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FDA Approves Oral Tx for PNH – FABHALTA

……………catching up on FDA approvals

The FDA approved a new ORAL therapy, Fabhalta (iptacopan) from Novartis, the first oral monotherapy 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. It provides comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). 

PNH is characterized by hemolysis, bone marrow failure, and thrombosis in varying combinations and levels of severity.  Up to 88% of patients on legacy treatment may have persistent anemia with over one-third of those patients requiring blood transfusions at least once per year. Nearly all patients treated with Fabhalta did not require blood transfusions.

Was approved with a Black Box Warning — FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.

The wholesale acquisition cost for Fabhalta is $26,900 for one month supply.

Since its approval, Novartis has confirmed that Fabhalta is being dispensed by at least two specialty pharmacies, Onco360 and Biologics by McKesson.

CLICK HERE to access prescribing information


Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

CLICK HERE to read the full press release


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.

PANTHERx Rare to Distribute Filsuvez

PANTHERx Rare was selected by Chiesi Global Rare Diseases for the Distribution of Filsuvez® (birch triterpenes) topical gel. Filsuvez is the first approved treatment for wounds associated with both dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Onco360 to Distribute Xpovio

Onco360, is now the national specialty pharmacy network partner for Karyopharm’s product Xpovio (selinexor), a first-in-class, XPO-1 inhibitor. Xpovio is approved in multiple oncology indications, including: (i) in combination with Velcade® (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Walgreens to Distribute Vivjoa

Walgreens specialty pharmacy patients now have exclusive access to Vivjoa, through AllianceRx Walgreens Pharmacy, a subsidiary of Walgreens. Vivjoa (oteseconazole), manufactured by Mycovia Pharmaceuticals, Inc., is the first FDA-approved medication to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in post-menopausal women or women who are not of reproductive potential.

PromptCare to Dispense Coagadex 

PromptCare has been selected by Kedrion Biopharma to dispense Coagadex, a limited-distribution therapy approved in 2015 by the U.S. Food and Drug Administration (FDA) for the treatment of factor X deficiency. Coagadex is the first and only FDA-approved therapy to treat hereditary factor X deficiency and is the only factor X concentrate available worldwide.

Amber Specialty Pharmacy to Dispense Rezdiffra

Amber Specialty Pharmacy announces that it will begin dispensing Madrigal’s Rezdiffra™, a medication recently approved by the FDA for the treatment of non-alcoholic steatohepatitis (NASH). Rezdiffra (resmetirom) is the first and only FDA-approved once-daily treatment for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).


Another Specialty Pharmacy Bites the Dust

Did you hear it too?

We are talking about hearing the melody to the old Queen song….. Anther One Bites the Dust!

The one biting the dust is Kroger Supermarkets. 

As numerous specialty pharmacies before them, Kroger just announced that they are spinning off their specialty pharmacy division as it no longer fits their strategic plans.

Should this sale be a surprise to anyone? No.

If you have an asset that is not delivering a satisfying ROI then it may be high time to sell. Also, given the Byzantine nature of drug access and purchasing, it requires larger and larger volumes to get the best acquisition prices and access to limited drugs, payer contracts, etc. Kroger has just not been able to break into the SP fast lane.

What is more interesting is the buyer in this deal….. Elevance Health.

Now pay attention…. this is complicated

  • Elevance is the fancy new branding of the former Anthem.
  • In mid-2022 Elevance Health launched new brands for two of its subsidiaries under one umbrella, called Carelon. 
  • Carelon includes the Elevance (Anthem’s) in-house pharmacy benefit manager Ingenio Rx now under CarelonRx
  • And…. Beacon Health Options, a behavioral health provider
  • And myNEXUS, a home healthcare company. 
  • And… Paragon Healthcare which operates more than 40 ambulatory and home infusion centers in eight states 
  • And….the acquisition of BioPlus specialty pharmacy in 2023…… which closes the loop on understanding the Elevance Health’s CarelonRx’s acquisition of the Kroger specialty pharmacy business.

That’s a very busy acquisition schedule! 

The company says that Carelon now serves 1 in 3 people in the U.S. in one way or another.


Kroger to sell specialty pharmacy business to Elevance Health’s CarelonRx

March 18, 2024 

(Reuters) – Grocer Kroger said on Monday it had entered a definitive agreement for the sale of its specialty pharmacy business to CarelonRx, a unit of U.S. health insurer Elevance Health.

