Xpert MTB/RIF: Update on preferential pricing, installation and start-up costs & post-marketing surveillance. Giorgio Roscigno 08 April 2011
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1 Xpert MTB/RIF: Update on preferential pricing, installation and start-up costs & post-marketing surveillance Giorgio Roscigno 08 April 2011
2 Global pricing FIND-negotiated prices available to: Governments, or government-funded institutions (Ministry of Health, associated hospitals, armed forces, prison services) NGOs recognized by the local Ministry of Health and UN-related organizations (e.g. IOM and UNICEF) Not-for-profit organizations (e.g. Médecins Sans Frontières, Save the Children, OXFAM and the International Committee of the Red Cross) Global funding mechanisms (e.g. GDF, UNITAID, PEPFAR, USAID, Global Fund), and implementing agencies (e.g. USA-CDC and The Union) Not-for-profit, private organizations recognized by the local Ministry of Health (e.g. private charities, private not-for-profit hospitals and clinics) on a case-by-case basis. Prices available in 145 low- and middle-income, and high burden countries
3 FIND-negotiated volume/price relationship Forecasted per-test price for FIND markets FIND-negotiated price FIND-negotiated price FIND-negotiated price Applicable global volumes (cartridges per annum) > 600,000 >1,700,000 >3,700,000 Price (Ex Works) US$ US$ US$ Ave % Reduction over EU* 75% 79% 84% *Average cost per cartridge in EU 50
4 FIND-negotiated instrument cost Instrument price for FIND markets GeneXpert 4-module with desktop GeneXpert 4-module with laptop Price (Ex Works) US$ 17,000 US$ 17,500 >60% reduction over EU/US
5 Maintenance and calibration costs (approximate) Standard: one-year warranty; 24-hour hotline and support Scenarios for after-sales service, support, maintenance and calibration Model 1: Cepheid Toulouse Model 2: Distributor Model 3: NTP staff Model 4: Web-based Estimated year Now Now Calibration (4 modules) US$ 1,400 US$ 1,400 US$ 1,000 US$ 500 Description Shipment (4 modules) In Toulouse (requires 2 shipments: site-toulouse) Local distributor basis (requires 2 local shipments: site-distributor) On-site (no swap out) US$ 400 US$ 200 None None Remotely, using a calibration kit (no swap out) Total US$ 1,800 US$ 1,600 US$ 1,000 US$ 500
6 Global pricing characteristics A single, published, global price for public health sector in 145 countries Price decreases with increasing total global volumes Target volume of > 750,000 in 2011, all markets all shipments Already shipped as many units in Q as for whole of 2010 On track for target volume Benefits of increasing volumes distributed equitably to all users (including small countries which do not usually have leverage) Transparent process FIND monitors global sales volumes on quarterly basis
7 Global pricing characteristics (II) FIND is leveraging its investments in development of Xpert MTB/RIF assay ( ), to reduce the price FIND-Cepheid contract based on COGS*, cost plus model Current price situation (private sector, Europe, US): Instrument: 40,000 45,000 ($55,000 $62,000) Test cartridge: ($55 $82) Ongoing cost-reduction programme in place e.g. different packaging configuration will reduce both cost of individual cartridge and cost of transport * = cost of goods
8 Contacts with the manufacturer from FIND countries Total 80 countries (55%) Includes 26 of 27 EXPAND-TB countries Afghanistan Congo, Republic of the Iraq Morocco Somalia Albania Costa Rica Jamaica Mozambique South Africa Algeria Ivory Coast Jordan Myanmar (Burma) Sri Lanka Angola Croatia Kazakhstan Namibia Sudan Antigua & Barbuda Cuba Kenya Nauru Sudan, South Argentina Djibouti Kiribati Nepal Suriname Armenia Dominica Korea, North Nicaragua Swaziland Azerbaijan Dominican Republic Kosovo Niger Syria Bangladesh Ecuador Kyrgyzstan Nigeria Tajikistan Belarus Egypt Laos Pakistan Tanzania Belize El Salvador Latvia Palau Thailand Benin Eritrea Lebanon Panama Timor-Leste Bolivia Estonia Lesotho Papua New Guinea Togo Bosnia Herzegovina Ethiopia Liberia Paraguay Tonga Botswana Fiji Libya Peru Tunisia Brazil Gabon Lithuania Philippines Turkmenistan Bulgaria Gambia, The Macedonia Romania Tuvalu Burkina Faso Gaza & West Bank Madagascar Russia Uganda Burundi Georgia Malawi Rwanda Ukraine Cabo Verde Ghana Malaysia Saint Kitts & Nevis Uruguay Cambodia Grenada Maldives Saint Lucia Uzbekistan Cameroon Guatemala Mali Saint Vincent & Grenadines Vanuatu Central African Rep Guinea Mauritania Samoa Venezuela Chad Guinea, Equatorial Mauritius Sao Tome & Principe Vietnam Chile Guinea-Bissau Mexico Senegal Western Sahara China Haiti Micronesia, Fed. States of Serbia Yemen Colombia Honduras Moldova Seychelles Zambia Comoros India Mongolia Sierra Leone Zimbabwe Congo, DRC Indonesia Montenegro Solomon Islands
