'Infuriating' Denial: Medicare Advantage Plan Reopens Case

 Detroit-based oncologist Clara Hwang, MD, could not believe what she was seeing.

"We are unable to approve your request for this drug," read a letter from WellCare, a Medicare Advantage plan.

Hwang had just prescribed darolutamide (Nubeqa) to her patient. The oral agent had received FDA approval a month prior, in August 2022, for patients just like this one — men with metastatic hormone-sensitive prostate cancer on a gonadotropin-releasing hormone (GnRH) analog or who had a bilateral orchiectomy.

"I prescribed within the indication," Hwang, a medical oncologist with Henry Ford Health specializing in genitourinary cancers, told Medscape Medical News. "The denial I got was infuriating."

The letter, which Hwang posted to Twitter, indicated that the prescription had been denied because the requested agent had to be provided in combination with a GnRH analog or after bilateral orchiectomy but, according to WellCare, the "records your doctor gave us did not show you met (any of) the requirements."

Hwang was confused.

When Hwang reviewed the prior authorization request, she saw her team had indicated the patient was receiving a GnRH analog. In fact, the request included all information needed to get the prescription approved.

Her team called WellCare to point out the error.

"The only possible conclusion was that the insurance company did not read the submitted information carefully enough, or were not able to interpret it correctly," Hwang said.

Medscape Medical News reached out to WellCare to find out why the initial denial happened and how they plan to prevent potential denial errors in the future. A WellCare spokesperson responded that the company "cannot comment on individual care plans due to privacy laws" but said that when members or clinicians have concerns, "we have policies and procedures in place to actively address those concerns and resolve the issue as quickly as possible."

Following a prior authorization denial, physicians typically cannot simply resubmit the request, even if it was a company error. When Hwang tweeted about the error on September 30, she received a response from WellCare asking her to "please follow the appeals process on the denial letter."

Before Hwang could send the appeals letter, she discovered WellCare had reopened the case and started the review process again.

Even though Hwang had bypassed the appeals process, it took over a week for the drug to be approved. The entire process took a few weeks, she said.

In the end, Hwang was relieved to secure the drug for her patient but wishes she and her team were not forced to go through such time-consuming steps to do so.

"This was one of the more frustrating prior authorization scenarios I've encountered," Hwang said.

Revamp on the Horizon?

In Michigan, 94% of physicians report that prior authorization red tape causes delays in care for their patients.

The denial Hwang encountered suggests that "the staff making these decisions do not have enough medical knowledge to make good decisions," she said.

A 2018 report from the Office of the Inspector General raised concerns about the prior authorization process: 75% of appeals following prior authorization denials in Medicare Advantage were overturned, suggesting that these plans are likely denying services that should have been approved when requested.

Potential fixes are on the way.

In April 2022, Michigan Gov. Gretchen Whitmer signed prior authorization reform into law, with the aim of reducing wait times as well as the time physician teams spend on this process. By June, the law will require insurers to make a standardized electronic prior authorization request transaction process available. And for urgent requests, the law says that the prior authorization is considered granted if the insurer fails to act within 72 hours of the submission. 

This is part of our Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here.

Please email vstern@medscape.net to share experiences with prior authorization or other challenges receiving care.

https://www.medscape.com/viewarticle/990948

IRS whistleblower alleges cover-up of Hunter Biden tax evasion in bombshell letter to Congress

  An IRS whistleblower has informed Congress that they want to come forward to reveal a coverup in the tax evasion investigation of first son Hunter Biden, according to a letter obtained by The Post.

A lawyer representing the agency employee informed a group of congressional committee leaders Wednesday that they need guidance on how to lawfully expose “preferential treatment” and false testimony to Congress by a “senior political appointee.”

The unnamed whistleblower is “a career IRS Criminal Supervisory Special Agent who has been overseeing the ongoing and sensitive investigation of a high-profile, controversial subject since early 2020,” the official’s attorney, Mark Lytle, wrote to seven members of Congress.

