Series K, Number 7
Injectables and Implants

CONTENTS

Home (Key Points)

New Implants Can Expand Access
Table 1. Comparing Implants
Table 2. Continuation Rates for New Implants
Table 3. Estimated Worldwide Use of Implants

Box: Which New Implant to Introduce?

Spotlight: From Norplant to Jadelle: Smooth Transition in a Dominican Republic Clinic

Preparing to Offer New Implants

Spotlight: Training Nurses Increases Implant Use in Ghana

Box: Information and Communication Technology Supports Implant Programs

Meeting Demand for New Implants Requires Supply and Access
Table 4. Key Resources for Program Managers and Providers of Implants

Bibliography

Credits

• Box: What Clients Should Know About Insertion and Removal
• INFO Reports: “Implants: Tools for Providers”

• Table 1: Comparing Implants
• Table 4: Key Resources for Program Managers and Providers of Implants

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Meeting Demand for New Implants Requires Supply and Access

Throughout the world use of implants remains low, but demand exceeds supply. Many women want implants but are unable to obtain them. Women who want implants but cannot get them go on waiting lists or choose another method. Some experts contend that the true demand for implants is unknown because there are not enough supplies and services available to meet demand (42).

Currently, few clinics offer implants. For example, in Ghana, only 17% of clinics surveyed by the Demographic and Health Surveys in 2002 offered contraceptive implants, and only 12% had them available on the day of the survey (30). In both Egypt and Kenya 13% of surveyed clinics offered implants. In Egypt 6% of clinics surveyed in 2002 and in Kenya 4% in 2004 actually had them available on the day of the survey (63).

Programs that do offer implants often experience shortages. Shortages have been reported in Zambia (39) and Tanzania, and also in Madagascar, where clinics were reported to have run out of implants on the same day that the shipments arrived (105).

In Kenya demand for implants continually out-runs supply (20, 42). Many women who want implants must choose other methods, while others prefer to wait—and risk unwanted pregnancy—until implants become available. Some Kenyan service providers keep lists of clients who are waiting for future shipments of implants (42). Word-of-mouth from satisfied users has created and sustained demand despite the recurrent stock-outs. A 2007 analysis of the implants market in Kenya concludes that, with an expansion of training in insertion, Kenya could make use of procurements of 200,000 implants per year. This would be an increase of more than fourfold, up from the 47,000 sets procured in 2005 (42).

Cost is the largest barrier to access to implants. Many of the reported shortages of implants are due to their cost. In terms of supply cost, after the levonorgestrel-IUD, implants are the most expensive supply method of family planning, currently up to US$27 per set. Equipment for insertion, program costs of training and retaining providers with insertion and removal skills, and the time involved in insertion and removal also contribute to the high costs of implants (60). By comparison, copperbearing IUDs, which last for at least 10 years, are available to the public sector for about US$0.21 to US$0.27 apiece (114).

The relatively high initial per-unit cost of implants has prevented widespread provision of implants in resource-poor countries. Donors have limited their purchases because of the high price (87, 105).

Fortunately, manufacturing costs are declining, donors and governments are placing larger orders and negotiating lower prices, and a lower-priced implant has become available— priced as low as US$4.50 per set. With such efforts to reduce costs, programs are more likely to be able to meet the demand for implants and to offer them to clients at lower prices.

Programs Estimate Implants Needed

A smooth transition to offering new implants requires sufficient supplies on hand. National family planning programs estimate the number of implants needed based on forecasted consumer demand, on one hand, and, on the other, the capacity of the program to provide clients with implants (87). In practice, it is often challenging to estimate requirements for implants accurately when they are new to the program.

Accurate estimates of the need for implants enable programs to place timely orders to manufacturers, donors, or procurement agents. The most accurate forecasts of consumer demand use several types of information. Usual information includes numbers of new and returning clients, recent trends in use and projected increases as implants become more available and changes in local population due to migration. The estimates of consumer demand, however, must be adjusted for program capacity, including the number of providers trained to offer implants (or any plans to train providers to offer them), the number of facilities that can provide implants, the availability of supplies required for insertion and removal (such as anesthetic, trocars, forceps), and in-country capacity to manage the distribution of implants, among other factors (87).

