If the Trump administration has struck a deal with insulin makers to lower their list prices for Medicare beneficiaries, someone forgot to tell the largest manufacturers of those products.
A spokeswoman for Sanofi told S&P Global Market Intelligence the French drugmaker has no such agreement on the table, let alone a proposal, while an Eli Lilly and Co. spokeswoman called the June 6 report in InsideHealthPolicy "rumors."
According to the report, the Centers for Medicare and Medicaid Services, or CMS, plans to soon reveal an agreement under which insulin manufactures would lower the cash price of their products for Medicare beneficiaries who choose to buy the medicines outside of their drug plans.
It said the CMS plan involved two pricing schemes for insulin: One in which drugmakers would negotiate prices and rebates with drug plans, as they do now, and another in which the manufacturers have agreed to lower their list prices to "roughly the rebated level that plans receive, with few-to-no rebates on that lower price."
The administration has already called for applying at least one-third of the discounts and rebates Medicare Part D plans receive from biopharmaceutical companies to the beneficiaries' out-of-pocket spending on their medicines at the pharmacy counter — a proposal included in President Donald Trump's fiscal 2019 budget request.
While Sanofi has no current agreement with CMS, the drugmaker plans to meet with the Department of Health and Human Services "in the next couple weeks" to discuss "an array of pricing-related issues," though not just insulin, company spokeswoman Ashleigh Koss told S&P Global Market Intelligence.
Koss noted that earlier this year, Sanofi launched its own program to lower out-of-pocket costs for its insulin products Lantus and Admelog to certain Americans.
But under existing federal rules, Sanofi is not permitted to offer its Insulins VALyou Savings Program to federally insured patients, Koss said.
The company, however, stated it was supportive of any effort that would allow it to extend the reach of the savings program.
It is unclear, however, whether lawmakers would need to ease anti-kickback rules to allow Medicare beneficiaries to participate in Sanofi's or other drugmakers' savings programs.
If the "rumors of a CMS program for insulin pricing" are true and the Trump administration is considering a proposal like the one described in the InsideHealthPolicy report, "it would be a welcome step forward in helping reduce patients' out-of-pocket costs," a spokeswoman for Lilly told S&P Global Market Intelligence.
A third insulin maker, Novo Nordisk A/S, did not respond to questions about the reported CMS deal.
On May 30, Trump said he had received a commitment from some of the nation's largest drugmakers for "voluntary massive drops in prices."
Trump said the administration planned to give more details by mid-June.
The White House, HHS, CMS and the Food and Drug Administration have all declined to respond to questions about which companies had agreed to lower their prices, or any other details. No biopharmaceutical companies have said they are among the manufacturers Trump was referencing in May, and industry groups have remained mum on the matter as well.
In May, CMS warned prescription drug plans participating in the Medicare Part D program that the agency would no longer tolerate so-called gag clauses in pharmacy contracts, which prevent pharmacists from telling customers when they can pay less in out-of-pocket costs for their prescription medicines by not using their insurance plans.
If CMS is able to reach some sort of an agreement for insulin manufacturers to lower their list prices, that cut is unlikely to be large, long-lasting or different from what would have happened under drugmakers' negotiations with Medicare insurance plans, Fiona Scott Morton?, a professor of economics at Yale University School of Management, tweeted in a response to S&P Global Market Intelligence.
"Persuasion isn't a strong force," she said.
Will right to try get ugly for drugmakers?
With the Right To Try Act now signed into law, drug manufacturers could find themselves under greater pressure, including targeted "naming and shaming" social media campaigns, to provide their unproven, experimental therapies to patients desperate for a cure.
The law permits Americans to bypass the FDA's compassionate-use process, also known as expanded access, for seeking experimental drugs. But the pharmaceutical companies cannot be forced under the Right To Try Act to provide their medicines to patients.
At last week's annual BIO International Conference in Boston, one biotech CEO, who did not want his company identified, said he had received a "threatening" phone call from a family member of a late-stage cancer patient seeking access to the company's experimental medicine under the new law.
He disclosed the circumstances about the threat during the question-and-answer portion of a BIO fireside chat with FDA Commissioner Scott Gottlieb.
Days after Trump signed the right-to-try legislation, Gottlieb clarified on Twitter that the "burden rests with sponsors developing potentially life-saving or life-extending drugs to consider making these products available, pre-approval, to patients who qualify for access."
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, also told her staff in a May 30 memo to direct anyone seeking medicines under the Right To Try Act to the drug's manufacturer.
At BIO, Gottlieb said regulators were working on how best to implement the new law — repeating what he said earlier on Twitter — despite being told in a May 31 letter by the legislation's author, Sen. Ron Johnson, R-Wis., that the Right To Try Act was intended to "diminish the FDA's power over people's lives, not increase it."
The Biotechnology Innovation Organization, which hosted last week's Boston conference, told S&P Global Market Intelligence that each of its member companies determine "their own policies and procedures for handling expanded access and right to try requests."
The organization said it has developed a set of principles to help inform those processes.
The Pharmaceutical Research and Manufacturers of America said that while it did not take a position on the right-to-try legislation, "we believe that any program must continue to protect patient safety."
The lobbying group told S&P Global Market Intelligence it had "engaged with a broad array of stakeholders during the legislative process, including the relevant committees of jurisdiction and regulatory agencies."
But right-to-try opponent Michael Becker, a former biotech executive who has been diagnosed with terminal cancer, told S&P Global Market Intelligence in a tweeted response that he feared that as patients are turned down by companies for access to unapproved treatments, they will launch social media campaigns, like the one that targeted Chimerix Inc. in 2014.
A firestorm erupted on Twitter and Facebook when Chimerix was slow to provide its experimental antiviral brincidofovir to a young cancer patient, Josh Hardy, to fight an adenovirus infection he had contracted after a bone marrow transplant.
The company was eventually able to provide brincidofovir to Hardy, but he died in 2016.
"Time will tell" whether more drug companies will experience similar strife, Becker said.
Deadly flu season for youngsters
The 2017-2018 U.S. influenza season turned out to be one of the deadliest in recent years for children, killing 172 pediatric patients, health officials reported June 8.
That number exceeded the 171 pediatric-related flu deaths reported during the 2012-2013 season, which previously held the record — excluding pandemics, such as in 2009-2010 when 358 children died of the H1N1 virus — the Centers for Disease Control and Prevention, or CDC, said.
Both the 2017-2018 and the 2012-2013 flu seasons were dominated by the H3N2 virus — a particularly nasty strain.
While preliminary data reported in February showed that the U.S. flu vaccine was only 36% effective overall, the shot worked much better in young children — demonstrating efficacy of 59% against the influenza A and B strains and 51% for the H3N2 virus alone.
But the CDC said about 80% of the flu-related pediatric deaths during the 2017-2018 season occurred in children who had not received a flu shot.
Nonetheless, with the efficacy of the influenza shot uncertain from season to season — ranging from 10% to about 60% in recent years — it is time for the U.S. to get serious about developing a universal flu vaccine and invest more resources, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told lawmakers in March.
