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NASP Survey Reveals Ongoing Pain Points With White Bagging

We’ve often written about white bagging, but today’s spotlight article bears yet another look. A recent NASP survey reinforces what many in specialty pharmacy already know: while awareness of white bagging is high, operational execution continues to vex the field. According to the NASP survey, a majority of respondents report active struggles around logistics, coordination, and financial alignment. 

Key Challenges

·  Supply chain and inventory risk — White bagging shifts the burden of drug delivery timing and storage to the provider site (infusion clinic or hospital) necessitating patient-specific inventory and managing  changes in dosing or therapy last minute that introduces waste, delays, and potential stockouts.

·  Coordination complexity — Because the specialty pharmacy (external to the site) controls dispatch, close coordination is paramount to avoid canceled or deferred infusions.

·  Liability and oversight gaps — When providers do not control procurement, they lose visibility into the handling, storage, and chain of custody of the drug — increasing safety and compliance risk.

·  Payment misalignment — Although payers push white bagging to shift cost structures, providers often lack commensurate reimbursement for the extra handling, scheduling, and inventory burden.

Emerging Solutions and Mitigations

·  Clear or ’in-system’ bagging models are gaining traction… the health system’s own specialty pharmacy procures and delivers to its clinics, maintaining internal control and reducing external dependencies. 

·  Stronger contracting and advance notice: Institutions are demanding advance payer notification, locked-in service-level agreements, and shared liability language in agreements.

·  Technology solutions: Systems that better integrate scheduling, inventory forecasts, and real-time delivery tracking help reduce misfires.

·  Advocacy and policy interventions: Professional bodies are pushing for rules that protect provider autonomy and patient safety, limiting when payers can mandate white bagging. 

The article also addresses a trend that’s emerging alongside white bagging, that of “zero-priced drugs”… drugs or tiers of drugs for which the patient (or provider site) has no out-of-pocket cost. These often include generic or preferred brand drugs, or specific drug classes adding yet another gambit to this four-dimensional chess game.

While payers see cost and control upside, providers face significant operational, clinical, and financial risks. For specialty pharmacy executives and provider leaders, the key is to anticipate these tensions, negotiate rigorously, invest in systems, and preserve clinical flexibility as new distribution policies proliferate.

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NASP Survey Spotlights Challenges of White Bagging

CLICK HERE to read the full article

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No Shortage of Denosumab Biosimilars – Bosaya & Aukelso

The FDA recently approved a ‘2fer’, two biosimilars for the same reference therapy. The two in question are Bosaya and Aukelso, denosumab biosimilars for all indications of Amgen’s Prolia and Xgeva. Both biosims are from Biocon Biologics Ltd. The FDA also granted provisional interchangeability designation for both biosimilars reinforcing their use for all FDA-approved indications of the reference products.

Denosumab, a human monoclonal antibody, supports bone resorption and reduces bone breakdown to increase bone mass and strength. It is most commonly used to treat osteoporosis in women to prevent fractures following menopause (Prolia) and prevent spinal cord compression or the need for radiation/surgery to the bone in patients with multiple myeloma and bone metastases from tumors (Xgeva).

These biosimilars add to an expanding roster of approved competitors. Notably, each new approval introduces two additional ‘branded biosimilar names’ to the market.

The company did not disclose pricing information, nor did it provide details regarding distribution plans for the therapies.

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FDA Approves Bosaya and Aukelso, Biosimilars to Reference Denosumab (Prolia and Xgeva)

CLICK HERE to access the full article

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FDA Approves New Oral Tx for NCFB – Brinsupri

The FDA recently approved a new ORAL therapy, Brinsupri (brensocatib) from Insmed Inc., indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.  Brinsupri is a dipeptidyl peptidase 1 (DPP1) inhibitor and is the first and only treatment for the condition. Non-Cystic Fibrosis Bronchiectasis is a serious, chronic lung disease that can lead to permanent lung damage.

Approximately 500,000 U.S. patients are diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB). This approval offers patients effective treatment to defer the frequent exacerbations when symptoms worsen. Symptoms include coughing, increased mucus, shortness of breath and fatigue. Until now, treatment options were limited to antibiotics, airway clearance devices, and in severe cases, surgery.

