Author: Randy Chase

………….. catching up on FDA Approvals

Here’s what we wrote back in July…..

The FDA recently approved a biosimilar….. big news…… huh?

But wait….. on the same day the FDA approved two biosimilars….. bigger news?

The earlier approvals included….. Yesafili (aflibercept-jbvf) from Biocon Biologics) and Opuviz(aflibercept-yszy) from Biogen, Samsung Bioepis.

BUT WAIT….. only weeks later the FDA has approved three more biosimilars for the same reference product! This has to be a record.

Shortly after the approvals originally noted, the FDA approved biosimilar Ahzantive (aflibercept-mrbb) referencing Eylea (aflibercept) from Formycon in late July for age-related macular degeneration.

Then the FDA approved Enzeevu (aflibercept-abzv) in August 2024.

Then the FDA approved another in mid September, Pavblu (aflibercept-ayyh) from Amgen also referencing Eylea .

The therapies are interchangeable biosimilars to reference product Eylea (aflibercept) from Regeneron. Ahzantive and Pavblu join Yesafili and Opuviz as vascular endothelial growth factor (VEGF) inhibitors and each is administered by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg (0.05 mL of 40 mg/mL solution) once every 8 weeks.

Regeneron recorded U.S. sales of $5.72 billion from Eylea in 2023. Regeneron’s Eylea intravitreal solution (40 mg/mL) is around $2,000. 

We think we might need a bigger basket!

PBMs have been increasingly under the regulatory microscope for some time…. and recent focus has never been more intense. The pushback from the industry has also been palpable…. no surprise there….. because there is a lot of $$$s involved with even small changes to the industry model.

While the current election has significantly toned down media attention on PBM healthcare hegemony it is opportune to assess what has happened so far and what changes on the regulatory level can reshape the marketplace.

The article below is thought provoking.  

It frames the key issues and lays out some timely questions…..

• How the role of the PBM has changed over time?
• How drug pricing arrangements vary – and also how they don’t?
• Why cross-subsidization of revenue across drug categories is such a big issue and,
• Who are the new players and their connections to the larger system and the value they may bring…..?

……. just to point out a few.

It is fair to say that the outcome of next month’s election…… especially in Congress,  may have a major impact on the near term future (and fortunes) of PBMs in the US.

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Understanding the debate over PBMs

CLICK HERE to read the full article

…………catching up on FDA approvals

The FDA has approved a new therapy, Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis, as a biosimilar to Janssen Biotech’s Stelara. Pyzchiva is available in a subcutaneous form as well as an infusible. Pyzchiva joins the ranks of only a handful of biosimilars to earn the title of interchangeability with the reference product. 

The approval of Pyzchiva marks the third ustekinumab approval for the US as well as the 14th interchangeable biosimilar.

Pyzchiva is indicated for—–

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.

Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while also specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Pyzchiva did not receive a Black Box warning there are a number of warnings and precautions.

Pyzchiva  will launch in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.

Artificial Intelligence (AI) is one of the leading topics in media today. But, for many people AI is about as easy to explain as Crypto Currency.

For those that work in pharmacy the application of AI is still rudimentary. Our Report today hopes to ramp up your understanding of how AI will impact the practice of pharmacy in profound ways.

A superb article (see below) that focuses on Artificial Intelligence and Pharmacy will seriously ramp up your personal intelligence level on the subject. Here are some highlights  to prompt your curiosity.….. 

How long has AI been around?

Alan Turing’s seminal work, “Computing Machinery and Intelligence,” published in 1950, marked the beginning of the artificial intelligence (AI) debate. 

What is the definition of AI?

One of the earliest definitions popped up in media in 2004 and defined AI as “the science and engineering of making intelligent machines, especially intelligent computer programs.

How is AI defined today, 20 years later? And what is Machine Learning?

• Artificial intelligence (AI) is a set of technologies that enable computers to perform a variety of advanced functions, including the ability to see, understand and translate spoken and written language, analyze data, make recommendations………

• Machine learning (ML) is a subfield of artificial intelligence that gives computers the ability to learn without explicitly being programmed and with the intellectual processes that are characteristic of humans, such as the ability to reason.

