MI4A - Market Information for

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1 MI4A - Market Information for Access to Vaccines HPV Vaccine - Global Market Study Joint UNICEF, UNFPA, WHO Meeting with manufacturers and suppliers Copenhagen, September 2018 Health agents are pictured during the first day of the yellow fever vaccination campaign in Kinshasa, on August 17, WHO /Eduardo Soteras Jalil 1

2 AMRO/PAHO Risks to vaccine affordability & availability MI4A as part of the solution 2

3 The WHA has repeatedly called for action on access to vaccine supply Total of 50 WHA Global Resolutions on access to medicines and vaccines + 45 regional Resolutions. Call for action also from GVAP (objective 5), SAGE (e.g. April 2015) At 71 st WHA, Member States have called on WHO to develop a Roadmap for Access to medicines and vaccines - target: endorsement at 72 nd WHA 3

4 Market Information for Access: the missing segment 4 Source: MI4A, GVAMM, UNICEF, Gavi, PAHO RF

5 MI4A to inform global and local access strategies Enhance the understanding of global vaccine demand, supply and pricing dynamics and identify affordability and shortage risks Convene global health partners to define strategies and guidance to address identified risks Strengthen national and regional capacity for improved access to vaccines supply MI4A builds on the success of the V3P project and on 2017 successful BCG and D&T pilots 5

6 Great advances in vaccine market intelligence Number of countries reporting over time by region & share by income group Source: WHO JRF/V3P 2018 Up from 47% last year 6

7 WHO Calls for Cervical Cancer Elimination A laboratory technician doing testing for Tuberculosis. 7 WHO / SEARO / Gary Hampton

8 WHO life course approach to cervical cancer control Primary Prevention Secondary Prevention Tertiary Prevention Girls 9-14 years HPV vaccination Girls and boys, as appropriate Health information and warnings about tobacco use Sexuality education tailored to age & culture Condom promotion/provision for those engaged in sexual activity Male circumcision Women > 30 years of age Screen and treat single visit approach Point-of-care rapid HPV testing for high risk HPV types Followed by immediate treatment On site treatment All women as needed Treatment of invasive cancer at any age and palliative care Ablative surgery Radiotherapy Chemotherapy Palliative Care 8

9 May 2018: WHO Director General s Call to Action to Eliminate Cervical Cancer 9

10 2030 TARGETS Proposed definition and 2030 targets Vision: A world without cervical cancer Goal: below 4 cases of cervical cancer per 100,000 woman-years 90% of girls fully vaccinated with HPV vaccine by 15 years of age 70% of women screened with an HPV test at 35 and 45 years of age and all managed appropriately 30% reduction in mortality from cervical cancer The 2030 targets and elimination threshold are subject to revision depending on the outcomes of the modeling and the WHO approval process Guiding principles: life course and public health approach, social justice and equity, integrated people-centered health services 10

11 HPV Vaccine Supply Health agents are pictured during the first day of the yellow fever vaccination campaign in Kinshasa, on August 17, WHO /Eduardo Soteras Jalil

12 HPV within the Global Vaccine Market HPV vaccines account for 15% of global vaccine market value but only 1% of global market volume (2017) 2017 Estimated Market Share: HPV4: 50% HPV9: 28% HPV2: 20% Unknown (HPV2/4): 2% Very high prices per dose in many HICs drives this high percent value in relation to low percent volume Source: MI4A Global Vaccine Market Report (draft August 2018), 2017 price and volume data 12

13 Three scenarios built based on alternative supply evolutions Current capacity Based on projected demand +10% Low case Base case High case Online: capacity evolution 1 supplier Limited increase Online/Pipeline: 9 vs. 4/2 allocation Based on demand projections* Pipeline: success & timeline 2 suppliers 2022 and 2025 PQ 12m (India) 24m (China) Pipeline : capacity evolution Moderate increase (in excess of 50m at peak) 2 suppliers Some increase Based on demand projections* 2 suppliers 2020 and 2023 PQ 12m (India) 24m (China) Larger increase (in excess of 100m at peak) 2 suppliers Larger increase Based on demand projections* 3 suppliers 2019, 2022 and 2024 PQ 12m (India) 24m (China) Very large increase (in excess of 160m at peak) Allocation constant across three scenarios All assumptions are defined by the MI4A team with advise from the MI4A Temporary Advisory Group Experts 13

