Viral Hepatitis Commodities Access in RLS

Glossary Terms List

ARVAntiretroviral
ARTAntiretroviral Therapy
BEBioequivalence
CHAIClinton Health Access Initiative Inc.
COCountry Office
CPTCarriage Paid To
CRPCollaborative Registration Procedure
CT / NGChlamydia Trachomatis / Neisseria Gonorrhea
CYCalendar Year
DAADirect-Acting Antivirals
DAPDelivery At Place
DCVDaclatasvir
EIDEarly Infant Diagnosis
ERPExpert Review Panel
FDCFixed-Dose Combination
FDFFinished Dosage Form
FOBFreight On Board
FPPFinished Pharmaceutical Product
GFATMThe Global Fund to Fight AIDS, Tuberculosis and Malaria
G/PGlecaprevir / Pibrentasvir (Fixed-Dose Combination)
HBVHepatitis B Virus
HCVHepatitis C Virus
HIVHuman Immunodeficiency Virus
IAImmunoassay
LDVLedispasvir
LMICLow-and Middle-Income Country
MoHMinistry of Health
MPPMedicines Patent Pool
MTBMycobacterium Tuberculosis
NATNucleic Acid Test
PAHOPan American Health Organization
PCRPolymerase Chain Reaction
PPMPooled Procurement Mechanism
QAQuality Assured
RBVRibavirin
RDTRapid Diagnostic Test
RNARibonucleic Acid
SOFSofosbuvir
SOF / DCVSofosbuvir / Daclatasvir (Fixed-Dose Combination)
SOF + DCVIndividual Sofosbuvir and Daclatasvir Combined
SOF / LDVSofosbuvir / Ledispasvir (Fixed-Dose Combination)
SOF / VELSofosbuvir / Velpatasvir (Fixed-Dose Combination)
SRAStringent Regulatory Authority
SVR12Sustained Virologic Response at week 12
VELVelpatasvir
VLViral Load
WHO PQ’dWorld Health Organization Prequalified

Hepatitis Commodities Access in Resource-Limited Settings

With the below mapping of hepatitis procurement processes for prevention tools, diagnostics, monitoring and treatment, the aim is to increase awareness and information on cost and procurement within the hepatitis community, in order to increase access to viral hepatitis medicines and technologies in low-and-middle income countries, including HBV birth-dose vaccine, HBV treatment and HCV cure uptake.

The mapping shows how to access hepatitis commodities at the best available price in your country. Prices are given as examples and are subject to change. The prices indicated below usually do not include freight, taxes and distribution costs.

The mapping was built in partnership with ICE-HBV Stakeholders and in particular the Medicines Patent Pool and the Clinton Health Access Initiative (Hepatitis C Report).

When looking into strategies to access viral hepatitis medicines in your country, the following questions are key starting points: 

  • First, check the WHO Global Health Sector Strategy on Viral Hepatitis.
  • Is there a national viral hepatitis program and does it include prevention, testing, treatment and care for HBV and HCV alike?
  • Is there enough budget for implementing the national program and/or what are the options for external funding?
  • What medicines for treating viral hepatitis are on the national Essential Medicine List (EML)? Is the list in line with WHO EML? Are the medicines/diagnostics pre-qualified by WHO or approved by other regulatory bodies (FDA, EMA, etc)
  • Are procurements happening within the frame of the national program? Are medicines procured directly by your Ministry of Health or through procurement agencies?
  • How many people are on treatment in your country? How many people pay out of pocket?

Procurement cycle

  • Plan your procurement ahead so you have a better position for negotiation and potentially reduce the end price per patient.
  • Make sure the prices you negotiate include the country mark-ups (taxes, margins, etc.)
  • Follow the cycle below:

Who to contact for quality insured pooled procurement:

Depending on their country, buyers can generally obtain better prices by using pooled procurement systems and patent pools licences such as these:

Medicines Patent Pool (MPP) & MedsPaL Database of Licenses

Main Database: medspal.org

MPP does not sell commodities, they negotiate voluntary licences for generic companies to produce quality-insured medicines. The list of available licences can be found on the MedsPal database. If a country is not covered by a MPP licence. Countries can approach MPP with a request to include a country in a licence using the contact below.