Because implants are relatively new to some programs, forecasting may require other ways to assess consumer demand. Clinics could keep track of requests for implants, for example. Also, the number of clients requesting longterm methods would suggest potential interest in implants. Logistics staff could periodically speak with providers about their perceptions of the demand. (Key resources for ensuring reliable implant supplies are listed in Table 4.)

Once implants start to arrive, at the national level donors can meet periodically to review quantities of implants ordered and ensure that total quantities will meet the need without overstocking. At service sites logistics officers should review stock levels and trends in use each month and place orders as needed to maintain stock (24, 87, 91). At the central warehouse many countries have computerized systems, such as Pipeline Monitoring and Procurement Planning System, to help with forecasting (45, 91) (see Box: Information and Communication Technology Supports Implant Programs).

Warehouses must also keep track of supplies and ensure that the facilities are adequate to ensure quality. Storage requirements for implants are similar to those for other contraceptive supplies, such as oral contraceptives. Implants must be stored in a dry place at room temperature, about 15 to 30°C (59 to 86°F), and away from direct sunlight. Generally, implants are labeled for a shelf-life of five years.

Countries often purchase a portion of the implants required directly from the manufacturers (11, 64). For example, in late 2007 Ethiopia’s Ministry of Health is in the process of placing an order for 160,000 sets of implants, and Tanzania’s Ministry of Health is ordering 50,000 sets (106). Many thousands more are needed, however.

For the remaining quantities needed, countries submit requests to donor agencies. Donors base their purchases from the manufacturers on the total number of implant sets requested by all countries, taking budgetary considerations and current inventory into account. USAID usually can purchase and supply to countries only a portion of the estimated annual requirement of implants, plus some reserve for emergency orders (87).

Donor Commitment Essential for Ensuring Supplies

The availability of implants to users depends on affordability. The majority of women in low-resource settings would be unable to pay the full cost of implants and implant insertion. Some governments, such as the Dominican Republic’s, do not purchase implants due to their high cost. They make implants available in governmental clinics only when they receive donations of supplies (11). Donor support and financial commitment from national ministries of health will be essential to meet the rising demand for implants.

Donors (and national family planning programs) must be able to purchase implants at the lowest possible price. The 2007 price for Implanon is about US$19 to US$25 (90) and for Jadelle is US$21 to US$27 (5). The Population Council developed Jadelle, largely with U.S. government funding, and then licensed it to Leiras Oy. Leiras Oy was taken over by Schering AG in 1996 and merged with Bayer in 2006. The resulting licensing company, Bayer Schering Pharma, is now making Jadelle more widely available at a lower price than before. Bayer Schering Pharma submitted the winning competitive bid to supply USAID with Jadelle in 2007, at US$21 per unit.

USAID makes the implants that it buys available to a variety of sectors. In 2007 USAID donated 74% of its implants to ministries of health, 24% to non-governmental organizations, and 2% to contraceptive social marketing organizations. In 2006 and 2007 Ethiopia, Rwanda, and Haiti received the largest amounts of implants from USAID (87).

Other large donor organizations also make bulk purchases of implants at discounted prices. In 2006 the International Planned Parenthood Federation (IPPF), the United Nations Population Fund (UNFPA), and USAID combined purchased about 270,000 sets of implants, a mix of Jadelle, Implanon, and Norplant, at an average price of US$28 per unit (see Web Table 1). Average prices have come down for 2007 (86, 105).

Cost-Effectiveness Studies Show Long-Term Returns

While the initial price of implants is high, they can be costeffective when used for a number of years. For example, at the cost of US$27 for Jadelle, if a woman continues to use the implant for a full five years, the cost of the implants divided by the number of pill cycles needed for the same number of years would be US$0.42. This is within the range of the cost of a cycle of oral contraceptive pills for which UNFPA pays US$0.16–US$0.63 per cycle. Also, over the long term, making implants available may reduce workload on the health system, and thus costs, because implants have higher continuation rates and are more effective than most other methods (47).

