On The Cover
Loren Bonner
“It’s a big step to have contraception available over the counter to help navigate some areas where reproductive health care might be limited,” said Lauren Lakdawala, PharmD, from Johns Hopkins Outpatient Specialty Pharmacy, during a packed presentation at APhA’s 2024 Annual Meeting & Exposition on hormonal contraception. The overturn of affected reproductive health care nationally, she noted.
In July 2023, FDA approved Opill, the first OTC birth control pill available in the United States allowing patients across the country to walk into a pharmacy and pick it up. Opill is a progestin-only birth control pill, meaning it doesn’t have an estrogen component like many prescription contraceptives.
While some pharmacies are choosing to stock Opill, interest from patients has been slow-moving and awareness is still building. Opill has only been available in pharmacies for a few months.
Cost is also a concern. Opill’s manufacturer, Perrigo, suggests a retail price of $20 for a 1-month supply with some discounts offered for 3-month and 6-month packs, but pharmacies are able to set their own prices. Some independent community pharmacies have chosen not to stock Opill because community pharmacies are selling it online or in-stores for less than they could.
“No one should be denied access to birth control pills over the counter due to cost barriers,” said Sally Rafie, PharmD, founder of The Birth Control Pharmacist. “We know that due to systemic racism, economic inequities, and other forms of oppression, any cost for birth control pills will be too high for some.”
Rafie said she is glad to see that Perrigo has introduced a consumer assistance program for those unable to pay Opill’s sticker price and to improve access.
The Affordability is Access Act, reintroduced by Congress in May 2023, would remove the prescription requirement for private insurance plans, allowing OTC birth control to be covered by insurance without the unnecessary prescription requirement.
The Affordable Care Act also includes coverage of prescription birth control with no cost-sharing. OTC contraception or a prescription with no cost-sharing provides an opportunity for pharmacists to discuss access, costs, and product options with patients.
Insurance coverage for OTC contraceptives
At the state level, there are currently nine states that have laws requiring coverage for OTC birth control. Health plans can also proactively provide this coverage.
One of those state laws—California’s—says that health plans regulated by the California Department of Managed Health Care must provide coverage of OTC contraceptives approved by FDA at no additional cost to members. According to Rafie, who practices in California, the procedure to obtain insurance coverage is still to be determined.
“Ideally, people would be able to apply their insurance at the point of sale to get instant coverage, whether they are purchasing it at a retail location or online,” she said. “Without this possibility, the options are either for people to purchase it out of pocket and then request reimbursement or the pharmacy team members have to get involved solely to obtain insurance coverage for the product. Requiring folks to interact and make this request of the pharmacy team members may be an insurmountable barrier to accessing it.”
Opill no longer feels over-the-counter in this scenario, said Rafie.
A 2023 report from Kaiser Family Foundation dug into insurance coverage of OTC oral contraceptives. Based on interviews with nearly 80 experts including pharmacists, health plan administrators, and state Medicaid officials involved in OTC contraception coverage in the states where they use state-only funds to provide this coverage for Medicaid enrollees, the report found that while several interviewees expressed confidence that their current billing process accommodates other nonprescribed OTC contraception, most state-level discussions on insurance coverage of Opill are in the preliminary stages.
Billing protocols for OTC contraception vary widely by health insurance plan and even within state Medicaid programs, leading to confusion for some pharmacists, noted interviewees. States do not usually determine the billing mechanism to be used.
Interviewees also expressed that there has been limited communication about billing for nonprescribed OTC contraception between pharmacies, PBMs, health plans, and state insurance departments.
The National Council for Prescription Drug Programs (NCPDP) recently created a new task group to start addressing billing for FDA-approved OTCs through pharmacies when there is no prescriber or prescription order.
According to Lisa Schwartz, PharmD, senior director of professional affairs at the National Community Pharmacists Association, the task group will look at “macguyvering” a solution to use prescription claim transactions in NCPDP’s Telecommunication Standard Version D.0 as well as more elegant solutions for the future.
“It’s not clear that the laws require these products to be dropped into the pharmacy’s dispensing workflow, but at least one pharmacy benefit manager is supporting its health plan clients by adjudicating no-Rx OTCs in the prescription benefit,” said Schwartz, who is part of the new task group. “For pharmacies, there are lots of unknowns around utilization management, audit liability, and reasonable reimbursement, and while these are outside the scope of the task group, pharmacy advocacy groups will be closely following introduction of similar legislation and rulemaking processes.”
