Month: October 2025

The FDA recently approved a new ORAL therapy, Hernexeos (zongertinib tablets) from Boehringer Ingelheim, indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) and whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. Hernexeos is a tyrosine kinase inhibitor therapy. Hernexeos is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with cases projected to surpass 3 million annually by 2040. Non-small cell lung cancer (NSCLC) accounts for the majority of diagnoses. Because early symptoms are often absent or misinterpreted, most patients are not identified until stage III or IV, when the disease has already spread to organs.

The company did not confirm pricing at the time of approval. A market analyst suggests that “Hernexeos will launch with an estimated $100,000 annual treatment cost and 10,000 eligible patients in the U.S., Hernexeos could generate $1 billion in peak sales—a figure that could rise with label expansions into first-line therapy or other HER2-mutant cancers.”

Onco360 Specialty Pharmacy has been selected as LD partner to distribute Hernexeos.

CLICK HERE to access prescribing information

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U.S. FDA grants accelerated approval to Boehringer’s Hernexeos as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC

CLICK HERE to read the company press release

Navitus Health Solutions recently announced a significant development in its transparency-driven pharmacy benefit management model. Beginning January 1, 2026, its clients will gain access to Costco Pharmacy’s cost-plus pricing for prescriptions at both retail and mail-order locations.

Under this model, drug costs are calculated based on Costco’s acquisition price, plus a fixed markup and a pharmacy service fee. For Navitus clients, this means direct access to the purchasing power of Costco, with the assurance that all savings are fully passed through under Navitus’ 100% pass-through PBM structure. Additionally, Costco cost-plus model clients will have the same clarity for brand and generic drugs across Costco locations.

The partnership also introduces a consumer-friendly convenience… members living within an hour of a Costco Pharmacy will be eligible for free same-day delivery through Instacart, expanding accessibility while reinforcing Costco’s reputation for efficiency and value.

Navitus emphasized that this heightened level of transparency equips payers with a powerful means to better control drug spend, while also ensuring clients benefit from fully auditable spending.

For the pharmaceutical industry, this partnership underscores the accelerating shift toward cost-plus pricing and transparent PBM models – an evolution that could fundamentally change how drug costs are managed across the healthcare system, particularly as stakeholders push back against longstanding frustrations with the traditional PBM approach.

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Costco Pharmacy partners with Navitus

CLICK HERE to read the press release

The FDA recently approved a new therapy, Zusduri (mitomycin) from UroGen Pharma. Zusduri, an alkylating drug, is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Zusduri is administered only by intravesical instillation once weekly for six weeks delivered directly into the bladder thereby eliminating the need for surgery. The medication targets low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). More than 59,000 U.S. patients yearly face this recurrent disease.

The company did not disclose pricing for Zusduri at the time of approval.
Similarly, no details as to distribution were released.

CLICK HERE to access prescribing information

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UroGen’s Zusduri wins FDA’s blessing as first therapy for certain bladder cancer patients, despite negative adcomm vote

CLICK HERE to read the article

The FDA recently approved a new oral therapy, Zegfrovy (sunvozertinib) from Dizal (Jiangsu) Pharmaceutical Co., Ltd., for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Zegfrovy is the only approved targeted oral treatment for NSCLC with EGFR exon20ins. Zegfrovy will compete with Rybrevant, an infused therapy, in this patient segment. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Roughly 2% of NSCLC patients have the genetic type, though it is the third most common type of EGFR mutation.

Dizal has not announced the cost of Zegfrovy.
The company has not announced details for logistics or distribution.

CLICK HERE to access prescribing information

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Dizal’s Zegfrovy (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

CLICK HERE to read the press release

The 2025 JD Power US Pharmacy Study reveals significant shifts in pharmacy customer satisfaction and industry trends that pose major concerns for brick-and-mortar pharmacies.

An important finding of the study is that chain drugstore customers are significantly more likely than those using supermarkets or mass-market retailers to consider switching pharmacies within the next year, revealing a growing openness to change. This trend is amplified by rising satisfaction scores at mail-order pharmacies.

Brick-and-mortar pharmacy closures have accelerated. In 2024, 2,275 more closures were reported in the first nine months, intensifying concerns about patient access to in-person pharmacy care. Recent news reports suggest many more closures are in the offing.

