A new remote-controlled contraceptive implant is in development and could be on the market by 2018. It would last up to 16 years, and women could turn off the device themselves without a trip to a health-care provider.
Birth control and technology may be meshing in new ways soon with the possible release of an implantable microchip that can release hormones to prevent pregnancy for up to 16 years. The device would be able to be turned off using a remote control if a woman decides she wants to become pregnant, and turned back on when she wants to prevent pregnancy again.
The Bill and Melinda Gates Foundation has announced that it is backing MicroCHIPS, a Massachusetts start-up that has developed this new technology, to help bring the product through the testing process. The new method could be available as early as 2018.
The chip contains tiny reservoirs of the hormone levonorgestrel, a form of progestin that is already used in many hormonal birth control methods. Once the device is implanted by a health-care provider into a woman’s arm, buttocks, or abdomen and turned on, a small electric charge will go through it each day melting the ultra-thin seal around the medication and delivering a 30-microgram dose of hormone into the body. The chip will do this every day for 16 years unless the woman decides to turn it off, which she would be able to do herself, without a trip to her health-care provider.
One concern that’s arisen in the initial reactions to this technology is that someone could theoretically turn the chip on or off without the woman’s knowledge. But Robert Farra, MicroCHIPS president and COO, told BBC News that this is less likely than it sounds. “Communication with the implant has to occur at skin contact level distance,” he said. “Someone across the room cannot reprogram your implant. Then we have secure encryption. That prevents someone from trying to interpret or intervene between the communications.”
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The company is working on additional encryption to make sure no information could be gathered from the microchip.
MicroCHIPS has already tested many aspects of the technology to see if it could deliver an osteoporosis medication that has traditionally been given to patients through injections. Initial studies in women found that the microchip was able to consistently administer an accurate dose of the medication. Moreover, the chip itself did not cause any adverse side effects.
According to MIT Technology Review, the idea to turn the chip into a birth control delivery system came from Bill Gates himself, who visited the lab two years ago and questioned whether the technology could be used as a long-acting reversible contraception (LARC) method.
Currently there are two LARC methods on the market—the intrauterine device (IUD) and the contraceptive implant. LARC methods have the highest efficacy rates against unintended pregnancy, in large part because they take user error out of the equation. Once the method is inserted, it works without any effort on the part of the user for a period of three to ten years. If a woman decides she wants to get pregnant, however, she needs to go to a health-care provider to have the device removed, and if she decides to go back on the method after pregnancy, she would need a new device. Both IUDs and implants have high up-front costs when not covered in part or full by insurance, compared to other methods.
If the chip comes to market, it could be a game changer in parts of the world where access to health-care providers and contraceptive methods is very limited. The chip technology is also being looked at to deliver medicines to treat diseases such as multiple sclerosis and diabetes.
Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills.
Private and public health insurance must cover up to a year’s supply of birth control under a new Hawaii law that advocates called the nation’s “strongest.”
The measure, signed by state Gov. David Ige (D) on Tuesday, applies to all FDA-approved contraceptive medications and devices.
Hawaii joins Washington, D.C., which also requires public and private insurers to cover up to 12 months of birth control at a time.
Oregon passed a similar measure in 2015, but that law requires patients to obtain an initial three-month supply of contraception before individuals can receive the full 12-month supply—which the Hawaii policy does not.
“At a time when politicians nationwide are chipping away at reproductive health care access, Hawaii is bucking the trend and setting a confident example of what states can do to actually improve access,” Laurie Field, Hawaii legislative director for Planned Parenthood Votes Northwest and Hawaii, said in a statement.
Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills. Both the American Congress of Obstetricians and Gynecologists (ACOG) and the U.S. Centers for Disease Control and Prevention recommend supplying up to one year of oral contraceptives at a time, as the Hawaii Senate Committee on Commerce, Consumer Protection, and Health noted in a 2016 conference report.
Fifty-sex percent of pregnancies in Hawaii are unintended, compared to the national average of 45 percent, according to figures from the Guttmacher Institute.
Women who received a year’s supply of birth control were about a third less likely to experience an unplanned pregnancy and were 46 percent less likely to have an abortion, compared to those receiving a one- or three-month supply, according to a 2011 study of 84,401 California women published in Obstetrics and Gynecology.
Reproductive rights advocates had championed the legislation, which was also backed by ACOG–Hawaii Section, the Hawaii Medical Association, and the Hawaii Public Health Association, among other medical groups.
“Everyone deserves affordable and accessible birth control that works for us, regardless of income or type of insurance,” Planned Parenthood’s Field said in her statement.
While the Affordable Care Act’s contraception mandate has done a lot to increase options and access to birth control, patients must still clear sometimes prohibitive hurdles to obtain prescriptions and refills on time. Nurx, a newly launched web-based app, seeks to helpeliminate barriers to contraception by “putting you in control of your own health.”
Nurx co-founder A. Edvard Engesæth, MD, told Rewire that preventive care is an issue he and his partner Hans Gangeskar feel strongly about, and complete access to contraception is an important part of improving that care.
“In our opinion, birth control should be available over the counter. In many countries, women do not need a prescription for birth control,” said Engesæth. “With the exception of Oregon—and in the near future, California as well, women need a [physician’s] prescription for their birth control. Why are we making it harder for women to get access to contraception in the United States? It simply doesn’t make sense. With our app, we are simply providing another option and making it more accessible for women.”
