TWN Info Service on Health Issues (July 07/02)

24 July 2007

New HIV/AIDS drugs 500% more costly, says MSF

The new HIV/AIDS drugs recommended by the WHO raise the cost for patients by nearly 500%, according to Medecins Sans Frontieres. This could affect the availability of these drugs in developing countries.

The article below details the problem and is reproduced with the permission of South-North Development Monitor (SUNS) #6299, 24 July 2007.

With best wishes
Evelyne Hong


Health: New first-line HIV/AIDS drugs 500% more costly, says MSF

By Kanaga Raja, Geneva, 23 July 2007

The use of newer, less toxic first-line HIV/AIDS anti-retroviral combinations, now recommended by the World Health Organization (WHO), has raised the cost for patients by nearly 500%, according to a new report by the international medical humanitarian group Medecins Sans Frontieres (MSF).

This finding by MSF was in the latest edition of its report "Untangling the Web of Price Reductions" released Monday at the fourth International AIDS Society Conference taking place in Sydney, Australia.

While there have been dramatic price reductions for second-line anti-retroviral treatment over the last year - largely stimulated by a compulsory license issued by Thailand - a worrying trend is that using less-toxic first-line combinations, newly recommended by the WHO, raises the cost for patients by nearly 500% - from $99 to up to $487.

"It's encouraging to see the price of second-line regimens finally starting to come down," said Karen Day, pharmacist with MSF's Campaign for Access to Essential Medicines.

"But we are worried that the lack of competition and dramatically higher prices for the newly-recommended WHO first-line could mean that people in developing countries may not be able to benefit from improved treatment that has been widely available in wealthy countries for years."

According to the MSF report, whereas most of the regimens previously recommended included stavudine (d4T) or zidovudine (AZT), the 2006 WHO treatment guidelines have added an improved first-line treatment based on combinations including Abacavir (ABC) and tenofovir disoproxil fumarate (TDF) as new Nucleoside Analogue Reverse Transcriptase Inhibitor options.

TDF is now becoming an emerging preferred first-line option because of its toxicity profile and increased availability in developing countries. It should be administered in combination with two drugs - one being either lamivudine (3TC) or emtricitabine (FTC), the other being either efavirenz (EFV) or nevirapine (NVP), said MSF.

MSF said that competition among multiple manufacturers is the main factor that has made prices of older anti-retrovirals (ARVs) come down. Treating an adult patient for one year with a triple anti-retroviral first-line regimen may now be as low as $99.

However, the improved first-line and second-line regimens now recommended by WHO include newer drugs that are more expensive, as few generic competitors exist and demand is still low. There is therefore a serious risk that the price crisis seen five years ago, with life-saving ARVs priced out of reach of those in need, is set to return, added MSF.

This is the case in Thailand, which issued compulsory licenses for three medicines, including the AIDS drugs EFV and LPV/r (Lopinavir/ritonavir) in November 2006 and January 2007, respectively, and Brazil, which did the same for EFV in May 2007.

[According to an article in the International Herald Tribune on 22 July, the pharmaceutical company Roche in June announced a global recall of its AIDS drug Viracept after it found that due to a flawed manufacturing process at its plant in Switzerland, some batches of its drug had been contaminated with a carcinogen.

[According to the article, the recall did not cause a great stir in Europe as the drug had fallen out of use there and been replaced by newer more expensive alternatives. The article noted however that tens of thousands take Viracept around the world, most of them poor people living with HIV/AIDS in developing countries. For instance, in Panama, the substitute drug Kaletra costs ten times more than Viracept. The Tribune article said that the situation has now left patients with the choice of either discontinuing the drug, or continuing to use the drug that might contain the contaminant.]

The MSF report said that most originator companies offer their most discounted prices only to a certain group of countries, usually to Least Developed Countries (LDCs) and countries in sub-Saharan Africa.

However, the companies do it differently: Merck extends "first category" prices to countries ranked as "low" and "medium" on the Human Development Index with HIV prevalence rates greater than 1%; GlaxoSmithKline offers differential prices for their products to all Global Fund grantees; and Gilead has established its own list of eligible countries using mixed criteria, including some middle-income countries.

