Author: Randy Chase

The FDA recently approved a therapy previously approved in 2021….. but with a very different indication and a new NDC. The approval was granted for Syfovre (pegcetacoplan injection) from Apellis Pharmaceuticals, Inc for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is the first and only therapy approved to treat geographic atrophy.  It is approved for intravitreal administration only by a qualified physician.

This is the second approval for the drug. The FDA first approved pegcetacoplan in paroxysmal nocturnal hemoglobinuria, a rare blood disorder where the immune system attacks red blood cells and platelets. It is marketed as Empaveli in that indication.

Although the approval did not include a black box warning the therapy can trigger ocular and periocular infections, active intraocular inflammation, endophthalmitis and retinal detachments among other adverse events.

The recommended dose for Syfovre is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.

The injection should be on the market by the beginning of March. The company announced launch price at $2,190 per vial before discounts. That translates into between $13,200 and $26,400 annually based on 30 vs. 60-day dosing.

Apellis did not announce distribution plans for Syfovre. Given its cost it is likely that it will be distributed by a specialty pharmacy distributor.

CLICK HERE to access prescribing information

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US FDA approves Apellis’ geographic atrophy therapy Syfovre

Syfovre is indicated for geographic atrophy patients with or without subfoveal involvement.

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD).

Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers to dose flexibility with a regimen of every 25 to 60 days for patients and physicians.  It provides comprehensive control of the complement cascade, which is part of the immune system of the body, by targeting C3.

Apellis Pharmaceuticals co-founder and CEO Cedric Francois said: “Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that Syfovre will make a meaningful difference in the lives of people with GA. GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment.”

The regulatory approval is based on positive data from the Phase III OAKS and DERBY trials conducted across a broad and representative population of GA patients. Syfovre reduced the GA lesion growth rate compared to sham injections in the OAKS and DERBY studies.

It also showed increasing effects of treatment over time, with up to 36% lesion growth reduction occurring between months 18 and 24. Syfovre’s safety profile is well-demonstrated after approximately 12,000 injections over 24 months.

Ever get a letter from more than 400 people? 

Not 400 letters…. 1 letter with four hundred+ signatories!

Over the last week more than 400 of the tippity topest brass in Pharma signed onto an open letter protesting the recent Texas court ruling blocking the sales of Mifepristone. Pharma’s response is generating as much news as the original ruling.

So what’s the unique motivation for so many big Pharma heavy weights to raise the alarm? Money and market stability

The primary worry is that a court could, on a whim (or a bias), rule that ANY drug approved by the FDA should be delisted nationally.  A monkey wrench in the gears could cost a manufacturer a huge amount of money even in the short term due to loss of revenue while sidelined, the disruption of physician prescribing preference, and the loss of patient confidence in their therapy….. just to cite a few impacts.

Expand the theory a bit and the same ‘legal logic’ could be applied to drugs in development questioning validity of drug trials and the FDA review and approval process. Drug development is very expensive and ‘time to launch’ in a competitive market translates into BIG money. Even the specter of such events would make any Pharma CEO quake in their lab booties.

CLICK HERE to read the open letter….. and even add your signature while at it.

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300 Biotech and Pharma CEOs Call for a Reversal of the Abortion Pill Ban

An open letter calls for a potential ban on abortion pill mifepristone to be reversed.

April 10, 2023 — Conflicting court rulings by federal judges in Texas and Washington last week left the future of a commonly used abortion pill in doubt. Now, more than 300 executives from biotech and pharmaceutical companies have signed an open letter opposing a Texas judge’s decision to stop the pill from being sold.

“We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place,” the CEOs wrote in the letter.

The CEO of pharma giant Pfizer, Albert Bourla, signed the letter, along with hundreds of smaller American biotech companies, including ReCode Therapeutics, Blackfynn, and Ovid Therapeutics. 

Roe v. Wade was overturned by the U.S. Supreme Court last summer, which had previously granted access to abortion health care nationwide. In the aftermath of that reversal, states independently decided whether or not abortion would be allowed or effectively banned. 

Last Friday, Trump-appointed U.S. District Judge Matthew Kacsmaryk ordered a suspension of the federally approved mifepristone, a drug that has been used for over two decades to terminate pregnancies. On the same day, Washington State’s U.S. District Judge Thomas O. Rice, who was appointed by the Obama administration, called for the opposite and directed the FDA not to roll back the abortion pill. 

