K-V Pharma (KV-A) Reports ACOG, SMFM Say Makena and 17P Compound 'Not Identical'
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K-V Pharmaceutical Company (NYSE: KV-A)(NYSE: KV-B) appreciates the decision of the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) to issue an information update and ensure that healthcare providers, patients, and the payer community have the facts regarding FDA-approved Makena™. The information update from ACOG and SMFM confirms that FDA-approved Makena and unapproved compounded 17P formulations are not identical. The update also emphasizes the importance of honoring the clinical decisions of healthcare professionals, and makes clear that previous ACOG and SMFM statements should not be used by payers to deny coverage for Makena.
The ACOG and SMFM update acknowledges that evidence from the NICHD MFMU Network study (Meis, et al.) supporting the use of hydroxyprogesterone caproate (17P) was based on drug manufactured under FDA's Good Manufacturing Practices (GMP) conditions, and not on drug made using compounding processes or obtained from compounding pharmacies. The drug used in the NICHD study is available today as FDA-approved Makena.
Access to FDA-approved Makena for clinically-indicated patients is an important public health priority. Certain payer coverage policies have been influenced by an incorrect belief that unapproved compounded 17P formulations are the same as Makena. These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare professional's medical judgment.
As part of our commitment to patients, we have made substantial efforts to help ensure affordable access to therapy, and patient co-pays for Makena are averaging approximately $12 per injection.
The ACOG and SMFM update acknowledges that evidence from the NICHD MFMU Network study (Meis, et al.) supporting the use of hydroxyprogesterone caproate (17P) was based on drug manufactured under FDA's Good Manufacturing Practices (GMP) conditions, and not on drug made using compounding processes or obtained from compounding pharmacies. The drug used in the NICHD study is available today as FDA-approved Makena.
Access to FDA-approved Makena for clinically-indicated patients is an important public health priority. Certain payer coverage policies have been influenced by an incorrect belief that unapproved compounded 17P formulations are the same as Makena. These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare professional's medical judgment.
As part of our commitment to patients, we have made substantial efforts to help ensure affordable access to therapy, and patient co-pays for Makena are averaging approximately $12 per injection.
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