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Drug Category: Men’s Health

Medication Class/Individual Agents: Androgens

I. Prior-Authorization Requirements

 Androgens

Clinical Notes
Drug Details

Drug Generic Name

Drug Brand Name

PA
Status
testosterone 1% gel packet Androgel BP PA  
testosterone 1% gel tube Testim PA  
testosterone 1% gel tube, packet, pump Vogelxo PA  
testosterone 1.62% gel packet, pump Androgel PA  
testosterone 2% gel pump Fortesta PA  
testosterone 2% solution Axiron PA  
testosterone buccal system Striant PA  
testosterone cypionate Depo-Testosterone PA  
testosterone enanthate Xyosted PA  
testosterone enanthate PA  
testosterone intramuscular pellet Testopel PA  
testosterone patch Androderm PA  
testosterone powder PA  
testosterone undecanoate Aveed ^ 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.

The Endocrine Society: Clinical Practice Guideline Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes (2010)1

  • Recommended initial testosterone replacement therapy (TRT) includes any of the following based on considerations of patient’s preference, pharmacokinetics of the formulation, treatment burden, and cost:
    • 75 - 100 mg testosterone enanthate or cypionate IM weekly or 150 - 200 mg every two weeks
    • one 2 to 4 mg testosterone patch applied every night
    • five to ten grams of 1% testosterone gel applied daily
    • 30 mg of a buccal tablet every 12 hours
    • Testosterone pellets implanted subcutaneously at intervals of three - six months
  • Therapy should be evaluated for efficacy at three - six months with serum level testing (between 300 - 800 ng/dL) and then annually.
  • Short-term testosterone therapy may be considered as adjunctive therapy in HIV-infected men with low testosterone (T) levels and weight loss to promote weight maintenance and gains in lean body mass and muscle strength.
  • Short-term testosterone therapy may be offered to men receiving high-dose glucocorticoids who have low T levels to promote preservation of lean body mass and bone mineral density. 

 

1. Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS et al; Endocrine Society . Clinical Practice Guideline: Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes. J Clin Endocrinol Metab. 2010;95(6):2536-2599.

 
Table Footnotes
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Delayed puberty
  • Hypogonadotropic hypogonadism
  • Metastatic mammary cancer (females)
  • Primary hypogonadism

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).

   

Androderm, Striant, Testopel, testosterone cypionate, testosterone enanthate, testosterone 1% gel packet and tube, testosterone 1.62% gel packet and pump, and testosterone 2% gel pump and solution and Xyosted for female members

  • Documentation of all the following is required:
    • diagnosis of metastatic mammary cancer. 

   

Androderm, Striant, Testopel, testosterone cypionate, testosterone enanthate, testosterone 1% gel packet and tube, testosterone 1.62% gel packet and pump, and testosterone 2% gel pump and solution for male members

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • a low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone). 

   

Aveed

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • a low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • an inadequate response to 90 days of therapy or adverse reaction to all of the following:
      • testosterone enanthate intramuscular injection; and
      • testosterone cypionate intramuscular injection. 

   

testosterone powder

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives of the requested drug cannot be used; and
    • appropriate tests and labs. 

 

Xyosted for male members

  • Documentation of all the following is required or a diagnosis of hypogonadism:
    • appropriate diagnosis; and
    • a low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • an inadequate response to 90 days of therapy or adverse reaction to all of the following:
      • testosterone enanthate intramuscular injection; and
      • testosterone cypionate intramuscular injection. 

 

Please note: The MassHealth agency does not pay for any drug when used for the treatment of male or female sexual dysfunction as described in 130 CMR 406.413(B): Drug Exclusions (see link below).

https://www.mass.gov/regulations/130-CMR-406000-pharmacy-services

Original Effective Date: 07/2011

Last Revised Date: 08/2019

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Last updated 10/09/19