- Does My Child Have a Language Disorder?
- Journalists Talk Hot Health Topics: Urgent Care Clinics Performing Abortions and Doulas’ Pay
- ASCs’ vendor problem
- Providence’s physician chief on its ‘holistic’ approach to value-based care
- What the Health? From KFF Health News: A New CDC Nominee, Again
- States Update Guardianship Laws To Keep Children of Immigrants Out of Foster Care
- Anesthesia job market faces ‘major disruption’
- Florida system raises $100M for new ED
- North Carolina system names COO
- Mark Cuban wants to bring drug manufacturing to hospitals’ doorsteps — literally
- UCI Health names chief AI officer
- Nevada hospital names CEO
- Saint Luke’s taps president for 2 hospitals
- Dental community mourns dentist killed in murder-suicide
- Mass General Brigham, CVS deal could raise healthcare spending $40M annually: Report
- Ideal Dental opens 1st Oklahoma practice, expands in 2 more states
- PDS Health eyes the next era of medical-dental integration
- Mark Cuban dives into direct contracting
- HCA executive pay by the numbers
- Iris Telehealth offers behavioral health analytics platform
- HHS names chief economist, regulatory leader to address healthcare affordability
- Loma Linda University Health names new president
- The best ASCs for colonoscopy, endoscopy in the South: US News
- Tennessee moves forward with CON repeal
- Dental schools take action to alleviate workforce shortages: 6 updates
- American Medical Group Association partners with Talkiatry to expand psych access
- Trump nominates CDC director
- ChristianaCare, Cardiovascular Physicians of Delaware to open joint venture ASC
- 5 states regulating AI in mental health
- Centerstone debuts $13M youth behavioral health campus in Missouri
- 3 DSOs making headlines
- Maine restricts noncompetes for rural healthcare workers
- Heartland Dental opens Florida office
- The 10 biggest ASC deals of the last 5 years
- Affordability, transparency: A look at large employers' top healthcare concerns
- 10 dental Medicaid updates to know from Q1
- White House eyes ibogaine research expansion
- New Weight Loss Research Questions Need for GLP-1 Drugs
- Trump Names CDC Director Pick
- SocialRx teams up with FQHC in NYC to prescribe arts and culture for chronically ill patients
- FDA To Review Whether To Allow More Access To Certain Peptides
- Rising Colon Cancer Deaths Hit Younger Adults Without Degrees Hardest
- The Healthccare Burnout Backlask (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators
- The Healthccare Burnout Backlask (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators
- Over 80% of PCPs concerned about financial stability over next several years
- Industry Voices—DOJ jumps into 340B cases over state law, raising questions about federal plans for the program
- FDA's accelerated approval pathway needs stronger transparency, evidence standards: ICER
- Most People Would Take A Blood Test For Alzheimer's, Study Says
- This Sexually Transmitted Infection Linked To Heart Attack, Stroke
- How Playtime at Age 2, Especially with Parents, Shapes Teen Fitness Habits
- New Depression Treatment Matches ECT with Less Memory Loss, Study Says
- Memory Problems? Your Salt Intake Could Make Matters Worse, Study Says
- Ultra-Processed Foods Linked To Fatty Muscles, Potential Knee Arthritis
- Your New Therapist: Chatty, Leaky, and Hardly Human
- Teva scores in appeal as court revives $177M verdict against Lilly in migraine patent spat
- Gen AI chatbots continually struggle with differential diagnoses, Mass General Brigham study finds
- Listen: With Little Federal Regulation, States Are Left To Shape the Rules on AI in Health Care
- Fierce Pharma Asia—Astellas’ stem cell therapy rethink; GSK’s bullish ADC plan; Daiichi’s OTC sale
- BIO comes out swinging with 'Fight of Our Lives' campaign for the industry’s 50th birthday
- The future of medical-dental integration is here
- Texas dentist has license suspended
- Efforts grow to limit corporate dental ownership, protect dentist autonomy: 6 updates
- What’s the deal with insurer mental health parity violations?