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the CEOs’ letter says.

By Prarthana Prakash, Fortune Magazine

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are three LD deals that have been recently publicly confirmed subsequent to the approvals.

ORSERDU Available through Biologics by McKesson

CARY, N.C., Feb. 10, 2023—Biologics by McKesson, an independent specialty pharmacy specializing in oncology and rare disease areas, was selected by Stemline Therapeutics Inc., as a limited distribution network specialty pharmacy provider for Orserdu (elacestrant).

ORSERDU Available through Onco360

ORSERDU is an estrogen receptor antagonist indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Biologics Named Exclusive Pharmacy for SKYCLARYS (omaveloxolone)

Biologics by McKesson was selected by Reata Pharmaceuticals as the sole specialty pharmacy provider for Skyclarys (omaveloxolone), the first and only treatment for Friedreich’s ataxia (FA). Skyclarys was approved by the U.S. Food and Drug Administration (FDA) on Feb. 28, 2023, for the treatment of FA in adults and adolescents aged 16 years and older, along with a rare pediatric disease priority review voucher.

If you have you ever tried to explain all the nuances behind the host of decisions to launch a new specialty therapy through limited distribution, then look no further. The article below does a yeoman’s job of explaining the ins and outs, ups and downs, and even some sideways of LD.

Limited distribution is the holy grail for a specialty pharmacy. Being selected as even one of a dozen (or more) specialty pharmacies ensures that the lucky SP will get a slice of what are typically a high ticket (and hopefully high margin $$s) prescriptions. Many a specialty pharmacy has gone from a ‘little engine that could’ to a behemoth SP in short order due to their success in landing limited distribution deals. At the other end of the spectrum, the ‘blessed’ SPs that are selected as the exclusive distribution partner for a new high-ticket therapy can see revenues skyrocket overnight (cash flow is the rocket fuel that SPs need to grow). 

SPs learned that breaking the limited distribution glass ceiling was their ticket to the big time. That also means being offered preferred contracts by PBMs and Payers for reimbursement (since the manufacturer’s selection alone doesn’t always guarantee payment.) And, that contract usually opens the door to other non-limited-distribution therapies that might have also been previously blocked to them.

The article below focuses on limited distribution for Oncology products…. which represent the bulk of all LD programs. It also provides some key metrics that determine what qualifies as a limited distribution therapy even beyond Oncology.  New hires working the specialty pharmacy segment would do well to familiarize themselves with this important area of specialty.

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Developing a Limited Distribution Plan for Oral Oncology Products

Mar 21, 2023 — The portfolio of oral oncology products has evolved over the past few years and so has the traditional model of distribution.

Distribution strategy is one of several key decisions that a manufacturer must make early in the process when launching a new oral oncology product. As the market has shifted from traditional community-based products to specialty medications, expanded solutions to better serve these products have evolved.

High-touch, oral oncology products require distribution solutions that are targeted toward maximizing patient outcomes. Limited distribution through a carefully selected specialty pharmacy network offers a greater level of patient care but also brings more complexity and the need for greater understanding to identify the right solution.

Why Select a Limited Specialty Pharmacy Distribution Model for Your Product?

CLICK HERE to access the full article

Walgreens has tripled down on acquisitions over the past year to the tune of several Billion $$$ in a quest to totally remodel the 122 year old pharmacy giant. So, with several quarters under their belt, is the strategy working? They would likely say….. quite well, thank you.

Here are the highlights from the article below:

• Walgreens Health tops 2.9 million contracted lives….up over 50% year on year
• Village MD now managing 806,000 value-based lives….up over 38% year on year
• Village MD ended the quarter with 729 locations, including Summit Health and City MD including 210 clinics collocated with Walgreens, compared to 94 collocated clinics a year ago.

It is challenging to make comparisons since there are really no other similarly integrated models with the broad scope we see in the WAGS model. That being said, the easiest metric is head count. In a relatively short time WAGS has racked up access to several million lives that come with a tangible degree of control.

It should be no surprise that specialty pharmacy is one area that will increasingly benefit from connectivity with prescribers in the Health division. Unfortunately, it is unlikely that we will see detailed financials that break out specialty revenues from this channel.

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Walgreens Touts Healthcare Transformation As Clinic Acquisitions Quicken

MARCH 28, 2023 — Continuing its transformation from a pharmacy chain to an integrated healthcare platform with a large retail footprint, Walgreens Boots Alliance (WBA) reported progress on its retail clinic initiatives as it saw the effects of COVID fade substantially.