Although Hunter, 53, isn’t named in the letter, a congressional source confirmed the complaint pertains to the first son, who reportedly borrowed about $2 million last year to pay off a federal tax bill assessed to income earned overseas.

Lytle did not immediately respond to a request for comment, nor did representatives of Hunter Biden. 

The White House referred an inquiry to the IRS and the Justice Department, which did not immediately respond.

“Despite serious risks of retaliation, my client is offering to provide you with information necessary to exercise your constitutional oversight function and wishes to make the disclosures in a non-partisan manner to the leadership of the relevant committees on both sides of the political aisle,” Lytle wrote.

An IRS whistleblower claimed in a letter to Congress that there was a coverup of Hunter Biden’s alleged tax evasion at the agency.

rian Lawless/PA Wire via ZUMA Press

“My client has already made legally protected disclosures internally at the IRS, through counsel to the US Treasury Inspector General for Tax Administration, and to the Department of Justice, Office of Inspector General. The protected disclosures: (1) contradict sworn testimony to Congress by a senior political appointee, (2) involve failure to mitigate clear conflicts of interest in the ultimate disposition of the case, and (3) detail examples of preferential treatment and politics improperly infecting decisions and protocols that would normally be followed by career law enforcement professionals in similar circumstances if the subject were not politically connected.”

The bombshell allegations have yet to be fleshed out by congressional investigators, but come as Republicans probe President Biden’s role in Hunter and first brother James Biden’s foreign business dealings dating to their powerful relative’s vice presidency.

Lytle wrote that tax-record privacy laws add a layer of complexity that will require guidance from Congress.

“Some of the protected disclosures contain information that is restricted by statute from unauthorized disclosure to protect taxpayer and tax return information,” Lytle wrote. “My client would like to share the same legally protected disclosures with Congress pursuant to 26 U.S.C. § 6103(f)(5) and the protections afforded by 5 U.S.C. 2302(b)(8)(C)—that he has already shared with other oversight authorities. Out of an abundance of caution regarding taxpayer privacy laws, my client has refrained from sharing certain information even with me in the course of seeking legal advice. Thus, it is challenging for me to make fully informed judgments about how best to proceed.”

The first statute referenced by Lytle is a section of federal law covering tax returns filed jointly by married couples. The second refers to a part of the law outlining prohibited actions by employees of the executive branch.

Hunter Biden reportedly borrowed $2 million to pay off a federal tax bill last year.

AP Photo/Patrick Semansky

“My goal is to ensure that my client can properly share his lawfully protected disclosures with congressional committees,” Lytle concluded. “Thus, I respectfully request that your committees work with me to facilitate sharing this information with congress legally and with the fully informed advice of counsel. With the appropriate legal protections and in the appropriate setting, I would be happy to meet with you and provide a more detailed proffer of the testimony my client could provide to Congress.”

The whistleblower’s emergence was quickly seized upon by the Biden family’s congressional critics.

“It’s deeply concerning that the Biden administration may be obstructing justice by blocking efforts to charge Hunter Biden for tax violations,” said House Oversight Committee Chairman James Comer (R-Ky.), who on Monday alleged that bank records show nine Biden family members appeared to benefit from overseas income.

The Oversight Committee “has been following the Bidens’ tangled web of complex corporate and finance records. It’s clear from our investigation that Hunter and other members of the Biden family engaged in deceptive, shady business schemes to avoid scrutiny as they made millions from foreign adversaries like China,” Comer added.

House Republicans are currently investigating President Biden’s potential role in business deals involving his brother James Biden and son Hunter.

Photo by Rick Friedman/Corbis via Getty Images

“We’ve been wondering all along where the heck the DOJ and the IRS have been. Nowe it appears the Biden administration may have been working overtime to prevent the Bidens from facing any consequences.”

Comer went on to promise his committee would “work to hold accountable anyone in the Biden administration who may be covering up this criminal activity.”

