What’s new in contraceptive technology?

Lots of great new contraceptive options are coming your way soon if you’re in the United States.  You may have already heard about Skyla, but do you know about Twirla and Cyclofem?  Read on and learn.

Skyla

Skyla (or the levonorgestrel 14 mcg IUD, or LNG-14) recently was approved by the FDA and has received a fair amount of attention.  It is now available from some providers and may be an excellent choice for some women.  The LNG-14 has three claims to fame: its smaller size (and, as a result, smaller inserter), its lower dose of progesterone, and its official approval for use by women who have never been pregnant.

First off, the smaller size: in the grand scheme of things, we’re talking about only a very tiny difference (the IUD itself is 1.1 by 1.2 inches, compared with Mirena’s 1.3 by 1.3 inches, while the inserter is 0.04 inches smaller than Mirena’s; see this great article for more details).  However, that very small difference may in fact make insertion of the device less painful for some women, particularly women who have never been pregnant and may be more likely to have a tighter cervix.  Since the data have yet to be published, I can’t tell you for sure if insertion is indeed less uncomfortable than insertion of other IUDs; however, preliminary presentations of the data (such as here) have indicated that, for women who have never been pregnant, those who underwent insertion of Skyla had less discomfort than those who were assigned to Mirena. 

Skyla releases less progesterone than the Mirena (without losing any of its contraceptive efficacy) which for some women is a good thing, but for others might not be.  One of the features of Mirena that is most appreciated by some users is that almost everyone experiences lighter periods over time, and many women no longer have periods at all.  For some women, that’s fabulous, while others would rather keep seeing their period.  Women using Skyla will mostly have lighter periods, but fewer of them will have no period (though some will, and there is no way to know ahead of time what any individual’s reaction will be).  Although Mirena exposes users to a very low systemic dose of progesterone (a dose low enough that most don’t notice it), for women who are extremely sensitive to artificial hormones it can still be too much.  If you’re in this category but there are reasons why a progesterone-releasing IUD is a good option for you (such as heavy periods), Skyla may be an excellent option.

Finally, on Skyla’s approval for women who have never been pregnant.  This is great news, but really, it’s not news; women who have never been pregnant can safely use any IUD, regardless of what is on the packaging.  We’ve known this for years, and doctors use products and medicines off-label all the time.  There’s nothing wrong with off-label use as long as there is good evidence to show that your practice is safe.  Fortunately, we have decades of data that prove that women who have never been pregnant can safely use any kind of IUD they want.  So the labeling for women who’ve never been pregnant may be generating a lot of buzz, but it’s nothing new.  However, if there are pesky insurance companies out there that won’t pay for IUDs for women who’ve never been pregnant because the label says it’s not OK, this might help push them along, so it can’t be bad.

There’s a lot to love about Skyla.  The smaller size might make it easier and more comfortable to insert for some women, and the lower hormone dose might be beneficial in some cases.  Unfortunately, Skyla only lasts for 3 years (as opposed to 5 for Mirena and 12 or more for the copper-IUD).  For some women who don’t like the idea of something lasting a long time this may a good thing, but for many having to get a new one placed after 3 years could be a drag, as it means another doctor’s visit and potentially more costs.

Twirla

Twirla (also known as AG 200-15) is a new contraceptive patch that uses a combination of progesterone and estrogen, similar to Ortho-Evra.  This method is not yet FDA approved but will likely be approved in the next year.  Twirla has a few claims to fame: its lower estrogen dose and its novel adhesive.  As for the lower estrogen dose, as only a few papers have been published on Twirla thus far, I don’t know for sure if the lower estrogen dose in this patch compared with Ortho-Evra leads to fewer side effects, but it is quite likely it does, and we know that this patch is just as effective as Ortho-Evra.  

So if you’re very sensitive to hormones and want to use a patch, Twirla may turn out to be a great option, especially if the side effects you experience on birth control are related to estrogen (such as nausea, bloating, or headaches) and you have reasons to want to continue using an estrogen-containing method, such as maintaining regular periods or to improve acne.  The novel adhesive may be good news for loyal patch fans who are annoyed by the little bits of adhesive residue that sometimes seep out next to where the patch is applied, or for women who want to use the patch but are among the minority of women for whom it just won’t stay on for the whole week.

Cyclofem

Cyclofem (also known as depot medroxyprogesterone acetate 15 mg/estradiol cypionate 5 mg) is not actually a new contraceptive; rather, it’s a method that’s been around for a while and has never really taken off, either in the US or abroad.  Cyclofem is an injectable contraceptive that was briefly marketed in the US as Lunelle about a decade ago, but has not been available recently.  It is used in some other countries around the world.  It has a lower dose of the progesterone that is used in Depo-Provera, the three-monthly injectable, and unlike Depo-provera also has estrogen.  Cyclofem’s claims to fame: the only combined hormonal injectable method available; convenience of once-monthly dosing.

Although Depo-Provera, or DMPA, is not one of the most popular methods in the U.S., it has loyal followers.  Some of the pros of DMPA are that injections are required only every three months, with a very forgiving window period allowing you to get your shot a few weeks early (in case you’re heading off for vacation) or a few weeks late (up to 15 weeks since the prior injection – considering the busy lives many of us lead, the more likely scenario), and that most women stop having periods within 6 to 12 months of starting the method.  DMPA only includes progesterone; for women who want an injectable that also has an estrogen, Cyclofem could be useful.  Women using Cyclofem generally continue to have regular periods, but the big drawback is that injections have to occur every month.  There are some situations where Cyclofem could be extremely useful; for instance, someone who wants to use a combined hormonal method but can’t swallow pills or someone who requires absolute privacy regarding her use of contraceptives.

