Supreme Court declined to hear case challenging legality of Obamacare

The Supreme Court will wait for a federal appeals court to decide on the constitutionality of the Affordable Care Act, meaning that a final decision on the law won’t come before the 2020 election.

The court declined on Tuesday to hear a lawsuit from 17 red states that seeks to dismantle the controversial healthcare law. A group of 20 blue states and the District of Columbia who are fighting the lawsuit had asked the Supreme Court to intervene in the case and circumvent a likely lengthy review by an appellate court.

The blue states had wanted the Supreme Court to intervene to end uncertainty in the healthcare industry because of the lawsuit.

America’s Health Insurance Plans, the leading insurance industry lobbying group, wrote an amicus brief supporting the blue states’ efforts.

The group said that the Supreme Court should hear the lawsuit to remove the “overhanging legal uncertainty” surrounding ACA coverage.

The Supreme Court did not give a reason for not taking up the case.

But red states and the Department of Justice, which is supporting the lawsuit, said that it was too early for the court to weigh in.

A three-judge panel of the Fifth Circuit Court of Appeals decided in December that the ACA’s individual mandate was unconstitutional. However, the court declined to decide on whether the rest of the law should go down with the mandate, which the red states’ lawsuit is requesting.

It punted back to Federal Judge Reed O’Connor, who originally ruled the ACA was unconstitutional. The appellate panel wants the judge to decide if the mandate could be severed.

O’Connor has yet to make a ruling on the mandate.

https://www.fiercehealthcare.com/payer/supreme-court-declined-to-hear-case-challenging-legality-aca

Chi-Med stops pivotal pancreatic cancer trial upon early success

Hutchison China MediTech has stopped a phase 3 trial of surufatinib in pancreatic neuroendocrine tumors early for positive efficacy. An independent data monitoring committee found the trial had hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.

Surufatinib is an oral angio-immuno kinase inhibitor designed to both inhibit the formation of new blood vessels and promote antitumor immune responses, giving it a dual mechanism of action that Chi-Med thinks will make it suitable for use in immunotherapy combinations.

For now though, the focus is on the use of surufatinib as a monotherapy. Surufatinib has cleared the monotherapy tests put in front of it to date, first coming through a phase 3 trial in advanced extrapancreatic neuroendocrine tumors and now showing efficacy in pancreatic neuroendocrine tumors.

The latest trial to read out enrolled close to 200 patients with advanced pancreatic neuroendocrine tumors in China and randomized them to receive surufatinib or placebo once a day for a month. Chi-Med is yet to share data from the trial, but the progression-free survival results were strong enough for the data committee to recommend stopping the study at a pre-planned interim analysis.

Equipped with the phase 3 data, Chi-Med plans to meet with Chinese regulators to discuss filing for approval of surufatinib in patients with pancreatic neuroendocrine tumors. A filing for approval of the drug in non-pancreatic neuroendocrine tumors is already being assessed by China’s National Medical Products Administration, which put it on its priority review pathway late last year.

Chi-Med CEO Christian Hogg thinks the back-to-back clinical successes position surufatinib to carve out a niche in the treatment of neuroendocrine tumors.

“These positive results for pancreatic neuroendocrine tumors reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumors. We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumor disease,” Hogg said.

Chi-Med is now building up a sales and marketing team in China ahead of trying to turn surufatinib into a significant commercial product. Plans are less advanced in the U.S., where Chi-Med is testing the drug in proof-of-concept trials.

https://www.fiercebiotech.com/biotech/chi-med-stops-pivotal-pancreatic-cancer-trial-upon-early-success

Medicare for All would cut household income by 11%: Heritage study

Most Americans will pay much higher taxes and earn less income if Medicare for All becomes law, a new study by The Heritage Foundation states.

“How ‘Medicare for All’ Harms Working Americans” found 73.5 percent of Americans would shoulder financial hardships under the proposed universal health care system.

Most workers would pay 21.2 percent more in federal payroll taxes, bringing the rate to 36.5 percent for most workers. Average annual disposable income for U.S. households would decrease by an average of $5,671.

In addition to income taxes, most American workers pay 15.3 percent in payroll tax, 12.4 percentage points of which funds Social Security and 2.9 percentage points goes to Medicare. The new payroll tax of 36.5 percent would apply to every dollar earned, from the lowest-paid worker to the highest, the study states.

People who receive health insurance from their employer would be hit with an even bigger decrease in household income. Their disposable income loss would be $10,554 because they would lose the tax advantages from their employer insurance, which is currently untaxed. The study, released on November 19, finds 87.2 percent of households with employer-sponsored health insurance would be financially worse off.

All Income Groups Lose

Proponents of Medicare for All argue a government-run system will benefit consumers by costing less than what they have been paying for private insurance or health care services paid for out of pocket. That assumption is false, the study states.

“Our analysis finds that in order to fund such a program, it would be necessary for the federal government to impose substantial, broad-based taxes equal to 21.2 percent of all wage and salary income,” study authors Edmund Haislmaier and Jamie Hall write.

The 21.2 percent tax on workers would be necessary to fund a program that not only replaces employer-paid insurance but also insurance for workers with no health plans and the “additional spending that would result from the program stimulating increased use of medical care.”

In addition, the Medicare for All proposals offered by contenders for the Democrat presidential nomination would cover many services currently not covered by Medicare, such as long-term care, the study states.

Lower-income working families that currently get their health care through Medicaid or the Children’s Health Insurance Program would also lose, because they too would be subjected to higher taxes, the study finds. Haislmaier and Hall calculate these families’ average household income would decrease by $5,592 a year.

The authors used data from the 2016 Medical Expenditure Panel Survey of 12,704 households in making their calculations.

Edmund Haislmaier and Jamie Hall, “How ‘Medicare for All’ Harms Working Americans,” The Heritage Foundation, November 19, 2019: https://www.heartland.org/publications-resources/publications/how-medicare-for-all-harms-working-americans

Trovagene up 30% ahead of onvansertib data presentation

Nano cap Trovagene (TROV +29.7%) is up on modestly higher volume ahead of a presentation of Phase 1b/2 data on lead candidate onvansertib in KRAS-positive colorectal cancer at the ASCO GI Cancers Symposium this Saturday, January 25.

https://seekingalpha.com/news/3533106-trovagene-up-30-ahead-of-onvansertib-data-presentation

Annovis Bio sets IPO terms

Annovis Bio (ANVS) has filed a preliminary prospectus for an IPO of ~1.4M common shares at $6 – 8 per share. Underwriters’ over-allotment will be an additional ~214K shares.

Lead candidate is ANVS-401 for the potential treatment of Alzheimer’s and Parkinson’s diseases.

https://seekingalpha.com/news/3533110-annovis-bio-sets-ipo-terms

FDA approves Axonics’ neurostimulator programmer

Axonics Modulation Technologies (NASDAQ:AXNX) announces FDA approval of second-generation Programmer for its r-SNM System under a premarket approval (“PMA”) application supplement.

The new Programmer is used to program the Axonics external trial neurostimulator as well as the implantable neurostimulator in both the procedure and post-operative environments.

https://seekingalpha.com/news/3532953-fda-approves-axonics-neurostimulator-programmer

1Life Healthcare sets terms of upsized IPO

1Life Healthcare (ONEM) has filed a prospectus for its IPO of 17.5M common shares at $14 – 16 per share. Underwriters’ over-allotment will be an additional ~2.6M shares.

Gross proceeds should be ~$263M (midpoint), up from $100M filed a few weeks ago.

https://seekingalpha.com/news/3532959-1life-healthcare-sets-terms-of-upsized-ipo