During its fiscal 2023 second-quarter earnings call on Tuesday (March 28) WBA CEO Rosalind Brewer called the second quarter of fiscal 2023 “a landmark quarter for our transformation to healthcare,” pointing to its $3.5 billion investment to support Village MD’s acquisition of Summit Health.

Saying the company is focusing more on “accelerating the build-out of our healthcare growth engine,” Brewer said “the addition of Summit Health is transformational. It creates one of the largest integrated provider platforms in the U.S., delivering quality affordable care for all patient populations, regardless of insurance or payer type.”

Brewer called the acquisition a “highly strategic transaction that expands Village MD’s addressable market with primary care, multi-specialty and urgent care, and reinforces our approach across the entire care continuum.”

WBA has added its fourth payer partner for its organic business, Horizon Blue Cross Blue Shield of New Jersey, and has signed five clinical trial contracts. She added that specialty pharmacy operator Shields Health Solutions and home health provider CareCentrix “both continue to perform well, which led to the accelerated acquisition of both entities. Shields closed on Dec. 28 and CareCentrix is scheduled to close this quarter.”

Chief Financial Officer James Kehoe said Walgreens Health’s organic business had 2.9 million contracted lives up over 50% year on year, with Village MD managing 806,000 value-based lives as the quarter ended, “reflecting year-over-year growth of 38% in the legacy Village MD business and the addition of 309,000 value based lives from Summit Health.”

He noted that Village MD ended the quarter with 729 locations, including Summit Health and City MD. There were 403 clinics for the legacy Village MD business at the end of the quarter compared to 270 at the end of the prior year period, including 210 clinics collocated with Walgreens, compared to 94 collocated clinics a year ago, he said.

In the old days (before the internet) the importance of a news item was often expressed in how many column inches the item was generating in newspapers. The topic we are focusing on today has been generating a huge amount of ‘ink’ in the past week and… it is about a therapy that was approved five years ago.

The FDA approved the biosimilar Hyrimoz (adalimumab-adaz) in 2018. As most of you mat recall, this biosimilar to Humira was blocked from market entry due to patent challenges. Those holds are finally coming off and the Hyrimoz launch is finally on track for this July.

The big news about Hyrimoz is that it has been reformulated with a high-concentration formulation (HCF) and is now also citrate free. The elimination of citrate is unique among the Humira biosimilars as a selling point since the citrate preservative causes some injection pain (akin to getting lemon juice in a paper cut). This may sound like a ‘nothing burger’ differentiation….. but any differentiation is better than none….. especially if you are stuck for talking points with a prescriber.

Pricing for Hyrimoz  was not announced.  By way of reference…. the GoodRx avg. retail for Humira is $9100 or $5100 with a coupon $5100 (2 pens= 1 month’s dosing) vs, Amjevita biosimilar priced at $4200 (also 2 pens). How payers will react to the pricing levels, given rebates, remains to be seen.

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FDA Approves Adalimumab-adaz High-Concentration Formulation Biosimilar

Mar 21, 2023

Aislinn Antrim, Editor

Sandoz intends to launch the latest Humira biosimilar in the United States on July 1, 2023.

The FDA has approved a citrate-free high-concentration formulation (HCF) of Sandoz’s biosimilar adalimumab-adaz injection (Hyrimoz) for 7 indications covered by adalimumab (Humira; AbbVie), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.1

Sandoz intends to launch the biosimilar in the United States on July 1, 2023, according to a press release.1

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, MBA, president of Sandoz Inc., head of North America, in the press release.1

Adalimumab is an inhibitor of tumor necrosis factor, a protein that is overproduced in certain autoimmune conditions, such as rheumatoid arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis. It causes inflammation and tissue destruction in joints, mucosa, or skin. In some cases, the immune system damages the body’s own tissues.1

The new approval is based on a phase 1 pharmacokinetics bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL HCF. The study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.1

“Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, MBA, president and CEO of the Arthritis Foundation, in the press release. “There are millions of patients affected by chronic inflammatory conditions that drastically impact their everyday lives. Given the high burden of disease for these conditions, biosimilars are one potential solution for health care providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”1

The first biosimilar for Humira was launched in February by Amgen and is expected to be the only adalimumab biosimilar on the market until July.2 Although implementing biosimilars in clinical practice can still be a challenge, biosimilars can offer enormous cost savings for patients and the broader health system.

