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Exploring RCT, RWE and alternative study designs as a path forward

Getting to answers about Biogen’s Aduhelm

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic treatments. Multidisciplinary approaches are essential for optimizing care, emphasizing the importance of collaboration among oncologists, neurosurgeons, and radiation specialists to tailor interventions based on individual patient profiles.

This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type. Unlike claims-based studies or survey-based research, this analysis draws from actual prior authorization cases, providing a direct window into the real-world challenges faced by prescribers and patients alike.

New Data Reveals What’s Behind Delays and Denials in RA Care

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiotherapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and overall prognosis. Continuous research and clinical trials are vital for further progress in this field.

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release. 

How One Brand Protected Market Share Amid Biosimilar Pressure

Novo Nordisk has some facility issues to address.

the company’s Bloomington, IN plant that was acquired as part of last year’s Catalent acquisition

 has received an FDA Form 483. This type of citation

 is typically given following an inspection that in the agency’s eyes, violates the Food Drug and Cosmetic (FD&C) Act, along with other related acts.

In this particular case, the Indiana manufacturer plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.

 These issues were found during the late-June to mid-July 2025 timeframe.

Unresolved complaints and equipment failures

This manufacturing plant also houses Regeneron and Scholar Rock therapies.

“Your investigation failed to determine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches,” the official report

 wrote. “The review of related deviations was limited to a one-year time frame, and no complaints were assessed. Although components were considered a potential root cause, no corrective or preventative actions were taken to address this. Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred. In addition, approximately 14 other deviations were opened as a result of a gap analysis conducted in response to this deviation.”

As far back as June 2022, multiple clients had raised complaints about “foreign matter” or “particles” found in lots that were produced at the site. Fast forwarding to the February 2024 and May 2025 timeframe, the plant logged around 10 work orders for “recurrent leaks and other failures” in a specific system.

 Some of those faced significant repair delays.

Novo Nordisk expands US manufacturing footprint

As alluded to previously, Catalent’s ownership officially changed hands December of last year, after Novo Holdings, Novo Nordisk’s parent company, agreed to acquire the CDMO in a $16.5 billion deal.

 These sites house fill-finish processes.

“We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,” Novo Nordisk president and CEO Lars Fruergaard Jorgensen commented at the time of the announcement. “The acquisition complements the significant investments we are already doing in active pharmaceutical ingredients facilities, and the sites will provide strategic flexibility to our existing supply network.”

Catalent announces layoffs amid shifting demand

In other Catalent news, the CDMO recently cited an “unexpected shift in demand from a large customer,” and will be laying off 350 employees from its Baltimore gene therapy plant.

“Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases/disorders,” a Catalent spokesperson told Endpoints News. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”

1. Silverman E, Chen E. Major US Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, and Other Problems, FDA Finds.

. August 21, 2025. Accessed August 25, 2025. 

https://www.statnews.com/pharmalot/2025/08/21/novo-nordisk-catalent-manufacturing-plant-inspection/

2. Saraceno N. Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant.

 August 20, 2025. Accessed August 25, 2025. 

https://www.pharmaceuticalcommerce.com/view/catalent-to-lay-off-350-workers-baltimore-gene-therapy-plant

3. FDA Form 483 Frequently Asked Questions.FDA

 January 9, 2020. Accessed August 25, 2025. 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions

4. Kansteiner F. Novo Plant Acquired in Catalent Buyout Faces Renewed FDA Scrutiny With Form 483: Stat.

 August 22, 2025. Accessed August 25, 2025. 

https://www.fiercepharma.com/manufacturing/novo-plant-acquired-catalent-buyout-faces-renewed-fda-scrutiny-form-483-stat

5. Manalac T. Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds.

https://www.biospace.com/fda/novo-acquired-catalent-plant-plagued-by-unresolved-pest-contamination-issues-fda-finds

https://www.statnews.com/wp-content/uploads/2025/08/catalent-form-483-jul-2025.pdf

Novo Nordisk's Bloomington, IN plant, acquired from Catalent, received an FDA Form 483 due to contamination issues, including atypical extrinsic particles like cat and human hair, and pest infestations. The plant, which also manufactures Regeneron and Scholar Rock therapies, failed to identify root causes or implement corrective actions. Despite previous complaints and equipment failures, these issues remain unresolved. Novo Nordisk's acquisition of Catalent's sites aims to expand its manufacturing capabilities. Meanwhile, Catalent announced layoffs at its Baltimore gene therapy plant due to shifting demand.

