What are the costs and burden associated with implementing the proposed, nonproprietary naming convention for biologics and biosimilars from the Food and Drug Administration (FDA)? It depends. All stakeholders will have to make some modifications to comply. However, the extent of the new naming convention is stakeholder specific and will also depend on the total number of drugs that will be involved. Those are among the findings of an in-depth study on the topic by Point-of-Care Partners (POCP), which undertook the project to better understand the range of stakeholders’ concerns and potential impacts.
How the naming convention would work. Requirements for the changeover were spelled out in the FDA’s January 2017 guidance. Going forward, all biologics and biosimilars will have a unique, non-proprietary name that is a combination of the drug’s core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters (e.g., infliximab-dyyb). These requirements apply to both newly licensed biologics and biosimilars, and will also be applied retrospectively to biologics already on the market.
According to the FDA, the new naming convention seeks to: 1) help prevent inadvertent substitution (which could lead to medication errors) of biological products that are not determined to be interchangeable by the FDA; and 2) support safety monitoring of all biological products after they are on the market by making it easier to accurately track their usage in all care settings (including outpatient, hospital and pharmacies) as well as trace adverse events back to the manufacturer and batch.
A work in progress. As expected, there are still many details to be worked out. For example, there is no final guidance on the format of the naming and suffix for interchangeable biosimilars as the FDA is still trying to determine if it’s best for the suffix of an interchangeable product to be “related” to its originator product or unique for pharmacovigilance purposes. In addition, retrospective name change of existing products is not ready for implementation because approval would be needed from the Office of Management and Budget, which routinely reviews the burden impacts of significant proposed regulatory guidance as required under the Paperwork Reduction Act. If and when it is implemented, it will be done with significant lead time. Also, as currently written, it will allow the manufacturer or holder of a Biologics License Application (BLA) to propose a suffix rather than having one randomly assigned.
In the future, the FDA wants to make sure name changes are communicated clearly to health information technology (health IT) vendors. Structured product label files will now include additional indicators (for example, a field for the biological drug substance name with suffix and beginning and ending dates of name) to help vendors link the old names and files together. This could help mitigate implementation concerns of drug data compendia vendors.
POCP’s study. To better understand the impact of the FDA’s new naming convention, POCP conducted in-depth interviews with key staff from drug data compendia, vendors and users of electronic health records (EHRs) and computerized physician order entry (CPOE) systems, pharmacists and a pharmacy system vendor. Findings show implementation of the guidance will, indeed, impact the industry, especially as it relates to existing biologics on the market, and, in most cases, stakeholders will be required to make some coding changes, system retrofits and other adaptations to accommodate the change. However, the extent of the impact is stakeholder specific and will also depend on the total number of drugs impacted by the guidance.
Study findings. Here are seven key findings reflecting specific stakeholders’ concerns and impacts.
Implementation concerns. While all stakeholders appreciate the FDA’s efforts, many are concerned about the costs, burden and unintended consequences of implementation. For example, the National Council for Prescription Drug Programs believes the “FDA’s new naming convention arises from an incomplete awareness of the comprehensive electronic programming, which underlies how drugs are prescribed and dispensed.” This infrastructure — largely due to federal efforts over nearly a decade to promote health IT — is now pervasive. As a result, the changeover in systems by the new naming convention could be costly and burdensome to implement. Some also fear unintended consequences. One of the most significant examples is potential payment delays created while all public and private payers retrofit their systems and formularies to accommodate the renaming of every biological drug, including those that have been marketed for years under a different nonproprietary name.
Changes occur in today’s market and are handled successfully. POCP’s research shows that implementation of the guidance might not be as burdensome or costly as some stakeholders had suggested. One reason is that the industry is used to making numerous changes in their systems related to the drugs used today. For example, changes often occur to National Drug Code (NDC) numbers, product descriptions and therapeutic classifications, not to mention product name changes. In our discussions with EHR vendors and pharmacists, all stated that they successfully manage these types of changes today with minimal impact on day-to-day operations. There are established methods for addressing these market changes. Therefore, changes to address the new naming convention for biologics and biosimilars are nothing new in that respect. However, many of the concerns voiced by industry relate to the total number of products that might be impacted by the new requirements. DailyMed lists roughly 15,000 NDCs. The sheer volume of potential changes is a significant concern.
Unclear scope. At this point, it is unclear whether the FDA’s guidance applies to every United States (US) product with an approved BLA or only to those on the Center for Drug Evaluation and Research (CDER) list of licensed biological products. To be sure, the answer to this will directly impact costs and burden. If the final rule applies solely to the those on the CDER list, it would affect name changes for only 131 products representing approximately 900 NDCs, as opposed to thousands that were referenced in many of the comments and concerns voiced to the FDA during the comment period on the guidance. The total number of NDCs affected could be much less if a name change applies only to products that have proposed multiple sources.