9 Sales so far in FIND countries Total 24 countries (14%) Includes 13 of 27 EXPAND-TB countries SALES IN AND 2011 Afghanistan Congo, Republic of the Iraq Morocco Somalia Albania Costa Rica Jamaica Mozambique South Africa Algeria Ivory Coast Jordan Myanmar (Burma) Sri Lanka Angola Croatia Kazakhstan Namibia Sudan Antigua & Barbuda Cuba Kenya Nauru Sudan, South Argentina Djibouti Kiribati Nepal Suriname Armenia Dominica Korea, North Nicaragua Swaziland Azerbaijan Dominican Republic Kosovo Niger Syria Bangladesh Ecuador Kyrgyzstan Nigeria Tajikistan Belarus Egypt Laos Pakistan Tanzania Belize El Salvador Latvia Palau Thailand Benin Eritrea Lebanon Panama Timor-Leste Bolivia Estonia Lesotho Papua New Guinea Togo Bosnia Herzegovina Ethiopia Liberia Paraguay Tonga Botswana Fiji Libya Peru Tunisia Brazil Gabon Lithuania Philippines Turkmenistan Bulgaria Gambia, The Macedonia Romania Tuvalu Burkina Faso Gaza & West Bank Madagascar Russia Uganda Burundi Georgia Malawi Rwanda Ukraine Cabo Verde Ghana Malaysia Saint Kitts & Nevis Uruguay Cambodia Grenada Maldives Saint Lucia Uzbekistan Cameroon Guatemala Mali Saint Vincent & Grenadines Vanuatu Central African Rep Guinea Mauritania Samoa Venezuela Chad Guinea, Equatorial Mauritius Sao Tome & Principe Vietnam Chile Guinea-Bissau Mexico Senegal Western Sahara China Haiti Micronesia, Fed. States of Serbia Yemen Colombia Honduras Moldova Seychelles Zambia Comoros India Mongolia Sierra Leone Zimbabwe Congo, DRC Indonesia Montenegro Solomon Islands Additional Inuit Population program
10 Post-marketing surveillance Cepheid is FDA-registered and ISO (as is FIND), and has fully functional regulatory affairs group in-house Cepheid is contractually bound to inform FIND of any major field event in relation to both instruments and reagents Cepheid technical management team reviews such events, and informs FIND on regular basis FIND will update WHO/GLI on a regular basis All GeneXpert systems have continuous online monitoring Cepheid gathers and analyses all data centrally, and can respond in real-time on instrument problems
11 Cepheid field market surveillance process no Process the communication Escalation required? Receipt of customer communication Record in the customer support database yes Complaint? Corrective Action: -Action plan -Root-cause analysis no yes Unique Case Number hazard or threat to human life? yes Immediate Action Required: -Inform regulatory authorities - Action plan -Root-cause analysis Solving Issue Algorithm Next Slide 11
12 Cepheid solving issue algorithm yes Send appropriate parts and inform ASAP Perform repair Is on site maintenance necessary? no Provide advice on how to solve the issue no no Issue solved? Issue solved? yes yes Close the Request 12
13 Installation and start-up In general installation and training costs are already covered in the purchase price Training is country dependent as a function of the presence of a local Cepheid agent Cepheid also offers a 2 day training course at Toulouse customer support centre free-of-charge Regular session : Once a month Last one : March Pointe Care Diagnostics, Zimbabwe (Authorized Service Provider) Next one : April On demand training: MSF (done in Paris) FIND WHO (2 sessions so far) 13
14 Installation and start-up (II) In general subsequent to training, the individuals are capable of installing the instrumentation themselves without any further support However Cepheid also offers remote training & support capability; Hotline, DVD-based with videos, Skype-based Recent examples installation & test of a new GX + support for first runs Xpert MTB RIF protocol. installation & test of a new GX Software + testing process PHONE VIDEOS DOCUMENTS PHONE DOCUMENTS SKYPE VIDEO SKYPE VIDEO Fundation Cambo KANTHA BOPHA children hospital Malawi-College of Medecine Malawi-College of Medicine Cambodia Cambodia Malawi Malawi Module(s) replacement PHONE DOCUMENT VIDEOS Mbaya Reference center Tanzania 14
15 Thank you
Countries Ranked by Per Capita Income A. IBRD Only 1 Category iv (over $7,185)
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