Search This Blog

Thursday, October 13, 2022

Supreme Court Rebuffs Novartis, Allows Generic Versions of MS Drug

 The U.S. Supreme Court on Thursday turned down Novartis' bid to block the launch of generic versions of the company's blockbuster multiple sclerosis drug Gilenya in a dispute with China's HEC Pharm Co Ltd and other generic drugmakers.

Novartis had asked the justices to suspend a lower court's ruling that lifted a ban on generic versions of Gilenya, the Switzerland-based company's third highest-selling drug last year with $2.8 billion in sales.

Novartis sued HEC and more than a dozen other generic drugmakers, accusing them of patent infringement, in Delaware federal court after they applied for U.S. Food and Drug Administration (FDA) approval of Gilenya generics.

Novartis settled with some of the drugmakers it had sued, allowing for some Gilenya generics before a key patent's 2027 expiration. Companies that settled with Novartis included India-based Aurobindo Pharma Ltd, Dr. Reddy's Laboratories and Sun Pharmaceutical Industries Ltd, Pennsylvania-based Viatris Inc's Mylan Pharmaceuticals and privately held Canada-based Apotex Inc.

The FDA in 2010 approved Gilenya, a once-daily pill used to treat relapsing forms of multiple sclerosis, a chronic disease that affects the central nervous system. Novartis said in September that it expects to lose $300 million in sales for the rest of 2022 if the Gilenya generics are launched.

The patent-focused U.S. Court of Appeals for the Federal Circuit ruled in June that a key Novartis patent for Gilenya was invalid.

U.S. Chief Justice John Roberts, granting a request by Novartis on Sept. 29, temporarily prevented the Federal Circuit from issuing a mandate as planned on Oct. 4 to lift a federal judge's injunction that blocked generic versions of Gilenya based on the Novartis patent claims.

Roberts acted after Novartis said that green-lighting the generics would hurt the company in "ways that could be impossible to calculate at an after-the-fact damages trial" and that it was likely to win a Supreme Court appeal of the underlying case.

HEC told the Supreme Court that Novartis makes $3.8 million per day from Gilenya sales in the United States alone.

"If Novartis does not prevail in this Court, it will improperly extract $3.8 million from payors and patients every day its requested stay remains in effect," HEC said. "And not one penny of those improper monopoly revenues will be recoverable from Novartis by anyone."

A spokesperson for Novartis said the company will "continue to vigorously defend the validity of the Gilenya patent" and plans to petition the high court to review the Federal Circuit's decision.

No Data To Recommend 'Preferential' Omicron Booster Jabs: WHO Panel

 by Caden Pearson via The Epoch Times (emphasis ours),

There isn’t enough data to recommend COVID-19 booster jabs for Omicron subvariants over the original virus, the World Health Organization’s (WHO’s) panel of vaccine experts said on Tuesday.

Four variant-containing mRNA vaccines that either include bivalent Omicron subvariants BA.1 or BA.4–5 in combination with the “ancestral virus” have been authorized for use as booster doses.

The Strategic Advisory Group of Experts on Immunization (SAGE) said in a statement that it reviewed the “safety and immunogenicity” of bivalent vaccines when given as a booster in adults compared to the results of a clinical trial from another kind of vaccine.

Bivalent vaccines are designed to target two different strains of the virus. They contain both the mRNA of the original virus strain and that of the Omicron variant, which accounts for almost all virus samples collected in the last 30 days.

The bivalent jabs targeting the dominant subvariant might only offer a “minute incremental benefit,” according to SAGE, which determined that the highest public health priority is to achieve high rates of a primary dose of vaccine containing the “ancestral strain” of the virus.

“[C]urrently available data are not sufficient to support the issuance of any preferential recommendation for bivalent variant-containing vaccine boosters over ancestral-virus-only boosters,” SAGE added.

Either a monovalent jab designed for the original strain or a bivalent variant-containing shot can be used as boosters, according to the WHO panel.

The WHO panel said these shots given as boosters four to six months after the last dose provide “improved protection against currently circulating SARS-CoV-2.”

“The bulk of the benefit is from the provision of in particular the first booster dose, irrespective of whether it is a monovalent or bivalent vaccine,” SAGE said.

‘Modest Effect’ Only Seen in Labs, Not Clinical Settings

The variant-containing vaccines neutralize the virus to the same extent as ancestral shots but have a “slightly superior neutralization of the Omicron variant, according to SAGE Executive Secretary Joachim Hombach.

