Author: Randy Chase

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.

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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

………….. catching up on FDA Approvals

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

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

The more interesting news is that the approval was for two different biosimilars….. and….. both have the same indication!…. perhaps that’s the biggest news.

The approvals included….. Yesafili (aflibercept-jbvf) from Biocon Biologics and Opuviz (aflibercept-yszy) from Biogen, Samsung Bioepis with an indication for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD); macular edema following retinal vein occlusion (RVO), diabetic macular edema, and diabetic retinopathy.

Both therapies  are the first interchangeable biosimilars to reference product Eylea (aflibercept) from Regeneron.  Yesafili and Opuviz are both 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 reference product, Eylea (intravitreal solution (40 mg/mL), is around $2,000. 

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FDA Approves First Biosimilars to Eylea

CLICK HERE to read the article

…….. catching up on FDA approvals

The FDA recently approved a new infused therapy, Imdelltra (tarlatamab-dlle) from Amgen, indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Imdelltra is the first bispecific delta-like ligand 3 (DLL3)-directed CD3 Tcell.  

Amgen said that it has been decades of no real treatment advances for this type of lung cancer. With small cell lung cancer, the disease has typically spread beyond the lung by the time it is diagnosed and most patients live just eight to 13 months after their diagnosis, despite having chemotherapy and immunotherapy.

Imdelltra was approved with a Black Box Warning for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome.

Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles. The company said trial patients were on the treatment for a median of over five months, which would equate to a commercial price of about $166,500.

CLICK HERE to access prescribing information

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FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

CLICK HERE to read the FDA press release

The FDA recently approved a trastuzumab biosimilar, Hercessi (trastuzumab-strf; HLX02) from Accord BioPharma, to reference product Herceptin, for the treatment of several forms of HER2-positive breast and gastric cancers. Hercessi is supplied in powder form for reconstitution prior to infusion.

Hercessi is the sixth trastuzumab biosimilar approval overall. 

Hercessi was granted interchangeable designation.

Prior biosimilars to trastuzumab are as follows—-

• Ogivri (trastuzumab-dkst)          December 2017
• Herzuma (trastuzumab-pkrb)    December 2018
• Ontruzant (trastuzumab-dttb)   January 2019
• Trazimera (trastuzumab-qyyp)   March 2019
• Kanjinti (trastuzumab-anns)       June 2019

HER2-positive, is an aggressive form of cancer in which cancer cells grow rapidly. However, HER2-positive breast cancer generally responds well to treatment.

Breast cancer is the most common cancer in women in the U.S., and HER2-positive breast cancer accounts for about 20 percent of all breast cancer diagnoses (in 2023, that’s 297,790 women and 2,800 men who will be diagnosed).

Pricing for Hercessi has not been confirmed. 

The company has not disclosed plans for distribution.

CLICK HERE to access prescribing information

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FDA Approves Hercessi, the Sixth Trastuzumab Biosimilar

CLICK HERE to read the full article