This report includes price information only for antiretrovirals (ARVs) that are recommended in WHO’s
latest ARV treatment guidelines or that have attributes that are favourable for use in resource-limited
settings. This means that the following drugs have been removed from the list included in last year’s
publication: enfuvirtide, maraviroc, nelfinavir, rilpivirine and tipravanir. One exception is stavudine, which remains in the publication despite no longer being recommended by WHO, because it is still procured for use in many treatment programmes.

Questionnaires were sent to both originator and generic companies manufacturing ARVs, requesting information on prices for developing countries, restrictions that apply to each of the prices quoted (eligibility criteria), and any additional specificity applicable to the quoted prices. The data were collected up to May 2012.

All originator companies marketing ARVs were included in the survey. But the list of generic producers is by no means exhaustive. Only generic companies that have at least one ARV quality-assured by the WHO Prequalification Programme or US FDA on the date of requesting price information were included in this publication. Initial questionnaires were sent to companies in March 2012.

The company Macleods was invited to contribute to this publication, but chose not to provide price information.

Some important preliminary remarks on the data presented in this report:

• The information on prices given in this publication only relates to ARVs. It does not include other costs linked to antiretroviral treatment, such as diagnosis, monitoring or treatment of opportunistic infections.

• The manufacturers provide the prices listed in this publication. The prices paid by the purchaser might be higher because of add-ons (such as import taxes and distribution mark-ups), or may be lower as a result of effective procurement procedures or negotiations. Therefore the document should not be viewed as a manufacturers’ price list.

• Companies use different trade terms (known as incoterms). These trade terms outline the responsibilities of the manufacturer and purchasers with regard to transport, international freight and insurance costs. Additional information and definitions of incoterms can be found in the ‘Abbreviations’ section at the end of this guide. The incoterms of the prices provided by the companies are reported in Annex 2.

• Originator and some generic companies have different eligibility criteria for differential pricing for countries and entities, meaning not all countries and entities can access the price that is mentioned in this guide. The different categories of prices are detailed on the drug profile pages. More detailed information on the different eligibility criteria is provided in Annex 2.

• The Clinton Foundation’s Health Access Initiative (CHAI) negotiates prices for ARVs and diagnostic tests with generic companies on behalf of national AIDS programmes included in their consortium. The Clinton Foundation has reached agreements with eight ARV manufacturers for 40 different ARV formulations, both paediatric and adult. The current CHAI price list can be found in Annex 6.

• Information on patents is only indicative and should be checked with national authorities. It should in no way form the basis of a procurement decision.

• As the information on the WHO Prequalification and the US FDA lists is updated regularly, these should be consulted for up-to-date information regarding quality.

General information

This section includes the history of the product (first approval, originator company and brand name), relevant WHO guidance, world sales of the originator product and basic patent information.

Table on price information – Developing Country Prices As Quoted by Companies

Price

All prices are quoted in United States Dollars (US$). Currency conversions were made on the day the price information was received using the currency converter site www.oanda.com. Prices are rounded up to the third decimal for unit price and to the nearest whole number for yearly price per patient.

The annual cost of treatment per patient per year (ppy) has been calculated according to the WHO dosing schedules multiplying the unit price (one tablet, capsule or millilitre) by the number of units required for the daily dose, and then by 365.The price of the smallest unit is included in brackets.

For paediatric treatments, prices are calculated for a 10kg child using recommended dosing based on the 10 to 10.9kg weight band, as it appears in the WHO paediatric antiretroviral treatment guidelines. This is an estimate, as the weight of a child increases during any given year. When it was not possible to calculate the dose for a 10kg child, only the unit price is indicated.

Within the tables, the information on the paediatric formulations is highlighted in light red in order to allow an easier distinction between adults and paediatric formulations.

Quality

Products quality-assured by the WHO Prequalification Programme or US FDA (as of June 2012) are in bold in the tables of drug prices.

Readers and purchasers wishing to obtain more information about the quality of ARVs are encouraged to consult the WHO Prequalification Programme website and the US FDA website for approved and tentatively approved ARVs, as these lists are updated regularly.

Categories 1 and 2 Access to price discounts

Each originator company applies different eligibility criteria for its discounted ARV prices. This means that a country that is eligible for a price discount from one company may be excluded from the list of eligible countries by another company. Companies often have two groups of countries that are eligible for their discounts, often called ‘category 1’ and ‘category 2’ countries, with category 1 including countries eligible for the deepest price discounts. Each company defines its own list of countries for categories 1 and 2. Please refer to Annex 2.

