FDA keeps door open to cheap versions of KV's Makena

KV Pharmaceutical's defense of its pricey preterm-labor drug rolls on. After the FDA announced that it found no major safety problems with compounded versions of KV's Makena drug, KV released a statement emphasizing another part of the FDA's announcement--that agency-approved drugs provide greater assurance of safety and efficacy.

KV ($KV.A) understandably wants to lean on the FDA's (also understandable) support for drugs that have its approval. But the upshot is that women will still have access to much-cheaper compounded versions of the hormone injection. What could change, however, is payers' attitudes toward reimbursing the expensive branded drug.

Here's the background: In November, the FDA announced that it would review compounded versions of Makena--a newly FDA-approved version of a hormone treatment long available at a small fraction of the price--after KV told the agency that the pharmacy-made injections were substandard. Now that FDA has reviewed its own samples--as well as samples provided by KV--the agency says it found that all of the APIs met standards for potency and total purity. When compared with Makena's NDA standards, a few of the samples fell short on some measures.

The FDA's statement said the FDA is applying its usual compounding-pharmacy enforcement standards, namely that it's done at a doctor's order and at a small scale. That's essentially the same approach the FDA announced last March after KV rolled out Makena at a price of $1,500, when compounded injections cost around $20 per dose. So it looks as if women can still have access to compounded versions, as long as their doctors choose that route.

But payers that put up hurdles to the still-pricey approved version--KV cut its price to $690 per dose after the initial outcry--might change their policies. It looks as if Medicaid will have to; the Center for Medicare and Medicaid Services issued its own statement, saying that state programs have to pay for FDA-approved drugs that qualify as covered under Medicaid's rebate program. Prior authorization has to follow Medicaid rules "without imposing unreasonable conditions."

"We believe the announcements from these two key agencies are a clear signal that compounding ... should not exceed the scope of traditional pharmacy compounding and that payers who have made access to Makena difficult should remove roadblocks."

- get the FDA release
- read the statement from KV
- check out the CMS statement