Republicans already had questioned the lethargic pace of a long-running criminal investigation of Hunter Biden by the US attorney’s office in Delaware, which reportedly is looking into potential tax fraud, illegal foreign lobbying, money laundering and lying about drug use on a federal gun-purchase form.

The FBI in December 2019 retrieved the first son’s abandoned laptop, which contained extensive information about income from ventures involving wealthy figures in China, Russia and Ukraine. Hunter confirmed he was under investigation for tax fraud shortly after his father won the 2020 election.

 “We appreciate this outreach and look forward to sitting down promptly with this individual to better understand the scope and detail of the concerns raised,” House Ways and Means Committee Chairman Jason Smith (R-Mo.) said Wednesday evening.

“It is our responsibility to ensure the tax code is applied fairly and appropriately to all Americans — whether through the oversight efforts this Committee initiates or the need for oversight that is brought to our attention.”

https://nypost.com/2023/04/19/irs-whistleblower-alleges-cover-up-of-hunter-biden-tax-evasion/

Russia Threatens To Give North Korea Advanced Weapons If Seoul Arms Ukraine

 Former Russian President and current Deputy Chairman of the Security Council Dmitry Medvedev has threatened that the Kremlin could give advanced weapons to North Korea if South Korea moves to send military aid to Ukraine. 

This comes in response to South Korean President Yoon Suk-yeol floating the possibility of a drastic policy shift. He'll travel to the United States next week for an official visit. He said in a Reuters interview published Wednesday, "If there is a situation the international community cannot condone, such as any large-scale attack on civilians, massacre or serious violation of the laws of war, it might be difficult for us to insist only on humanitarian or financial support."

"I believe there won't be limitations to the extent of the support to defend and restore a country that's been illegally invaded both under international and domestic law," Yoon explained. "Considering our relationship with the parties engaged in the war and developments in the battlefield, we will take the most appropriate measures," he added.

As Reuters notes, "It was the first time that Seoul suggested a willingness to provide weapons to Ukraine, more than a year after ruling out the possibility of lethal aid."

Last year, US officials and Western media made accusations that North Korea was supplying Russia with artillery ammo and other defense items.

But if Russia actually gave advanced weapons to Pyongyang and the Kim Jong-Un regime, Washington would go ballistic, particularly at this sensitive moment of heightened tensions following repeat missile tests by the north.

But Medvedev is threatening just that, according to Russian media:

"I wonder what the residents of this nation would say when they see the newest example of Russian weapons in possession of their closest neighbors, our partners from the DPRK [Democratic People’s Republic of Korea]?" Medvedev wrote on social media.

The threat certainly ups the ante and is likely to impact Seoul's decision-making. 

Some South Korean officials have reportedly mulled the possibility of indirectly aiding Ukraine, which would involve making the weapons available to a third-party country which in turn would arm Kiev. Likely this scenario is something the Biden administration would support.

https://www.zerohedge.com/geopolitical/russia-threatens-given-north-korea-advanced-weapons-if-seoul-arms-ukraine

Clostridia Microbiota Cocktail Prevents Recurrent C. Diff

 An oral, investigational live biotherapeutic product containing eight strains of commensal Clostridia prevented recurrent Clostridioides difficile infections in a randomized, double-blind phase II trial.

In the 79-participant study, recurrences at 8 weeks using a combined laboratory and clinical definition were detected in 13.8% of those who received high-dose VE303, as compared with 45.5% of those assigned to placebo (P=0.006), reported Jeffrey Silber, MD, of Vedanta Biosciences in Cambridge, Massachusetts, and colleagues.

The recurrence rate in a low-dose VE303 arm of the study (37%) was not significantly better than placebo (P=0.30), according to the findings in JAMA

opens in a new tab or window, which were also presented at the European Congress of Clinical Microbiology & Infectious Diseasesopens in a new tab or window in Copenhagen, Denmark.

