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Two Hospital Systems Get Hitched to do Specialty

Here’s an interesting new twist on hospitals and health systems opening their own specialty pharmacies….. PA-based Geisinger Clinic and NY-based Bassett Healthcare are getting hitched to do exactly that.

Hospital systems tend to be monolithic. However, as the master might say “There may be great wisdom, grasshopper, to share great burdens.” Let’s put that into business terms….. economy, efficiency, utility, scope, and leverage come to mind.

It is expensive to start a large SP operation from scratch…. so sharing costs…. Economy

Sharing operations… everything from IT to toilet paper…… Efficiency

Squeeze the best ROI from investments in hardware, dispensing gear, etc…. Utility

Size still matters when it comes to geography….. patients….. Scope

Last, and certainly not least, purchasing power with manufacturers and suppliers….. Leverage

Our list is not exhaustive but gives some insight on why the marriage may be made in pharmacy heaven. It is interesting that this is a home grown initiative with no mention of a third party specialty pharmacy ‘growth accelerator’ behind the curtain.

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Bassett Healthcare Network Partnering with Geisinger on Plans to Open Specialty Pharmacy in 2024

CLICK HERE to read the full article

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FDA Approved a New Tx for DMD – Agamree

There was a big development for DMA patients last June with the FDA approval of Elevidys (delandistrogene moxeparvovec-rokl) from Sarepta Therapeutics. Elevidys was the first and only gene therapy approved for Duchenne Muscular Dystrophy (DMD). But there was were two hitches in the giddyap…it was approved only for patients with a confirmed mutation in the DMD gene, and, its $3.2 million cost makes  access a real obstacle. 

We missed covering the more recent approval of another therapy for DMD that is not a gene therapy….. but one that has broad application in the category. The FDA approved Agamree (vamorolone) from Santhera Pharmaceuticals, a novel corticosteroid with favorable side effects.  It is provided in an oral suspension form. 

It is estimated that between 11,000 and 13,000 patients in the U.S. are affected by DMD, with approximately 70% of patients currently receiving concomitant corticosteroid treatment. DMD, is the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and death. 

Click Here for prescribing information

Catalyst holds the exclusive north American license to commercialize Agamree.

Pricing for Agamree is not nearly as costly as the big ticket gene therapy at under $10,000 per year for most patients based on weight. There has been no update on limited distribution.

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Catalyst Pharmaceuticals Reports FDA Approval of AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy Granted to Santhera Pharmaceuticals

CLICK HERE to read the full Catalyst press release

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You Can Now Make a Drug Using a 3D Printer

I always enjoy news about innovative developments in pharmacy. 

The article below tickled our interest.

The article details how Texas A&M has successfully developed a breakthrough compounding technique using 3D Printing to create patient-specific doses especially targeting children as an underserved patient segment.

First, there are many solid drugs where even the lowest manufacturer strength is inappropriate for children. Compounding has always been the go-to alternative in that case. Secondly, kids usually don’t like to take medicine….. and even a compounded liquid option is often a battle to administer. 

Imagine if you will…. a compounded, dose-appropriate 3D tablet with a yummy tasting coating. 

This sounds like a winner-winner chicken dinner option for many children.

Most specialty pharmacies don’t do compounding. However, there are about 7,500 compounding pharmacies in the US and 3D printing of certain drugs could be a great addition to their toolboxes. Whether 3D printing has a ‘fit’ in specialty pharmacy is not clear…. but, some visionary specialty pharmacist out there might be smarter than this commentator.

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3D Printing Could Create Tailored Medications for Children

Pharmacists and engineers at Texas A&M University, in College Station, have developed a 3D printing process capable of producing the exact dose of medication needed by a child, meant to be used in hospitals and pharmacies on an as-needed basis.

CLICK HERE to access the full article

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Is Rightway the New Right Way for PBMs

When a Fortune 100 company breaks the mold on anything it is news. Recently, Tyson Foods made a mold-breaking move and showed it was not averse to playing chicken with the PBM industry (poultry pun… if ya hadn’t noticed).

As noted in the article below, Tyson filed for divorce with its PBM, Caremark, and partnered up with Rightway, a startup that was founded only  in 2017. Their model is radically different from the decades old PBM model.

The first big difference is that Rightway only charges a defined per member management fee. 

What, no finagling with obscure (and often usurious) formulae to determine profits?

That is nothing short of a transformation of the oligopolistic PBM pantheon. 

But wait…. there’s more…. since Rightway doesn’t profit  via margins on sales, it can pass through drug cost… at cost!

