Xyosted — Medica

Initial criteria

• Approve for 1 year if ONE of the following:
• A) Initial therapy – ALL of the following (i, ii, iii):
• i. Patient has persistent signs and symptoms of androgen deficiency (pre-treatment) AND
• ii. Two pre-treatment serum testosterone (total or bioavailable) measurements taken in the morning on two separate days AND
• iii. Both values are low per normal laboratory reference values;
• OR
• B) Patient currently receiving testosterone therapy – BOTH of the following:
• i. Patient has persistent signs and symptoms of androgen deficiency (pre-treatment) AND
• ii. At least one pre-treatment serum testosterone (total or bioavailable) level was low per normal laboratory reference values.

Approval duration

1 year