"In the high-dose VE303 group, all CDI [C. difficile infection] recurrences through week 8 occurred by day 11, likely due to subsequent colonization of VE303 strains and VE303-induced restoration of the gut microbiota community," wrote Silber and co-authors. "Most participants experienced sustained cure through week 24, suggesting that VE303 has a durable effect."

VE303 strains colonized rapidly during the 14-day dosing period, the researchers said, and "participants with high VE303 colonization had a lower probability of CDI recurrence than those with low colonization, suggesting a positive exposure-response relationship."

Derived from healthy human stool samples, Silber's group explained that "VE303 is a defined bacterial consortium composed of eight well-characterized, nonpathogenic, nontoxigenic, commensal strains of Clostridia" -- five strains from cluster XIVa, two from cluster IV, and one from cluster XVII.

They said the low recurrence rate with high-dose VE303 as well as the absolute risk reduction of 30.5% versus placebo compare favorably to other microbiota products tested in trials, including the first-ever product approved by the FDA

opens in a new tab or window last December for preventing recurrent C. difficile infections.

The current phase II trialopens in a new tab or window from Silber and colleagues was conducted from February 2019 to September 2021 in Canada and the U.S., randomly assigning 29 adult patients with C. difficile infections to high-dose VE303 (8 × 10⁹ colony-forming units [CFUs]), 27 to low-dose VE303 (1.6 × 10⁹ CFUs), and 22 to placebo, all delivered orally once-daily for 14 days.

Criteria for enrollment included patients having had one or more laboratory-confirmed C. difficile infections within the last 6 months, or those deemed to be at high risk for recurrence -- age 75 or older; or age 65 to under 75 but with creatinine clearance below 60 mL/min/1.73 m², proton pump inhibitor use, and history of a C. difficile infection more than 6 months ago.

Participants had a median age of 63.5 years, 70.5% were women, and the vast majority were white (96.2%).

Most (72%) were treated with vancomycin during their qualifying C. difficile infection episode, and 21% received fidaxomicin, mirroring current practice, according to Silber and colleagues.

The primary 8-week efficacy analysis for recurrence included three definitions, with each involving diarrhea consistent with a C. difficile infection plus:

• A toxin-positive stool sample
• A toxin-positive stool sample or positive polymerase chain reaction (PCR) test result
• A toxin-positive stool sample or PCR test result plus participants treated with an antibiotic for a C. difficile infection but who did not have a confirmatory laboratory test

Under the first definition (toxin-positive stool sample), recurrence rates were 13.8% with high-dose VE303 and 22.7% with placebo, a non-significant difference. Under the second definition (toxin-positive stool sample or positive PCR), these rates were 13.8% and 36.4%, respectively, representing a significant absolute adjusted risk reduction of 21.1% (95% CI 3-42).

The third definition, which uses a combined laboratory and clinical approach, represents "a pragmatic approach used clinically" and endorsed by guidelines, the researchers said, though they acknowledged this could be seen as a limitation, as two recurrences were diagnosed without a positive laboratory test.

Secondary endpoints included recurrences out to week 24 as well as stool microbiome endpoints (VE303 strain colonization, fecal microbiome diversity). In follow-up through week 24, there were two more recurrences, one in each of the VE303 groups.

Treatment-emergent adverse events (AEs) were reported in 53.3% of the high-dose VE303 group, 29.6% of the low-dose group, and 31.8% of the placebo group, with the majority of VE303 events being gastrointestinal and mild in intensity.

Approximately 10% of patients in the VE303 groups reported a severe or serious treatment-emergent AE. Four patients in the high-dose group discontinued due to an AE, as well as two in the low-dose group and one in the placebo group.

Other limitations cited by the authors included issues surrounding testing accuracy, enrollment problems due to the pandemic, and the "availability of open-label fecal microbial transplant in many areas." Noting the predominantly white patient population as well, Silber's group said an adequately sized and powered phase III trial is being planned "with an emphasis on enrolling a more diverse study population."

