OCs: extended and continuous dosing regimens

July 1, 2008

Birth control regimens that manipulate the hormone-free interval: telling patients what to expect.

Oral contraceptive (OC) regimens that manipulate the hormone-free interval are getting more popular now that there are several products specifically approved by the FDA for this indication. Of course, cyclic or monthly withdrawal bleeding when using hormonal contraception is not physiologically necessary. The traditional OC cyclic dosing (21 days of active hormone, 7-day hormone-free interval) was chosen instead for its ability to mimic the natural menstrual cycle and to conform to 1950s' societal pressures-not for its biological superiority.1,2

Our goal here is to explore issues surrounding the manipulation of the OC hormone-free interval (via shortening, delaying, or eliminating it) for the clinician. For the purpose of this article, the term "extended oral contraceptive dosing" refers to shortening the hormone-free interval and "continuous dosing" refers to delaying or eliminating that interval. While we'll be focusing on oral contraceptive pills, the contraceptive vaginal ring has also been found to be acceptable and tolerable for extended use.3 That said, however, the vaginal ring has not been approved by the FDA for extended use; therefore, doing so would be off-label.

Prescribing an alternative dosing regimen

Third-party payer coverage of oral contraceptives varies when using a traditional pill (21 days of active hormone, 7-day hormone-free interval) for an extended or continuous purpose. Continuous use of OCs requires four extra packs of pills per year (17 instead of 13) unless you are prescribing one of the specialized OC formulations listed in Table 1. Many insurance companies will only allow a woman to obtain one to three packs of pills at any one time, and some are very specific that the next pack cannot be obtained until almost an entire month has passed.

Fortunately, there's a way your patient can avoid being denied an early refill: if you're prescribing a traditional pill for an extended or continuous purpose, make sure to state this on your prescription ("pills to be taken without a placebo week for menstrual suppression"). If you're prescribing extended or continuous dosing for a specific medical indication, also state your diagnosis code (menstrual-associated migraines, dysmenorrhea, menorrhagia). Although this is a "hassle," many traditional OCs may have a lower co-pay or greater availability than newer products because they are offered at Title X clinics. You may want to discuss this with your patient.

Satisfaction

It should come as no surprise that the concept of having fewer scheduled bleeding episodes appeals to many women.4 Most women surveyed prefer a menstrual bleeding frequency of every 3 months or not at all.5 Menstrual suppression has its social benefits, too: increased convenience, less money spent on hygiene products, fewer missed school or work days due to menstruation-related symptoms, and improved quality of life.2,6 But that said, alternate OC dosing regimens are not ideal for all women-some women like a monthly cycle to reassure them they are not pregnant, for example. Clinicians should therefore be prepared to individualize regimens. Usually, satisfaction rates are high with any type of OC-dosing regimen and studies show no major differences in satisfaction levels between dosing regimens.6-8