“It’s a relatively modest effect which we can see in the laboratory,” he said, adding that they cannot “relate these laboratory measures with an increase in clinical protection” because there’s no data on effectiveness.

https://www.zerohedge.com/medical/no-data-recommend-preferential-omicron-booster-jabs-who-panel

What employers expect to drive up health plan costs in 2023

 Employers are expecting their health plan costs to increase by a median of 7 percent in 2023, according to a Sept. 20 survey from the International Foundation of Employee Benefit Plans.

The International Foundation of Employee Benefit Plans compiled responses from 300 corporate/single employers, public employers/governmental entities and multi-employer benefit funds. Respondents were asked to name one primary reason for cost increases. Here are the top five answers:

1. Catastrophic claims (17 percent)

2. Medical provider costs (14 percent) 

3. Utilization due to chronic conditions (13 percent)

4. Utilization due to delayed preventive/elective card during the pandemic (12 percent) 

5. Specialty/costly prescription drugs (10 percent)

https://www.beckerspayer.com/payer/what-employers-expect-to-drive-up-health-plan-costs-in-2023.html

AMA: 3 out of 4 states have 'highly concentrated' PBM markets

 Most state and city-level drug markets are highly-concentrated, with one pharmacy benefit manager controlling a large share of the market, a new report from the American Medical Association found. 

The report, published Oct. 13, used 2020 data from individuals with commercial drug benefits tied to medical benefits. The report does not include data from Medicare and Medicaid. 

The analysis found 3 out of 4 states have highly-concentrated PBM markets, and 4 out of 5 metropolitan areas had highly-concentrated markets. 

Other findings of note from the study: 

  1. Express Scripts had the largest nationwide market share of any PBM, at 22 percent. OptumRX had a 17 percent share and Prime Therapeutics had 15 percent. 

  2. The 10 largest PBMs control 97 percent of the commercial drug market, and the four largest PBMs control around 66 percent.

  3. Payers that were vertically integrated with a PBM cover around 69 percent of people with commercial drug insurance. 

  4. The share of vertically integrated PBMs varied across states. South Dakota had the lowest rate of vertical integration, with 6 percent of the PBM market share vertically integrated with an insurer. North Carolina had the highest rate, at 97 percent. 

  5. The report found UnitedHealthcare is the largest commercial drug insurer, followed by Kaiser Permanente and Elevance Health (Anthem). 

The AMA has raised concerns about the integration of payers and PBMs in the past, writing to the Federal Trade Commission in April to urge "careful monitoring" of integration and consolidation in the PBM space. 

"PBM markets require careful scrutiny as less competition and more vertical integration can embolden anti-competitive business practices to the detriment of patients," AMA President Jack Resneck Jr., MD, said in a news release. 

Read the full report here.

https://www.beckerspayer.com/payer/ama-analysis-finds-3-out-of-4-states-have-highly-concentrated-pbm-markets.html

HHS renews COVID-19 Public Health Emergency for 11th time

 When President Joe Biden declared the COVID-19 pandemic "over" Sept. 18, his message divided the medical community and sent a clear message: the nation is moving on from COVID-19.

On Oct. 13, HHS extended the public health emergency once again and sent another clear message: the healthcare system is not ready to move on.

"There's 400 people dying every day, and most of those are in hospitals," Chip Kahn, president and CEO at the Federation of American Hospitals, told Becker's. "I don't think we're really into a new normal where we can say with confidence that this is still not an exceptional situation."

HHS last renewed the PHE July 15 for an additional 90 days — it also told states it would provide a notice 60 days before if it did decide to end it. Aug. 14, the date in which states would have 60 days' notice, came without a peep from the federal agency, all but confirming the declaration would be extended once more.

The 11th renewal of the PHE since its first declaration in January 2020 allows the country to continue operating under pandemic-era policies until at least the next deadline: Jan. 11, 2023.

But continuing to label the current situation as an emergency while also declaring that emergency over is increasingly being questioned.

Illinois Gov. JB Pritzker was asked in a political debate Oct. 6 why his state has now issued the same PHE 34 times since March 2020. Ten states still have their emergencies in effect.

"We're following the federal disaster declaration," Mr. Pritzker said. "It allows us to bring in Medicaid funds and support people who have COVID-19 and support our hospitals."

Sen. Richard Burr of North Carolina, the top ranking Republican on the Senate health committee, asked in a Sept. 19 letter to the president when Medicaid redeterminations would begin again, or when federal employees and contractors would no longer need to get vaccinated.

"Without a clear plan to wind down pandemic-era policies, the deficit will continue to balloon and the effectiveness of public health measures will wane as the American people continue to be confused by mixed messages and distrust of federal officials," he wrote.

The number of Americans who say they're concerned about COVID-19 is 57 percent — among the lowest seen throughout the pandemic, according to a Sept. 14 Ipsos poll. In addition, 82 percent believe the country is in a better pandemic position now than it was one year ago.

