State Senator Jeff Irwin (D-Ann Arbor) will file a bill to to reinforce Michigan’s existing cancer treatment mandate which requires State regulated health insurance plans to cover all new genetic therapies.  DIFS hasn't cited a single Michigan insurer for violating this mandate since its inception in 1989: 

https://www.propublica.org/article/michigan-state-health-plans-cancer-treatments

Michigan Lawmaker to Introduce Bill Requiring State Health Plans to Cover Cutting-Edge Cancer Treatments

After ProPublica reported on a Michigan insurer that wouldn’t cover a cancer patient’s last-chance treatment, a state lawmaker said he would introduce a measure compelling health plans to cover a new generation of advanced cancer therapies.

By Robin Fields and Maya Miller - March 5, 2024

Spurred by a ProPublica story about an insurer that denied coverage of the only therapy that could have saved the life of a 50-year-old father of two, a Michigan lawmaker plans to introduce a bill Tuesday requiring health plans in the state to cover cutting-edge cancer treatments.

In February 2020, Forrest VanPatten died fighting Priority Health, one of Michigan’s largest health insurers, over its refusal to pay for CAR-T cell therapy, his last-chance treatment. The therapy works by genetically reengineering patients’ own cells, then infusing them back into the body to beat back their disease.

Michigan has long required insurers to cover proven cancer treatments, but according to internal emails, some Priority Health executives argued that CAR-T was a gene therapy, not a drug, and thus not subject to the state’s coverage mandate.

State Sen. Jeff Irwin, D-Ann Arbor, plans to file the new bill to make explicit that Michigan’s cancer treatment coverage mandate includes a new generation of genetic and immunotherapies, including CAR-T.

Earlier this year, Michigan’s top insurance regulator told health plans they had to cover these treatments. Irwin’s measure would codify that guidance, ensuring it’s not dependent on one regulator’s interpretation of the law. He said he wanted the state’s requirements to be abundantly clear to both patients and insurers.

“I feel that the insurance company in this case was painting outside the lines,” Irwin said Monday in an interview. “This change that we’re making, I think, is going to make it hard to impossible for someone to make that same decision again around these particular treatments.”

The bill’s introduction was bittersweet for the VanPatten family. “If this helps any other family, any other person, we are all for it,” said Betty VanPatten, Forrest’s widow. “It just feels like they got one over on everybody.” Betty and her children said they hope Priority Health faces repercussions for the decision to deny coverage for Forrest’s treatment.

Priority Health’s decision not to pay for CAR-T cancer treatments was almost entirely motivated by the medication’s high cost, former employees told ProPublica. “It was, ‘This was really expensive, how do we stop payment?’” recalled Dr. John Fox, Priority Health’s associate chief medical officer at the time.

When the Food and Drug Administration approved the first CAR-T therapy in 2017, Fox tried unsuccessfully to persuade executives at Priority Health to cover it, citing Michigan’s law. He left his position with the health plan in 2019, in large part because he was disillusioned with the company’s decision not to pay for life-prolonging cancer therapies.

In an earlier statement to ProPublica, Priority Health said that “there was a lack of consensus in the medical community regarding the treatment” when it was first approved, and that the company began offering coverage after “extensive clinical work improved the treatment.” But well before VanPatten’s doctors requested Priority Health’s approval for the treatment in early 2020, an alliance of leading U.S. cancer treatment centers concluded there was substantial consensus about the treatment’s efficacy.

Asked about Irwin’s bill, Priority Health spokesperson Mark Geary said in a written statement that the company complies with all existing federal and state laws and has been providing coverage for CAR-T cell therapy for several years. “We also stand ready to continue to work with lawmakers and regulators in Michigan to find ways to offer Michiganders affordable access to effective, evidence-based treatments and procedures,” Geary wrote.

In the aftermath of ProPublica’s story, several Michigan lawmakers called out the state’s insurance department for not investigating Priority Health’s actions in the VanPatten case and failing to enforce the law that requires coverage of cancer drugs.

Regulators acknowledged they hadn’t cited a single Michigan insurer for violating the mandate since it was created in 1989.

Under existing law, the Michigan Department of Insurance and Financial Services can levy fines against insurers that fail to comply and can even suspend or revoke their licenses.

In an emailed statement, Communications Director Laura Hall said the agency anticipated backing Irwin’s proposal. The department, she wrote, “supports efforts to embed protections for cancer patients in state law.”

If Irwin’s proposal passes, not all Michigan health plans will have to follow it. Some employers pay directly for workers’ health care, hiring insurers to process claims. These plans are regulated by the federal government and are exempt from state coverage requirements, though some follow them voluntarily.

The FDA is now having second thoughts about the efficacy of CAR-T therapies, especially in newly discovered cases of blood cancers.  There are also significant safety concerns. This despite six different CAR-T therapies having been approved by FDA in 2017:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flag-safety-concerns-jj-bristols-car-t-therapies-2024-03-13/

US FDA staff raise concerns over data from J&J, Bristol's CAR-T therapies
By Bhanvi Satija and Sneha S K - March 13, 2024

March 13 (Reuters) - The U.S. Food and Drug Administration's staff on Wednesday raised concerns that it was unclear if Johnson & Johnson (JNJ.N) and Bristol Myers Squibb's (BMY.N) cell therapies would benefit blood cancer patients when given as early treatments.

Regulatory approval for the therapies as earlier treatments could expand their use to a larger subset of blood cancer patients who are less sick than those treated with multiple therapies. The therapies - J&J's Carvykti and Bristol's Abecma - belong to class known as CAR-T.

"I think there is a need for these therapies as patients are relapsing earlier," said Eric Smith from Boston's Dana Farber Cancer Institute.

FDA's staffers pointed to a pattern of early deaths in late-stage trials of the therapies, saying that it raised questions over the effectiveness of the treatments in extending the time patients live after receiving them.
Carvykti and Abecma are approved by the FDA to treat patients with multiple myeloma who have received at least four prior lines of treatment.

J&J partners with Legend Biotech (LEGN.O), while 2seventy bio (TSVT.O) is Bristol's partner for Abecma.

Guggenheim analyst Kelsey Goodwin said the FDA's stance was harsher-than-expected, but expects both therapies to gain approval.

In late-stage studies, both the treatments helped extend the time patients live before their disease begins to worsen.

About 8% of trial patients died after receiving Carvykti or Abecma - a proportion higher than those being treated with standard of care therapies.

While data for Carvykti does not clearly establish the need for an additional trial, further overall survival data from Abecma may not be sufficient to overcome the risk of early deaths, the reviewers said.

J&J said it remained confident in the clinical profile of Carvykti.

The meeting of FDA's independent advisers set for Friday will be closely watched by investors to understand the regulator's view on CAR-T therapies, after recent safety concerns over the treatments.

Does anyone see a bright line between FDA and industry any more?

All I see is Pharma hauling on one end of the rope, Insurance on the other, and FDA suspended in the middle pretending to serve the public interest.