Month: September 2023

Now here’s a two-fer for ya.

First, there’s the news that another specialty pharmacy has been christened.

Second, we learn what a group of zebras is called.

Let’s start with the second one….. why not?

Familiar with “terms of venery”….. me neither!

Terms of venery is a collective noun that means ‘a group of animals’. You know, the colorful, fanciful names given to animal groups like a murder of crows, a covey of partridges, and, my fav, a congress of orangutans, etc.

• A bit of trivia — the first grouping of group names can be traced back to The Book of Saint Albans published ln 1486. 

A group of zebras is called….. are you ready…. a ZEAL….which brings us back to the first news item. 

Recently a new specialty pharmacy opened in Pittsburgh. OK, that is not breaking news…. but it is noteworthy as it has been a pack of dogs’ ages since we’ve heard of a new SP opening doors…. especially given the challenges SPs have been wrestling with in recent years.

So, why did they name their pharmacy Zeal Specialty?  

As stated in their press release, “The zebra, due to the uniqueness of its stripes, is the official symbol of the rare disease community”.  As such, someone came up with a nifty name for this new pharmacy. Time will tell if Zeal will show sufficiently different stripes to successfully navigate the complex waters filled with a ‘float of SP crocodiles’ already established in the rare disease category.

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Zeal Specialty Pharmacy Opens for Business

PITTSBURGH /PRNewswire/ — Jonathan Ogurchak, Chief Executive Officer and Co-Founder of Zeal SP, LLC, today announces the launch of a new nation-wide Specialty Pharmacy: Zeal. The pharmacy is located at 100 Business Center Drive, Suite 300, Pittsburgh, PA 15205.

“Patients need options when it comes to specialty care”, said Dr. Ogurchak, a specialty industry veteran. “Our brand-new facility in Pittsburgh – close to Pittsburgh International Airport and in the heart of the specialty pharmacy industry – allows us to efficiently care for patients leveraging the latest technologies and with the best talent the industry has to offer.”

When I was a kid going to Yankee Stadium for a baseball outing the hawkers selling programs would say…. “Ya can’t tell the players without a program!”

Today, that could easily apply to specialty pharmacy. Ya can’t easily tell one biosimilar or cell or gene therapy from another without a program. In years past, several sources (usually PBMs) were kind enough to publish such ‘programs’. But, alas, those days are gone. However, we were pleased to review a nifty ‘program’ (actually more of a hefty booklet) from Ascella Health which recently published its Q2-2023 Specialty & Rare Pipeline Digest….. which we highly recommend.

The Digest includes hefty detail on recent FDA specialty med approvals, pending, and upcoming approvals with PDUFA dates. But wait….. there’s more….! 

The Digest charts out cell and gene therapies and biosimilars. It includes detail for each therapy including brand/generic, the manufacturer, route of admin, mechanism, stage in the approval process, and even suggested cost of therapy!  And, if that’s not enough, the digest also includes an expert opinion on the impact each therapy may have in its space. 

Best yet…. IT IS FREE!

CLICK HERE to access the program…. ummm….. Digest

Visit the Resources section of the AscellaHealth website at  https://ascellahealth.com/ and register to receive future communications.

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AscellaHealth Releases Inaugural Specialty & Rare Pipeline Digest

July 27, 2023 — BERWYN, Pa.–(BUSINESS WIRE)–AscellaHealth, a global healthcare and specialty pharmacy solutions organization, today released its Q2 2023 Specialty & Rare Pipeline Digest™, the industry’s most comprehensive resource on new, pending & projected Specialty and Rare Disease drug launches, and cell & gene therapies, biosimilars, and generics. This complimentary, valuable source of industry information supports the specialty drug market needs of stakeholders and decision-makers including pharmaceutical manufacturers, payers and providers, with essential updates on products that are making an impact for millions of individuals living with or affected by rare disease or complex chronic conditions.

Earlier this year the Pharmaceutical Strategies Group published a nifty report on trends in pharmacy benefits management. And, lo and behold, PSG has now doubled down with another nifty report….. this time on specialty spend and trend…. a topic near and dear to most of our readers. It is also one of the only exhaustive reports to be released since the large PBMS all seem to have abandoned publishing similar reports. Kudos to PSG

The biggest top line numbers that we can dish up for you relate to spend for 2022 and the next three years.  PSG and Artemetrx suggest that the 2022 trend of 14% growth will be followed by three years of 13% growth….. not bad for a squishy economy. Utilization and mix remained constant with prior years. 

Spend showed pressures from rebates….. which should surprise no one. Perhaps the most memorable finding is that the shift of specialty drugs from the medical benefit to the pharmacy benefit tipped total specialty spend to north of 56%!

This report deserves a deep dive….. and update your old PowerPoint presentations!

