Nicholas Jacobus

The nine drugs apart of the pilot program will test the rebate model for future program participants.
Stock.Adobe.com 

The US Health Resources and Services Administration (HRSA) revealed the initial nine drugs to be included in the 340B rebate model. The decision comes after pharma companies filed suit in regard to how 340B eligible hospitals should handle drug payments.

What is the 340B rebate model pilot program?

According to a statement on HRSA’s website, the 340B Rebate Model Pilot Program includes a select group of drugs from certain manufacturers who have submitted plans meeting specific criteria approved by HRSA. The statement continues to mention that the pilot program aims at assisting the development process for approving future models that are consistent with the 340B statute and Administration’s goals.

The pilot program is scheduled to start on January 1, 2026.

“Under the 340B Rebate Model Pilot Program, covered entities must continue to make purchases through their 340B wholesaler account and must ensure they are only requesting rebates on the above drugs dispensed to 340B eligible patients after a purchase is made,” said HRSA, in a statement on its website. “Manufacturers should work with their distributor partners to ensure the WAC price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.”

What drugs are included in the 340B rebate model pilot program?

HRSA announced the following nine company’s drugs are set to be included in the rebate pilot program.

Novo Nordisk Inc., Novolog; Flexpen, Penfill, Fiasp; Flextouch, Penfill

What lead to HRSA approving a 340B rebate model?

Back in December 2024, Johnson & Johnson, Bristol Myers Squibb, and Eli Lilly sued HRSA, challenging the agency’s ability to review and approve 340B program rebate models. In the suit, the companies proposed a plan to implement cash rebates for 340B drug purchases, resulting in HRSA sending each drug manufacturer warning letters in regard to the manufacturers abilities to unilaterally implement a rebate model without first submitting the model to the agency for review.

 Additionally, the lawsuit challenges the implementation of a rebate model, of the drug manufactures discretion, along with challenging the requirement to obtain prior approval from the agency before implementation.

Why was the 340b drug pricing program originally created?

In 1992, the 340B Drug Pricing Program was created with the goal of being able to incentivize safety net hospitals and clinics that support the low-income and underserved populations by discounting outpatient drug costs.

 By providing the ability to dispense discounted drugs, these facilities are able to directly impact more patients, in the form of additional health care services and programs.

Health Resources and Services Administration 

https://www.hrsa.gov/opa/340b-model-pilot-program

Study Highlights Need for Greater Transparency in 340B Drug Pricing Program 

https://www.pharmexec.com/view/study-highlights-need-for-greater-transparency-in-340b-drug-pricing-program

https://www.feldesman.com/the-340b-program-rebate-bait-and-switch/

Articles

The US Health Resources and Services Administration (HRSA) has announced the inclusion of nine drugs in the 340B Rebate Model Pilot Program, set to begin on January 1, 2026. This initiative follows legal challenges from pharmaceutical companies regarding the management of 340B drug payments. The pilot program aims to develop future models aligned with the 340B statute and administrative goals. The 340B Drug Pricing Program, established in 1992, was designed to support safety net hospitals and clinics by providing discounted outpatient drug costs to benefit low-income and underserved populations.

Nine drugs from leading manufacturers will participate in HRSA’s new 340B rebate model pilot program, set to begin in 2026, which aims to evaluate a rebate-based framework for future drug pricing models amid ongoing industry litigation.

Health Resources & Services Administration Announces Initial Drugs Apart of 340B Rebate Model Pilot Program 

The investment is aimed at boosting oral medicine manufacturing capacity.
Stock.Adobe.com

Eli Lilly and Company revealed plans to invest upwards of $1.2 billion to expand and enhance its manufacturing site in Carolina, Puerto Rico.

The investment is aimed at integrating advanced technologies, while also enhancing its production capabilities within its existing location and supporting the company’s growing portfolio of oral solid medicines.

"This historic investment stands as proof of what can be achieved when the private sector and government work hand in hand toward a shared vision of competitiveness and economic growth," said Sebastian Negron Reichard, secretary of the department of economic development and commerce, Puerto Rico. "For over sixty years, Lilly has trusted Puerto Rico, its people, its talent and its potential. Today, that trust translates into new capacity, advanced technologies, investment and long-term economic value for our island. This is exactly the kind of partnership that defines our economic development strategy and strengthens Puerto Rico's position as a global leader in life sciences manufacturing."

Why is Lilly focused on investing in its Puerto Rico manufacturing site?

Lilly del Caribe is expected to be one of the selected facilities to manufacture orforglipron, Lilly’s first oral small molecule GLP-1 receptor agonist.

The $1.2 billion investment is a reflection of Puerto Rico’s impact in Lilly’s manufacturing agenda, and was included in Lilly’s previously announced $50 billion capital investment aiming to expand US-based manufacturing capabilities.

Additionally,the investment enables the facility to deploy highly advanced technologies in oral solid medicine manufacturing, including dock-to-dock automation and material flow, paperless manufacturing, process analytical technology, and spray-dried dispersion, which allows oral medicines to be effectively absorbed.