"I think it's the policymakers that are making the judgment because they're not happy with the implications of the PHE in terms of spending," Mr. Kahn said. "Also it's symbolic. If the president said we moved on and there's still a PHE, then that may put pressure symbolically on the White House to say by Nov. 15 that we're going to have to move on."

Moving on isn't so simple. The pandemic-era policies led to a complete overhaul of telehealth and who can use it, they fast-tracked approvals of COVID-19 vaccines and treatments, and they preserved healthcare coverage for millions of Medicaid beneficiaries nationwide.

Preserving telehealth

In April 2020, HHS relaxed telehealth restrictions and told providers it would not enforce HIPAA rules around audio-only telehealth services, meaning video calls could be used to treat patients.

In June, the agency released new guidance explaining how providers can maintain HIPAA compliance with telehealth post-PHE because the nonenforcement policy will only remain in effect while the PHE is in place.

Lawmakers are also looking to extend virtual opioid use disorder treatments for individuals with high-deductible health plans. The current rule allowing payers to offer virtual care to members before they meet their deductibles is set to expire at the end of this year.

In addition, waivers that allow patients to be virtually-prescribed buprenorphine for opioid use disorder will also expire when the PHE does. 

For Medicare, preserving telehealth flexibilities is also still a work in progress. Medicare has covered the cost of telehealth visits and allowed all Medicare-enrolled providers to bill for telehealth services since early 2020. 

As of now, the Medicare flexibilities will end 151 days after the PHE expires. In July, the House passed The Advancing Telehealth Beyond COVID-19 Act, but the legislation must still be approved by the Senate for Medicare patients to continue using telehealth through 2024.

Medicaid redeterminations

Medicaid enrollment initially swelled as a result of early pandemic joblessness and a continuous coverage requirement of the Families First Coronavirus Response Act, meaning states had to keep people enrolled in Medicaid for as long as there was a pandemic. Since February 2020, total Medicaid/Children's Health Insurance Program enrollment has increased by 17.7 million people, or nearly 25 percent.

If the public health emergency expires, a redetermination process will begin a major disenrollment of Medicaid beneficiaries, likely over the course of a year. Once that occurs, HHS estimates up to 15 million people could lose Medicaid coverage.

All payers operating Medicaid plans will be affected, but those with higher enrollments are expected to be more impacted. The loss of beneficiaries will be mitigated through the Inflation Reduction Act's extension of ACA premium tax credits through the end of 2025, which will allow some to regain coverage in the individual market.

Commercialization of COVID-19 vaccines and treatments

Until this fall, the federal government purchased and made available COVID-19 vaccines and treatments at no cost, but the process has begun to shift those costs to the commercial market.

"My hope is that in 2023, you're going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You're going to see commercialization of some of these things," White House COVID-19 Response Coordinator Ashish Jha, MD, said Aug. 16.

The onus will fall on payers to become more involved in pricing negotiations, likely leading to higher premiums for members. Commercialization would also leave the over 26 million uninsured individuals in the U.S. with a major disadvantage in accessing free vaccines and treatments.

Some of these products only went to market after fast-track approval from the Food and Drug Administration's emergency use authorizations, including vaccines. According to Bloomberg Law, that doesn't mean the products disappear once the PHE does.

EUAs must be initially justified by a PHE, but the former is not reliant on the latter to exist. If HHS does terminate an EUA, it must provide an advanced public notice and begin a transition period "for proper dispositioning of the product." 

Physicians: This is still an emergency

It isn't just the public and politicians looking to move on from COVID. 

Starting Oct. 20, the CDC will no longer publish daily updates on total cases and deaths, instead opting to share the data every Wednesday. The agency has also dropped its quarantine protocols for everyone and masking requirements for healthcare facilities not located in a high-transmission community — much to the dismay of some physicians.

"That means that places with substantial transmission can unmask sick patients who haven't been tested for COVID, right next to the elderly, chemo patients, people with pulmonary disorders, and pregnant women? My kid could identify the flaws with this plan," said Megan Ranney, MD, emergency physician and academic dean of Brown University School of Public Health in Providence, R.I. 

After the president declared the pandemic over, physicians across the country took to social media to express their disagreement.

"Heck no. With all due respect, [President Biden] — you're wrong. Pandemic is not over. Almost 3,000 Americans are dying from #COVID19 every single week," Eric Feigl-Ding, PhD, an epidemiologist and former faculty member at Boston-based Harvard Medical School, tweeted. "A weekly 9/11 is a very big deal. Don't even get me started on #LongCOVID — wreaking havoc on millions more."

