Service on Intellectual Property Issues (Oct19/02)
global campaign to lower price of crucial TB drug
Geneva, 11 Oct (Kanaga Raja) - The medical humanitarian organisation Medecins Sans Frontieres (MSF) has launched a global campaign on 10 October that calls on pharmaceutical giant Johnson & Johnson (J&J) to lower the price of its life-saving anti-tuberculosis (TB) drug bedaquiline to no more than US$1 per day for everyone who needs it.
MSF said it is demanding this price cut considering the joint contributions that were made in the development of this drug, including by MSF itself.
According to MSF, this will enable the scale-up of drug-resistant TB (DR-TB) treatment and reduce deaths.
According to a statement issued by the organisation on 10 October, MSF said it has been joined by TB activists and civil society in protests outside of J&J offices in the US, South Africa, Brazil, Belgium, Ukraine and Spain, demanding that J&J make the drug available for people with DR-TB for no more than "a dollar a day".
"Bedaquiline was developed using taxpayer money and contributions from the global TB community," said Sharonann Lynch, HIV & TB Policy Advisor for MSF's Access Campaign.
"Those who contributed to bedaquiline's development should have a say in how the drug is priced. We're calling on J&J to price bedaquiline at no more than $1 per day so that it can be made available to all people with drug- resistant TB. We will not back down until the price of bedaquiline is brought down," she added.
MSF pointed out that bedaquiline was developed with considerable taxpayer, non-profit and philanthropic support.
Much of the critical work to inform the use of the drug and demonstrate its therapeutic value was conducted by the TB research community, health ministries, and treatment providers including MSF, and was financed by taxpayers and other donors, it said.
"Despite this joint research and development effort by the global TB community, J&J alone owns the patent on the drug in many countries and has sole rights to determine in which countries the drug will be sold."
Moreover, said MSF, J&J also benefited from a significant financial windfall as it obtained a Priority Review Voucher from the US Food and Drug Administration (USFDA), that can be used to get accelerated marketing approval for another of its drugs.
MSF said that J&J currently charges double the price that the organisation is asking.
J&J has priced bedaquiline at $400 for a six-month treatment course for countries eligible to buy the drug through the Global Drug Facility (GDF), a TB drug and diagnostic procurement mechanism, operating out of a UN agency.
However, researchers from the University of Liverpool have calculated that bedaquiline could be produced and sold at a profit for much less - as little as 25 cents per day if at least 108,000 treatment courses were sold per year.
At $1 per day, the price of bedaquiline would be $600 per person for the 20 months of treatment that many DR- TB patients require, said MSF.
In comparison, the lowest price J&J charges today for 20 months of bedaquiline is nearly $1,200 ($2 per day) in countries eligible to purchase through GDF, while J&J charges other countries much more.
This high price affects the scale-up of the drug in many countries struggling with DR-TB epidemics, considering that bedaquiline is just one of multiple drugs required in treatment regimens, said the MSF statement.
According to MSF, bedaquiline is one of only three new TB drugs to be developed in over half a century (the others are delamanid and pretomanid).
The previously recommended DR-TB treatment regimens used by most countries required people to take as many as 20 pills a day for up to two years and endure painful daily injections and severe side effects ranging from psychosis and persistent nausea to deafness.
These sub-optimal treatments only managed to cure 55% of people with MDR-TB and just 34% of people with extensively drug-resistant tuberculosis (XDR-TB), said MSF.
Based on data generated by the TB community showing improved treatment outcomes in people who received bedaquiline, the World Health Organization in 2018 recommended bedaquiline be used as a core part of an all- oral treatment regimen, replacing the injected drugs.
According to MSF, increased use of bedaquiline has already shown benefits, even among people more likely to have poorer treatment outcomes, including people living with HIV, and people with pre-XDR-TB and XDR-TB.
For example: in Belarus, among 244 people who were treated with bedaquiline - 96% of whom had either pre- XDR-TB or XDR-TB - the treatment success rate increased to 87%.
"We have seen so many patients go deaf, lose their jobs or lose their lives because they had no option other than the excruciating TB drugs that had to be injected," said Pilar Ustero, Medical Advisor for MSF's Access Campaign.
"Now, bedaquiline is proving to be a game changer, giving those people with DR-TB who can access it a better chance to be cured, without the toxic side effects. We need this drug to be affordable for everyone who needs it, everywhere," Ustero added.
According to MSF, since WHO recommended the use of bedaquiline a year ago as a core drug for the treatment of MDR-TB, less than 12,000 people were treated with a regimen including bedaquiline according to national TB programmes.
"This is a paltry figure considering that an estimated 80% of the 558,000 people who develop DR-TB annually (Global TB report 2018) should be treated with this drug," it said.
Rapid rollout of better-tolerated treatment containing bedaquiline will happen only if J&J makes it widely available in an affordable way, including by allowing other TB drug manufacturers to make generic versions, MSF added.
According to MSF, across its projects in 14 countries as of September 2018, more than 2,000 people have been treated with newer TB drugs, including 633 with delamanid - the only other new TB drug developed in more than 40 years - 1,530 with bedaquiline, and 227 with a combination of both medicines.
Earlier, in another statement issued on 9 October, MSF called for the price of delamanid to be lowered and to be offered outside of South Africa.
MSF said it acknowledges the lower price offered to the government of South Africa for the newer anti-TB drug, delamanid.
It however called for it to be significantly lower and expanded to all countries in need.
It noted that Mylan, which licenses the drug from the patent-holder Otsuka, will charge US$940 for a six-month treatment course ($157 per month) as of 1 June 2020 in South Africa.
Delamanid is used in combination with other drugs to treat people with drug-resistant TB (DR-TB), including the hard-to-treat extensively drug-resistant TB (XDR-TB).
According to MSF, delamanid is one of the most expensive drugs used to treat drug-resistant tuberculosis (DR- TB), priced at $1,700 for a six-month treatment course ($283 a month) through the Global Drug Facility.
It is just one of multiple drugs needed to treat the disease. Its high price is a key driver of the high overall cost of treating people with multi-drug-resistant TB (MDR-TB) and XDR-TB, said MSF.
A full 20-month treatment course for one person can cost $8,000 to $12,000 through GDF, depending upon the length of treatment and the other drugs that make up the treatment regimen.
The high price has had a chilling effect on treatment scale-up, MSF pointed out.
Although delamanid was conditionally approved by the European Medicines Agency in April 2014, as of the end of August 2019, only 2,902 people have ever been treated with delamanid according to the DR-TB Scale-Up Treatment Action Team of global TB experts, which receives updates from National TB Programmes and large treatment providers, such as MSF.
MSF urged more countries to make the switch from older, toxic treatments that need to be injected to all-oral regimens that contain the newer drugs, including delamanid.
These newer drugs are critical to improving the otherwise abysmal cure rates of 55% and 34% for MDR-TB and XDR-TB, respectively, it said.
MSF noted that researchers from the University of Liverpool have calculated that delamanid could be produced and sold at a profit for much less - ranging from $5-16 per month if the drug is scaled up by national TB programmes.