- Remarks at the Options Market Structure Roundtable
- Wider care gaps predicted as mental health parity rule faces rollback
- Sheppard Pratt gets $16.5M for behavioral health expansion
- Former Deputy Surgeon General Erica Schwartz, M.D., nominated as CDC director
- Verily Health simplifies medical jargon alphabet soup with AI-powered app in new campaign
- 10 trends in behavioral health usage: Report
- Cattywampus: Statement on the CAT Concept Release
- Providers' advantage on out-of-network billing disputes likely to continue: Capstone
- Butterflies and Condors: Remarks at the Options Market Roundtable
- Viatris, Teva kick off separate recalls over dissolution, raw material issues
- Mental health ED visits at Children’s Hospital Colorado jump 20% in April
- Rising ACA Costs Leave Many Unable To Pay for Coverage
- One Lot of Xanax Recalled Nationwide Over Quality Issue, FDA Says
- Cough Drops From Several Brands Being Recalled, FDA Says
- CDC May Get New Leader as Officials Consider Erica Schwartz
- Statement at the Roundtable on Options
- Opening Remarks at the Options Market Structure Roundtable
- APA launches resource library for trusted digital mental health tools
- E-Bikes And E-Scooters A Growing Menace On City Streets, Study Says
- 'Absent or trivial' effects: Anti-amyloid Alzheimer's drugs called into question once again
- RFK Jr. kicks off string of congressional hearings to talk White House budget plan
- This Simple Step Could Improve The Benefits From Your Regular Workouts
- New Alzheimer's Drugs Provide No Meaningful Benefit, Major Evidence Review Concludes
- Air Pollution and Weather Tied to Migraines
- Study Says Stress, Weight And Hormones Alter Timing of Puberty in Girls
- Why Walking Remains Unsteady After Partial Spinal Cord Injury
- Roche to launch another Elevidys study after EU rejection of Duchenne gene therapy
- Lilly answers FDA's call for more Foundayo safety info, plotting diabetes filing in parallel
- New Federal Medicaid Rules Require One Month of Work. Some States Demand More.
- As US Birth Rate Falls, Feds’ Response May Make Pregnancy More Dangerous
- Omnicom brews Olixir from FCB Health, rebranding storied agency after Interpublic takeover
- DiMe-led initiative brings together pharma, virtual providers, digital pharmacies to develop blueprint for DTC pharma models
- UPDATED: Heeding RFK Jr.'s call, FDA reclassifies 12 unapproved peptides ahead of advisory committee meeting
- Carrot launches proprietary AI platform for personalized fertility, family care
- UC Health workers plan open-ended, system-wide strike for May 14
- Baylor Scott & White Health Plan to depart individual market, Medicaid this year
- In industry's latest OTC pivot, Daiichi Sankyo lines up $1.5B consumer health unit sale to beverage giant Suntory
- EPA Delays Decisions on 'Forever Chemicals'
- Wildlife Trade Tied To Higher Risk of Diseases Spreading to Humans
- Yes, This is the Worst Pollen Season Ever — Until Next Year
- GoodRx launches 7.2-mg Wegovy dose for self-pay patients at $399 per month
- Progyny unveils new fertility benefit option for small, mid-size employers
- Providers back bipartisan bill eliminating Medicare chronic care management cost sharing
- New Weight Loss Pill, Foundayo, Gets Approval But FDA Seeks More Safety Data
- Seqster launches new data tool to turn clinical sites into 'research-ready data collection points'
- Gilead widens global Yeztugo access agreement, but MSF says supply is 'not nearly enough'
- Novartis CEO Vas Narasimhan joins Anthropic’s board as biopharma’s ties to AI deepen
- Behavioral health utilization is up with anxiety disorders leading demand, report finds
- Does Your Child Have A Concussion? These Are The Signs, Review Says
- AI Reveals Negative Labels in Medical Records for Sickle Cell Patients
- 'Food-as-Medicine' Improves Life for Heart Failure Patients
- Silent Heart Rhythm Problem Might Triple Risk Of Heart Failure In Seniors
- Blood Test Predicts Alzheimer's Years Before Symptoms, Brain Changes
- An Infectious Combo Triples Risk Of MS, Study Says
- Astellas manufacturing chief views reliable supply, bridging research as his production 'north star'
- Physician compensation up 3% in 2025, but not all specialties saw raises: Medscape
- Pfizer recruits former Angel Lucy Liu for latest mission against cancer
- Teva launches new online schizophrenia community project
- One man’s journey from gambling addiction to recovery and advocacy
- Rural Nebraska Dialysis Unit Closes Despite the State’s $219M in Rural Health Funding
- Medi-Cal Immigrant Enrollment Is Dropping. Researchers Point to Trump’s Policies.
