Female Condoms Will Now Be Prescription Only

The female condom, sold under the name F2C, will no longer be available in pharmacy aisles. Veru Health, the company that makes the product, is moving to a prescription distribution model. The company is hoping to take advantage of the birth control benefits under the Affordable Care Act (ACA) and increase use of the method by getting providers involved in the process. Advocates, however, note that this move comes with a hefty price increase that could leave the uninsured with no access to the condom.

F2C, sometimes called an internal condom, is a barrier method that was originally designed to be inserted into the vagina. But, while the U.S. Food and Drug Administration has only approved the use of female condoms for vaginal sex, people also use them during anal sex to prevent sexually transmitted infections (STI), including HIV. F2C provides protection against pregnancy as well as STIs by preventing the exchange of bodily fluids (including semen) and blocking some skin-to-skin contact.

The female condom is not very popular in the U.S. There is little data on the use of this method as STI protection, and National Health Statistics Reports shows that a very small percentage (less than 0.3%) of women using contraception rely on it as their primary method of birth control.

Those people who do use the method could, until now, purchase it the same way one would purchase a box of male condoms: It was available on store shelves for approximately $3.50 a condom. That’s significantly more expensive than the male condom, but it still meant that you could walk out with a three-pack for under $10.

The problem, according to Brian Groch, Veru’s chief commercial officer, was that nobody did. He told TheBody.com that the product just didn’t sell in retail. He offered an example of one large retail chain that reported selling less than $12 worth of F2C in the last two years despite having it in numerous stores. Most people who use the product, according to Groch, get it from public health organizations such as STI clinics and health departments who can buy it at a deep discount. Groch says that continuing to invest in a retail sales model was simply unsustainable for the company given the poor sales.

Up to $20 Each for the Uninsured

So, the company is trying another model. As a prescription method, F2C should be covered by insurers at no cost to the consumer because female condoms are one of the 18 methods identified in the ACA (also known as Obamacare) birth control mandate. Theoretically, this means that anyone who has insurance can walk into a pharmacy with a prescription and walk out with a box of F2C for free.

Advocates worry, however, that it might not be that simple, and some people might no longer be able to access the product. For example, would insurance cover the device for anyone who identifies as male given that it has only been approved for use by women? Natalie Cramer, senior director of Prevention and Care Program and Policy at the National Association of State and Territorial AIDS Directors (NASTAD), told TheBody.com, “I think there are a lot of steps that would need to happen to make sure this would be covered even in the best-case scenario where everyone had health insurance.”

There is also uncertainty about how much F2C would cost from a pharmacy under any scenario in which it was not 100% percent covered by insurance. Say a customer’s insurance refused to cover it for whatever reason, and the person wanted to buy it anyhow at full price. The product is no longer available as three-pack, and Groch says he sells the now-standard 12-pack to a wholesaler for just under $120. Full price for the customer, however, could be as much as double that, meaning up to $20 per device.

And price may become much more of an issue in the near future because the ACA and its birth control mandate are both under attack. The House of Representatives has passed a replacement plan, the Senate is working own replacement plan, and in the meantime, President Trump has targeted the birth control mandate specifically. A memo leaked last week suggests that, while the ACA is still in place, Trump plans to expand the exemption to the birth control mandate, which currently applies only to religious organizations, to any employer that has religious or moral objections. Until it happens, we can’t know what percent of secular employers will take advantage of this change, but it certainly could leave more people without the free birth control they’ve been enjoying for the last few years.

Jessica Terlikowski, of the Chicago AIDS Foundation, thinks the timing of Veru’s decision is terrible. She told TheBody.com: “The decision is particularly staggering given that that Affordable Care Act, Medicaid and family planning programs are on the chopping block. If Republicans get their way, these programs will be gutted leaving the only receptive partner-initiated barrier method out of reach for people living with and vulnerable to HIV.”

For those without insurance, the product could continue to be accessed through health departments and other non-profit organizations, where available. Groch says they have no plans to change the price of the product being sold to these organizations. Veru also sells F2C at a discounted rate to health care providers that qualify for 340B drug pricing, such as Ryan White clinics and State AIDS Drug Assistance Programs. The price to these organizations did increase because the discount is based on the new, higher price.

The company believes that one of the reason the product doesn’t sell well is the lack of awareness and education about it. It is hoping that the move to a prescription model will get providers involved as advocates for F2C, and it is currently working to educate gynecologists, urologists, infectious disease specialists and other providers. But public health leaders who have long advocated for the female condom say they weren’t informed in advance about the changes in access or pricing.

Cramer explained, “It’s truly disappointing that there wasn’t any direct communication (to health departments and advocacy groups), particularly because health departments and advocacy organizations have been such strong champions of the FC2.”