Several detailed analyses have concluded that in the long run implants are relatively less expensive than shorter term methods such as pills and injectables, particularly when such factors as staff time, facility costs (such as consultation space), and equipment are taken into account (21, 66). A study in Mali found that, when implants are used for several years, they are comparable in cost to other methods. The study examined several actual costs including providers’ time and costs of supplies and equipment. Researchers concluded that after four years of contraceptive use the cost of providing a couple with a year of contraceptive protection was similar for Norplant, oral contraceptives, IUDs, and injectables (21). Another study, done in a clinic in Turkey, compared the costs of Norplant with the costs of oral contraceptives, taking into account the costs of supplies and staff time spent in counseling and follow-up visits, and actual continuation rates. The analysis estimated the total costs for one month of Norplant use at US$1.04 and one month of oral contraceptives use at US$1.58 (76).

A modeling study in the United Kingdom (UK) comparing the levonorgestrel IUD, medroxyprogesterone acetate (DMPA), and Implanon, examined health care resources from the National Health Service’s perspective. The study found that the levonorgestrel IUD was the most cost-effective long-term method in terms of unintended pregnancies prevented, but Implanon was more cost-effective than DMPA, primarily because of the additional pregnancies that implants avert (117). Another UK modeling study found that Implanon was the most cost-effective in terms of unintended pregnancies avoided (and avoiding the costs associated with birth, miscarriage, and abortion) when compared with Norplant and a levonorgestrel IUD, DMPA, and oral contraceptives. This model used perfect-use effectiveness rates (how well the method protects against pregnancy when used consistently and correctly) and national discontinuation rates for each method (77).

The cost-effectiveness of implants and other long-acting methods rises with length of use. Experience in both clinical trials and actual program use shows that most users of the new implants keep them for at least three years. Review of continuation data for Implanon, Jadelle, and Sino-Implant (II) from eight studies in a wide range of countries finds that 78% to 96% of users keep their implants for at least one year, and 50% to 86% keep their implants for at least three years (see Table 2). (Implanon is intended for only three years of use.) In a multi-country study of Jadelle, over 55% of users continued using the implant up to the maximum five years (96).

Implant services can be kept more cost-effective by avoiding routine follow-up visits, which provide no additional health benefits (61). No routine return visit is required until it is time to remove the implants (122). Of course, the client should be clearly invited to return any time she wishes, for any question or problem or any other reason (124).

Reducing Costs Will Improve Access

Why are implants so much more expensive than other contraceptive methods? First, both Jadelle and Implanon are owned by private pharmaceutical companies. The manufacturers try to recover expenditures for research and marketing as well as to make a profit before patents expire and they face potential price competition from other manufacturers. Second, the manufacturing technology is particularly costly and complex. The manufacturer must have skills in handling both polymers to make the rods and small quantities of steroids. Production processes must be carefully controlled to ensure the right release rate. Costs could probably come down with the development of better technology and further research into making the production process cheaper (34). Third, manufacturing costs per unit depend on volume. Compared with orders for other contraceptives, current orders for implants are small. Implants could become cheaper as orders increase (6).

A technician at the Dahua Pharmaceutical plant in Shanghai, China, assembles Sino-Implant (II) rods. The company is manufacturing the implants in a new facility, which adheres to industry quality standards. By 2007 Dahua Pharmaceutical had distributed 5.3 million units of Sino-Implant (II), mostly in China. (© 2006 Markus Steiner/Family Health International)

Generic (nonexclusive) production of implants could reduce prices dramatically (33). Sino-Implant (II), developed by an academic collaboration and purchased by a company in China, is an example. The patent on Jadelle has expired, and therefore generic versions are legally possible. In the U.S. the patent on Implanon expires on September 29, 2009. There may be one or two other companies looking into producing generic implants. If experience with the production of other hormonal contraceptives is a guide, however, most companies would find it hard to meet acceptable quality assurance criteria (34, 35). Over the long term, manufacturers in the global south can be encouraged to raise their quality standards and consider making generic implants, as they commonly do other contraceptives (33). In the short term, implant prices already are falling as donors negotiate better prices for larger quantities. Manufacturers’ prices generally decline over time in any case. The strategies for providing lower-cost implants in the near future include pursuing registration of Sino- Implant (II), the cheapest implant available.

