A guide to accessing HBV Medicines & Diagnostics in resource-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)

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Quality Insured Pooled Procurement Systems

global procurement fund

GPRO

unicef

IDA foundation

UNDP

Other Procurement Options

 

 

HBV Vaccines Infants: first dose within 24 hours of birth. Followed by 2 or 3 doses to complete primary series. 

No booster dose is required/supported by evidence.

Recommended for all.

 Y       
        UNICEF  
HBV Birth-Dose Vaccine  Should be given within 24 hours of birth.  Y      
           
HBV Testing & Monitoring          
RDTs  Recommended for detection of HBsAg and delivered at point of care to improve access and linkage to care and treatment.     Global Fund ($ 0.9)

GPRO (1.20 per test includes S&I)

 
HBV viral load  DNA nucleic acid test (NAT) recommended as strategy for guiding whether to treat or not.     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 Preferred use for first and second line treatment. Y Yes, see countries.  
TDF Recommended. Y  Yes, see countries. 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  Yes, see countries. GPRO  <$6/month or <$72 /year (includes S&I)  
HCV Testing & Monitoring          
RDTs  Recommended for detection of HCV antibody at point of care to improve access and linkage to care and treatment.      Global Fund ($ 1.10)

GPRO $1 per test (includes S&I)

 

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

 

         
daclatasvir  Recommended use in combination with sofobuvir in people aged ≥18 as combination is pangenotypic.

Recommended not in combination with other drugs in people aged 12-17 with susceptible genotypes.

 Y  Yes, see countries. Global Fund  
sofosbuvir  Recommended use in combination with daclatasvir in people aged ≥18 as combination is pangenotypic.

Recommended not in combination with other drugs in people aged 12-17 with susceptible genotypes.

 Y  Yes, see countries. Global Fund  
sofosbuvir + daclatasvir (12 weeks)  Recommended in people aged ≥18 years.  Y, but as separate drugs (not as a single drug).  Yes, see countries. Global Fund

UNDP ($ 89)

IDA Foundation ($ 85)

GPRO ($90, includes S&I)

 
sofosbuvir + velpatasvir  Recommended in people aged ≥18 years.  Y  Yes, see countries. UNDP ($ 270)

Global Fund

GPRO ($80, includes S&I)

 
sofosbuvir + ledipasvir  Recommended +/- ribavirin.  Y  Yes, see countries. Global Fund  
glecaprevir/pibrentasvir

 

Recommended in people aged ≥18 years.  Y  Yes, see countries.