Global TB response advocates express continued concern about drug’s price
First, a word about the significance of bedaquiline. The first new antituberculosis drug to be developed in nearly half a century, it was given fast-tracked approval by the U.S. Food and Drug Administration at the end of 2012 to speed access to the drug for the hundreds of thousands of people worldwide who had run out of other options to treat multidrug-resistant TB. Developed by pharmaceutical company Johnson & Johnson, the breakthrough medicine came with caveats. It had not yet been as widely tested as a drug is optimally required to be before reaching the market, and in limited trials, it was linked to a prolonged interval between heart beats that was noted as a potentially fatal side effect. But those tests also showed the drug hastened and sustained clearance of tuberculosis bacteria, improved cure rates and reduced periods of infectiousness. And, unlike the treatment that was the last resort for multidrug-resistant patients at the time, it did not cause irreversible hearing loss. When the FDA approved bedaquiline, with more testing to be done, marketed as Sirturo, it became the new last resort.
That was two years ago. In the time since, a continued half a million people or more have come down with multidrug-resistant TB on a yearly basis, and in 2013, about 210,000 of them died of the disease, a release from Johnson and Johnson noted last week. During that time, only a few hundred people worldwide have been treated with Sirturo.
Johnson and Johnson’s announcement of a donation of 30,000 courses of the drug, to be made available in about 100 countries, including some of those hardest hit by TB, through a collaboration with USAID over the next four years, would change that. In the process, a representative of the company noted, greater access to the drug also is expected to deliver answers to questions its accelerated approval left hanging — including its safety, a clearer look at its effectiveness, and its best use.
So why are some of the most prominent global TB treatment access advocates disappointed by this announcement of what Johnson and Johnson announced was about $30 million worth of its product?
Médecins Sans Frontières, for example, issued a statement following the announcement, saying:
“Drug donations are not a long-term solution to meeting the needs of patients; donations are time-limited stopgap fixes that come with restrictions on where, how and who can access the medicine.”
Some of the answer lies in the math of roughly 30,000 courses of treatment at $30 million, which breaks down to a $1,000 price for a single course of the drug. While that price makes for a generous donation, TB community advocates say, it makes for limited access for the other tens of thousands of people who will need the drug — which would be but one component of treatment for a disease that the drug company’s release notes is a disease that “thrives in communities with weak health care systems, lack of funding, poor treatment outcomes and lack of political commitment,”
The math reflects a tiered pricing system that Johnson and Johnson’s bedaquiline Global Access Leader Ross Underwood said was derived through both a World Health Organization consultant’s and the company’s own cost-effectiveness studies. That system sets the price of bedaquiline at $900 a course in low-income countries, and $3,000 a course in middle income countries.
It is a system that puts the drug out of reach where it is needed most, TB community advocates told the drug company in a letter three months ago. Organizations signing the letter included Médecins Sans Frontières, Treatment Action Group, Partners in Health, AIDS-Free World, TBCAB (a global tb community advisory board), CRAG (a TB community research advisory group), GCTA (Global Coalition of TB Activists), and RESULTS. In it, they noted that public funding had helped support the development of the drug, and asked to meet with representatives of the company to discuss lowering the price, eliminate the “middle income” price tier, license generic companies to manufacture and market the drug, among other measures to make the drug more widely affordable. They argued that lowering the cost of the drug would speed its use, and answers to questions remaining about the drug. The meeting went well, one of the advocates present, Dalene von Delft of TB Proof wrote at the time.
“Advocacy groups are still awaiting feedback from Janssen after the meeting,” wrote von Delft, a South African physician who contracted TB in her work, and received one of the first courses of bedaquiline after the previous treatment began to cause hearing loss. The group of advocates, she added, “was very grateful for the company’s willingness to meet and listen to the problems and obstacles in the field.”
Representatives of the drug company told them word of changes would come by the end of the year.
That word came in the donation and partnership announcement last week.
“We recognize that price is a barrier but it’s not the largest barrier to treatment,” Underwood of Johnson & Johnson said today. The partnership would address other barriers, and set a course for further moves to make the drug accessible, he said.
“It’s important to acknowledge the donation,” said Erica Lessem of Treatment Action Group Monday. “It’s a nice gesture, but its really not a sustainable solution to access to medicine.”