News & Commentary

Pediatric Drugs’ Costly Incarnation


There’s a new twist in the recent uproar about how pharmaceutical companies are spiking costs for variations of medicines that have been around for decades. Little children often have a difficult time swallowing pills. Pharmacists can make liquid versions, but there’s a risk of an adverse reaction to these ad hoc versions. So it figures that standardized liquid forms of older medications would find a market.

Unfortunately, insurers may have a difficult time swallowing the prices. Lisinopril and enalapril are ACE inhibitors that can be used to treat hypertension in children, a relatively rare condition. But the liquid formulation of lisinopril, Qbrelis, is priced 775 times higher than the generic tablet, and the liquid formulation of enalapril, Epaned, is priced 121 times higher than the generic tablet. Both formulations are made by Silvergate Pharmaceuticals in suburban Denver.

Luke A. Probst and Thomas R. Welch, MD, of Upstate Golisano Children’s Hospital, Syracuse, N.Y., wrote in the February 23 issue of the New England Journal of Medicine that “once liquid preparations are available, pharmacies are precluded from dispensing ad hoc formulations. In many instances, instead of a month’s supply of an extemporaneously compounded preparation costing a pharmacy less than $20, the commercially marketed liquid will have a wholesale acquisition cost of $1,000 or more.”

Probst and Welch acknowledge that the development and marketing of a pediatric liquid drug can be costly. The complexity of the drug, preclinical and clinical testing, regulatory filings, the size of the market, and the length of market exclusivity all add to the costs.

“Intuitively, though, the costs should be less than the costs to develop an entirely new drug,” they write. “Pricing models should take such a difference into consideration. Streamlining the regulatory requirements related to the development of pediatric drug formulations as well as responsible pricing models could preclude the call for legislative cost controls.”

UP NEXT

Legislation and regulation
By Richard Mark Kirkner
Legislation and regulation
By Richard Mark Kirkner
Legislation and regulation
By Richard Mark Kirkner