Just a couple of drug pricing updates this morning as I wait for the coffee to finish brewing:
Gilead (WSJ) has a new Hep-C drug that is good for all the major subtypes of the virus:
Gilead Sciences Inc. received U.S. Food and Drug Administration approval for its Epclusa hepatitis C combination drug and priced the treatment below its older drugs for the disease.
It is being priced at roughly $75,000 wholesale so with discounts that most insurers get, the total cost of the treatment regime is probably south of $60,000 on average. The interesting thing to me is that it is a better drug but cheaper. The big thing in the Hep-C space is that there are several viable near substitute cures available now so there is some downward price pressure.
As more and more states and Fedeal insurance programs/regulators are mandating that anyone with Hep-C get access to these cures, that is creating a huge pool of people who are eligible for them. This is producing a strong incentive for other pharmacy companies to introduce “me-too” drugs to get in on the gravy train.
— Peter Ubel (@peterubel) June 20, 2016
But AstraZeneca filed a lawsuit on Monday claiming the US Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition.
The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8…
Last month, the drug maker won FDA approval to sell Crestor to treat children with a rare genetic disorder called homozygous familial hypercholesterolemia or HoFH, which causes very high cholesterol. Under the Orphan Drug Act, the company was awarded an additional seven years of marketing exclusivity for Crestor, but only for treating this particular rare, or orphan, disease.
The FDA wants to allow generic manufacturers to not label their version of Crestor with any pediatric information. Brand Crestor would still be the authorized drug for HoFH although after six months to a year, most doctors who treat HoFH will have enough dosing data from brand name Crestor to figure out what how to prescribe the generic versions at a far lower co-pay/co-insurance for their patients. The FDA proposal would allow the generics to compete for the vast majority of usages of this drug class which would lead to much lower costs.
AstraZeneca wants a ruling that states that generics must have the entire label instead of a condensed/restricted label. That rule would protect this tiny carve-out market while also denying the generics access to the massive money making market of adult statin.
And finally general Rx data:
Important to read, uses new data. Seems to say A full 1/4 of top-selling drugs have doubled net prices since 2009. https://t.co/5GHBtlt5HU
— Andy Slavitt (@ASlavitt) June 29, 2016