Report

Involving industry in the fight against TB

A new report shows that the private tuberculosis (TB) drug market is now as large as the public market. Given that the private market has irregular practices that could be driving treatment failures and the emergence of drug-resistant TB, it is imperative that policy makers expand Public-Private Mix (PPM) programmes

Tuberculosis (TB) is widely considered a public health concern and its treatment a public sector responsibility. But according to a study published recently in the journal PLoS ONE, the in the private sector TB treatment is ignored at our peril. Across 10 high-burden countries, there is as much TB drug volumes in the private sector as is in the public sector — and at least a third of all private sector dosages of first-line TB drugs fall outside national and international treatment recommendations. Any resulting drug misuse could be responsible for many treatment failures and for escalating the emergence of multi-drug-resistant TB (MDR-TB), which is further worsening the TB epidemic.

TB kills nearly two million people each year, mostly in the developing world. One of the drivers of the epidemic is the old and inadequate treatment. There have been no new TB drug classes for nearly 50 years and the current regimens available take six to nine months, and are too long and complex for resource-poor settings. Because of that, many patients are unable to complete their drug regimen, which leads to drug resistance, an emerging global health threat. The treatment for drug-resistant TB can take two years or longer, involve multiple drugs and injectables, and is much more expensive than first-line treatment. According to WHO, there were 440,000 cases of MDR-TB in 2008; for those MDR-TB patients who were able to access MDR-TB treatment, at least a third still died.

The research, conducted by the TB Alliance and IMS Health, a healthcare market research and consulting-services firm, is the first detailed study of the private TB drug market across multiple high-burden countries (HBCs). 60 per cent of the world’s TB burden is present in the 10 study countries (Bangladesh, China, India, Indonesia, Pakistan, Philippines, Russian Federation, South Africa, Thailand, and Vietnam).

Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organisation dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, the Alliance aims to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB alliance operates with funding from the Bill & Melinda Gates Foundation, the UK Department for International Development, the US Agency for International Development, the European Commission, and the US Food and Drug Administration.

The report titled, 'Size and Usage Patterns of Private TB Drug Markets in the High Burden Countries', concludes that private TB drug markets in several HBCs are substantial, stable, and complicated. This calls for appropriate policy and market responses, including expansion of Public-Private Mix (PPM) programmes, greater reach, flexibility and appeal of public programmes, regulatory and quality enforcement, and expansion of public MDR-TB treatment programmes.

The researchers used IMS Health data to analyse private TB drug consumption in 10 high HBCs, after first mapping how well IMS data coverage overlapped with private markets. They defined private markets as any channels not used or influenced by national TB programmes. Private markets in four countries — Pakistan, the Philippines, Indonesia and India – had the largest relative sales volumes; annually, they sold enough first line TB drugs to provide 65-117 per cent of the respective countries’ estimated annual incident cases with a standard six-eight month regimen. First line drug volumes in five countries were predominantly fixed dose combinations (FDCs), but predominantly loose drugs in the other five.

Across 10 countries, these drugs were available in 37 (loose drug) plus 74 (FDCs) distinct strengths. There were 54 distinct, significant first line manufacturers (range 2-11 per country), and most companies sold TB drugs in only a single study country. FDC markets were, however, more concentrated, with four companies capturing 69 per cent of FDC volume across the 10 countries. Among second line drugs, fluoroquinolones were widely available, with significant volumes used for TB in India, Pakistan and Indonesia. However, certain WHO-recommended drugs were not available and in general there were insufficient drug volumes to cover the majority of the expected burden of multidrug-resistant TB.

TB requires lengthy, supervised treatment to maximise cure rates and minimise the development of drug resistance, and in low-income settings this task is thought to be more achievable in the public sector. By contrast, the private sector treatment landscape in these countries is largely unregulated and fragmented; for example, the study detected 111 different first-line TB drug dosages and combinations, compared to the 14 deemed necessary by the Stop TB Partnership’s Global Drug Facility.

“The private sector is keeping alive the confusion that existed previously in the public sector,” said Dr William Wells, the study’s lead author and Director of Market Access at the TB Alliance. “With this new baseline understanding of the TB drug market, we can no longer ignore the private sector’s critical role in the access equation for TB treatment and in the task of protecting both current drugs and new regimens from the development of resistance.”

Other key findings of the report

Public and private sectors are both major channels of treatment for TB patients. Nearly equal amounts of TB drugs are dispensed in public and private sectors (enough to treat 67 per cent vs. 66 per cent of estimated incidence, respectively).

The size of the private sector for TB drugs varies between countries, but has been steady within most countries over the past five years.

Four of the biggest HBCs – India, Indonesia, Pakistan, and Philippines — had particularly large private sectors. Enough TB drugs are sold in their private sectors to treat all, or nearly all, incident TB patients with a full TB drug regimen. This is without even considering the 60 — 80 per cent coverage by the public sector.

Few patients receive MDR-TB treatment in the public sector — and the data reveal that the private sector is not stepping in to fill the gap. Private sector sales have the capacity to cover only approximately one to ten per cent of MDR-TB patients (or zero per cent in three study countries) with anything approaching a full regimen. However, with new, rapid diagnostics becoming available, this market may expand rapidly, thus highlighting the urgency for action now.

More than one-third (35 per cent) of all TB treatment in the private sector fall outside national and international treatment recommendations, and constitute non-recommended strengths. There were 111 different first-line TB drug dosages and combinations detected in the private sector, compared to the 14 deemed necessary. The chaos surrounding what should be standard treatment can contribute to escalating rates of MDR-TB and further worsening the TB epidemic.

Indian scenario

India has the largest private drug market by far, estimated to hold enough drugs to treat more than two million cases. Nearly 60 per cent of dosing strengths in the Indian private markets do not correspond with standard TB treatment guidelines — nearly twice the average of the other countries studied.

MDR-TB treatment rates are low within the private sector, showing that the private market has not stepped in to fill the growing gap in treatment for patients in need.

“During the past decade, the world has seen a reawakening of TB drug development efforts, and the first wave of new TB treatments will be introduced within the next few years,” said Dr Mel Spigelman, President and Chief Executive Officer TB Alliance. “This study fills a critical gap in our knowledge base.”

“Most countries covered in this study have public-private mix (PPM) programmes for TB care,” said Mario Raviglione, Director of the Stop TB Department at the WHO. “Based on country experiences, these programmes have shown good results in optimising TB management by private care providers. However, the size of the response is not commensurate with the size of the challenge; there is enormous scope to expand these programmes urgently. Private providers following best practices should be supported through accreditation and access to free TB drugs from the public sector, while those not doing so should be regulated. Greater government and international support is needed for these efforts and also for improved regulatory oversight and quality assurance of TB drugs. A dual track approach of collaboration and regulation is the logical way forward. We ought to make private providers responsible partners of the public sector in controlling TB and MDR-TB.”