New methods gain favor with women, but Pill use remains strong
Survey results: Patch use drops, contraceptive ring sees uptick
Review the contraceptive options offered at your facility as you head to the next examination room. What choices do you have to present to your next patient?
The contraceptive vaginal ring (NuvaRing, Organon; West Orange, NJ) and the transdermal contraceptive (Ortho Evra, Ortho-McNeil Pharmaceutical; Raritan, NJ) have become standard options at many facilities since both were approved by the Food and Drug Administration (FDA) in 2001. About 80% of participants in the 2006 Contraception Survey conducted by Contraceptive Technology Update say they offer NuvaRing, up from 76% in 2005.
NuvaRing is starting to catch on, reports Jackie Bodden, MSN, RN-C, ARNP, program director/nurse practitioner at the Southwest Wisconsin Community Action Program Reproductive Health Care Center in Platteville, WI. "More clients are willing to try the method," she notes. "Many were squeamish about inserting it themselves at first, but those who have tried it are very happy with the method and have no desire to switch."
NuvaRing is a popular option at the University of Chicago Student Care Center, says Cherie Dupuis, RN, MSN, NP, a nurse practitioner at the facility. Graduate students, resident physicians, and medical students find favor with the method, while younger patients stick with the Pill, she notes.
NuvaRing releases a continuous low dose of the estrogen ethinyl estradiol and the progestin etonogestrel at an average rate of 0.120 mg etonogestrel and 0.015 mg ethinyl estradiol per day over a 21-day period of use.
Patch use falls off
Results of the 2006 survey show a slight drop when it comes to the Ortho Evra contraceptive patch. About 88% of participants said their facility now offers the patch, compared to about 93% in 2005. Each transdermal patch contains 20 mcg of the estrogen ethinyl estradiol and 150 mcg of the progestin norelgestromin, the primary active metabolite of norgestimate. Designed to be changed once a week and worn for three weeks, it consists of an adhesive medicated layer worn against the skin, protected by a waterproof polyester layer.
Edward Linn, MD, chairman of the OB/GYN department and director of the Centre for Women's Health at Rush North Shore Medical Center in Skokie, IL, says "We are prescribing less Evra and slightly more NuvaRing. Patients were very eager to try Evra when it was launched; however, there is less demand for the product for initial use."
Beth Sperring, ARNP, a nurse practitioner at the Suwannee County Health Department in Live Oak, FL, says that response to Ortho Evra has been favorable, although the negative press the method received this year has affected patient requests for the option. Information from two case control studies of the patch released earlier in 2006 indicates that while there is no increased risk of heart attack or stroke, data are conflicting when it comes to venous thromboembolism (VTE).1,2
Results from the first study suggest that risk of nonfatal VTE for the patch is similar to the risk for pills containing similar hormonal components. Findings from the second study, whose interim results were released by the patch's manufacturer and have not yet been published, indicate an approximate twofold increase in the risk of VTE in patch users compared with those using a comparable oral contraceptive (OC). The FDA now has updated the labeling to include this information from the two studies.
A previous update in November 2005 had added a bolded warning that the patch exposes women to higher total amounts of estrogen than a typical birth control pill containing 35 mcg estrogen.
What does the new label information mean to women who are using or considering using Ortho Evra? The FDA, in a question and answer sheet regarding the September 2006 updated labeling, says, "Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health care provider about using Ortho Evra vs. other contraceptive options."3
Is price a problem?
Many publicly funded family planning clinics did a double-take this summer when Ortho-McNeil, manufacturer of the Ortho Evra patch and other oral contraceptives, raised its prices on such methods. While the company has subsequently dropped the amount of the increase on the patch and five of its most popular pills, prices still are higher than previously paid by clinics.
In the past, Ortho-McNeil has offered birth control options to public clinics at lower prices than retail through the federal program 340B. The federal formula used to calculate 340B prices takes into account a drug's commercial price and its Medicaid price. While the formula for pricing is confidential, the company previously was charging pennies for OC packs and $10-$12 for Ortho Evra.4
According to a May 2006 financial report for Johnson & Johnson of New Brunswick, NJ, Ortho-McNeil's parent company, the company's hormonal contraceptive segment experienced an operational sales decline of 15.7% primarily due to generic competition in oral contraceptives, partially offset by strong growth in its low-dose pill, Ortho Tri-Cyclen Lo.5 The patch experienced what Ortho termed a "significant decline" in sales as a result of labeling changes and negative media coverage concerning product safety.5 The decline in sales may have influenced the subsequent price increase; the company has issued no statement on the increase.
The National Family Planning and Reproductive Health Association (NFPRHA), which negotiates pricing with Ortho on behalf of public clinics, announced in September 2006 that Ortho had dropped its increase on five pills. According to NFPRHA, the following five oral contraceptives have been lowered to $3.20 per cycle:
- Ortho-Novum 7/7/7;
- Ortho-Cyclen;
- Ortho Tri-Cyclen;
- Ortho Micronor;
- Ortho Tri-Cyclen Lo.
Ortho's new prices reflect a 92-94% discount off list price, NFPRHA states.6 NFPRHA also was able to negotiate a reduction on the price increase for the patch. The cost of the Ortho Evra patch initially jumped from $10-$12 to more than $22 during the initial increase; the new price is $15.4
Even with the drops in price, many family planning facilities will be taking a hard look at upcoming budgets and formularies to see which Ortho methods will continue to be in use. Inflation-adjusted funding through Title X has declined by two-thirds since 1980, according to the New York City-based Guttmacher Institute.7
NuvaRing is priced at $15 at the Women's Clinic at the University of Florida Student Health Care Center in Gainesville and thus has proven popular with patients, says Phylis Craig, ARNP, clinic supervisor. "Many students on the patch came in to change methods when they learned of the potential problems with it," she notes. "We are now doing new starts on the patch, but the cost makes it one of our least-used methods."
References
- Jick SS, Kaye JA, Russmann S, et al. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 µg of ethinyl estradiol. Contraception 2006; 73:223-228.
- Ortho Women's Health & Urology. Results of Two Epidemiological Studies Provide Important New Clinical Information About the Safety of Ortho Evra. Press release. Raritan, NJ; Feb. 16, 2006.
- Food and Drug Administration. Questions and Answers. Ortho Evra (norelgestromin/ethinyl estradiol). Fact sheet. Rockville, MD; Sept. 20, 2006.
- Schaffer A. The 1,800-fold price hike. Slate 2006; accessed at: www.slate.com/id/2148264.
- Johnson & Johnson. United States Securities and Exchange Commission. Form 10-Q. Accessed at: www.investor.jnj.com.
- National Family Planning and Reproductive Health Association. Ortho lowers its pill prices for public health clinics. Accessed at: www.nfprha.org.
- Sonfield A, Gold RB. Conservatives' agenda threatens public funding for family planning. Guttmacher Rep Pub Policy 2005; 8:4-7.
Resource
The Food and Drug Administration (FDA) has posted the September 2006 updated labeling for Ortho Evra, as well as a question-and-answer sheet, on its web site, www.fda.gov. Under "Products FDA Regulates," click on "Drugs," then under "September 20," click on "Ortho Evra Information" to access the information.
The contraceptive vaginal ring (NuvaRing, Organon; West Orange, NJ) and the transdermal contraceptive (Ortho Evra, Ortho-McNeil Pharmaceutical; Raritan, NJ) have become standard options at many facilities since both were approved by the Food and Drug Administration (FDA) in 2001.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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