Just these two major differentiators could revolutionize the PBM industry and calm the pressures for stiff regulation on the legacy PBMs now bubbling to the surface in Washington.

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Why this Fortune 100 company swapped from Caremark to a startup PBM

By Paige MinemyerJan 24, 2024 

Amid an ongoing conversation about pharmacy benefit managers and the role they play in rising drug costs, a Fortune 100 company is making the jump from one of the industry’s biggest players to a startup.

Tyson Foods will be one of the first major companies to drop one of the so-called “big three” of the PBM industry by moving on from its long-term contract with CVS Health’s Caremark to sign on with Rightway, a startup that was founded in 2017.

The new contract went into effect on Jan. 1.

CLICK HERE to read the full article

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Walgreens….. Whither thou Goest?

There has been scant news over the past year about big moves involving sales and strategic acquisitions in the specialty pharmacy space. 

Today my internet news spider searches lit up like a July 4th firecracker. 

***Walgreens appears primed to sell off Shields Health… and the number could be $4 billion.***

….. WOW!

As you may recall we’ve reported on Shields many times over the years. They offer an off-the-shelf solution for hospitals (their primary customer base) to open their own specialty pharmacies. Once open, Shields also offers ongoing management services. Their income, therefore, is derived from the consulting services to get an operation up and running and then a management fee for day-to-day operations. 

Therein is the problem….. the income may be good for a time….. but is it generating the ROI that justifies keeping Shields in the Walgreens toolbox? Consider too…. Once you build the man a boat and then how to fish the fisherman no longer needs to pay someone else for doing what he/she can now do themselves. 

If you trade stocks, you should know when it is time to sell a stock (ask any TESLA stock owner)….. especially when Walgreens’ buy-in for Shields was north of a Billion dollars. It is hard to believe that anyone would pay $4 billion….. but there are lots of people with big money and are willing to put it at high risk.

From Walgreens’ perspective, the profit from the sale would far and away be greater than yearly earnings could ever match. Walgreens also seems to need cash to shore up some of its other subsidiaries, especially when lending rates are not attractive.

FORBES and SeekingAlpha both issued reports on the Walgreens deal. It also appears that Walgreens will return to its roots and shore up its own specialty pharmacy which has been overshadowed by the hospital focused strategy Walgreens had embraced.

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Walgreens exploring $4B+ sale of Shields Health specialty pharmacy business – report

CLICK HERE to read the SeekingAlpha report

CLICK HERE to read the Forbes report

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FDA Approves Novel BioBetter for UC & Crohn’s – Zymfentra

Earlier this week we sent a Report outlining why the term ‘BioBETTER’ should be added to your pharma vocabulary. Today we introduce a new biosimilar that is considered a BioBETTER. If you missed that report a BioBETTER is a product that is a biosimilar that has been altered in a way to improve effectiveness, ease of use, etc. A poor example might be the addition of an additive like STP to your gas tank to improve engine performance.

The FDA recently approved a new biosimilar, Zymfentra (infliximab-dyyb) from Celltrion, Inc.  Zymfentra is a subcutaneous (SC) formulation of Inflectra, a biosimilar to Remicade.  It is the world’s first and only subcutaneous infliximab product. 

Zymfentra is a novel tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously and moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously. The approval, however, included a Black Box Warning citing a long list of warnings and precautions. 

The label specifies that Zymfentra is for subcutaneous use only. Additionally, Zymfentra is indicated as maintenance treatment only, starting at Week 10 and thereafter for patients who must complete an intravenous induction regimen with an infliximab product before starting Zymfentra.

CLICK HERE to access Prescribing Information

We will strive to identify any new biosimilar approval that qualifies for the unique designation as a BioBETTER.

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BIOBETTERS…. What’s in Your Vocabulary?

What is a Biobetter?

An article published by the Center for Biosimilars used a new word to the specialty pharmacy lexicon…… BioBetter….. prompting us to say “What’s that?”

Biobetter is not a common term in the United States but, perhaps, the term needs to be added to the US Pharma lexicon!

A good example is a recent FDA approval of sub-q  Zymfentra (infliximab-dyyb) a reference product to Inflectra which was approved as an infused therapy in 2016. We will cover this approval later this week.

So WHAT?

The WHAT is that the FDA determined Zymfentra to be a novel drug because it allows for subcutaneous (vs. IV) administration. It was awarded its own unique NDA.

