Appeal type: Medical necessity
Decision: Upheld

Gynecological
Pharmacy/Prescription Drugs

Diagnosis: polycystic ovarian syndrome
Treatment: Lo Loestrin Tab. 
The insurer denied the Lo Loestrin Tab. The health plan's determination is upheld. 

The patient has a prior 7 day trial of Junel that was reported to cause depression. There are no other trials of oral contraceptives noted and the patient has not exhausted options on the preferred plan formulary. The patient has prior use of Junel Fe only as an alternative. She has also been treated with Metformin for her polycystic ovarian syndrome. The patient was recently seen for phone consultation given her contraceptive surveillance. She reported that the health plan was making her try a new contraceptive. She had no night sweats. She was currently taking Lo Loestrin for contraceptive care. She had no weight change. There were no genitourinary problems. She has no complaints. She was given a new prescription for Yaz 3-0.2 milligrams (mg) tablets for contraception. She denied a history of migraine or thrombosis. She was a nonsmoker.
At issue is the medical necessity of Lo Loestrin Tab 1-10-1.

No, Lo Loestrin Tab 1-10-1 is not medically necessary for this patient.

Based upon the medical documentation provided and the plan formulary options, there would be no medical necessity for the use of Lo Loestrin 1-10-1 for the treatment of polycystic ovarian syndrome. The patient is reported to have been able to take this medication as it is the only oral contraceptive that had no side effects with. However, the patient is noted to have only had a prior trial of Junel Fe 1.5/30 and had severe depression as a side effect of the higher estrogen level as reported by her provide.r The prior trial of Junel was for 7 days duration. The patient has been prescribed a formulary alternative of generic Yaz and also has the option of generic Apri. In this case, there is no benefit of Lo Loestrin over the use of the plan's preferred formulary alternatives of generic Yaz or Apri.

The American College of Obstetrics and Gynecology (ACOG) states the following:

"Can hormonal contraceptives prevent or be used to treat ovarian cysts?

By preventing ovulation, hormonal contraception should reduce the findings of follicular and corpus luteal cysts on ultrasound examination as suggested by the results of small case series reports. Such cysts are rarely of clinical significance although they may lead to unnecessary repeat ultrasound studies when discovered incidentally. Not all follicular activity is suppressed with low-dose oral contraceptives (OCs), and small ovarian cysts are common in users of these formulations. Case-control studies have failed to demonstrate a difference in the rate of detection of functional ovarian cysts in women using either monophasic or triphasic combined OCs "

Thus, there is no recognized benefit of low dose estrogens in prevention of or control of polycystic ovarian syndrome.

ACOG also states the following:

"What are the effects of hormonal contraception in women with depressed mood?

Women with depressive disorders can use all methods of hormonal contraception per the US Medical Eligibility Criteria (USMEC category 1) because depressive symptoms do not appear to worsen with use of any method of hormonal contraception, including DepoProvera (DMPA)."

Thus, there is no contraindication for oral contraceptives and depression. There is no indication of worsening depression on these medications. This was noted in only a 7 day trial of Junel in this case.

Based upon these data, the patient can safely use the plan's preferred formulary options. Lo Loestrin Tab 1-10-1 is not medically necessary.