Use of biosimilars in general is sharply increasing. Annual FDA approvals for biosimilars peaked in 2019 with 10 approvals, followed by declines in 2020 and 2021 due to the COVID-19 pandemic. However, 2022 saw that trend rising again,3 and biosimilar approvals for blockbuster drugs such as Humira promise to continue the uptick into 2023.

We missed one!

The FDA recently (back on January 27^th) approved a new ORAL therapy, Orserdu (elacestrant) from Stemline Therapeutics, Inc., indicated for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 

Orserdu is the first oral Selective Estrogen Receptor Degrader (SERD) that has shown improved efficacy over standard of care (SOC) treatments in patients with advanced breast cancer. 

Attempting to pin down prevalence numbers, given the variables listed in the indication, is akin to picking the next winning Powerball number. Published studies have not yet been able to determine the exact prevalence rate of ESR1 mutations but set the outer boundaries between 11-55%. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. Approximately 20–40% of patients who have received aromatase inhibition (AI) for MBC have ESR1 mutations, with prevalence varying by sites of metastatic disease. These mutations rarely exist (0–3%) in primary tumors but are relatively common in metastatic endocrine therapy-resistant breast cancer lesions, with a wide-ranging prevalence of 6–55%.

Orserdu hit the market at a discounted price of $24,000 for a month’s supply (345mg) and $7500 for thirty 86 mg tablets.

Stemline announced that Orserdu will only be available through limited distribution. 

CLICK HERE to access prescribing information

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FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant.

Efficacy was evaluated in EMERALD (NCT03778931), a randomized, open-label, active-controlled, multicenter trial that enrolled 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer of which 228 patients had ESR1 mutations. Patients were required to have disease progression on one or two prior lines of endocrine therapy, including one line containing a CDK4/6 inhibitor. Eligible patients could have received up to one prior line of chemotherapy in the advanced or metastatic setting. Patients were randomized (1:1) to receive elacestrant 345 mg orally once daily (n=239) or investigator’s choice of endocrine therapy (n=239), which included fulvestrant (n=166) or an aromatase inhibitor (n=73). Randomization was stratified by ESR1 mutation status (detected vs. not detected), prior treatment with fulvestrant (yes vs. no), and visceral metastasis (yes vs. no). ESR1 mutational status was determined by blood circulating tumor deoxyribonucleic acid (ctDNA) using the Guardant360 CDx assay and was limited to ESR1 missense mutations in the ligand binding domain.

The major efficacy outcome measure was progression-free survival (PFS), assessed by a blinded imaging review committee. A statistically significant difference in PFS was observed in the intention to treat (ITT) population and in the subgroup of patients with ESR1 mutations.

In the 228 (48%) patients with ESR1 mutations, median PFS was 3.8 months (95% CI: 2.2, 7.3) in the elacestrant arm and 1.9 months (95% CI: 1.9, 2.1) in the fulvestrant or aromatase inhibitor arm (hazard ratio [HR] of 0.55 [95% CI: 0.39, 0.77], 2-sided p-value=0.0005).

An exploratory analysis of PFS in the 250 (52%) patients without ESR1 mutations showed a HR 0.86 (95% CI: 0.63, 1.19) indicating that the improvement in the ITT population was primarily attributed to the results seen in the ESR1 mutated population.

The most common adverse events (≥10%), including laboratory abnormalities, were musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia.

The recommended elacestrant dose is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity.

This application was granted priority review and fast track designation.

Remicade is one of the cornerstone therapies in the market racking up billions in annual sales. But J&J-Janssen didn’t appreciate the approvals of four biosimilars starting in 2016. Since the Remicade biosims were able to go market (unlike Humira biosims, for example), J&J Janssen pushed restrictive contracts on health insurers and health care providers according to the lawsuit. This would have the effect of edging out the biosims and likely price reductions and margin erosion.

Remicade is priced at about $4,000 per dose or about $26,000 for a full year of treatment. In 2022, Remicade generated sales of $2.3 billion, down from $3.2 billion in 2021. Johnson & Johnson’s successor to Remicade, Stelara, was its top-selling pharmaceutical with sales of $9.7 billion last year, up 7% from $9.1 billion in 2021.

