Month: March 2023

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.

The number of biosimilars launching in 2023 will spike as legal challenges around patent infringement are finally expiring. That will only exacerbate the problem of biosim adoption that has been inherent in the marketplace since biosims started to be approved in 2015. In short, biosimilars are still struggling to gain traction….. and a recent survey says that communications are at the heart of the problem.

Some of the survey highlights include:

• Oncologists felt that switching decisions were typically initiated by pharmacies (29.0%) or hospital/treatment centers (19.4%). Note, there is only a handful of biosimilars with ‘an interchangeable’ designation. 
• Patients (55.2%) said they were given an option to switch to a biosimilar. 63.9% went through with the switch / 8.6% declined to switch.
• Patients reported (40.8%) that they were never notified of a payer driven biosimilar switch, and only 26.4% said their oncologist or physician briefed them.
• The top three most common reasons for switching, as reported by oncologists

   – Payer requirements (23.5%), 

   – Biosimilars were considered identical (14.1%), and 

   – Hospitals wanted to save money (12.9%).

• Only 9.3% of patients felt that the payers could be trusted to make the right decisions about switching! It is also noteworthy that only 12.1% of oncologists felt similarly!
• 35.3% of patients felt they had been given the opportunity to ask questions about biosimilars 
• Only 43.4% of patients felt that the biosimilar would be as effective in treating their cancer!
• And, only 79.4% of oncologists felt the biosimilar would be just as effective as the reference product!!!

As the researchers said, “If biosimilar acceptance is to grow, it’s going to take a great deal of work to improve the levels of trust between payers, patients, and oncologists.”

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Researchers Identify a Communications Breakdown Over Biosimilars

June 6, 2022Researchers have identified what they say is a critical lack of communication about biosimilars between patients with breast cancer and their oncologists, based on surveys conducted from 2020 to 2021.

They also said many switches from the reference product Herceptin (trastuzumab) are dictated by payers and much needs to be done to improve the levels of trust between payers, patients, and oncologists if biosimilar acceptance is to grow.

“There is a need for tailored and effective patient and oncologist information and education on trastuzumab biosimilars, along with improved health care communications regarding switching,” wrote lead author Elizabeth Lerner Papautsky, Ph.D., M.S., an assistant professor in the Department of Biomedical and Health Information Sciences at the University of Illinois at Chicago. Papautsky and her colleagues reported their results in May in the journal Breast Cancer Research and Treatment.

In two separate surveys, Papautsky and her colleagues collected responses from 143 patients with breast cancer and 33 medical oncologists. The researchers said that 63.9% of patients reported they had been switched to a trastuzumab biosimilar–most often Kanjinti (69.8%)–and of those, 40.8% reported they had been given no prior notice they would be switched.

In none of the responses did oncologists ever say that the switch to a biosimilar was initiated by them. It was most commonly the case that the switch was mandated by the payer (45.2%). Oncologists were much more likely than patients to report satisfaction with the way biosimilar information had been communicated.

“The discrepancy between patient-reported experiences and oncologists’ perceptions of the patient experience suggests a lack of adequate information that may be a challenge not only to the uptake of trastuzumab biosimilars, but to the patient oncologist relationship,” Papautsky and her fellow researchers wrote.

The authors expressed strong concern that these communication gaps be rectified because, they said, Herceptin is a costly drug and biosimilars represent an important opportunity to improve patient access and lower the cost of health care. Payers have latched onto the savings aspect, they said. “Literature suggests that with increasing availability of biosimilars, a variety of switching scenarios have become common across disease types.”

They cautioned that “with guidelines often being vague, the practice of switching is largely unregulated.”

Because of the above-described patient/doctor disconnect on biosimilars, many patients resorted to self-directed research to find out about these biologic alternatives, the report said.

Among patients participating in the survey, 58.1% were fully covered by private insurance and 99.3% and 91.4% were female and white, respectively. Responding oncologists were most likely to work in an urban setting (68.0%) or at an academic center or affiliate (35.3%).

Despite the communication problems, most patients (55.2%) said they were given an option to switch to a Herceptin biosimilar–it wasn’t forced on them. And of patients who responded, 63.9% went through with the switch. Papautsky said 8.6% declined to switch.

However, lack of prior notification about switching was a problem, patients reported (40.8%); and just 26.4% said their treating oncologist or physician briefed them beforehand about biosimilars. Smaller percentages of patients said they got that type of information instead from advanced practice practitioners (5.7%), chemotherapy nurses (15.5%), or others.

Oncologists said that if not dictated by payers, switching decisions were typically initiated by pharmacies (29.0%) or hospital/treatment center administrations (19.4%).

