Teva Pharm gets approval in China for Huntington’s treatment

China has given the greenlight to Teva Pharmaceutical Industries’ Austedo treatment for Huntington’s disease, the company said.

Teva’s CEO Kare Schultz said the drug would be priced somewhat lower in China than in the United States. However, it will not yet be eligible for coverage under China’s national insurance scheme, which means it will only be affordable initially to a limited proportion of patients in the world’s second-largest drug market.

Austedo was included in China’s fast-tracked approval channel as a rare disease treatment of “significant clinical advantage”. It has been approved to alleviate uncontrollable movements in patients with Huntington’s disease – a hereditary brain disorder that often appears in middle age – or tardive dyskinesia, a spokesperson at the Israel-based drugmaker said.

Austedo, which is expected to generate sales of $650 million in the United States this year, costs around $60,000 a year per patient in the United States before insurance coverage, Schultz said.

Austedo needs to be significantly cheaper than $60,000 a year to be affordable to most patients in China, where major commercial insurance programmes are yet to cover Huntington’s disease, said Cao Xi, who runs “Hyacinth Care”, a Shanghai-based non-profit organization dedicated to the disease.

“We would go in with a strategy of being in the specialized clinics first, so there would not be broad access in the beginning,” Schultz told Reuters in an interview prior to the Chinese approval.

Annual treatment costs for Chinese patients were around 12,000 yuan ($1,687) on average in 2018, according to a survey conducted by Hyacinth Care involving about 360 participates who suffer from Huntington’s disease or carry a mutant gene related to the illness.

“If [the drug is] too expensive, we hope there could be some national medical insurance-related policies to help patients afford the drug,” said Cao, who has a relative with Huntington’s disease.

China has pledged to include more rare disease drugs in its central government-backed nationwide insurance scheme, which most patients, especially less affluent ones, rely on to pay drug bills.

“You start with a private launch… and then it’s many years typically before you get into the national process,” Schultz said. “You’re talking about a launch which is basically not government-aid[ed] to begin with.”

Austedo was approved in the United States to treat chorea associated with Huntington’s disease and tardive dyskinesia in 2017. Revenues from sales of the drug in North America surged 64 per cent to $122 million in the first quarter.