So, J&J-Janssen was ordered to pay $25 million in the settlement. On my budget $25million is a lot of cash….. but for a huge pharma company it is the proverbial equivalent to a mosquito bite on an elephant’s behind. So why bother to cover what is essentially a ‘non-event’? The ruling is precedent…. and precedent in the legal world can be impactful. Any time a pharma company loses in court the market pays attention and is encouraged to pursue relief for other wanna-be drugs struggling with similar restrictive market practices.

Approved Remicade biosimilars:

04/2016               Inflectra

05/2017               Renflexis

12/2017               Ixifi

06/2020               Avsola

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Johnson & Johnson and Janssen Biotech settle Remicade class action lawsuit after 6 years

Mar 20, 2023 — Johnson & Johnson will pay $25 million to resolve a 6-year-old class action lawsuit that alleged the company and its Horsham-based subsidiary Janssen Biotech violated federal and state antitrust and consumer-protection laws.

The lawsuit, filed in September 2017 by the National Employees Health Plan on behalf of consumers and third-party payors, alleged the companies acted improperly to block competition for their blockbuster drug Remicade. ……………………………

CLICK HERE to read full article

Today we spotlight an article that details the leading healthcare services companies. While the information may be old news for many of you, it may be a blank page for a new hire.

Employees that understand where their industry fits in the economic…. and competitive…. scheme of things are likely to be better employees. So, this easy read article can be a good primer for those newbies as part of a package of their onboarding orientation.

The only criticism of the article that we feel compelled to offer is that specialty pharmacy is barely mentioned. Virtually all of these companies are in the top 10 largest SPs in the US. Employees in the specialty pharmacy industry should understand the important dynamics of being both a health services company and a SP in today’s marketplace.

CLICK HERE to access the complete article

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Top 10 Best Healthcare Services Companies In USA 2023

Healthcare services companies in the USA in 2023 are on the cutting edge of providing quality care and services to patients. With advances in technology, healthcare companies are able to offer more personalized treatments for a variety of conditions.

March 6, 2023

Companies such as Clearwater Diagnostics, One Health Solutions, and Proactive Care offer comprehensive solutions that include diagnosis, treatment, and prevention services. These organizations are focused on providing the best care available, with an emphasis on preventive care. In addition, they are also utilizing artificial intelligence (AI) to increase accuracy and efficiency in their services.

Additionally, they are also focusing on incorporating technology into their strategies to create data-driven insights. For example, Clearwater Diagnostics is utilizing machine learning to predict patient’s likely outcomes based on their health data. Finally, these companies are collaborating with other organizations to better understand how to meet customer needs and provide the best possible care.

All in all, healthcare services companies in the US in 2023 are innovating and creating solutions to make healthcare more accessible and efficient for everyone.

IMPORTANCE

Healthcare services companies in the USA will continue to be of great importance in 2023.  In 2023, they will be essential partners in helping to improve the quality and efficiency of healthcare delivery. They will also play an important role in supporting public health initiatives, such as disease prevention and early diagnosis. Moreover, they will help develop innovative treatments and technologies that will help reduce costs and improve access to care.

As the US moves towards a more unified healthcare system, leading companies will be indispensable in providing the necessary expertise and resources. Additionally, they will need to keep up with the latest advancements in medical technology to ensure their services stay relevant and reliable.

In short, healthcare services companies will remain essential for delivering quality and cost-efficient care.

Here are 10 of the leading US healthcare services companies in 2023.

UnitedHealth Group – UnitedHealth Group is a diversified health and well-being company dedicated to helping people live healthier lives. The company offers a comprehensive portfolio of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides technology and information-enabled health services. UnitedHealth Group serves more than 130 million people worldwide, employing over 250,000 people across the globe.

UnitedHealthcare offers a full range of health plans and services, including Medicare and Medicaid plans, individual and family health plans, government plans, and employer plans. It also provides pharmacy benefit management services, behavioral health services, vision and dental coverage, international health insurance, worker’s compensation, and data analytics services.

Optum is an integrated services and technology platform focused on enhancing the quality, efficiency, and availability of healthcare services. It offers a broad suite of services that include clinical health services, data analytics, and business transformation. It has investments in clinically-integrated networks and analytics technology as well as specialty care provider organizations.

