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Saturday, April 2, 2022

CMS to give $110M to boost participation in Medicaid's Money Follows the Person program

 The Biden administration will distribute more than $110 million to help expand home and community-based services in Medicaid via the Money Follows the Person program that aims to boost home-based care for Medicaid beneficiaries. 

The Centers for Medicare and Medicaid Services announced Thursday that the funding will open the door for more than 20 states and territories not participating in the program.

“Our healthcare system works best when it meets us where we are and helps us get to where we want to be,” said CMS Administrator Chiquita Brooks-LaSure in a statement Thursday. “With this new funding opportunity, we’re expanding a program with a proven track record of helping seniors and people with disabilities transition safely from institutional care to their own homes and communities.”

Money Follows the Person was approved back in 2005 and aims to reduce the use of institutional-based services and transition beneficiaries to more home and community-based services. 

The additional funding aims to help states and territories get a new program off the ground, including recruiting home-care providers and experts for transition coordination and how to establish system assessments to understand how home-care services can support residents, according to a release on the funding. 

Any state Medicaid agency that isn’t participating in the program has until May 31 to apply for the new funding.

States that are already participating in the program will get an increased reimbursement rate for any supplemental services to be 100% federally funded with no requirement for a state match. 

CMS also is expanding the definition of a supplemental service to include short-term housing and food assistance. 

The funding comes as the Biden administration has moved to increase access to home-based services, especially considering the COVID-19 pandemic that caused an explosion in telehealth use. 

The $1.75 trillion Build Back Better Act had included $150 billion in funding to overhaul home care, but the legislation stalled last year due to insufficient Democratic support in the Senate. 

CMS has also made moves to boost home-based services in Medicare and Medicaid. The agency issued a dialysis payment rule last year that aimed to decrease health disparities in access to home dialysis services. 

https://www.fiercehealthcare.com/payers/cms-give-110m-boost-participation-medicaids-money-follows-person-program

Glaxo: From Q1 2022 Results Co Will Report Results Under Three Segments

 * GLAXOSMITHKLINE PLC - GSK - SEGMENT AND PRODUCT SALES REPORTING CHANGES

* GSK: FROM Q1 2022 RESULTS GSK WILL REPORT RESULTS UNDER THREE SEGMENTS

* GSK - CONSUMER HEALTHCARE SEGMENT WILL BE REPORTED AS A "CONTINUING OPERATION" UNTIL SUCH TIME AS FORMAL CRITERIA FOR TREATING IT OTHERWISE

* GSK - SALES OF BRANDS DIVESTED IN Q1 2021 WILL NOT BE REPORTED IN SEPARATE BRANDS DIVESTED CATEGORY FOR COMPARATIVE PERIODS OF 2021

* GSK - AS A RESULT OF CHANGES, FROM Q1 2022 PRESENTATION OF A SEPARATE CATEGORY FOR BRANDS DIVESTED AND UNDER REVIEW WILL NO LONGER BE REQUIRED

* GSK: THREE PRODUCT GROUPS WILL BE SPECIALTY MEDICINES PRODUCTS, GENERAL MEDICINES PRODUCTS, AND VACCINES PRODUCTS 

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GSK-Says-From-Q1-2022-Results-Co-Will-Report-Results-Under-Three-Segments-39938946/

Pentagon Clarifies No 'Offensive' Bioweapons At US-Linked Ukraine Labs

 by Dave DeCamp via AntiWar.com, 

A Pentagon official told Congress on Friday that there are no "offensive" biological weapons in any of the dozens of US-linked labs in Ukraine.

"I can say to you unequivocally there are no offensive biologic weapons in the Ukraine laboratories that the United States has been involved with," Deborah Rosenbaum, the assistant secretary of defense for nuclear, chemical, and biological defense programs, told the House Armed Services subcommittee.

