pharmacy

No prior authorization is required for Fulphila or Udenyca when dispensed through a pharmacy.

Prior authorization for Neulasta and Neulasta Onpro is required when dispensed through a pharmacy. These products are generally not covered through the pharmacy, as they are labeled for professional administration.

Hospital Outpatient and Home IV

Pegfilgrastim (Neulasta, Neulasta Onpro, Fulphila, and Udenyca) is generally not covered when administered at a hospital outpatient facility or home IV setting. Members receiving care at these settings must use a biosimilar (Fulphila or Udenyca), which is covered when dispensed through a pharmacy. Members may self-administer the biosimilar, or bring the medication to their physician to be professionally administered if needed.

Definitions

Neulasta is a leukocyte growth factor indicated:

  • To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Limitations of use: Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Fulphila is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Udenyca is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: Udenyca is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Setting: The type of physical site where the drug is provided. Settings for professional administration include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

Pharmacy Dispensing is the distribution of a medication from a board-certified pharmacy for use by a specific patient. The pharmacy generally requires payment at the point of sale (when the medication is being dispensed). The medication dispensed by a pharmacy is labeled for a specific patient, and is intended for use by that patient. The medication may be delivered directly to a specific patient, or to a clinic or hospital for administration to that same patient.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:
HCPCS

Codes

Description

J2505

Injection, Pegfilgrastim, 6 mg

Q5108

Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg

Q5111

Injection, Pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg

NDC

Codes

Description

55513019201

Neulasta Onpro 6 MG/0.6ML PSKT

55513019001

Neulasta 6 MG/0.6ML SOSY

67457083306

Fulphila 6 MG/0.6ML SOSY

70114010101

Udenyca 6 MG/0.6ML SOSY

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Neulasta package insert. Amgen Inc., One Amgen Center Drive. Thousand Oaks, CA, 91320-1799. June, 2018.
  2. Fulphila package insert.MylanGmbH, Steinhausen, Switzerland CH-6312. June, 2018.
  3. UDENYCA package insert. Coherus BioSciences, Inc. Redwood City, CA, 94065-1442. November, 2018.

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Policy activity

  • 08/13/2018 - Date of origin
  • 01/01/2019 - Effective date
Revision date
  • 11/05/2018

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