UnitedHealth Group has a strong presence in the U.S., with operations in all 50 states and Puerto Rico. It also has global locations in more than 30 countries, providing services to more than 100 million customers. Its total revenue for 2020 was $242.2 billion, showing steady growth since its founding in 1977. The company’s commitment to corporate social responsibility includes a focus on delivering better health outcomes, improving access to care, and making health care more affordable.

CVS Health – CVS Health is a leading healthcare company focused on making quality care accessible and affordable. The company operates more than 9,800 retail locations across the US, including pharmacies, retail clinics, specialty pharmacies, and infusion services.

CVS Health also provides a number of innovative services to help people manage their healthcare needs, such as mail order pharmacy services and MinuteClinics, a convenient walk-in clinic service. Through its innovative offerings, CVS Health is committed to helping people on their path to better health.

In addition, CVS Health is dedicated to making a positive impact in communities by supporting local organizations that provide access to health care and other social services.

CVS Health has been recognized for its commitment to community health initiatives and its corporate responsibility efforts, receiving awards from organizations such as the National Association of Board of Pharmacy and the American Heart Association.

AmerisourceBergen – AmerisourceBergen is a global healthcare services and solutions company. It operates in three distinct business segments—Distribution Services, Specialty Solutions, and Pharmaceutical Solutions. Distribution Services provides pharmaceuticals and other healthcare products to pharmacies, hospitals, and healthcare systems.

Specialty Solutions provides specialty pharmaceuticals and support services to oncology patients and physicians. Pharmaceutical Solutions offers technology-enabled pharmacy services, including medication management and medication therapy management.

AmerisourceBergen has been in business for over 30 years and is headquartered in Pennsylvania. As one of the largest pharmaceutical distributors in the United States, AmerisourceBergen serves more than 60,000 customers globally. The company employs approximately 18,000 associates worldwide. In addition, it is the largest independent wholesaler of pharmaceutical products in the world.

AmerisourceBergen has a commitment to helping patients get the medications they need. It strives to improve patient care by providing product availability, specialty pharmacy services, and purchasing programs that enable its customers to increase efficiencies. It also works with government agencies and pharmaceutical companies to ensure efficient distribution of medications and healthcare supplies.

AmerisourceBergen focuses on developing innovative value-added services for its customers. It offers a wide range of services, including supply chain optimization, patient access programs, therapeutic resource centers, and specialty patient services. The company also focuses on advancing industry standards and partnerships to help improve patient access and quality outcomes.

AmerisourceBergen’s commitment to corporate responsibility includes investing in communities and organizations dedicated to improving healthcare delivery and access. The company has received numerous awards for its contributions to healthcare and its commitment to social responsibility.

These awards include the Healthcare Supply Chain Leadership Award from the National Association of Wholesaler-Distributors, the Health IT Award from the American Medical Association, and the Corporate Citizenship Award from the U.S. Department of Health and Human Services.

McKesson Corporation – McKesson Corporation is a Fortune 5 healthcare services and information technology company based in San Francisco, California. Founded in 1833, McKesson has grown to become one of the world’s largest healthcare services companies, with operations in 25 countries around the world.

The company is organized into four major business units: McKesson US Pharmaceutical; McKesson Technology Solutions; McKesson Specialty Health; and McKesson Ventures.

McKesson US Pharmaceutical provides drug distribution, pharmacy management, and other services to healthcare organizations in the United States. The company operates a network of over 16,000 pharmacies, making it the largest pharmaceutical distributor in the United States. McKesson Technology Solutions provides software and IT services for healthcare organizations, including electronic health records (EHR), analytics, billing, and claims processing. McKesson Specialty Health is a provider of specialty pharmaceutical care and services. Finally, McKesson Ventures invests in promising healthcare companies.

In addition to its broad range of products and services, McKesson is committed to modernizing the healthcare system through technology. Through its innovative solutions, the company is helping to improve patient outcomes, reduce costs, and make healthcare more affordable. McKesson also works to support the greater health and wellbeing of people and communities around the world.

Walgreens Boots Alliance (WBA) – Walgreens Boots Alliance (WBA) is a global pharmacy-led, health and well-being enterprise. Founded in 1901, it operates the largest retail pharmacy chain in the United States and one of the largest in the world. WBA’s mission is to help people across the world lead healthier and happier lives through greater access to quality healthcare and pharmacy services.

The company is headquartered in Deerfield, Illinois and operates over 9,000 drugstores in 11 countries, mainly in Europe and North America. WBA owns and manages brands such as Walgreens, Boots, Duane Reade, and Alliance Healthcare.

