Pharmaceutical Spotlight: Drug Costs, New Profit/Aging Drugs, Program 340B & More
This week on the BioBlog, we’re taking a closer look at the pharmaceutical industry. Roche is tweaking an aging cancer drug and marketing its replica for MS, demonstrating how profits can be generated from existing medications. Dr. June, the pioneer of immunotherapy, is featured in another article as his treatment developed from research with HIV patients is likely to receive FDA approval quite soon. Drug costs, program 340B and more are all part of this week’s look at the pharmaceutical industry.
The FDA is taking steps to help consumers priced out of the drugs they need. Scott Gottlieb, FDA Commissioner, expressed a desire for increased competition and greater choice for American consumers. Among the ideas Gottlieb expressed is the need for more rapid approval of generic drugs. The FDA has, in the past, seemed open also to granting broader approval for drugs to treat orphan diseases.
Controversial drug program 340B is in the news again. A Federal panel recommended on Monday that Medicare scrap the plan, which allows hospitals with poorer patients to purchase drugs at cheaper prices and keep the savings. The plan has come under fire recently with claims that hospitals are profiting excessively from the program.
New research published online Tuesday found Amgen, Inc.’s Repatha would need significant price reductions in order to meet a measure of cost-effectiveness for certain patients. This is true even when the benefits of the inhibitor shown in the company’s FOURIER outcomes trial are taken into account. The drug combo has the potential to prevent 2.9 million major cardiovascular events over a lifetime horizon but remains far above the cost-effectiveness threshold.
Novartis’ breakthrough leukemia drug holds great promise but the cost is so high doctors fear patients won’t be able to afford it. Leading physicians state this is a revolutionary drug but a ‘quantum leap’ in cost. The current price being quoted is $649,000 for one dose. The drug, CTL019, belongs to a new class of medications called CAR T-cell therapies, which involve harvesting patients’ immune cells and genetically altering them to kill cancer.
Makers of over the counter medications are willing to pay for FDA review of their products, a new report shows. This is part of the FDA’s overhaul of OTC drugs.
The National Comprehensive Cancer Network® (NCCN®) is collaborating with Evinance to integrate the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) into the Evinance Decision Support Platform. This will allow for point-of-care access to treatment recommendations derived from the NCCN Guidelines®. The NCCN Guidelines are the recognized standard for clinical policy in cancer care and are the most thorough and most frequently updated clinical practice guidelines available in any area of medicine.
Immunologist Carl June, a University of Pennsylvania professor, is hailed as the father of modern immune therapy. His work with adult stem cells with HIV patients is leading the way for revolutionary treatments for many diseases using the body’s own immune system. Dr. June’s CAR T-cell treatment has achieved excellent results for leukemia patients and may be FDA approved within weeks. More than 90% of pediatric patients with acute lymphoblastic leukemia in a subsequent clinical trial went into remission after being infused with Dr. June’s CAR T-cells.
Pharmaceutical company Roche tweaked cancer drug Rituxan and remarketed it for multiple sclerosis patients. Today, Rituxan is the most prescribed M.S. treatment in Sweden. Roche created a nearly identical drug for M.S. and is now marketing it elsewhere. A look at how tweaking an aging drug can generate continual profits.