Price increase for IUD proves problematic for family planners

Providers review their options following Mirena price increase

Signs have been pointing toward a renaissance for intrauterine devices (IUDs). Since 2005, IUD use has gone up by 161%, according to SDI Health, a health care analytics firm in Plymouth Meeting, PA.1 The birth control method is now making inroads on other preventive methods: IUD insertions increased 23% between January 2008 and January 2009, while during that same period, total contraceptive prescriptions fell by 2.6%.1

However, such increases might be impacted by the March 2010 announcement by Wayne, NJ-based Bayer HealthCare Pharmaceuticals to increase the list price of its levonorgestrel intrauterine system (LNG IUS), Mirena. According to company spokesperson Rose Talarico, the new list price of Mirena of $703.05 reflects the first price increase since September 2007, when the device listed for about $470 per unit.

Why was the increase instituted? The decision to increase the list price of the device "reflects the value that it offers to women who choose intrauterine contraception and over the long effective life of the product" of five years, Talarico says. At the new list price, over a five-year period, the average monthly cost of Mirena still is lower than the costs for branded oral contraceptives, she notes.

Mirena now carries an additional approved indication to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. The Food and Drug Administration (FDA) gave approval to the indication in October 2009, which made Mirena the first intrauterine device approved for this additional use. Does the company plan to offer increased assistance to women who cannot pay for the Mirena? According to Talarico, Bayer supports the ARCH Foundation, a not-for-profit foundation established to assist low-income patients who do not have insurance coverage for Mirena.

"Bayer is dedicated to women's health and committed to providing contraceptive options that are safe, effective, affordable, and well-matched to the needs of the women we serve," says Talarico. "We also provide our medications, including Mirena, to those in need and are committed to maintaining and improving access to Mirena through public health and patient support programs."

How about ParaGard?

Are similar price increases on the way for the other intrauterine contraceptive, the Copper T 380A intrauterine device (ParaGard Copper T 380A IUD, Duramed Pharmaceuticals, now Teva Women's Health, Woodcliff Lake, NJ)? No, says George Jones, group product manager for Teva Women's Health.

"The per unit Wholesale Acquisition Cost of ParaGard remains at $392 a unit," says Jones. "We want to reassure the reproductive health/family planning community that we currently have no plans to take the type of substantial price increase that Bayer has instituted with Mirena."

Are there any changes in pricing planned in light of recent U.S. health care reform legislation? No, says Jones. "Teva Women's Health values its relationship with reproductive health professionals and remains fully committed to bringing clinically important, cost-effective products to health care providers and patients," says Jones. "In this challenging economic environment, we will not put undue pressure on patients when it comes to family planning and long-acting contraceptive methods."

New LNG IUD?

The recently announced price increase for the Mirena IUD is "so discouraging," observes Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. However, there might be another levonorgestrel IUD on the horizon, Hatcher notes. Medicines360, a San Francisco non-profit company, has joined forces with European women's health pharmaceutical company Uteron Pharma Operations in Liege, Belgium, to develop a long-acting LNG IUD. A Phase III trial is under way.2

"One can only hope that this generic LNG IUD will gain approval quickly," says Hatcher.

What is your response?

How will the Mirena price increase impact your clinical practice? For the nine physicians at Women's Health Group, a Thornton, CO, obstetrics and gynecology facility, Mirena insertions will drop sharply when the practice's stock of devices has been used, says Susan Lawrence, facility spokesperson. The physicians have been inserting an average of 50 Mirena IUSs per month; however, when Bayer announced Mirena's price increase, the practice alerted its patients that once its supply of Mirena devices is exhausted, it will no longer continue to stock the device, says Lawrence.

"In this time of excessive health care costs, there is simply no excuse for this attempt to raise prices just before health care reform potentially becomes a reality," states a bulletin issued by the facility. "This is just wrong and we need to stand up to this price gouging and reject it."

Women's Health Group will offer ParaGard as the intrauterine contraceptive option, or it will insert a Mirena if a patient brings it in herself, says Lawrence.

What has been the response to the clinic's action? "We got some positive feedback via e-mail the same day the announcement hit our e-mail list," says Lawrence. "Patients were happy to see a medical practice taking a stand and being an advocate for the patient."

Avoid Internet options

ParaGard is indicated for up to 10 years for intrauterine contraception; the Mirena is indicated for up to five years. While the cost of intrauterine contraception is very low when it is amortized over the average time of utilization, its initial cost often presents "sticker shock" for potential users.3

Clinicians might be tempted by lower-priced units advertised on web sites for their private patients who do not qualify for public assistance through such programs as the ARCH Foundation, states Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School Of Medicine at the University of California in Los Angeles in a 2009 editorial published in Contraception. These units might pose problems for patients and providers, the editorial states.

For products that are temperature sensitive, such as the LNG-IUS, conditions during transport might substantially impact product efficacy, states the editorial. If an item is ordered online from the United Kingdom or Canada, the product might be shipped in the hull of an airplane or allowed to rest on a warehouse platform in the heat. In such variable environments, the product destabilizes and might not deliver the drug as desired.3

Legal problems have arisen from use of foreign intrauterine contraceptives, the editorial states. In California, providers placed foreign units in patients and billed the state under its Medicaid programs for reimbursement. This practice was termed as Medicaid fraud since providers did not use FDA-approved products. One physician has settled his case, while another physician is at risk for jail time, the editorial states.3

"As a result of the misguided altruism (or greed) of a few clinicians, all IUD providers in the state programs must now retain a patient-specific invoice for at least three years for each IUD they place," states the editorial.3

References

  1. Melnick M. The IUD reborn. Newsweek 2010. Accessed at www.newsweek.com/id/235939.
  2. Jensen JT. Future methods of contraception: what's in the pipeline? Presented at the 2010 Contraceptive Technology conference. San Francisco, March 2010; Boston, April 2010.
  3. Nelson AL. Buyer beware. Contraception2009; 80:495-465.

Resource

To obtain more information about the ARCH Foundation Patient Assistance Program for Mirena, visit www.archfoundation.com. The patient application form is available in English and Spanish. Click on "Application." Providers may call (877) 393-9071 weekdays 8:30 a.m. to 5 p.m. Eastern. Callers may leave a confidential message for a patient case coordinator 24/7. Patient case coordinators are available to address callers with specific language needs.