Sino-Implant (II) is cheaper. Efforts are underway to increase the availability of Sino-Implant (II), which now has a wholesale price of about US$4.50. Manufactured by Shanghai Dahua Pharmaceutical, this implant has been available in China since 1997. It has been exported to and used in Indonesia since 2002. To date, Shanghai Dahua Pharmaceutical has distributed 5.3 million units of Sino-Implant (II). The company is manufacturing the implants in a new facility that adheres to industry quality standards (107). This implant is well-suited for widespread international registration because of its low price and because it is a “two-rod levonorgestrel-releasing implant,” as listed in the March 2007 edition of the WHO Model List of Essential Medicines (123).

Family Health International (FHI) is working with local partners throughout Africa to ensure that Sino-Implant (II) meets regulatory standards for safety and quality—testing the rods as well as obtaining a second evaluation from an independent U.S.-based laboratory. FHI will help local partners register the implants with national drug regulatory authorities in Egypt and several other countries. As part of this initiative, FHI has negotiated price ceilings for the public and non-profit sectors once national drug regulatory authorities have approved the product (107).

Are clients willing to pay? While many women attending public clinics are accustomed to receiving family planning services free of charge, some women are willing to pay for good-quality family planning services, including a wider range of contraceptive choices that includes implants. Most private non-profit family planning clinics already recover at least some of the costs of services directly from consumers (2, 29).

Some programs make services more affordable through cross-subsidy, charging more than the program’s costs to provide less expensive services such as condoms or pills, to subsidize more expensive services such as implant insertion, and thus allow lower prices. Other strategies include slidingscale fees—charging clients fees based on their ability to pay. Sliding-scale fees are more successful in middle-income countries, where some consumers can afford to pay higher prices, than in the poorest countries (3).

Private clinics in Kenya charge the equivalent of US$30 and in the Dominican Republic, US$54 for implant insertion. The charges cover the costs of the implants and operational costs of providing the implants, including staffing (11, 42). In Nigeria, where the implants are subsidized by the government, clients pay the equivalent of about US$15 for Implanon (64). Still, the relatively high price of implants compared with other contraceptive methods is one of the main reasons for low use that were cited by program staff in Jos, Nigeria (65).

Studies that ask prospective and current contraceptive users how much they would be willing to pay for contraceptive methods (known as “willingness-to-pay studies”) can be helpful in setting an initial consumer price for new implants (2, 29). Once an initial price is decided, program managers might conduct brief, small-scale pricing trials in a few service delivery points to ensure that the price is reasonable.

In Guatemala USAID and the Population Council conducted a willingness-to-pay survey before introducing Norplant in clinics of the Asociación Pro-Bienestar de la Familia de Guatemala (APROFAM). Information from this survey was used to set the price of the product at 90 Quetzales, or almost US$12 (2).

Although some clients may be able to pay something, in reality most women will be unable to pay the full cost of implants and will require at least some subsidy. In Kenya the insertion fee charged at many public facilities amounts to US$7, but less or nothing at all if a client cannot pay the usual fee. Efforts there to create a true private-sector market for implants, without donor support, have failed because the product has been too expensive to date (42).

Some programs have especially subsidized implants in an effort to encourage their use. When Norplant was introduced in Thailand in 1991, just over half of women received them at no charge. Because the national family planning program wanted to increase contraceptive use, the implants were highly subsidized, and the maximum price charged for Norplant amounted to US$8 (49). Because Egypt’s ministry of health wanted to support the introduction of Norplant, it shifted from charging the equivalent of about US$3.50 to charging no fee at all. Demand for Norplant insertions at all ministry health facilities increased substantially (22). In the face of limited resources for reproductive health, increasing subsidies likely means cuts elsewhere. Programs will have to examine their priorities and decide how much to subsidize implants over other reproductive health services.

The new contraceptive implants hold substantial promise and are likely to broaden the appeal of the method. They are an important option in the range of long-acting methods. As family planning programs begin introducing the new implants or making the transition from Norplant, demand can be expected to rise. To meet the demand, programs will need to rely on donor and government subsidies, greater availability of lower-priced implants, and sharing the cost with users. Such strategies to improve access at lower cost will be key to the success of this contraceptive method.