Makena Pregnancy Drug Fight Rages On - In February 2011, A furor erupted across the nation as KV Pharmaceuticals, a company that had gained the Food and Drug Administration's approval to sell a commonly prescribed pregnancy drug, was going to raise the price of that drug from $20 to $1,500 per dose.
Previously, hydroxyprogesterone capoate, a synthetic hormone referred to as 17P, could only be obtained from compounding pharmacists, which sometimes led to irregularities in the consistency of quality. Makena promised this consistency, as well as the ability to preserve the drug, which had not been possible before.
Every year 17P is administered to approximately 300,000 pregnant women in America on a weekly basis for an average of 20 weeks, as an effective means of preventing per-term births that could lead to serious complications. Makena's initial list price raised the cost of saving a single baby from $400 to $30,000.
Lawmakers, medical professionals, and the public responded angrily, calling KV's move unthinkable. KV pharmaceuticals proceeded to send threatening letters to pharmacists across the nation, demanding that they stop making 17P, promising an FDA crackdown on those who continued to do so.
On March 30, the FDA responded with a statement which said that no such crackdown was coming and that pharmacists were allowed to continue compounding the drug. Effectively, generic forms of the drug were still legal and would remain available.
On April 1, KV responded by slashing its list price from $1,500 to $690 per dose, a price which many claimed was still too high. Charity giant, March of Dimes, reacted by cutting all ties with Makena, and KV Pharmaceuticals.
The makers of Makena are quick to point out that they have a patient assistance program, through which patients may obtain the drug for as little as $20 per dose, or in some extreme cases, completely free of charge. Unfortunately, the assistance program involves a complicated sliding scale that will still drive up the cost of medical coverage. For those on Medicaid the news is even worse. KV only offers a 23.1 percent rebate to Medicaid, which means the government will still have to pay $530.61 for a drug that is has never paid for in the past. ( yahoo.com )
Previously, hydroxyprogesterone capoate, a synthetic hormone referred to as 17P, could only be obtained from compounding pharmacists, which sometimes led to irregularities in the consistency of quality. Makena promised this consistency, as well as the ability to preserve the drug, which had not been possible before.
Every year 17P is administered to approximately 300,000 pregnant women in America on a weekly basis for an average of 20 weeks, as an effective means of preventing per-term births that could lead to serious complications. Makena's initial list price raised the cost of saving a single baby from $400 to $30,000.
Lawmakers, medical professionals, and the public responded angrily, calling KV's move unthinkable. KV pharmaceuticals proceeded to send threatening letters to pharmacists across the nation, demanding that they stop making 17P, promising an FDA crackdown on those who continued to do so.
On March 30, the FDA responded with a statement which said that no such crackdown was coming and that pharmacists were allowed to continue compounding the drug. Effectively, generic forms of the drug were still legal and would remain available.
On April 1, KV responded by slashing its list price from $1,500 to $690 per dose, a price which many claimed was still too high. Charity giant, March of Dimes, reacted by cutting all ties with Makena, and KV Pharmaceuticals.
The makers of Makena are quick to point out that they have a patient assistance program, through which patients may obtain the drug for as little as $20 per dose, or in some extreme cases, completely free of charge. Unfortunately, the assistance program involves a complicated sliding scale that will still drive up the cost of medical coverage. For those on Medicaid the news is even worse. KV only offers a 23.1 percent rebate to Medicaid, which means the government will still have to pay $530.61 for a drug that is has never paid for in the past. ( yahoo.com )
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