Disclosures

The study was funded by the Office of the Assistant Secretary for Preparedness and Response; and the Biomedical Advanced Research and Development Authority.

Along with Silber, multiple co-authors reported employment by Vedanta Biosciences, the company developing the drug.

Primary Source

JAMA

Source Reference: opens in a new tab or windowLouie T, et al "VE303, a defined bacterial consortium, for prevention of recurrent Clostridioides difficile infection: a randomized clinical trial" JAMA 2023; DOI: 10.1001/jama.2023.4314.

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/104098

CAR T-Cell Therapy Shows Promise in Advanced Kidney Cancer

 An off-the-shelf, allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD70 demonstrated antitumor activity in patients with advanced clear cell renal cell carcinoma (RCC), according to results from the phase I TRAVERSE trial

opens in a new tab or window.

Three of 18 efficacy-evaluable patients (17%) responded to treatment with ALLO-316, and the disease control rate (DCR) reached 89%, reported Samer Srour, MD, of the University of Texas MD Anderson Cancer Center in Houston.

All three responses involved patients with CD70-positive disease, leading to an objective response rate (ORR) of 30% in this subset of 10 patients. The DCR was 100% and the median progression-free survival was 5 months in this subgroup, Srour said during the American Association for Cancer Research (AACR)

opens in a new tab or window annual meeting.

Srour said he and his colleagues were "very encouraged" by the antitumor activity demonstrated in these patients who expressed CD70, particularly since they were treated at the lowest dose levels of 40 to 80×10⁶.

"With this off-the-shelf CAR T product, we are seeing encouraging antitumor activity with no unexpected safety signal," he added, noting that the median time from study enrollment to treatment initiation was 5 days, and as little as 1 day.

"This is very important when compared to autologous products, where it takes a minimum of 2.5 to 3 weeks," he said, suggesting that ALLO-316 meets an unmet need for patients who need urgent treatment.

AACR discussant John Haanen, MD, PhD, of the Netherlands Cancer Institute in Amsterdam, called CD70 "an interesting target for this disease." However, he added, "the target needs to be expressed, otherwise I don't think we should expose patients to this drug."

In explaining the rationale behind targeting CD70, Srour noted that while CAR T-cell therapy has been practice-changing in hematologic malignancies, "when it comes to solid tumors, we have been behind with CAR T-cell therapy, and there are a lot of challenges in having a successful CAR T-cell therapy in solid tumors."

CD70, a type II transmembrane glycoprotein, is expressed in a variety of hematologic and solid tumor cancers, including up to 80% of RCCs, and has restricted expression in normal tissue, Srour said, thus making it a promising target for CAR T therapy.

ALLO-316 also has "some unique features that might make it more attractive to treat kidney cancer," he noted. For example, to reduce the risk of graft-versus-host disease, the T-cell receptor alpha is disrupted with ALLO-316 cells. In addition, CD52 is knocked out to allow the use of ALLO-647, an anti-CD52 monoclonal antibody that depletes host T cells and improves the persistence of allogeneic CAR T cells.

For this multicenter, dose-escalation study, Srour and team looked at two conditioning regimens and four cell dose levels, ranging from 40 to 240×10⁶. Nine patients received ALLO-316 at the lowest dose level of 40×10⁶, eight received a dose level of 80×10⁶, and two patients received 120×10⁶. ALLO-316 infusions were administered 48 hours after lymphodepletion conditioning with fludarabine/cyclophosphamide, with or without ALLO-647.

The median age of participants was 62, and 84% were men. Patients were heavily pretreated, with a median of three lines of prior therapy; 73.7% received more than one checkpoint inhibitor and 52.6% received more than one tyrosine kinase inhibitor.

Safety data were comparable to that demonstrated with autologous CAR T-cell therapies. All-grade and grade 3 or higher treatment-emergent adverse effects included infusion-related reactions (5% and 0%, respectively), cytokine release syndrome (58% and 5%), neurotoxicity (68% and 11%), infection (42% and 21%), and prolonged grade 3 or higher cytopenia at day 28 (16%).