The Pentagon funds labs in Ukraine through its Defense Threat Reduction Agency (DTRA). According to a Pentagon fact sheet released last month, since 2005, the US has "invested" $200 million in "supporting 46 Ukrainian laboratories, health facilities, and diagnostic sites."

Moscow has accused Ukraine of conducting an emergency clean-up of a secret Pentagon-funded biological weapons program when Russia invaded. The World Health Organization said it advised Ukraine to destroy "high-threat pathogens" around the time of the invasion.

For their part, the US maintains that the program in Ukraine and other former Soviet states is meant to reduce the threat of biological weapons left over from the Soviet Union. While downplaying the threat of the labs, Pentagon officials have also warned that they could still contain Soviet-era bioweapons.

Robert Pope, the director of the DTRA’s Cooperative Threat Reduction Program, told the Bulletin of the Atomic Scientists in February that the labs might contain Soviet bioweapons and warned that the fighting in Ukraine could lead to the release of a dangerous pathogen.

The Biden administration has tried to portray any concerns about the labs as "Russian propaganda." When the issue gained more media attention, Biden officials started accusing Moscow of plotting to use chemical or biological weapons, but the US hasn’t presented any evidence to back up its claims.

https://www.zerohedge.com/geopolitical/pentagon-says-pathogens-us-linked-ukraine-labs-not-offensive-bioweapons

Most Chinese Biotech Stocks Can Continue US Listing After New Audit Framework

 

  • According to a Bloomberg report, U.S. regulators could reportedly have full access to auditing reports from most of the 200-plus China-based companies listed in New York in mid-2022.

  • In the drafting stage, the framework from the China Securities Regulatory Commission and other national agencies would let most Chinese firms keep their U.S. listings, Bloomberg said, citing anonymous sources. But those that hold sensitive data could still be delisted.

  • Nearly 300 companies are on the SEC's initial list of those at risk of falling off the Nasdaq, including four biopharma stocks, BeiGene Ltd (NASDAQ: BGNE), Hutchmed China Ltd (NASDAQ: HCM), Zai Lab Ltd (NASDAQ: ZLAB) and CASI Pharmaceuticals Inc (NASDAQ: CASI).

  • If the plan proceeds, non-compliant businesses will be kicked off the New York Stock Exchange and Nasdaq in 2024.

  • In a move to come into compliance, Hutchmed said this week it would assess "the merits of appointing an auditor outside of China." Zai Lab said it plans to review its audit process, as well.

  • Earlier Friday, CASI said it will evaluate options, "which include but are not limited to adding business processes and control to meet the requirements of the HFCAA."

Biotech Investors: Mark Your Calendar For April PDUFA Dates

 Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

The month of March saw several approvals coming through, while outright rejection and postponements were few and far between. Three new molecular entities, or NMEs, were approved during the month. NMEs are drugs that contain active moieties that haven't been previously approved by the FDA. It's, therefore, an indicator of innovation in drug research.

Marinus Pharmaceuticals, Inc.'s (NASDAQ:MRNS) Ztalmy, indicated to treat seizures associated with a rare genetic condition known as CDKL-5 deficiency disorder (CDD), was among the NMEs that scored win the FDA in March. H.C. Wainwright analyst Douglas Tsao expects peak U.S. sales potential of $92 million for Ztalmy, given CDD is a relatively small market.

Other NMEs approved during the month included Bristol-Myers Squibb Company's (NYSE:BMY) melanoma combo therapy Opdualag and Novartis AG's (NYSE:NVS) Pluvicto for treating a certain type of advanced, castration-resistant prostate cancer.

On the flip side, Akebia Therapeutics, Inc.'s (NASDAQ:AKBA) vadadustat was rejected by the FDA as a treatment option for anemia in chronic kidney disease patients.

Here are the key PDUFA dates scheduled for April.

Can BioXCel Push Psychiatric Disorder-Associated Agitation Drug Past Finish Line?

