When Eli Lilly announced in 2017 that it would stop producing quinidine, it was the only medication approved for severe malaria treatment in the U.S.

As quinidine supplies dwindled, the Centers for Disease Control and Prevention made available artesunate, a better drug that is the international gold standard for treating severe malaria, free of charge via request. But that process posed problems.

Because artesunate had not yet been approved by the Food and Drug Administration, patients needing treatment for severe malaria were required to sign lengthy and confusing consent forms for “investigational use” of the drug. It also had to be shipped directly from a limited number of CDC quarantine stations, which resulted in deadly delays in care.

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In May 2020, the FDA approved a form of artesunate made by Amivas LLC. Global health and travel medicine specialists were elated that this superior therapy for severe malaria, which had been available for years in other countries, was finally available in the U.S. Yet that approval was accompanied by a 150-fold jump in price: Artesunate costs about $30,000 for an average course of treatment for an adult, compared to less than $200 for quinidine in 2018.

In most African countries, artesunate treatment costs $5 or less, highlighting the pitfalls of the American drug market.

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Artesunate manufactured outside the U.S. can’t be imported here because it doesn’t currently meet FDA requirements. Amivas has attributed the price it set to the cost of FDA licensing and production, combined with the small market for artesunate in the U.S. Only about 300 people develop severe malaria in the U.S. each year, but without rapid effective treatment the disease can be fatal.

It’s a perfect case study for why Congress and the FDA need to address the market failures for so-called rare diseases, including severe malaria and many other neglected tropical infections such as stool worm infections, leprosy, or parasitic infections of the brain, like neurocysticercosis, toxoplasmosis, and rat lungworm meningitis. Together, these infections affect thousands of Americans.

It’s past time to prioritize legislative and policy approaches that provide U.S. residents with affordable, timely, and reliable access to drugs for rare conditions. Drugs that are considered essential by the World Health Organization — like artesunate — should be at the top of the list. FDA approval of imported drugs from qualified suppliers could be one way of addressing this issue.

In the meantime, given the high risk of critical illness and death with severe malaria, the price and availability of artesunate require an urgent solution.

The financial crisis facing health care systems during the pandemic and the resulting lean hospital budgets mean that medications for uncommon diseases like malaria may not be stocked by most hospitals. When purchased after a case is diagnosed, because of its limited availability, distributors take anywhere from 12 hours — at best — to five days to deliver the drug, a dangerous delay in care.

The U.S. government should consider mechanisms to cover artesunate drug costs for hospitals, such as through support of the CDC’s current distribution program, direct reimbursement to health care systems, or partnership with Amivas, the single U.S. producer of artesunate. Another way the manufacturer could provide artesunate at a more reasonable cost would be for the FDA to award it a priority review voucher for orphan drugs. This program seeks to encourage bringing drugs for underserved conditions, such as artesunate, to market by offsetting the entry costs. The sale of a voucher, valued at millions, by Amivas could allow it to sell artesunate at a lower cost.

It is shocking to think that U.S. citizens may receive better treatment for severe malaria at lower cost in a low-income country than they would at home. It is even more shocking to contemplate that some people with severe malaria in the U.S. may not be able to get the treatment they need given the cost and barriers preventing doctors from obtaining the only FDA-approved therapy.

We urge legislators and the FDA to consider ways to ensure that artesunate and other drugs for rare conditions will be available in a timely and affordable manner to all in the U.S. who require it.

Anne E.P. Frosch is an infectious diseases physician at Hennepin Healthcare and assistant professor of medicine at the University of Minnesota. Aileen Ahiskali is an infectious diseases pharmacist at Hennepin Healthcare. Chandy C. John is a pediatric infectious diseases physician, director of the Ryan White Center for Pediatric Infectious Disease and Global Health, and professor of pediatrics and medicine, all at Indiana University School of Medicine.

Source: STATNEWS.COM

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