A guide to accessing HBV Medicines & Diagnostics in ressource-limited settings

Purpose of this page:

Technical advice on how to access viral hepatitis commodities at the best cost.

Scope:

Procurement processes for prevention tools, diagnostics, monitoring and treatment (Global Fund, UNDP, PAHO, UNICEF, I+Solutions, IDA Foundation, PFSCM, WHO-AFRO, GPRO, MPP)

Expected outcomes: increased access to viral hepaitis medicines and technologies in LMICs, including HBV birth-dose vaccine roll-out, HBV treatment and HCV cure uptake.

Introduction

The important questions to address to define your viral hepatitis medicines access strategies are:
  • A national viral hepatitis program, including prevention, testing, treatment and care for HBV and HCV alike. Important to note that in most LMICs, there are no proper surveillance systems in place but also other elements are missing partially or fully in spite of the fact that formally they might have a program.
  • Enough budget for implementing national program and/or options for external funding.
  • What medicines for treating viral hepatitis are on national EML? Is it in line with WHO EML?
  • Are procurements happening within the frame of a national program? Are medicines procured directly by your MoH or through procurement agencies? How many people are on treatment? How many people pay out of pocket?
In terms of availability, accessibility and affordability of medicines, buyers (LMICs) need to pay attention to the following scenarios:
  • Are the needed medicines (and needed combinations or formulations) patented in your country? also there is a need to know if a medicine is registered in a country (not filed for registration, filed or registered)
  • If patented, is the country included in a licence – either through MPP (e.g. DAC, DAC/SOF, G/P) or bilateral licence (e.g. SOF and other Gilead products)?
    • If yes, a country can procure medicines through the indicated licence.
    • If not, check if a compulsory licence is issued.
  • If there is a patent and no licence (nor VL, neither CL), there might be other access strategies (e.g. direct price negotiations, pilot programs for key populations that might trigger expansion of programs to general populations, etc)
  • If there is no patent and no licence, buyers can potentially:
    • Buy from MPP licencees as MPP licences enable procurements if there is no patent infringement.
    • For direct negotiations with generic companies, it is advisable to ensure that the commodity is prequalified by WHO:who.int/prequal.
  • Map in country mark-ups. Choose companies who offer inclusive pricing (CHAI report) and minimize.
  • Plan procurement so reduce prices per patient.
How to access quality insured pooled procurement systems:

Depending on the country, buyers can generally obtain better prices by using pooled procurement systems such as the ones below.

The Global Fund pooled procurement system for non-grant recipients, for governments and non-governmental organizations in LMIC.

Some countries can obtain better prices through direct negotiations with companies (for instance in India, SOF/DAC at $ 69 per course).

Procurement options:

Tool WHO Guidelines Recommendations  Essential Medicine

(Yes/No)

MPP Licence

(Yes/No)

Quality Insured Pooled Procurement Systems Other Procurement Options
HBV Vaccines          
        UNICEF  
HBV Birth-Dose Vaccine          
           
HBV Testing & Monitoring          
RDTs       Global Fund ($ 0.9)

GPRO (1.20 per test includes S&I)

 
HBV viral load –       GPRO $16 per test with S&I & instrument, $ 14 for without instrument.  
HBV Antivirals WHO (2015) Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection)              

 

 
Entecavir Y Y   Global Fund ($ 384/year)

 

 
TDF Y Y   Global Fund’s ($ 28.8/year)

UNDP ($ 23/year)

IDA Foundation ($ 57/year)

UNICEF ($ 31/year)

GPRO $48/year (includes shipping & insurance)

 
TAF

 

 

N N   GPRO  <$6/month or <$72 /year (includes S&I)  
HCV Testing & Monitoring          
RDTs       Global Fund ($ 1.10)

GPRO $1 per test (includes S&I)

 

 
HCV viral load       GPRO $16 per test with S&I & instrument, $ 14 for without instrument.  
HCV Cures

 

         
daclatasvir       Global Fund  
sofosbuvir       Global Fund  
sofosbuvir + daclatasvir (12 weeks)       Global Fund

UNDP ($ 89)

IDA Foundation ($ 85)

GPRO ($90, includes S&I)

 
sof + vel       UNDP ($ 270)

Global Fund

GPRO ($80, includes S&I)

 
sofosbuvir/ ledipasvir       Global Fund  
glecaprevir/pibrentasvir