  • Company: BioXcel Therapeutics, Inc. (NASDAQ:BTAI)
  • Type of Application: new drug application
  • Candidate: dexmedetomidine (BXCL501)
  • Indication: agitation associated with schizophrenia and bipolar disorders I and II.
  • Date: April 5

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. The original PDUFA date of Jan. 5, 2022 was pushed back by three months, with BoXcel communicating that the FDA needed three more months to review data pertaining to analyses of clinical data submitted by the company upon the regulator's information request.

Regeneron Awaits Approval Of Antibody Cocktail For Prophylactic Treatment Of COVID-19

  • Company: Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN)
  • Type of Application: BLA
  • Candidate: REGEN-COV
  • Indication: prophylactic treatment of COVID-19
  • Date: April 13

Regeneron's REGEN-COV is a cocktail of two monoclonal antibodies, namely casirivimab and imdevimab, that's designed to block infectivity of SARS-CoV-2 using the company's proprietary VeloImmune and VelociSuite technologies. The biopharma has a collaboration agreement with Roche Holding AG (OTC:RHHBY) for increasing global supply.

Alnylam Hopes To Get Clearance For Second RNAi Therapeutic For ATTR Amyloidosis

  • Company: Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY)
  • Type of Application: NDA
  • Candidate: Vutrisiran
  • Indication: polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) polyneuropathy
  • Date: April 14

Vutrisiran is an investigational RNAi therapeutic being evaluated for treating hATTR in adults. hATTR is an inherited, progressively debilitating and fatal disease caused by mutations in the TTR gene, which will cause the build up of amyloid protein in organs and tissues. Vutrisiran is a second-generation, subcutaneous formulation of Alnylam's Onpattro, which was approved for the same indication. Onpattro is administered intravenously.

No or no-go For Amneal's Avastin Biosimilar

  • Company: Amneal Pharmaceuticals, Inc. (NYSE:AMRX)
  • Type of Application: BLA
  • Candidate: Bevacizumab
  • Indication: colorectal cancer
  • Date: April 17

Amneal's Bevacizumab regulatory application was accepted for standard review pursuant to Section 351(k) pathway of the Public Health Service Act, to the Biosimilar User Fee Act. The biosimilar was developed in collaboration with mAbxience, a Spain-based biotechnology company. Bevacizumab is the biosimilar version of Roche's Genentech unit's Avastin. Upon approval, the company expects to market it under the proprietary name Alymsys.

Bevacizumab is a vascular endothelial growth factor inhibitor. Amneal is seeking approval for Bevacizumab for the treatment of metastatic colorectal cancer. According to IQVI, U.S. annual sales for Bevacizumab for the 12 months ended April 2021 were approximately $2.8 billion.

Bristol-Myers Squibb Hopes For No Further Heartache On Heart Disease Drug

  • Company: Bristol-Myers Squibb Company (NYSE:BMY) & LianBio (NASDAQ:LIAN)
  • Type of Application: NDA
  • Candidate: mavacamten
  • Indication: symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
  • Date: April 28

Mavacamten is a cardiac myosin inhibitor that demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in a pivotal trial. The investigational therapy came into Bristol-Myers Squibb's stable through its Myokardia acquisition. Myokardia and LianBio initially collaborated to develop mavacamten.

HCM is a chronic, progressive disease characterized by the abnormal thickening of heart muscle, which makes it difficult for the heart to pump blood. It affects one in every 500 persons and can lead to cardiac dysfunction and other debilitating symptoms.

In November, the company communicated an extension to the review period for mavacamten, and gave a new PDUFA date of April 28.

Can Supernus Snag Label Expansion For ADHD Drug?

  • Company: Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN)
  • Type of Application: supplemental NDA
  • Candidate: Qelbree (viloxazine extended-release capsules)
  • Indication: attention deficit hyperactivity disorder
  • Date: April 29

Qelbree received its first approval in April 2021 for treating ADHD in pediatric patients, ages six to 17 years. The company now expects to make the treatment available to adult patients, who according to the company number around 10 million in the U.S.

