The New York State Office of Cannabis Management on Thursday said it's increasing the number of conditional adult-use retail dispensary licenses to 300 from 150. At last check, the state has issued 66 provisional conditional adult-use retail dispensary (CAURD) licenses and four dispensaries have opened. The CAURD program provides licenses to justice-involved individuals to operate cannabis businesses. Under the new plan, Brooklyn will receive 38 CAURD licenses, up from 19, Manhattan will receive 44 CAURD licenses, up from 22, and Queens will receive 32 licenses, up from 16. The state received 900 applications for CAURD licenses.
Thursday, March 2, 2023
CareDx Q4, Full-Year Revenues Rise on Back of Cash Collections, Test Volumes
CareDx reported after the close of the market on Monday year-over-year revenue gains of 4 percent for the fourth quarter of 2022 and 9 percent for the full year.
The Brisbane, California-based company finished the three months ended Dec. 31 with $82.4 million in revenues compared to $79.2 million for the same quarter in 2021, narrowly beating analysts' average estimate of $81.7 million. Shares in CareDx were up approximately 20 percent, to $17.65 per share, in Tuesday morning trading on the Nasdaq.
The firm attributed much of the increase to cash collection, which amounted to 110 percent of testing service revenues in the quarter, representing an approximately 10 percent year-over-year rise. The company also said that it provided approximately 47,700 AlloMap and AlloSure patient results in Q4, up 14 percent from the prior-year quarter. Fourth quarter test volume also included 2,300 AlloSure Lung tests.
Testing services revenue for the fourth quarter of 2021 fell 5 percent to $65.4 million from $68.7 million in the same period of 2021. At the same time, fourth quarter product revenues rose 12 percent year-over-year to $8.6 million from $7.7 million. Revenue from patient and digital solutions nearly tripled in Q4 to $8.4 million from $2.9 million.
In a conference call with investors, CareDx President and CEO Reg Seeto commented on the potential for further growth in test revenue, noting that during the fourth quarter, the International Society for Heart and Lung Transplantation announced new guidelines that support expanded use of AlloMap and AlloSure in routine monitoring of heart transplant patients.
"This inclusion in ISHL guidelines should lead to increased reimbursement over time," he said.
Seeto also noted that the company is working with Palmetto's MolDx program to acquire Medicare coverage for AlloSure Lung.
"This potential improvement in coverage represents the single greatest opportunity for the company," he stated.
CareDx's Q4 R&D spending rose 7 percent to $23.6 million from $22.0 million a year ago, while its SG&A expenses grew 7 percent to $48.5 million from $45.5 million a year ago.
Fourth quarter net loss increased to $18.3 million, or $.34 per share, from $16.2 million, or $.31 per share, in the same quarter a year ago. CareDx reported an adjusted loss per share of $.07, bettering the Wall Street expectation of a loss per share of $.09.
CareDx reported $321.8 million in total revenues for 2022, up 9 percent from $296.4 million in 2021. Annual testing service revenue rose 2 percent year-over-year to $263.7 million from $259.3 million. Similarly, product revenue rose 9 percent to $29.3 million from $26.8 million in the prior year. Full-year revenue from patient and digital solutions again nearly tripled to $28.8 million in 2022 from $10.3 million a year ago.
The company said that its full-year AlloMap and AlloSure testing volumes grew 19 percent to approximately 182,000 tests.
The company's full-year R&D spending shot up 18 percent to $90.4 million from $76.5 million in 2021, while its SG&A expenses ballooned 29 percent to $196.4 million from $152.2 million a year earlier.
CareDx CFO Abhishek Jain attributed part of the spending spike to clinical study payments and to a partnership-related milestone payment made to an undisclosed entity.
Full-year net loss rose to $76.6 million, or $1.44 per share, from $30.7 million, or $.59 per share in 2021. Adjusted loss per share was $.39, bettering analysts' average expectation of a loss per share of $.41.
Seeto noted that fourth quarter transplant volumes only grew by 2 percent sequentially, part of a downward sequential trend that has continued into 2023, with current quarterly data for the first seven weeks showing a 3 percent decline across all organs.
"One of the key reasons behind this trend is that living donor kidney transplants remain below the pre-COVID levels and staffing shortages [are] continuing in the transplant hospital centers," he said.
However, Seeto stated that the firm sees potential for volumes to double in the next five to 10 years.
CareDx finished the year with $89.9 million in cash and cash equivalents and $203.2 million in marketable securities.
The company said it anticipates full-year 2023 revenue within the range of $328 million to $338 million.
