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Today, we explore BIO’s recommendations for how CMS can safeguard patient access under Medicare Part D, along with insights on a California Supreme Court case that could affect the complex drug development process, plus more news to know. (748 words, 3 minutes, 44 seconds).
As we observe Veterans Day, we honor America’s veterans for their service and sacrifice. Check out our past coverage on how biotech supports veterans and ways to advocate for women veterans. |
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CMS must address Part D plan abuse of IRA provisions designed to protect patient access |
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BIO has once again requested that the Centers for Medicare & Medicaid Services (CMS) take steps to protect patient access—asking the agency to address concerns over Medicare Part D plan policies aimed at medicines developed and marketed by small biotech companies.
Why it matters: Many Inflation Reduction Act-related changes are happening to the Part D benefit in 2025. This includes a new Part D discount program where manufacturers must pay a portion of Part D costs.
The law included phase-in provisions—to protect small biotechs from absorbing these costs all at once, and to protect patient access.
However: There are instances where Part D plans have asked small biotechs to pay Part D plans an increased rebate to account for the fact that plans must bear phase-in costs or else be subject to burdensome utilization management, such as step therapy, or even non-coverage.
BIO's take: CMS should increase oversight of Part D plan formulary rules, and specifically scrutinize access restrictions. BIO will continue to push the agency to do the right thing in the interest of patients and ensure that PBM/Part D plan shenanigans are stopped.
Read more at Bio.News.
Do you need guidance on the open enrollment process? MAPRx, a coalition of 60+ patient groups, has provided resources to guide patients through the changes, both positive and negative. Read more at Bio.News. |
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BIO explains drug development process in amicus brief supporting Gilead
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Drugmakers dealing with the complex process of developing medicines must be allowed to decide against trying to bring a drug to market, BIO explains in an amicus brief filed with the California Supreme Court on Nov. 4.
What the plaintiffs said: Even though drugs using tenofovir disoproxil fumarate (TDF) are safe and effective, plaintiffs argue Gilead should be held liable for not getting the antiviral tenofovir alafenamide fumarate (TAF) to market sooner because TAF has fewer side effects.
What BIO said: BIO defended Gilead’s right to make drug development decisions in an earlier amicus brief filed on March 12. BIO supported Gilead’s appeal for summary dismissal, and the California Supreme Court agreed to review the case.
In a new amicus brief, BIO explains the complexities of drug development. Investors need to know that drugmakers will not be sued for developing safe, effective drugs with Food and Drug Administration (FDA) approval.
BIO’s view: “Imposing liability on a company for selling an FDA-approved, admittedly non-defective medicine because of some subsequent medical advance creates an untenable and ultimately unworkable liability regime,” the brief argues.
Read more at Bio.News.
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What Else to Read This Week
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7% percent of workers on dairies with reported cases of avian flu test positive. The tests, held at dairies in Michigan and Colorado, indicated a need for further testing among farmworkers, says the Centers for Disease Control and Prevention (CDC). All of the workers who tested positive worked cleaning the milking parlor, confirming the high level of the virus in the milk of infected cattle. Half of those who tested positive indicated no symptoms, while others reported symptoms ranging from itchy eyes to sore throat, sneezing, diarrhea, and headaches.
Coordination, communication, education, planning—those are some of BIO’s recommendations to the Food and Drug Administration (FDA) on how to make the new Rare Disease Innovation Hub most effective at promoting the development of orphan drugs. Read more at Bio.News.
Merck Animal Health is reshaping the future of livestock management,reports Vet Candy. The BIO member recently launched two new technologies to enhance efficiency, animal welfare, and data accuracy on the farm: SenseHub® Dairy Youngstock, the first monitoring system tailored for calves from birth through their first year, and widespread availability of ALLFLEX APR handheld RFID readers. “Merck is giving producers powerful tools to improve operations, ensure animal health, and streamline information management,” says Vet Candy.
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Beltway Report: What's Ahead in Washington
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BIO released the following statement after the election: “We look forward to working closely with President-elect Trump, his incoming Administration, and members of Congress on both sides of the aisle to ensure that we have leadership in government that advances the ‘virtuous circle’ of innovation coming from America’s great biotechnology companies. The public health and our national security are best served by strong leadership that respects and advances science and medicine and ensures that the United States and our allies continue to lead the world in biotechnology.”
Meanwhile, on Thursday, officials from the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention will testify at a House Select Subcommittee on the Coronavirus Pandemic hearing, “Preparing for the Next Pandemic: Lessons Learned and The Path Forward.” |
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