Unlike the other new methods I’ve described, it’s hard for me to believe this method will take off in the US context outside of some specialized settings, as the majority of women who can’t take pills will probably be well-served with either a contraceptive patch or ring, and women who need to use an “invisible” method will in most cases do very well with an IUD or a contraceptive implant.  Monthly visits to the doctor for injections are just not practical for most women in a US context.  Despite my pessimism, I do hope that Cyclofem finds its niche; more choices are always better, and there will always be women who find that a given method works very well for them.

What about plans for the next five and ten years?  There are lots of great products in the works, from a much lower-cost generic version of the Mirena IUD being developed by Medicines360 (this could really be a game changer for women in many low-income countries; not only is the levonorgestrel IUD a great contraceptive method, but it also is a first-line treatment for many other gynecological conditions that are currently treated with surgery in settings where it is unavailable) to a contraceptive vaginal ring that can be used for a whole year.  A new female condom that may be easier to use and more comfortable is also in the works.

Acknowledgments: This post was inspired by a great webinar from the Association of Reproductive Health Professionals.

Diagnosis: Female?

Lots of people are talking about the decision on the part of HHS that all forms of contraception be covered for all insured men and women for “free” as basic preventive services under health reform. This decision came not a minute too soon. Recently I found myself having to call in a prior authorization for birth control for one of my patients. At first I figured it was just that the insurance didn’t pay for the birth control patch, Ortho-Evra, but did pay for other methods. However, it turned out to be more complicated. The entire conversation took a half hour and went more or less as follows:

Me: This is Dr. Pro Choice. I’m calling to get a prior authorization for ortho-evra for my patient.

Customer Service Associate: OK, let me look into that for you…(5 minutes of terrible muzak later) I’m showing we don’t cover that medication.

Me: Right, that’s why I’m calling. Can you tell me why you don’t cover that medication?

CSA: Let me look into that for you… (5 minutes of even worse muzak later) We don’t cover any contraceptive methods.

Me: What? Are you sure?

CSA: Yes Ma’am, this plan that your patient signed up for does not cover contraceptive methods.

Me: (after a moment of disbelief) So how can I get this for my patient? She can’t afford it on her own. She has Medicaid.

CSA: You can make an application.

Me: Great, let’s do that.

CSA: What is the diagnosis?

Me: Diagnosis?

CSA: Yes, what is the diagnosis?

Me: (long pause) Female?

CSA: That is not an accepted diagnosis

Me: Human? Able to get pregnant? Sexually active?

CSA: Those are not accepted either.

Me: Umm, OK, menorrhagia [not the real reason but a ‘real’ diagnosis].

[1 minute on hold]

CSA: Your request has been approved.

I wish I could say I made this up, but it happened just a few weeks before this decision came from HHS. There IS no diagnosis code justifying contraception as a way to avoid pregnancy, because diagnosis codes are built around illness. Avoiding pregnancy usually isn’t about already being sick, it’s about preventing something from happening. So birth control clearly belongs in the list of preventive services.

I fear politics will get in the way of the HHS ruling that all contraceptive services be covered free of charge under all insurers starting next year, but if not, women with private or public insurance will not have to pay for their birth control. This is a huge step for all women, and a small step for doctors like me who will no longer have to have conversations such as the one above.

Want To Eliminate The Need For Abortion? Make Contraception Accessible

According to Reuters, the number of women who say they have used emergency contraception has more than doubled – from about 4% in 2002 to 10% in less than 10 years. This is likely due to the decision to make the “morning after pill” available over the counter. In other words, when you make contraception safe, accessible, and affordable*, people will use it, thereby preventing the unintended pregnancies that often result in termination.

If you are under 17, you must have a prescription, which requires a doctor’s note, which in many cases requires involving a parent. EC also needs to be taken within 120 hours (5 days), and the sooner, the better. If you’ve ever tried to get an appointment with your doctor in a timely manner, you know how difficult that can be unless you show up at the emergency room having been both stabbed and shot – and even then, you’re probably behind a guy with a tree trunk through his torso. This arbitrary rule would seem to indicate that teenagers’ contraceptive needs are not as important to lawmakers as the ongoing desire to (inadequately) police their morals and values.

Let us be clear: emergency contraception is called that for a reason. It is contraception. If you are pregnant, it will not terminate the pregnancy. It is the equivalent of a condom, or the pill – but it can work after those have failed, preventing sperm from fertilizing the egg. It is the “oops the condom broke” answer we never used to have. It is the “crap – did I take my pill this morning??” you may not need to panic about the answer to. Emergency contraception is a lovely solution to the impasse between “I don’t want to get pregnant” and “I got pregnant and don’t want to be pregnant.” If the goal is really to lower the number of abortions people have, the simplest, most graceful solution is to lower the number of unintended pregnancies. Lawmakers, take note: promoting the availability, accessibility, and affordability of contraception serves to prove that people want to make the best decisions for themselves. Catch your policy up to our reality.

*According to Planned Parenthood, the pill can cost $10-$70. Imagine how helpful it is to have it covered by insurance or a co-pay. It can cost up to $250 if you’re under 17 and need a doctor’s visit and a prescription – imagine how many young people could prevent a pregnancy and avoid an abortion entirely if some strange moral social code decided that access was better for them than an unintended pregnancy!