Still, COVID-19 numbers have continued their downward trend. The nation's seven-day case average was 40,631 as of Oct. 9, a 25 percent decrease in the last two weeks. The CDC forecasts new hospital admissions will remain stable or have an uncertain trend over the next month, and deaths are expected to fall.

"We don't know what's going to happen in the next few months," Mr. Kahn said. "And if we look at Europe and the U.K., we see COVID on the rise. It is still a present issue."

https://www.beckerspayer.com/policy-updates/hhs-renews-covid-19-phe-for-11th-time-heres-why.html

CVS Health wants to own 'entire spectrum' of healthcare, CEO says

 CVS Health wants to be in charge of the "entire spectrum of someone's health journey," the company's chief executive said at an Oct. 12 event in Boston reported on by the Boston Business Journal.

CEO Karen Lynch pointed to how the company already delivers medication at the pharmacy, finances treatments through insurance company Aetna, provides low-cost urgent care at its MinuteClinics, and now intends to give care at home through its planned $8 billion acquisition of Signify Health, she reportedly said at the Boston College Chief Executives Club meeting.

Ms. Lynch said the company also plans to expand into primary care and expects to announce an acquisition later this year, the Business Journal reported Oct. 13. CVS is rumored to be in exclusive talks to buy Cano Health, a primary care firm focused on seniors.

Ms. Lynch told the crowd CVS has advantages over fellow healthcare disruptor Amazon, which recently agreed to acquire primary care chain One Medical for $3.9 billion, according to the story. "[Customers] really want to trust and engage with companies that have earned the right to be in healthcare," she said. "I think about Amazon as sort of a transactional company today."

https://www.beckershospitalreview.com/disruptors/cvs-health-wants-to-own-entire-spectrum-of-healthcare-ceo-says.html

Doctors Warn Pfizer's Paxlovid Can Interact With Common Medications

 Pfizer's Covid-19 treatment that's definitely not a profitable Ivermectin knockoff (despite both functioning as protease inhibitors) turns out to pose an increased risk of severe illness in Covid-19 patients who have a history of cardiovascular disease.

Paxlovid - Pfizer's Covid medication notably taken by Joe Biden, Jill Biden and Dr. Anthony Fauci - before all three had "rare" (and then not-so rare) cases of "rebound Covid" - can have dangerous interactions with some of the most common medications for cardiovascular disease, including various statins and heart failure therapies, according to a Wednesday paper published in the Journal of the American College of Cardiology.

In it, researchers found that the combination of nirmatrelvir and ritonavir, two antivirals which comprise Pfizer’s Paxlovid, can interact with a number of commonly prescribed cardiovascular medications. According to the paper, Ritonavir, which was approved to treat HIV in 1996, impacts the CYP450 pathway that’s involved in metabolizing a number of medications—as well as the P-glycoprotein drug efflux pump, the Epoch Times reports.

"Co-administration of [Paxlovid] with medications commonly used to manage cardiovascular conditions can potentially cause significant drug-drug interactions and may lead to severe adverse effects," reads an abstract. "It is crucial to be aware of such interactions and take appropriate measures to avoid them."

The paper also notes that interactions between Paxlovid and some blood thinners can cause a higher risk of bleeding, while interactions between Paxlovid and cholesterol medications such as Statins can be toxic, CNN reports, citing the paper.

"Awareness of the presence of drug-drug interactions of Paxlovid with common cardiovascular drugs is key. System-level interventions by integrating drug-drug interactions into electronic medical records could help avoid related adverse events," said lead author Saru Ganatra, MD, who works at Lahey Hospital and Medical Center in Burlington, Massachusetts.

"Paxlovid could be incorporated into an order set, which allows physicians, whether it be primary care physicians or cardiology providers, to consciously rule out any contraindications to the co-administration of Paxlovid," Ganatra continued, adding that there needs to be "consultation" with healthcare providers and pharmacists to avoid interactions.

As the Epoch Times notes, a U.S. Food and Drug Administration (FDA) fact sheet (pdf) of Paxlovid for health care providers goes into detail about possible drug interactions that can prompt life-threatening reactions.

The medications include but aren’t limited to anti-seizure medications, drugs for irregular heart rhythms, drugs for high blood pressure and high cholesterol, antidepressants and anti-anxiety medications, antidepressants and anti-anxiety medications, steroids, HIV treatments, blood thinners, and erectile dysfunction medications.

The importance of medication reconciliation before initiation of nirmatrelvir/ritonavir cannot be overemphasized to avoid serious drug-drug interactions,” the authors of the paper wrote Wednesday, referring to Paxlovid.

https://www.zerohedge.com/markets/severe-adverse-effects-doctors-warn-pfizers-paxlovid-can-interact-common-medications