At $125,000 Per Dose, Will This Be the Most Expensive Drug in the World?
By Katie Thomas, New York Times
The Food and Drug Administration has approved the first drug to treat patients with spinal muscular atrophy, a disease that, in its most severe form, kills infants before they turn 2.
“This is a life-changing event, and this will change the course of this disease,” Dr. Mary K. Schroth, a lung specialist in Madison, Wisconsin, who treats children who have the disease, said of the approval, which was made last week. Schroth has worked as a paid consultant to Biogen, which is selling the drug.
The drug, called Spinraza, by some estimates will be among the most expensive drugs in the world.
Biogen, which is licensing Spinraza from Ionis Pharmaceuticals, said one dose will have a list price of $125,000. That means the drug will cost $625,000-$750,000 to cover the five or six doses needed in the first year, and about $375,000 annually after that, to cover the necessary three doses a year. Patients will presumably take Spinraza for the rest of their lives.
The pricing could put the drug in the cross hairs of lawmakers and critics of high drug prices, and perhaps discourage insurers from covering it.
Geoffrey C. Porges, an analyst for Leerink Partners, said the price could lead some insurers to balk or to limit the drug to patients who are the most severely affected, such as infants, even though the FDA has approved Spinraza for all patients with the condition.
The price of the drug would be comparable to some other drugs that treat rare diseases. A spokeswoman for Biogen said the company set the price after considering several factors, including the cost to the health care system and the clinical value it brought to patients.
Ligia Del Bianco, the spokeswoman, said Biogen had set up a program to help families navigate insurance approvals and other logistics, and will provide financial assistance.
About 1 in 10,000 babies are born with spinal muscular atrophy — or about 400 a year in the United States — and it is among the leading genetic causes of death in infants.
To Learn More:
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Maker of High-Priced Prostate Cancer Drug Targeted by U.S. Lawmakers (by Linda A. Johnson, Associated Press)
Hedge Fund Ethics Hit Drug Industry as “Rare Disease” Loophole Causes Cost of Medicine to Suddenly Skyrocket (by Danny Biederman and Noel Brinkerhoff, AllGov)
Generic Medicines Used to be Cheap…Not Any More (by Noel Brinkerhoff and Steve Straehley, AllGov)
Lawmakers Tentatively Challenge Drug Makers over Outrageous Costs for Medicine (by Noel Brinkerhoff and Danny Biederman, AllGov)
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