Insmed will price Brinsupri at $88,000 per year before discounts during a company conference call.

The company also confirmed that Brinsupri will launch via specialty pharmacy limited distribution. Three SPs have confirmed their selection by Insmed as a distributor of the therapy, PantherRx Rare, Maxor Specialty Pharmacy, and Amber Specialty Pharmacy.

CLICK HERE to access prescribing information

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FDA Approves BRINSUPRI (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

CLICK HERE to read the company press release

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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 early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are six LD deals that have been publicly confirmed subsequent to their FDA approvals.

Onco360 to Distribute Ibtrozi

Onco360 has been selected as a national pharmacy partner by Nuvation Bio Inc. for Ibtrozi (taletrectinib), a kinase inhibitor approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Onco360 to Distribute Qinlock

Onco360 has been selected as a pharmacy partner by Deciphera Pharmaceuticals, LLC for Qinlock (ripretinib) approved for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Onco360 to Distribute Romvimza

Onco360 has been selected as a specialty pharmacy partner by Deciphera Pharmaceuticals, LLC for Romvimza (vimseltinib), which has been approved by the U.S. Food and Drug Administration for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Onco360 to Distribute Augtyro

Onco360 has been selected as a specialty pharmacy partner by Bristol Myers Squibb for Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy.

LeMed Specialty Pharmacy to Distribute Harliku

LeMed Specialty Pharmacy was named by Cycle Pharmaceuticals to be the exclusive specialty pharmacy for specialty pharmacy distribution and services for Harliku (nitisinone) tablets. Harliku is the first and only FDA-approved treatment for use in alkaptonuria (AKU). LeMed will manage commercial and non-commercial dispensing for Harliku across the United States.

Ekterly Specialty Pharmacy Network

KalVista Pharmaceuticals has announced that CVS Specialty, Accredo, Optum, and Orsini have been selected as the specialty pharmacy partners for Ekterly (sebetralstat). Ekterly is an FDA-approved oral therapy for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

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Join the Cell and Gene Therapy Party

There is a professional organization for nearly every segment of health care, each typically publishing papers and articles on their specific area of focus. These publications are invaluable sources of information that also enable us to produce our Reports.

Recently, we have concentrated on cell and gene therapy due to significant advancements and activity within this field a segment of great interest for manufacturers, and payers alike. This sector has seen the emergence of new companies, technological breakthroughs, and even cures for certain diseases.

In this context, we introduce the American Society of Gene and Cell Therapy (ASGCT). Notably, ASGCT recently hosted their Annual Meeting in New Orleans. Unlike many annual gatherings, it is highly likely that the various presentations were well attended, given the rapid pace of developments in this field. Every scrap of new research or new technology could hold substantial value.

The accompanying article is recommended for a brief read to pique your interest. It highlights how several companies are positioning themselves to revolutionize the industry, moving towards a future where personalized, effective treatments for complex diseases are increasingly attainable. We will be on alert for other articles tackling the other remaining, thorny issue….. affordability.

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Gene and Cell Therapies in Focus at ASGCT 2025: Tackling Rare Diseases, Autoimmune Conditions, and More

Click Here to access the article

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Is Your Therapy Performing as Advertised?

Today our spotlight is on how well a gene therapy approved in early 2024 has performed with a lookback at several years preapproval and over a year post launch.

The specific therapy is not the primary focus of this report. Rather, it serves as an example to assess whether a therapy truly performs as advertised.

This ‘one-and-done’ therapy was introduced at a price of $3.5 million. The pre-approval trial results were exceptionally favorable, meeting the aspirations of any manufacturer. The outcomes were so impressive that the manufacturer confidently offered insurers a warranty providing “financial protections” in case the therapy failed to deliver as promised or even if its efficacy did not persist. It is important to note that the trials were relatively small for this orphan therapy, further challenging the confidence level of good outcomes in a larger population.

It is uncommon to encounter such positive feedback as the following:

·    After the first year, no treatment-related adverse events were reported.

·    Of the nine serious adverse events documented in four participants, none were related to the treatment.

·    There was no discontinuation or dropout from the study resulting from adverse events or death.

·    No participant resumed legacy therapy during the trial.”

A comprehensive review of the article could serve as a benchmark for any manufacturer aiming to achieve excellence in the launch of new drugs.