- Ionis exec shares method to the Madness after 2026 Drug Name Tournament win
- Abridge expands clinical decision support solution with UpToDate partnership, new NEJM, JAMA content tie-ups
- Travere maps course for Filspari's $3B US opportunity after landmark rare disease nod
- Hospitals with more disadvantaged patients fall short on price transparency, study finds
- FDA tells Eli Lilly to round up more safety info on key obesity launch Foundayo
- Meat Consumption Rises as Protein Trend Grows, Experts Warn
- Bill would force payers to apply DTC drug purchases to patient deductibles
- Nuts.com Recalls 10,000+ Pounds of Candy Over Allergy Risk
- Listen to the Latest ‘KFF Health News Minute’
- Keebler Health secures $16M in series A funding for AI-powered risk adjustment platform
- Sam’s Club Recalls Children’s Pajamas Due to Fire Hazard
- Small Talk? It May Be Better Than You Think
- J&J, chasing $100B year, sports immunology ‘dual powerhouse’ of Tremfya and new launch Icotyde
- Long-Term Opioid Prescriptions Fall By About A Quarter
- Gut Bacteria Might Drive Rare Food Allergy in Children, Study Finds
- Stents Can Ease Long-Term Symptoms Of Deep Vein Thrombosis, Trial Shows
- Young Cancer Survivors Face Doubled Risk Of Subsequent New Cancer
- Does Your Child Have Nightmares? Here's One Solution
- Novo taps OpenAI to deploy AI across R&D, manufacturing and corporate functions
- Pfizer rebuked by FDA for misleading Adcetris ads on Facebook
- FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
- FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
- Freedom of Associations
- Interfacing with our Inner Demons: Comments on the Division of Trading and Markets' Statement on Certain User Interfaces
- Staff Statement Regarding Broker-Dealer Registration of Certain User Interfaces Utilized to Prepare Transactions in Crypto Asset Securities
- Statement Regarding Staff No-Action Letter to Bank of England
Even the FTC has had it with the avarice of Pharmacy Benefit Managers (PBMs). The FTC just withdrew its past statements that forcing PBMs to disclose their dealings with pharmaceutical manufacturers, sellers, health care insurers, and drug consumers would undermine their ability to lower healthcare costs.
The latest example of PBMs' surreptitious pricing games are the biosimilar versions of AbbVie's arthritis drug Humira (adalimumab), which are now available. Branded Humira was one of the world's best selling (and very expensive) prescription drugs when it was under patent. Adalimumab costs are still driving health care insurance premium pricing in Michigan and across the country:
Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen'
By Patrick Wingrove - July 25, 2023July 25 (Reuters) - Cheaper versions of one of the most costly and widely used arthritis treatments in the U.S. are likely to fuel further scrutiny of the middlemen that negotiate drug prices for most insured Americans from lawmakers and the federal government, according to healthcare experts.
Seven drugmakers this month launched their own versions, known as biosimilars, of AbbVie's (ABBV.N) flagship arthritis drug Humira, once the world's top-selling prescription medicine. Three have kept their list price within 5%-7% of AbbVie's, two priced at an 85% discount and two have offered both types of prices.
Once several competing versions of a drug become available prices tend to plummet, although less so with complex biotech drugs like Humira. Traditional generic pills that are exact copies and easily produced can quickly drop prices by 90% or more. Other biosimilars have had price cuts of around 50% on launch, according to data from the Association for Accessible Medicines trade group.
"That list prices of Humira and its biosimilars remain high even with robust competition should fuel calls to reform our Byzantine, dysfunctional pharmaceutical supply chain," said Ameet Sarpatwari, a professor and drug pricing authority at Harvard Medical School.
For insured patients who are often on the hook for co-pays of 10% to 25% of the list price, the savings have been minimal.
Lawmakers and the Federal Trade Commission (FTC) have been investigating the role of PBMs in rising healthcare costs. Several bills are in the works that would require them to make their business dealings public, including the fees they earn on transactions.
The FTC last week withdrew past statements suggesting that forcing PBMs to disclose their dealings would undermine their ability to lower healthcare costs, adding that the industry has changed since then.
The three biggest PBMs, CVS Health's (CVS.N) Caremark, Cigna Group's (CI.N) Express Scripts, and UnitedHealth Group's (UNH.N) Optum RX, declined to comment.
PBMs say they play an important role in holding down drug costs for their clients, including employers and health insurance plans, and that most after-market discounts go to their customers.
'AN OPAQUE OPERATION'
Amgen (AMGN.O) called attention to the middlemen when it launched Amjevita, the first approved near copy of Humira, in January. It set two prices for its version, saying PBMs prefer a higher list price from which they garner after-market discounts. In return, drugs receive a low co-pay or other preferable coverage terms.
Amgen offered 5% and 55% discounts to AbbVie's $6,922 per month Humira price tag, and both were included on drug coverage lists at two large PBMs.
