In this week’s Innovation Partners BioBlog, we look at many of the top stories highlighting the conversation about drug prices. Canada’s acting ambassador nixes the Trump Administration’s suggestion that Canadian drug imports will lower prices. Neulasta has another competitor as a third biosimilar enters the market. And a top regulator of Medicare and Medicaid decries the “half million dollar” drug launches as unsustainable. Read on for more top stories from the world of health and medicine from Innovation Partners.
MD Anderson’s Hahn picked as next FDA commissioner
President Trump has nominated Stephen Hahn as the next FDA commissioner. If confirmed, Hahn replaces Scott Gottlieb, who left the agency in the spring. Ned Sharpless, who served as the interim FDA commissioner, will return to his post at the National Cancer Institute. Admiral Brett Giroir, an official at the Department of Health and Human Services (HHS), will continue leading the agency until the new pick is confirmed.
How CVS is using digital tools to boost specialty pharmacy adherence
CVS has deployed new digital tools to help with patient outcomes and adherence. A pilot program monitoring patients with chronic myeloid leukemia (CML) through secure text messages found that patients were 22% more likely to optimally adhere to their medications.CML patients must achieve a 90% or better adherence to their medications after diagnosis to significantly reduce their chance of readmission. Patients received education and coaching through text messages during the pilot program.
Canadian ambassador tells White House drug import plan unworkable, not enough supplies
Canada’s acting ambassador to the U.S. told the White House that the country’s drug supply is too small to support imports into the United States. Acting Ambassador Kirsten Hillman met with Joe Grogan, White House director of the Domestic Policy Council, and other White House officials on November 1, and made it clear that Canada’s market for pharmaceuticals is too small to make any impact on pricing in the United States. Canada represents only 2% of global pharmaceutical consumption.
CMS retains 340B, site-neutral payment cuts in final hospital payment rule
The Trump administration finalized a hospital payment rule Friday that retains proposed cuts to off-campus clinics and the 340B drug discount program. The changes outlined in the hospital Outpatient Prospective Payment System (OPPS) rule come despite both cuts being struck down in legal challenges and amid major pushback from providers. The administration’s goal is to have payments to off-campus clinics in line with standalone physicians’ offices. The move will save an estimated $14 per visit to beneficiaries.
After years-long delay, Novartis’ Sandoz finally wins Neulasta biosimilar nod
Novartis now has its biosimilar to Amgen’s Neulasta after three years. The latest study data helped Ziextenzo, the biosimilar, to win approval. Ziextenzo boosts white blood cells called neutrophils in cancer patients receiving chemotherapy. Two other Neulasta biosimilars, Mylan and Coherus, are offered at up to 33% discounts. This has created competition for Neulasta with Ziextenzo now adding pressure to Amgen’s Neulasta sales.
Physician groups satisfied with improved payment for E/M codes, reduced documentation in new Medicare rule
The American Medical Association (AMA) appeared satisfied with the new coding changes released by the Centers for Medicare & Medicaid Services (CMS). The CMS changes to E/M codes were included in the Medicare final rule released in early November. The changes represent the first major coding changes in 25 years.
U.S. Blames Drug Shortages on Low Prices and a ‘Broken Marketplace’
A federal report cited low prices for generic drugs and a healthcare marketplace that ignores the rules of supply and demand as the reason for chronic drug shortages. The report, Drug Shortages: Root Causes and Potential Solutions, identified three causes for chronic drug shortages: 1. lack of incentives for manufacturers to produce less profitable drugs; 2. a market that does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and 3. logistical and regulatory challenges make it difficult for the market to recover from a disruption.
Verma questions limit of high launch prices for new drugs
Seema Verma, the top regular of Medicare and Medicaid, demanded answers as to why the launch prices of new drugs are so high. Verma made the point that these expensive medications are unsustainable. For example, the hepatitis C drug Sovaldi from Gilead Sciences launched for just under $100,000 for a year’s supply. Despite raising these questions, Verma does not support House Speaker Nancy Pelosi’s plan to give Medicare the power to negotiate lower prices and force manufacturers to offer negotiated prices to commercial plans.