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HealthPartners

Coverage criteria policies

Burosumab (Crysvita®)

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

Crysvita requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Crysvita requires prior authorization from HealthPartners Pharmacy Administration. 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).

Initial Authorizations:

  1. Prescribed by nephrologist or endocrinologist; and,
  2. Prescribed for patients diagnosed with X-Linked Hypophosphatemia, with diagnosis support by either:
    1. FGF23>30 pg/Ml; or,
    2. PHEX-gene mutation; and,
  3. Patient is at least 1 years old; and,
  4. No phosphate and/or active vitamin D received within 1 week prior to start of therapy; and,
  5. Reduced renal tubular resorption of phosphate to glomerular filtration rate (TmP/GFR), defined as a value of <4 mg/dL for patients <15 years, and a value of <3 mg/dL for all other ages. TmP/GFR is variable by patient characteristics such as age and gender; exceptions considered on a case-by-case basis with provider rationale; and,
  6. Baseline serum phosphorous consistent with hypophosphatemia; and,
  7. No renal impairment (GFR>30mL/min); and,
  8. Crysvita is prescribed within the FDA approved regimen.
  9. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial authorization will be provided for 6 months.

Reauthorizations:

  1. Patient must continue to meet criteria 1, 2, 3, 6, 7, and 8 above; and,
  2. Patient has been seen by provider within the past 12 months; and,
  3. Patient is benefiting from use of the medication, as defined by one of the following:
    1. Improved serum phosphorous; or,
    2. Decreased Rickets severity score; or,
    3. Decrease in frequency of fractures or pseudo-fractures.

Reauthorizations will be provided for 12 months.

Definitions

Crysvita is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.

Setting: The type of physical site where the drug is provided. Settings 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.

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

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J3490

Unclassified biologics (use before 1/1/2019)

J0584

Injection, burosumab-twza 1 mg (effective 1/1/2019)

NDC Codes

Codes

Description

69794010201

Crysvita 10 MG/ML SOLN

69794020301

Crysvita 20 MG/ML SOLN

69794030401

Crysvita 30 MG/ML SOLN

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. Crysvita package insert, Ultragenyx Pharmaceutical Inc. Novato, CA, 94949, 4/2018.

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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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