December 18, 2015
Written by David Hubacher, FHI 360
This post originally appeared on GHSP’s website here.
The contraceptive known as the levonorgestrel intrauterine system (LNG IUS) was developed in the 1970s. The product releases small amounts of progestin into the uterus and improves contraceptive action compared with earlier inert plastic devices. The first commercialized LNG IUS set a high standard for future contraceptive development. Relative to other reversible contraceptives, the LNG IUS has the highest effectiveness levels (combining the highest product continuation rates with over 99% efficacy).1 The duration of action is 5 years (likely more), and the product provides important non-contraceptive benefits related to how it thins the lining of the uterus and reduces menstrual blood loss; from these effects, it may alleviate and/or prevent iron deficiency anemia. However, because of historically high product cost and a variety of other reasons, the LNG IUS is not widely available to women in resource-poor settings.
The legacy product was first approved in Finland in 1990, in the rest of Europe in the 1990s, and in the United States in 20002; today it is registered in more than 100 countries, and 2014 revenue topped US$900 million (personal communication with Klaus Brill, Bayer HealthCare Pharmaceutical, June 30, 2015, citing the Bayer Annual Report 2014). Because of the product’s great success, even at a high retail price, other companies have recently developed similar technologies in the hopes of entering global markets with lower-cost products. Currently, 5 different pharmaceutical companies make an LNG IUS. Two Indian companies had products approved in India in 2011 and 2012,3,4 and a third Indian company may soon have a product available.5 A Belgian company makes an LNG IUS that was approved in Europe in 2014 and in the United States in 2015.6
As of 2015, no major international donor agency has issued and executed a tender for purchasing the LNG IUS. Thus, the per unit cost for the public sector is unknown. For drugs to be purchased in large quantities by major international donor agencies, such as the US Agency for International Development (USAID) and the United Nations Population Fund (UNFPA), the products must first be approved by a stringent regulatory authority (e.g., an American, European, or Japanese authority) or by the World Health Organization (WHO) through its Prequalification Programme. Then, the products must be registered at the national level in recipient countries. Currently, only the legacy product meets these criteria for procurement; hopefully, one or more of the other products will soon be eligible as well. Together, these actions may foster eventual purchase of a low-cost product by an international donor agency.
In this paper, I provide a summary of the obstacles to interest in the LNG IUS. Then, I outline 6 main reasons why donor agencies should purchase the LNG IUS and why family planning programs should incorporate the method into their services.
Read the full article here.