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:
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.