Costs of future therapies worry Medicaid programs

With Megan R. Wilson

WHAT THE UPCOMING BLOCKBUSTER DRUGS COULD MEAN FOR MEDICAIDThe approval last month of a controversial and expensive drug for amyotrophic lateral sclerosis, along with the prospect that another treatment for Alzheimer’s disease will gain accelerated approval in January, got us thinking – the implications for Medicare. are pretty clear, but what about Medicaid, which is required to cover FDA-approved drugs?

This is not an apples to apples comparison, Lauren found out after talking to Medicaid experts. Medicare will likely take most of the tab on both treatments (bearing in mind that an approval has yet to occur). Medicaid is typically responsible for cost-sharing obligations for dual-enrollment beneficiaries on Part B drugs, which is why the controversial Alzheimer’s treatment Aduhelm has also caused a stir in this program.

But if the potential Alzheimer’s drug lecanemab is approved and covered by the same restriction as Aduhelm – that patients are enrolled in a required confirmatory trial – “the concerns for Medicaid are probably not that high. just from a cost perspective,” Jack said. Rollins, director of federal policy at the National Association of Medicaid Directors.

And it’s worth noting that ALS is a condition for which patients may be eligible to enroll in Medicare before age 65, which means Relyvrio, the powder drug approved by the FDA in September, could be covered by Medicare Part D, which excludes Medicaid from cost sharing. to hang up.

Blockbusters to watch: Medicaid experts say states are closely watching the ongoing development of cell and gene therapies over the next few years, especially those targeting diseases affecting pediatric and non-white populations. These specialty drugs have the potential to be curative, but high upfront costs of millions of dollars, along with a small but uncertain pool of patients who could benefit from them, could wreak havoc on state budgets in the future.

One example is Zynteglo, which the FDA approved in August as the first cell-based gene therapy to treat beta-thalassemia, a blood disorder that may require regular red blood cell transfusions. Donna Sullivan, chief pharmacy officer for the Washington State Health Care Authority, told Lauren that her state has identified about five or six Medicaid clients who rely on transfusions and may be candidates for the treatment, which has a list price of $2. $8 million for a single. processing time.

The authority also monitors more “moderately priced” drugs – tens of thousands a year – that are prescribed to a wider population covered by Medicaid, such as HIV and cystic fibrosis treatments taken during the a patient’s life.

IT’S WEDNESDAY. WELCOME TO PRESCRIPTION PULSE. Feline friends, rejoice — an NIH study dubbed CATNIP, naturally) suggests that a combination of monoclonal antibodies and allergies can provide lasting relief for people with cat allergies.

Send tips and feedback to David Lim ([email protected] Where @davidalim), Lauren Gardner ([email protected] Where @Gardner_LM) or Katherine Ellen Foley ([email protected] Where @katherineefoley).

TODAY ON OUR PODCAST PULSE CHECK, Alice Miranda Ollstein shares with Krista Mahr a dispatch from her reporting in Pennsylvania and Michigan on doctors heading into the campaign trail ahead of midterms. Plus, Dr. Katie McHugh on moving her abortion practice to other states.

DOCTORS ASK PATIENTS TO FOCUS ON ANTIBIOTICS BILLDoctors are lobbying lawmakers to pass legislation that would reshape the market for new antimicrobial drugs. The goal is to make improving patient outcomes the top priority of any new incentives created by Congress, Lauren reports.

Doctors like Reshma Ramachandran of the Yale School of Medicine and former FDA official John Powers argue that the bill, known as the PASTEUR law. 3932, does not primarily focus on identifying and promoting new treatments that might be effective in treating patients with resistant insects. Previous congressional efforts to address antibiotic market challenges resulted in “more drugs, and none of them improved patient outcomes,” said Powers, now a professor of clinical medicine at the George Washington University. University School of Medicine, which argues that’s because the drugs aren’t being studied in people who actually need them.

Updated version: The senses. Michael Bennett (D-Colo.) and Todd Young (R-Ind.), two of PASTEUR’s main sponsors, offered an updated version as an amendment to the Defense Authorization Bill for the fiscal year 2023 “based on feedback we received to ensure contracts are awarded to treatments that improve patient outcomes,” a Bennet spokesperson said. The amendment also comes with a price of $6 billion, up from $11 billion in the original release.

But clinician advocates say the changes are not enough. The bill payments are another incentive “to be added for new antibiotics instead of clinically thinking, ‘Are these drugs going to treat the resistant infections that we’re seeing now?'” Ramachandran said.

CDRH LAUNCH VALVE PILOT — The FDA is already moving forward with its Total Product Lifecycle Advisory Program pilot program for medical devices. In January, the agency will unveil a soft launch of its Medical Device User Fee Amendments V initiative. And the FDA plans to enroll up to 15 devices within its Office of Cardiovascular Devices’ Office of Health Technology 2 over the course of the 2023 financial year.

The pilot — which appears consistent with the language of the MDUFA V Commitment Letter — is intended to provide FDA feedback early in a medical device’s development cycle to identify submission issues and help avoid setbacks. Initially, the pilot will focus on designated breakthrough devices before moving to inclusion of Safer Technologies program devices in fiscal year 2026.

The agency is seeking comment on the order in which health technology offices should be added to the pilot, what information is useful for manufacturer decision-making, and which specific patient groups, insurers and provider organizations are well suited for providing evidence information. sponsorship generation strategies.

THE ORGANIC LEADER AVOIDED DURING THE WEEKENDThe pharmaceutical world is trying to catch up on all the details surrounding what appears to be the ousting of former Biotechnology Innovation Organization CEO Michelle McMurry-Heath, who resigned Monday night amid unrest between her and board members. administration of the association, reports Megan.

Lobbyists and industry executives say part of the reason for McMurry-Heath’s departure stemmed from the desire of some board members to be more active in promoting social justice issues. (Megan urges you to call her if you know anything more — she can keep you anonymous.) McMurry-Heath, a doctor by training who was on the Biden administration’s shortlist last year to lead the FDA , reportedly resisted engaging in non-biotech activities. problems.

Trade association politics – and dealing with members’ competing interests and egos – can be brutal, but running BIO comes with its own set of challenges: the group has several dozen people on its board and around 1,000 members. in the biopharmaceutical, agricultural sciences and biodefense sectors.

The Wall Street Journal first reported over the weekend that McMurry-Heath was “on leave.” On Monday evening, BIO announced that she had resigned. Then, after 11 p.m. that same night, the group named an interim replacement: Rachel King, co-founder and former CEO of GlycoMimetics, a biotech company working to develop therapies for diseases like cancer.

The Biden administration is stepping up its campaign to convince Americans to get a bivalent recall this month, but adoption so far is low, POLITICO’s Krista Mahr and Adam Cancryn report.

The FDA released a notice on Friday outlining generic drug user fee rates for fiscal year 2023 after retracting a previously released version.

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