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发帖数: 123 | 1 Ther-Rx Corporation Takes Action to Further Ensure High-Risk Women Are Able
to Access FDA-Approved Makena™
Announces Reduction in Price and Expansion of Patient Assistance Program for
Makena™
PR Newswire
ST. LOUIS, April 1, 2011
ST. LOUIS, April 1, 2011 /PRNewswire/ -- As part of its ongoing efforts to
ensure that high-risk women have access to FDA-approved Makena instead of
unapproved, unregulated compounded drugs, Ther-Rx Corporation, a subsidiary
of K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), announced
today important initiatives to reduce the cost of Makena™ (
hydroxyprogesterone caproate injection) and encourage stakeholders to
provide timely access to this important FDA-approved medication. Effective
immediately, Ther-Rx has:
Reduced the list price of Makena by nearly 55 percent, to $690 per injection
;
Will offer supplemental rebates that, in conjunction with the list price
reduction and the standard Medicaid rebate of 23.1 percent, will result in a
substantially reduced cost per injection for state Medicaid agencies
compared to list price. This will help ensure that every woman who is
prescribed Makena – regardless of her ability to pay – has the comfort of
knowing a medication that has been rigorously reviewed by FDA for safety and
efficacy is available to her;
Capped the costs for a full course of therapy to a maximum of three vials (
15 injections) for contracted health insurance plans and state Medicaid
agencies; and
Expanded the Company's patient assistance program for patients who are
prescribed this important medication by removing income caps to qualify for
financial assistance. 85 percent of patients will pay $20 or less per
injection for FDA-approved Makena, and patients whose financial need is
greatest would receive FDA-approved Makena at no out-of-pocket cost.
Under the new pricing structure, the Company believes that the use of Makena
by eligible patients will deliver net cost savings to Medicaid programs and
private insurance plans in year one, based on third-party economic modeling
of costs associated with the condition.
"Ensuring access to an FDA-approved sterile, injectable medication,
manufactured under mandatory strict quality controls, is in the best
interests of all high-risk women," said Greg Divis, Chief Executive Officer,
K-V Pharmaceutical Company and President, Ther-Rx Corporation. "We
understand the concerns that key stakeholders raised under our original
pricing structure. We also recognize the current budget challenges facing
state Medicaid programs and other payers. In conjunction with our
substantial reduction in price, it is our sincere hope that all committed
stakeholders will take appropriate action to provide timely access to this
important FDA-approved medication."
The FDA granted Makena orphan drug status and approved the drug on February
3, 2011. | D******9
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