How can AI impact healthcare?

AI can help doctors and medical providers deliver more accurate diagnoses and treatment plans. Also, AI can help make healthcare more predictive and proactive by analyzing big data to develop improved preventive care recommendations for patients.

How can AI impact the Practice of Pharmacy?

AI technologies provide pharmacists with tools and systems that help them make accurate and evidence-based clinical decisions. By using AI algorithms and ML, pharmacists can quickly analyze large amounts of patient data, including medical records, lab results and medication profiles. This allows them to identify potential drug-drug interactions, assess the safety and efficacy of medicines, and personalize treatment plans.

How will AI impact Pharmacy in the future?

• AI will not only detect adverse drug events but will predict them. AI will, assist clinical decision support systems with medication-related decisions, automate dispensing processes pharmacies, optimize medication dosages, detect drug-drug interactions, improve adherence through smart technologies, and more.

• AI will be used to improve service delivery / efficiency.  Chatbots will simulate interactions between customers and customer service representatives. Chatbots will automatically resolve customer complaints and queries, and route difficult questions to human staff. Chatbots in pharmacies can be programmed to simulate interactions between pharmacists and patients.

• AI will improve operations through inventory management to predict patients’ future requirements, stock them, and use personalized software to send e-mails to remind patients of drug requirements. 

• AI will control prescription fulfilment with robotic systems picking and packing. Such early systems are already demonstrating that these systems can deliver orals and injectables with a higher level of accuracy than human fulfillment.  Automated system capabilities have successfully demonstrated the ability to prepare sterile preparations for chemotherapy as well as fill intravascular syringes with the appropriate medications.

What will the new world of AI in Pharmacy be called?

The authors suggest the term “pharmacointelligence,” i.e., the integration of AI/ ML and similar advanced technologies into pharmacy practice with the sole aim of improving patient care and safety. 

How should schools of Pharmacy respond to AI?

The authors also recommend that the concepts of AI/ ML be incorporated into the pharmacy curriculum and stakeholders should be kept abreast of innovations in this field through continuous education. As these technologies evolve at a rapid pace, the education system for pharmacists must adapt to ensure that our profession is prepared to lead these changes in care.

******* 

HAL9000 strongly suggests that you READ the full article….. !

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Artificial Intelligence in the Field of Pharmacy Practice: 

A literature review

CLICK HERE to access the full article

Earlier this week we sent a Report on Walmart opening twenty-five specialty pharmacies. That was about organic growth. Today we are reporting on the changing hands of a long-established specialty pharmacy, BioMatrix Specialty Infusion Pharmacy…. which is likely to also be a story about growth.

Headquartered in Plantation, Florida, BioMatrix was formed in 2015 through the merger of Matrix Health Group and BiologicTx, two specialty pharmacy companies.  With a network of seven pharmacies, the Company became a leading provider for patients with blood disorders, organ transplants and other chronic and acute diseases and conditions.  

In 2016, BioMatrix was acquired by Acon Investments leading to carving out low-margin oral therapies in favor of pursuing higher-margin infused therapies in opportune growth categories. Unlike more recent transactions, Acon sold its investment position in BioMatrix to another investment firm, Frazier Healthcare Partners. It will be interesting to see what the next iteration of BioMatrix will look like in the next years.

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ACON COMPLETES SALE OF BIOMATRIX SPECIALTY INFUSION PHARMACY

CLICK HERE to read the full press release

……….. catching up on FDA Approvals

The FDA recently approved a new therapy, Ohtuvayre (ensifentrine) from Verona Pharma plc, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.  Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ohtuvayre is administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

COPD causes difficulty in breathing and affects approximately 16 million people in the US.   

According to the CDC, COPD is the sixth leading cause of death in the United States. 

Ohtuvayre is the first new treatment for the inflammatory condition in over a decade. Two pharma competitors (Regeneron and Sanofi) are working on similar anti-inflammatory therapies. Ohtuvayre has a low side effect / adverse reaction profile.

CLICK HERE to access prescribing information

Verona Pharma said Ohtuvayre will launch at a wholesale price of $2,950 per month / +-$35,000 annually.

The company did not disclose plans for distribution. 

