Market Update. Human Papillomavirus vaccine (HPV) Vaccine Industry Consultation November 2016

Transcription

1 Market Update Human Papillomavirus vaccine (HPV) Vaccine Industry Consultation November 2016 UNICEF/UNI196303/Georgiev Philipp Kalpaxis, Vaccine Centre/UNICEF Supply Division

2 Background In 2013, UNICEF began procuring HPV vaccines for Gavi-supported programs and on behalf of self-financing middle-income countries (MICs). Following an international tender invitation in late 2012, UNICEF established LTAs with both manufacturers of WHO pre-qualified HPV vaccines for supply to Gavi-supported programs during the period HPV vaccine delivery programmes across LICs and MICs were still in very early stages of development initial awards were made against confirmed country demand. Additional incremental awards were made during the tender period as new country demand materialized and approval/timing for further introductions was confirmed. Demand from self-funding countries through UNICEF has so far been irregular ad hoc tender invitations were issued in the absence of LTAs (lack of long-term demand visibility and industry response to the MIC new vaccine tender did not allow for the establishment of such).

3 Historical procurement of HPV vaccines through UNICEF 3,000,000 2,500,000 # OF DOSES 2,000,000 1,500,000 1,000, , (YTD) GAVI PS (GAVI) PS (NON-GAVI)

4 Historical procurement of HPV vaccines through UNICEF Country Preference Distribution by number of countries Distribution by number of doses 7% 38% 62% 93% HPV4 HPV2 HPV4 HPV2

5 With Gavi s support, 23 countries implemented HPV demos and 3 went national Gavi introduced funding through two pathways: demo and national Gavi support increased HPV implementation experience Country with experience? No Yes Demo programme Support for max. 15k girls Scaleup National introduction Support for single-age cohort National introductions (3) Demonstration introductions (23) Approved demo + national (7)* not applied (35) Successful uptake of demos, but limited national scale-ups * Demos: Burundi, Cambodia, Indonesia (Exceptional Catalytic), Kenya 2nd Demo, Nigeria, and São Tomé. National: Bolivia (exceptional catalytic) Source: Gavi, the Vaccine Alliance

6 Procurement volumes in the early years of the program have been much lower than projected 25,000,000 20,000,000 # OF DOSES 15,000,000 10,000,000 Actual (GAVI + co-financing) RFP forecast 5,000,000 Adjusted for 2- dose schedule (YTD)

7 Current Gavi support for HPV reached its goal to vaccinate 1M girls by 2015, but target of 30M by 2020 is at risk? Source: Gavi, the Vaccine Alliance

8 Main challenges for increasing HPV uptake Vaccine demand Competing health and vaccine priorities Vaccine price and programmatic cost Programme design

9 Two strategic shifts will allow up to 40M girls to be reached by 2020 Two proposed Strategic shifts... Higher...allow and to achieve faster impact original if target one-time up to support 40M for up fully to 5 vaccinated additional age girls cohorts by 2020 is given Direct national introduction, with option of a phased roll-out Accumulated Girls by fully immunized girls (M) years of age years Updated forecast (Sept. 2016) years New strategy SDF12 (Dec 2015) 16 years years 40 ~ 900k deaths averted 3 Additional girls protected through multi-age cohort support in year 1 Multi-age cohort vaccination in year of introduction years 13 years 10 ~ 450k 12 years Girls protected deaths 1 11 years through averted routine 0 programme years years Assuming in average countries target 3 additional Year 1 age cohorts 1 Year 2 Year 3 Year 4 Year 5 with average coverage of ~65% 2 Year since start of national roll-out 1. Considering average age of primary school completion is 12.1 years in targeted countries 2. Weighted average coverage across all targeted cohorts considering all supported countries in (range: 50-80%) 3. Considers direct impact, i.e. herd immunit NOT included- deaths averted is over 30 years Source: Market shaping and finance Source: Gavi, the Vaccine Alliance

10 Procurement on behalf of self-financing MICs So far, unpredictable demand that resulted in procurement on behalf 5 MICs. We anticipate MIC demand through UNICEF to increase as additional countries consider HPV vaccine introductions. However, HPV vaccine price & lack of visibility remains a concern for self-financing countries that are considering the long-term sustainability of programs. Manufacturer price commitments for MICs transitioned out of Gavi support have been an encouraging step. Can we use the next tender to positively adjust the market?

11 Tender 2017 for Gavi & MICs(?) Adjust forecast by incorporating the impact of stepwise national introductions and multi-age cohorts. New forecast to serve as basis for the tender invitation to be issued 2H 2017 for supply starting in January Objectives: healthy supplier base with new market entrants during the tender period supply to accommodate country product preference affordable prices for Gavi programs and selffinancing countries to reduce hesitancy for national introduction/increase vaccine uptake Longer term, Adresses strategic supply security Partially or indirectly impacted by procurement actions Near term, tactical supply security Directly influenced by procurement actions 6. Total System Effectiveness 3. Buffer Capacity Developed jointly by BMGF, Gavi and UNICEF Healthy Markets Framework 7. Long Term Competition 4. Individual Supplier Risk 8. Product Innovation 5. NRA Risk 2. Accommodate Country Presentation Preference 1. Supply meets demand Below Threshold 0. Inadequate Supply Consider the impact of product innovations(e.g. HPV9), their prequalification, evolution of demand and Gavi s future portfolio. Counting on suppliers to honor commitments to transitioned countries in their offers. Attribute Tier Attributes Increasing Cost Costn WAPn Cost3 WAP3 Cost2 WAP2 Lowest Reasonable

12 UNICEF/SUDA2014-XX228/Noorani