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The cash price for a single month of Vanda Pharmaceuticals’ highly advertised “Non-24” sleeping pill averages $15,000.  This translates to $500 a night or $180,000 a year for basically a sleeping pill that targets the melatonin receptors in the brain.  A four month supply of melatonin readily available without a prescription at any grocery store or pharmacy costs about $6.

This drug, more properly known as Hetlioz, gained FDA marketing approval in 2014.  That year the cost for one month of Hetlioz was an egregious $7500.  By 2017 it rose to in excess of $13,000 and surpassed $15,00 by early 2018.

The “Non-24” pill sold as Hetlioz contains a molecule similar to but somewhat different from over-the-counter melatonin preparations.  For obvious reasons the American Academy of Sleep Medicine suggests beginning with at least several months of non-prescription melatonin.

Not surprisingly prescriptions for this drug require very thorough review by insurance companies.  Strict pre-certification criteria must be met prior to authorization.  And of course no one could afford these outrageous prices or even the co-payments without special assistance from the manufacturer in drastically limiting out of pocket costs.

Not only does the price seem totally unrelated to the cost of research, development or preparation of the drug, evidence does not exist to suggest Hetlioz offers any advantages compared to the over-the-counter product.

Two tests submitted to the FDA in support of the product evaluated only 104 individuals – half received Hetlioz while the remainder were randomized to placebo.  Studies did not compare the pricey Hetlioz against its inexpensive competitor.

Continuing this very peculiar saga, Hetlioz passed through the FDA approval process specifically intended only for totally blind individuals – those lacking any light perception.  Studies presented to the FDA examined only this condition.  All of the paperwork submitted to the FDA as well as all of the agency’s internal documents were limited to the totally blind.

Imagine the surprise when the FDA finally published its final approval.  In an apparent clerical error, someone at the FDA omitted the words “in blind individuals without light perception.”  In theory this allows prescriptions not limited to the intended audience of 65,000 – 95,000 people. Instead it expands the indication to anyone suffering an array of circadian rhythm disturbances.

Amazingly the FDA refused to correct their error.

To compound this outrageous story, in early 2018 the company requested the FDA expand the indications for Hetlioz to include jet lag.  If approved the potential target population would expand into the tens of millions rather than fewer than one hundred thousand.

Imagine a sleeping pill costing considerably more than cancer chemotherapy.  Kind of difficult to understand this peculiar situation.  Only in America.

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