Category: Uncategorized

The FDA recently approved a new therapy, Omvoh (mirikizumab-mrkz) from Eli Lilly and Company, for the treatment of moderately to severely active ulcerative colitis (UC) in adults. 

Most noteworthy is that Omvoh is available in both Infused and Subcutaneous forms. 

· The recommended induction dosage is 300 mg by intravenous infusion at weeks 0, 4, and 8.

·    The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter. 

Ulcerative colitis is a type of inflammatory bowel disease (IBD). It causes inflammation and ulcers, or sores, in the large intestine. Scientists still do not know the main cause of ulcerative colitis, however, environmental factors, imbalance in the gut and immune system are suspected leading contributors. Genetics also play a role in ulcerative colitis, as well as age (most are diagnosed between the ages of 15 and 30.) and ethnicity as Caucasians and those of Ashkenazi Jewish descent are at a higher risk for developing the disease.

Symptoms range from mild to severe with periods of worsening symptoms — called flares — and diminished symptoms — called remission — occurring over time.

Common symptoms of ulcerative colitis include:

·        nausea

·        diarrhea

·        bloody stools with mucus

·        abdominal pain or cramping

·        inability to pass stools despite frequent urges

·        rectal bleeding

·        fatigue

·        unintentional weight loss

·        loss of appetite

·        dehydration

Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration. It is presumed that access to the IV form will be through national distributors. Lilly has not announced whether the subcutaneous form will be restricted to limited distribution.

CLICK HERE to read prescribing information

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FDA Approves Lilly’s Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

·        Omvoh delivered significant improvement in bowel urgency, reported by people with UC 

·        Lilly’s first approved treatment for a type of inflammatory bowel disease

INDIANAPOLIS, /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.

CLICK HERE to read the full Lilly press release

Mark Cuban can now be called a pharmacy trend setter. 

We’ve read about his cost-plus drugs model….. and it seems that Express Scripts (ESI) feels that offering a similar pricing model to their clients is a great idea. 

Yeah, one PBM may not qualify as a trend….. but it is a start.

ESI has begun to offer a product called ClearNetwork to clients using Wholesale Acquisition Cost, Predictive Acquisition Cost, or National Average Drug Acquisition Cost to decide on the ‘’estimated’ price for each drug in their formulary. A pharmacy fee and a second fee of 15% then added (not clear if that is a combined 15% or two separate fees). ESI has been quoted as saying that the fees will be transparent to clients and pharmacies (no mention of patients, however).

According to the article below, “The option will apply to a plan sponsor’s list of covered generic, branded and specialty medications.” This model is being offered to the 65,000 retail pharmacies in its network. It is not clear is participation is part of the recontracting going on where pharmacy reimbursements are being cut significantly.

ESI will add fees onto each prescription to cover its cost for providing its package of PBM services.

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Express Scripts’ New Option Models Mark Cuban’s Cost Plus Drugs

This is the latest offering by Express Scripts that aims to bring transparency to prescription drug costs.

CLICK HERE to read the full article

…………catching up on FDA approvals

The FDA has approved a new therapy, Wezlana (ustekinumab-auub) from Amgen, Inc., as a biosimilar to Janssen Biotech’s Stelara. Wezlana is available in a subcutaneous form as well as an infusible. . Wezlana joins the ranks of only a handful of biosimilars to also earn the title if interchangeability with the reference product. 

Wezlana is indicated for—–

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, 
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
• active psoriatic arthritis.

Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

While Wezlana did not receive a Black Box warning there are a number of warnings and precautions.

Amgen intends to launch Wezlana in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.

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FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

CLICK HERE to read the FDA press release

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

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

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?