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.

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, testosterone undecanoate capsule, 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.