Merck, Humana, Teva, and Government Health Regulations in the News
In this week’s Innovation Partners BioBlog, we share updates from companies such as Humana, Merck, and Teva. Humana has chosen to exit industry trade group AHIP, while Teva and Merck announce updates on important new drugs. This and more in this week’s Innovation Partners BioBlog.
The Medicare Payment Advisory Commission, or MedPAC, says one of the two payment tracks set up under a new reimbursement system is too burdensome to physicians. There is concern that it will not help improve care. Details in the article on the new reimbursement system and the list of concerns expressed by MedPAC.
Humana has now become the third large insurer to leave the industry trade group, America’s Health Insurance Plans. United Health, followed by Aetna, were the first two to leave the group. Humana cited business reasons rather than policy differences in the decision, spurred perhaps by the rumored acquisition of Humana by Walgreens or another company.
Although President Trump has repeatedly stated he wishes the government to negotiate drug prices, the new head of HHS, Alex Azar, stated during his confirmation hearings that he doesn’t believe that negotiations are the answer to lowering drug prices for consumers. Azar did say that under some circumstances negotiation makes sense, but only if it preserved both patient access and industry innovation.
As of January 1, 2018, changes to 340B went into effect. These changes reduce reimbursement rates on 340B qualified drugs from 6% above the sales price to 22.5% less than the sales price. The ruling will only impact certain hospitals. Details in the article.
Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First-Line Treatment of Acute Promyelocytic Leukemia
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide.
Merck’s KEYTRUDA(R) (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (KEYNOTE-189)
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer OS and PFS than pemetrexed plus platinum chemotherapy alone. The safety profile of KEYTRUDA in this combination was consistent with that previously observed.