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Multiyear Follow-up Study Shows Positive Results for Hemophilia B Gene Therapy

CLICK HERE to read the full article

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Priority Review Lapse Disrupts Rare & Orphan Drugs Pipeline

A fog of uncertainty hangs thickly in the air. Manufacturers find themselves wringing their hands in the aftermath of sweeping layoffs and shifting policies at the Department of Health and Human Services, the FDA, and elsewhere.

The article that follows shines a spotlight on a single program emblematic of this collective anxiety: the pediatric priority review voucher initiative, now among the earliest casualties of fiscal cutbacks. One might expect that a program championing treatments for rare and orphan pediatric diseases would win easy favor in the political arena—yet even such causes can be ground to dust in all the political meat grinding.

The fate of voucher programs at large remains uncertain, casting a long shadow. The article notes a particular complication: “Despite widespread support, the priority review program faces some opposition – especially regarding companies redeeming vouchers for drugs outside the rare disease sphere; critics maintain these incentives should be reserved solely for treatments targeting rare conditions.”

Ultimately, as ever, it all boils down to finances. With the program’s future hanging in the balance, investors hesitate, less willing to commit resources amidst the ongoing uncertainty.

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FDA Layoffs and Priority Review Program’s Lapse Disrupt Rare Disease Pipeline

The expiration of the FDA’s pediatric priority review voucher program is creating uncertainty for rare disease drug developers.

CLICK HERE to access the full article

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FDA Approves Novel Tx for Hemophilia A and B – Qfitlia

The FDA recently approved a new treatment, Qfitlia (fitusiran) from Sanofi, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).

Qfitlia uses a different pathway in the coagulation system to rebalance hemostasis. Qfitlia is approved for those with hemophilia A and B, but, unlike most treatments for the disorder, it also can be used by patients regardless of their inhibitor status.

Traditionally, blood factors are IV administered, however, Qfitlia is administered via a subcutaneous injection making it a convenient option. Qfitlia can be administered once every two months. Dosage and frequency can also be adjusted using a companion diagnostic test.

Over the last three years, the FDA has approved six new hemophilia drugs, including three gene therapies. Qfitlia jumps into this crowded treatment landscape but it is the only therapy approved for all types of hemophilia.

The company has not announced distribution details.

The company has set a list price for Qfitlia at $642,000 annually.

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FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

CLICK HERE to access the FDA press release

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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 early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are six LD deals that have been publicly confirmed subsequent to their approvals.

PANTHERx Rare to Distribute Vigafyde

PANTHERx Rare was selected by Upsher-Smith for the distribution of Vigafyde (vigabatrin), a ready-to-use, concentrated oral solution approved for the treatment of infantile spasms in pediatric patients one month to two years old.

PANTHERx Rare to Distribute Vykat

PANTHERx Rare was selected by Soleno Therapeutics to distribute Vykat XR (diazoxide choline extended-release tablets), for the treatment of hyperphagia in individuals four years of age and older with Prader-Willi syndrome (PWS).

Orsini to Distribute Encelto

Orsini Specialty Pharmacy has been selected by Neurotech Pharmaceuticals, Inc., as the exclusive specialty pharmacy partner for Encelto (revakinagene taroretcel-lwey), an FDA-approved encapsulated cell therapy implant for the treatment of Macular Telangiectasia type 2 (MacTel).

CareMed to Distribute Vanrafia

CareMed has been selected by Novartis Pharmaceuticals to join the Limited Distribution Network for Vanrafia (atrasentan), indicated for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) and are at risk of rapid disease progression.

(CareMed is an independent Specialty Pharmacy that is an affiliate of Onco360 Specialty Pharmacy)

Soleo Health to Distribute Qfitlia

Soleo Health has been named the exclusive in-network specialty pharmacy for Qfitlia (fitusiran) by Sanofi. Qfitlia is the first antithrombin-lowering therapy for hemophilia. Qfitlia was approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors.

Onco360 to Distribute Avmapki – Fakzynja CO-PACK

Onco360 has been selected as a national pharmacy partner by Verastem Oncology for Avmapki – Fakzynja CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. 

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WAGS Stung by $50 million Anti-Kickback Penalty

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