Academy of Managed Care Pharmacy Issues Statement on AHCA
Good morning, I am
AMCP supports the implementation of a robust biosimilars pathway to ensure that Americans continue to receive access to safe, effective, and affordable biologics and biosimilars. AMCP has been working extensively with the
AMCP generally supports the flexible, step-wise, and totality of the evidence approach to demonstrating interchangeability. AMCP also commends the
AMCP also urges the
AMCP is pleased that the draft interchangeability guidance included the possibility of using postmarketing surveillance and pharmacovigilance for purposes of making interchangeability determinations. AMCP has taken a proactive approach to pharmacovigilance; for example, the
The final guidance documents for naming and labeling have helped provide additional clarity on the requirements of the biosimilars pathway. Although AMCP is concerned about the final naming guidance's use of a randomized 4-letter suffix for all biologics and biosimilars, AMCP does support the use of a shared nonproprietary name for biosimilars, reference biologics and interchangeable biologic products--as well as a requirement to use the National Drug Code on all claims to identify product, lot number, and package size. AMCP believes that the use of the random four-letter suffix does not ensure easy product identification. Rather the suffix adds an additional unnecessary data element that a) may result in medication errors because of transcription errors in databases associated with the additional characters added by the suffix, and b) may lead to disincentives to use certain biosimilars of reference products because they appear unrelated to each other.
Last but not least, AMCP has made a significant commitment to educating health care providers, including pharmacists, physicians and nurses. In 2016, AMCP launched the
Thank you again for this opportunity. AMCP looks forward to continuing its work with
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