The article from the Centers for Biosimilars explains why the term BIOBETTER should be in common use in the US…… it is now used routinely in Europe. The idea being that we are very likely to see a big uptick in new drug approvals of therapies resulting from intentionally altering an existing  biologic product to improve clinical outcomes. 

Examples of meaningful differences include….. allowing for more time between doses or enhanced tolerability compared with the reference product.  “Other examples of biobetters now include;

Susvimo (based on Lucentis [ranibizumab), Kadcyla (based on Herceptin [trastuzumab), Gazva (based on Rituxan [rituximab), and Neulasta Onpro (based on Neulasta [pegfilgrastim).”

So, are you ready to include Biobetters into your vocabulary?

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Limited Distribution Updates

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 five LD deals that have been publicly confirmed subsequent to their approvals.

Onco360 to Distribute Fabhalta 

Onco360 has been selected as a pharmacy partner by Novartis for Fabhalta (iptacopan) the first oral monotherapy approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing control of red blood cell destruction within and outside the blood vessels.

Biologics to Distribute Fabhalta

Biologics has been selected by Novartis as a specialty pharmacy provider for Fabhalta (iptacopan). Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), a chronic and rare blood disorder that involves the destruction of red blood cells.

Walgreens added to Distribute Ycanth

Walgreens joins Verrica’s existing specialty pharmacy, Nufactor (originally announced as the ‘exclusive distributor’) to dispense Ycanth, the first FDA approved treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

Orsini Specialty Pharmacy exclusive Distributor for Wainua 

Orsini was selected as the exclusive specialty pharmacy for Wainua (eplontersen) for adults with hereditary transthyretin-mediated amyloid polyneuropathy. Wainua is a subcutaneous injection that can be self-administered.

PANTHERx Rare to Distribute Zilbrysq

PANTHERx Rare was selected by UCB to dispense Zilbrysq, a new FDA-approved therapy for the treatment of adults with gMG who are anti-AChR antibody positive.

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Many Low-Cost Txs from Canada Excluded from Specialty Pharmacy Access

There was a flood of media coverage following the FDA’s announcement that they have approved Florida’s request to import low-cost drugs from Canada. While that may bode well for many  patients, one needs to dig a bit deeper to understand whether this decision will be a golden egg for specialty pharmacies.

It is highly likely that other states will quickly jump on this band wagon….  especially since it reads well in political press releases. But, it does not look all that promising for SPs.

The FDA approval requires a ‘plan’ that includes a host of compliance requirements…. and a few exclusions. The exclusions are what tosses a wet blanket on the opportunity for SPs.

Here is where the blanket gets wet…..

Florida must implement its plan in compliance with the requirements of the Department of Health and Human Services’ Safe Importation Action Plan, which was finalized in 2020.

The plan specifies that the following categories are excluded:

  • biological products
  • drug with a REMS
  • infused drugs / intravenously injected drugs
  • controlled substances
  • drugs inhaled during surgery, and
  • certain parenteral drugs

What appears to be absent in the plan, however, are subcutaneously/IM/etc. administered, non-biologic drugs. Hmmmmm?

It will be interesting to see if this slice of opportunity is worth the effort for SPs to pursue participation.

CLICK HERE to read the FDA Safe Importation Action Plan

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FDA Authorizes Florida’s Drug Importation Program

CLICK HERE to read the FDA press release

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UCB Picks 20 SPs+ for Its Sub-q Psoriasis TX – Bimzelx

………. Catching up on FDA approvals

The FDA approved a new therapy at the tail end of last year (it was November and, yes, we are trying to get caught up with the flood of approvals at the end of 2023)….. anyways…. the new therapy is Bimzelx (bimekizumab-bkzx) from UCB approved for the treatment of adults with moderate to severe plaque psoriasis. 

Bimzelx is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).

Click Here for prescribing information

UCB is offering Bimzelxr as an autoinjector or pre-filled syringe at a list price of $7,200 per syringe. The recommended dosage is 320 mg (given as two subcutaneous injections of 160 mg each) at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. That translates into 10 cycles per year requiring 2 syringes per cycle or 20 syringes which prices out annually at $144,000.

Unlike almost every other specialty manufacturer, UCB has created an “Enhanced Network of Specialty Pharmacies” that provide additional product-specific patient support.  Even more noteworthy, UCB is making the therapy available through all other specialty pharmacies….. but without all the ‘extra’ bennies available through the ‘enhanced’ SPs. 

CLICK HERE for the ‘Enhanced’ list   

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BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

Click Here to access the full press release

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