Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are seven LD deals that have been publicly confirmed subsequent to their approvals.

Biologics to Dispense Vanflyta

Biologics by McKesson was selected by Daiichi Sankyo, Inc., as a specialty pharmacy provider for Vanflyta (quizartinib).  Vanflyta is indicated for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test. 

Orsini Specialty Exclusive Distributor for Veopoz

Orsini Specialty Pharmacy announced that Regeneron Pharmaceuticals, Inc. has chosen Orsini to be the exclusive specialty pharmacy partner for Veopoz (pozelimab-bbfg). A monoclonal antibody, Veopoz is the first and only treatment for those living with CHAPLE disease, an ultra-rare and life-threatening hereditary disease.

Orsini Specialty to Dispense Pombiliti / Opfolda

Orsini Specialty Pharmacy has been selected by Amicus Therapeutics to dispense Pombiliti and Opfolda, a two-component treatment approved for certain patients with late-onset Pompe disease. Pombiliti is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency).

Nufactor Exclusive Specialty Pharmacy for Ycanth

Nufactor, Inc., a subsidiary of FFF Enterprises Inc., announced that it has partnered with Verrica Pharmaceuticals to be the exclusive specialty pharmacy to dispense Ycanth, the first FDA approved treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

Onco360 to Dispense Ojjaara

Onco360 has been selected as a pharmacy partner by GlaxoSmithKline for Ojjaara (momelotinib) a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

Onco360 to Dispense Akeega

Onco360 has been selected as a pharmacy partner by The Janssen Pharmaceutical Companies of Johnson & Johnson for Akeega (niraparib and abiraterone acetate). Akeega is indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

CarePartners Pharmacy named exclusive distributor of Yuflyma

CarePartners Pharmacy has been named the exclusive distributor for Yuflyma, a biosimilar to Humira. Yuflyma was approved by the FDA in May, 2023. by Celltrion Healthcare, Celltrion’s distribution unit, said Monday it has signed a deal with US specialty pharmacy chain CarePartners Pharmacy to sell its Humira biosimilar Yuflyma in the US market. Celltrion inked an exclusive contract with CarePartners.

It’s ALIVE!!!  Artificial Intelligence is here.

The article below details how HCSC, which covers about 18 million members in Illinois, Montana, New Mexico, Oklahoma and Texas, has introduced the power of AI to fast-track their very hectic prior auth volume. The company received about 1.5 million prior authorization requests in 2022.

What is most impressive is that they claim prior auths can be processed 1,400 times faster than using the traditional method.  WOW! They say that AI technology is now used for 93% of HCSC members for a limited number of procedure codes while they ramp up AI to handle even more procedure codes. 

HCSC also developed  an algorithm that mines historical prior authorization approvals to make it easier to approve treatment within seconds. If the request for a prior auth meets all criteria it is approved with no human intervention. The requests that fall through the sifter then go into a traditional prior authorization review.

Will AI completely eliminate manual review?

— Unlikely, at least in the foreseeable future.

Specific procedure codes and requests for certain (many?) specialty medications are likely to still be subject to lots of review involving extra documentation such as lab tests, genetic testing, site of service, etc. etc. It is conceivable that even these elements could be automated….. but given the difficulty in linking all these disparate criteria into one platform will be a big challenge in the short term.

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How HCSC is using AI to speed up prior authorization

Health Care Service Corporation says using augmented intelligence allows it to process prior authorization requests about 1,400 times faster than before. 

Jul 17, 2023  – Of the many tools that payers use to control costs, prior authorization ranks high on the list of what providers and patients find particularly vexing. However, Health Care Service Corporation hopes to fine-tune the process using the power of artificial intelligence. —–article continues—–

CLICK HERE to access the complete article

Catching up on a slew of FDA approvals in recent weeks….. whew!

The FDA  recently approved a new therapy, Veopoz (pozelimab-bbfg) from Regeneron, for the treatment of adult and pediatric patients 1 year of age and older with Chaple disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for Chaple. Administration is by intravenous or subcutaneous injection.

Chaple is an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system. In healthy individuals, the complement system is a mechanism for destroying microbes. However, those living with Chaple are unable to regulate complement activity due to mutations in their CD55 gene. Without proper CD55 regulation, the complement system may attack normal cells, causing damage to blood and lymph vessels along the upper digestive tract and leading to the loss of circulating proteins. 

There are fewer than 10 patients with Chaple disease diagnosed in the U.S.

Regeneron confirmed that the cost of Veopoz will be $34,600 per vial. 

Veopoz will launch through specialty distribution. 

CLICK HERE to access prescribing information

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VEOPOZ (POZELIMAB-BBFG) RECEIVES FDA APPROVAL AS THE FIRST TREATMENT FOR CHILDREN AND ADULTS WITH CHAPLE DISEASE

CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms

Approval represents 10th FDA-approved medicine invented by Regeneron

With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg biologics license application (BLA) have been addressed

FDA action on the aflibercept 8 mg BLA is expected in the next few weeks

TARRYTOWN, N.Y., Aug. 18, 2023  — Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed. FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.

……….article continues…………..

CLICK HERE to access the full press release

Catching up on recent approvals…..

Earlier this week we sent a Report on the approval of Talvey from Janssen Pharmaceuticals indicated for he treatment of adult patients with relapsed or refractory multiple myeloma. Within days the FDA issued approval for another subcutaneous therapy, Elrexfio (elranatamab-bcmm) from Pfizer, Inc. Talvey was a first-in-class bispecific antibody.

Like Talvey, Elrexfio is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Similarly, approval of Elrexfio included a Black Box Warning for cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). The assigned REMS program includes monitoring requirement for oral toxicity, weight loss, infections, cytopenias, skin toxicity, hepatoxicity and embryo-fetal toxicity. Seeing a trend here?

Approval requires that patients be hospitalized for 48 hours after all doses within the step-up dosing schedule. Another coincidence to be sure.

Pfizer did not disclose details for distribution or logistics at the time of approval. 

The company did confirm that Elrexfio will launch at a cost of $41,500 per month (about $330,000 annually). This compares with Talvey’s launch price of $45,000 per month.

Given its cost, complex dosing schedule and multiple risks, Elrexfio will likely be handled through specialty pharmacy distribution.

CLICK HERE for full prescribing information

Catching up on recent approvals…..

The FDA recently approved a new subcutaneous therapy, Talvey (talquetamab-tgvs) from Janssen Pharmaceutical (a J&J company) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talvey is a first-in-class bispecific antibody.

Approval included a Black Box Warning for cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). The assigned REMS program includes monitoring requirement for oral toxicity, weight loss, infections, cytopenias, skin toxicity, hepatoxicity and embryo-fetal toxicity.

Approval requires that patients be hospitalized for 48 hours after all doses within the step-up dosing schedule.

Janssen did not disclose details for distribution or logistics at the time of approval. 

The company did confirm that Talvey will launch at a cost of $45,000 per month.

Given its cost, complex dosing schedule and multiple risks Talvey is expected to be channeled through specialty pharmacy distribution. 

CLICK HERE to access prescribing information

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U.S. FDA Approves Talvey (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

Bispecific antibody targeting GPRC5D receptor showed an overall response rate of more than 70 percent with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy

HORSHAM, Pa. /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.1 This indication is approved under accelerated approval based on response rate and durability of response.1 Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).  article continues……….

CLICK HERE to read the full press release

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.