Author: Randy Chase

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

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

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 4^th 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

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.

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?

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.

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

………. 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

Happy New Year….. or to be said otherwise, What’s Happy About It?

The article below doesn’t trumpet the benefit of the changes implemented by Congress ‘fixing’ the vexing issue of direct and indirect reimbursement (DIR) fees that grew by 107,000% over the past decade. As specialty pharmacies know all too well, these fees have cut deeply into profit margins….. and there was a glimmer of hope that the new regulations would be the ‘fix’ they were hoping for. 

According to the article, PBMs are implementing flanking maneuvers that could be even more onerous than DIR fees.

For example—–

• Express Scripts has sent out contracts announcing that it would pay pharmacies approximately 10% below average wholesale price (AWP), “meaning they could lose money on every prescription they fill.”

• “Specialty pharmacies have been receiving new contracts with even more drastic cuts, as much as AWP minus 20%”

• “Specialty pharmacies have been particularly hard-hit, but I think pharmacies across the board of all types have seen their 2024 contract agreements tank in terms of the rates.”

• “PBMs can continue to claw back fees from pharmacies even with this new rule.”

As the adage goes, winning one battle does not mean that the war has been won.

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PBMs Implement Sweeping Reimbursement Cuts and Ramp Up Audits

CLICK HERE to access the full article

…..catching up on FDA Approvals

The FDA has approved a new subcutaneous therapy, Zilbrysq (zilucoplan) from UCB, for the treatment of adults with generalized myasthenia gravis.  Zilbrysq is the first once-daily subcutaneous, targeted C5 complement inhibitor for gMG. It is the only once-daily gMG-target therapy for self-administration.

gMG is a rare autoimmune disease with a global prevalence of 100–350 cases per every 1 million people. Symptoms of the disease include severe muscular weakness, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the respiratory muscles.

Zilbrysq was approved with a Black Box Warning for serious meningococcal infections.

CLICK HERE to access prescribing information 

UCB has not yet confirmed pricing for Zilbrysq.

Given that Zilbrysq is a self-administered, sub-q therapy with a Black Box Warning, it is expected that it will be channeled through specialty pharmacy limited distribution.

CLICK HERE to access the full UCB press release