Month: May 2025

The past year has brought rough financial seas to Walgreens. As recently as this January we reported on Walgreens plans to possibly go private after closing underperforming retail stores and whole divisions such as VillageMD. 

We said then that Walgreens (WAGS) is facing a serious reversal of fortunes to the tune of $billions$ of dollars. The numbers are jaw dropping….. about 10 years ago Walgreens’ market cap was more than $100 billion. They ended the year with a valuation of only $8 billion.

Earlier this month WAGS had yet another major problem to resolve…. a federal anti-kickback charge by the US government. In this case they were able to settle for $50 million.

This story is less about Walgreens and more about the fact that the government is still vigilant about anti-kickback schemes such as that conducted by WAGS. While the financial penalty my only sting, the impact to the company reputation and ability to qualify for other government programs can be impacted. Remember, under the federal False Claims Act, whistleblowers are entitled to a portion of whatever money the government is able to recover.

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Walgreens to pay $50M in anti-kickback case

• Company gave illegal discounts, government says
• Walgreens marketed a savings plan without checking if people were covered by Medicare or Medicaid, officials said. 

CLICK HERE to read the full article

Today’s Report spotlights a relatively insignificant event in therapy distribution. We are talking about COSTCO, yes the warehouse retailer. What they did is simply add a new drug to their pharmacy inventory, a little therapy called Steqeyma. In doing so, however, it reinforced a major shift in the specialty pharmacy industry.

Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), has been added to the Costco Member Prescription Program. Still not impressed? Read on….

Adding a biosmilar to a prescription drug discount card program is not hugely surprising.

What is surprising is that COSTCO has been discreetly adding other specialty pharmacy therapies for several years. In fact, they are affirming that there are now “COSTCO Specialty Pharmacies.”

To be fair, a host of other retailers have been playing in the specialty pharmacy sand box for years. That COSTCO appears to be fully committed to be a player says a lot about the SP market and the shifting competitive landscape. 

The company said that the formulary including the specialty products is currently available for self-funded employer plans and Costco members who are uninsured and want to pay cash for their Steqeyma prescription or who have been denied coverage by their insurers.

FYI…. Steqeyma is available in both subcutaneous injection and intravenous infusion and is indicated for the treatment of plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn’s disease (CD) and ulcerative colitis (UC) in adult patients.

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Celltrion’s Steqeyma (ustekinumab-stba), now added to the Costco Member Prescription Program

CLICK HERE to read the full article

The FDA recently approved one… no wait, two… no wait, is it really one times two denosumab biosimilars…..?? The/these approval/s include Ospomyv (denosumab-dssb) and Xbryk (denosumab-dssb)… it/they are from Samsung Bioepis.

NO WAIT… the FDA approved yet another pair of denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) from Celltrion.

And if that’s not enough, Wyost and Jubbonti were approved as Prolia and Xgeva biosims in 2024.

All of these biosims were approved as interchangeable with the reference products, Prolia and Xgeva from Amgen.

You should be familiar with the big differences between these ‘twin’ injectables. But, one has a twice yearly administration schedule… the other has a much more frequent dosing schedule. While both products are included in the same FDA approved prescribing information document you need to scroll way down (e.g., page 96) to read the details for the ‘twin’s’ therapy detail and the dosing information for completely different indications. 

CLICK HERE to access prescribing information for Ospomyv and Xbryk

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FDA, EMA Approve Second Pair of Denosumab Biosimilars

CLICK HERE to read the full article 

The FDA recently approved a new ORAL therapy, Romvimza (vimseltinib) from Deciphera Pharmaceuticals, LLC, indicated for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Tenosynovial giant cell tumor (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treated through surgical resection. Treatment with TGCT typically involves direct removal of the tumor nodule. Treatment for diffused-type TGCT (DTGCT) with larger tumors affecting major joints, includes total synovectomy, joint replacement, or, in extremely rare cases, or amputation.

The highest prevalence of TGCT accounts for approximately 45% of total cases. Giant cell tumors can occur in the knee, ankle, hip, and other areas. The article cites that diffuse TGCT was most frequently observed in the knee, with an estimated 30,000 cases in the US in 2023.

Pricing details for Romvimza have not yet been announced.

Distribution details have not yet been announced by the company.

CLIC HERE to access prescribing information

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FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

CLICK HERE to read the full press release

How do you validate value? 

How do you demonstrate the ability to ‘walk the talk’?

The National Association of Specialty Pharmacy (NASP) has taken its years of specialty pharmacy knowledge and suggests it has a model that answers those questions. The validation points include improved patient outcomes, reduced costs, better medication adherence, cutting waste and increased patient safety.

If you think all this sounds familiar, it should. It has been the mantra for the SP industry for decades. What is different is the degree of proactive intervention that should push the standard of care past the performance ‘red line’.

NASP is still at work adding detail to the framework to facilitate implementation. For example, the framework will include a variety of new metrics such as affordability, supply chain impact, and tracking not only the number of interventions as well as the type such as patient, physician, care team, financial, etc., etc. to paint a very broad picture and understanding of each patient’s journey.

The current standard of care is already expensive. And, the expanded vision suggested by the framework would logically be even more costly. Perhaps AI may provide the secret sauce need to make the framework a reality.

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NASP’s 5-Step Procedure Tracks Patient Intervention Effectiveness

CLICK HERE to read the full article