Lily’s planned investment into its Lilly del Caribe manufacturing site in Puerto Rico continues the company’s recent trend of investing back into its manufacturing sites, as Lilly announced its plans to build a 

 in its India-based manufacturing site, and a 

 in constructing a new manufacturing site in Houston, Texas.

"After 60 years, Lilly del Caribe continues to play an important role in making life-changing medicines for people in the U.S. and beyond," said Edgardo Hernandez, executive vice president and president of Lilly manufacturing operations. "Our continued investments in capacity, infrastructure, advanced technologies and highly specialized jobs will further cement the site's significance in Lilly's global manufacturing network. Our progress builds on the dedication and expertise of our local team, helping us deliver new medicines for patients around the world."

The planned investment in expansion is set to create up to 1000 construction jobs, with an additional 100 high-tech manufacturing positions, while also reflecting Lilly’s support of local bioscience growth, by its scholarship offering for students studying engineering, science, technology, and business.

Comments from Puerto Rico’s governor on the planned investment

"This announcement reflects the very essence of our public policy, which is to position Puerto Rico as a strategic hub for advanced manufacturing, innovation and national economic security," said Jenniffer Gonzalez-Colon, governor of Puerto Rico. "Lilly's multimillion-dollar expansion is a resounding vote of confidence in our people, our infrastructure and our long-term competitiveness within the U.S. supply chain. It demonstrates that global companies can continue to grow and thrive here, while Puerto Rico contributes in a meaningful way to the resilience of the nation's most critical industries."

Lilly announces more than $1.2 billion investment in Puerto Rico facility to boost oral medicine manufacturing capacity in the United States 

https://www.prnewswire.com/news-releases/lilly-announces-more-than-1-2-billion-investment-in-puerto-rico-facility-to-boost-oral-medicine-manufacturing-capacity-in-the-united-states-302597678.html

Eli Lilly and Company plans to invest over $1.2 billion to expand its manufacturing site in Carolina, Puerto Rico, enhancing production capabilities and integrating advanced technologies. This investment supports Lilly's growing portfolio of oral solid medicines and aligns with its $50 billion capital investment strategy to expand U.S.-based manufacturing. The expansion will create up to 1,000 construction jobs and 100 high-tech manufacturing positions. The initiative underscores Puerto Rico's strategic role in Lilly's global manufacturing network and its contribution to the U.S. supply chain's resilience and competitiveness.

The investment is aimed at boosting oral medicine manufacturing capacity.

Eli Lilly Planning $1.2 Billion Investment in Puerto Rico Manufacturing Site 

The partnership marks the first time patients using LillyDirect can access self-pay pricing for Zepbound at a retail pharmacy location.
Image courtesy of Elli Lilly and Company 

Eli Lilly and Company announced its strategic collaboration with Walmart Pharmacy that aims to expand access to its direct-to-consumer (DTC) pricing for Zepbound (tirzepatide) single-dose vials through LillyDirect, Lilly’s DTC healthcare platform.

Zepbound vials are expected to be available for pick-up through Walmart pharmacies nationwide beginning in mid-November.

“Managing a chronic disease like obesity can be a significant and ongoing burden—physically, emotionally, and financially,” said Jennifer Mazur, SVP and general manager of LillyDirect. “This collaboration with Walmart is designed to reduce that burden by streamlining access to prescribed treatment. By combining LillyDirect’s innovative, patient-centered platform with Walmart’s nationwide pharmacy footprint, we’re expanding options for patients facing access challenges, making it easier to start and stay on authentic Lilly medicine.”

Who will access to this direct-to-consumer pricing option?

According to a press release from Walmart, Zepbound single-dose vials will be offered in all approved strengths, and patients with a valid on-label prescription will be able to access Zepbound vials directly without using insurance. 

Additionally, Lilly’s collaboration with Walmart expands its convenient access to Zepbound for patients, including those who prefer the convenience and ease of pick-up pharmacies such as Walmart’s.

The partnership now provides customers, who are initiating or continuing their therapy with Zepbound, the option to have their prescriptions routed directly to LillyDirect’s Self Pay Pharmacy Solutions through their health care provider’s electronic health record system, along with offering the ability to choose the option that best fits their lifestyle during the check-out process.

Offers include free home delivery from LillyDirect or convenient local pick-up at Walmart Pharmacy, with the price for Zepbound single-dose vials remaining the same for both LillyDirect options.

What is the pricing of Zepbound single-dose vials through LillyDirect?

Patients with a valid, on-label Zepbound prescription, regardless of their insurance status, will be offered the following prices on Zepbound doses:

$349 per month for the 2.5 mg recommended starting dose

$499 per month for all other doses (5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg)

Patients must meet the requirements for the Zepbound Self Pay Journey Program, which is designed to support continuity of care and access, to access the $499 monthly price for doses higher than 5 mg,

“Life is busy, and this will help people discover new, easy ways to get their medication,” said Kevin Host, senior vice president of Pharmacy at Walmart. “We are known for building great relationships with our patients, and our teams look forward to doing more of that through making this pickup option available from our trusted pharmacists and pharmacy technicians.”

