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Tuesday, February 15, 2022

Biden's inflationary health care agenda

 Poll after poll shows that Americans’ top concern is high inflation. Inflation, which most harms low-income families and seniors on fixed incomes, is largely attributable to President Biden’s spending binge. Rising inflation is forcing Americans to cut back in all sorts of ways, from driving less due to high gas prices to replacing family-favorite meals with less preferred options.

Despite the death of the Build Back Better Act, Biden is aiming to resurrect failed big-spending proposals that would increase health care prices and prices throughout the entire economy.

First, Biden is proposing to permanently increase ObamaCare subsidies that limit what households pay for a benchmark ObamaCare plan. This structure contributes to health inflation by making enrollees insensitive to premium increases. Health insurers can raise prices, with taxpayers picking up the tab.

While competition among insurers can help curtail inflationary pressure from ObamaCare’s perverse subsidies, many areas of the country lack adequate competition. One-third of counties have only one or two insurers selling ObamaCare plans. In these counties, insurers have substantial pricing power, and studies show that increased premiums and inflated prices result. 

Last year’s American Rescue Plan (ARP) Act worsened ObamaCare’s inflationary subsidy structure in two ways. First, it increased the taxpayer share of the premium. Second, it removed the income cap on subsidy eligibility.

ObamaCare limited its subsidies to people with income below 400 percent of the poverty line — $111,000 for a family of four in 2022. By eliminating that cap, ARP brought more people into ObamaCare’s inflationary subsidy structure. According to the Congressional Budget Office, three-quarters of the expanded subsidies’ cost – about $15 billion a year – went to people who already had coverage. This spending did not increase insurance coverage but did increase inflation.

The expanded subsidies expire at the end of the year. Some congressional Democrats are seeking to make them permanent. This would drive up premiums and prices for health care as well as for other goods and services. These higher costs would harm both taxpayers and most people with private coverage since they don’t qualify for such lavish subsidies. Policymakers should reform ObamaCare’s subsidy structure, rather than expand it.

A second Biden health policy is even more inflationary. The president is proposing to further increase federal payments to states for Medicaid — the program that finances health and long-term care expenses for mainly lower-income Americans. With this approach, Biden seeks to build on the primary Democratic health policy priority of the past decade, pumping up federal spending to induce states to expand Medicaid. One clear problem: Increased Washington funding has caused an explosion in improper federal Medicaid spending, which a new government report estimates at $100 billion annually.

In addition to driving massive improper and wasteful spending, the macro-effect of greater federal Medicaid spending is inflationary. ARP increased federal Medicaid spending by about 10 percent. States enjoyed record revenue collections over the past two years, even when they did not need additional funds. For example, California (a tax and spend state) has had a 20 percent boost in tax revenue during the pandemic.

States used the additional federal money, including about $30 billion in higher Medicaid payments in 2021 from ARP, to increase overall spending. As government spending goes up, more money is chasing the same amount of goods and services, so prices rise.

Washington must stop harmful existing policies toward states that are driving inflation, much less lavish even more money on states. This includes congressional Democrats’ new proposals, such as establishing a new Medicaid-like program in states that have not adopted ObamaCare’s expansion and creating a home and community-based program financed with increased federal money. 

When Congress enacted ARP last year, the temporary increases in ObamaCare subsidies and the higher federal Medicaid spending were poor uses of taxpayer dollars that produced large waste and caused higher inflation. Policymakers must learn from that failure and not exacerbate already high inflation by making these bad temporary policies permanent. Instead, to reduce inflationary pressure in the economy, policymakers should let the temporarily enhanced ObamaCare subsidies expire and halt the flow of excessive federal Medicaid funds to states. 

Brian Blase, who served as a special assistant to President Trump at the National Economic Council, is president of Paragon Health Institute.

https://thehill.com/opinion/healthcare/594349-bidens-inflationary-health-care-agenda

Federal judge blocks Air Force from booting service member over vaccine refusal

 A Georgia federal judge blocked the Air Force from booting a service member who objected to receiving the COVID-19 vaccine for religious reasons.

In a preliminary injunction issued Tuesday, U.S. District Judge Tilman Self III ordered the Air Force to refrain from taking “any adverse action” against the unnamed Air Force officer on the basis of “this lawsuit or her request for religious accommodation, specifically including forcing her to retire.”

“Given ‘the Nation’s essential commitment to religious freedom[,]’ Plaintiff’s harm—a constitutional injury involving her right to freely exercise her religion—is not a mere trivial grievance,” Self wrote in a blistering rebuke of the mandate.