This means that if a country qualifies for the discounted prices offered by one company, it may not necessarily be included in the list of eligible countries of another company.

The report also noted that products provided under these schemes frequently remain unavailable in countries because the products are not registered or marketed. It stressed that the pace of registration of ARVs (including generic formulations as they become available) is of critical importance.

It is strongly recommended for countries to accelerate registration of needed ARVs, applying fast-track procedures for WHO pre-qualified products, and thus avoiding unnecessary delays. Offers of differential prices, however loudly trumpeted, are meaningless if a manufacturer does not take the step of registering the product in countries where it is needed, said the report.

The report also said that although some patients benefit from differential prices, prices for new drugs are still too high, mainly because there is no or not enough competition. In the absence of competition, prices of new drugs will never drop to the level of first-line drugs.

An MSF analysis of Brazil and Thailand's efforts at providing universal access to anti-retroviral therapy shows that compulsory licenses have been far more effective in bringing prices down than negotiating price reductions with companies or relying on companies' differential pricing schemes.

In January 2007, Thailand issued a "compulsory license" to overcome the patent barrier on the important drug for use in second line treatment, lopinavir/ritonavir, allowing the country to legally either import the drug or produce it locally.

"Just one year ago, treating a patient with a second-line regimen containing lopinavir/ritonavir in Thailand cost $2,800 per year, said Kannikar Kijtiwatchakul, MSF Campaigner in Thailand.

"Thanks to competition since the compulsory license, treating that same patient with a second-line regimen will now cost $695 - four times less. But this is still far too expensive for the majority of people in Thailand, where the average annual salary is $1,600."

MSF's experience trying to obtain newer AIDS medicines over the past two years has shown that significant delays persist between when newer treatments become available in wealthy countries, and when they become available in the developing world.

"I work in Sydney and also have been treating patients with AIDS in countries like Malawi and Mozambique and the gaps I have witnessed are alarming," said Dr Alexandra Calmy, HIV/AIDS Advisor for MSF's Campaign for Access to Essential Medicines.

"At this conference in Sydney, we're seeing presentations on several promising drugs. These drugs should be available in Africa, Asia and Latin America at the same time as they are marketed in rich countries, not only after years of fighting for access to them. This means including the needs of people living in developing countries into the R&D plans from the beginning."

The MSF report also noted that until recently, most small children were treated with liquid formulations. These syrups or oral solutions are ill-adapted for use in remote settings, as they are complex to reconstitute and administer; can have an unpleasant taste; and are cumbersome to transport and store. They are also expensive.

Developments in the course of the last year have brought some improvement, said the report. Several generic manufacturers have introduced paediatric Fixed Dose Combinations (FDCs) for first-line therapy (such as the FDC d4T/3TC/NVP manufactured by both Cipla and Ranbaxy).

However, not all problems have been resolved by this move. The dosages of these existing FDCs differ from each other, since guidance from WHO on recommended dosages came too late for manufacturers.

The slowness of WHO in giving clear recommendations has created a problem that risks delaying the development of paediatric FDCs, and, ultimately, the administration of adequate treatment for children, said MSF.

Another major problem for which no solution is on the horizon is that there are no second-line formulations in the pipeline for children and more formulations are needed to complete the spectrum of regimens needed in an AIDS programme.

The report urged donors and international organisations to prioritise paediatric AIDS therapy, and work pro-actively to encourage much-needed R&D for this neglected group of patients.

According to UNAIDS and WHO, an estimated 250,000 to 350,000 deaths were averted in 2005 because of expanded access to AIDS treatment, but this picture must be balanced with the 2.9 million people who died of AIDS-related illnesses in 2006.

Patents should not be a barrier to accessing affordable medicines, increasing generic competition and assuring that the appropriate fixed dose combinations, including those for children, are developed. Flexibilities in both international and national patent rules exist to allow for this and there is no excuse for obstructing the use of these safeguards, said the MSF report.

MSF currently provides anti-retroviral treatment to more than 100,000 patients in over 30 countries, including to over 7,000 children.