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Table 55: Androgens


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Androgen Therapy

Medication Class/Individual Agents: Androgens

I. Prior-Authorization Requirements

 Androgens

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

methyltestosterone PA  
testosterone 1% gel packet Androgel PA  
testosterone 1% gel tube Testim PA   BP
testosterone 1% gel tube, packet, pump Vogelxo PA  
testosterone 1.62% gel packet Androgel PA  
testosterone 1.62% gel pump Androgel PA  
testosterone 2% gel pump Fortesta PA  
testosterone 2% solution PA  
testosterone cypionate Depo-Testosterone PA  
testosterone enanthate Xyosted PA  
testosterone enanthate PA  
testosterone intramuscular pellet Testopel PA  
testosterone nasal gel Natesto PA  
testosterone patch Androderm PA  
testosterone undecanoate capsule Jatenzo PA  
testosterone undecanoate capsule Tlando PA  
testosterone undecanoate injection Aveed PA   MB

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 Men with Hypogonadism (2018)1

  • The Endocrine Society recommends the use of testosterone replacement therapy (TRT) in men with low testosterone levels due to hypogonadism, drug therapy and human immunodeficiency virus (HIV) infection who are experiencing related complications. However, they recommend against the use of testosterone in older members with age-related decline in testosterone levels and lack of related symptoms.1
  • The International Society for the Study of the Aging Male as well as the European Association of Urology state the diagnosis of male hypogonadism should be based on signs and symptoms of androgen deficiency, together with consistently low serum testosterone levels. 2,3
  • Choice of therapy should be a joint decision between the member and physician and should be made after consideration of member preferences, the pharmacokinetic profiles of the respective agents, treatment burden and cost.
  • Several organizations recommend discussing the cessation of TRT three to six months after initiation of treatment in individuals who experience normalization of total testosterone levels but fail to achieve symptom improvement.4,5

 

Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018 May 1;103(5):1715-44.
Lunenfeld B, Mskhalaya G, Zitzmann M, Arver S, Kalinchenko S, Tishova Y, Morgentaler A. Recommendations on the diagnosis, treatment and monitoring of hypogonadism in men. Aging Male. 2015; 18(1): 5 to 15. Doi: 10.3109/13685538.2015.1004049.
Dohle GR, Arver S, Bettochi C, Jones TH, Kliesch S, Punab M. European Association of Urology: Guidelines on male hypogonadism.  Male hypogonadism. 2015 Mar. Available from: http://uroweb.org/wp-content/uploads/18-Male-Hypogonadism_LR1.pdf.
Mulhall JP, Trost LW, Brannigan RE, Kurtz EG, Redmon JB, Chiles KA, et al. American Urological Association (AUA). Evaluation and management of testosterone deficiency (2018). Available from: https://www.auanet.org/guidelines/testosterone-deficiency-guideline.
Qaseem A, Horwitch CA, vijan S, Etxeandia-Ikobaltzeta I, Kansagara D. Testosterone treatment in adult men with age-related low testosterone: A clinical guideline from the American College of Physicians. Annals of Internal Medicine. 2020 Jan 21;172(2): 126-134.

 
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.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Delayed puberty
  • Hypogonadotropic hypogonadism
  • Metastatic mammary cancer (female sex assigned at birth)
  • Primary hypogonadism

non-FDA-approved, for example:

  • Delayed puberty
  • Gender identity disorder
  • Gender dysphoria
  • Therapy after gender reassignment surgery

Note: The above lists may not include all FDA-approved and non-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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

   

Androderm, Natesto, 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

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • for testosterone 1% gel 2.5 gram packet (Androgel) and testosterone 1.62% gel 1.25 gram packet, one of the following: 
      • requested quantity is ≤ one packet/day; or
      • clinical rationale for exceeding the quantity limit.