14 Supply Projections Substantial increase in global supply in the mid-long term with broad range resulting from different possible outcomes of development and scale-up efforts Current Short term (2-3 years) Mid term (4-6 years) Long term (9 years +) Low Base High 14

15 Demand Health agents are pictured during the first day of the yellow fever vaccination campaign in Kinshasa, on August 17, WHO /Eduardo Soteras Jalil

16 HPV Introduction Status MICs and Gavi countries lag far behind HICs and PAHO procuring 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Disease Burden 0% HICs PAHO Non-Gavi, non- PAHO MICs 13% 9% 26% 52% Introduced Not Introduced Gavi 81 countries (42%) have introduced HPV as of May 2018 Countries that have introduced account for only 25% of the global target population Only 13 of the Gavi 73 countries have introduced HPV, but have >50% of HPV cases MICs, of which only 39% have introduced, account for greater disease burden than HICs and PAHO combined Source: WHO/IVB Database, as of 15 May HPV Burden WHO Position Paper

17 Drivers of Demand Country introductions Multi-age cohort campaigns (MACs) Country recommendation of girls vs. gender neutral Coverage (routine and MACs) Schedule Also relevant but not to be factored directly into the forecasting: hesitancy, cost 17

18 Elimination Scenarios Demand Forecast Scenarios Header Text Schedule Gender Introductions Routine Coverage MACs Base Case High 2-dose Girls* All countries by 2030 Regional estimates & large country specific, +1-3%/year 48 Gavi-supported (10-14 years), no additional Header Text Schedule Gender Introductions Routine Coverage MACs No additional MACs 2-dose 48 Gavi-supported (10-14 years), no additional +1-3%/year, all countries at least 80% MACs 2-dose Girls* All countries by 2030 All new intro countries years (80% coverage) coverage in 2030 Elimination Faster 2-dose 9-14 years, 1-dose years All new intro countries years (80% coverage) and years (50% coverage) 1-dose Elimination MACs 1-dose (all countries except USA, Australia. Switches from ) Girls* Accelerated introductions for countries 2022+, all countries by X coverage increase, all countries at least 90% coverage in 2030 All new intro countries (80% coverage) Gender neutral (Elimination) 2-dose Girls & Boys All countries by %/year for low, all countries at least 80% coverage in 2030 All new intro countries (80% coverage) (+ boys in new intro HICs, EUR UMICs and PAHO UMICs) *Except countries that have already introduced gender neutral HPV immunization 18

19 Demand assessment in summary 200,000,000 Medium Base Case 1-dose Base demand stabilises at 110 M doses Increasing coverage & more aggressive MACs in elimination scenarios increase total demand by M 150,000, ,000,000 50,000, Elimination no extra MACs Elimination MACs Elimination MACs 1-dose Elimination MACs Gender Neutral Elimination MACs A possible 1 dose schedule will decrease total demand but not halve (-250M) Adoption of gender neutral policies will increase total demand by 125M MACs drive major demand increases and will require coordination to avoid peaks China and India introductions will be major drives of demand in all scenarios Source: GVMM 19

20 HPV introductions in Africa Country Strategy Primary target Coverage (2 nd dose) Rwanda 2014 (Gavi) Uganda 2015 (Gavi) Lesotho 2012 Seychelles 2014 South Africa 2014 Botswana 2015 Bi annual School based (campaign -> routine) & HF/outreach Continuous HF & Routine outreach. PIRI coinciding with Child Health days (April/October) 12 yrs 93% (2016) 11 yrs 40% (2017) Schools Status: Interrupted due to budget constraints - - Bi annual School based outreach, integrated in school health programme Bi annual School based outreach integrated in school health programme Bi annual Schools and HF/outreach Standard yrs (OOS) Primary 6 90% (2016) Grade 4 (9 yrs +) 62% (2016) 75% (2016) Mauritius 2016 Bi annual Schools and HF/outreach 9 yrs 73% (2016 Sao Tomé 2017 (Gavi) Tanzania 2018 (Gavi) Zimbabwe (Gavi) Bi-annual Schools and HF/outreach (Nationwide Demo) 10 yrs >90% (2017) Continuous HF & Routine outreach. PIRI Apr/Nov 14 yrs Annual (May), Schools and HF/outreach 9-14 yrs 86% (2018) HPV1 Strong demand for HPV vaccine introduction from African countries Limited visibility on supply as constraint for introductions in non-gavi eligible countries (eg Angola, Eswatini, Namibia) Supply constraint leads to increased transaction costs (programmatically) for countries 20

