GSK Announces B-Well Study Results, Bepirovirsen Shows Significant Efficacy
Ionis Pharmaceuticals (IONS) partner GSK (GSK) announced results from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, evaluating the safety and efficacy of bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis B. The studies included over 1,800 patients from 29 countries. GSK licensed bepirovirsen from Ionis and the two companies have collaborated on its development. The B-Well studies met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen of1000 IU/ml where an even greater effect was demonstrated. The studies demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies. Full results will be submitted for presentation at an upcoming scientific congress, published in a peer-reviewed journal and used to support regulatory submissions to health authorities worldwide. If approved, bepirovirsen has the potential to become the first finite, six-month therapeutic option for CHB and to serve as a backbone for future sequential treatment strategies.
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Trump Administration Launches Medicare Drug Price Negotiations
- Expansion of Drug Negotiations: The Trump administration has expanded Medicare drug price negotiations to include treatments administered in doctors' offices for conditions such as diabetes and HIV, affecting 15 drugs set to take effect in 2028, aiming to reduce out-of-pocket costs for beneficiaries.
- Spending Overview: According to the Centers for Medicare and Medicaid Services, approximately 1.8 million beneficiaries utilized these medications between 2024 and 2025, accounting for about $27 billion in spending, highlighting the significance of Medicare expenditures in drug price negotiations.
- Pharmaceutical Impact Assessment: Analysts indicate that for 14 of the drugs, only Gilead's Biktarvy significantly impacts the company's estimated 2027 global sales, representing around 8%, while other drugs' Medicare revenue exposure is limited to 0% to 3%, suggesting minimal overall revenue impact for pharmaceutical companies.
- Kaiser Settlement on Fraud: Kaiser Permanente has agreed to a historic $556 million settlement over Medicare Advantage fraud allegations, reflecting the government's stringent enforcement stance on Medicare fraud, which could have far-reaching implications for the industry.
US Expands Medicare Drug Price Negotiation Scope
- Expanded Negotiation Scope: The CMS has included Medicare Part B drugs in its price negotiation program for the first time, marking a significant expansion that is expected to increase pressure on high-cost drug pricing.
- Significant Savings Potential: CMS estimates that if the negotiated prices from the second cycle had been in effect in 2024, Medicare could have saved approximately $8.5 billion in net drug costs, translating to a 36% reduction in spending across selected drugs, thereby alleviating financial burdens on seniors and taxpayers.
- Transparency in Drug Selection: CMS released a list of 50 eligible drugs for negotiation, with 15 selected based on high spending, demonstrating the agency's commitment to transparency and fairness in drug pricing, which aims to enhance public trust.
- Future Negotiation Timeline: Negotiations with participating drug manufacturers are scheduled for 2026, with any agreed prices set to take effect on January 1, 2028, providing manufacturers ample preparation time while also bringing anticipated price adjustments for Medicare beneficiaries.
