TUBERCULOSIS: need to solve problems around the pricing and supply of DR-TB medicines

Aarti Dhar As a new rapid diagnostic test, endorsed by the World Health Organisation (WHO), will finally help detect more people with drug-resistant tuberculosis (DR-TB), there was need to solve problems around the pricing and supply of DR-TB medicines, according to a report by international medical humanitarian organisation Médecins Sans Frontières (MSF).

The DR-TB is on the rise, but less than 7 per cent of 4,40,000 new cases each year receive treatment. It kills 150,000 people in the world annually, according to the WHO. India is one of the countries with the highest burden of DR-TB cases in the world, with more than 99,000 new cases each year.
The MSF report, released to mark World TB Day, shows that DR-TB drugs are riddled with persistent supply and price problems that must be urgently addressed.
The report examines medicines used to treat DR-TB according to the number of suppliers, quality assurance and price, based on information obtained from the Global Drug Facility and drug manufacturers.
The report highlights that four of the recommended DR-TB medicines are available from only one quality-assured generic source.
Relying on a sole supplier whose production could be disrupted or stopped at any time always carries a risk of dangerous treatment interruption for patients. For example, supplies of injectable drug kanamycin were disrupted in 2010, leading to a temporary global stock out.
“In India and several other countries, resistance to TB drugs is a serious public health issue, which cannot be allowed to get worse,” said Blessina Kumar of Stop TB Partnership.
“Patients have been stuck in a vicious circle – not enough people are diagnosed, and drug supply problems along with high prices stand in the way of putting more people on treatment.”
Additionally, the MSF report found that several DR-TB medicines are very expensive, with prices for two drugs having increased by more than 600 per cent and one drug by more than 800 per cent over the last decade.
A 24-month DR-TB treatment regimen can cost as much as $9,000 for one patient — 470 times more than the $19 per patient it costs to cure standard, drug-sensitive TB.
“Now that we have a new test that can detect DR-TB in less than two hours instead of three months, we're going to see many more people who will need reliable drug supplies to get treated,” said Joanna Ladomirska, Medical Coordinator for MSF in India.
“We need to see some immediate action to improve access to DR-TB drugs so that more people are started on treatment and transmission of this disease is reduced. This is particularly important in India, given the high burden of DR-TB here,” said Ladomirska.
The low demand for DR-TB drugs had made the market unattractive for producers, which was reinforcing the supply and price problems.
One way to kick start increased production of some of these drugs is for donors to guarantee purchase volumes for several years to producers upfront.
Other mechanisms such as better forecasting of the mid-to long-term needs for DR-TB drugs are also needed to help attract more producers to the market, to improve supply security and increase competition that helps brings prices down.
“With faster diagnosis and better treatment models of the DR-TB, we need to fix the supply and price issues with DR-TB drugs. We also need to see newer drugs developed,” said Ladomirska.
http://www.thehindu.com/health/article1564679.ece

TUBERCULOSIS: WHO urges roll-out of new TB test despite worries over cost

A test that can detect TB, including drug-resistant forms, in less than two hours could revolutionise treatment of the disease, according to the World Health Organisation, which is urging its roll-out across the globe.
Tuberculosis killed 4,700 people every day last year. The annual death toll of 1.7 million includes 380,000 people who are at particular risk because they have HIV, the virus that depresses the immune system and causes Aids.
The current diagnostic test for TB has been used for 125 years. It involves microscopic examination of a sputum sample and is not ideal because it doesn’t easily detect the growing number of strains that are resistant to antibiotics, or TB where the patient is also infected with HIV.
Some patients have to wait as long as three months to be diagnosed, which means their treatment is delayed and their prospects of recovery are reduced. The long wait also increases the chances they will infect others and, if they are given the wrong antibiotics for their particular strain of TB, drug resistance can worsen.
The new test delivers a result in 100 minutes. Dr. Mario Raviglione, Director of the WHO’s Stop TB department, said, “This new test represents a milestone for global TB diagnosis and care. It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease.”
He added, “We have the scientific evidence, we have defined the policy, and now we aim to support implementation for impact in countries.” The number of TB cases is set to rise as the test is rolled out. The WHO says drug-resistant cases could increase threefold and the number of cases where the patient is co-infected with HIV could double.
Trials and demonstration studies have been carried out over 18 months in a number of different countries, involving more than 8,000 patients. The test is a fully-automated nucleic acid amplification test, which the WHO says is simple and safe to use. It incorporates modern DNA technology that can be used outside of conventional laboratories - although the need for a constant electricity supply may be a problem in rural settings.
The major issue will now be cost. The market price for the equipment is $55,000 to $62,000, with an additional $55 to $82 for the cartridges it uses. The makers, Cepheid, have agreed to cut the price by 75 per cent for the poorest countries. However, at $16.86 per test, the cost is higher than the current system and the roll-out will depend on donor funding.
http://www.thehindu.com/health/medicine-and-research/article941615.ece