Lilly Direct’s statement on the collaboration

“The growth of LillyDirect’s direct-to-consumer offering underscores the momentum behind a more modern, consumer-driven model of care,” said Mazur. “LillyDirect, powered by Walmart, builds on that progress—extending convenience and choice to patients while reinforcing LillyDirect’s mission to empower more people on their health journey.”

LillyDirect and Walmart Pharmacy Launch First Retail Pick-Up Option With Direct-to-Consumer Pricing for Zepbound 

https://corporate.walmart.com/news/2025/10/29/lillydirect-and-walmart-pharmacy-launch-first-retail-pick-up-option-with-direct-to-consumer-pricing-for-zepbound

Eli Lilly and Company has partnered with Walmart Pharmacy to enhance access to Zepbound (tirzepatide) single-dose vials through LillyDirect, their direct-to-consumer healthcare platform. This collaboration allows patients with valid prescriptions to purchase Zepbound at set prices without insurance, offering both home delivery and Walmart pharmacy pick-up options. The initiative aims to alleviate the burden of managing chronic diseases like obesity by providing streamlined access to treatment. Pricing is set at $349 per month for the starting dose and $499 for higher doses, contingent on program requirements.

The partnership will provide DTC options at locations nationwide.

Lilly Announces Partnership with Walmart Pharmacy Launching First Retail Pick-Up Option Offering Direct-To-Consumer Priced Zepbound 

LogiPharma USA 2025: What Topics Do You Think Will headline the 25th LogiPharma USA?

In a recent panel discussion on supply chain security, Krenar Komoni emphasized the growing importance of collaboration among vendors, logistics providers, and technology companies to combat evolving threats in the industry. The conversation highlighted two main types of theft impacting the supply chain: direct theft, where goods are physically stolen from trailers or containers, and strategic theft, a more sophisticated form involving social engineering tactics where fake carriers impersonate legitimate ones to intercept shipments.

To address these risks, panelists discussed a multi-layered security approach. Tools like carrier vetting software, GPS trackers, seals, and even armed escorts were identified as part of a tiered defense system. Komoni stressed that no single solution can fully secure a supply chain; rather, companies must integrate multiple protective measures into their operations to build resilience.

A major highlight of the discussion was the shift in the pharmaceutical industry from passive monitoring to real-time tracking, accelerated by new technologies like the Solo Pro device. This transition enhances visibility and responsiveness in managing high-value or sensitive shipments.The panel also explored how closer partnerships between logistics providers, shippers, and tech firms are strengthening the supply chain. This “triangle” of collaboration allows for better implementation and use of advanced technologies, increasing trust and efficiency across the board.

Looking ahead, Komoni noted that AI and automation will play a larger role in supply chain security, helping to predict threats and streamline operations in a rapidly evolving environment. The session concluded with a clear takeaway: securing the supply chain requires continuous adaptation, strong relationships, and layered, technology-driven solutions.

A transcript of Komoni’s conversation with 

What topics do you think will headline the 25th LogiPharma USA?

 I really believe the topic that we're going to continue to discuss is around how AI is infiltrated into our businesses, and how it's helping us run supply chains better, especially helping companies automate their supply chains today, I don't know if it feels only for me, but I believe the world's moving very fast, and the speed at which is accelerating, like the concept of singularity, everything is moving to an exponential pace at speed.

If you look at where open AI and ChatGPT were a year ago compared to 24 months ago, there's been tremendous amount of progress, and that progress is so much faster and better a month from now, but pharma moves a little slow because of regulatory requirements, which is a good thing, because these are medicines that are going in our bodies are in life saving, but it's going to have a put a lot of pressure on companies to innovate and innovate quicker than they have. 

I believe five years from now, even three years from now, four years from now, this is a topic we're going to continue to discuss. And I believe it's a challenge on its own, but I'm very excited to be part of people who are going to help pharmaceutical companies tackle it.

Collaboration among vendors, logistics providers, and technology companies is crucial to counteract supply chain threats, including direct and strategic theft. A multi-layered security approach, integrating tools like carrier vetting software and GPS trackers, is essential for resilience. The pharmaceutical industry is shifting from passive monitoring to real-time tracking, enhancing shipment management. Strong partnerships within the supply chain "triangle" improve technology implementation and efficiency. AI and automation are expected to play a significant role in future supply chain security, necessitating continuous adaptation and innovation.

Krenar Komoni, founder and CEO of Tive, predicts that AI-driven automation and its accelerating impact on pharmaceutical supply chains will remain a headline topic at LogiPharma USA, as the industry faces growing pressure to innovate while balancing strict regulatory requirements.