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Executive Summary

Governmental jurisdictions are purchasing Wyeth-Ayerst's implantable long-term contraceptive Norplant for distribution to a broader constituency including non-Medicaid poor women. The product is being purchased through federal, state and local programs. Maryland, for example, is instituting a program to promote the use of Norplant in women who do not qualify for Medicaid but do not have insurance and cannot afford to pay for the product. Medicaid already provides Norplant to eligible women. In his Jan. 14 "State of the State" address, Maryland Gov. Donald Schaefer (D) proposed budgeting $940,000 to provide Norplant to 2,350 women who want the contraceptive. Under the plan, the state also would promote vasectomies and is proposing to spend $10,500 to perform the procedure on a projected 30 men. If approved by the state legislature, the plan will go into effect July 1. Washington, D.C. also has discussed an experimental program to provide Norplant to the city's residents. The program has not begun, but the plan is to use federal funding under Title X Public Health Service Grants in order to purchase the drug for distribution to family planning clinics. Virginia has been providing Norplant, as well as other contraceptives, for a year through Medicaid and other programs for the poor and near poor. The state purchased 1,700 Norplant kits in 1992, about half for Medicaid beneficiaries and half for women with incomes up to 180% of the poverty level. The product has been distributed through Virginia's 100 county and city health departments and 150 family planning centers. Virginia has not budgeted a specific amount for Norplant but has made the contraceptive available through federal block grants to the state, Title X funds and the Norplant Foundation, funded by Wyeth-Ayerst. The price to physicians for the Norplant system is $365. It was raised 10% in October. States have received a rebate from Wyeth-Ayerst for Norplant kits provided under Medicaid, and they expect to receive similar rebates for those provided under other government programs in 1993. The combined associated medical costs of implantation and removal are approximately $300. In comparison, oral contraceptives cost about $18 to $24 per cycle at retail or $216 to $288 a year. The down side of Norplant is that women are not required to make monthly visits to their clinics, as they are to receive 30-day supplies of OCs; consequently, they may forego regular examinations by a physician, a health department official noted. Norplant is approved for Medicaid reimbursement in all 50 states and the District of Columbia. Wyeth-Ayerst contributed $2.8 mil. to the Norplant Foundation, which provides Norplant kits to doctors of women who are not eligible for Medicaid and have a certain income level. Upjohn launched Depo-Provera at a physician price of $29.50 per dose. The drug cost does not include the cost of office visits or administration charges. At the price to physicians, the quarterly 150 mg injections of Depo-Provera will cost a total of $120 a year. The cost of administering the injections over a one-year period has been estimated at around $80. Depo-Provera (medroxyprogesterone acetate) was approved in October as the first injectable contraceptive ("The Pink Sheet" Nov. 2, 1992, T&G-2). It has been marketed in different concentrations as an anti-cancer agent: the contraceptive price is about three times higher per mg than the recent list price of the cancer treating concentrations. Upjohn said Depo-Provera's cost reflects the length of time that was involved in getting the drug to market and the extent of contraceptive information and educational materials that have been developed. The company noted that the cost of Depo-Provera is within the range of other contraceptives. Comparing the annualized prices of Depo-Provera, Norplant and oral contraceptives, Norplant appears to cost less than Depo- Provera and both are less expensive than OCs. Depo-Provera will be available at a "special price" to government-funded clinics and to other family planning organizations, Upjohn said. The company has yet to negotiate the price with each organization. According to the National Family Planning and Reproductive Health Association, which represents about 90% of the 4,000 federally funded family planning clinics, Norplant is in great demand by clinic patients; some clinics have waiting lists of about 300 women. Wyeth said that over 60% of Norplant is sold to private physicians and that approximately half a million women have had Norplant insertions since the product was launched in February 1991. NFPRHA predicts that Depo-Provera will be "very popular" both with women who go to its clinics and who use private practitioners, and for women who do not have problems complying with contraceptive regimens as well as those who do. At a Jan. 12 press briefing on the Depo-Provera launch, the Association of Reproductive Health Professionals, a national association of physicians and educators, discussed implementation of an education campaign about contraceptive counseling for physicians and nurse practitioners. Upjohn provided ARHP with a grant to create the educational campaign, which involves "distribution of educational videos, brochures and newsletters to more than 55,000 gynecologists, family practice physicians, nurse practitioners and family planning clinics across the country," an Upjohn press release says. Included in the materials are 20,000 packets containing Spanish videos and brochures for clinics and physicians in Spanish-speaking areas. "The video and brochure for patients discuss the five principle reversible categories of birth control, answer candid questions about contraception and provide a supplement to medical counsel on birth control options," the press release notes. The information to physicians provides "counseling information and patient selection criteria, including information about lactating women and those who have had problems with other contraceptives." ARHP also will publish a special 16-page issue of its publication Clinical Proceedings, which discusses different contraceptive methods, including Depo-Provera. In 1991, ARHP started four-hour training sessions for physicians and nurse practitioners on the insertion and removal of Norplant. Patient labeling for Depo-Provera lists the risks of irregular bleeding, bone mineral changes, cancer and side effects, including weight gain. "Use of Depo-Provera may be associated with a decrease in the amount of mineral stored in your bones," patient labeling states. "This could increase your risk of developing bone fractures." Upjohn is preparing a protocol for Phase IV studies of bone mineral density. The patient labeling states that "women under 35 years of age whose first exposure to Depo-Provera was within the previous four years may have a slightly increased risk of developing breast cancer similar to that seen with oral contraceptives."

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