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The FDA recently approved yet another – first in class -cellular therapy, Amtagvi (lifileucel) from Iovance Biotherapeutics Inc., indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies.

Exposure to ultraviolet light is the leading cause of Melanoma, a form of skin.  Melanomas represent approximately 1% of all skin cancers yet are related to a significant number of cancer-related deaths as they metastasize. 

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells. Tumor tissue from the patient is surgically removed and their T cells are separated from the sample. The resulting therapy is then infused in the patient as a single dose. This is the first FDA-approved tumor-derived T cell immunotherapy.

Amtagvi was approved with a Boxed Warning due to prolonged severe low blood count, severe infection, cardiac disorder, respiratory or renal function failure. 

CLICK HERE for prescribing information

The company confirmed that Amtagvi will carry a list price of $515,000.

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FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

CLICK HERE to read the full article

It is not often that I see a report of an event that is so extraordinary that it is jaw dropping. A report that BioPlus Specialty Pharmacy experienced a data breach in 2021 which, in itself, would not typically be extraordinary. However, the settlement imposed on BioPlus was a WHOPPING $2.2 million! That is the jaw dropping part.

We’ve often written about similar data breaches as warning signs for other specialty pharmacies to learn from and take actions that, which may be costly to implement but are cheap in the long run should something ‘hit the fan’.

In this case, the ‘fan’ cost BioPlus a tremendous amount  of cash. The article below mentions that the data breach exposed sensitive patient information of approximately 350,000 individuals. The amount of the fine is likely influenced by the size of the breach.

The yet unanswered question is….. “What’s Next?”Data security is already well established and most specialty pharmacies have already expended a lot of effort to build up their data firewalls and overall security. Will more regulation prevent future data breaches? Probably not…… given the ingenuity of those that will go anywhere at any time to get data either for ‘fun’ or profit. 

In a landmark settlement, BioPlus Specialty Pharmacy compensates for a significant data breach with $2.2 million, setting precedents for data privacy.

CLICK here to read the full article

……..catching up on FDA approvals

The FDA recently approved a new form of Eohilia (budesonide oral suspension) from Takeda , the first and only FDA-approved oral therapy for patients 11 years and older with eosinophilic esophagitis (EoE). Budesonide was first approved by the FDA under the brand name Pulmicort in 1997 as an oral inhalation formulation for the treatment of asthma.

EoE is a chronic disease that can significantly impact patients causing esophageal inflammation and intermittent symptoms of choking and difficult or painful swallowing.  The largest study in the U.S. found the prevalence of EoE to be 57/100,000, or approximately 152,000 cases.

Eohilia is given over a 12-week course in single-dose 2 mg/10 ml stick packs, taken twice daily. It has a wholesale acquisition cost of $1,875 per month.  Eohilia  will compete with Dupixent which costs around $3,800 for two prefilled pens, which are taken either once a week or once every other week for EoE. Eohilia is supplied in a carton containing 60 single-dose stick packs.

Takeda did not disclose distribution details. As Eohilia is limited to 12 weeks of treatment and has a relatively low cost compared to most specialty pharmacy therapies, it would not be surprising to see this therapy available through open access.

Click here for prescribing information

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FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)

— 12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older

— EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing

Click here to read the full article

……..catching up on FDA Approvals

The FDA recently approved a new infused therapy, Avzivi (bevacizumab-tnjn) from Bio-Thera Solutions, as a biosimilar to AVASTIN (bevacizumab). It did not receive an interchangeable designation.

Avzivi is indicated for the treatment of (refer to prescribing information for full indication):

• Metastatic colorectal cancer, in combination 
• Metastatic colorectal cancer, in combination 
• Non-squamous non-small cell lung cancer, in combination 
• Recurrent glioblastoma in adults
• Metastatic renal cell carcinoma in combination 
• Cervical cancer, in combination 
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination.

CLICK HERE to access prescribing information

Four biosimilar versions of Avastin were previously approved: 

• Mvasi (bevacizumab-awwb), 
• Zirabev (bevacizumab-bvzr), 
• Alymsys (bevacizumab-maly), and 
• Vegzelma (bevacizumab-adcd).

