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Bayer’s PR release on newly approved IUD for birth control omits costs, novelty


4 Star

FDA Approves Bayer's Kyleena™ (Levonorgestrel-Releasing Intrauterine System) 19.5 mg for Prevention of Pregnancy for up to Five Years

Our Review Summary

Holding an IUD birth control device in handThe news release focuses on a forthcoming birth control product called Kyleena. The product is implanted in the uterus and releases the hormone levonorgestrel, which the release says can prevent pregnancy for up to five years. The release does a fair job of describing the clinical trial that led to FDA’s approval of Kyleena, and also addresses potential side effects associated with the product. However, the release does not address cost at all. The release also fails to discuss similar alternatives that are already on the market, or even offer any information comparing the effectiveness of Kyleena relative to other forms of birth control.

[Editor’s note: Bayer makes a number of IUD contraceptive devices including Mirena and a permanent contraceptive called Essure. This release stacks up favorably to a Bayer news release on Essure which we also reviewed (and discussed in a blog post) in terms of discussing harms, quantified benefits and quality of evidence. However, neither release addressed costs.]


Why This Matters

According to the CDC, more than 7 percent of U.S. women use long-term, reversible contraceptives — i.e., intrauterine systems or implants — to avoid unwanted pregnancy. The widespread use of these technologies means that they are both economically important and — more importantly — that such birth control systems have a significant impact on the health and well-being of millions of women. As such, it is newsworthy when new products receive FDA approval and come to market. But in order for potential users — and their healthcare providers — to make sense of a new product, they need some basic information. For example, they need to know how the new product compares to existing products on the market — and how much they will cost. This release falls short on both of those fronts.


Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Costs are not discussed at all. Given that this release was issued by the manufacturer of Kyleena, the oversight is especially odd. If anyone would be able to speak to potential cost, it would be them. The product appears to be similar to another birth control product also marketed by Bayer, called Mirena. It is not easy to find a clear price for Mirena, but a 2014 story on the site ClearHealthCosts says that Mirena costs in the neighborhood of $700 or $800 — not including any medical fees related to having the device put into place. It is also not clear whether Kyleena may be covered by insurance plans.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?


This gets a satisfactory rating, but it’s really a toss-up. First, the release does offer information on the rate of (presumably unexpected) pregnancies among patients who were using Kyleena. That’s good, and is why we award a satisfactory rating here. However, the information is provided based on the Pearl Index, which most readers are unlikely to be familiar with.

The Pearl Index is commonly regarded as a standard metric for evaluating contraceptive effectiveness.  The effectiveness of Kyleena is cited as 1.45 pregnancies per 100 women over 5 years of use. That can be compared with other available levonorgestrel products approved for 5 years, which contain higher amounts of active hormone (52 mg levonorgestrel vs 19.5 in Kyleena) and have slightly better effectiveness (0.5 to 1.1 pregnancies per 100 women).  An additional benefit of the higher-dose levonorgestrel IUDs for some women is reduction in menstrual bleeding (30-50% of women stop having periods after 2 years of use), as well as reduction in volume of menstrual flow and menstrual cramps. There is no data cited on Kyleena’s effects on these outcomes.

The release would have been stronger if it had placed the information in better context. How does it compare to other, similar birth control methods — such as Mirena, which we mentioned above? We’ll address this at greater length below, under the Compare Alternatives criterion.

Does the news release adequately explain/quantify the harms of the intervention?


The release goes into this at length, which is good. What would have been even better would have been for the release to compare the likelihood of potential side effects for Kyleena with the likelihood of side effects for other products on the market.

Does the news release seem to grasp the quality of the evidence?


The release describes the relevant clinical trial in detail, earning this a satisfactory rating. That said, there is one question that the release does not address at all — whether the trial had a control group. That’s an important point, and it’s not clear why this issue isn’t addressed.

There is a strong implication that there was no control group. The lack of control group is not necessarily a problem since the main outcome of interest is prevention of pregnancy.  A control group would be helpful in putting the rates of adverse effects into context.

Does the news release commit disease-mongering?


No disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?


The release is clearly marked as being from the manufacturer of Kyleena.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

This is not satisfactory on two levels. First, Kyleena is described as an intrauterine system that releases levonorgestrel in order to prevent pregnancy, and it is described preventing pregnancy for up to five years. Another product from Bayer, Mirena, is an intrauterine device that releases levonorgestrel in order to prevent pregnancy. It also is described as preventing pregnancy for up to five years. When a company is releasing a new product that, to the non-expert audience, looks an awful lot like an existing product, the company needs to clearly describe how the products are different — in terms of mechanism, benefit, cost and risk. Other levonorgestrel-releasing devices/implants include Liletta and Skyla. How does Kyleena differ from them? Second, and more broadly, the efficacy of Kyleena at preventing unwanted pregnancy is not compared to the broader suite of birth control options available. All in all, this is a significant oversight. Potential users of Kyleena should be able to clearly compare the costs, risks and benefits of the new product to existing products. And if the product is as advantageous as the manufacturer wants the market to believe, an up-front comparison would actually help convince consumers.

There are two classes of levonorgestrel IUDs currently on the market that vary in the amount of active hormone they contain: 1) 52 mg IUDs (Mirena and Liletta) and 2) a 13.5 mg IUD (Skyla). There are two important differences between them. First, the higher dose IUDs are effective for five years, whereas the lower dose Skyla is effective for three years. Second, there are differences in side effects, which for some women may make one preferable to the other. Mirena and Liletta can reduce the frequency and amount of bleeding, as well as menstrual cramping; Skyla has little effect on these factors.  With a lower dose of levonorgestrel  IUD (19.5 mg) compared to the other 5-year IUDs, Kyleena would seem to be Bayer’s effort to create a lower dose IUD that is effective for 5 years.  In this context, it would be especially helpful to know how its “side effects” (whether beneficial or not) compare to those of the other IUDs.

Does the news release establish the availability of the treatment/test/product/procedure?


The release states that Kyleena will be available by prescription in October 2016.

Does the news release establish the true novelty of the approach?

Not Satisfactory

As noted above, it’s not clear from this release (at least to a non-expert audience) how Kyleena differs from other, intrauterine levonorgestrel-releasing products that are already on the market.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?


The release doesn’t engage in sensationalistic language.

The release may be slightly out-of-bounds, however, when it states, at the top, that “Kyleena offers women an important new long-term, reversible contraception option.”  Who decides what makes something “important”? It’s a tricky question. Based on the limited information in the release, it’s not clear that the term applies here or that the product offers significant differences from other products already on the market.

Total Score: 7 of 10 Satisfactory

Comments (1)

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Kelly Herson

June 29, 2017 at 1:45 pm

Thanks for informative works. Yet, you keep comparing Kyleena to Mirena, while it is much more similar to Skyla (by Bayer). I really think you should mention Skyla in this article.