Contact: Mila Maistat

E-mail: lmaistat@medicinespatentpool.org

IDA Foundation

Headquarters (Holland): idafoundation.org

Phone: +31 20 4033051

Regional Offices: idafoundation.org/en/who-we-are/offices

The Global Fund to Fight AIDS, Tuberculosis and Malaria

For Medicines, contact Uranchimeg Badarch at badarch@theglobalfund.org

For Diagnostics, contact Azizkhon Jafarov at jafarov@theglobalfund.org

UNDP

Contact: Zafar Yuldashev

E-Mail: zafar.yuldashev@undp.org

UNICEF Procurement

Commodities Pricing Database (June 2021)

HBV Vaccines

HBV Vaccines

WHO Guidelines Recommendations:

  • 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.
  • Adult catch-up vaccination recommended.

WHO EML Listed?

  • Yes

Possible Quality Insured Pooled Procurement Systems:

  • UNICEF:
    • Children and adults: $0.24 USD to $0.30 USD/dose
    • Adult single dose: $0.70 USD/dose

HBV Birth-Dose Vaccine

WHO Guidelines Recommendations:

  • Should be given within 24 hours of birth.

WHO EML Listed?

  • Yes

Possible Quality Insured Pooled Procurement Systems:

  • UNICEF: $0.24 USD to $0.60 USD/dose
HBV Testing & Monitoring

Rapid Diagnostic Tests

WHO Guidelines Recommendations

  • Recommended for detection of HBsAg and delivered at point of care to improve access and linkage to care and treatment.

Possible Quality Insured Pooled Procurement Systems:

  • Global Fund: $0.90/test

HBV Viral Load Test

WHO Guidelines Recommendations:

  • Global Fund: Cepheid Xpert® HCV Viral Load – USD 16.55
HBV Antivirals

HBV Antivirals

WHO Guidelines Recommendations:

  • WHO (2015) Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection.

Entecavir

WHO Guidelines Recommendations:

  • Preferred use for first- and second-line treatment.

WHO EML Listed?

  • Yes

MPP Licensed?

Tenofovir Disoproxil TDF

WHO Guidelines Recommendations:

  • Recommended

WHO EML Listed?

  • Yes

MPP Licensed?

Possible Quality Insured Pooled Procurement Systems:

  • Global Fund: $28.80/year
  • UNDP: $23/year
  • IDA Foundation: $57/year
  • UNICEF: $31/year

Tenofovir Alafenamide TAF

MPP Licensed?

Possible Quality Insured Pooled Procurement Systems:

HCV Testing & Monitoring

Rapid Diagnostic Tests

WHO Guidelines Recommendations:

  • Recommended for detection of HCV antibody at point of care to improve access and linkage to care and treatment.

Possible Quality Insured Pooled Procurement Systems:

  • Global Fund: $1.10/test

HCV Viral Load

WHO Guidelines Recommendations:

  • Quantitative NAT is recommended.

Possible Quality Insured Pooled Procurement Systems:

  • Global Fund: $14.9/test (Cepheid)

    • HCV Cures

    Daclatasvir

    WHO Guidelines Recommendations:

    • Recommended use in combination with Sofobuvir in people aged ≥18 as combination is pan genotypic.
    • Recommended not in combination with other drugs in people aged 12-17 with susceptible genotypes.  

    WHO EML Listed?

    • Yes

    MPP Licensed?

    Possible Quality Insured Pooled Procurement Systems:

    • Global Fund: $79

    Sofosbuvir

    WHO Guidelines Recommendations:

    • Recommended use in combination with Daclatasvir in people aged ≥18 as combination is pan genotypic.
    • Recommended not in combination with other drugs in people aged 12-17 with susceptible genotypes.  

    WHO EML Listed?

    • Yes

    MPP Licensed?

    Possible Quality Insured Pooled Procurement Systems:

    • Global Fund: $79

    Sofosbuvir + Daclatasvir (12 weeks)

    WHO Guidelines Recommendations:             

    • Recommended in people aged ≥18 years.       

    WHO EML Listed?

    • Yes, but as separate drugs (not as a single drug).     

    MPP Licensed?

    Possible Quality Insured Pooled Procurement Systems:

    • Global Fund: $94
    • UNDP: $89
    • IDA Foundation: $85

    Sofosbuvir + Velpatasvir

    WHO Guidelines Recommendations:             

    • Recommended in people aged ≥18 years.       

    WHO EML Listed?

    • Yes

    MPP Licensed?

    Possible Quality Insured Pooled Procurement Systems:

    • UNDP: $270

    Sofosbuvir + Ledipasvir

    WHO Guidelines Recommendations:     

    • Recommended +/- ribavirin.

    WHO EML Listed?

    • Yes

    MPP Licensed?

    Glecaprevir / Pibrentasvir

    WHO Guidelines Recommendations:           

    • Recommended in people aged ≥18 years.       

    WHO EML Listed?

    • Yes

    MPP Licensed?