By Tony Schueth, CEO & Managing Partner
Biosimilars now are set to hit the US market with the recent recommendation that the government approve Novartis’s Zarxio cancer drug as a biosimilar alternative to Amgen’s Neupogen. This sets the stage for profound changes in US healthcare, with opportunities and challenges in the world of health information technology (healthIT).
Unlike generic medicines where the active ingredients are identical, biosimilars are similar to but not identical copies of the originator biologic. Biologics made by different manufacturers differ from the original product and from each other.
Biosimilars had no pathway for approval by the Food and Drug Administration (FDA) until 2010, when the Biologics Price Competition and Innovation Act of 2009 was enacted as part of the Patient Protection and Affordable Care Act. The FDA has been under fire because no approvals have been forthcoming. Now the door has been opened and we can expect to see biosimilars coming onstream in a big way in the near future. (For a more detailed primer on biosimilars, see our article in the December 2014 issue of HIT Perspectives.)
The introduction of biosimilars will create numerous challenges and opportunities for healthIT. We will be discussing them in future issues of HIT Perspectives.But just to whet your appetite, consider the following examples:
- Adding NDC and lot number to the drug ecosystem. The Drug Quality and Security Act (DQSA) of 2013—aka the track and trace legislation–calls for adding NDC codes and lot numbers to the drug ordering, prescribing and dispensing processes. The idea is to have this information available to the prescriber to make it easier to identify and trace a particular batch of medications back through the chain in cases of possible adverse drug events (ADEs)—a major issue when it comes to biosimilars. That is easier said than done.For example, the NDC number in NCPDP transactions may be populated with a ‘representative’—not an actual—number.The field for lot number is not universally populated throughout the drug supply chain ecosystem. It is optional for NCPDP’s RxFill, which currently is rarely used but could help facilitate the tracking of ADEs with some modifications.
- Standards. The introduction of biosimilars adds new uses of standards and creates new roles for others. For example, a variety of standards already exist for the capture and transport of prescription drug information, including the National Council for Prescription Drug Programs (NCPDP) SCRIPT and the Health Level Seven (HL7) Clinical Document Architecture (CDA). GS1—like CDA—is a broader format that represents information from other sources generally for inclusion in a bar code. GS-1 also can standardize and combine NDC and lot number into a single representation. There also are standards for drug and ingredient identification, which currently are used by different stakeholders in different ways for different use cases. Which standards will be selected for specific use cases? How will that be decided? By whom?
- Changes to electronic health records (EHRs). EHRs are now central to the patient care and prescribing process. However, as currently configured and used, enhancements are needed to enable EHRs to capture and retain NDC and Lot number, as well as to document ADEs and report that information electronically to the FDA and others. EHR vendors will need to adapt to evolving standards related to the adoption and tracking of biosimilars as use cases are developed. To add to the complexity, use cases must be in sync with future regulatory guidance by the FDA, which has not been an active player in the EHR and healthIT spaces to date.
Needless to say, the healthIT competitive and regulatory landscapes for biosimilars are complex and rapidly evolving.Point-of-Care Partners (POCP) is tracking developments in biosimilars because of our expertise in electronic medication management, EHRs and electronic prescribing, as well as our expertise in identifying and addressing emerging issues in those areas. POCP’s expertise can help stakeholders such as pharmacies, PBMs, pharmaceutical manufacturers and EHR vendors understand how the entrance of biosimilars will impact their business and healthIT. Let us put our knowledge to work for you.