An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout. 

Novo Nordisk’s Indiana Plant Flagged by FDA for Contamination and Safety Lapses

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic treatments. Multidisciplinary approaches are essential for optimizing care, emphasizing the importance of collaboration among oncologists, neurosurgeons, and radiation specialists to tailor interventions based on individual patient profiles and tumor characteristics.

Case study on how a neuro biologic brand leveraged SamaCare’s insights and interventions platform to decrease patient access friction and improve patient starts. 

How One Neuro Brand Cut Through Prior Auth Barriers

Following an eight-day bench trial, a judge has issued a final judgement ruling that pharmacy benefits manager Caremark—a subsidiary of CVS Health—must pay $289.9 million in damages to Sarah Behnke, in a False Claims Act whistleblower case.

In June, the court had originally ruled that the PBM had encouraged insurers—including Behnke’s former employer, Aetna—to submit inflated drug claims to the federal government that dated back to 2010.

Allegations of underpayment to pharmacies

Behnke also had claimed that Caremark was underpaying pharmacies such as Walgreens and Rite Aid for medications. She had originally filed the lawsuit in 2014, several years before CVS Health had even completed its acquisition of Aetna in 2018.

The initial damages during the June ruling had been set at $95 million, but those have since tripled, with the breakdown being:

Fraudulent Medicare claims undermine public trust

In other words, the defendants were liable for false and inflated drug prices that had been reported to the government for prescriptions filled for Medicare Part D beneficiaries, resulting in the federal government overpaying these generics.

According to the court, the $4.8 million represents a per-claim penalty "near the top of the statutory range" of $5,500 to $11,000, given the fact that "Caremark's misconduct was serious." CVS had claimed that Behnke’s allegations were not fully supported, arguing that the original $95 million penalty was sufficient. Despite the argument, Judge Mitchell Goldberg felt that fraudulent Medicare claims were going to undermine public trust in the Centers for Medicare & Medicaid Services (CMS).

"This is a terrific outcome for our client and the US government and taxpayers," said Executive Shareholder David F. Sorensen, who led Berger Montague's trial team, the led law firm representing Behnke.

The court found that the Caremark defendants were liable for false and inflated drug prices that had been reported to the government for prescriptions filled for Medicare Part D beneficiaries at two national chain pharmacies (Walgreens and Rite Aid), causing the federal government to overpay for these generic drugs.

Broader legal battles in the pharma industry

The latest ruling is among a flurry of legal battles taking place within the pharma industry. Recently, Texas filed a lawsuit

 against Eli Lilly over bribery allegations, claiming that Lilly used various practices to illegally induce medical providers in the state to prescribe Lilly’s products instead of its competitors. The complaint called out two programs that Lilly provided for HCPs: a free nurses program and reimbursement support service.

“Big Pharma compromised medical decision-making by engaging in an illegal kickback scheme,” said Texas State Attorney General Ken Paxton. “Eli Lilly fraudulently sought to maximize profits at taxpayer expense and put corporate greed over people’s health. I will not stand by while corporations unlawfully manipulate our healthcare system to line their own pockets.”

Separately, GSK has reached an mRNA patent settlement

 with BioNTech, CureVac, and Pfizer, ending US litigation over COVID-19 and influenza vaccines. The deal reduces GSK’s future royalty obligations on its mRNA programs and could pave the way for a global resolution following BioNTech’s planned CureVac acquisition. No liability was admitted by any party.

Among the main settlement terms, BioNTech will pay GSK $370 million upfront and 1% royalties on US sales of licensed products from Jan. 1, 2025, along with $130 million and 1% royalties on rest-of-world sales following the closing of the deal.

Meanwhile, CureVac will receive $370 million at closing, along with $50 million from GSK for monetizing a portion of US product royalties due under its existing license agreement.

