Newly FDA-approved over-the-counter birth control pill fully covered by any Washington state health insurance

Unlike most places in the United States, the newly approved over-the-counter birth control pill will be fully covered by any state-regulated health insurance in Washington.

State law requires all over-the-counter birth control in Washington to be covered by health insurance with no cost sharing, deductible or co-pay, according to a spokesperson for the Washington State Office of the Insurance Commissioner. Once the newly approved over-the-counter Opill contraceptive hits pharmacies sometime next year, the medicine will be fully covered without a prescription for Washingtonians with health insurance.

“At the point of sale, you’d show your insurance card and should not have to pay anything,” said Stephanie Marquis, public affairs director for the Washington State Office of the Insurance Commissioner.

The Federal Drug Administration approved the over-the-counter contraception pill on July 13 – marking the first time such a drug has been approved in the United States for use without a prescription. Most similar birth control pills on the market still will require a prescription. The FDA-authorization only applies to Opill, a daily estrogen-free contraceptive sold by drug manufacturer Perrigo.

First approved for prescription use in 1973, federal regulators have now found the drug behind the Opill can be used by consumers safely and effectively by only relying on the “nonprescription drug labeling without any assistance from a health care professional.”

“Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product. When properly used, Opill is safe and effective,” the FDA said in a news release.

The U.S. joins more than 100 countries in the world where an over-the-counter birth control option is already available.

With FDA authorization in hand, Perrigo intends to roll out their over-the-counter birth control pill early next year – with hopes to expand access to women and other individuals capable of pregnancy who may face difficulties in obtaining a prescription for the pill. Much of that expanded access is dependent on over-the-counter birth control being affordable in addition to prescription-free. Perrigo has not yet announced how much Opill will cost consumers out of pocket but promised in a news release the drug will be “accessible and affordable.”

In most states the out-of-pocket cost of Opill will not be covered by insurance, while a prescribed version of the same drug would be covered – limiting the amount of access the over-the-counter drug could bring in many places. Washington is one of 13 states that requires all health insurances to cover over-the-counter birth control with no cost sharing. This currently includes products such as condoms, spermicides, emergency contraceptives and sponges, and will soon include Opill. State law also prevents in-network pharmacies from charging a copayment or coinsurance for an FDA-approved contraceptive method.

Oregon is one of the other states that requires insurance coverage of over-the-counter birth control, while other nearby states like Idaho and Montana do not.

Uninsured Washingtonians still will have to pay for Opill out of pocket, but Marquis noted there may be certain clinics in the state that decide to cover that cost for the uninsured.

Regardless of the out-of-pocket cost for prescription-free birth control pills, OB-GYN and University of Washington Medical School Professor Anne-Marie Amies Oelschlager said in an interview that Opill will “greatly increase the accessibility for birth control among many Washington state residents.”

Many rural counties of Washington and other states have no or only one OB-GYN – meaning patients in remote areas may have to drive farther to find a provider who can write them a prescription, Oelschlager said. These doctor visits also can be prohibitively expensive under some insurances, even if the pill is completely covered. Those in such situations may prefer to obtain the pill at their local pharmacy, rather than visit a doctor .

“People wanting to use birth control and avoid a pregnancy should be given the opportunity and the autonomy to access that and be able to pick that up over the counter,” Oelschlager said. “This is going to be much more effective than using condoms or emergency contraception like Plan B, which is available now. Even if people don’t use it perfectly, they’re probably still going to be more protected than they would be with current over-the-counter methods.”

Oelschlager also noted many countries have made the pill available over the counter for years, and patients are generally able to follow the instructions without the help of a medical professional.

“We always worry about people reading the packaging and following the instructions, but in general, the contraceptive efficacy of this pill has been as good as when it is prescribed.”

Those who typically obtain prescription birth control may also find use for the over-the-counter version, Oelschlager said. Many providers require patients to be seen at least once a year when they refill a birth control pill prescription. This can lead to gaps in coverage where the patient may want to purchase Opill to supplement their prescription until their next doctor’s appointment.

“A patient’s birth control might be running low. They might need to get a refill, but they’re office says they have to be seen first. To me, this is not an acceptable reason to not refill a birth control pill that’s working well for a patient. But that is the policy of some practices,” Oelschlager said. “And that means the patient has to scramble to get to see a provider.”

The lack of a prescription, and option to pay out of pocket, also gives women and other people who can become pregnant added privacy in their medical decisions.

“Even though all our health care visits are supposed to be private, often visits will show up on an insurance explanation of benefits. And even if a patient pays out of pocket and they don’t use their insurance to pay for their (prescribed) contraception, it could mean that someone in their household who they do not want to know they are on birth control, finds out.”

An example Oelschlager cited is an abusive partner who is trying to control the use of their significant other’s contraception use. In that case, a victim might purchase Opill to escape the scrutiny of their abuser and to not become pregnant.

She also pointed to adolescents who do not want their parents to know they are using birth control.

“A teenager may be having sex but do not want their parent or guardian to know for whatever reason. Without the over-the-counter pill, they might just use condoms or no contraception and be at risk for pregnancy.”

Even with supportive parents, adolescents may face barriers receiving care by an OB-GYN.

“A lot of adolescents don’t have money, and they don’t have access to transportation. And so they really rely on adults around them to get them to visit. But if the provider is far away, this is something they could do until they are able to access a provider.”

Opill can be used for an individual as young as 15. Children who are not yet menstruating should not use a birth control pill.

Most birth control pills use a mix of estrogen and progestin to stop ovulation in those who can become pregnant and ensure there is no egg that can be fertilized by sperm. A second type of contraceptive pill only uses progestin and does not reliably halt ovulation. Instead, progestin-only pills prevent pregnancy by thinning the uterine lining – causing cervical mucus to thicken. This prevents sperm from getting past the mucus and reaching an egg, if there is one. Each type of birth control pill is about equally effective at preventing pregnancy, according to Oelschlager.

Opill only uses progestin. Any birth control pill containing estrogen and any progestin-only pill besides Opill will still require a prescription.

According to Oelschlager, the primary practical difference between the two kinds of pills is that estrogen-containing pills bring a higher risk of blood clots, increased blood pressure and of migraine headaches. But she stressed that both types of contraceptive pills are safe for the vast majority of people, and that pregnancy has a much higher risk of all those side effects.

The primary downside to progestin-only pills is they require users to take them within the same three hours each day to remain effective.

“You have to be pretty conscientious about taking it the same time each day,” Oelschlager said. “It’s a very, very low-dose pill. And it’s not the most effective for birth control if you don’t take it at the same time each day.”

Oelschlager recommends those who struggle to remember to take their pills each day do not use the over-the-counter Opill, if they can help it. Instead, those patients should consider long-acting but reversible methods of birth control like an implanted IUD.

The most common side effects of the Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating. The drug should not be used by those who have or had breast cancer, but the drug is safe to use for those who breastfeed. It does not protect against any sexually transmitted infection, so Oelschlager also recommends continued use of condoms or other barrier methods of contraception for those having sex outside of a monogamous relationship.