In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease “The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder.
The new medicine, called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics. Its authorization is a scientific triumph for the technology that can efficiently and precisely repair DNA mutations — ushering in a new era of genetic medicines for inherited diseases.”
Biden-Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition “[The]Biden-Harris Administration is announcing new actions to promote competition in health care and support lowering prescription drug costs for American families, including the release of a proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions, which specifies that price can be a factor in considering whether a drug is accessible to the public. The Administration believes taxpayer-funded medications should be reasonably available and affordable.”
Read the entire release.
About health insurance/insurers
CVS To Rebrand Growing Health Services As ‘CVS Healthspire’ “To help ‘demonstrate the connection and convenience CVS Health uniquely delivers,’ [CEO Karen] Lynch said Monday…that the company has created the CVS Healthspire name for the company’s health services segment that includes: Oak Street; Signify; more than 1,100 MinuteClinics; Caremark pharmacy benefit manager (PBM); and the newly created Cordavis, a new company that is working directly with drug makers to produce and commercialize “biosimilar” drugs, the less expensive versions of expensive brand prescriptions derived from biotechnology.”
Over 7 million people have signed up for 2024 Obamacare plans “Nearly 7.3 million Americans so far have signed up for health insurance for next year through the Affordable Care Act's (ACA) marketplace, according to data released by the U.S. Department of Health and Human Services on Wednesday.The enrolment for 2024 includes 1.6 million new additions to the marketplace, the data showed.”
10 payers audited for Medicare Advantage overpayments in 2023 “OIG audits found over $213 million in estimated Medicare Advantage overpayments in 2023.
According to the agency's fall semiannual report, the agency issued 65 audits with an expected $82.7 million in recoveries between April and September 2023.”
See the accompanying list of individual companies.
Man sentenced to prison for $30M scheme that defrauded major payers “A Tulsa, Okla., man was sentenced to 54 months in prison for a scheme that involved submitting more than $30 million in claims to major payers for COVID-19 testing services that were never performed.
William Gray, 50, admitted that he and his co-conspirators accessed private patient information from electronic medical records, according to a Nov. 30 Justice Department news release. They then used the information to submit claims to insurance providers for COVID-19 testing services that were never performed.
The insurance companies that were billed fraudulent claims were Blue Cross Blue Shield, Cigna, UnitedHealthcare, Aetna, Humana and Molina Healthcare. The companies collectively reimbursed $7 million of the fraudulent claims. Mr. Gray was ordered to pay that amount in restitution.”
Comment: Fraud of this magnitude does not usually occur for private insurance companies.
About hospitals and healthcare systems
Trinity vs. CommonSpirit vs. Providence: How 3 nonprofit systems' finances compare “Three of the largest nonprofit health systems, Providence, CommonSpirit and Trinity Health, reported operating losses and margins in the red for the three months ending Sept. 30, with higher labor and supply costs across the board. However, the systems all experienced increases in revenue as patient volumes continue to rebound.”
A busy week of mergers and acquisitions FYI
The Joint Commission announces Responsible Use of Health Data Certification for U.S. hospitals “The Joint Commission… announced a voluntary Responsible Use of Health Data™ (RUHD™) Certification program for U.S. hospitals and critical access hospitals, effective Jan. 1, 2024. Protecting patient privacy is a foundational element of a strong data use policy. The new certification will provide guidance and recognize healthcare organizations navigating the appropriate sensitivities needed to safely use data for purposes beyond clinical care, known as secondary use of data.”
Tough year ahead for healthcare credit ratings, more defaults expected “Moody's Investor Services expects healthcare company defaults to increase next year as credit ratings deteriorate.
In a Nov. 30 report, Moody's noted nearly 21% of the 192 North America-based healthcare companies on its credit ratings list were at B3 Negative ratings or lower, up from nearly 18% on Dec. 31, 2022. In 2023, 10 healthcare companies defaulted and nine on the B3 negative list were further downgraded, according to the report.”