Durability of Response

Srour said that about half of the patients with CD70-positive RCC had responses that were more than 4 months, and that some patients have been able to extend response with a second infusion of the CAR T-cell product.

Haanen suggested that the limited duration of response was likely due to the use of lower doses, "but could also be due to the heterogenous expression that we see in solid cancers."

He and Srour were later asked what the minimum duration of response should be to justify the use of this therapy and to adopt it broadly.

"We have to realize we are treating patients who are at the end stage of the disease, so these are patients who are highly pretreated," he said. "Of course, what you would like to see are durable and deep responses, but this study is still at an early phase. We'll want to see if at higher doses there are more patients having a response, and especially by only selecting patients that are expressing the target [CD70]. Without expressing the target, you cannot expect any effect of the CAR T cells."

Srour agreed that the goal is to see deep and durable responses, but highlighted the fact that this was just a one-time infusion of ALLO-316.

"Hopefully, as we see with hematological malignancies, we'll see 2, 3, or 5 years," he said. "But, even if you get 6 or 8 months from one infusion, you can redo it and get another 6 or 8 months."

Disclosures

The trial was sponsored by Allogene Therapeutics.

Srour reported a relationship with Novartis.

Haanen reported relationships with Bristol Myers Squibb, CureVac, GSK, Imcyse, Iovance Bio, Instil Bio, Immunocore, Ipsen, Merck Serono, MSD, Molecular Partners, Novartis, Pfizer, Roche/Genentech, Sanofi, Scenic, and Third Rock Ventures. Through his work, the Netherlands Cancer Institute has received grant support from Amgen, Asher Bio, BioNTech, Bristol Myers Squibb, MSD, Novartis, and Sastra Cell Therapy.

Primary Source

American Association for Cancer Research

Source Reference: opens in a new tab or windowSrour S, et al "TRAVERSE: A phase 1 multicenter study evaluating the safety and efficacy of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma" AACR 2023; Abstract CT011.

https://www.medpagetoday.com/meetingcoverage/aacr/104102

Bone Density Loss Seen After Bariatric Surgery in Teens

 Although bariatric surgery is quite effective for weight loss in teens with obesity, it also may weaken the bones, according to a prospective longitudinal study.

Over the course of 1 year after undergoing sleeve gastrectomy, teens saw a 12 mg/cm³ drop in average vertebral bone mineral density (BMD), while nonsurgical controls saw no change (P<0.001), reported Miriam Bredella, MD, of Massachusetts General Hospital in Boston, and colleagues.

Sleeve gastrectomy patients also saw a 6 mg/cm³ reduction in cortical vertebral BMD versus a 4 mg/cm³ reduction in those who didn't opt for surgery (P=0.52), the group wrote in the Journal of Bone and Mineral Research

opens in a new tab or window.

Furthermore, sleeve patients had a significant 2.8% decrease in bending stiffness, while nonsurgical controls had a 2.5% increase in this measure.

While other measures, including body strength, thigh muscle area, visceral adipose tissue, and trabecular vertebral BMD initially looked like they significantly decreased for the surgical patients, these differences were no longer significant after adjustment for 12-month change in body mass index (BMI). Essentially, these reductions were all attributable to the drop in BMI that occurred after surgery.

"Weight loss surgery is very effective in treating obesity and obesity-associated comorbidities in adolescents and young adults with obesity; however, it can cause loss of bone density and strength," said Bredella in a statement.

"We hope that our study raises awareness of the importance of bone health after weight loss surgery, so physicians can make sure that children eat a healthy diet with enough calcium and vitamin D and engage in weight-bearing activity to build up muscle mass, which is good for bones," she added.

These findings don't necessarily come as a surprise, as many forms of bariatric surgeryopens in a new tab or window are associated with a reduction in nutrient absorption after removal of parts of the stomach. Postsurgical nutritional supplementation is therefore vital for patients.