"And, what real interest can our military leaders have in furthering a requirement that violates the very document they swore to support and defend?” the judge continued. “The Court is unquestionably confident that the Air Force will remain healthy enough to carry out its critical national defense mission even if Plaintiff remains unvaccinated and is not forced to retire.”

Ann Stefanek, a spokesperson for the Air Force, told The Hill that the service is “aware of the preliminary injunction and will abide by the Court’s Order until the matter is legally resolved. The Air Force has no other comments about this ongoing litigation.”

The case was filed in January by the Thomas Moore Society on behalf of the service member, who says they served for over 25 years.

According to the organization, the service member says they object to the COVID-19 vaccine for religious reasons, and because they have natural immunity to COVID-19 from prior infection. She was denied a request for religious accommodation in December and filed suit a month later.

The Air Force gave its active-duty service members until Nov. 2 to be vaccinated, while Air National Guard and Reservists had until Dec. 31 to be inoculated.

It wasn’t until last Tuesday that the service said it had granted religious exemptions to the mandate — approving nine out of thousands that it has received.

Similar rulings have been handed down by other federal courts over the past couple of months.

In early January, federal Judge Reed O’Connor in the Northern District of Texas blocked the Navy from taking adverse actions against a group of 35 Navy sailors who had religious objections to the mandate.

On Feb. 2, in a case brought by Liberty Counsel, U.S. District Judge Steven Merryday of the Middle District of Florida temporarily barred the Navy and Marines from “diminishing or altering in any manner and for any reason the current status” of a Navy commander and Marine Corps lieutenant colonel for not getting vaccinated through a hearing that was scheduled for Feb. 11.

Merryday extended his order that day following the hearing, Liberty Counsel said at the time.

https://thehill.com/policy/defense/air-force/594443-georgia-federal-court-judge-air-force-from-booting-service-member

Court strikes down Boston's vaccine mandate for unionized first responders

 A judge on Tuesday blocked a COVID-19 vaccine mandate for certain first responders, writing in her order that the city's mandate cannot be enforced on the members of three unions until legal challenges are resolved.

Massachusetts Appeals Court Judge Sabita Singh ruled on Tuesday that Boston Mayor Michelle Wu’s vaccine mandate for city employees cannot be enforced until a disagreement between the city and three unions — Boston Firefighters Local 718, Boston Police Superior Officers Federation and the Boston Police Detectives Benevolent Society — has been resolved, Boston.com reported.

“Given the limited harm to the city and the public health interest it seeks to promote, and the substantial harm likely to be sustained by the unions in the absence of an injunction, the balance of harms favors the issuance of an injunction to preserve the status quo, in view of the unions’ likelihood of success on the merits," Singh wrote in her order.

While this dispute is ongoing, an agreement between Boston and the unions that requires city employees get vaccinated or get tested weekly for COVID-19 will remain in place.

Wu issued her mandate for city employees shortly after she was elected as Boston's first female and first Asian mayor in November.

A spokesperson for the Boston city government told the news outlet that the city was disappointed by the ruling on Tuesday.

“To protect communities and workplaces against COVID-19, courts across the country have repeatedly recognized the rights of state and local governments to require public employees to be vaccinated," they said. "More than 95 percent of the City’s workforce is vaccinated because of the policy we enacted. Our workers and residents who rely on city services deserve to be protected."

In a statement on social media, the Boston Police Superior Officers Federation said the union was not waging an anti-vaccination fight. The organization said that it was "a chance to hold our elected leaders accountable while protecting our member’s labor rights."

https://thehill.com/homenews/state-watch/594455-court-strikes-down-bostons-vaccine-mandate-for-unionized-first

CVS to Give At-Home Covid-19 Tests at No Cost Up Front

 CVS Health Corp. said Tuesday that it would provide at-home Covid-19 tests at no up-front cost to customers.

A new program would allow people to enter their insurance information and receive free tests. Previously, customers had to pay for tests out of pocket and submit reimbursement claims. The program would expand access, a CVS executive said.

Rules the federal government announced last month required private health insurers to cover at-home Covid-19 tests, a measure implemented as Omicron cases surged.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/CVS-to-Give-At-Home-Covid-19-Tests-at-No-Cost-Up-Front-39478674/

No end in sight for Larimar’s hold woes

 Larimar Therapeutics is on the slide – again. Fears over the future of its Friedreich’s ataxia project CTI-1601 caused shares to fall 66% today, after the FDA yesterday failed to lift a clinical hold and requested further data. Last May the regulator halted work on CTI-1601 after several deaths in non-human primates. Today there were also concerns about Larimar’s cash position, despite assurances of funding until 2023. Larimar now risks falling further behind in the race to get a Friedreich’s product to market, a prize that could be claimed by Reata, which is set to complete a rolling NDA for its Nrf2 activator omaveloxolone by the end of this quarter, leading to a potential launch in early 2023 – although the company's credibility took a hit last year over its lead project, bardoxolone. Others are also edging closer to the finish line. PTC Therapeutics and Retrotope have projects in phase 3, with pivotal data from the former’s vatiquinone due in the second half of 2023, and Retrotope expected to report data for RT001 soon, after competing its 65-patient study in December. Even if CTI-1601 does get back into the clinic the market might already be sewn up.

