ARV Provision and Pricing in North Macedonia
Discover insights on the provision and pricing of Antiretroviral drugs in North Macedonia, including procurement practices, cost per patient per year, regimens in use, and funding sources. Learn about the regional meeting on access to ARV drugs in Southeast European countries held on December 15, 2020.
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Presentation Transcript
Provision of ARVs in North Macedonia and their prices Regional meeting on access to and prices of ARV drugs in SEE countries 15 December 2020 Andrej Senih
Procurement practice Source of funding for ARV treatment: National HIV Program since 2011 National HIV Program (MoH) Procurement: annual tender annual tender conducted by Infectious Diseases Clinic allows for both registered and non both registered and non- -registered medicines apply, though registered products are given priority registered medicines to requirement for non-registered products: WHO prequalification, approval / tentative approval or registration by EU or other stringent regulatory authorities FDA
Cost per patient per year in 2020 Average cost per patient per year: Average cost per patient per year: c.1,898 1,898 EUR Average cost PPPY for the most widely used regimen (TDF/FTC/EFV600 51% of patients): 328 328 EUR (I.e. the average cost for 49% of patients is c. 3,468 EUR PPPY)
Regimens in use in N. Macedonia and their cost Regimens in use in N. Macedonia and their cost Proportion of Proportion of patients patients Cost per patient per Cost per patient per year in EUR year in EUR Treatment regimen Treatment regimen tenofovir disoproxil / emtricitabine / efavirenz600 51% 328 abacavir / lamivudine / dolutegravir 11% 5,347 tenofovir disoproxil / emtricitabine + nevirapine* 11% 874 tenofovir disoproxil / emtricitabine + darunavir 8% 1,549 tenofovir disoproxil / emtricitabine + raltegravir 5% 4,100 tenofovir disoproxil / emtricitabine + dolutegravir 3% 5,644 Other regimens used (individualized): tenofovir disoproxil / emtricitabine / rilpivirine tenofovir disoproxil / emtricitabine + atazanavir abacavir / lamivudine + nevirapine* abacavir / lamivudine + efavirenz600 abacavir / lamivudine + darunavir* abacavir / lamivudine + raltegravir abacavir / lamivudine + lopinavir/ritonavir* tenofovir alafenamide / emtricitabine / elvitegravir / cobicistat tenofovir alafenamide / emtricitabine + darunavir tenofovir alafenamide / emtricitabine + nevirapine* <12% 4,600 *regimens not listed among the recommended/preferred or alternative regimens in either WHO or EACS Guidelines
Regimens in use in N. Macedonia registered registered vs. non non- -registered registered products Proportion of Proportion of patients patients Cost per patient per Cost per patient per year in EUR year in EUR Treatment regimen Treatment regimen tenofovir disoproxil / emtricitabine / efavirenz600 51% 328 abacavir / lamivudine / dolutegravir 11% 5,347 tenofovir disoproxil / emtricitabine + nevirapine 11% 874 tenofovir disoproxil / emtricitabine + darunavir 8% 1,549 tenofovir disoproxil / emtricitabine + raltegravir 5% 4,100 tenofovir disoproxil / emtricitabine + dolutegravir 3% 5,644 Other regimens used (individualized): tenofovir disoproxil / emtricitabine / rilpivirine tenofovir disoproxil / emtricitabine + atazanavir abacavir / lamivudine + nevirapine abacavir / lamivudine + efavirenz600 abacavir / lamivudine + darunavir abacavir / lamivudine + raltegravir abacavir / lamivudine + lopinavir/ritonavir tenofovir alafenamide / emtricitabine / elvitegravir / cobicistat tenofovir alafenamide / emtricitabine + darunavir tenofovir alafenamide / emtricitabine + nevirapine <12% 4,600 REGISTERED vs. NON-REGISTERED
Regimens in use in N. Macedonia originator originator vs. generic generic products Proportion of Proportion of patients patients Cost per patient per Cost per patient per year in EUR year in EUR Treatment regimen Treatment regimen tenofovir disoproxil / emtricitabine / efavirenz600 51% 328 abacavir / lamivudine / dolutegravir 11% 5,347 tenofovir disoproxil / emtricitabine + nevirapine 11% 874 tenofovir disoproxil / emtricitabine + darunavir 8% 1,549 tenofovir disoproxil / emtricitabine + raltegravir 5% 4,100 tenofovir disoproxil / emtricitabine + dolutegravir 3% 5,644 Other regimens used (individualized): tenofovir disoproxil / emtricitabine / rilpivirine tenofovir disoproxil / emtricitabine + atazanavir abacavir / lamivudine + nevirapine abacavir / lamivudine + efavirenz600 abacavir / lamivudine + darunavir abacavir / lamivudine + raltegravir abacavir / lamivudine + lopinavir/ritonavir tenofovir alafenamide / emtricitabine / elvitegravir / cobicistat tenofovir alafenamide / emtricitabine + darunavir tenofovir alafenamide / emtricitabine + nevirapine <12% 4,600 ORIGINATOR vs. GENERIC
Price of individual ARV medicines per monthly package medicine medicine price per monthly package in EUR price per monthly package in EUR tenofovir disoproxil / emtricitabine 20.10 tenofovir disoproxil / emtricitabine / efavirenz600 27.28 tenofovir disoproxil / emtricitabine / rilpivirine 603.49 abacavir / lamivudine 193.49 registered registered abacavir / lamivudine / dolutegravir 445.59 efavirenz600 42.48 dolutegravir 450.27 darunavir 109 nevirapine 52.70 atazanavir 427.55 not not lopinavir/ritonavir 238.96 registered registered raltegravir 321.61 tenofovir alafenamide / emtricitabine 525.22 tenofovir alafenamide / emtricitabine / elvitegravir / cobicistat 804.56 ORIGINATOR vs. GENERIC
Key challenges Lack of interest to register ARVs Low quantities of procured ARVs lead to high prices for generic medicines Pricing methodology allows for relatively high prices of generic medicines: e.g. registered price of TDF by Emcure is 91 EUR per month Patent protection on key ARVs e.g. DTG and TDF/3TC/DTG as well as applicable data exclusivity and market exclusivity provisions Budgeting for ARVs does not follow actual costs nor annual increase of patients who need to start treatment e.g. budget for ARVs has not increased for 3 years in a row (2019- 2021), while # of patients increased by 50%
Lessons learnt from previous procurement practices Strategizing around how tenders are formulated is very important Encouraging the entry of generic products where possible has worked through local distributors Collaboration between Clinic and patient organization has helped helped institute regular national procurements of ARVs, relying on lower-priced generic medicines where possible and significantly improve treatment options over the last 7 years
Potential objectives on improving access to HIV medicines in N. Macedonia Adjust government pricing methodology to limit unjustifiably high prices of generic medicines Provide incentives for registration of generic ARVs, where possible Advocate for patent exemption re. DTG and TDF/3TC/DTG Introduce a clear procedure for budgeting for ARVs and improve strategic formulation of tenders Optimize treatment regimens, in line with latest WHO and EACS guidelines