However, to keep this in perspective, prior studies have also linked obesity with a higher risk for weaker bonesopens in a new tab or window.

Bredella's group explained that all sleeve patients were provided with both calcium and vitamin D supplementation based on 25OHD levels: those with 25OHD levels of 20 to 30 ng/mL received 4,000 IU/day; those with levels of 12 to 20 ng/mL received 50,000 IU/week for 2 months; and those with levels under 12 ng/mL took 50,000 IU/week for 3 months.

There were no significant drops in calcium, phosphorus, and vitamin D and no increases in parathyroid hormone levels after surgery. "This suggests that the BMI-independent reductions in bending strength and cortical BMD reflect alterations other than mechanical unloading or insufficient calcium or vitamin D intake," Bredella and team wrote.

The prospective study compared 29 patients who underwent sleeve gastrectomy with 30 nonsurgical controls. All participants had to be 13 to 25 years old and have moderate-to-severe obesity (BMI of ≥35) with at least one comorbidity or a BMI of ≥40. None of the adolescents could weigh over 441 lb due to weight limitations of the CT and MRI scanners.

The vast majority were female; average baseline BMI in sleeve patients was 47.4 and weight was 294.1 lb. About 45% of sleeve patients were white, 28% were Hispanic, and 17% were Black.

During the year-long follow-up, sleeve patients lost an average of 75.6 lb, while nonsurgical controls had no significant weight change. Sleeve patients also saw a 12.3-point drop in BMI.

"A longer follow-up period is necessary to determine whether the deleterious changes in vertebral strength will continue and lead to spine fractures," the group concluded.

Disclosures

Bredella's group reported no disclosures.

Primary Source

Journal of Bone and Mineral Research

Source Reference: opens in a new tab or windowHuber FA, et al "Biomechanical CT to assess bone after sleeve gastrectomy in adolescents with obesity: a prospective longitudinal study" J Bone Miner Res 2023; DOI: 10.1002/jbmr.4784.

https://www.medpagetoday.com/pediatrics/obesity/104105

Amgen wins appeal in US patent case over generic psoriasis drugs

 

Amgen Inc convinced a U.S. appeals court on Wednesday to uphold patents that barred generic versions of its blockbuster psoriasis drug Otezla proposed by Zydus Pharmaceuticals and Novartis' Sandoz Inc.

The U.S. Court of Appeals for the Federal Circuit affirmed a New Jersey federal court's ruling that Amgen patents covering the drug were valid and that the proposed generics would infringe them.

The ruling blocks proposed Otezla generics until 2028. The Federal Circuit also upheld a decision to invalidate one of Amgen's patents that Sandoz said would have barred its generics until 2034.

A spokesperson for Sandoz said Wednesday that the company was pleased with the decision allowing for Otezla generics in 2028 instead of 2034.

Representatives for Amgen and Zydus did not immediately respond to requests for comment.

Thousand Oaks, California-based Amgen sold over $2.2 billion worth of Otezla worldwide last year, according to a company filing with the U.S. Securities and Exchange Commission.

Amgen bought Otezla from Celgene Corp in 2019 for $13.4 billion. Celgene sued several drugmakers over their proposed Otezla generics starting in 2018, and 17 of the 19 lawsuits have been settled since.

U.S. District Judge Michael Shipp said in 2021 that Switzerland-based Sandoz and India-based Zydus' generics would infringe three Amgen patents.

Zydus and Sandoz appealed the decision that two of the infringed patents were valid. The Federal Circuit on Wednesday affirmed the ruling.

The court also affirmed that Amgen's patent that would have expired in 2034 was invalid over Amgen's cross-appeal.

The case is Amgen Inc v. Sandoz Inc, U.S. Court of Appeals for the Federal Circuit, Nos. 22-1147 and 22-1149.

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/Amgen-wins-appeal-in-US-patent-case-over-generic-psoriasis-drugs-43545333/