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Multi-drug Resistant Tuberculosis

Major opportunity to increase access to newer, safer DR-TB drugs is at risk

With newer TB drugs to go off patent in 2023, MSF calls on J&J, Otsuka, and TB Alliance to remove additional barriers blocking generic manufacturers from entering the market.

Geneva, 8 November 2022 – A report released today by Doctors Without Borders (MSF) finds that two newer tuberculosis (TB) drugs – bedaquiline and delamanid – going off patent in 2023 presents a critical opportunity to increase access to shorter, safer and better treatment for people with drug-resistant forms of the disease (DR-TB), but these additional barriers need to be removed so more manufacturers can enter the market and bring prices down.

The report – DR-TB Drugs Under the Microscope, 8th edition – surveys the pricing and patent landscape of DR-TB medicines for adults and children and finds that extremely high prices are still being charged for newer TB drugs, a key factor hampering treatment scale-up. With DR-TB cases increasing for the first time in years, MSF called on pharmaceutical corporations and other drug developers to immediately dismantle the barriers blocking generic manufacturers from entering the market, so that production of these drugs can be scaled up, leading to increased access to affordable, safer, and more effective medicines for people who need them. 

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Sinethemba takes her daily regimen for XDR-TB at 10am each day. She also takes two additional delamanid tablets at night. Her grandmother’s determination and love, combined with receiving a six-month trial of one the newest DR-TB drugs on the market likely saved her life this year. Current regimen: delamanid, linezolid, pyrazinamide, ethambutol, clofazimine, high dose levofloxacin, terizidone.
Sydelle WIllow Smith
There is an urgent need for delamanid to be more widely available for patients for whom an effective regimen cannot otherwise be formulated. The high price of delamanid is not only limiting our capacity to treat more patients but is also limiting the efforts of national TB Programmes to scale up the treatment. Dr Mabel Morales, Medical Coordinator for MSF in India

"I was diagnosed with DR-TB in 2013 and was treated with older medicines with terrible side effects that left me in significant pain, did not cure me, and ultimately resulted in the loss of one of my lungs," said Meera Yadav, XDR-TB survivor in Mumbai, India and co-petitioner in a TB survivors’ court case for the Indian government to override patents on bedaquiline and delamanid. “When I was finally able to access the newer, lifesaving TB drugs, I realised that no one should have to go through such a harrowing experience – it is outrageous that patents and other barriers are stopping anyone who needs these TB drugs from accessing them.”

Currently, bedaquiline and delamanid are still patented medicines for which the originator pharmaceutical corporations, Johnson & Johnson (J&J) and Otsuka, respectively, have a global monopoly blocking price-lowering competition among generic manufacturers. According to research that estimates the cost of production plus a profit, delamanid is a shocking 13-18 times more expensive than it could be; ranging from R22,493.06 (US $1,250) to R30,590.5 ($1,700) for a 6-month treatment course, when it could be priced at t R1,727.4 ($96). Bedaquiline is almost three times more expensive than it could be, at R4,858.5 ($270) for a 6-month treatment course when it could be R 1,835.43 ($102). 

"In our Mumbai clinic, we are receiving increasing numbers of patients with TB with complex resistance who are in need of bedaquiline and delamanid to form an effective treatment regimen,” said Dr Mabel Morales, Medical Coordinator for MSF in India. “There is an urgent need for delamanid to be more widely available for patients for whom an effective regimen cannot otherwise be formulated. The high price of delamanid is not only limiting our capacity to treat more patients but is also limiting the efforts of national TB Programmes to scale up the treatment.” 

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Bedaquiline, delamanid, and pretomanid are game-changing TB drugs that could help save many more lives, so everyone with DR-TB should be able to access them Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign

In addition to bedaquiline and delamanid, pretomanid remains an important component of DR-TB treatment regimens, including in the new BPaLM regimen evaluated in MSF’s TB PRACTECAL clinical trial and recommended by WHO in May 2022. However, the current lowest global price for this regimen is out of reach at around R12,433.72 ($700) for a six-month course, with pretomanid alone accounting for nearly half the cost at R5, 965.88 ($336). Given the significant public funding that the TB Alliance received for the development of pretomanid, this is unacceptable, especially considering that research estimates it could be produced and sold at profit of R3,728.77 ($210), much less than its current price. MSF has contended that in total, the price of a complete DR-TB treatment course should be no more than R8,876.95 ($500) per person.

“Bedaquiline, delamanid, and pretomanid are game-changing TB drugs that could help save many more lives, so everyone with DR-TB should be able to access them,” said Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign. “Drug corporations should not put their profits over people’s lives. It’s time for all three newer TB drugs to be affordable.”

Additionally, the limited number of children being diagnosed and treated for DR-TB means that manufacturers may not consider the paediatric TB market viable, even though children affected by DR-TB can now be treated with complete regimens made up of medicines in child-friendly formulations. Governments need to urgently step-up efforts to diagnose and treat more children with DR-TB, and pool their needs and procurement across countries to help secure sustainable supply. There needs to be more competition among generic and originator companies to bring prices of newer medicines, bedaquiline and delamanid, down after patents expire. 
 

DR-TB DRUGS UNDER THE MICROSCOPE 2022 8TH EDITION pdf — 444.42 KB

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Notes to the Editor:
MSF is one of the largest non-governmental providers of TB treatment in the world. In 2021, 17,221 people in MSF’s care were started on TB treatment, including 2,309 with drug-resistant TB.
1 MSF is mindful of high level of resistance to fluoroquinolones in some regions (e.g., India) and that BPaLM (specifically the “M” = moxifloxacin belonging to the fluoroquinolone drug class) may not always be appropriate, which is why individualised regimens containing the other new drug delamanid combined with bedaquiline, linezolid, clofazimine and other DR-TB drugs are important in such contexts. In addition, alternative regimens are being tested in the MSF sponsored endTB-Q clinical trial and were tested in the TB-PRACTECAL trial.    
 

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