Chinese Biopharma Hutchmed Knocks FDA Door For Approval Of Neuroendocrine Tumor Treatment Candidate

  • Company: HUTCHMED (China) Limited (NASDAQ:HCM)
  • Type of Application: NDA
  • Candidate: surufatinib
  • Indication: pancreatic and extra-pancreatic neuroendocrine tumors (NET)
  • Date: April 30

Hutchmed's surufatinib is marketed in China under the brand name Sulanda. Surufatinib is evaluated as a treatment option for NET, which forms in cells interacting with the nervous system or in glands that produce hormones. It originates mostly in the gut and lungs and can be benign or malignant.

Will Axsome Add A Drug To Crowded Migraine Market?

  • Company: Axsome Therapeutics, Inc. (NASDAQ:AXSM)
  • Type of Application: NDA
  • Candidate: meloxicam-rizatriptan (AXS-007)
  • Indication: acute migraine
  • Date: April 30

AXS-07 (MoSEIC meloxicam-rizatriptan) is an oral, rapidly absorbed, multi-mechanistic, investigational medicine for migraine. According to CDC, over 37 million Americans suffer from migraine.

AXS-007, if approved, will be joining a crowded field, comprising AbbVie, Inc. (NYSE:ABBV), Eli Lilly & Company (NYSE:LLY) and Biohaven Holding Company Limited (NYSE:BHVN).

Coherus, Chinese Partner Seek Approval For Nasopharyngeal Cancer Treatment

  • Company: Coherus BioSciences, Inc. (NASDAQ:CHRS)
  • Type of Application: BLA
  • Candidate: Toripalimab
  • Indication: nasopharyngeal caner
  • Date: April 30

Coherus is developing toripalimab, an anti PD-1 monoclonal antibody, along with China's Junshi Biosciences. The investigational treatment is being evaluated in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Adcom Calendar

FDA's Oncologic Drugs Advisory Committee is scheduled to meet on April 22 to discuss TG Therapeutics, Inc.'s (NASDAQ:TGTX) sNDA for Ukoniq (umbralisib) tablets, and BLA for ublituximab injection. The proposed indication for these two products is in combination for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The committee will also discuss the existing umbralisib indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma approved under accelerated approval regulations.

https://markets.businessinsider.com/news/stocks/attention-biotech-investors-mark-your-calendar-for-april-pdufa-dates-1031327374

Pharmacists Get More Leeway to Offer Treatment With Testing

 When Reyna or Justin Ansley or one of their three kids feels sick and needs to be tested for strep throat or flu, there's a good chance they'll head to their local pharmacy in Hemingford or Alliance, Nebraska. Dave Randolph, the proprietor of both locations of Dave's Pharmacy, can do a rapid test, give them medicine if they need it, and send them on their way.

"I'm a cattle rancher," said Reyna Ansley, whose family lives about 15 miles outside Hemingford. "You don't necessarily have the time to drive to the doctor and sit in the waiting room. It's really quicker through Dave."

The Ansleys don't have health insurance and using the pharmacy, where Randolph charges $50 to $60 to do the tests, is cheaper than paying up to $200 for an office visit with a local doctor, Ansley said. If the test is positive, the medications generally cost $20 to $30.

Randolph's ability to provide treatments for flu and strep throat is somewhat unusual. He can do so in Nebraska because he has an annual collaborative practice agreement with a local doctor that is subject to state approval.

The easy availability of pharmacists also helped propel them into a key role during the pandemic as they became a go-to resource for covid-19 testing and vaccines. Yet even before covid engulfed the country, many states were giving pharmacists a bigger role in consumers' health.