About pharma
AbbVie to acquire Cerevel for $8.7 billion “In its second major buyout in the last week, AbbVie said Wednesday that it reached a deal to acquire Pfizer spinout Cerevel Therapeutics for $45 per share in cash, or roughly $8.7 billion, in a move aimed at bolstering its portfolio of neuroscience treatments. The announcement comes days after AbbVie struck a deal to take over ImmunoGen for $10.1 billion as it looks to expand its pipeline in the face of biosimilar competition for its top seller Humira (adalimumab)…
The acquisition will give it access to multiple clinical-stage and preclinical assets across diseases including schizophrenia, Parkinson's disease and mood disorders. AbbVie's neuroscience portfolio, which brought in a total $2 billion in sales in the third quarter, is centred on the migraine drugs Ubrelvy (ubrogepant) and Qulipta (atogepant), the atypical antipsychotic Vraylar (cariprazine), and Botox (onabotulinumtoxinA) for therapeutic use.”
CVS to revamp drug pricing model “CVS Pharmacy is taking a cue from Mark Cuban Cost Plus Drugs and will launch a pharmacy reimbursement model built around a drug's cost, a pharmacy services fee and a set markup.
The new approach, CVS CostVantage, will define a drug's cost and related reimbursement for contracted pharmacy benefit managers and payers, according to a Dec. 5 news release from CVS.
The new ‘cost plus’ model will be available to consumers in 2024 and will incorporate PBM contracts with commercial payers in 2025…”
Roche (RHHBY) to Acquire Obesity Drug Maker Carmot for $2.7B “Swiss pharma giant, announced that it will acquire the privately owned U.S.-based company, Carmot Therapeutics, Inc. for $2.7 billion. It did so in a bid to foray into the lucrative obesity market.
Per the terms of the agreement, Roche will pay Carmot’s equity holders $2.7 billion in cash upon closing. Carmot’s equity holders are also entitled to receive up to $400 million as milestone payments.
The acquisition provides Roche access to Carmot’s differentiated portfolio of incretins, including lead assets CT-388, CT-996 and CT-868.
CT-388, a dual GLP-1/GIP receptor agonist, is being evaluated for the treatment of obesity in patients with and without type 2 diabetes, injected subcutaneously once a week. This candidate is phase II-ready and has the potential to work as a standalone as well as combination therapy to improve weight loss.
CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently in phase I, is intended to treat obesity in patients with and without type 2 diabetes.
CT-868, a phase-II, once-daily subcutaneous injectable, is a dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients who are obese.
Per the company, the incretin-based portfolio could also be expanded to other indications where incretins play a role, including cardiovascular, retinal and neurodegenerative diseases.”
AbbVie’s domination of top drug ad spenders continues, with overall spending holding high See the list for top advertised drugs.
'No one was spared': 2023 biopharma funds projected to fall $13B YOY, Pitchbook finds “By the end of the year, biopharmas are projected to have raised about $24 billion across about 840 transactions—the lowest tally in four years, according to a new PitchBook analysis.
This is compared to annual values of $38.1 billion in 2020, $53.9 billion in 2021 and $36.9 billion for 2022, representing a $12.9 billion drop.”
US sets policy to seize patents of government-funded drugs if price deemed too high “The Biden Administration on Thursday announced it is setting new policy that will allow it to seize patents for medicines developed with government funding if it believes their prices are too high.
The policy creates a roadmap for the government's so-called march-in rights, which have never been used before. They would allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder does not make them available to the public on reasonable terms.”
A Texas judge grants a pregnant woman permission to get an abortion despite the state’s ban “A Texas judge on Thursday gave a pregnant woman whose fetus has a fatal diagnosis permission to get an abortion in an unprecedented challenge over bans that more than a dozen states have enacted since Roe v. Wade was overturned.
The lawsuit by Kate Cox, a 31-year-old mother of two from the Dallas area, is believed to be the first time since the landmark U.S. Supreme Court decision last year that a woman has asked a court to approve an abortion. The order only applies to Cox and her attorneys afterward spoke cautiously about any wider impacts, calling it unfeasible that scores of other women seeking abortions would also now to turn to courts.”
About healthcare IT
Genetic testing firm 23andMe admits hackers accessed DNA data of 7m users “The genetic testing company 23andMe has said that nearly 7 million people have been affected by a security breach that put DNA ancestry information into the hands of hackers who broke into the site in early October.”
About health technology
US FDA clears Becton's less-invasive blood collection device Becton Dickinson said on Thursday the U.S. Food and Drug Administration (FDA) cleared its finger-prick blood collection device that could provide a less-invasive option for some commonly ordered lab tests.
The device, BD MiniDraw Collection System, can help collect blood samples from a patient's finger through a trained healthcare professional without the need to do it from a vein, the company said.”