Biosimilar Recommendation Means Challenges and Opportunities Ahead for HealthIT


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. 


ePrescribing Requires Continued Industry Focus; More AzHeC-Like Initiatives Needed


By Tony Schueth, CEO & Managing Partner

ePrescribing has become an integral component of healthcare delivery and the preferred method of prescribing non-controlled medications.  Last year,  58% of eligible non-controlled prescription were transmitted electronically through the Surescripts network. In addition, 73% of office-based physicians ePrescribed, a 4% increase over 2012.[1] The 4% increase is less than I would have expected in year 3 of Meaningful Use (MU), 11 years after the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) and 6 years after the passage of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), landmark pieces of legislation that paved the way for ePrescribing.   

Electronic prescribing of controlled substances (EPCS), however, is just starting to take root after the DEA’s Interim Final Rule allowed it on June 1, 2010.  In 2013, 13% of our total 3.85 billion retail prescriptions were for controlled drugs and 330,000 NewRx EPCS messages were sent across the Surescripts network.  This means that approximately .07% of controlled prescriptions were electronically prescribed via Surescripts last year.  At NCPDP’s August Workgroup meeting, Surescripts reported that through July 31, 570,000 EPCS prescriptions (or .11%) were transmitted via their network.

What can we do as an industry to meaningfully advance EPCS?  Consider that a significant percentage of EPCS prescriptions last year were filled in Arizona, where a focused multi-stakeholder initiative to advance EPCS was orchestrated through the  Arizona Health-e Connection (AzHeC).  As reported in  a previous POCP blog, this initiative removed EPCS barriers and provided a model for achieving EPCS growth.   

From May to December 2013, Arizona saw a greater than 10-fold increase in the number of ePrescribing Controlled Substances (EPCS) prescribers, and an increase from less than 200 to nearly 16,000 EPCS transactions transmitted per month via five different EHR and ePrescribing systems.  This effort worked because of a coordinated state-wide effort, eliminating the “which comes first, the chicken or the egg?” problem; meaning, in some areas pharmacies were ready but physicians not, or vice versa.  Point-of-Care Partners supported the state’s Regional Extension Center (REC) in this effort.  

The 2013 Results: Arizona EPCS By The Numbers

AzHEC_GraphTranslating the Value

The DEA believes that EPCS could save up to $700 million annually. Between 3% and 9% of drugs that are diverted for abuse are tied to fraud and forgery of paper prescriptions.[2] EPCS holds great promise for reducing drug-related deaths and improving medication management through EHRs and pharmacy systems, if these systems are enabled and their users are prepared for EPCS. This is no small task, considering that the requirements for each contributor to the EPCS equation are unique and laws vary by state.

As conveyed in our AzHeC case study, “Each state — and situation — is different, and a multitude of  key variables must be taken into account in putting together a successful plan. While Arizona achieved noteworthy success with its program, the fact is, what worked in Arizona worked in Arizona, and may not be optimal for other geographies.”

 “Danger, Danger” Healthcare Industry

So, as an industry we’ve accomplished a heck of a lot when it comes to ePrescribing.  Is it enough?  The answer is absolutely not, especially when it comes to EPCS.  For MU, EPCS is just part of the ePrescribing equation, and physicians can achieve their measures if they don’t prescribe controlled substances electronically.

For EPCS, regulations aren’t going to get us where we need to go.    ePrescribing still requires geographically-focused efforts, particularly for EPCS, to reach its potential and justify EHR and other investments.  We need more AzHeC-like initiatives.

As an industry, we don’t want it to take 10 years for EPCS to reach the tipping point, and we do not want ePrescribing to lose momentum.   With  focused efforts and the continued support of industry leaders, we can spur EPCS adoption and begin to reap its many benefits in much less time.

[1] and [2] Surescripts 2013 National Progress Report and Safe-Rx Rankings


Does formulary decision support improve patient compliance?


By Michael Burger, Senior Consultant

Policymakers, payers and providers view health information technology (health IT) as a tool to help improve patients’ medication compliance, among its many benefits. This is important because patient non-compliance with their drugs costs billions of dollars annually in unnecessary care, adverse outcomes and deaths. 

Research that investigates the relationships between health IT, costs and patient outcomes slowly is emerging. Findings are mixed. For example, a new study published at Biomed Central, explored, in part, whether a formulary decision support (FDS) function in an ePrescribing system might improve patient compliance and reduce costs. 

Using claims data from 2004 and 2005, the researchers examined the impact of ”non-interruptive” vs. “interruptive” FDS on patient compliance for angiontensin receptor blockers and inhaled steroids. In the end, it apparently didn’t matter which FDS method was used because there was no real impact on patients’ compliance or out-of-pocket costs.  It appears to us that this finding was less a result of the FDS method, but more to do with the study medications, which had only marginal price differences between them.The researchers noted that in order to impact cost-related non-adherence, formulary decision support will likely need to be paired with complementary drug benefit design.

The study did show an impact of FDS on brand selection at the point of prescribing, since generic alternatives were not available for the study medications. In the study, depending on the ePrescribing system that was used, non-interruptive FDS displayed a symbol indicating that an alternative was available. The interruptive FDS was more directive, automatically displaying a message suggesting that prescribers consider specific alternatives.  Study results indicated that prescribing decisions were more directly influenced by the interruptive FDS. This suggests that FDS might be a tool to help physicians choose among brands; however, more work needs to be done to better understand the effectiveness of formulary representation and messaging on prescribing decisions.

To our mind, the study also illuminates the challenges that such research designs and findings pose for policymakers and vendors owing to the age of the data that were used and the technological advances that have taken place since then. The researchers used 2004 Horizon Blue Cross/Blue Shield data from prescribers using a standalone ePrescribing application (iScribe), and 2005 claims data from Caremark. The vast majority of ePrescribing is done within EHRs today.  Formulary decision support and formulary status in ePrescribing systems—standalone and EHR — have come a long way in the intervening years. While studies based on happenings of a decade ago are instructive in today’s world, they clearly lack the value of studies grounded in current data and technology.  We hope the researchers get a chance to try this study again, using more current information from claims and from EHRs themselves.