ICA FOUNDATIONInternational Contraceptive Access

June 2015 1

ICA FOUNDATION

• Public-private partnership between Population Council and Bayer

• Not-for-profit registered in Finland in 2004

• Provides contraceptive products, e.g., levonorgestrel releasing intrauterine system (LNG IUS) to public health organizations such as multilaterals, governments, or NGOs for use in their programs

• Aims to serve the reproductive needs of women and families in resource-poor settings in developing countries

• Member of the Reproductive Health Supplies Coalition

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ASPIRATIONS OF ICA

• Increase the well being of women and families in resource-poor settings

• ICA Foundation will generate value by ensuring public benefit by providing LNG IUS contraceptive devices (new contraceptive technology) on a not- for-profit basis and serving the reproductive needs of women and families in poor and vulnerable populations in developing world

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• Product consists of a T-shaped plastic frame and white cylinder shaped hormone reservoir around the vertical arm of the frame, with two nylon threads for removal.

• The system contains 52 mg of the hormone levonorgestrel (LNG) and releases 20µg/24h in the uterus for up to five years of protection.

• Registered in 3 countries (Ghana, Kenya and Nigeria)

• Mirena® has been commercially available since 1990, currently registered in over 120 countries

LEVONORGESTREL INTRA-UTERINE SYSTEM

• The LNG IUS contraceptive was developed in the 1970s by Population Council and Bayer Oy, combining the best features of both oral contraceptives and the IUD.

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CHARACTERISTICS OF LNG IUS

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• Highly effective: failure rate ~0.2% at 1year and cumulative failure rate 0.7% at 5 years

• High continuation rate: more than 90% of users continue each year of use

• Significantly reduces menstrual blood loss

• Approved treatment for women suffering of heavy menstrual bleeding

• Rapid return to fertility after removal

• More cost-effective than oral contraceptives, condoms and injectable contraception over five years

Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014

Backman T, Huhtala S, Blom T, et al. Length of use and symptoms associated with premature removal of the levonorgestrel intrauterine system: a nation-wide study of 17,360 users. BJOG 2000;107:335–9

Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing intrauterine device and Nova T. Contraception 1992;45:575–84

Trussell J. Update on the cost-effectiveness of contraceptives in the United States. Contraception 2010;82:391

LNG IUS MECHANISMS OF ACTION

• Thickens cervical mucus

• Inhibits sperm function in uterus

• Reduces monthly growth of the lining of the uterus making periods lighter and shorter *

• No evidence of any interference in the fertilization process

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* There is no evidence that the LNG IUS can prevent implantation

Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014

ALTERNATIVE TO STERILIZATION

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• The contraceptive efficacy of LNG IUS is similar to that of female sterilization, with full reversibility of fertility upon removal (unlike sterilization)

• Up to 40% of women sterilized at age 30 or younger, will regret their decision or request reversal of the surgery

• Heavy menstrual bleeding increases in late reproductive years: In contrast to sterilization which does not have an effect on periods, LNG-IUS offers the benefit of shorter and lighter periods

Sources: Grimes and Michell: Intrauterine contraception as an alternative to interval tubal sterilization. Contraception 2008;77:6-9

Bayer Ag: LNG IUS Corporate core data sheet Jan 2014

TREATMENT FOR HEAVY MENSTRUAL BLEEDING

• Use of LNG IUS makes periods lighter, shorter and less painful

• Over 12 months, blood loss reduced by 80-96% in women with heavy menstrual bleeding

• Clinical improvement in associated anemia

• Hemoglobin levels rise 1.8g/L in one year of use with LNG-IUS, compared to a decrease of 1.2g/L with Copper-T.

• Irregular bleeding or spotting common in first 3-6 months; 20% with amenorrhea at 12 months

Sources: Bayer AG: LNG IUS Corporate Core Data Sheet Jan 2014

Luukkainen 1987; Rezan and Chi, 2007; Sitruk-Ware, 20078

SUBSTITUTE FOR WOMEN AWAITING HYSTERECTOMY

Source: Lahteenmaki et al, 1998

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Client

Health system policies, programs

and providers

Family and community

relationships

Method characteristics

CONCEPTUAL FRAMEWORK

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PRIORITY CLIENT GROUP

• Women who want long-term effective and reversible contraception

• Women with heavy menstrual bleeding or for whom Copper IUDs are unsuitable

• Women with contraindications to use estrogen; Women who need endometrial protection due to estrogen therapy

• Potential target groups: Post partum and post abortion women

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LNG IUS DONATION PROCEDURES

• Service delivery organization submit LNG IUS project proposal to ICA Foundation

• LNG IUS is registered or special permission to import and use the product is sought from country of donation

• Training materials are provided regarding LNG IUS insertion/removal and comprehensive family planning provision and counseling

• LNG IUS is incorporated into existing service delivery strategy

• Donation recipient provides updates on numbers of insertions as well as progress and possible challenges of distribution

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Who can apply for LNG IUS?

International development and public health organizations, such as multilateral, governmental, or non-governmental organizations for use in their programs. LNG IUS donations are not available for biomedical research purposes, including clinical trials.

How to apply?

Interested applicants should complete a project proposal form on ICA Foundation’s website and submit it for assessment and approval.

For more information please contact ICA Foundation:

Mailing address: ICA Foundation, PO Box 581, FI-20101 Turku, FinlandE-mail: information@ica-foundation.org Website: http://www.ica-foundation.org

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ICA CUMULATIVE DONATIONS: 71,240 LNG IUS (June 2015)

COUNTRY PROJECTS

Latin America• Bolivia• Brazil• Colombia• Curacao• Dominican Rep.• Ecuador• El Salvador• Haiti• Mexico• Paraguay• Saint Lucia

Africa• DR Congo• Ethiopia• Ghana• Kenya• Lesotho• Malawi• Nigeria• South Africa• Uganda• Zambia• Zimbabwe

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Asia• Afghanistan• Bangladesh• Cambodia• Indonesia• Mongolia• Sri Lanka

ROLE OF NETWORKS

Partnerships with service delivery networks, such as Marie Stopes International (MSI), International Planned Parenthood Federation (IPPF), AmeriCares and Partners In Health (PIH) allow for efficient delivery of LNG IUS in multiple countries through existing infrastructures, and assist in meeting the Foundation’s objectives.

They potentially have greater capacity for training, supervision and logistics management as well as meeting reporting requirements.

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BOARD MEMBERS

John Townsend (Chairman)Population Council

Klaus Brill (Vice-Chairman)Bayer Pharma AG

Demet GuralCaroline Crosbie (Deputy Member)Pathfinder International

Vanessa Cullins Planned Parenthood Federation of America (PPFA)

Sarah Onyango Maria Cristina Ramirez (Deputy Member) International Planned Parenthood Federation

Pamela BarnesYetnayet Asfaw (Deputy Member) EngenderHealth

James SailerRebecca Brodsky (Deputy Member)Population Council

Johanna KouruBayer Oy

Annette Velleur (Deputy Member) Bayer Pharma AG

ADVISORY MEMBERS Luis BahamondesUnicamp

Annette Gabriel KfW

Claus-Peter JanischMedical Consultant

Jeff SpielerUnited States Agency for International Development (USAID)

Robert ZinserRotary International

Roy Jacobstein IntraHealth

SECRETARYJoanna Holopainen Bayer Oy

OFFICERHeather Chadwick Population Council

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