Gifthealth's Richardson on Direct-to-Patient Models and Drug Pricing

"Cost Plus feeds daily pricing updates to TrumpRx, which functions as a referral hub rather than a direct seller. Mr. Cuban has been publicly supportive of the initiative while noting that some drugs listed on TrumpRx are already available as cheaper generics through Cost Plus. Equip-A-Pharma: In May 2025, Cost Plus was among four partners selected for Equip-A-Pharma, a collaboration between HHS, the Defense Advanced Research Projects Agency, and the private sector aimed at bolstering U.S.-based drug manufacturing using AI and other technologies. Cost Plus deployed an AI-enabled automated platform to produce active pharmaceutical ingredients, including lidocaine and diltiazem, with each partner expected to submit an abbreviated new drug application to the FDA within a year of the program’s launch." (Becker's Hospital Review, May 2026) https://lnkd.in/gcxCzghi

According to Fierce Pharma, the FDA is floating a new drug repurposing initiative. This raises questions about control, evidence standards, and the future of indication sequencing. The initiative will be inviting patients, clinicians, and stakeholders to suggest new uses for approved drugs. By doing so, the agency could open a parallel pathway that could shift how indications are prioritised and pursued. This approach will increase pressure around off-label use, named patient programmes, and compassionate access. If stakeholders can publicly advocate for specific repurposing opportunities, manufacturers may face mounting demands to support uses they hadn't planned to pursue—or that compete with their carefully sequenced commercial strategies. The commercial implications are significant. Indication sequencing matters enormously for pricing, market positioning, and evidence generation strategies. The FDA's request for comments closes June 11. Manufacturers with products potentially affected by this initiative should be engaging now—not just to suggest candidates, but to understand how this framework might impact their control over evidence generation and commercial strategy. I'm Natalie Shalet; I help teams derisk their programmes and evidence generation to ensure success. https://lnkd.in/eS4u9fCv

Glass contamination in injectable oncology drugs is not just a manufacturing misstep—it is a core trust issue at a time when product quality scrutiny is at an all-time high. Sun Pharma’s recall of a batch of doxorubicin hydrochloride liposome vials due to glass particle contamination highlights the ongoing challenge of upholding GMP standards under increasing pressure from regulators and payers. For those in oversight and quality roles, this incident reinforces the rising cost—both reputational and operational—when legacy compliance gaps resurface at scale. If you are managing supply chain risk or regulatory relationships, this development serves as another signal that short-term fixes or limited transparency will not fly. The lack of detailed root cause disclosure from Sun only amplifies anxieties for partners and prescribers alike. Pharmaceutical executives and quality leaders must be ready to answer tough questions about how their organizations anticipate, prevent, and communicate around quality events—especially when patient safety is on the line. How confident are you in your own organization’s ability to spot, contain, and address silent threats before they spark a full-scale market recall? https://lnkd.in/eHsgQBy6

Over $300 billion in prescription drug revenue is expected to lose exclusivity between 2025 and 2030. With continued pressure on the pharmaceutical life cycle, new policies and trends may serve as options to sustain value. These shifts empower patients, putting more decision-making in their hands: ➡️ ACNU expands expands over-the-counter access. ➡️ Direct-to-patient strategies, including TrumpRx (a core element of Most-Favored-Nation deals), provide a cash-pay option when insurance coverage is lacking. At L.E.K., we advise on loss-of-exclusivity strategy, while closely following the evolving regulatory and access landscape. The latest Executive Insights article from Lain Anderson, Max Cambras, Anna Ondik, and me explores these topics in more depth. https://lnkd.in/ehQsrkkt #Biopharma #MarketAccess #DTC #DTP #MFN #TrumpRx #ACNU

Canadian Drug Access Update (Part 1) — Week of April 26 to May 1, 2026 CDA’s procedural updates are out and will apply to all onco and non-onco submissions, effective Aug 7th and Aug 20th, respectively . (Pharmaceutical Reviews Update — Issue 61 | CDA-AMC) https://lnkd.in/eyYUEkau Some highlights: 1. Key requests during the call for feedback were acknowledged and incorporated: draft recommendation and sponsor feedback timelines remain unchanged 2. Big step towards transparency during the reconsideration process - innovator’s reasons for reconsideration and review reports presented to the expert committee will now be published 3. PACES gets eligibility expansion - an underutilized pathway that can produce significant reduction in time to market (through CDA & subsequent pCPA process) 4. Other updates incorporate an accelerated resubmission process, testing procedure assessments (TPAs), resubmissions and an updated expert committee meeting schedule #CanadianPharma #DrugAccess #HTA #CDAAMC #pCPA #HealthCanada #INESSS #MarketAccess #RegulatoryAffairs

This week’s edition of The Formulary is live. It returns to a recurring question in pharmaceutical policy: are we solving for lower prices, or are we solving for real access? Here’s a quick glance at this issue: 1. MFN pricing is back at the center of the federal affordability conversation. The White House projects $529B in MFN savings over 10 years 2. FDA proposes formally excluding semaglutide, tirzepatide, and liraglutide from the 503B outsourcing facility bulk drug substances list 3. FDA launches real-time clinical trial pilot: AstraZeneca and Amgen are the inaugural participants, giving FDA access to live trial data as it's generated, not after submission 4. Federal PBM reform enforcement begins July 1: Department of Labor will start enforcing pass-through pricing and transparency requirements under the Consolidated Appropriations Act of 2026 5. California SB 41 sets the national bar for PBM reform, bans spread pricing, mandates flat-dollar fees only for contracts from January 1, 2026 6. Colorado, Maryland, and Minnesota's Prescription Drug Affordability Boards are pushing the frontier setting upper payment limits on some of the most prescribed drugs in the U.S Read this week’s issue here: https://lnkd.in/geiiCrw8 #PharmaceuticalPolicy #DrugPricing #HealthPolicy #PBMReform #TheFormulary

Trump signed the Most-Favored-Nation drug pricing executive order. Here's what it means for pharma in simple terms: - U.S. drug prices will now be tied to what other rich countries pay - Single-source brand drugs and biologics are the primary targets - Future U.S. launch prices capped against international benchmarks This is the biggest shift in U.S. drug pricing in decades. Swipe through the PDF for the full breakdown 👇 Complete analysis link in the comment #DrugPricing #MFN #Pharma #Healthcare #TrumpPolicy #Medicaid #BigPharma