Updates on products
Notice on procurement of Nevirapine-based ARV regimens for adults/adolescents (LZN-adult; NVP-200mg)
Because nevirapine-based regimens are no longer recommended by WHO due to clinical inferiority reasons, as of March 1st, 2019, Global Fund financing can no longer be used for the procurement of adult formulations of nevirapine-based ARVs and hence they will no longer be listed on wambo.org. Please contact your country team should you need more information on how to proceed.
Lower ARV prices | Cost, space, and environmental savings through improved, more efficient packaging
Following the Global Fund’s latest tender for anti-retroviral (ARV) medicines, ARV reference prices are now lower, with first line regimens at USD 72 per person per year or less (USD 6 per month). Details of the tender outcomes can be found at: https://www.theglobalfund.org/en/news/2018-07-16-new-agreements-with-hiv-drug-suppliers-to-save-usd324-million/.
Packaging improvements and savings
In addition to lower product prices, Principal Recipients can now save additional costs on freight and logistics, by selecting optimized outer packaging for key, high-volume 1st line products.
By selecting the catalogue option marked “no carton”, Principal Recipients can significantly reduce freight costs and optimize storage throughout the supply chain, consuming around 50% less space in containers, warehouses, clinics. This option also reduces paper consumption and materials-use throughout the product lifecycle, and preserves packaging quality (no damaged cartons upon distribution to the patient).
This packaging will soon be the norm, with the “with-carton” variants being discontinued in the medium-term.
Further freight savings and volume reductions can also be achieved with the 90-day multi-month dispensing pack for stable patients.
Typical catalogue option “with carton” (108 bottles per shipper)
New catalogue option “without carton” (144 bottles per shipper)
You can order carton-less products using the below links, or by using the search and browse function:
For more information on ARV Innovative Packaging, click here .
Update on price equalization of Artemether-lumefantrine dispersible formulations for children
When ordering Artemether-lumefantrine (AL) for children with malaria, countries can now choose the preferred dispersible formulation of AL as price has been removed as a barrier from this optimal choice. The World Health Organization recommends that young children and infants be offered pediatric formulations, with a preference for dispersible tablets; dispersible tablets are expected to be easier for caregivers to administer, requiring only a small amount of water, with anticipated improvements in compliance and dosing accuracy over crushed solid tablets. By being offered dispersible formulations, more children are expected to receive the full amount of medicine they need to survive a brush with malaria. This price equalization of the preferred formulation for children is a result of an updated sourcing strategy implemented by the Global Fund’s Sourcing Team.
The Global Fund’s current strategy for sourcing antimalarial medicines includes a specific objective to lower price differentials for better formulations. The competitive tender issued as part of this strategy included an incentive to suppliers to offer dispersible AL products at prices close to or at the price of non-dispersible AL child pack sizes. Suppliers responded, and across the four currently eligible suppliers of AL dispersible formulations, the Global Fund can now set the reference price for AL dispersible 6×1 and 6×2 equivalent to that of AL non-dispersible 6×1 and 6×2. Within a constrained budget, countries no longer have to consider trade-offs between patient access, in terms of numbers of children reached, and preferred formulations for children, when ordering AL.
For additional information on the reference prices, visit https://www.theglobalfund.org/media/5812/ppm_actreferencepricing_table_en.pdf?u=636560099920000000
For additional information on the Global Fund’s Antimalarial Medicines Sourcing Strategy, visit https://www.theglobalfund.org/en/sourcing-management/health-products/antimalarial-medicines/
Update on Newly Available WHO Recommended ARVs
Dolutegravir (DTG) Fixed Dose Combinations with Lamivudine and Tenofovir.
Two manufacturers have recently received tentative FDA approval for their triple fixed-dose combination of the dolutegravir based regimen (with tenofovir and lamivudine) that is now eligible for Global Fund financing and procurement. Dolutegravir (DTG) has been recommended by WHO as an alternative first-line ARV regimen. DTG based regimens are likely to improve the quality of treatment and retention, offering significant programmatic advantages related to HIV drug resistance and tolerability in relation to previous regimens.
Countries considering procurement of DTG should ensure a safe and effective transition to this regimen. Supply chains should be prepared, to ensure no stock outs or risk of treatment disruption. Relevant policies, guidelines, regulatory approvals and registrations should be in place. For countries planning transition, we recommend budgeting first-line regimens at USD 6.75/month (thereference price for TLD and TLE 30 pack as at Sept. 2017. This should present no budget barrier for transitioning to TLD. See PPM reference pricing.
Procurement planning: Regular commercial production by both of the eligible manufacturers is expected to commence shortly. As with all procurement requests, they should be made in good time to enable the best value to be achieved in terms of both product and freight costs. Procurement requests are recommended to be placed at least 6 months in advance to enable best value to be achieved.
Lower Dose Efavirenz Fixed Dose Combinations with Lamivudine and Tenofovir.
A 400mg version of the tenofovir-based triple fixed-dose combination with lamivudine and efavirenz has recently received tentative FDA approval and is now eligible for Global Fund financing and procurement. This product is an alternative first-line option recommended in the current WHO ARV guidelines. Systematic reviews show that it has comparable efficacy and improved safety compared to EFV at the standard dose (600mg). Countries considering procurement should ensure a safe and effective transition to this regimen. Supply chains should be prepared, to ensure no stock outs or risk of treatment disruption. Relevant policies, guidelines, regulatory approvals andregistrations should be in place. Procurement planning: Regular commercial production has commenced. As with all procurement requests, they should be made in good time to enable the best value to be achieved in terms of both product and freight costs. Procurement requests are recommended to be placed at least 4-5 months in advance to enable best value to be achieved.
WHO Questions & Answers on transition to new ARV regimens
For further information please consult:
1) WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recomendations for a public health approach. Second . Geneva : s.n., 2016. p. 480. 978 92 4 154968 4. [Online] http://who.int/hiv/pub/arv/arv-2016/en/
2) WHO Policy Brief: Transition to New Antiretrovirals in HIV Programmes. July 2017. http://www.who.int/entity/hiv/pub/toolkits/transition-to-new-arv/en/index.html
3) The Clinton Foundation New HIV Product Introduction Toolkit. https://www.newhivdrugs.org
4) WHO Technical Update: Transition to New Antiretroviral Drugs in HIV Programmes: Clinical and Programmatic Considerations. July 2017. http://www.who.int/hiv/pub/toolkits/transition-to-new-arv-technical-update/en/