TUBERCULOSIS: Patients' Costs and Cost-Effectiveness of Tuberculosis Treatment in DOTS and Non-DOTS Facilities in Rio de Janeiro, Brazil

Costs of tuberculosis diagnosis and treatment may represent a significant burden for the poor and for the health system in resource-poor countries.
The aim of this study was to analyze patients' costs of tuberculosis care and to estimate the incremental cost-effectiveness ratio (ICER) of the directly observed treatment (DOT) strategy per completed treatment in Rio de Janeiro, Brazil.
We interviewed 218 adult patients with bacteriologically confirmed pulmonary tuberculosis. Information on direct (out-of-pocket expenses) and indirect (hours lost) costs, loss in income and costs with extra help were gathered through a questionnaire. Healthcare system additional costs due to supervision of pill-intake were calculated considering staff salaries. Effectiveness was measured by treatment completion rate. The ICER of DOT compared to self-administered therapy (SAT) was calculated.
DOT increased costs during the treatment phase, while SAT increased costs in the pre-diagnostic phase, for both the patient and the health system. Treatment completion rates were 71% in SAT facilities and 79% in DOT facilities. Costs per completed treatment were US$ 194 for patients and U$ 189 for the health system in SAT facilities, compared to US$ 336 and US$ 726 in DOT facilities. The ICER was US$ 6,616 per completed DOT treatment compared to SAT.
Costs incurred by TB patients are high in Rio de Janeiro, especially for those under DOT. The DOT strategy doubles patients' costs and increases by fourfold the health system costs per completed treatment. The additional costs for DOT may be one of the contributing factors to the completion rates below the targeted 85% recommended by WHO.
Background
Costs of tuberculosis diagnosis and treatment may represent a significant burden for the poor and for the health system in resource-poor countries.
Objectives
The aim of this study was to analyze patients' costs of tuberculosis care and to estimate the incremental cost-effectiveness ratio (ICER) of the directly observed treatment (DOT) strategy per completed treatment in Rio de Janeiro, Brazil.
Methods
We interviewed 218 adult patients with bacteriologically confirmed pulmonary tuberculosis. Information on direct (out-of-pocket expenses) and indirect (hours lost) costs, loss in income and costs with extra help were gathered through a questionnaire. Healthcare system additional costs due to supervision of pill-intake were calculated considering staff salaries. Effectiveness was measured by treatment completion rate. The ICER of DOT compared to self-administered therapy (SAT) was calculated.
Principal Findings
DOT increased costs during the treatment phase, while SAT increased costs in the pre-diagnostic phase, for both the patient and the health system. Treatment completion rates were 71% in SAT facilities and 79% in DOT facilities. Costs per completed treatment were US$ 194 for patients and U$ 189 for the health system in SAT facilities, compared to US$ 336 and US$ 726 in DOT facilities. The ICER was US$ 6,616 per completed DOT treatment compared to SAT.
Conclusions
Costs incurred by TB patients are high in Rio de Janeiro, especially for those under DOT. The DOT strategy doubles patients' costs and increases by fourfold the health system costs per completed treatment. The additional costs for DOT may be one of the contributing factors to the completion rates below the targeted 85% recommended by WHO.
http://www.blogger.com/post-create.g?blogID=3604033512937490051

