HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
Diagnostic manufacturers commit to:
76. Implement and adhere to global access pricing reflective of global demand volumes that ensures consistent reagent pricing across governments and partners within all 145 low- and middle-income countries and regions, and provide a transparent breakdown of pricing for the products and services sold.
77. Implement more consolidated and flexible all-inclusive bundled, or other novel, pricing models that incorporate the menu of any essential molecular tests critical to public health (ie. HIV, TB, HBV, HCV, HPV, MPXV, SARS-CoV-2, etc) instead of separate instrument, consumable, and service procurement models.
78. Reconsider current volume commitment numbers for transitioning to flexible all-inclusive bundled, or other novel, pricing models as current mechanisms are limiting country participation, access, and benefit to novel procurement approaches.
79. Improve oversight and transparency of authorized distributors/representatives under service level agreements that address poor service and lack of adherence to global access pricing schemes.
80. Offer payment terms that better reflect the capability and structures of buyers.
81. Introduce available and upcoming assays on all available proprietary devices, including obtaining the necessary regulatory approvals.
82. Implement a standardized template for service level agreements that clearly spell out minimum performance indicators, including target up-time and failure rate thresholds (with consideration for different causes), plus a mitigation plan when thresholds are exceeded, while committing to improve response times for maintenance and repair programs.
83. Ensure instruments, both laboratory-based and point-of-care, include data connectivity options or are compatible with and can be exported to standard dashboards or databases used in LMICs.
84. Rapidly communicate stock shortages with major buyers and work on joint mitigation strategies. During pandemics or other outbreaks, continue to produce and supply essential tests in order to ensure supply security for critical diseases, such as HIV and TB.
85. Include and standardize multi-lingual display interfaces.
86. Provide three-year advance warning of device discontinuation and transition plans to ensure smooth and cost-minimal transitions to new platforms, including end-of-life equipment removal.
Roche commits to:
100. Work towards reducing disease silos for diagnostics in order to encourage and support diagnostic integration and multiplex testing to allow use of current platforms to address multiple diseases.
101. Work towards accelerating multi-disease diagnostic network optimization at the national level to support increased access to diagnostic tests, testing and network efficiencies and improvement in specimen-to-clinical action turnaround.
102. Continue the transparent global access ceiling price across molecular assays (HIV, TB, HCV, HBV, HPV, SARS-COV2 assays) and transparently provide volume thresholds for further volume-based price reductions.
103. Ensure the plasma separation card is affordable and consider expanding accessibility to other, non-proprietary technologies.
104. Support smooth and cost-minimal transition from CAP/CTM devices to new platforms.
All partners commit to:
163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment.
164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care.
165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.
166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.
Diagnostic manufacturers[1] commit to:
174. Generate data on new and existing WHO-recommended tests where evidence is lacking for children, including evidence on using alternative (non-sputum-based) sample types.
175. Develop quality-assured, affordable, less invasive alternative specimen processing methods or products (not based only on sputum) that can be used for the paediatric population at the primary health care level, such as urine, stool, tongue swabs or saliva.
176. Work with procurers to monitor stock levels and consumption rates to improve forecasting aimed at minimising the likelihood of stockouts, maintain sufficient regional buffer stock levels and have mitigation plans in place to ensure service continuity
177. Begin moving from a separate instrument, consumable, and service procurement towards more consolidated, all-inclusive pricing models that pool volumes across diseases (i.e. TB, HIV, HBV, HCV, HPV, MPXV, SARS-CoV-2, etc.) and that include service and maintenance.
178. Provide service level agreements to all countries that are monitored according to standardised key performance indicators for all technology types and their offered service plans
179. Ensure TB molecular products that are WHO recommended achieve WHO pre-qualification by 2024 and the required post-marketing surveillance is in place.
Roche commits to:
192. Support and strengthen a shared and integrated diagnostic network maximising the multidisease capability (HIV, TB, HBV, HCV, HPV, SARS_COV2, etc.) on current instrumentation.
193. Introduce transparent global access ceiling prices across molecular assays (TB, HIV, HCV, HBV, HPV assays, SARS_COV2, etc.) and transparently provide volume thresholds for further volume based price reductions.
[1] Abbott, Cepheid, Hologic, Molbio, Roche.
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76. ONGOING. Roche Global Access Program (GAP) pricing is applicable for 89 countries. We work closely with additional LMICs to offer access pricing that reflects local market conditions.