Mom rips ‘despicable’ Biden for laughing at blame claim for sons’ fentanyl deaths’
A Michigan mom whose two sons died of fentanyl overdoses has slammed President Biden as “despicable” after he laughed off the false claim that his administration was to blame for their deaths.
Rebecca Kiessling, whose sons Caleb, 20, and Kyler, 18, died in July 2020 after taking fentanyl-laced Percocet pills, took aim at Biden on Wednesday night after he used her family’s story to knock GOP Rep. Marjorie Taylor Greene’s suggestion he was responsible for the fatalities.
“This is how you speak about the death of my sons? Because a congresswoman misspoke? You mock the loss of my sons?” Kiessling said in a scathing video posted on Facebook.
Kiessling had testified before the House Homeland Security Committee on Tuesday about the loss of her sons, telling Congress that more should be done to stop fentanyl imports.
Greene (R-Ga.) quickly seized on Kiessling’s testimony, suggesting that the brothers might still be alive if the Biden administration had secured the border and stopped the flow of drugs into the US.
Biden, 80, poked fun at Greene on Wednesday night, chuckling as he told a gathering of House Democrats in Baltimore that the boys died under the Trump administration.
“I’ve read she was very specific recently saying that a mom, a poor mother who lost two kids to fentanyl, that I killed her sons. Well, the interesting thing: That fentanyl they took came during the last administration,” the president said, adding a “heh-heh” as one or two audience members murmured in disapproval of Greene.
A furious Kiessling said she was “shocked” at Biden’s reaction and demanded an apology from the commander-in-chief.
“How dare you. What is the matter with you? Almost every Democrat on the committee offered condolences, they at least had the decency to do that,” she said in the video. “You can’t even do that? You have to mock my pain?”
While Kiessling acknowledged that her sons died six months before Biden was elected, she slammed the government’s handling of the fentanyl crisis ever since.
“What about the 22% increase in fentanyl deaths since you became president?” Kiessling asked.
“That represents tens of thousands of US citizens who died under your watch, an increase in tens of thousands. That represents double that number of the parents who are suffering.
“You’re going to keep laughing? About those who did die under your watch? Do we have to bring them in so you can look them in the eyes and laugh?”
She added that she wished Biden would show “some serious concern for the lives lost” — and that his behavior speaks volumes and “tells you where his heart is.”
Apart from Kiessling’s scathing criticism, shocked critics also lashed out at Biden’s tone-deaf clap-back.
“@POTUS needs to apologize for this immediately. No person, let alone the president of the United States, laughs when speaking about a mother who lost two sons to fentanyl poisoning,” Sen. Mike Lee (R-Utah) tweeted.
The official House Republican Twitter account reacted with a single word: “DISGUSTING.”
“Biden just laughed while talking about a Mom whose kid was killed with Fentanyl. This is so incredibly inappropriate and vile,” conservative podcaster Robby Starbuck added.
The Republican National Committee’s Jake Schneider also weighed in, tweeting: “Truly the lowest bar possible for Biden — what a disgusting person. Losing children to fentanyl trafficking is never, ever funny. Just vile.”
https://nypost.com/2023/03/02/mom-slams-biden-for-laughing-over-sons-fentanyl-deaths/
DexCom shares gain as Medicare to expand CGM coverage in April
DexCom Inc (NASDAQ:DXCM) shares jumped more than 6% Thursday after it was revealed that Medicare will cover continuous glucose monitors (CGMs) for a wider group of patients starting in April.
Citi analysts explained in a note that the updated policy from the Centers for Medicare and Medicaid Services reveals that effective April 16, to obtain CGM coverage, "Medicare beneficiaries must only be 'insulin-treated' versus 'insulin-treated with at least one daily administration of insulin,' therefore, expanding coverage to any beneficiary taking any form of insulin."
The analysts stated that Abbott has sized the Medicare basal population at 1.5 million individuals and 4M in total, including commercial, while DexCom has sized the total basal market at 3M.
"With the finalized LCD, we believe these numbers in the U.S. could be larger, a win for both ABT and DXCM. We reiterate our Buy ratings on ABT and DXCM," wrote the analysts.
Meanwhile, Stifel analysts said that basal (background insulin) coverage is "an important positive catalyst for DXCM/ABT, and could serve as a market growth accelerant."
'Costs of Diabetes Drug Prescription Claims Plunge After Metabolic Surgery'
Health insurance providers saved big on prescription diabetes medications after patients underwent metabolic surgery, according to claims-based registry data from Michigan.