It offers a wide range of products including prescription drugs, over-the-counter medications, beauty products, health and wellness items, and convenience foods. WBA also offers healthcare services such as vision, travel health insurance, diabetes management, and health coaching.

The company has invested heavily in digital transformation, launching mobile apps and creating an integrated customer experience across its channels. WBA is committed to helping people live healthier lives and supporting local communities by providing accessible healthcare services and resources.

Cardinal Health – Cardinal Health is a Fortune 500 healthcare services and products company headquartered in Dublin, Ohio. The company provides medical and pharmaceutical products and services to over 100,000 locations including hospitals, pharmacies, physician offices, and more.

A new Cardinal Health report examines shifts in biosimilars industry

Cardinal Health has been providing medical and healthcare products and services since 1979 and employs around 33,000 people across its worldwide operations.

Cardinal Health’s portfolio includes a full range of products and services that support the entire continuum of care. These include medication management, supply chain solutions, laboratory and pharmacy automation, diagnostic imaging, home health care, nutrition, dialysis, and other clinical products. Additionally, Cardinal Health provides consulting services and educational programs to help customers deliver better patient outcomes.

The company is committed to improving healthcare access, quality and efficiency through innovative, custom-focused solutions. Cardinal Health seeks to improve the safety, quality and cost effectiveness of healthcare through the development of clinical and technology solutions for providers, payers and patients.

Through their integrated enterprise, Cardinal Health works with manufacturers and healthcare providers to streamline processes, reduce costs and create efficiencies, ultimately helping healthcare providers deliver the best possible care to their patients.

Cardinal Health is also deeply invested in community health initiatives. The company supports organizations dedicated to delivering better healthcare to underserved populations, providing financial and resources support to those in need. In 2017, the company donated $24 million to various charities and is committed to making a difference in global health.

Humana – Humana is a Fortune 500 company that offers healthcare services to individuals, employers, and the government. Founded in 1961, it has grown to become one of the largest providers of health coverage in the United States. The company provides medical insurance plans, including Medicare and Medicaid services, as well as behavioral health and pharmacy services.

Humana also offers preventive care services, such as screening for chronic diseases, vaccinations, and lab tests. Its goal is to improve people’s overall health and well-being. Through its various programs, Humana seeks to help members access quality healthcare, stay healthy, and support their families. The company uses innovative technologies and data analytics to provide personalized solutions for its members.

Additionally, Humana strives to create positive social impact through initiatives that support diversity and inclusion, health equity, and environmental sustainability. With over 13 million members across the U.S., Humana is committed to providing innovative, high-quality healthcare services and improving the lives of the people it serves.

Optum – Optum is a healthcare technology and services company based in the United States. The company was founded in 2011 and is a subsidiary of UnitedHealth Group. Optum operates in three main segments: OptumHealth, OptumInsight, and OptumRx.

OptumHealth focuses on delivering patient-centered, integrated care management services, including clinical care management, behavioral health services, and consumer engagement programs. OptumInsight provides data analytics, technology, and consulting services to healthcare providers, payers, and life sciences companies to help them optimize their operations, improve quality of care, and reduce costs.

OptumRx is a pharmacy benefit management company that provides prescription drug benefit programs to employers, health plans, and government agencies.

Optum has a global presence, serving customers across the healthcare industry, including hospitals, physicians, health plans, life sciences companies, and government agencies.

The company has a strong commitment to innovation and invests heavily in research and development to drive healthcare transformation. Optum is also committed to social responsibility and has launched several initiatives to promote health equity and access to care for underserved communities.

In 2020, Optum reported revenues of $136 billion and employed over 300,000 people worldwide. The company is recognized as a leader in the healthcare industry and has received numerous awards for its innovation, culture, and commitment to social responsibility.

Centene Corporation – Centene Corporation is a healthcare enterprise based in the United States. The company was founded in 1984 and is headquartered in St. Louis, Missouri. Centene operates in the healthcare services sector, with a focus on providing managed care and related services to individuals receiving healthcare benefits.

The company offers a wide range of healthcare services, including Medicaid, Medicare, health insurance marketplace, and commercial healthcare plans. Centene also provides specialty services such as behavioral health, pharmacy benefit management, and telehealth services. The company serves over 25 million individuals in all 50 states and internationally, primarily through government-sponsored healthcare programs.

