Author: Randy Chase

Does the US pharmacy marketplace need another discount card?

The answer is a resounding ‘YES’…….. if that new card is the newest thing since sliced bread, the better mousetrap, the nitro charge in the road racer.

As noted in the article below, we will see the launch of a very different type of consumer Rx discount card on January 1st. And that card will be very, very different from the run-of-the-mill discount card.

First, the new card from Rx Save will offer consumers the same discount that they can get through other now available discount cards. BUT….. there will be a big difference. If the consumer wants to pay out of pocket, the Rx Save Card automatically searches deals from multiple discount cards, so they can choose the cheapest option. Now that should get your attention.

BUT WAIT…. it gets more interesting….. the consumer can also choose to purchase the drug through their employer’s insurance using the card at point of sale and the claim will be processed routinely as if it were a traditional PBM channel transaction. This option would be chosen if the cost through the employer’s insurance / PBM is lower than the lowest discount card option (theoretically that is possible but hard to imagine). 

Either way, ya got to be scratching yer head at this point!

We look forward to hearing how effectively this card works post launch.

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New Type of Pharmacy Discount Card to Launch in January

The Rx Save Card is a new, employer-funded, pre-paid pharmacy discount service that allows consumers to pick between PBM prices and prices available through traditional discount cards.

CLICK HERE to access the full article

…………………….catching up on recent FDA approvals

The FDA recently approved a new Sub-q therapy, Yorvipath (palopegteriparatide, developed as TransCon PTH) from Ascendis Pharma, to treat hypoparathyroidism in adults. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs. The disease affects an estimated 70,000 to 90,000 people in the United States.

Yorvipath is a once daily subcutaneous therapy. Dosage is individualized with the recommended starting dosage of 18 mcg once daily and is then titrated in 3 mcg increments or decrements with the goal of maintaining serum calcium within the normal range without the need for active vitamin D (e.g., calcitriol) or therapeutic calcium doses (elemental calcium >600 mg/day). Calcium supplementation sufficient to meet daily dietary requirements may be continued.

Patients must be monitored daily for clinical signs and symptoms of hypocalcemia or hypercalcemia.

CLICK HERE for prescribing information

Ascendis Pharma suggests a $150,000 to $160,000 wholesale acquisition price with about a $130,000 net price.

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FDA approves new drug for hypoparathyroidism, a rare disorder

The U.S. Food and Drug Administration has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. Yorvipath was not studied in adults with acute post-surgical hypoparathyroidism.

CLICK HERE to read the full FDA press release

……………..catching up on recent FDA approvals

The FDA recently approved a new therapy, Kisunla (donanemab-azbt) from Eli Lilly and Company, indicated for the treatment of adults with early symptomatic Alzheimer’s Disease (AD).  Approval includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. 

Kisunla is administered monthly by infusion and the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. As noted in our Reports on FDA approvals of other recently approved therapies for AD, amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. It is believed that excessive buildup of amyloid plaques in the brain can lead to memory and thinking issues associated with AD. Kisunla can help the body remove the excessive buildup of amyloid plaques.

The price of each vial of Kisunla is $695.65.  The total cost of Kisunla will vary by patient based on the removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. As such, sample costs associated with the therapy can range from ~ $12,500 (6 months), to $32,000 (12 months), to $48,700 (18 months), etc.

The company indicated that Kisunla will launch through specialty pharmacy limited distribution.

Click here to access prescribing information

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Lilly’s Kisunla (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer’s Disease

Click here to access the full press release

So, you think you know everything about RARE DISEASES and how inexorably linked pharmacy, specifically specialty pharmacy, is to treatment development?

Can you pass the QUIZ?

The article below is a great quick read / study guide for anyone (shall we even say….. everyone) in specialty pharmacy today if they are serious about playing in the ‘rare’ sandbox with sufficient knowledge to earn a passing grade.

Here are some of the essential top line FAQs…..

·        How many people live with a rare disease today in the US?

·        How many people does it take for a drug to qualify for an Orphan Drug designation?

·        How many rare diseases and conditions are there?

·        What is the ARC Program run by CDER?

·        What are the four (4) expedited review programs and how do they differ?

·        And, last but not least, what the heck does CDER stand for? And how about CBER too?

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9 Things to Know About CDER’s Efforts on Rare Diseases

CLICK HERE to read the full article from the FDA

The Orphan Drug Act defines a rare disease as any disease or condition that affects less than 200,000 people in the U.S. There are approximately 25 to 30 million Americans living with a rare disease (about 1 in 10 people). Many rare conditions are life-threatening, and most do not have treatments. Accelerating the development of safe and effective drugs is CDER’s core mission, and CDER understands there are unique challenges in demonstrating the safety and effectiveness of drugs that treat rare diseases.

………….. 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.

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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