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FDA Approves Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin

• Avzivi (BAT1706) is Bio-Thera Solutions’ second FDA approved product in the United States
• Avzivi® is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States

CLICK HERE to read the full press release

The National Association of Specialty Pharmacy (NASP) recently released the results of a patient satisfaction survey of specialty pharmacies. The results are worth evaluating…… closely. Ultimately, satisfaction will influence patient preferences as to the type of specialty pharmacy they will prefer to use in the future.

The survey included 17,477 customers at 35 participating specialty pharmacies.

Here are the key findings… (the sample size is a bit small but is large wnough to ponder the findings)

• Academic medical center specialty pharmacies (13) scored highest—an average of 93.7% 
• Non-academic health-system specialty pharmacies (12) —92.8% 
• Independent specialty pharmacies (10) slid back to third place —89.2%.

Scores increased for all specialty pharmacies across the board from 2021 to 2022 in five key areas: 

• communication with the pharmacy team; 
• pharmacy’s ability to return calls in a timely manner;
• patient knowledge of their health conditions; 
• timeliness of prescription deliveries; and 
• keeping patients informed of their prescription status.

Here is where it gets interesting…. especially if you are at an independent specialty pharmacy. The survey also calculated Net Promoter Scores (NPSs), a person’s likelihood of recommending the pharmacy to family and friends.

• Academic specialty pharmacies had an 84.5 NPS
• Health-system pharmacies chipped in at 81.6 
• But…… Independent pharmacies only garnered a measly rate of 69.2….. ouch!

Independent specialty pharmacies should look in the mirror to see why hospital owned / operated SPs are doing much better on the NPS scale. These SPs are looking to drive as many patients into their column as possible. Now would be the time for independent SPs to seriously relook at patient satisfaction and think of things that will positively impact future contacts….. and not rest on past laurels.

Can’t you see I’m on a losing streak?

I can’t get no, oh, no, no, no, satisfaction…. hey, hey, hey

…………….the Rolling Stones seem to have seen the light

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The Key Drivers of Specialty Pharmacy Customer Satisfaction

Communication, trust cited in NASP survey

CLICK HERE to read the full article

…… catching up o FDA approvals

The FDA has approved a new specialty topical gel, Filsuvez (birch triterpenes) from Chiesi Farmaceutici S.p.A. Parma, indicated for the treatment of the rare, devastating skin disease epidermolysis bullosa (EB).

EB is a genetic, connective tissue disease that causes the skin to become fragile and blister. The condition can worsen to be life-threatening including the development of aggressive squamous cell carcinomas and infections.

The overall incidence and prevalence of EB are 19.6 and 11.07 cases per million live births, respectively. The incidence and prevalence of junctional epidermolysis bullosa are estimated at 2.68 and 0.49 cases per one million live births.

Chiesi has not published acquisition pricing. However, they have confirmed that PANTHER Rx Rare was selected as a limited distribution partner for Filsuvez.

CLICK HERE for prescribing information

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After Amryt buyout, Chiesi scores with FDA nod for rare skin disease treatment Filsuvez

The FDA’s approval of rare skin disease drug Filsuvez gives Chiesi Global Rare Diseases its third nod for a new drug from the U.S. regulator this year. (Chiesi)

Seven months after Krystal Biotech became the first company to gain FDA approval to treat, Chiesi Farmaceutici has followed suit.

CLICK HERE to read the full article

We’ve often written about the battle being fought around site-of-care. As we’ve suggested previously, it comes down to one word….. MONEY.

Payers have been turning up the flame under the pot in which the battle is being fought. They are increasingly looking to move in more aggressive ways to redirect patinets away from comparatively very expensive hospital outpatient departments and into alternate site of care.

The article below lays out one new strategy by a large payer, Blue Cross Blue Shield of Michigan, to redirect their members to lower cost sites of care. A new policy that went into effect few weeks ago included a targeted list of drugs “may be covered only when administered at the following sites of care:

• Doctor’s or other health care provider’s office
• The member’s home, administered by a home infusion therapy provider
• Ambulatory infusion center.”

Here are the targeted therapies…

• Bavencio
• Imfinzi
• Imjudo
• Jemperli
• Keytruda
• Libtayo
• Opdivo
• Opdualag
• Tecentriq
• Yervoy
• Zynyz

We will not be surprised to see other payers follow this strategy….. especially as each newly infused therapy appears break new records for price.

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Additional drugs to have site-of-care requirements for some Blue Cross commercial members, starting March 15

CLICK HERE to read the press release

……………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

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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

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).

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.

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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.