The Friedreich's ataxia clinical pipeline
ProjectCompanyDescriptionTrial details
Phase 3
OmaveloxoloneReataNrf2 stimulantRolling NDA to complete in Q1 2022 
RT001RetrotopeDeuterated polyunsaturated fatty acidPh3 completed Nov 2021
Vatiquinone (EPI-743)PTC Therapeutics15-lipoxygenase inhibitor Move-FA completes Apr 2023
Phase 2
Leriglitazone (MIN-102)Minoryx TherapeuticsPPAR-gamma agonistFrames reported Dec 2020; primary endpoint "inconclusive"; development continues
Phase 1
CTI-1601Larimar TherapeuticsRecombinant fusion proteinPh1 MAD trial reported May 2021; on clinical hold
IXC-109Ixchel PharmaMonomethyl fumarate prodrugNot in trial databases
Source: Evaluate Pharma.

https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/no-end-sight-larimars-hold-woes

Omecamtiv disappoints again

 The Meteoric-HF trial was not crucial to Cytokinetics’ ambitions for the heart failure asset omecamtiv mecarbil, but the company could still have done with a hit. Instead the study’s failure today narrows the project’s potential market, and heightens tensions over the FDA’s ongoing review. That review is based on Galactic-HF, a trial whose primary analysis managed a weak hit. Cytokinetics is therefore pinning hopes on a subgroup with severe heart failure; the FDA will pronounce on this evidence by the Pdufa date of November 30. Whatever the agency’s verdict, any chance of expanding into a wider population has likely been ruled out by the Meteoric-HF miss. This study showed omecamtiv, a cardiac myosin activator, to be no better than placebo at improving exercise capacity in patients with heart failure with reduced ejection fraction; full data are to come at ACC in early April. According to Mizuho analysts Meteoric-HF could have supported a supplemental filing and a possible 10-20% increase in sales, but they point out that investor expectations were low going into this readout “as they are with omecamtiv in general”. Perhaps this explains the muted share price reaction: Cytokinetics is down just 2% in early trade. 


https://www.evaluate.com/vantage/articles/news/trial-results-snippets/omecamtiv-disappoints-again

Forecast WW sales ($m)Omecamtiv mecarbilConsensus sales forecasts2021202220232024202520260100200300400
Evaluate Vantage



Asco Plenary – pancreatic cancer, a new Kras battleground

 Amgen and Mirati’s Kras inhibitors are already set for a showdown in non-small cell and colorectal cancers. The next battleground could be late-line Kras G12C-mutated pancreatic cancer, and data on Amgen’s Lumakras being presented today at the Asco Plenary Series allow a cross-trial comparison against results Mirati presented at Asco-GI last month with its rival, adagrasib. With the usual caveats about cross-trial comparisons and small patient numbers, adagrasib again looks to have the edge on efficacy, but with higher toxicity. Still, there were no deaths or treatment-related discontinuations with either asset. The next question, how big this market could be, will be top of investors’ minds after recent disappointing Lumakras sales in NSCLC. According to both Mirati and Amgen Kras G12C mutations account for just 2% of pancreatic cancers, so this looks like a very small niche. A bigger target could be Kras G12D mutants, which make up 36% of those with pancreatic cancer, Mirati reckons. The group has a G12D project, MRTX1133, in preclinical development.

Cross-trial comparison of Lumakras vs adagrasib in Kras G12C-mutant pancreatic cancer
Product/ projectCompanyTrialCut-off dateNORRMedian PFSTRAEsGrade ≥3 TRAEs 
LumakrasAmgenPh1/2 Codebreak-100Nov 1, 20213821%4.0mth42%16%
AdagrasibMiratiPh1/2 Krystal-1Sep 10, 202110*50%**6.6mth87%***27%***
*Pts had pancreatic ductal adenocarcinoma, which accounts for >90% of pancreatic cancers; **Includes 1 unconfirmed PR; ***Analysis includes 30 pts with GI cancers. ORR=objective response rate; TRAE=treatment-related adverse events. Source: Asco Plenary & Asco-GI.

https://www.evaluate.com/vantage/articles/events/conferences-snippets/asco-plenary-pancreatic-cancer-new-kras-battleground