The FDA makes progress in designating orphan drugs, it costs less to develop a new drug than previously thought, and a new cholesterol test method doesn’t require fasting.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Competing Health Bills
But first, on Wednesday 2 competing healthcare reform bills were introduced. Republican senators Bill Cassidy of Louisiana and Lindsey Graham of South Carolina unveiled an ACA repeal bill that got rid of the individual mandate and some of the law’s taxes, while placing a spending cap on Medicaid.
Meanwhile, Senator Bernie Sanders, the independent from Vermont, revived his calls for a single-payer plan. His Medicare for All bill has the support of 15 Democrats and would eliminate the role of private insurers.
FDA Cleans Up Backlog
FDA Commissioner Scott Gottlieb, MD, had promised to get rid of the backlog of orphan drug requests by September 21, and this week he announced that the agency finished ahead of schedule.
Now, FDA will streamline the process, which Gottlieb said will include incentives as more biologics apply for the program. However, he said it’s important to identify loopholes so companies don’t avoid important studies, especially those in children.
Orphan drug designation allows companies to streamline reviews for treatments in conditions that affect fewer than 200,000 people. The program has doubled in size between 2012 and 2016.
Cost of Bringing Drugs to Market
How much does it cost to bring a drug to market? It’s a lot, but not as much as once thought, according to a study in JAMAInternal Medicine.
Some estimates have put the cost as high as 2.7 billion dollars, but an analysis that used data from SEC filings found the average cost was 648 million dollars, and put the average time in development at 7.3 years. The researchers used data from 10 recently developed cancer drugs.
An editorial that appeared with the study said the findings contradict recent claims by drug makers. Wrote Merrill Goozner, the former editor of Modern Healthcare, “Current pharmaceutical industry pricing policies are unrelated to the cost of research and development. Policy makers can safely take steps to rein in drug prices without fear of jeopardizing innovation.”
New Cholesterol Test
For years, the gold standard to test for low-density lipoprotein (LDL) cholesterol required patients to fast overnight. But a new cholesterol calculation developed at Johns Hopkins doesn’t require fasting. Quest Diagnostics and Johns Hopkins have signed an agreement to convert to this new, more accurate testing method, which is important given the way LDL cholesterol is treated today.
As Utah Lipid Center’s Eliot Brinton, MD, told The American Journal of Managed Care, the older method became less accurate as a patient’s LDL cholesterol level dropped. Several factors have come together to drive the need for a new test method:
Clinical guidelines adopted in 2013 called for more people to take statins and at higher doses.
Many high-intensity statins, as well as ezetimibe, have come off patent, making them cheaper for patients to use.
PCSK9 inhibitors are now available, and can reduce cholesterol levels up to 60%.
Said Dr Brinton, “We’re treating LDL cholesterol more aggressively, so the inaccuracy of the calculation becomes even more important. A more accurate test at a lower level is a big deal.”
A new survey finds specialists such as oncologists and urologists have not yet made the operational changes needed to comply with MACRA, the law that calls on physicians and health systems to adopt value-based payment models.
The study by Integra Connect, which included 58 percent oncologists and 42 percent urologists, found these physicians do not fully understand the impact of the law. The survey found:
71% say they are learning but “have a long way to go”
56% want to deliver savings through practice transformation
40% are still using existing tools to meet MACRA requirements
24% are practicing without any changes
The study found that many practices don’t have a clear understanding of what is required of them or haven’t made plans to invest in necessary technology.
ASCO Communication Guidelines
Doctor-patient communication is essential to good care, and with that in mind, the American Society of Clinical Oncology has published guidelines to help clinicians do the best job possible in talking to patients with cancer and their families.
The guidelines were developed after a systematic literature review to address nine key questions about communication in the cancer setting, and were published in the Journal of Clinical Oncology. Overall, the authors said clinicians must focus on offering empathy and making sure that patients understand what they are saying.
ASCO made recommendations in the following areas:
Core communication skills
Discussing goals and prognosis
Discussing treatment options, including clinical trials
Discussing end-of-life care
Facilitating family involvement
Overcoming barriers to communication
Discussing the cost of care
Meeting needs of the underserved
Training clinicians to be better communicators
For all of us at the Managed Markets News Network, I’m Laura Joszt.