Transcript Foundation PowerPoint Template - Reproductive Health Supplies

Sayana® Press Injectable
Contraceptive: Planning for
Introduction
Trisha Wood, Program Officer
Family Planning/Reproductive Health
Global Development Program
Reproductive Health Supplies Coalition meeting
October 4, 2012
Formerly known as depo-subQ provera 104™ in the Uniject®
injection system, Sayana Press is a registered trademark of
Pfizer, Inc.
Product information and evidence
Photo: PATH/Patrick McKern
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What is Uniject™?
Developed by PATH
Made by BD (Becton, Dickinson and Company)
Single dose
Prefilled and sterile
Non-reusable
Used with:
• Hepatitis B vaccine
• Oxytocin
• Tetanus toxoid
• Cyclofem
In these countries:
• Bolivia
• Brazil
• China
• Egypt
• Guatemala
• India
• Indonesia
• Vietnam
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New technology: Sayana Press
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150 mg DMPA.
Delivered every 3 months.
Glass vial with syringe.
Intramuscular injection.
1” needle.
Site: deep muscle tissue.
99% contraceptive efficacy.
Depo-Provera® brand:
Pfizer, Inc.
• Generic equivalents:
various manufacturers.
New technology
Sayana Press
Sayana Press
DMPA IM 150
Current standard
DMPA IM 150
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104 mg DMPA.
Delivered every 3 months.
Prefilled in Uniject.
Subcutaneous injection.
3/8” needle.
Site: subcutaneous fat.
Equivalent contraceptive
efficacy, safety, and side
effects.
• Pfizer Inc. product:
patent until 2020.
Value
Benefits
Features
What are the benefits of Sayana Press?
Single, exact dose,
all-in-one presentation
Reduced weight
and volume
Non-reusable
Easier to transport
and store, less waste
to dispose
Improved
injection safety
Subcutaneous injection
Simplified injection
procedures
Simpler, shorter
training
Eliminates mismatch of
syringe/vial supplies
Increased
acceptability and
use by lower-level
health care workers
Uniquely suited to
home and
self-injection
Overview of pilot introduction initiative
Photo: PATH/Gabe Bienczycki
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Pilot introduction of Sayana Press
London Summit on Family Planning, July 2012
 Pilot introduction of Sayana Press announced at
the Family Planning Summit.1
 Goal to reach up to an additional three million
women with injectable contraceptives using
Sayana Press.
 Funding partners: DFID, UNFPA, USAID,
Bill & Melinda Gates Foundation.
1Innovative
partnership to deliver convenient contraceptives to up to
three million women. (Press release). July 11, 2012. Available at:
www.path.org/news/pr120711-depo-uniject.php
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Pilot introduction of Sayana Press
 Deliver 12 million units in approximately 5 countries in
Sub-Saharan Africa and South Asia, 2013–2016 (4 years).
Objectives
 Demonstrate expanded access to injectables for new users,
improve continuation, and reduce delivery costs.
o NOT to replace DMPA-IM.
 Demonstrate Sayana Press delivery through non-clinic channels—
community-based distribution, outreach, and social marketing.
 Evaluate value proposition of Sayana Press:
o Generate information for global donors and country family
planning decision-makers.
o Inform decision-making about whether to include Sayana Press
in family planning programs in the future.
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Pilot introduction of Sayana Press
Pilot introduction countries—final list pending
 Country identification informed by country government agreement,
evaluation plan, donor priorities, pilot introduction strategies.
Product registration
 Product will be fully registered at country level before pilot
introductions begin.
Pilot introduction implementation
 Various country partners will implement service delivery:
o Government programs, including community-based distributors
and community health workers.
o NGO outreach and community-based programs.
o Social marketing.
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 What information is needed to make
procurement and program decisions
about Sayana Press?
 Are there potential pilot introduction
sites with unmet need for injectables?
o Locations where delivery using
Sayana Press could expand
access and increase number of
users.
 What information can we gather about
demand for Sayana Press in potential
introduction sites?
PATH/Monique Berlier
Pilot introduction—
country considerations
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Thank You
© 2011 Bill & Melinda Gates Foundation. All Rights Reserved.
Bill & Melinda Gates Foundation is a registered trademark in the United States and other countries.
Sayana Press regulatory pathway
Activity
2011
2012
2013
2014
2015
2016
Pfizer received provisional MHRA
(European) approval
Pfizer completes final MHRA
requirements:
• Online training materials produced
and approved
• Process validation (PV) batches
• Certificate of Pharmaceutical Product
with marketing statement from
Belgian regulatory authorities
• Final MHRA approval expected
Pfizer prepares/submits country
registration dossiers
Country regulatory approvals
July 2012
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