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Coverage criteria policies

Chorionic gonadotropin (Novarel® and Synarel®) – Minnesota Health Care Programs

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

Human chorionic gonadotropin (Novarel) and nafarelin acetate (Synarel) require prior authorization from HealthPartners Pharmacy Administration.

Coverage

All requests for doses exceeding the FDA-approved regimen will not be covered.

Human chorionic gonadotropin (Novarel) authorization criteria:
Treatment of cryptorchidism and hypogonadism
  1. Patient is a male who is at least 4 years of age; and,
  2. Is not being used to induce spermatogenesis ; and,
  3. Follows indication based FDA approved dosing below
    1. Cryptorchidism:
      1. 4,000 units 3 times/week for 3 weeks; or,
      2. 5,000 units every second day for 4 injections; or,
      3. 500 units 3 times/week for 4 to 6 weeks; or,
      4. 15 injections of 500 to 1,000 units administered over 6 weeks; or,
    2. Hypogonadism:
      1. 500 to1,000 units 3 times/week for 3 weeks followed by same dosing twice weekly for 3 weeks; or,
      2. 4,000 units 3 times/week for 6 to 9 months, then decreased to 2,000 units 3 times weekly for 3 months

Initial authorizations will be for two months in duration.

Nafarelin acetate (Synarel) authorization criteria:
Treatment of endometriosis
  1. Not prescribed for fertility, for ovulation or to help conception occur; and,
  2. Prescribed for the treatment of endometriosis; and,
  3. Patient is 18 years of age or older; and,
  4. Patient is not pregnant; and,
  5. Prescribed by or in consultation with an OB/GYN practitioner; and,
  6. Patient has tried and failed or has a contraindication to all of the following first line therapies; and,
    1. Non-steroidal anti-inflammatory therapy
    2. Continuous therapy with oral contraceptives
  7. Dosed no more frequent than 4 sprays per day
Treatment of precocious puberty
  1. Prescribed by or in consultation with pediatrician or endocrinologist; and,
  2. Dosing does not exceed 9 sprays per day

Initial authorizations will be for 2 months in duration.

Reauthorizations will be for 6 months in duration.

Quantity limit:

Novarel: 40,000 units per 28 days

Synarel: 24 ml per 28 days

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

    J0725

    Injection, chorionic gonadotropin, per 1,000 USP units (Novarel)

    J3490

    Unclassified Drugs

NDC

    Codes

    Description

    55566150101

    Novarel 10000 UNIT SOLR

    00025016608

    Synarel 2 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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/novarel.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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