The three most common reasons for switching, as reported by oncologists, were payer requirements (23.5%), biosimilars were considered identical to Herceptin (14.1%), and hospitals wanted to save money (12.9%).

Few patients or oncologists felt that the payers could be trusted to make the right decisions about switching (9.3% vs 12.1%, respectively). Patients were less likely than oncologists to agree they had been given the opportunity to ask questions about biosimilars (35.3% vs 58.8%) or that the biosimilar would be as effective in treating the cancer (43.4% vs 79.4%).

Tony Hagen, Managed Healthcare 

The article below should be a learning moment for the specialty pharmacy industry. It is all about going digital…. but it does not get lost in techno babble. It makes the  argument that the specialty pharmacy industry is essentially just now emerging from its Paleolithic age….  yep, when the Neanderthals roamed. Heck, it is an industry that still depends heavily on the fax machine!

The article presents examples of other industries that benefitted from embracing  digital interoperability through open protocols. If you can’t define ‘digital interoperability’ then you really must read the article. Admittedly, achieving digital interoperability across the healthcare spectrum faces a host of obstacles especially when healthcare providers are reluctant to spend big bucks on the transition and competition among insurers is intense. 

The article stops short of stating the obvious….. that the specialty pharmacy industry is at a tipping point. The industry has wrung virtually the last drop of efficiency that is possible without a major breakthrough and digital interoperability seems to be a solution.

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Specialty Pharma’s Next Big Opportunity: It’s Time for Patient Access to Adopt an Open Protocol

In January 2020, the financial conglomerate Visa announced it was acquiring a relatively unknown startup, Plaid, for $5.3 billion. Corporate acquisitions like these are not uncommon, but someone at the United States Department of Justice took notice of this announcement. Visa had established a stranglehold on financial transactions. The Justice Department moved to stop the acquisition on grounds that Plaid posed “a threat to this monopoly: it has been developing an innovative new solution that would be a substitute for Visa’s online debit services.”

Plaid derives its power because of, not in spite of, its invisibility ― a power Visa and ultimately the government could not deny. When a consumer transfers funds electronically from one financial platform to another, or makes a deposit, or applies for a mortgage, there’s a decent chance Plaid is involved. It is the software that powers interoperability among various financial services brokers. It seamlessly patches together transactions that would otherwise be very complicated. Visa, which at the time reportedly held roughly 70 percent of the online debit market, had good reason to feel threatened. Plaid unearthed a way to charge merchants and consumers less for the convenience of online connectivity.

Ultimately, both parties backed out of the acquisition. Visa’s attempted $5.3 billion purchase price looked like a bargain when Plaid was valued at approximately $13.4 billion in a Series D funding round in April 2022.

A similar inflection point now faces the specialty pharmaceutical industry. Along their journey, specialty pharma patients interact with a series of siloed institutions: clinics, specialty pharmacies, copay program vendors, patient assistance programs, nurses, etc. Not unlike the financial industry, these institutions still exchange patient information via fax machines. Facilitating digital interoperability among these various stakeholders is paramount. So what lessons can be gained from the story of Plaid’s meteoric rise?

To diagnose the problem facing specialty pharma, a brief history lesson is in order. The healthcare industry earnestly embarked on its first major digital transformation in the 1990s, when the large-scale transition to electronic recordkeeping began. The industry preference for paper did not disappear overnight. Health systems were slow to digitize their filing cabinets full of charts and other patient data. The Institute of Medicine first advocated a shift from paper-based to electronic medical records in 1992, yet only 13 percent of U.S. healthcare facilities were found to have an EHR system fully implemented by 2004. Many are still making the transition.

Today, specialty drug sales represent more than half of all drug spending. This sector of the healthcare industry has both the incentive ― and the financial wherewithal ― to make the patient experience as seamless as possible. Yet in many ways, it is more backwards than the fintech industry before Plaid. When Plaid effectively forced financial institutions to take an open-protocol approach to digital interoperability, “Every bank (took) their five-year strategy on digitizing and brought it down into one or two years,” CEO Zach Perret said in an interview with Fortune magazine.

In healthcare in general, and specifically in patient services, the transition to an open-protocol approach has been slow and uneven. Open protocol, simply put, is a digital language that facilitates electronic transactions among prescribers, pharmacies, patient support vendors, data aggregators, insurers, and other stakeholders in the specialty pharmaceutical patient journey. Taking “an open protocol approach” means standardizing the open and shared application programming interfaces (APIs) within an industry, or a subsector of a larger industry. Widespread adoption of these protocols allows every stakeholder in the environment to expect a well-defined behavior when interfacing digitally with one another.

The power of the open-protocol approach has been realized across many industries. Look at the example of Twilio. In 2008, the startup launched its first API to make and receive phone calls entirely in the cloud. Now, six years following its IPO, the company is worth billions. Its suite of related tools includes platforms for data security, speech analytics, and customer relations management.