Among 760 patients with type 2 diabetes who underwent metabolic surgery, the mean decrease in diabetes prescription payments made by the insurer was $4,133 per patient -- $6,736 for gastric bypass and $3,409 for sleeve gastrectomy -- in the 360 days after surgery compared with the 360 days before surgery, reported Oliver A. Varban, MD, of Henry Ford Health in Detroit, and colleagues.
Also at 360 days after surgery, 67.7% of patients with follow-up were not filling any prescriptions for any type of diabetes medication, they noted in a research letter published in JAMA Surgery
"Given that 34% of all patients undergoing metabolic surgery in Michigan have diabetes and a total of 54,454 metabolic procedures were performed between 2015 and 2021, it is estimated that insurance providers in Michigan saved more than $76.5 million on diabetes medications in the 360 days following surgery," Varban and team wrote.
Of note, most savings occurred within the first 120 days after surgery, they said.
"We found a considerable cost savings resulting from discontinuation of medications for diabetes after metabolic surgery, which only represented prescription activity for 1 year following metabolic surgery and did not account for potential cumulative savings as a result of long-term diabetes remission or downstream cost benefits associated with optimizing diabetes management," the group noted.
For this study, Varban and co-authors used the Michigan Value Collaborative claims data registry, a consortium of more than 100 nonfederal acute care hospitals in Michigan, and included 760 patients undergoing gastric bypass (22%) or sleeve gastrectomy (78%) from 2015 to 2021.
Mean patient age was 49, and 66.3% were women. About 84% of patients had hypertension, 73.4% had hyperlipidemia, and 60.8% had obstructive sleep apnea.
In the 120 days prior to surgery, 88% of patients had filled an outpatient oral diabetes medication prescription, 30% filled an insulin prescription, and 21% filled a GLP-1 receptor agonist prescription. More than half of patients were only on an oral agent prior to surgery, and another third were on multimodal therapy.
The price-standardized 30-day payment for surgery was $14,832.
Varban and colleagues noted that their study only included patients with Blue Cross Blue Shield Preferred Provider Organization commercial insurance or Medicare Advantage membership who were continuously enrolled in a prescription plan for 120 days prior to surgery and at least 240 days after surgery, and their findings don't necessarily reflect those with other insurance plans.
"Given that fewer than 1% of the eligible population undergo surgical treatment for obesity and metabolic disease in the U.S. and only one-fourth of patients undergoing surgery are diagnosed with diabetes, we believe that there is an opportunity to decrease the financial and medical burden of diabetes," they concluded.
Disclosures
This study was supported by Blue Cross Blue Shield of Michigan/Blue Care Network.
Varban reported salary support from Blue Cross Blue Shield of Michigan for leadership and participation in the Michigan Bariatric Surgery Collaborative during the conduct of the study. Other co-authors also reported relationships with the Blue Cross Blue Shield Blue Care Network of Michigan.
Primary Source
JAMA Surgery
Source Reference: Varban OA, et al "Financial impact of metabolic surgery on prescription diabetes medications in Michigan" JAMA Surg 2023; DOI: 10.1001/jamasurg.2022.7749.
Highest U.S. Prescriber of Ivermectin and HCQ
Stella Immanuel, MD, was the nation's top prescriber of hydroxychloroquine and ivermectin over the past 2 years, a MedPage Today analysis of prescription data has found.
In 2021, Immanuel wrote just over 69,000 prescriptions for hydroxychloroquine -- vastly above the average of 43 prescriptions in the database MedPage Today reviewed. Rheumatologists, who prescribe hydroxychloroquine for autoimmune diseases, wrote 561 hydroxychloroquine prescriptions, on average, that year.
Immanuel also wrote almost 32,000 prescriptions for ivermectin in 2021, well above the average of 15.
Although her prescribing declined in 2022, Immanuel remained the highest prescriber of both medications in the U.S. last year, writing 30,996 prescriptions for hydroxychloroquine and 16,085 prescriptions for ivermectin.
As for 2020, data were only available for the second half of the year, but for those 6 months, Immanuel was the highest prescriber of hydroxychloroquine and ivermectin, at nearly 10,000 and 1,500 ivermectin prescriptions, respectively.
The figures come from an analysis of data from Symphony Health, which tracks U.S. prescription data by analyzing claims from both commercial and federal sources.
While the database does not provide the specific indication for which the drugs were prescribed, sources believe that based on Immanuel's telemedicine operation, they were likely doled out for COVID-19 treatment and prevention.
"It verges on malpractice," Adrian Hernandez, MD, vice dean and executive director of the Duke Clinical Research Institute in Durham, North Carolina, said of Immanuel's prescribing practices. "Prescribing a drug that has zero benefits [in COVID-19], and potential harm, is not what we should be doing in medical practice."