Given that the potential patient population is quite large and annual cost is in the specialty pharmacy territory, we anticipate that Ohtuvayre will launch in open distribution or through a multi-SP LD network.

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US FDA New Drug Application Approval of Ohtuvayre (ensifentrine) for the Maintenance Treatment of COPD 

CLICK HERE to read the press release

……….catching up on FDA approvals

We usually don’t report on expanded indications for a therapy previously approved by the FDA.

This time one such approval is noteworthy.

It is not uncommon that a new therapy comes to market and, within months, then applies for an expanded indication. There is a pattern wherein the initial NDC is often for a rare / orphan condition that is fast-tracked enabling supplemental filings to also be fast-tracked. The new approval of Kevzara is a clear exception to that rule.

Way back in 2017 the FDA approved Kevzara (sarilumab), from Sanofi, indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Clinical trials started post-approval to include juvenile arthritis. 

Like the Energizer Bunny….. Sanofi kept going and going and going  in the ensuing 7 years to expand the 2017 indication….. and succeeded. They finally received approval for the treatment of individuals with active polyarticular juvenile idiopathic arthritis (pJIA). pJIA is a form of arthritis that affects multiple joints at one time.

As Kevzara is a sub-q therapy, specialty pharmacies may be alert to distribution opportunities.

CLICK HERE to access prescribing information

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FDA Approves Sarilumab for Active Polyarticular Juvenile Idiopathic Arthritis

CLICK HERE to read the press release

We’ve written about Value-Based Contracting (VBC) numerous times. 

The logic of VBC is self-evident. 

However, the feasibility and implementation of VBC is a totally different matter….. it is simply not easy. 

Great ideas often pop up but fade away because they are too hard to manage. 

VBC may soon be the exception to the rule.

VBC requires a team effort. As we know, forming a team in most organizations can be a nightmare and healthcare is a poster child for poorly formed team efforts.  None the less, VBC has not withered and is striving to blossom in rocky soil.

The article below is some proof of the prospects for VBC. Key members in VBC are health plan providers who have been skeptical of the entanglements that VBC portends. As you are likely familiar, health plans have a long-standing national association, AHIP (America’s Health Insurance Plans), and, based on their comments, the organization seems to be warming up to VBC. 

There is already proof of concept that VBC works for health plans.  The prospect that manufacturers will be accountable (usually financially) is a lever that clearly can work in health plans’ favor. 

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Providers are Key to Success of Value-Based Specialty Programs | AHIP 2024

CLICK HERE to read the full article

The FDA recently approved a new infused therapy, Rytelo (imetelstat) from Geron Corporation, for the treatment of adult patients with low – to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is an oligonucleotide telomerase inhibitor and is the first and only telomerase inhibitor approved by the FDA. It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In MDS, abnormal bone marrow cells often express an enzyme, telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. 

The company has priced a single dose (47 mg) of Rytelo at $2,471. 

Actual dosage is determined by patient weight.

Distribution will be supported by specialty pharmacies.  

Onco360 has confirmed that it was named as a distribution partner.

CLICK HERE for prescribing information

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

CLICK HERE to read the full article

In the third century BCE a wonder of the world, the Colossus of Rhodes, stood as testament to ever lasting power and strength. As history tells, even a colossus will eventually fall. Now, in the 21^stcentury, a colossus in the pharmaceutical industry is rapidly falling away…. and is a harbinger of the demise of other, perhaps smaller, colossi. 

Ok…. We are talking about the colossus called Humira.

Yes, this pharmacy powerhouse therapy has held the #1 position on the US leader board for the past two decades. However, even PBMs are now throwing in the towel and are starting to embrace less costly biosimilars to dethrone the king.

By example, PBM colossi CVS and Accredo / Evernorth are now demoting Humira and adding biosimilars in preferred positions on their formularies.  With that ice broken….. and payers and patients and government pushing for cost relief….. the tea leaves now confirm that biosimilars have finally found their footing in the marketplace…… THE BARBARIANS ARE AT THE GATE!

The article below is the closest thing to a eulogy we have heard in quite a while…. and it cites some sober statistics.

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PBMs Start to Embrace Biosimilars

CLICK HERE to access the full article