77. ONGOING. Roche has proactively created all-inclusive pricing models across TB, HBV, HCV, HPV, & HIV, leveraging the experience of all-inclusive pricing offered for HIV VL & EID testing, linked to the USAID RFP.
78 ONGOING. Roche continues to consider other access challenges, including those specific to countries where we work with distributor partners in order to reflect access pricing to the end user.
79. ONGOING. See response to #78.
81. ONGOING. Roche continues to assess on-going diagnostic needs and is fully committed to following the required regulatory processes.
82. ONGOING. Roche is building on the experience from HIV all-inclusive pricing to provide this approach to a broader range of our testing solutions. See Response #77.
83. ONGOING. Roche supports data connectivity. There are ongoing challenges within countries regarding data sharing agreements and privacy that covers digital topics broadly. Support in managing these aspects are welcomed.
84. ONGOING: Roche worked closely with USAID, CDC, PFSCM and the Global Fund to ensure continuity of HIV program testing during the COVID-19 pandemic.
85. COMPLETED. The software on Roche instruments as well as instructions for use for reagents are available in multiple languages as part of our standard procedures.
86. COMPLETED. For our current CAP/CTM transition, Roche provided more than 5 years notice. This practice will continue in the future.
100. ONGOING: Roche is actively supporting integration of testing working through partnerships with PEPFAR and the Global Fund (technical assistance), along with practical experience across several countries where integration of testing has already taken place within HIV testing labs.
101. ONGOING. Roche is actively supporting multi-disease diagnostic testing and network optimization through our Global Fund partnership as well as working directly with Lab Directorates and Ministries of Health to support efforts towards integration.
102. ONGOING. Roche’s Global Access Program (GAP) provides sustainable pricing across a range of testing solutions, including HIV, TB, HPV, HBV, HCV and SARS-CoV-2, to governments and funders in eligible countries, alongside working with partners to deliver comprehensive solutions along the patient pathway.
103. ONGOING. Roche is actively supporting the implementation of the cobas Plasma Separation Card across several countries, including Mozambique where this is a critical part of the HIV program. Through Roche Healthcare Consultancy Services, we support product agnostic approaches to lab system strengthening linked within several partnerships (e.g. CDC ILB, Global Fund, Go Further Partnership and Jhpiego).
Roche remains open to discussions with partners and other vendors for use of the cobas plasma separation cards on non-proprietary technologies.
104. ONGOING. Transition from CAP/CTM to x800 is underway and expected to be completed by the end of 2024.
174. ONGOING. Roche is currently enrolled in multiple studies for the use of oral swabs as an alternative sample type and will evaluate this sample type in children as well. Should this be adopted, Roche intends to add this sample type to our current label.
175. ONGOING. Roche has studies underway investigating the use of swabs. See #174.
176. NOT YET STARTED. Roche has experience doing this for HIV testing and we can explore this possibility for TB, specifically where TB/HIV integration is taking place as a starting point.
177. ONGOING. Roche has proactively created all-inclusive pricing models across TB, HBV, HCV, HPV, etc. leveraging the experience of all-inclusive pricing offered for HIV VL & EID testing linked to the USAID RFP. The pricing is fully transparent and aims to harmonize pricing across buyers within countries.
178. ONGOING. Roche provides this as part of our all-inclusive pricing model.
179. COMPLETED. cobas MTB and cobas MTB-RIF/INH tests for use on cobas 5/6/8800 System are included in WHO guidelines.
ONGOING. Roche is undergoing the PQ process for our cobas MTB and cobas MTB-RIF/INH tests and awaiting direction from the WHO PQ Unit on timelines.
192. ONGOING. Roche’s Global Access Program (GAP) provides sustainable pricing across a range of testing solutions, including HIV, TB, HPV, HBV, HCV and SARS-CoV-2, to governments and funders in eligible countries, alongside working with partners to deliver comprehensive solutions along the patient pathway. Supporting evaluations and implementation workshops are ongoing in 5 countries in Africa to include cobas MTB-RIF/INH in national guidelines and to begin testing within labs including integration with HIV testing.
193. ONGOING. Roche’s Global Access Program (GAP) provides sustainable pricing across a range of testing solutions, including HIV, TB, HPV, HBV, HCV and SARS-CoV-2, to governments and funders in eligible countries, alongside working with partners to deliver comprehensive solutions along the patient pathway.