Despite these closures, the 2024 JD Power’s report found that brick-and-mortar pharmacies still led in customer satisfaction compared to mail-order, supermarket, and mass-market retail outlets. However, the market is shifting quickly with supermarkets such as Wegmans and mass-market retailers like Sam’s Club ahead of chain drugstores in the 2025 report.

As alternative pharmacy models gain popularity – and market share – the industry stands at a pivotal moment. Persistent declines in satisfaction and widespread drugstore closures signal a market in flux, suggesting a transformational change may soon be in play.

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Brick-and-Mortar Pharmacy Satisfaction Decreases Below Supermarkets, Mail Order

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The FDA recently approved an ORAL therapy, Ekterly (sebetralstat) from KalVista Pharmaceuticals, indicated as an oral treatment for acute hereditary angioedema (HAE) attacks in patients aged 12 and older, after a delay attributed to FDA resource constraints.

HAE is a rare genetic disorder causing C1 esterase inhibitor dysfunction, leading to potentially life-threatening swelling attacks. The approval of Ekterly represents a significant advancement in the management of HAE, offering patients a more convenient, effective, and timely treatment option. This can lead to better overall patient outcomes and an improved quality of life for those affected by this rare genetic disorder. The company is promoting the therapy as a Potential Foundational Treatment with this oral form clinically superior to the time delays associated with injectable alternatives.

CLICK HERE to access prescribing information

KalVista said the Ekterly will cost $16,720 per dose. The drug will be packaged in a portable blister card that contains two doses.

The company has since disclosed details for logistics and distribution announcing that CVS Specialty, Accredo, Optum, and Orsini have been selected as the specialty pharmacy partners for Ekterly (sebetralstat).

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KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly

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The latest round of price negotiations has captured the attention of industry insiders and consumers alike, signaling potential shifts across the market landscape. As companies and suppliers sit down at the bargaining table, the stakes are high—not just for the parties directly involved, but for the broader market ecosystem influenced by these negotiations. Most noteworthy of mention are the numerous approved and pipeline biosimilar drugs that add complexity to the outcome.

The attached article starts with a grabber line….. “Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.”

By negotiating a new fixed price for a brand drug Medicare patients are unable to benefit from the lower cost biosimilar drug when one is approved. Most of the drugs being negotiated do not yet compete with an approved biosimilar. In short, thia stymies achieving a potential best price through generic and biosimilar competition

The article goes on to offer insight on the long term implications for access and cost suggesting “There is a reluctance of firms to develop biosimilars due to the risk of government price negotiations will hinder the full realization of biosimilar cost savings.” The article also explains a ‘Biosimilar Void’ and offers several policy change recommendations.

CLICK HERE to read the full article

This Report takes a deep dive into the complex world of rare and orphan drugs – and the unique challenges of how they’re priced. This week we highlight two insightful articles. As we peel back the layers, some surprising and thought-provoking insights emerge.

The Blockbuster Orphan Paradox: Medicare’s Rare Disease Dilemma
The ‘One Big Beautiful Bill Act (OBBBA) of 2025’ reshaped Medicare’s new drug price negotiation program by expanding protections for rare disease drugs. Building on the 2022 Inflation Reduction Act (IRA), which exempted “pure orphan” drugs (single rare disease use), the OBBBA went further: it shields drugs with multiple orphan designations and delays negotiation for drugs that add common disease indications, starting the negotiation clock only from their first non-orphan approval.

Analysts call this the ‘blockbuster orphan paradox.’ Drugs once seen as risky bets for rare diseases now bring in billions, especially cancer treatments. In 2023 alone, exempt drugs cost Medicare over $30 billion. By keeping these blockbusters out of negotiations, projected savings dropped sharply.

Beyond lost savings, exemptions may distort drug development incentives. Manufacturers may avoid pursuing non-orphan indications—even where patients would benefit—to preserve exemption status. This risks slowing broader innovation while sustaining blockbuster profits in rare disease markets.

The policy dilemma is clear… exemptions protect investment in rare disease therapies but at the cost of Medicare’s ability to lower prices on its most expensive drugs. Future legislation may seek to narrow or reconsider these carve-outs. Without reform, Medicare’s negotiation program are primed to be undermined by the very blockbusters that reform was designed to address.

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The Blockbuster Orphan Paradox: Consequences of Special Treatment of Rare Disease Drugs In Medicare Negotiation

CLICK HERE to read the full article