21 Supply Demand Balance Health agents are pictured during the first day of the yellow fever vaccination campaign in Kinshasa, on August 17, WHO /Eduardo Soteras Jalil

22 Supply-demand Balance Base Case Only from 2024 supply sufficient to support medium base case demand (with risks) MACs drive supply constraints; routine only demand can be covered starting from 2020 Aggressive push for capacity increases as well as faster product development and registration /PQ could potentially support base demand inclusive of MACs from 2022 (with risks) Insufficient supply: flexibility less than 10% Tight supply: flexibility between 10% and 50% Sufficient supply: more than 50% flexibility Locally supplied domestic demand for Brazil, Argentina, China and India excluded Static picture of demand does not account for unmet demand recovery in later years 22

23 Supply Demand Balance Base Case Even a phased switch to 9 valent to further magnify supply risk especially in the mid-term. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 100% 94% 94% Low 66% Current Short term (2-3 years) Mid term (4-5 years) Base 73% Locally supplied domestic demand for Brazil, Argentina, China and India excluded 23

24 Supply-demand Balance Elimination Scenarios Balance further deteriorates in elimination scenarios mainly due to impact of MACs with supply constraints until 2026/2027 in all scenarios. Aggressive push for capacity increases, faster product development and careful MACs planning allows to start roll out the strategies in Current Short term Mid term Long Term Elim. No Extra Macs High Supply 88% 68% 193% 254% Elim. No Extra Macs Base Supply 88% 68% 87% 165% Elmination MACs (China&India MACs Incl.) High Supply 74% 66% 125% 220% Elmination MACs (China&India MACs Incl.) Base Supply 74% 66% 56% 143% Elimination Faster ( MACs) (China&India MACs Incl.) High Supply 65% 49% 92% 202% Elimination Faster ( MACs) (China&India MACs Incl.) Base Supply 65% 49% 41% 131% Insufficient supply: flexibility less than 10% Tight supply: flexibility between 10% and 50% Sufficient supply: more than 50% flexibility Locally supplied domestic demand for Brazil, Argentina, China and India excluded India and China MACs not domestically supplied (too big and too early vs. ramp up of suppliers) Static picture of demand does not account for unmet demand recovery in later years 24

25 Supply-demand Balance 1 dose/gender neutral Implementation of single dose schedule allows anticipated balance to 2022/2023 but does not allow roll-out of full elimination strategy with MACs until 2025 Implementation of gender neutral policy in selected countries possible only starting from 2026/2027 with high supply or with no MACs (base supply) Current Short term Mid term Long Term 1-dose Base Case Base Supply 88% 70% 166% 363% 1-dose Elim MACs (China&India MACs incl) High Supply 74% 66% 149% 389% 1-dose Elim MACs (China&India MACs incl.) Base Supply 74% 66% 67% 266% Gender Neut. Elim MACs (China&India MACs incl.) High Supply 74% 62% 113% 192% Gender Neut. Elim MACs (China&India MACs incl.) Base Supply 74% 62% 51% 125% Gender Neut. Elim. Routine only Base Supply 84% 110% 91% 136% Insufficient supply: flexibility less than 10% Tight supply: flexibility between 10% and 50% Sufficient supply: more than 50% flexibility Locally supplied domestic demand for Brazil, Argentina, China and India excluded India and China MACs not domestically supplied (too big and too early vs. ramp up of suppliers) Static picture of demand does not account for unmet demand recovery in later years 25

26 Affordability issues 26

27 2017 HPV prices High price per dose and price variability affect access Average self-procuring MICs prices 3X higher than Gavi and ~1.5X PAHO Some MICs paying higher prices than HICs HPV price commitments to former Gavi countries are not an option for all Source: V3P, 2017 data 27

28 Access risks and potential areas for action 28

29 Moving forward 29

30 Thank you And more to come at the HPV test session Tuesday at 16:00! 30