Indeed, until attacks and restrictions on reproductive health care are eliminated and contraception is available to all who need it, there will be a market for services like Nurx to fill the void.
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The Nurx format is extremely simple. First, select your brand, answer a few questions, and enter your insurance and shipping information. Second, a doctor in your state reviews the request and writes the prescription. Third, your prescription is delivered for free, typically within 24 hours.
Nurx accepts most insurance, including Medicaid, and can typically provide next-day delivery free of charge—with a two-hour delivery option in the works. (Nurx covers the cost of the delivery, while insurance pays for the medication.) For those without insurance, it offers options for as little as $15 and provides a free doctor consultation. It is HIPAA compliant (they keep your information safe and private) and offers automatic refills.
Dr. Pratima Gupta, reproductive health advocacy fellow with Physicians for Reproductive Health, agrees that contraception should become even more easily available.
“We need to trust and empower women via giving them the option to access safe, effective, and over-the-counter birth control pills,” said Gupta. “Today’s woman is busy, connected to technology, and rightfully expects to obtain all her needs from a website.”
“Unfortunately, it is us, in the medical community, who are often the hindrance to a woman from obtaining her birth control pill or a refill,” she added. “Some clinics mandate a physical exam, a consent form, are only open certain hours, and many other reasons that are not patient-centered or based on evidence.”
The ability to process insurance claims makes this app a stand-out for Gupta.
“This is the major drawback about some over-the-counter birth control proposals,” she said, “so I appreciate and support that Nurx has determined a way to address this issue and ensure insurance coverage.”
Nurx initially launched as a beta version in the Bay Area of California with an expansion to the entire state, whichpassed a law this year allowing pharmacists to prescribe birth control for patients without a doctor’s approval. Engesæth says they are working on the legalities and logistics of bringing the service to other states.
“Nearly all sexually active women in the United States between 15 and 44 have used birth control at some point,” said Engesæth, citing the Guttmacher Institute. “Women use birth control because it ‘allows them to better care for themselves and their families, complete their education, and achieve economic security.’ Additionally, more than half of birth control users in the United States use it to treat medical issues in addition to preventing pregnancies. Just a few examples include ovarian cancer, ovarian cysts, endometriosis, and endometrial cancer.”
To co-founders Engesæth and Gangeskar, Nurx is their way of fighting back against a political climate where legislators seem determined to eliminate access to reproductive health care, including the Affordable Care Act’s birth control mandate requiring employer-provided health plans to cover contraception with no out-of-pocket cost to employees. A number of employers have seen fit to challenge the government in court, even as growing evidence shows the benefits of contraception for not just individuals but for global economies.
“Anything that increases access to birth control and decreases barriers to provision has my full support,” said Gupta.
“Unfortunately, despite the ACA including coverage for all FDA-approved contraception with no cost sharing, this is not the reality in practice for all,” she explained. “Some women have tiered coverage, meaning they have to demonstrate ‘failure’—which is not clearly defined—of one type of birth control pill before they can get a prescription for [another type of contraception like] the birth control ring, which may have been what they desired in the first place.”
Because “failure” is difficult to demonstrate, insurance companies can dodge coverage by making patients jump through impossible hoops to prove they should be prescribed something that’s potentially more expensive. While the patient and their doctor may consider needs beyond preventing pregnancy—such as preventing migraines, cramps, or heavy bleeding—if the prescribed generic is doing its primary job, it can be problematic proving a different method is needed.
And that’s not the only gap.
“Some women still have co-pays or have to pay up front and then seek a reimbursement,” Gupta continued. “While Obamacare was a huge step toward single-payer coverage and decreasing the number of uninsured individuals, navigating the details, the coverage, the confidentiality clauses, etc. are still quite overwhelming for most.”
The simplicity and speed of a service like Nurx certainly has the potential to cut through that type of red tape for a number of individuals. Those without transportation or who have hectic, unpredictable work schedules would be able to avoid missing refills or being late obtaining the annual prescription, which must be written anew each year. Engesæth and Gangeskar also intend to lower the app’s age restriction (the beta version was only for users 18 and older) to include younger teens—a group that can benefit from a physician who doesn’t also treat their parents.
For Gupta, the next logical step is for birth control to be available nationwide without a prescriptionover the counter (OTC).
“Clinical data indicate that OTC access to oral contraceptives is likely safe. Contraindications are few and self-reported, except for hypertension, which could be self-assessed or measured by a pharmacist,” she said. “Data from recent studies show that women can self-screen for contraindications as accurately as trained providers and requiring provider intervention does not prevent contraindicated women from using oral contraceptives.”
Gupta added that OTC access cannot replace a clinic visit for some patients, but studies demonstrate that most women would continue preventive screenings even if they could get the pill without seeing their doctor.
“Evidence indicates that for women at all ages who do not smoke, taking oral contraceptives is significantly safer than pregnancy,” Gupta added.
Despite some social conservatives supporting OTC contraception—which Guttmacher explains as attempts to “counter their anti-contraception image, even as they continue their efforts to dismantle the very programs and policies that support increased access to contraceptives”—removing the prescription requirement from oral contraception is hardly universally supported.
As long as challenges remain in place through insurance coverage gaps and prescription hurdles, innovations like Nurx are crucial to advancing reproductive rights in the 21st century.