Centene is committed to improving access to quality healthcare services and reducing healthcare disparities. The company has launched several initiatives aimed at addressing social determinants of health, such as housing, food security, and transportation. Centene has also made significant investments in technology and innovation to improve the delivery of healthcare services and enhance patient outcomes.

In 2020, Centene reported revenues of $111.1 billion and employed over 70,000 people worldwide. The company is recognized as a leader in the healthcare industry and has received numerous awards for its innovation, corporate social responsibility, and commitment to diversity and inclusion.

Express Scripts Holding Company – Express Scripts Holding Company is a pharmacy benefit management company based in the United States. The company was founded in 1986 and is headquartered in St. Louis, Missouri.

Express Scripts provides a variety of services related to prescription drug benefits, including mail-order pharmacy services, specialty pharmacy services, and clinical programs designed to help patients manage chronic conditions.

Express scripts to drop customized drugs coverage

The company operates in a highly regulated industry and works closely with healthcare providers, payers, and pharmaceutical manufacturers to help manage the cost and quality of prescription drug benefits. In addition to its core pharmacy benefit management services, Express Scripts also provides data analytics, consulting, and other related services.

Express Scripts has grown significantly over the years through a combination of organic growth and acquisitions. In 2018, the company was acquired by Cigna, a global health services company, in a transaction valued at $67 billion. Today, Express Scripts operates as a subsidiary of Cigna and continues to be a major player in the pharmacy benefit management industry, serving millions of patients across the United States.

CONCLUSION

In 2023, the healthcare services industry in the US is expected to experience significant growth. The Affordable Care Act and other health reform measures have increased demand for health services, while technological advances are allowing greater access to quality care.

These developments have bolstered the business of healthcare services companies, providing opportunities for expansion in areas such as telemedicine, remote monitoring, mHealth apps, and AI-driven solutions. Furthermore, a growing aging population and changes to reimbursement models will continue to drive the industry’s growth over the next few years.

Last week the FDA approved a new oral solution therapy, Daybue (trofinetide) from Acadia Pharmaceuticals Inc., for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.

Rett syndrome is a rare and severe neurodevelopmental disorder that occurs primarily in girls with onset as early as 1-2 years of age. Rett syndrome is believed to affect 6,000 to 9,000 patients in the United States. Only about 4,500 U.S. patients have been diagnosed. Symptoms range from loss of speech, mobility, and muscle tone as well as seizures, breathing problems, slowed growth, and near-constant hand movement.

Although approval did not carry a black box warning, the approval did include warnings and precautions for diarrhea and vomiting which may be particularly risky for the youngest patients.

Acadia did not confirm price for Daybue; however, analysts estimate a launch price of $450,000 annually. Given the small number of potential patients in the US, its cost, and side effect profile, it is expected that Daybue will launch through limited distribution.

CLICK HERE to access prescribing information.

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U.S. FDA approves Acadia’s genetic Rett syndrome drug

March 10 (Reuters) – The U.S. Food and Drug Administration approved Acadia Pharmaceuticals Inc’s drug for the treatment of Rett syndrome, a genetic brain disorder, the company said on Friday, making it the first approved drug for the condition.

The U.S. health regulator’s decision allows use of the trofinetide, to be sold under the brand name Daybue, in adult and pediatric patients two years of age and older and comes with a warning of diarrhea and weight loss.

The approval comes months after the FDA declined to approve expanded use of Acadia’s drug Nuplazid to treat psychosis related to Alzheimer’s disease. Analysts have said approval of Daybue would help drive growth for the company in the near term.

“We have put a lot of planning into potential commercialization of trofinetide, including resources for patients to access the drug,” said Acadia senior executive Kathie Bishop ahead of the approval.

Acadia forecasts sales of Nuplazid – its only drug on the market – of between $520 and $550 million this year, above analysts’ median expectations of $532.8 million, according to Refinitiv data. With the drugmaker facing a loss of exclusivity for Nuplazid in 2028, investors have pinned their hopes on a successful trofinetide launch.

After the FDA declined to approve the expanded use of Nuplazid, Acadia said it would not pursue that indication for Nuplazid further. The drugmaker plans to focus its resources on late-stage development of Nuplazid to treat symptoms of schizophrenia and early-stage development of another candidate, ACP-204, for Alzheimer’s-related psychosis.