In the subsequent nearly three months, only 9% of all patients that used the drug had gotten the lower priced version, according to industry trade group Biosimilars Forum.
Healthcare experts say that trend could continue even though Express Scripts and Optum RX added both the high- and low-priced biosimilars from Novartis' Sandoz unit to their coverage this month.
It also could take years for current proposals to result in meaningful savings for consumers, experts on the U.S. healthcare system say. Stricter rules on how these companies can operate, including restrictions on how they determine charges and a possible reimagining of their business model, would help, they said.
Law professor Robin Feldman from University California College of the Law, San Francisco, said some legislative proposals, like one from Democratic Senator Ron Wyden on how PBMs determine their fees, could make a dent provided they stop the companies from making up lost revenue elsewhere.
The U.S. government spent about $9 billion on Humira in 2021.
"The basic challenge here is PBMs made a lot of sense 30 years ago," Wyden said. He told Reuters this month that PBMs should release more detailed information about how they operate.
A bipartisan bill in the works led by Republican Senator Chuck Grassley would require PBMs to report to the FTC payments received from health plans and fees charged to pharmacies.
Earlier this month, Grassley told Reuters the PBM system was “an opaque operation. Transparency brings accountability, and there’s no accountability.”
"Who gets the benefit of the rebates?" he asked. "In most cases you’ll find out that local pharmacists and consumers don’t benefit much from it."
"Generic" Humira has been a long time coming. Michigan proposed bills defining how pharmacies could substitute these generic-equivalent drugs in 2015, and passed one in 2018.
The big cost-driver lobbying those particular bills was manufacturers. Any barrier to the biosimilars (generic equivalent) meant more money for the original manufacturer. They got VERY creative with their barriers.
I testified, with help from a patient right in the middle of the bad policy impact. We had some impact the first time around. That testimony is reproduced here.
https://mihealthfreedom.org/lansing-battles-over-biologics/
From today's Morning Brew:
CVS got a taste of its own medicine after Blue Shield of California said it will replace CVS’s pharmacy benefit manager system with other companies, including Amazon Pharmacy and Mark Cuban’s Cost Plugs Drugs business, to supply cheaper drugs to its members. The move poses an existential threat to the entire pharmacy-benefit manager model.
Amgen back in the news trying to bring another biosimilar ("generic") to market.
Original patent holders are twisting in the wind, leveraging every sector of government to extend these extremely lucrative biologic patents.
This time, it was the courts that delayed more affordable drugs.
Stelara Biosimilar OK'd With Interchangeability
— But patent settlement may keep new product off market until 2025
A biosimilar version of the multipurpose biologic drug ustekinumab has been approved by the FDA and can be swapped interchangeably with the original product sold as Stelara.
The new version carries the brand name Wezlana and the generic name sports the suffix -auub, the FDA said in announcing the approval late Tuesday. Amgen is the manufacturer.
Indications for Wezlana in adults are the same as for Stelara:
- Moderate to severe plaque psoriasis, for patients who otherwise could receive phototherapy or systemic therapy
- Active psoriatic arthritis
- Moderate to severe Crohn's disease
- Moderate to severe ulcerative colitis
Like Stelara, the new version is also approved for children ages 6 and older with plaque psoriasis or psoriatic arthritis. Neither product has yet been okayed for pediatric bowel disorders.
Wezlana's label will also contain all the same cautions and warnings as Stelara's, such as heightened infection risk.
Ustekinumab is a dual inhibitor of interleukins 12 and 23. It was among the first biologic drugs that patients could self-inject.
The approval for interchangeability is a coup for Amgen, as only a handful of other biologics have gained that status. It required an extra level of clinical testing to demonstrate that patients experienced no issues when switching between the two versions. With this designation, pharmacies can substitute the biosimilar for the original drug without the prescriber having to specify it.
HHS Secretary Xavier Becerra issued a statement applauding the FDA decision as promoting competition and lower drug costs. "Today's action by the FDA is a welcome step forward to approve a biosimilar for a drug taken by tens of thousands of Americans," he said. "Through President Biden's Inflation Reduction Act, we were able to remove some of the incentives for drug companies to block biosimilar and generic drugs from entering the market -- instead encouraging healthy competition."
That latter boast, however, seems odd in light of an agreement reached earlier this year between Amgen and Stelara's maker, Johnson & Johnson, that appears likely to keep Wezlana off pharmacy shelves for more than year. As typically happens with biosimilars, J&J had sued Amgen preemptively for patent infringement. In May, they settled out of court; full terms weren't disclosed but Amgen said it could have to wait until Jan. 1, 2025, to begin selling its version.
https://www.medpagetoday.com/rheumatology/generalrheumatology/107102
How much changed in 10 months!
