Pretomanid, a new anti-tuberculosis (TB) drug approved by the U.S. Food and Drug Administration (FDA), has raised hopes of better treatment for the most drug-resistant patients. However, its pricing, which is yet to be made public by drug maker Mylan, has made doctors and activists batting for affordable TB treatment curious.
After bedaquiline and delamanid, pretomanid is the third new drug in the last over 40 years. While bedaquiline is manufactured by Belgian pharmaceutical company Janssen, delamanid is developed by pharmaceutical corporation Otsuka. Pretomanid is, however, the first to be developed and registered by a not-for-profit organisation TB Alliance.
Médecins Sans Frontières (MSF), a non-profit that has been working in TB care for nearly 30 years, has said that pretomanid must be made affordable to everyone, especially considering the taxpayer and philanthropic contributions that went into its development.
The MSF has also questioned why the price has not been made public yet.
Pretomanid is part of the same class of drugs (nitroimidazoles) as delamanid, which at $1,700 for a six-month course, continues to remain out of reach for patients. “Some patients need to take the drug for more than six months, depending on their resistance. Affordability is thus the biggest challenge in drug-resistant TB,” said Stobdan Kalon, strategic advisor for MSF projects in India. “We hope the new drug, which comes from the same class as delamanid, creates competition and results in cost reduction,” he said.
Pretomanid has been approved as part of a three-drug regimen, the others being bedaquiline and linezolid. It is referred to as the BPaL regimen. While the MSF has called for treatment of drug-resistant TB to be no higher than $500 per person for a complete treatment course, it estimates the cost of BPaL regimen would go much higher.
Mumbai-based chest physician Dr. Zarir Udwadia said it is a question of both access and cost. “Bedaquiline has always been difficult to access. I hope pretomanid is not as hard to deliver to patients who often die due to lack of access.” He said, “The other two drugs in the regimen being expensive, one hopes that the high cost of pretomanid does not make the regimen unaffordable. All eyes are on Mylan.”
A spokesperson from Mylan said the company has historically been a leader in reducing the price of drugs for patients and programmes in developing countries, and will continue to do so with pretomanid. “We have not announced our launch price for pretomanid tablets in low- and lower-middle income countries yet, in part because pricing discussions with global procurement bodies were pending the FDA approval. Now that it has been received, discussions can begin,” he said.
Activists have also raised questions about the confidentiality of the agreement between Mylan and TB Alliance. “The agreement is shrouded in secrecy. It has to be made public so the terms and conditions are known to everyone,” said Leena Menghaney, who heads the Access Campaign in South Asia for the MSF. “Another question is why should TB Alliance have an exclusive partnership with Mylan?” she asked.
A response from TB Alliance to a query sent by The Hindu said there will be non-exclusive licensing in approximately 140 low- and middle-income countries after November 2020.
“In the same way that Mylan is required to produce quality product as evidenced by either approval from a Stringent Regulatory Authority or WHO pre-qualification, the same will be required of all further manufacturers to ensure that only quality assured pretomanid is being sold. This reflects TB Alliance’s commitment to ensuring affordable and sustainable access to new TB treatments that are of high quality,” it said.
