Remember last month, when the FDA approved Makena -- a drug to reduce the risk of preterm births? That was...
Remember last month, when the FDA approved Makena -- a drug to reduce the risk of preterm births? That was great news and a move that was applauded my many doctors and organizations, including the March of Dimes. While many are still very positive about it, some bad news has followed. The cost of Makena is as much as 15,000% Yes, you read that correctly - fifteen thousand percent. What is now called Makena, a form of progesterone that was previously mixed in compounding pharmacies, was never specifically approved to prevent or reduce the risk of preterm births. However, as I shared here last month, the FDA granted approval to KV Pharmaceuticals to exclusively sell Makena. That means that pharmacies will no longer be allowed to compound their own version of it. In fact, according to Yahoo news, "[l]ast month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug." Currently, women who use the compounded version of Makena pay $10 to $20 per injection. They take the injection once per week for as many as 20 weeks. KV Pharmaceuticals will raise the price to $1,500 per injection. Again, you read that correctly -- from $10 to 20 per injection to $1,500 per injection. Furthermore, Makena has been granted orphan drug status by the FDA, which means that only KV Pharmaceuticals will be able to make and sell it for the next seven years. While many obstetricians who were previously pleased with the news of Makena receiving FDA approval changed their tune when they learned of the price, the company insists that the cost is well worth the results.
The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone. "Makena can help offset some of those costs," Divis told The Associated Press. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena." (Source: Yahoo news)
Additionally, Ther-RX Corporation, a subsidiary of KV Pharmaceuticals and the company that will market Makena, says that it will offer a patient assistance program so that uninsured and low-income expectant moms who need Makena will still be able to receive it. However, others insist that the intense price increase will cause problems.
But Snow and others said someone is going to have to pay the higher price. Some of the burden will fall on health insurance companies, which will have to raise premiums or other costs to their other customers. And some will fall on cash-strapped state Medicaid programs, which may be forced to stop paying for the drug or enroll fewer people. (Source: Yahoo New)
For example, the insurance giant Aetna currently covers the cost of the generic form of Makena for about 1,000 women per year. An Aetna representative said the company will continue to do so, but their annual cost of covering Makena for those 1,000 women will increase to $30 million each year. So, what do you think? Is the FDA approval of Makena a good thing? Likely, it means more women will have access to a drug that helps reduce the risk of preterm labor. At the same time, the dramatic cost increase might make it difficult or impossible for some women who would have otherwise had access to receive it. Share your thoughts in the comments section. More on preterm birth

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