Michael Abrams, MPH, PhD, a senior researcher at watchdog group Public Citizen, said the prescribing figures "seem excessive, and plausibly irresponsible."
The numbers "seem to point to substantial rogue and potentially dangerous prescribing of hydroxychloroquine and ivermectin as treatments or prophylactics for COVID," Abrams said.
Immanuel said in an email to MedPage Today that the prescriptions were written "both in clinic and under the umbrella of our telemedicine service and all the doctors working for me." She also stated that her "legal team will be contacting [MedPage Today] if there was any negative backlash as a result of this unnecessary disclosure of information."
Enabled Through Telemedicine?
It's unclear how, exactly, Immanuel achieved such a high volume of prescribing, but she does run a telemedicine operation through her website, DrStellaMD.com.
On its homepage, visitors can click a button to "register to get Hydroxychloroquine or Ivermectin via a telemedicine consultation with one of [sic] licensed physicians or nurse practitioners."
Once patients fill out the online request form, those seeking hydroxychloroquine or ivermectin as prophylaxis will receive a text message, phone call, or email depending on their medical history, the website states. Sick patients, however, require a phone call.
The website then offers something of a disclaimer: "Remember that these are controversial treatment protocols used off label so do your research before you sign up," it states.
Patients can choose from a list of options based on their condition: COVID treatment with symptoms, COVID prevention, drug refill, or general treatment. There's an option for new or existing patients.
When MedPage Today browsed the online clinic, a pop-up message stated that all prescriptions for hydroxychloroquine and ivermectin would be paid for on the website and shipped directly by mom-and-pop pharmacies, as mainstream pharmacies were pushing back on filling the scripts.
Abrams warned that online prescribers are "a general concern these days."
"Despite highly questionable diagnostic and treatment-plan quality, online prescribers are increasingly steering consumers to remedies that may be wrong or even dangerous," Abrams said.
In 2021, the House Select Subcommittee on the Coronavirus Crisis launched an investigation into another COVID-related telemedicine company, SpeakWithAnMD.com. The site was affiliated with America's Frontline Doctors, a controversial group whose founder, Simone Gold, MD, JD, served time in prison for storming the U.S. Capitol on Jan. 6, 2021.
The subcommittee accused the operation of profiting off of COVID-19 misinformation. A final report, however, was never issued, and is unlikely to come now that a new Congress is in session.
Dangerous Prescribing
During the pandemic, controversial groups touted hydroxychloroquine and ivermectin as "miracle" cures for COVID-19, even though study after study has consistently shown both to be ineffective for treating or protecting against the disease.
Hernandez, who was one of the principal investigators in the ACTIV-6 trial that examined repurposed medicines for COVID, said that while both hydroxychloroquine and ivermectin are relatively safe drugs, there's an "opportunity cost" to prescribing them for COVID patients.
Since safe and effective prophylactics such as vaccines and treatments such as antivirals exist, clinicians can harm patients by using these ineffective alternatives, Hernandez said.
Beyond a lack of efficacy and an opportunity cost, experts told MedPage Today that the volume of prescriptions Immanuel logged seems too high to afford quality care to patients.
Andrea Sikora, PharmD, associate professor of clinical and administrative pharmacy at the University of Georgia in Augusta, said it would be "difficult to know a patient well enough to make a nuanced decision about the risks and benefits of any prescription drug."
Information about a patient's medical history, their labs, or even their COVID test results may not be possible to obtain when prescribing at such a volume, Sikora said.
Medical Board Action
The Texas Medical Board previously took action against Immanuel for failing to provide informed consent to a patient who received a hydroxychloroquine prescription from her.
On Oct. 15, 2021, the board issued a "remedial plan
" in which Immanuel was to submit her informed consent plan to the board for all off-label treatments she provides.
But on Jan. 4, 2022, the remedial plan was terminated "due to completion of all requirements," according to the website of the Texas Medical Board.
In addition to Texas, Immanuel holds active licenses in Arizona, Arkansas, Colorado, Connecticut, Kentucky, Louisiana, and Michigan. None of those states list the Texas action in their databases.
A Powerful Platform
Immanuel initially made headlines in July 2020 when she spoke at a rally held on the steps of the U.S. Supreme Court organized by America's Frontline Doctors. She claimed to have treated 350 patients with hydroxychloroquine at that point, and none had died.
Since then, Immanuel has ridden a wave of COVID-related infamy. In addition to telemedicine, her website includes a marketplace for supplements to fight against COVID and mpox, a place to click to "receive prayers for the jab," and bookings for a religious retreat at her Bethel Revival Ranch.
