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Drug Category: Hormones

Medication Class/Individual Agents: Gonadotropin-Releasing Hormone Analogs

I. Prior-Authorization Requirements

 Hormones – Gonadotropin-Releasing Hormone Analogs

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

degarelix Firmagon PA  
elagolix Orilissa PA  
goserelin Zoladex PA  
histrelin-Supprelin LA Supprelin LA PA  
histrelin-Vantas Vantas PA  
leuprolide Eligard PA  
leuprolide Lupron PA  
leuprolide / norethindrone Lupaneta Pack PA  
nafarelin Synarel PA  
triptorelin Trelstar PA  
triptorelin Triptodur PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

For PA drugs, one of the following FDA-approved indications must be met. For unlabeled uses, approval will be considered based on current medical evidence.

  • breast cancer (advanced) – Zoladex
  • central precocious puberty – Lupron, Supprelin LA, Synarel, Triptodur 
  • endometrial thinning – Zoladex
  • endometriosis – Lupaneta Pack, Lupron, Orilissa, Synarel, Zoladex
  • prostatic cancer (advanced) – Eligard, Firmagon, Lupron, Trelstar, Vantas, Zoladex
  • prostatic carcinoma (Stage B2-C) – Zoladex
  • uterine leiomyomata – Lupron

Class Contraindication:

  • pregnancy category X 
 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • breast cancer (advanced) – Zoladex 
  • central precocious puberty – Lupron, Supprelin LA, Synarel, Triptodur 
  • endometrial thinning – Zoladex 
  • endometriosis – Lupaneta Pack, Lupron, Orilissa, Synarel, Zoladex 
  • prostatic cancer (advanced) – Eligard, Firmagon, Lupron, Treslstar, Vantas, Zoladex 
  • uterine leiomyomata – Lupron

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

  

Advanced breast cancer (Zoladex)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and frequency. 

SmartPA: Claims for Zoladex will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for breast cancer.

 

Advanced prostate cancer (Eligard, Firmagon, Lupron, Trelstar, Vantas, Zoladex) 

  • Documentation of the following is required:
    • appropriate diagnosis; and 
    • appropriate dose and frequency for the product form chosen.

SmartPA: Claims for Eligard, Firmagon, leuprolide 14 mg/2.8 mL 2 week kit and vial, Lupron (7.5 mg 1 month kit, 22.5 mg 3 month kit, 30 mg 4 month kit, and 45 mg 6 month kit), Trelstar, Vantas, and Zoladex will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for prostate cancer.

 

Endometrial thinning prior to endometrial ablation (Zoladex)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and frequency; and
    • anticipated surgery date.

  

Endometriosis (Lupaneta Pack, Lupron, Orilissa, Synarel, Zoladex)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and frequency; and
    • inadequate response or adverse reaction to one non-steroidal anti-inflammatory drug (NSAID), or contraindication to all NSAIDs; and
    • inadequate response or adverse reaction to one hormonal contraceptive, or contraindication to all hormonal contraceptives; and
    • for requests for Orilissa, inadequate response, adverse reaction, or contraindication to Lupron.

    

Idiopathic or neurogenic central precocious puberty (CPP) (Lupron, Supprelin LA, Synarel, Triptodur)

  • Documentation of the following is required:
    • a diagnosis of CPP with onset of secondary sex characteristics before age eight years (female) or nine years (males); and 
    • prescriber is a pediatric endrocrinologist or documentation of a consultation with a pediatric endrocrinologist is provided; and 
    • member is currently less than 11 years (females) or 12 years (males) of age; and
    • for requests for Triptodur, inadequate response, adverse reaction, or contraindication to Lupron.

  

Uterine leiomyomata (Lupron)

  • Documentation of the following is required:
    • a diagnosis of uterine leiomyomata; and
    • appropriate dose and frequency; and
    • anticipated surgery date or clinical rationale why surgical intervention is not appropriate. 

 

Note: The decision on whether PA is required is based on information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 05/2001

Last Revised Date: 08/2019


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Last updated 11/08/19