The proposed launch of a new tuberculosis drug generates price disputes

MUMBAI: The proposed launch of the recently approved 'advance' drug, Pretomanide , for extensively drug resistant (XDR) tuberculosis in high-load countries, including India, it has sparked a massive debate on the TB drug pricing .

The three-drug cocktail, drug developer TB Alliance's Pretomanide combined with Linezolid and Johnson & Johnson's Bedaquiline, will be priced at $1,040 for a complete regimen of six months - over double the price being proposed by many health activists.

Defense groups, which have fought a long battle against pharmaceutical companies for exorbitant medical treatments, feel that high prices are barriers to access and prevent their expansion. Against them are multinational companies and innovators who feel that a lower price will be unsustainable, given the low numbers and niche population.

The XDR-TB population is around 10% of multi-drug-resistant tuberculosis (MDR) TB segment, which affects about five lakh patients globally. Of these, only around 12,000 were treated for XDR-TB globally in 2018, so this is the market for the threedrug regime, people close to the development told TOI. Of those 12,000 patients, around 2,700 treated for XDR-TB were from India.

The price of medicines depends largely on volumes. Currently, the number of patients treated for XDR-TB is very low. Enlargement is expected to occur over the years. In addition, prices are expected to fall once the regime is approved, they added.

The 'global access price' of Pretomanide at $364 for a six-month treatment, will be available in 150 high-burden TB countries, including India. Recently, global non-profit drug developer, TB Alliance granted rights to domestic company, Macleods Pharmaceuticals to develop and commercialise the therapy. This is after its agreement with US drugmaker Mylan in April. Anil Soni, global head of Infectious Diseases at Mylan, said, "This (price) is lower compared to alternative XDR-TB regimens, which last at least 20 months and cost between $2,000 to $8,000," he added.

Health activists, including Médecins Sans Frontières (MSF), have estimated generic versions of Pretomanide to be sold for less than a dollar a day. According to MSF, only 20% people with DR-TB who need these newer drugs are able to get them. "People are tired of waiting for access to better drugs. It's time for J&J, Otsuka, Mylan and TB Alliance to allow people to access medicines they need," said Sharonann Lynch, HIV & TB Policy Advisor, MSF Access Campaign.

But Soni countered, the regimen price reflects an initial price for Pretomanide of $2/day (for Mylan). The $1 per day target is from a paper published in 2017. This is an academic estimate based on assumptions, including the price of active pharmaceutical ingredient. For Pretomanide , there was no reference API cost in 2017, as the paper makes clear, Soni adds.