The Kaiser Family Foundation report also raised the issue of addressing quantity limits for OTC contraception.
Retailers’ choice
Lakdawala said they have been worried about which retailers would provide Opill and how they would make it available. Pharmacies can choose to stock it behind the counter or have it easily accessible on pharmacy shelves. Lakdawala said it seems like most are making it available on pharmacy shelves.
If pharmacies choose to carry Opill, it may likely depend on location and demographics. Many pharmacists have said the OTC option is being considered in more rural locales where access to reproductive health care options may be more limited.
Still, other pharmacies may choose to stock it because of the type of pharmacy they are. Equitas Health is a regional LGBTQ+ and HIV/AIDS–serving nonprofit community health care system. All five of their pharmacy locations in the Columbus, OH, area chose to stock Opill.
“We decided to carry it because of the patients we serve, it breaks down barriers,” said Grace Havens, PharmD, a PGY-1 community-based pharmacy resident at Equitas Health and The Ohio State University.
She said Opill can often start a conversation with a patient in their pharmacy. Pharmacists can connect a patient with other health care services in the Equitas Health network if needed.
“In terms of giving access in our pharmacy, we are connected to medical centers and we can do a warm handoff for patients,” said Havens.
If a patient is experiencing cost issues, she could connect the patient to a provider who can write a prescription for Opill in order for it to be covered by insurance.
Pharmacists prescribing birth control
During the APhA2024 session, speakers polled audience members and found that 72% of pharmacists in the room don’t prescribe hormonal contraception but would like to.
Currently, 29 states allow pharmacists to prescribe hormonal contraceptives. However, due to lack of reimbursement, many pharmacies opt out of providing birth control services even if their state allows it. For a pharmacist to prescribe contraception to a patient, they typically must provide certain patient services like a medical intake and BP reading, and evaluate the patient for any contraindications if they are receiving estrogen-containing pills.
In more recent months, some states have tried to increase access to reproductive health care in pharmacies even more. In March 2024, the New York State Department of Health issued an order to formally put in place a new law establishing access to hormonal contraception from pharmacists without a physician’s order.
In New Jersey, under rules adopted by the state Board of Medical Examiners and the state Board of Pharmacy in 2024, qualified pharmacists can provide self-administered hormonal contraceptives—including injectable contraceptives, pills, patches, and rings—without a prescription. Pharmacists who wish to do this must complete a 4-hour training program.
At least two dozen other states have preceded New York and New Jersey in granting pharmacists some capacity to dispense contraception without a prescription.
For Opill access, with over half of U.S. states allowing pharmacists to provide hormonal contraceptives directly to patients, pharmacists in those states are able to facilitate coverage of Opill.
“I think progestin-only pills are a wonderful option and I prescribe them regularly,” said Rafie. ■
Counseling on Opill
Sometimes referred to as the minipill, progestin-only pills such as Opill require more diligence than combination pills, but there are almost no contraindications to using them. Typically, it’s the estrogen in the combined birth control products that have all the contraindications with blood clots being a main concern.
Opill’s package insert is user friendly and many pharmacists use it to counsel patients on the option. As for what to tell patients when they come to the counter inquiring about using Opill, Katie Meyer, PharmD, APhA’s senior director of content creation, spoke on APhA’s The First Fill podcast and shared five pointers for pharmacists:
- When beginning the medication, backup contraception should be used for at least 2 days.
- It is crucial for the patient to take the pill at the same time every day within a 3-hour window. This is to ensure stable hormonal blood levels. Deviating from this regular schedule can lead to fluctuations in hormone levels, reducing contraceptive efficacy and increasing the risk of unintended pregnancy. Until the patient is back on track with a regular schedule for 2 days, a backup method should be used.
- Some common adverse effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. Patients may have some bleeding between periods. It’s usually temporary and does not mean there is a problem. However, if bleeding is prolonged (more than 8 days) and unusually heavy, patients should contact their health care provider.
- Opill is contraindicated for use by individuals who are pregnant, may be pregnant, have a history of breast cancer, undiagnosed abdominal uterine bleeding, active liver tumors, acute liver disease, and any history of any hypersensitivity reacting to components of the medication.
- Opill is not to be used as emergency contraception and does not protect against STIs. To prevent STIs, individuals should use condoms. ■