at and beyond the horizon: new technologies to increase choice and address unmet need panel on unmet...

At and Beyond the Horizon: New Technologiesto Increase Choice and Address Unmet Need

Panel on Unmet Need and Method MixInternational Conference on Family Planning

Addis Ababa, EthiopiaNovember 15, 2013

Jeff Spieler

Senior Technical Advisor for Science and Technology

Office of Population and RHBureau for Global Health

USAID/Washington

Rationale for improved and new methods

At the horizon: Improved contraceptive technologies

LNG-IUS

Sayana Press (Depo subQ in Uniject)

SILCS Diaphragm

Woman’s Condom

Beyond the horizon: New technologies

NES/EE Contraceptive Vaginal Ring (CVR)

Biodegradable Contraceptive Implants/Pellets

Multi-Purpose Prevention Technologies (MTPs)

New contraceptive methods Still Needed

Future challenges

Topics in this presentation

Health/side effects, 23%

Infrequent sex, 21%

Postpartum/breastfeeding, 17%

No access/high cost, 8%

Unaware of methods, 4%

Perceived subfecund, 2%

Source: Darroch et al, Guttmacher Institute, 2011.

Client-level reasons for non-use, women with unmet need for FP, 3 regions

LNG-IUS

Sayana Press (Depo subQ in Uniject)

SILCS Diaphragm

Woman’s Condom

At the horizon (within 5 years):Improved contraceptive technologies

Programs can apply to the International Contraceptive Access Foundation for free donations of the LNG-IUS at see http://www.ica-foundation.org/

The LNG-IUS: The best of both worlds

Oral contraceptives Intrauterine devices

• Highly effective

• Reduction of menstrual loss

• Reduction of pelvic inflammatory disease

• No daily motivation

• Long-acting

• Estrogen-free

• Rapidly reversible

Levonorgestrelintrauterine system

Highly effective/(when used correctly and consistently)

Reduction of menstrual loss Reduction of pelvic

inflammatory disease (PID)

Highly effective No daily motivation Long-acting (up to 5 yrs) Estrogen-free Rapidly reversible

Years

Levonorgestrel intrauterine system

Cu IUD

0 1 2 3 4 5

3

2

1

0

-1

-2

-3

-4

g/l

Change in hemoglobin during 5 years of use

Hormonal Intrauterine Contraceptive System

Depo-subQ Provera 104: New formulation for subQ injection New name 30% lower dose (104 mg vs. 150 mg) Rapid onset of action Same effectiveness, same length of protection

(>3 months) Approved by USFDA (2005) and EMA/UK

Uniject: Single dose, single package Prefilled, sterile, non-reusable Short needles for subQ injection – allows easier

use by non-clinical personnel/CHWs Compact; easy to use and store Potential for home- and self-injection Approved by EMA and LDC registration

forthcoming Available for roll-out in 2014; PK study on-going

for injection in arm; acceptability studies completed 2013

Potential “home run”

New formulation of Depo-Provera: Sayana Press (Depo-subQ in Uniject)

SILCS DiaphragmImage Credit: PATH/Patrick McKern.

Woman’s CondomImage Credit: PATH/Patrick McKern.

Two new female barrier methods: SILCS Diaphragm and Woman's Condom

New Technologies

NES/EE Contraceptive Vaginal Ring (CVR)

Biodegradable Contraceptive Implants/Pellets

Multi-Purpose Prevention Technologies (MTPs)

New contraceptive methods still needed

Beyond the Horizon (5-15 years): New Contraceptive Technologies

NES/EE Contraceptive Vaginal Ring (CVR): First long-acting method that is user-controlled Nestorone® / Ethinyl Estradiol 1-Year Ring

(Core Technology)

*Delivers NES/EE 150/15µg /day, 13 cycles of 3 weeks on followed by 1 week offFDA approval expected in 2015Developed by the Population CouncilSponsored by USAID, NICHD, WHO

8.4 mm (3/8”) in cross section58 mm (2 1/4”) in diameter

NES CoreNES Core

NES / EE CoreNES / EE Core

Biodegradable Contraceptive Implant/Pellet

Biodegradable Contraceptive Implant Pellets Effective contraceptive placed under

the skin

Similar to, but much smaller than, an implant

Easy to insert

Biodegradability would eliminate the need for removal at the end of one year BUT can be removed

Landscape analysis of manufacturers underway (FHI360)

“On demand” products: Used at the time of intercourse

Appropriate for women who have intermittent sex, or who would like more direct control over their own protection

Sustained release products: User-initiated, but do not require daily

action

Should increase adherence, and therefore overall effectiveness

Priorities for first-generation MPTs

Some additional methods would likely have immediate application if they were of low cost:

1.Non-hormonal, non-steroidal and/or non-estrogen containing OCs, or novel progestin-only OCs

2.Non-surgical methods of male and female sterilization

3.A highly effective and safe vaginal spermicide

4.Post-testicular methods for men

New Contraceptive Methods Needed

Short Term – Improve programs and access, and help women successfully use current methods

Medium Term - Improve current methods to address reasons for non-use, e,g., reduce side effects and make methods easier to use, including confidentially and during breastfeeding

Long Term - Develop totally new methods to offer new approaches to contraception that address women’s reasons for unmet need and discontinuation

Future Challenges