1)
The following
Testosterone replacement products require prior authorization:
a.
Testosterone gel
1.62%
b.
Testosterone cypionate
injections.
c.
Testosterone enanthate
d.
Testosterone
pellets(Testopel)
2)
The role of
testosterone
replacement to treat the decline in serum testosterone concentration that occurs
with increasing age in men in the absence of identifiable pituitary,
hypothalamic, or testicular disease is uncertain.
Testosterone replacement
for members with complex or multiple endocrine diagnosis require management by
endocrinologist.3) Testosterone replacement products are considered medically
necessary for members who meet all
of the following criteria for the initial request.
Initial approval for 3 months.
a.
Member
does not have any of the following:
i.
diagnosis of prostate cancer or breast
cancer;
ii.
Hematocrit > 50%
iii.
Palpable prostate nodule
or induration on digital rectal exam within the last 6 months
iv.
PSA > 4ng/ml or 3ng/ml in
African-American men or men with first-degree relative with prostate cancer or
an increase in PSA without further urologic evaluation.
v.
Untreated severe
obstructive sleep apnea
vi.
Severe lower urinary
tract symptoms
vii.
Poorly controlled
heart failure,
viii.
Myocardial infarction or stroke within the last 6 months,
b.
Member has subnormal
(less than 280mg/dl)
morning (fasting and
drawn between 8 to 10 AM) serum total testosterone concentration
on three (3) separate occasions (copies of lab reports with time/date stamp and
with normal range indicated from lab must be provided). Serum free testosterone
levels may only be considered if total testosterone levels remain borderline.
Testing must be performed at an independent lab with recording of the time of
the day and fasting status.
c.
Appropriate diagnostic evaluation has been done to
determine the cause of androgen deficiency. For secondary hypogonadism
evaluation and recommendations from an endocrine specialist is required.
d.
Member must have at least
3 symptoms/signs of androgen deficiency from listing below:
i.
Eunuchoidism, aspermia
ii.
Loss of body hair
(axillary and pubic)
iii.
Hot flashes, sweats
iv.
Breast discomfort and
gynecomastia
v.
Height loss, bone loss
vi.
Low trauma fracture
vii.
Decreased sex drive
viii.
Decreased morning
erections
ix.
Needing to shave less
often
e.
Other causes of above
symptoms have been ruled out. Symptoms and signs such as fatigue, depression,
anemia reduced muscle strength and increased fat mass are not specific for
hypogonadism.
f.
Testosterone therapy
is not indicated for decreased
sperm counts. Testosterone therapy decreases sperm production further by
suppressing pituitary gonadotropin secretion.
g.
There is documentation of discussion with the member about potential benefits
and risks of testosterone replacement therapy and member’s involvement in
decision making.
h.
Per Endocrine Society Guidelines when testosterone therapy is instituted, the
clinicians should aim at achieving T concentrations in the mid-normal range
(500-600 ng/dL) during treatment with any of the approved formulations, taking
into consideration patient preference, pharmacokinetics, formulation-specific
adverse effects, treatment burden, and cost. Dosage should be reduced if levels
are higher than the mid-normal range.
i.
Monitoring should be done
2 to 3 months after initiation of testosterone therapy and after changing a
dose. When the dose appears to be stable, monitoring every 6 to 12 months should
suffice. They should also be monitored for undesirable effects.
j.
Serum testosterone should
be measured midway between injections in men who are receiving testosterone
enanthate or cypionate, and the value should be mid normal, eg, 500 to
600 ng/dL. The dose should be reduced if higher values are obtained.
k.
Recommended dose is 100
to 200 mg every two weeks. It can be administered either by the patient himself
or by someone in the patient`s household. The patient should be seen
approximately two to three months later, and if he is bothered by fluctuations
in energy, mood, or libido, the regimen can be changed to 50 to 100 mg once a
week or transdermal testosterone can be offered again.
l.
Testosterone dosing or
frequency which is not based on standard clinical guidelines as well as frequent
monitoring for it are not covered.
m.
Use of Aromatase
inhibitors in combination with testosterone therapy has not been clinically
proven and therefore is not covered.
n.
Initial approval for
therapy is for 3 months.
3)
For renewal requests,
approval based on meeting all of the following criteria.
Renewal is generally approved for 6 months.
a.
Member does not have
breast cancer or prostate cancer.
b.
Member does not have
hematocrit > 54%
c.
Member does not have
palpable prostate nodule or induration on digital rectal exam within the past
six months.
d.
Member does not have PSA
> 4ng/ml or 3ng/ml in African-American men or men with first-degree relatives
with prostate cancer, or increase in PSA level of by more than 1.4 ng/mL in any
one-year period.
e.
Members does not have
untreated severe obstructive sleep apnea
f.
Member does not have
severe lower urinary tract symptoms
g.
Member does not have
poorly controlled heart failure
h.
Member is not planning
conception in next 6 months.
i.
Member has had fasting
morning (8 to 10am) total testosterone levels within last 3 months.
j.
Member has had provider
evaluation for potential adverse effects from testosterone replacement within
past three months.
4)
Members who are
transitioning to QualChoice and are currently on testosterone therapy, are
allowed a 90 days transition period for continuity of care. Any additional
requests for testosterone require documentation of above renewal criteria.
5)
For Testopel, the
quantity of pellets is limited to 6 pellets every three months.