A Marketplace Radio report today broke great news for patients everywhere who depend on biologics (insulin, chemo, RA and other immunologic drugs).
It's buried inside the PBM story, so I'll break it down a little.
I'm still disgusted with PBM middlemen in the drug market. I'm watching closely for market forces to eliminate them, and I think Michigan lawmakers were wrong to extend their lifespan with licensing. It's more legitimacy than they deserve. (Besides giving state government even more power in the market.)
BUT....
Even PBMs serve a useful function once in awhile. Check out that 81% savings on a "generic" version of Humira!
When I testified back in 2015, the best guess anyone had was 40-60%. This is really good news about what's possible with our highest-priced drugs.
Audio at the link.
The biggest middleman in the prescription drug supply chain now makes drugs
PBMs negotiate prescription prices between drugmakers and health insurers, and manage the initial paperwork and negotiation for prescription drug claims. They’re middlemen companies at the center of a complicated supply chain. PBMs often determine how much insurers pay for patient prescriptions and also operate their own pharmacies.
Prescription drugs have a complicated supply chain. At the center of that are those PBMs. PBMs have existed since the 1960s, though in the past few decades, they’ve stuck their hands into every part of the pharmaceutical supply chain pie. Except one pie — they didn’t make the drugs.
But now the largest PBM has also decided to do just that. On April 1, CVS Health entered the specialty drug manufacturing business.
Regulators have been taking a hard look at PBMs.
Marketplace Hosted by Kai Ryssdal
“There clearly is something that is not working in our pharmaceutical marketplace,” said Rahul Rao, deputy director of the Federal Trade Commission’s Bureau of Competition. “We see the smoke. Now let’s find the fire.”
The FTC thinks the fire might be PBMs. The agency invited the public to submit complaints about PBMs in February 2022.
“I think we received over 24,000 comments from doctors and independent pharmacists and patients just talking about the struggles that they feel on a day-to-day basis,” Rao said.
One common complaint? Pharmaceutical mergers creating mega-companies.
“The PBM and pharmacy market is not a normal or healthy functioning market,” Rao said. “It is so consolidated, with so few players.”
For example, you probably know CVS as a brick-and-mortar pharmacy chain with extremely long receipts. But it also owns the third-largest health insurer, Aetna, and the largest PBM, CVS Caremark.
These mergers are everywhere in pharmaceutical products. The FTC worries they hurt healthy competition. And critics say PBMs already benefit from higher drug prices.
In 2023, CVS founded Cordavis, a wholly owned subsidiary of CVS Health, to manufacture prescription drugs. Cordavis’ focus is on bringing biosimilar medications to the American market; these are generics for expensive specialty drugs called biologicals.
“By 2030, there is a $100 billion opportunity in biosimilars,” said Sree Chaguturu, chief medical officer of CVS Health.
Cordavis has started by making Hyrimoz, a biosimilar for Humira, which treats autoimmune disorders. Once Humira’s U.S. patents expired, CVS swooped in with Hyrimoz.
In the three weeks after it hit the market, Chaguturu said that 93% of CVS prescriptions were filled with the new biosimilar. That shows the power of CVS’ market saturation; it pushed Hyrimoz through every arm of its business.
CVS said the list price of Hyrimoz is 81% cheaper than brand-name Humira. And that’s saving their insurers a lot of money, Chaguturu said: “$140 million in gross savings on their drug benefit spend.”
Chaguturu doesn’t think so.
“Our commitment is to our clients and to the patients and members that they serve to lower drug pricing,” he said.
Not everyone agrees.
“It’s very intuitive that there’s a conflict of interest, because you’re essentially negotiating with yourself,” said Neeraj Sood, a health care economist at the University of Southern California’s Price School of Public Policy. He’s studied what PBM consolidation does to prices.
“I don’t think it’s a good idea for CVS to have its own biosimilar,” Sood said.
While CVS’ entry into biosimilars might help cut drug prices short term, “I think in the long run, what’s gonna happen is it’s going to erode competition in the biosimilar market,” he said.
And, Sood added, less competition could eventually bring drug costs back up.
I 100% agree with Mr. Sood. (Dr?)
The consolidation needs to stop. Go, FTC!
Get MHF Insights
News and tips for your healthcare freedom.
We never spam you. One-step unsubscribe.














