Provision of ARVs in North Macedonia and their
Description: 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 (MoH)
Related Topics
Download Presentation
"Provision of ARVs in North Macedonia and their" is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Presentation Transcript
slide1. 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<br>
slide2. Procurement practice Source of funding for ARV treatment: National HIV Program (MoH) – since 2011
Procurement: annual tender conducted by Infectious Diseases Clinic
– allows for both registered and non-registered medicines to apply, though registered products are given priority
– requirement for non-registered products: WHO prequalification, FDA approval / tentative approval or registration by EU or other stringent regulatory authorities<br>
slide3. Cost per patient per year in 2020 Average cost per patient per year: c.1,898 EUR
Average cost PPPY for the most widely used regimen
(TDF/FTC/EFV600 – 51% of patients): 328 EUR
(I.e. the average cost for 49% of patients is c. 3,468 EUR PPPY)<br>
slide4. Regimens in use in N. Macedonia and their cost<br>
slide5. Regimens in use in N. Macedonia – registered vs. non-registered products<br>
slide6. Regimens in use in N. Macedonia – originator vs. generic products<br>
slide7. Price of individual ARV medicines per monthly package<br>
slide8. 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%<br>
slide9. 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<br>
slide10. 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<br>
15 December 2020
Andrej Senih<br>
slide2. Procurement practice Source of funding for ARV treatment: National HIV Program (MoH) – since 2011
Procurement: annual tender conducted by Infectious Diseases Clinic
– allows for both registered and non-registered medicines to apply, though registered products are given priority
– requirement for non-registered products: WHO prequalification, FDA approval / tentative approval or registration by EU or other stringent regulatory authorities<br>
slide3. Cost per patient per year in 2020 Average cost per patient per year: c.1,898 EUR
Average cost PPPY for the most widely used regimen
(TDF/FTC/EFV600 – 51% of patients): 328 EUR
(I.e. the average cost for 49% of patients is c. 3,468 EUR PPPY)<br>
slide4. Regimens in use in N. Macedonia and their cost<br>
slide5. Regimens in use in N. Macedonia – registered vs. non-registered products<br>
slide6. Regimens in use in N. Macedonia – originator vs. generic products<br>
slide7. Price of individual ARV medicines per monthly package<br>
slide8. 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%<br>
slide9. 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<br>
slide10. 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<br>