NCPDP Action Group Focused on Biologics and Biosimilars

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By Brian Bamberger, Practice Lead, Life Sciences

Biologics and biosimilars are starting to burst into the American market. Biosimilars are expected to quickly become mainstream in the near future because of their significant cost-savings and patient care implications. Recognizing their potential and patient safety implications, how can the unique challenges of biologics and biosimilars be addressed when folding them into the electronic health record landscape?

This was the focus of a July 21 Stakeholder Action Group (SAG) meeting of leaders of key industry stakeholders at the National Council for Prescription Drug Programs (NCPDP). Attendees included pharmacies, electronic health record (EHR) vendors, electronic prescribing infrastructure providers, pharmaceutical manufacturers, health care providers and other industry groups.

Unique challenges of biologics and biosimilars. Compared to traditional medications, biologics and biosimilars have unique properties—in terms of their manufacturing and the legal requirements related to their use. In addition, biologics and biosimilars are typically specialty medications, which as a whole still rely on antiquated phone-fax-paper methods for gaining payer approvals and engaging patients with specialty pharmacies.Those are among the reasons why changes will be needed when folding biologics and biosimilars information into the electronic health information ecosystem. The SAG discussed a number of these challenges, including:

  • Manufacturing variability. The composition of biologics and biosimilars vary among manufacturers and the lots they produce. This is important information that when captured in the electronic health record (EHR) may improve the reporting detail in adverse drug event (AE) reports.
  • Pharmacy substitution rules. States are leading the way in proposing and enacting substitution legislation for biosimilars. Most include a notification to the prescriber if an interchangeable biosimilar is available (even if there is no substitution). Not surprisingly, these requirements differ by state. How should these varying requirements be addressed in prescriber EHR systems to satisfy the needs of prescribers, pharmacies and states? The accuracy of the reported NDC numbers by pharmacies was also examined with an open question about NDC information in the EHR to identify drugs that were both prescribed and dispensed.
  • Adverse event reporting. Today, the Food and Drug Administration receives AE reports directly from healthcare professionals, consumers and manufacturers. Biologics and biosimilars are expected to generate a higher number of AE reports due to the complex conditions they treat. The reporting is typically based on the information a physician has available, which may be incomplete. For example, the EHR may contain information on which drug was prescribed, rather than the drug that actually was dispensed. As a result, the patient’s medication history may not be complete. This in turn causes the adverse event to be reported on the drug that was prescribed to the patent, rather than what was actually administered or dispensed.

Opportunities. The SAG discussed opportunities for reporting of biologics and biosimilar on current infrastructure and transactions. Two possibilities were identified for reporting administered or dispensed medications to patients. The first is RxFill, which is a Meaningful Use 3 requirement for EHR systems but isn’t used much today. The RxFill message tells the prescriber that the patient has picked up the medication from the pharmacy for each fill. The second is RxHistory, which also is available to the prescriber at the point of prescribing.  While very useful, the information may not be complete.

The SAG recommended that NCPDP convene a Task Group to develop use cases for biologics and biosimilars for both transactions. It also recommended the development of pilots to test the use of the transactions for biologics and biosimilars when an interchangeable biosimilar is available. A pilot can also be used to address the accuracy of NDC numbers in these messages.

Next steps.  The creation of the Task Group was just approved by NCPDP at the August Workgroup meetings.  Stay tuned for results of the Task Group’s deliberations and the development of pilots.

Brian Bamberger

Brian Bamberger

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