Immanuel also runs the Fire Power Ministries, which features her sermons on its Facebook page. She also runs a brick-and-mortar clinic, Rehoboth Medical Center, in Houston.
Immanuel was banned from Twitter during the pandemic, but after Elon Musk took over the platform and scrapped its COVID misinformation policy late last year, Twitter reinstated Immanuel's account.
"Finally my personal account is restored after two years being suspended for saying Hydroxychloroquine works," Immanuel tweeted in January. She added that she would continue to tweet from the account for Fire Power Ministries, which is verified on Twitter.
"Covid is completely treatable and preventable," Immanuel tweeted from her ministry account late last year. Adding that hydroxychloroquine and ivermectin work early, she encouraged patients to "get it in your medicine cabinet now" and "don't wait till you are sick."
https://www.medpagetoday.com/special-reports/exclusives/103353
AstraZeneca, Merck's Lynparza to face FDA panel in prostate cancer bid
After several market withdrawals, the FDA’s scrutiny around the PARP inhibitor class of cancer drugs doesn't seem to be abating.
The FDA plans to gather external experts for an advisory committee meeting to review AstraZeneca and Merck & Co.’s application for Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the two companies said Thursday.
The meeting of the FDA's Oncologic Drugs Advisory Committee is scheduled for April 28. The FDA’s independent advisers will review data from the phase 3 PROpel trial, which previously showed that Lynparza, in combination with Johnson & Johnson’s Zytiga, can stave off disease progression or death compared with Zytiga alone.
Based on the PROpel data, the FDA will likely have questions about whether Lynparza has proven its case in a broad mCRPC population or if the benefit is limited to a patient subgroup.
In the study, the Lynparza and Zytiga combo cut the risk of progression or death by 34% over Zytiga alone, regardless of tumor mutation status. The benefit was more pronounced in patients with homologous recombination repair (HRR) mutations, where the Lynparza regimen cut the risk by 50%.
In non-HRR mutation patients, the magnitude of benefit came in at 24%. Those data were presented at last year’s ASCO Genitourinary Cancers Symposium (ASCO GU).
More recently, AZ and Merck last month presented the final patient survival analysis. After nearly half of all patients had died in the PROpel trial, the Lynparza-Zytiga duo showed a 19% reduction in the risk of death. The improvement wasn’t statistically significant. Those in the Lynparza arm lived a median 42.1 months, versus 34.7 months in the control group, the partners said at this year’s ASCO GU meeting.
Digging into patient subgroups, investigators found that the HRR-mutated population enjoyed a wider 44% survival benefit, whereas the death risk reduction in the non-HRR group was just 11%. Even in the HRR-mutated group, those with BRCA mutations logged a large 71% death risk reduction. When those BRCA-mutated cases were excluded, the rest of the PROpel participants on Lynparza only saw a 9% death risk reduction.
While the overall survival benefit was greatest in the BRCA-mutated group, trends toward longer survival were observed across subgroups, the investigators noted.
Before the FDA raised the advisory committee hurdle, Lynparza and Zytiga won a European approval in December for mCRPC patients for whom chemotherapy isn’t clinically indicated. The go-ahead doesn't have any restrictions on tumor mutation status.
In the U.S., Lynparza boasts an mCRPC approval as a single agent following prior treatment, but only in HRR-mutated patients.
A few days ago, European drug reviewers also recommended an mCRPC approval for another PARP inhibitor, Zejula, in combination with Zytiga in a fixed-dose combination that Johnson & Johnson plans to market as Akeega. But the backing was only for BRCA-mutated tumors because that cocktail had failed to show a tumor progression benefit beyond that cancer subtype.
Meanwhile, Pfizer’s application for its PARP drug Talzenna and Xtandi in mCRPC is currently under an FDA priority review. That submission was also based on progression-free survival data as the overall survival analysis remains immature.
The FDA’s close attention to Lynparza—and the broader PARP inhibitor class—predates mCRPC. After noticing concerning signs suggesting potential harm to patients’ long-term life expectancy, the FDA last year persuaded drugmakers to pull their PARP inhibitor approvals in late-line ovarian cancer. GSK, at the FDA’s request, limited Zejula’s second-line maintenance ovarian cancer use to only cover patients with BRCA mutations.
Clovis Oncology was perhaps the most seriously hurt by the FDA’s renewed scrutiny. The company has filed for bankruptcy after withdrawing and limiting the ovarian cancer uses of Rubraca, its only commercial product.
Desperate for a new revenue stream, Clovis recently went against the FDA’s request for more mature overall survival data and petitioned the agency to approve Rubraca as a first-line maintenance therapy. The FDA has threatened to hold an advisory committee on that application.
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