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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: 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

Drug
Notes

testosterone 1% gel packet Androgel PA   BP
testosterone 1% gel tube Testim PA  
testosterone 1% gel tube, packet, pump Vogelxo PA  
testosterone 1.62% gel packet Androgel PA  
testosterone 1.62% gel pump Androgel PA   BP
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 powder PA  
testosterone undecanoate capsule Jatenzo PA  
testosterone undecanoate injection 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 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 patients 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 that 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 patient and physician and should be made after consideration of patient 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.
 
^ 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, 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 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. 

   

Jatenzo

  • 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 or adverse reaction to two non-injectable formulations of testosterone, or a contraindication to all non-injectable formulations of testosterone. 

    

testosterone enanthate for female members

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

   

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

  • 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. 

 

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: 03/2021


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Last updated 10/18/21

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