CLICK HERE to access the full report

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State of Specialty Spend and Trend Report Released by Pharmaceutical Strategies Group

Spend and trend rise in 2022 forecasted to continue

July 25, 2023 — DALLAS–(BUSINESS WIRE)–Pharmaceutical Strategies Group (PSG), an EPIC company, is pleased to announce the release of its proprietary Artemetrx State of Specialty Spend and Trend report, sponsored by Walmart. The seventh annual report uses integrated pharmacy and medical claims data to provide a holistic view of specialty drug spend and trend. First published in 2017, this report is the sole comprehensive analysis of specialty drug spending, powered by the industry’s leading integrated dataset through Artemetrx.

“Walmart is a people-led company who puts the customer and patient first to deliver quality care and medications they need. Our Specialty pharmacy practice is focused on delivering cost-effective medications to help patients manage their complex conditions.”

Specialty drug trend continued to be driven primarily by claim utilization, accounting for nearly three-quarters of the overall 14.1% gross trend. However, cost per claim played……  the article continues

We sent a Report on compounding back in July. At that time we were alerting those pharmacies that engage in compounding that numerous new standards were being rolled out. Today there is another issue to which compounders need to be very attuned. If your specialty pharmacy isn’t into compounding….. read on regardless and learn something about your industry.

The focus of today’s Report is on 503A compounding and the regulations that restrict that practice. In short, sections 503A (and 503B) of the FDA Act set conditions under which compounded drug products are exempt from certain federal requirements.  One common exemption is when a drug in short supply. That has never been as tangible a problem as it has been of late with a big increase in the number of drugs not available either due to shortages, product discontinuation, or other supply chain issues. However, there is a BIG caveat….. compounding should not be conducted “regularly or in inordinate amounts.”  That means that a compounder should not produce the ‘copy’ in large batches (i.e., manufacturing levels) and that each dose compounded should be a result of a valid prescription (i.e., not anticipated demand).

Manufacturers are alert to compounders that cross the line….. going from reactive compounding to proactive manufacturing. That’s when PHARMA lawyers get involved with lawsuits claiming everything from patent infringement, to trademark infringement, to unfair competition….. and so forth and so on. There are federal and even state laws and Boards of Pharmacy regulations that have cropped up around these issues….. the lawyers are the only ones who are happy.

If you are interested in digging into the nitty gritty of the maze that surrounds compounding and 503A spend a few minutes to read the article.

CLICK HERE to access the full article

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Legal Battles Intensify: Pharmaceutical Manufacturers’ Lawsuits Targeting Compounding Pharmacies

Analyzing the patent and trademark challenges faced by 503A compounding pharmacies.

Pharmacy compounding is a fundamental component of pharmacy practice and is essential to the provision of health care. However, for years, pharmaceutical manufacturers have been filing lawsuits against compounding pharmacies, accusing the pharmacies of infringing on their patents.

This rise in legal actions is driven by the growing prevalence of compounding practices over the years, despite the heightened regulatory oversight imposed on 503A compounding at the federal level through the Drug Quality & Security Act (DQSA),1 and at the state level through state boards of pharmacy.

Lawsuits often have claims based on…….  the Pharmacy Times article continues

In recent weeks two leading specialty pharmacies announced their plans to strategically expand their footprint in the specialty pharmacy ambulatory infusion space. Curiously, that falls on the heels of Walgreens’ divestiture of Option Care which, only a year ago, was the largest infusion provider in the US. That move may have been heavily influenced by Walgreens’ desire to pay down debt, continue support of the company’s strategic priorities, and further drive forward its transformation to a consumer-centric healthcare company.

The two providers of which we speak are Soleo Health and Hy-Vee Health. One may ask if they saw Walgreens’ exit as an wiggle room to further grow their positions in the ambulatory infusion segment.

Soleo Health announced that it is opening an ambulatory center in Cincinnati offering a full range of specialty infusion therapies as well as pharmacy dispensing services. More recently, Soleo announced the opening of a Boise, Idaho, pharmacy and infusion center location. The new facilities add to Soleo’s 23 pharmacy locations nationally as well as more than 40 infusion centers throughout the U.S.

Hy-Vee announced the opening of its first Hy-Vee Health infusion clinic in West Des Moines, Iowa. The freestanding clinic is staffed by licensed physicians and nurses. Aaron Wiese, president of Hy-Vee, Inc., said “Our vision for Hy-Vee Health is to provide convenient, cost-effective health solutions for patients across the United States.” Even more recently Hy-Vee announced the opening of a new clinic in Chicago.

If one looks at the number of ultra-high-cost infused therapies approved in the past few years one can make a strong case for ambulatory specialty infusion….. especially if it is a lower cost site of service vs. hospital outpatient facilities….. something that payers are getting more bullish about.