Criteria for Testosterone Replacement Therapy

[bamiteko]

Currently our policy on testosterone replacement therapy is that the member has diagnosis of primary or secondary hypogonadism and no contraindications to therapy. We are thinking of asking for testosterone levels in addition to diagnosis. Does anyone else have similar policies for testosterone replacement (Androgel, Androderm, Testim, Striant etc)? And if so what criteria do you use?

[chantell.reagan]

Our analysis of 10 plans identified publicly available policies for testosterone products only for 3 plans:

o BlueCross BlueShield of Alabama Testim and Androgel policies only include diagnosis requirements

o Wellpoint policy includes diagnosis requirements as well as the testosterone level below the reference laboratory range

o Coventry policy requires a total or free testosterone level below the reference laboratory range (AND in some cases elevated FSH/LH or abnormal pituitary function)

[Nochmar]

Our plan doesn't have any strict policies about testosterone, but most of our business is in our own pharmacies, so our staff steps in when they believe something is being done contrary to the benefit. We cover it for males for hormone replacement, so if testosterone were prescribed for a female patient, our staff would intervene.

[MedNecessReviewer]

Considering the abuse potential and non-medically necessary use of these products, asking for a testosterone level may help verify and justify treatment for hypogonadism. I believe obtaining a testosterone level is needed in order to diagnosis hypogondaism, so many physicians will have the lab value available. Go for it!

[jacqueline.kostick]

According to the Endocrine Society, the threshold testosterone level below which symptoms of androgen deficiency and adverse health outcomes occur is not known and may be age-dependent. In addition, the testosterone concentration below which testosterone administration improves outcomes is unknown and may vary among individuals and among target organs. Therefore, the available evidence may not substantiate the use of a specific threshold for testosterone level below which clinical androgen deficiency occurs and that can confirm the diagnosis of hypogonadism in all patients.

However, based on the guidelines issued by the Endocrine Society on the use of testosterone therapy in adult men with androgen deficiency syndromes, the suggested lower limit of the normal testosterone range in healthy young men is approximately 300 ng/dL (10.4 nmol/L). Also, the guidelines emphasize that this level may vary between laboratories and it is suggested to use the lower limit of the reference range established by individual laboratories. In addition, the guidelines recommend confirming the diagnosis by repeating the measurement of morning total testosterone and in some patients by measurement of free or bioavailable testosterone level (a confirmed low T [e.g. Total T <300 ng/dL; or free or bio T <normal (e.g. free T <5 ng/dL)]).

To distinguish between primary (testicular) and secondary (pituitary hypothalamic) hypogonadism, the guidelines recommend measurement of serum LH and FSH levels.

If clinically indicated or in the presence of severe secondary hypogonadism (testosterone level <150 ng/dL), an assessment of anterior pituitary function can uncover other pituitary hormone deficiencies.

Upon initiation of testosterone therapy, the guidelines suggest monitoring testosterone levels 3 months.

Source:
Endocrine Society Clinical Practice Guideline Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes. J Clin Endocrinol Metab. 2006 Jun.

[participant2]

The only management that my plan has around TRPs is a gender edit (to deny for females).

[diana.papshev]

One of our visitors wanted to share the following criteria required by their plan:

Criteria for testosterone approval:

For primary testosterone deficiency due to age-associated decline:
Attach the following labs/supporting material:

• Two total serum testosterone levels, both of which should be <200 ng/dL, and LH.
• Chart note that includes at least one associated symptom such as low bone density or decreased muscle mass (Note: sexual dysfunction is not approvable, due to lack of benefit with testosterone replacement.)

For primary testosterone deficiency due to documented medical condition:
Attach the following labs/supporting material:

• Low serum testosterone (male, normal range 300-1,000 ng/dl)
• Elevated serum LH (male, normal range 7 to 24 IU/L ) and/or FSH (male, normal range 1.5-12.4 IU/L)
• Chart note that includes documented medical condition

For secondary hypogonadism:
Attach the following labs/supporting material:

• Diagnosis by endocrinologist
• Low testosterone concentration
• Normal or reduced serum LH and FSH