Bedaquiline debate: Domicile requirement for TB patients to get live-saving drug may no longer apply

Authorities allow patient from Patna to get treatment in Delhi, giving hope to others who have the condition.

An unreasonable domicile requirement that was responsible for denying the life-saving bedaquiline drug to many patients suffering from drug-resistant tuberculosis may no longer apply.

On Friday, the Central Tuberculosis Division agreed to provide bedaquiline to an 18-year-old Delhi resident, Priya, who suffers from drug-resistant tuberculosis. She had been denied the drug by Delhi’s National Institute of Tuberculosis and Respiratory Diseases on the grounds that she was originally from Patna and not domiciled in the capital.

To establish domicile, citizens have to provide proof of continuous residence in a state for a period of time in a state by presenting a document such as an electricity bill or rent agreement. In Delhi, people who want to establish domicile must prove that they have lived in the city for three years.

The National Institute of Tuberculosis and Respiratory Diseases is one of the six centres in the country that have rolled out the conditional access programme for bedaquiline. Bedaquiline has shown good results for patients of drug-resistant TB for whom all other lines of treatment have failed.

Though the drug is not available in the open market, the Central Drug Standard Control Organisation has allowed the drug only to be made available in public hospitals. The drug is also accessible for compassionate use where the manufacturer provides drug free of cost if patients can prove that they will die without the medicine.

Priya, whose name has been changed to protect her identity, had moved the Delhi High Court after she was barred from receiving the drug. On Friday, in a move that bring hope to others in similar circumstances, the TB division told the court that it will not deny treatment to eligible patients on grounds of domicile, said Anand Grover from the nonprofit Lawyer’s Collective who appeared for Priya.

The government on Friday went as far as making an exception in this case and agreed to provide bedaquiline to Priya, even though she is currently being treated in Mumbai under Dr Zarir Udwadia, a consultant chest physician at PD Hinduja Hospital. Her condition has been getting much worse over the past week.

Under the bedaquiline programme, patients being administered the drug have to be monitored weekly, and therefore need to stay in close proximity to the hospital. However, there were many instances of patients being denied treatment even though they had agreed to stay in Delhi during the process. Domicile was essential, the hospital would insist.

The success of this case could well pave the way for rolling out bedaquiline to patients who do not live in in the cities in which centres are located: Delhi, Mumbai, Chennai, Ahmedabad, and Guwahati.

Six years of TB

Among those who have been cheered by the announcement is a 27-year-old Sikkim resident who also suffers from extensively drug resistant tuberculosis and was denied treatment on the grounds of domicile. “I am told that there is a possibility of getting bedaquiline for her,” said her elder sister who is taking care of her. “I hope she gets it.”

The 27-year-old, whose identity cannot be disclosed to maintain her confidentiality, has suffered from TB for most of her adult life.

She contracted TB in 2001, when she was 14 years old. She was treated for six months and declared “fully cured”, said her sister in a telephonic conversation.

In 2009, when she was studying a diploma course in Chennai, she contracted TB again and was diagnosed with multi-drug resistant TB. She had to leave her studies mid-way and come back home to Gangtok.

The doctors did not prepare a complete profile of the drugs to which she was resistant, said her sister. “Her report was wrong,” she said. “She was given a drug despite being resistant to it.”

The treatment for multidrug resistant TB failed, and in 2014, she was diagnosed with extremely drug resistant TB, said her sister.

In the middle of this treatment, the woman suffered fits, which her sister feels is possibly due to the toxic drugs, and was given treatment for epilepsy. In 2016, she had failed this treatment, her sister said.

In May 2016, her sister took her to National Institute of Tuberculosis and Respiratory Diseases, Delhi, where she was told there was a new drug that could be used to treat her sister. Her sister gave her sputum sample for a drug susceptibility test and they waited for four months for the results. They were willing to rent a room, and provide the hospital with the requisite papers to start the treatment.

However, she hit the same roadblock as Priya. She was denied treatment on the grounds that she was not domiciled in Delhi.

“They gave me hope, and I was happy,” the patient’s sister said. But when the results were out, the doctor told me that it was only available for Delhi residents. I asked him where do I take my sister now?”

Hope for cure

In the meanwhile, her sister consulted Dr Udwadia in August, who put her on a different regime and asked her to apply for bedaquiline on compassionate grounds.

“Some of the medicines Dr Udwadia prescribed are working on her and she is better,” her sister said. “If she gets bedaquiline, maybe she will get cured.”

The family is in touch with Ketho Angami, founder member of Nagaland Users’ Network, that worked for the rights of narcotics users and also involved with working for the rights of HIV and TB patients.

“Since the domicile issue does not remain after this case, we will try get access to this drug in Delhi’s TB Institute where she has already undergone drug susceptibility test,” said Angami.

Grover of the Lawyers’ Collective is confident that the government will not create barriers to treatment on the grounds of domicile. “I do not think other eligible patients in a similar position should have a problem accessing bedaquiline,” he said.

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