TUBERCULOSIS: effects of alcohol and money on getting treated

DURBAN, 4 June 2010 (PLUSNEWS) - A complex mix of issues drives drug-resistant tuberculosis (TB) patients to default on medication, not least of which are alcohol and money, according to new research presented by Medicines Sans Frontiers (MSF), the international medical charity, at the South African TB Conference in the east-coast city of Durban. When 22 percent of drug-resistant TB patients defaulted on treatment at one of MSF's clinics in the Cape Town township of Khayelitsha, despite access to services such as counselling and treatment support groups, TB councillors reviewed patient records to find out why. Busisiwe Beko, a counsellor and former drug-resistant TB patient, found that household instability - often caused by a household member's alcohol abuse - circular migration to and from the neighbouring Eastern Cape Province, and financial pressures, were among the primary factors derailing treatment. Treating drug-resistant TB - including multidrug-resistant TB (MDR-TB) and extremely drug-resistant TB (XDR-TB) - can take up to 24 months and comes with a battery of injections, pills, and adverse reactions that leave many unable to work, even when they are no longer infectious. "They cannot return to work until their cultures are clear - we have this fear that they are using public transport [to get to work], so we are trying to minimise the chance of infections," Beko told IRIN/PlusNews. Research presented by MSF's Yvonne Xhaso found that patients' inability to work made financial support crucial during this time. About 50 percent of drug-resistant TB patients have no form of income at diagnosis, and it can take as much as six months to obtain a public grant. Patients wishing to access a monthly government disability grant of R1,080 (US$154.00) must submit various forms, including a physical examination by a doctor, a police affidavit, and a letter from a former employer. Xhaso said there were often delays that extended this process for months, and she has recommended that the Department of Social Development streamline the process. South Africa has the fifth highest TB incidence in the world, according to the World Health Organization, and the TB epidemic is fuelled by a high HIV prevalence rate of about 18 percent.

TUBERCULOSIS: Cost of resistance to treatment

Multi-drug resistant strains of tuberculosis (TB) could become dominant forms of the disease in the next few decades, adding heavy financial and medical burdens to already struggling health systems, doctors said on Wednesday.
In a series of studies into TB, scientists said “superbug” strains of the disease were already gaining ground in some countries and called for greater investment into research and development of new drugs and possible vaccines.
Multidrug-resistant tuberculosis, known as MDR-TB, has much lower cure rates, higher death rates, and costs far more to treat than normal TB, they warned.
An estimated 440,000 MDR-TB infections occurred around the world in 2008, accounting for 3.6 percent of known cases.
Neel Gandhi of New York’s Yeshiva University and Paul Nunn of the World Health Organization in Geneva, who conducted one of the studies, found that India and China had around 50 percent of the global MDR-TB burden, followed by Russia with 9 percent.
“Unless countries invest substantially in management of MDR TB, the possibility remains that MDR strains could become the dominant form,” they wrote.
“The future possibility of strains that are totally resistant to all anti-tuberculosis drugs is not inconceivable.”
TB — which causes around 1.8 million deaths worldwide every year, or nearly 5,000 people a day — is often associated with poverty and is one of the leading causes of death among people in economically productive age-groups in developing nations.
Of a 11 million active cases of TB recording in 2008, 95 percent of cases were in low- and middle-income countries.
It is caused by the Mycobacterium tuberculosis bacteria and can be cured with antibiotics, but they must be taken daily for months to be effective and public health funding cuts in some countries may mean fewer drugs are available.
Because people do not always take the drugs properly, MDR-TB strains are starting to take hold and the WHO says there is an urgent need for countries to set up laboratories to fight it.
Gandhi and Nunn said MDR-TB treatment is less effective, requiring 24 months of treatment rather than the usual 6 months, and far more expensive — costing an average of $3,500 in drugs per patient versus around $20 per patient for normal cases.
“Even though there are fewer cases of drug-resistant TB, the cost and complexity of their management place a significantly greater burden on the health system,” they said.
In other studies in the series, which was published by The Lancet on Wednesday, scientists said the combined impact of new drugs, vaccines, and diagnostic tests could cut worldwide incidence of TB by 94 percent by 2050, but the investment needed to bring this about it falling way too short.
Only around a quarter of the funding needed is being put into TB drug research and development, they said, and called for new ways of encouraging pharmaceutical firms into the field.
“Development of new drugs for TB is lengthy, expensive, and risky, and the expected revenues are too small to justify commercial investment,” wrote Zhenkun Ma of the Global Alliance for TB Drug Development. “New financing and market incentive mechanisms are needed.”
According to the studies, there are 11 potential TB vaccines being tested in human trials and up to 10 experimental medicines in the TB drug “pipeline.” Since many drugs fail in late-stage trials, this handful of possibilities is unlikely to be enough.
“To eliminate TB as a public health concern by 2050, all responsible parties need to work together to strengthen the global anti-tuberculosis drug pipeline,” the scientists said.
http://www.ethiopianreview.com/news/116379