To know whether a country is eligible for a discounted price offered by a given company, or to find out in which category a given country is placed by different companies, please refer to Annex 2.

Price Changes Over time – Chart on the Evolution of the lowest price quoted for developing countries

This chart shows the price evolution over time, for both originator and generic products, as quoted to MSF for the purpose of this document since 2001.

The graph shows the lowest-priced generic product that is quality-assured by the WHO Prequalification Programme or US FDA.

Spotlight on access issues – a look at paediatrics and patents

The most salient issues related to access to each product are summarised here. The focus is on the availability of products, their affordability and their adaptability for developing countries.

Two additional sections have been included to discuss and highlight specific issues with regard to paediatrics and patents.

Clinton Foundation prices
Further discounts through CHAI. The CHAI consortium list is found in Annex 6.

This report is a pricing guide, and as such does not include detailed information about the quality of the products listed. However, quality is important and price should not be the only factor determining procurement decisions.

Readers and purchasers wishing to obtain more information about drug quality are therefore encouraged to consult the WHO List of Prequalified Medicinal Products which contains the products that ‘meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis medicines’ or the US FDA Approved and Tentatively Approved Antiretrovirals List.

WHO Prequalification

More commonly known as WHO Prequalification, the WHO List of Prequalified Medicinal Products was initiated by the WHO and developed in collaboration with other United Nations organisations, principally for procurement by UN agencies. The project evaluates pharmaceutical manufacturers and products according to WHO-recommended standards of quality and compliance with Good Manufacturing Practices.

WHO’s Prequalification Programme is a benchmark for the identification of quality essential medicines and has significantly improved access to quality medicines over the past years. A key factor of success has been that financial support to national programmes has been dependent on purchasing medicines respecting clear quality assurance criteria. In this the WHO Prequalification Programme has played an important role, providing guidance to purchasers on the quality of medicines and thereby creating a positive market dynamic where manufacturers strive to reach WHO standards in order to comply with procurement policies.

WHO recognises the evaluation of generic products by regulatory authorities that apply stringent standards for quality, similar to those recommended by WHO, such as, but not limited to, the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada.

US Food and Drug Administration

In May 2004, in support of the US President’s Emergency Plan for AIDS Relief (PEPFAR), US FDA announced an initiative to help ensure that those being served by PEPFAR would receive safe, effective, and quality manufactured antiretroviral drugs.

According to this scheme, products are “tentatively approved” by US FDA. This means that although existing patents and/or other exclusive rights prevent marketing of the product in the US, the product meets all of the US FDA’s safety, efficacy, and quality standards required for marketing in the US. Upon expiry of the patent or other exclusive rights in the US, tentatively approved products will be authorised for marketing in the country.

It should be noted that although the WHO prequalification system recognises the US FDA “tentative approval” scheme under PEPFAR, the inverse does not apply. Only generic products that have a tentative approval by the US FDA are eligible for procurement under PEPFAR.

Donor procurement policies

The Global Fund to Fight AIDS, Tuberculosis and Malaria has recently changed its quality assurance policy so that Global Fund grant funds may only be used to procure antiretrovirals, anti-tuberculosis and anti-malarial finished products that are either prequalified by the WHO Prequalification Programme, authorised for use by a Stringent Drug Regulatory Authority (SRA), or recommended for use by an
Expert Review Panel (ERP).⁹⁴

Unfortunately, the majority of donors today do not have sufficient quality assurance criteria, giving a wrong signal to manufacturers by removing the incentive to comply with WHO norms and standards, and potentially endangering patients’ health in countries where the regulatory system remains weak.

Quality of drugs in the data provided in Untangling the Web

Manufacturers who have at least one antiretroviral quality-assured by WHO Prequalification or US FDA were invited to participate in this publication.

But not all the products listed in this report have been quality-assured by WHO Prequalification or US FDA, and only some of them are used by MSF in its own projects. Products included in the List of Prequalified Medicinal Products (as of June 2012), or in the US FDA Approved and Tentatively Approved Antiretrovirals List, appear in bold in the tables of drug prices.

Please consult the websites for WHO Prequalification¹⁰⁵ and the US FDA Approved and Tentatively Approved Antiretrovirals¹⁰⁶ for the latest list of prequalified products and for information on the status of dossier assessment.