According to the National Alliance of State Pharmacy Associations, more than a dozen states have expanded what pharmacists can do to include testing and treating people for illnesses such as strep throat, flu, and urinary tract infections and preventing HIV. Some states allow pharmacists to prescribe oral contraceptives or drugs to help people quit smoking. Typically, pharmacists have prescribing authority under agreements with doctors or rules called statewide protocols.

But a limited number of states have gone further, allowing pharmacists to prescribe medications on their own to treat a broad range of conditions for which there are rapid point-of-care tests, if it's appropriate based on clinical guidelines.

"We're seeing more states looking at direct prescribing authority now as opposed to collaborative practice agreements," said Allie Jo Shipman, director of state policy at the National Alliance of State Pharmacy Associations. The alliance offers point-of-care testing and point-of-care treating training programs for pharmacists and pharmacy students.

The Biden administration, which has leaned on pharmacies to help battle the covid pandemic by administering vaccines and tests, is now calling for a limited number of pharmacies with retail clinics that employ doctors or other health care workers with prescribing authority to directly provide medication rapidly to people who test positive for the virus. The "test-to-treat" program is designed to make sure that people with covid get a course of antiviral medication quickly because it is most effective if used within five days of when someone shows symptoms.

Pharmacists say their expanded efforts on covid have helped raise their profile.

"One of the big things that came out of covid is that consumers understand that pharmacies do offer these services that are high-quality and convenient and support their health," said B. Douglas Hoey, CEO of the National Community Pharmacists Association, which represents the interests of independent pharmacists.

But physicians don't necessarily welcome this development. Doctor groups have long objected to the taking on of certain types of patient care by pharmacists, nurse practitioners, physician assistants, and other nondoctors unless it is overseen by or approved by physicians.

In November, the American Medical Association, which represents doctors, announced that since 2019, it had successfully opposed more than 100 legislative actions that would have expanded nonphysicians' scope of practice, called scope creep. The group also issued a statement criticizing the Biden administration's plan to allow pharmacy-based clinics to prescribe covid antiviral medications, saying that the program poses a danger to patient safety and risks negative health outcomes. And the AMA unsuccessfully opposed a federal decision to let pharmacists give covid vaccines to children younger than 18.

Meanwhile, the American College of Physicians, which represents internists, announced it "opposes independent pharmacist prescriptive privileges and initiation of drug therapy outside of a collective practice agreement, physician standing order or supervision, or similar arrangement."

The AMA didn't respond to questions about independent pharmacist prescribing, and the ACP declined to comment on its policy.

But are physicians correct that patient safety is at risk if a doctor isn't involved in prescribing decisions? Pharmacists say that they want to provide care in line with their training and skills and that they know their limits. And they note that timely prescribing is vital for treating covid and other infectious diseases.

They also note that pharmacists are increasingly part of the multidisciplinary clinical teams that direct patient care at hospitals and in health care systems.

"Pharmacists are the professionals that are the most trained to deal with drug interactions," said Rita Jew, a pharmacist who is president of the Institute for Safe Medication Practices, a nonprofit that focuses on preventing medication errors. "We monitor patients for both efficacy and side effects. So from that perspective, it's not a safety concern. Delay in treatment is a concern."

Many pharmacists are eager to expand their menu of patient services, but payment remains a problem. Pharmacists aren't generally recognized as service providers under Medicare and don't typically receive payment when they spend time evaluating, testing, or treating patients. Many private insurers follow Medicare's lead on payment.

For many people, pharmacies are convenient and familiar. More than 90% of people in the United States live within 5 miles of a community pharmacy, and Medicare beneficiaries visit the pharmacy nearly twice as often as they do their primary care physician.

Dr. Jeffrey Singer, a general surgeon and a senior fellow at the libertarian Cato Institute, wrote a recent blog post suggesting that doctors who object to nonphysician prescribing may be more worried about competition than patient safety.

