Author: Randy Chase

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.

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 is a basket full of LD deals that have been recently publicly confirmed subsequent to FDA approval.

AcariaHealth to dispense Elevidys

AcariaHealth announced that it has been selected by Sarepta Therapeutics, Inc. as part of the limited distribution network for gene therapy Elevidys (delandistrogene moxeparvovec-rokl), approved for the treatment of ambulatory pediatric patients aged four through five years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. 

Amber Specialty Pharmacy Selected to Dispense Vowst

Amber Specialty Pharmacy has been selected as one of only two pharmacies nationally selected by Aimmune Therapeutics, to support the launch of Vowst indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Orsini Specialty Pharmacy to dispense Vowst

Orsini Specialty Pharmacy announced that Aimmune Therapeutics has selected it as a limited distribution partner for Vowst (fecal microbiota spores, live – brpk) indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). 

Orsini Specialty Pharmacy to dispense Austedo

Orsini Specialty Pharmacy announced that they now has access to Austedo XR (deutetrabenazine) for treating Tardive Dyskinesia (TD) and Chorea associated with Huntington’s Disease (HD).

Orsini pharmacy selected to supply Roctavian

Orsini Specialty Pharmacy has been selected to distribute the new gene therapy Roctavian (valoctocogene roxaparvovec-rvox) for use by individuals with hemophilia A. The one-time treatment from BioMarin Pharmaceutical is the first gene therapy ever approved by the FDA for eligible adults.

PANTHERx Rare selected to supply Rystiggo

PANTHERx Rare announced that it has been selected by UCB as a limited distribution partner to provide Rystiggo (rozanolixizumab-noli) FDA-approved treatment for both anti- acetylcholine receptor (AChR) anti- muscle-specific tyrosine kinase (MuSK) antibody positive adult patients with generalized myasthenia gravis (gMG).

Catching up on recent specialty approvals————

The FDA recently approved a new ORAL, kinase inhibitor therapy, Vanflyta (quizartinib) from Daiichi Sankyo Company, Ltd., 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. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

Vanflyta was approved with a Black Box warning and REMS. 

CLICK HERE to access prescribing information

AML is one of the most common forms of leukemia in adults and an estimated 20,380 new cases diagnosed in the U.S. in 2023.  Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival.  The five-year survival rate for patients with FLT3-ITD AML has been reported at approximately 20%.

VANFLYTA is the first and only FLT3 inhibitor to be approved specifically for FLT3-ITD positive AML and across the three phases of treatment – induction, consolidation and maintenance in patients without transplant – for newly diagnosed AML.

Daiichi Sankyo will launch Vanflyta at $546 per tablet. Total cost per patient will vary based on number of cycles (induction, consolidation, maintenance). By comparison, Xospata, another FLT3 therapy, comes with the highest price tag at $750 a day.

Distribution logistics were not announced at the time of approval. However, it is expected that Vanflyta will launch through specialty pharmacy limited distribution.

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Vanflyta First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

First and only FLT3 inhibitor approved across three phases of AML treatment, when added to chemotherapy, improved overall survival

Jul 20, 2023 TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)– Daiichi Sankyo (TSE: 4568) today announced that Vanflyta (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) 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. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

Earlier this week we sent a Report on biosimilar utilization and trends. Today we follow up with some stats from another credible source that add a few new insights.

AmerisourceBergen Corp (ABC) recently published results from a survey of payers related to treatment of biosimilars within their coverage policies. The findings are worth considering for future planning.

Top line highlights—

Organization types: 51 payors / advisors representing 300 million covered lives

(about 90% of the U.S. population)

• 55% health plans
• 24% integrated delivery networks, and
• 22% pharmacy benefit managers

• 45% said their organization would allow multiple biosimilars
• 35% said they would select a single preferred biosimilar and
• 4% said they would prefer the reference product.
• 16% selected ‘Other’ (hmmmmm??)

• 96% and 82% of respondents, respectively, said that lower price and contracting arrangements (legal speak for rebates) continue to drive preference for a reference product.
• 88% of respondents said that interchangeability will inevitably force the shift to greater biosimilar adoption.

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What’s Driving Biosimilar Decision Making? AmerisourceBergen Payor Survey Has Some Answers

Biosimilar competition is heating up, with eight biosimilars to adalimumab (Humira, AbbVie) already launched in 2023 and more on the horizon. Other reference products also have anywhere from two to five biosimilar competitors. With this intense level of competition, payors are more likely to select multiple biosimilars for the same product, rather than a single biosimilar or the reference product only, according to a survey from AmerisourceBergen…..

CLICK HERE to read the full article

by Gina Shaw, Pharmacy Continuum

A recently released study on payor practices related to biosimilars was detailed in an article published by the Center for Biosimilars….. and some of the findings are thought provoking.

Here are the highlights from the study:

• The study identified 1181 coverage decisions for 19 commercially available biosimilars, representing 7 reference products and 28 indications
• Health plans dictated coverage exclusions or step therapy limitations on biosimilars in 229 (19.4%) of the 1181 coverage decisions
• Payers were more likely to restrict biosimilar coverage for pediatric populations whereas the reverse was observed for all other categories, including Oncology, for specialty biosimilars.
• Biosimilar utilization was higher for diseases with US prevalence higher than 1,000,000 cases
• Biosimilar utilization was higher if the health plan did not contract with 1 of the 3 major pharmacy benefit managers
• Payers were less likely to enforce restrictions on the biosimilar if:

— the biosimilar was indicated for cancer treatments 

— if the product was the first biosimilar to market

— there were two available biosimilar competitors, and

— could generate annual list price savings of more than $15,000 per patient. 

• However, payers were most restrictive if the biosimilar did not have a cost-effectiveness measure available.

While many of the findings are confirmatory, the report doesn’t address the underlying dynamics of how rebates affect payer policies over preferred utilization of reference products.

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Payers Reveal Most Significant Factors Impacting Biosimilar Coverage Decisions

Jun 29, 2023

Justina Petrullo    AJMC Center for Biosimilars

It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the strongest factors associated with biosimilar coverage decisions by US commercial health plans relative to reference products.

Cancer treatment, pediatric population, and coverage restriction of reference products were discovered as some of the most significant factors associated with biosimilar coverage decisions by commercial health plans in the US relative to their reference products, according to BioDrugs.

CLICK HERE to access the full article