If you think you are seeing a lot of ads for sleep-related drugs lately you are right. Pharma is rolling out a banquet of "sleep disorders" like Delayed Sleep Phase Disorder, Advanced Sleep Phase Disorder, Non-24-hour Sleep-Wake Disorder, Irregular Sleep Wake Rhythm, Jet Lag Disorder and Shift Work Sleep Disorder. These are on top of the predecessor conditions of Chronic, Acute, Transient, Initial and Middle-Of-The-Night Insomnia, Early-Morning Wakening Disorder and Non-Restful Sleep Disorder.
The conditions constitute Pharma's global circadian rhythm sleep disorder market which was valued at $1.31 billion two years ago.
"You can't see me because of radio" and I can't see you because I'm totally blind" said an avalanche of ads for Non-24-hour Sleep-Wake Disorder in past years to boost "awareness" of the obscure circadian rhythm disorder. The narrator says his blindness doesn't "hold me back" but he often "struggles to keep up" because he is not "sleeping through the night." He then says, "Sound familiar? You're not alone!" The ads are from the Washington, DC-based drug company Vanda whose drug candidate for people who are blind and have Non-24, Hetlioz, was approved in the U.S. in 2014.
At the time of U.S. approval, there were only 146 citations for the disorder in the entire U.S. National Library of Medicine. By comparison, there are 8,463 citations for the plague. Today, there are undoubtedly more cases of Non-24.
Vanda developed Hetlioz as an "orphan drug"--a drug that is not commercially viable because it treats a small part of the population, in this case the blind. Benefits to a Pharma company developing an orphan drug in the U.S. include tax credits of 50%, research grants and a waiver of the $2.2 million new drug application fee.
But Vanda got lucky say Pharmacy Times.
"When the FDA approved Hetlioz, however, it did not specify in the product indication that the drug was solely for use in blind patients. According to consumer watchdog Public Citizen, at least 26 FDA review documents signed by 42 agency officials prior to Hetlioz 's approval explicitly stated that Vanda Pharmaceuticals was seeking approval for use in totally blind patients.
The FDA's blunder opened the door for the drug's use in a wide range of sleep disorders in patients who are not blind. Pharmacy benefit managers and insurance companies cannot limit the use of this drug to blind patients, as these requests will be overturned. Overturned denials lead to poor member satisfaction and a lower Star rating from the US Centers for Medicare & Medicaid Services, which can result in the loss of a Medicare contract."
The FDA blunder likely explains the aggressive "selling" of the disease. "Could You Have Non-24?" solicits the Vanda Non-24 website. In addition to sleep problems, symptoms include strained relationships, irritability, difficulty concentrating and being "frustrated because no one seems to understand what you're going through." Is that you?
It is notable that the symptoms of Non-24 are the same as used to sell most behavioral drugs including antidepressants, atypical antipsychotics, anxiety drugs, "mood stabilizers" and drugs for "adult ADHD." Hey, everyone needs a pill!
I called the Non-24 phone number when the ads first ran and asked the "health educator" if I could have Non-24 even though I am not blind. I was told "you don't have to be blind to have Non-24" though it is more common in blind people. When I asked if there was a pill I could take if I had symptoms, my educator said he was unable to answer that because, "I am not a doctor," and promised to send me more information.
Why should people care about Pharma's latest financial maneuver when there are so many similar brazen industry moves that raise our health care costs? Here is why. Even though Vanda used government breaks, our tax dollars, to develop the "orphan" Hetlioz, it has the audacity to charge $16,402 for a supply for 30 capsules. They say beggars can't be choosy but apparently orphan drug makers can be greedy.