SmartPA: Claims for Androderm, Natesto, Testopel, testosterone cypionate, testosterone enanthate, testosterone 1% gel 5 gram packet, testosterone 1 % gel packet and tube, testosterone 1.62% gel 2.5 gram packet and pump, and testosterone 2% gel pump and solution will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for primary hypogonadism or hypogonadotropic hypogonadism and a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.†
SmartPA: Claims for testosterone 1% gel 2.5 gram packet at a quantity of ≤1 unit/day and testosterone 1.62% gel 1.25 gram packet at a quantity of ≤1 unit/day will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for primary hypogonadism or hypogonadotropic hypogonadism and a history of paid MassHealth pharmacy claims of the requested agent for at least 90 out of the last 120 days.†

   

Any testosterone product used for delayed puberty

  • Documentation of all the following is required:
    • individual drug criteria must be met first where applicable; and
    • appropriate diagnosis; and
    • prescriber is a pediatric endocrinologist or consultation notes from a pediatric endocrinologist are provided; and
    • member is ≥ 14 years of age and < 17 years of age; and
    • one of the following:
      • Tanner staging of I or II for sexual maturation ratings; or 
      • other physical signs of delayed puberty such as: arm span exceeding the member's height by > 5 cm, abnormal testicular growth (testicular volume < 4 mL), bone ages documented as less than the member's current age; and
    • low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone).

      

Any testosterone product used for gender identity disorder, gender dysphoria, therapy after gender reassignment surgery

  • Documentation of all the following is required:
    • individual drug criteria must be met first where applicable, excluding testosterone levels prior to initiating therapy; and
    • diagnosis of one of the following:
      • gender identity disorder; or
      • gender dysphoria; or
      • transgenderism; or
      • therapy after gender reassignment surgery.

 

SmartPA: Claims for Androderm, Natesto, Testopel, testosterone cypionate, testosterone enanthate, testosterone 1% gel 5 gram packet, testosterone 1% gel packet and tube, testosterone 1.62% gel 2.5 gram packet and pump, and testosterone 2% gel pump and solution will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of sex reassignment.†
SmartPA: Claims for testosterone 1% gel 2.5 gram packet at a quantity of ≤1 unit/day and testosterone 1.62% gel 1.25 gram packet at a quantity of ≤1 unit/day will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for gender identity disorder or personal history of sex reassignment.†

 

Aveed

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

   

Jatenzo and Tlando

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • inadequate response (defined as ≥ 90 days of therapy) or adverse reaction to two or a contraindication to all non-injectable formulations of testosterone; and
    • for Jatenzo, one of the following:
      • requested quantity is ≤ two units/day; or
      • clinical rationale for exceeding the quantity limit. 


methyltestosterone for members assigned female sex at birth

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and 
    • for methyltestosterone capsules, medical necessity for use of capsules instead of tablets.

  

methyltestosterone for members assigned male sex at birth

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • inadequate response (defined as ≥ 90 days of therapy), adverse reaction, or contraindication to Jatenzo or Tlando; and
    • inadequate response (defined as ≥ 90 days of therapy) or adverse reaction to two non-injectable formulations of testosterone, or a contraindication to all non-injectable formulations of testosterone; and
    • appropriate dosing; and 
    • for methyltestosterone capsules, medical necessity for use of capsules instead of tablets.

  

testosterone enanthate for members assigned female sex at birth

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

 

Xyosted

  • Documentation of all the following is required:
    • appropriate diagnosis; and
    • low testosterone level with dates drawn and reference ranges (< 300 ng/dL total serum testosterone); and
    • one of the following:
      • inadequate response (defined as ≥ 90 days of therapy), adverse reaction, or contraindication to both of the following: testosterone cypionate intramuscular injection, testosterone enanthate intramuscular injection; or
      • both of the following:
        • member has needle phobia; and
        • inadequate response (defined as ≥ 90 days of therapy), or adverse reaction to two or contraindication to all non-injectable formulations of testosterone.

 

Please note: The MassHealth agency does not pay for any drug when used for the treatment of 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

 

Note: The decision on whether PA is required is based upon 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: 07/2011

Last Revised Date: 05/2024


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Last updated 05/16/24

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