Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Contraception.
Treatment: Lo Loestrin FE FE 1/10 tablets (Pre-Service).
The insurer denied the Lo Loestrin FE FE 1/10 tablets (Pre-Service).
The denial is overturned.

The patient is a female who needs contraception.  She was on Lo Loestrin approximately five years ago and did well with it.  Over the past five years, she has tried Aviane, Minastrin 24, and Loestrin 1/20s.  She had headaches and depression.  Her provider wants her to be on Lo Loestrin.

Yes, the proposed Lo Loestrin FE FE 1/10 tablets is medically necessary.
According to the American College of Obstetrics and Gynecology (ACOG), to standardize national practice, the United States Food and Drug Administration (FDA) was given the authority to approve generic versions of branded pharmaceutical products by the Drug Price Competition and Patent Term Restoration Act. Before 1984, manufacturers of generic products had to submit clinical safety and efficacy data for their products just as the innovator drug manufacturer had to do for initial approval. Since 1984, generic products including generic oral contraceptive (OC) products must demonstrate pharmaceutical equivalence, meaning that this new generic product contains the same active ingredients, identical in strength and dosage, as the branded product. This generic product also must be bioequivalent, meaning that blood levels obtained in clinical trials demonstrate a rate and extent of absorption not substantially different from the branded product.

Given an individual's variations in metabolism, it is probably impossible to improve our knowledge of OCs (oral contraceptives) by completing larger studies; effectiveness and side effects will tend to be overwhelmed by other nonpharmaceutical effects. Breakthrough bleeding, which is a common cause of OC (oral contraceptive) discontinuation, is related to missed pills, smoking, infection, and possibly drug interactions, which will tend to overwhelm subtle variations between already confirmed bioequivalent and pharmaceutically equivalent products. As the FDA (Food and Drug Administration) has pointed out, patients may be more likely to be aware of symptoms when substitutions occur or if they have been told they are taking a generic brand.

Generic OCs (oral contraceptives) approved by the FDA (Food and Drug Administration) have been shown to be bioequivalent and pharmaceutically equivalent to the branded product and are interchangeable. There are no evidence-based data to challenge this conclusion. However, because of possible effects on patient compliance, the American College of Obstetricians and Gynecologists supports patient or clinician requests for branded OCs (oral contraceptives) or continuation of the same generic or branded OC (oral contraceptive) if the request is based on clinical experience or concerns regarding packaging or compliance, or if the branded product is considered a better choice for that individual patient. Women should be informed when a different OC (oral contraceptive) is substituted for a previously prescribed OC (oral contraceptive)

In review of the medical record and the information provided by the ACOG (American College of Obstetrics and Gynecology), the patient has been on Lo Loestrin in the past with compliance and no side effects.  She has tried several other oral contraceptives that have caused headaches and depression.  There is not a generic form of Lo Loestrin.  The ACOG (American College of Obstetrics and Gynecology) supports clinician requests for branded forms of contraception based on clinical experience and compliance.  Therefore, because there is not a generic and the patient has done well with it and there is concern for adverse health effects with other oral contraceptives, the request is medically necessary.

The decision to deny the medication was based on formulary versus the clinical scenario.  The patient has had adverse effects from several birth control pills, but had done well on Lo Loestrin.  The provider's concern was for patient safety and compliance.  To continue to try alternate formulary options would be to continue to put the patient's health in jeopardy.  Therefore, the denial was not in the best interest of the patient.