Tag: Rx

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: MEDPAC thinks Medicaid programs should be able to have their own rx coverage process other than “well I guess if it made it through the p*ss poor FDA process, we have to pay for it.”

 
 

Clipped from: https://www.axios.com/pro/health-care-policy/2023/01/27/medicaid-commission-drug-coverage-flexibility

Illustration: Megan Robinson/Axios

The Medicaid and CHIP Payment and Access Commission voted Friday to ask Congress to let states restrict Medicaid coverage of a drug when Medicare only covers it in clinical trials and while other data is collected on effectiveness.

Why it matters: Unlike Medicare, Medicaid has to fully cover FDA approved drugs regardless of their cost or how much real-world evidence exists on the drug’s effectiveness — which has the potential to wreak havoc on state budgets.

• The commission wants Congress to level the playing field between Medicaid and other insurers and give states the option for more flexibility.
  

Reality check: Lawmakers on both sides of the aisle support making it harder for Medicare to limit coverage of FDA-approved drugs — so it would be an uphill battle to get Congress to expand the coverage pathway to Medicaid.

• Regardless, the vote indicates this is a difficult issue that Medicaid stakeholders aren’t likely to drop anytime soon.
  

Driving the news: Last year, regulators decided Medicare will cover the controversial Alzheimer’s drug Aduhelm only for patients enrolled in randomized clinical trials.

• The National Association of Medicaid Directors said in a February letter that limiting Medicare coverage would shift costs onto state Medicaid programs, since Medicaid programs don’t have the same option to restrict coverage.
  

Giving Medicaid the ability to cover drugs only in clinical trial settings could take some financial pressure off of states to cover expensive but questionably effective drugs, according to MACPAC.

• The policy could also encourage drug manufacturers to move through traditional FDA approval and show adequate clinical benefit, the commission said.
  

 
 

• But MACPAC noted during Thursday’s meeting that limiting Medicaid coverage of drugs can reduce beneficiaries’ access to therapeutics and create more administrative work for prescribing providers.
  

What they’re saying: “To me, the key issue here is that we’re talking about medications that have potential benefit, but we don’t actually know if it’s an actual benefit yet,” MACPAC Commissioner Angelo Giardino said during the commission’s Thursday meeting.

• Commissioner Heidi Allen was the lone member to vote against the recommendation.
  
• “I think [this flexibility] has equity and access implications, and it’s hard for us to look into the future to say what those would be,” Allen, a social work professor at Columbia University, said during the Thursday meeting.
  

 
 

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: The state is asking for more for this one drug than for its entire I/DD waiting list.

 
 

Nebraska officials are predicting that a controversial new Alzheimer’s drug could drive up state Medicaid costs by more than $16 million annually.

That includes the cost of the drug, Aduhelm, plus monthly intravenous infusions used to deliver the drug and the regular laboratory tests and brain scans needed to monitor its effects.

The cost of covering Aduhelm is among several issues listed in the Department of Health and Human Services budget request for the two-year period ending June 30, 2025. The submission of agency budget requests to the Governor’s Office kicked off the months-long process of crafting a new state budget.

While the $16 million request pales in comparison to the $2.5 billion annual cost of Nebraska Medicaid, the budget impact would be larger than the $15 million requested for the first year of HHS salary increases or the $11.9 million requested to serve 250 Nebraskans with developmental disabilities on the state’s waiting list.

According to the HHS request, state tax dollars would cover nearly $7 million of the cost, with the remaining $9 million coming from federal funds.

The federal Food and Drug Administration approved Aduhelm, the brand name for aducanumab, in June 2021. The drug is the first new Alzheimer’s drug approved in two decades and the first of a class of medications targeting the amyloid plaques that develop in the brains of Alzheimer’s patients.

The decision proved immediately controversial. Clinical trials showed that the drug reduced amyloid in the brain, which the FDA said is reasonably likely to slow the progression of the disease in Alzheimer’s patients.

“This could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer,” said Angel Horton Frank, a spokeswoman for the Alzheimer’s Association of Nebraska.

Critics said the drug showed only mixed benefits in clinical trials leading up to the FDA decision, despite an initial price tag of $56,000 a year. Biogen, the drug’s manufacturer, has since cut the cost to about $28,200 a year. Critics also pointed out that the drug was approved through an accelerated FDA process.

In January, the Centers for Medicare and Medicaid Services announced that Medicare would cover Aduhelm only for people who get it through a clinical trial. That decision came as several private insurers announced that they would not cover the drug, labeling it experimental.

Federal law, however, requires Medicaid programs to cover nearly all FDA-approved drugs. As a result, the decision to sharply limit Medicare coverage of Aduhelm means the full cost of the drug and associated care will fall on Medicaid for qualifying patients.

Medicare is a federal health program for people 65 and older or with disabilities. Medicaid is a state-federal program for low-income people. For low-income seniors, Medicaid pays what Medicare does not.

Frank, the state Alzheimer’s Association spokeswoman, said the organization believes Medicaid should cover aducanumab.

“Americans living with Alzheimer’s disease are entitled to access FDA-approved therapies, just as are people with conditions like cancer, heart disease and HIV/AIDS,” she said.

The Alzheimer’s Association estimates that more than 35,000 people in Nebraska have Alzheimer’s or dementia, out of some 6 million people nationwide.

It’s unclear whether anyone in Nebraska has started using the drug. Nationally, doctors have been reluctant to prescribe it.

Frank referred that question to Dr. Daniel Murman, director of the University of Nebraska Medical Center’s memory disorders and behavioral neurology program. He said he has no patients getting the drug currently because of its cost and the lack of insurance coverage.

But he said the medical center will be part of a clinical trial of Aduhelm for people at early stages of the disease, making it possible for participants to qualify for Medicare coverage.

Murman expressed hope about the potential for drugs like aducanumab. Just this week, drugmakers Eisai and Biogen reported that a medication called lecanemab had slowed clinical decline in Alzheimer’s patients by 27% in clinical trials when compared with a placebo. Similar drugs are in varying stages of development.

“I am optimistic that this treatment approach will be an important breakthrough in the treatment of patients with Alzheimer’s disease who are at the earliest stages of their disease and if clinical benefits are confirmed, then this class of medications should be covered by Medicaid and other payers,” Murman said.

Myzette Howell discusses the process of caregiving for her parents Loretta and Percy Howell, who have diagnosed with Alzheimer’s Disease.

 
 

Clipped from: https://nonpareilonline.com/news/state-and-regional/nebraska-medicaid-officials-seek-16-million-a-year-for-new-alzheimers-drug/article_9ace8e7e-3b3a-5666-9331-3ffe7b8a6d29.html