If the healthtech and pharmatech industries can harness this opportunity to standardize their most common digital tasks, integrating record-keeping and transactions among the various parties will be blazing-fast compared to today. This is the essential lesson pharmatech and healtech firms can glean from what Plaid did for the fintech industry.

If an open-protocol approach facilitates convenience, what’s the holdup? As in finance, traditional healthcare stakeholders tend not to share information very efficiently with their competitors. Interoperability has never been an explicit goal of the industry. Yet for specialty pharmaceutical patients, interacting with stakeholders in multiple silos is the norm. Routinely, these patients will need at least one transaction to obtain their prescriptions from the prescriber, then another with the office to provide their HIPAA, TCPA and hub consent, then interact with the hub regarding their coverage, then again with a specialty pharmacy regarding their shipments and out-of-pocket payment, then another to process their copay, another with a patient assistance program, another for adherence support, etc. The patient’s journey is typically long and complicated ― to say nothing of their own recovery from the condition for which they seek treatment.

You may ask: Can an open protocol be HIPAA compliant? HIPAA does not specifically prohibit using and sharing open protocol-based software. Neither does “open protocol” inherently mean “insecure.” Although the industry’s reticence toward sharing back-end software protocols is understandable, nothing is standing in the way of community problem-solving toward ensuring that any private health data transmitted via open protocols remains secure. On the contrary, an open protocol can easily enable such monitoring of the passed data, much better than fax machines and FTP transfers. For now, this reticence is making life more complicated for patients. Their patient journey typically requires engaging with discrete service providers who are often using antiquated means of communication. 

The discussion around how to integrate an open-protocol approach into a complicated system governed by HIPAA has been going on for years. Yet many key players in the industry are still on step zero: converting their primary mode of communication from paper to digital. 

The time to cross that bridge has passed. As the case study of Plaid makes clear, the time for the industry to embrace open protocol is now.

by Yishai Knobel, CEO and co-founder of RxWare 12/01/2022 

This week the FDA approved a new ORAL specialty drug, Skyclarys (omaveloxolone) from Reata Pharmaceutical, indicated for the treatment of Friedreich’s Ataxia in adults and adolescents aged 16 years and older. Friedreich’s Ataxia is a rare condition that affects about 5,000 patients in the United States. This oral med is administered once daily.

The company was granted orphan drug, fast track and rare pediatric disease designations from the FDA. With this approval, the agency granted a rare pediatric disease priority review voucher.

Friedreich’s ataxia causes progressive damage to the spinal cord, peripheral nerves, and the brain, resulting in uncoordinated muscle movement, poor balance, difficulty walking, changes in speech and swallowing, and a shortened lifespan. The condition can also cause heart disease. This disease tends to develop in children and teenagers and gradually worsens over time.

Reata confirmed that he annual WAC cost for Skyclarys will be $370,000.

Given its cost and the relatively small patient base, it is likely that Skyclarys will launch through limited distribution.

CLICK HERE to access prescribing information 

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FDA approves first treatment for Friedreich’s ataxia

FDA has approved Skyclarys (omaveloxolone) as the first treatment for Friedreich’s ataxia, a rare, inherited, degenerative disease that damages the nervous system, characterized by impaired coordination and walking.

Patients take Skyclarys capsules orally without food once a day at a recommended dosage of 150 mg.

The efficacy and safety of Skyclarys to treat Friedreich’s ataxia was evaluated in a 48-week randomized, placebo-controlled, and double-blind study [Study 1 (NCT02255435)] and an open-label extension.

Study 1 enrolled 103 individuals with Friedreich’s ataxia who received placebo (52 individuals) or Skyclarys 150 mg (51 individuals) for 48 weeks. Of the research participants, 53% were male, 97% were white, and the mean age was 24 years at study entry. Nine (18%) patients were younger than age 18.

The primary objective was to evaluate the change in the modified Friedreich’s Ataxia Rating Scale (mFARS) score compared to placebo at week 48. The mFARS is a clinical assessment that measures disease progression, namely swallowing and speech (bulbar), upper limb coordination, lower limb coordination, and upright stability. Individuals receiving Skyclarys performed better on the mFARS than people receiving placebo.

In a post hoc analysis, individuals who continued treatment with Skyclarys in an open-label extension for up to three years performed better on the mFARS compared to a matched set of untreated patients from a natural history study.

Safety Information

The most common side effects of Skyclarys were an increase in alanine transaminase and an increase of aspartate aminotransferase, which can be signs of liver damage, headache, nausea, abdominal pain, fatigue, diarrhea and musculoskeletal pain.