1. Pharmacy Benefits Manager Caremark Must Pay $290 Million After Trebled Damages and Assessed False Claims Act Penalties. PR Newswire. August 21, 2025. Accessed August 22, 2025. 

https://www.prnewswire.com/news-releases/pharmacy-benefits-manager-caremark-must-pay-290-million-after-trebled-damages-and-assessed-false-claims-act-penalties-302535821.html

2. Pennsylvania judge hits CVS with $289M fine in whistleblower suit. 

. August 21, 2025. Accessed August 22, 2025. 

https://www.fiercehealthcare.com/payers/pennsylvania-judge-hits-cvs-289m-fine-whistleblower-suit

3. Hollan M. Texas Sues Eli Lilly for Allegedly Bribing Providers to Prescribe Drugs. 

. August 13, 2025. Accessed August 22, 2025. 

https://www.pharmexec.com/view/texas-sues-eli-lilly-allegedly-bribing-providers-prescribe-drugs

4. Tracy D. GSK Gains $370 Million Upfront, Reduced Royalties in CureVac mRNA Patent Settlement Agreement with Pfizer, BioNTech. 

. August 8, 2025. Accessed August 22, 2025. 

https://www.pharmexec.com/view/gsk-gains-370-million-upfront-reduced-royalties-curevac-mrna-patent-settlement-agreement-pfizer-biontech

A judge has ruled that Caremark, a CVS Health subsidiary, must pay $289.9 million in damages in a False Claims Act case, with plans to appeal. The case involved inflated drug claims submitted to the federal government, leading to overpayments for Medicare Part D prescriptions. The ruling is part of broader legal challenges in the pharmaceutical industry, including a lawsuit against Eli Lilly for alleged bribery and a patent settlement involving GSK, BioNTech, CureVac, and Pfizer over mRNA technology, which could influence future royalty obligations.

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

CVS Caremark Ordered to Pay $290 Million in False Claims Act Whistleblower Case

DSCSA stands for the Drug Supply Chain Security Act, and is 

 by the FDA. It was originally signed into law aspart of the 

 in November of 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain. 

 for pharmaceutical drug tracing, giving manufacturers, distributors, and dispensers steps to establish an interoperable electronic system to identify and trace prescription drugs at the package level to prevent harmful drugs from entering the US drug supply and protect healthcare providers and patients from counterfeit, unapproved, or potentially dangerous products.

 is where each drug package is assigned a unique identifier-combined that enables end-to-end visibility from the manufacturer to the end consumer.

What standards are used for electronic exchange?

 (electronic product code information services) are considered the go-to. Global location numbers—GLNs—are used to track product location.

Who are considered authorized trading partners?

“To be considered an authorized trading partner, a manufacturer or repackager must have a valid registration in accordance with section 510 of the FD&C Act and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be considered an authorized trading partner, a wholesale distributor must have a valid license under State law or section 583 of the FD&C Act, in accordance with section 121 582(a)(6) of the FD&C Act , comply with the licensure reporting requirements in section 122 503(e) of the FD&C Act, as amended by DSCSA, and accept or transfer direct ownership 123 of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.

“Similarly, to be considered an authorized trading partner, a 3PL must have a valid license under State law or section 584(a)(1) of the FD&C Act, in accordance with section 582(a)(7) of the FD&C Act, comply with the licensure reporting requirements under section 584(b) of the FD&C Act (21 U.S.C. 360eee-3), and accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. A dispenser must have a valid license under State law and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.”

Most recently, On Oct. 9, 2024—49 days before the end of the one-year stabilization period under the DSCSA—the FDA 

for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements.

The exemption duration varies by partner type:

Manufacturers and Repackagers: Until May 27, 2025

Wholesale Distributors: Until Aug. 27, 2025

Dispensers with 26 or more full-time employees: Until Nov. 27, 2025 (this excludes small dispensers, which are exempt until Nov. 27, 2026)

What is the industry’s overall readiness for the DSCSA to take full effect?

 from around the sector is that data is being exchange at a much higher rate. Most of the distributors and manufacturers are saying that they’re we’re fully connected with most, if not all their customers and that data is actually moving.

The Drug Supply Chain Security Act (DSCSA), enforced by the FDA, was established to enhance the security and traceability of pharmaceutical products. It mandates an interoperable electronic system for tracking prescription drugs to prevent counterfeit or dangerous products from entering the U.S. supply chain. Serialization assigns unique identifiers to drug packages, ensuring visibility from manufacturer to consumer. GS1 standards, like EPCIS, facilitate electronic exchanges. Authorized trading partners must comply with specific licensing and registration requirements. Enforcement of DSCSA has faced delays, with varying exemption durations for different partner types.

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain. 

Scott Swain

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