Impacts on drug compendia. The new guidance will have the greatest impact on drug compendia as they will have the most work to retrofit systems. These companies believe the new naming requirement is unnecessary because their current algorithms and processes already accomplish what the FDA hopes to achieve, namely preventing inadvertent substitution, tracking biologics through the entire system and tracing adverse events back to the manufacturer. Compendia currently follow a specific process for creating the files and databases used by EHRs, hospital information systems and pharmacy system vendors. As part of it, compendia vendors group similar products using specific identifiers, including International Nonproprietary Name (INN), strength and dosage form. This process of grouping drugs will likely be impacted by the guidance. For example, compendia will need to recreate links between old and new generic names for all products, update the data they provide to clients and potentially introduce different files and processes for biologics. This could impact their clients as there are many variations in how their files are currently implemented at various vendors and institutions. For the compendia themselves, current research estimates that the coding changes necessary to accommodate the addition of an FDA-approved suffix could take up to 50 hours per product. However, if compendia can handle these products in a similar manner as they do today, there will be less of an impact on both their own operations and to their client base.
The drug database companies believe there is no reason to change this current process and the introduction of this new naming convention will simply cause unneeded confusion among prescribers. Some went so far as to argue that using suffixes will lead to higher prescribing of source medications, thus defeating the cost-saving purpose of introducing biosimilars. Furthermore, compendia executives with whom we’ve spoken argue that the proposed naming convention will not help improve the ability to track and trace an adverse event, which they believe is better handled through existing processes. These include capturing and storing the accurate dispensed medication data in all of the systems involved with the medication prescribing and dispensing process. At the end of the day, the costs and impacts to compendia will be based on the total volume of NDCs impacted, including any potential changes needed to regroup and/or implement indicators of the biosimilar and biologic reference product relationships.
Impacts on EHRs. According to the ambulatory and acute EHR vendors and their users with whom we’ve spoken, name changes for biologics and biosimilars would have minimal to no impact on their systems and operations. Today, most EHR vendors will take the file(s) that compendia provide, run a quality check and prepare it for loading into their system. Updates to the drug file appear in the EHR anywhere between 2 weeks and 6 months, depending on the configuration of the EHR and the timing of when a practice updates its database. Because NDC and name changes happen today, most believe there would be limited impact in terms of cost and resources to handle these changes. That said, EHR vendors should pay attention to the FDA’s guidance and any communications from the drug compendia related to this topic. Due to the large number of NDCs that may be impacted by the FDA’s guidance, for example, it would be prudent for EHR vendors to take time to review the files in more detail. Also, depending on how the drug compendia choose to handle the changes, additional programming may be needed for an EHR vendor to link old and new NDCs, and the biologics may end up being provided in a separate file for the EHR vendor to download. If this route is taken by compendia vendors, the impact to EHRs would be greater than they are anticipating today.
Another area identified that may impact EHRs is the messaging to the provider when an electronic refill message is sent from the pharmacy to the provider. If a name change occurs and the linkage between the old and new name has not been made in the drug file, it may appear to the provider that the drug is no longer available for prescribing when, in fact, it is simply a name change for the drug. At the end of the day, EHR vendors should focus on taking extra time to thoroughly review changes to compendia files and review the links to ensure proper messages are being provided to the prescriber regarding the name change. This is highly recommended as a best practice, which is better implemented sooner rather than later.
Impacts on pharmacy (retail, mail, specialty, long-term care). The pharmacy stakeholders with whom we’ve spoken don’t anticipate that a name change alone for biologics and biosimilars will have substantial impact on pharmacy operations. Like EHR vendors, pharmacy system vendors use the compendia files, which link products into appropriate groups and thus can be used to identify similar products and provide a guide for substitution. Additional time and resources will likely be needed to quality check the files due to the potentially large number of changes.
The greater impact to the pharmacy staff and systems is related to the back-end processes, as opposed to the front-end dispensing of the drug. The FDA guidance addresses name change only and does not indicate if an NDC change must occur along with the name change. If an NDC change occurs along with a name change, billing and inventory management may be impacted during the transition period from old to new NDC. It is likely that there will be a transition period in which a pharmacy would have inventory with both the old and new NDC numbers. Any billing of product during that time would have to be carefully reviewed to ensure that the pharmacy is billing for the NDC number that was dispensed. There would be no programming changes required related to this issue because these are primarily process and operations changes to ensure that the name and/or NDC changes are clearly communicated to staff to ensure the correct billing of existing inventory during the transition period.
Impacts on hospitals, clinics, infusion centers and related facilities. For the most part, a name change alone will have limited impact on existing ambulatory and hospital electronic prescribing systems for the same reasons we have stated above: changes to product names and NDCs occur today and are handled by all stakeholders. However, discussions with users of CPOE systems in hospitals revealed that their main concern was related to how ancillary systems would need to be integrated with their EHR or CPOE system, such as lab and radiology software integrations. In reality, the vendors and facilities have no control over what changes may be needed in the application program interfaces (APIs) that are used by add-on products to the primary EHR or CPOE systems. Facilities could experience a bigger impact if a name or NDC change requires significant alterations to interfaces or if updates are needed to APIs.
Bringing it all together. Through our research and interviews with stakeholder groups, we’ve determined that the guidance provided by the FDA concerning biologic and biosimilar naming will have an impact on all stakeholders in the industry. However, the extent of that impact depends on the volume of products involved as well as the extent of the change (i.e., name only or name and NDC number). The consensus among industry stakeholders with which we’ve spoken was that the guidance will likely pertain to the smaller list of drugs — those on the CDER list versus all US products with an approved BLA. POCP has been keeping on top of this issue. Let us know if you would like more information. We’d be happy to do a deeper dive for you on the market impacts of the FDA’s new guidance and our research. Contact me at firstname.lastname@example.org.
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