"Rather than work to prevent laws that could meet the needs of patients, the onus is on the profession to persuade people that they need to see a doctor," Singer said in an interview, adding that he has relied on pharmacists' expertise in his practice. "I ask them, 'Is there any particular problem with this drug?' They have the software. And that's what they're trained to do."

In Arkansas, a 2021 law gave pharmacists the authority to treat conditions for which there are point-of-care tests, as long as they follow statewide protocols established by the state board of pharmacy and the state medical board.

"There are myriad tests that are on the market now that are quick and inexpensive and that can really increase access dramatically for folks who don't have time or resources to go to a primary care provider," said Scott Pace, a pharmacist and co-owner of Kavanaugh Pharmacy in Little Rock, Arkansas.

But pharmacists aren't interested in replacing physicians, said Shipman. "We want to come alongside physicians," she said. "We want to be another health care provider. In the middle of the pandemic, we need more help. The burden is too great to be carried by any one provider."

https://www.medscape.com/viewarticle/971418

In-Person ACC Meeting Returns, Serving Diet Intervention Studies and More

 Much-anticipated data on salt restriction and nutrition education are on the menu at this weekend's American College of Cardiology (ACC) meeting, which welcomes in-person attendees for the first time since the start of the COVID-19 pandemic.

The meeting will take place in Washington, D.C., and will also offer virtual streaming and participation for some sessions.

Among ACC's late-breaking scientific presentations scheduled for Saturday is SODIUM-HF, the largest and longest-running randomized trial of salt restriction in patients with heart failure. If nutritional counseling reduces sodium intake and cuts down on major adverse events or hospitalizations at 1 year, SODIUM-HF could be the study that strengthens the limited evidence base for curbing dietary salt.

Primary prevention guidelines currently recommend limiting salt, but do not endorse a specific target daily amount.

Also notable at this year's ACC meeting is the SuperWIN trial, which tested how nutrition education sessions in grocery stores, coupled with online tools, might help people adhere to the heart-healthy Dietary Approaches to Stop Hypertension (DASH) diet. A partnership with the Kroger supermarket chain allowed researchers to determine how participants' eating habits changed after 3 months based on their grocery purchasing data. SuperWIN will be presented on Sunday in a late-breaking trial session.

Other highlights of the scientific program include:

  • VALOR-HCM: A phase III trial evaluating mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy; topline results were previously announced, with the cardiac myosin inhibitor reportedly cutting down the need for septal reduction therapy at week 16
  • POISE-3: In this large trial, tranexamic acid is put to the test for bleeding prevention in noncardiac surgery

  • PROTECT: Also in the setting of noncardiac surgery, this study looked at intraoperative hypothermia versus aggressive warming to 98.6ยบ F to find which is associated with less myocardial injury at 30 days

  • CHAP: In this randomized trial, pregnant women with chronic hypertension are treated with a blood pressure target goal of 140/90 mm Hg, with pregnancy outcomes compared against untreated controls

  • PROMPT: A cluster-randomized trial on using electronic health record alerts to improve prescribing of guideline-directed medical therapy for heart failure
  • TRANSLATE-TIMI 70: A dose-finding study evaluating the lipid-lowering effects of vupanorsen, an antisense oligonucleotide inhibiting ANGPTL3 synthesis

  • FLAVOUR: A head-to-head comparison of fractional flow reserve versus intravascular ultrasound to guide angioplasty in people with intermediate coronary stenosis

On Friday, the eve of the ACC meeting's kickoff, updated heart failure guidelines will be released. A Saturday session will be dedicated to the new recommendations.

The conference comes during a time when states across the U.S. are relaxing their pandemic restrictions, despite the spread of the Omicron subvariant BA.2.

For a safe return to an in-person meeting experience, ACC organizers are requiring attendees to provide proof of full COVID vaccination (booster optional), which will be verified when they pass one of four physical health and safety checkpoints. Additionally, masks must be worn in the convention center.

https://www.medpagetoday.com/meetingcoverage/acc/97974