Monday, June 17, 2019

Bernie demands to know why once-free prescription drug now costs $375K

“The unfortunate reality is that the United States pays, by far, the highest prescription drug prices in the world,.

In response to Catalyst Pharmaceuticals recently raising the price of a once-free drug to $375,000, Sen. Bernie Sanders wrote a letter demanding answers from the Department of Health and Human Services and the U.S. Centers for Medicare and Medicaid Services about the cost to taxpayers. According to his letter, Sen. Sanders wrote, “It is abundantly clear that Catalyst expects taxpayers, primarily through Medicare and Medicaid, to foot the bill for its price gouging.”

In a letter addressed to Alex Azar, the secretary of Health and Human Services, and Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, Sanders said, “I am writing to request information regarding the price Catalyst Pharmaceuticals will charge Medicare and Medicaid for Firdapse, a drug used to treat a rare neuromuscular disease known as Lambert-Eaton myasthenic syndrome (LEMS), and the impact this price will have on patients with LEMS and taxpayers.”

In people with LEMS, the body’s own immune system attacks the neuromuscular junction (the connection between nerves and muscles) and disrupts the ability of nerve cells to send signals to muscle cells. LEMS may be associated with other autoimmune diseases, but more commonly occurs in patients with cancer such as small cell lung cancer, where its onset precedes or coincides with the diagnosis of cancer. The prevalence of LEMS is estimated to be three per million individuals worldwide.

In November, the U.S. Food and Drug Administration (FDA) approved Firdapse (amifampridine) tablets for the treatment of LEMS in adults. Although patients with LEMS have been able to access the drug for free from Jacobus Pharmaceutical through the FDA’s compassionate use program, Catalyst Pharmaceuticals announced in December that they plan to raise the price of Firdapse to $375,000.

“The unfortunate reality is that the United States pays, by far, the highest prescription drug prices in the world,” Sanders noted. “Although federal and state governments are the largest prescription drug purchasers in the country, Medicare is not permitted to negotiate drug prices directly with drug manufacturers. This remains true despite the president’s repeated campaign promises to leverage the government’s purchasing power to negotiate better deals on drug prices.”

According to Securities and Exchange Commission filings for 2018, Catalyst conducted market research and determined that “most LEMS patients have insurance coverage,” including approximately “40 percent Medicare, Medicaid, [and] 10 percent dually eligible for both Medicare and Medicaid.”

“Catalyst’s top priority is improving patient care in the LEMS community and potentially elsewhere within the neuromuscular community,” the company said in an email to CBS MoneyWatch. “We will respond to Senator Sanders’ letter in a timely manner and provide information about Firdapse and the programs that we have in place to raise awareness of LEMS, facilitate accurate and timely diagnosis, and broaden affordable patient access to an FDA-approved treatment.”

Sanders concluded the letter by asking Secretary Azar and Administrator Verma what impact the drastically increased price of Firdapse will have on U.S. taxpayers regarding the price Medicare and Medicaid patients will pay for the drug. Sanders asked, “What steps will your agencies take to stop drug companies such as Catalyst from profiteering off patients covered by Medicare and Medicaid?”

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