The financial terms of the deal were not disclosed.

The retailer’s specialty pharmacy business serves patients with chronic illnesses that require complex care.

Kroger Specialty Pharmacy is separate from other Kroger Family of Pharmacies, including in-store retail pharmacies and The Little Clinics, which are not included in the deal.

The deal, subject to customary closing conditions and regulatory approvals, is expected to close in the second half of 2024. It is not expected to impact Kroger’s 2024 fiscal forecasts.


FDA Approves Oral Tx for Breast Cancer – Trugap

……..catching up on FDA approvals

The FDA recently approved a new ORAL therapy, Truqap (capivasertib) from AstraZeneca Pharmaceuticals (AZ), for co-administration with Faslodex (fulvestrant) for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Breast cancer is the most common cancer and one of the leading causes of cancer-related death worldwide. HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype, with more than 65% of tumors considered HR-positive and HER2-low or HER2-negative. Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN occur frequently, affecting up to 50% of patients with advanced HR-positive breast cancer.

Published cost of Truqap oral tablets, in either 160 mg or 200mg strengths, is around $24,000 for a supply of 64 tablets. Approved dosage of Trugap is 400 mg orally taken twice daily for 4 days followed by 3 days off. That translates into 4 tablets per day, 16 per week over the 4 ‘on’ days, which therefore translates into 4 weeks of therapy in a 64 tablet bottle. Therapy may continue until disease progression or unacceptable toxicity.

Since approval, AZ has named Biologics by McKesson as its specialty pharmacy dispensing partner.

CLICK HERE for Prescribing Information


FDA approves capivasertib with fulvestrant for breast cancer  

CLICK HERE to read the FDA press release


FDA Approves 1st Tx for Rare Non-Cancerous Tumors – Ogsiveo

……..catching up on FDA approvals

The FDA approved a new ORAL therapy, Ogsiveo (nirogacestat) to SpringWorks Therapeutics Inc., for adult patients with progressing desmoid tumors who require systemic treatment.  Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas. 

Desmoid tumors are diagnosed in about 3 to 5 people per million a year. Previous treatments included surgery, chemotherapy, radiation and tyrosine kinase inhibitors, Unfortunately, recurrence rates have remained high. The tumors commonly invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life.

SpringWorks announced that Ogsiveo will be sold in the U.S. at a list price of $29,000 for a 30-day supply.  Since launch the company also announced that Ogsiveo would be available through select specialty distributors or through its limited specialty pharmacy network which includes Onco360 and Biologics by McKesson.

CLICK HERE for prescribing information

CLICK HERE for the FDA press release


PBM Swan Song Time?

Let’s see if we can get your attention……

“The market structure we have right now—three big PBMs dominating the market—will probably not be the one we will be with over the long run.”

That statement is central to the article we suggest today for your reading pleasure. It strongly suggests that the way PBMs operate, and the service offerings they are already offering in response to market pressures, are shifting the ground under which healthcare is delivered. We suggest that providers in the delivery channel also need to understand these changes to survive and thrive.

The article starts out by detailing how Blue Shield of California chopped its well established PBM in favor of a tutti frutti solution that includes —–

  • Amazon Pharmacy – fulfillment
  • Mark Cuban Cost Plus Drug Company – simple, transparent, pricing 
  • Abarca – claims technology
  • Prime Therapeutics – negotiate savings with drug manufacturers toward value-based models 
  • CVS Caremark – will continue supporting specialty pharmacy services

The article is thought provoking as it is a peek behind the curtain of what appears to be the next generation of PBM hegemony. Most staff are only generally familiar with the ‘OG’ PBM model so this article should be considered required reading. 


PBMs Are Evolving. Here’s What HR Needs to Know

When nonprofit health insurer Blue Shield of California announced in August that it was making a significant shift in how it administers pharmacy benefits for its 4.8 million members, the health insurance industry took notice, and so did the financial markets: CVS Health, the parent company of the insurer’s outgoing pharmacy benefits manager (PBM), saw its stock plummet 8 percent the day Blue Shield made its decision public.

The Oakland-based insurer’s new model, called Pharmacy Care Reimagined, includes new relationships with four entities in addition to the CVS PBM, known as CVS Caremark. In announcing the new model, Blue Shield said……………………………

CICK HERE to read the full article

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