Drug Compendia

Listing a BLA-Approved Product Competing with Devices in Drug Compendia

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer was launching a new product approved through a BLA that would compete with similar products that are approved as devices. The manufacturer sought to better understand how these competitor products were categorized and optimize how their BLA-approved product would be listed in the pricing and clinical compendia.
PHSL SolutionPHSL examined competitor devices in four different drug compendia. Analysis focused on areas that may differentiate a BLA-approved product from a device. PHSL drafted compendia submission forms to ensure proper and complete documentation related to product naming, description, and pricing was communicated with each drug compendia.
ResultsPHSL recommended communications to drug compendia that ensured the manufacturer’s product was appropriately listed and well-positioned in relation to its device competitors.

Post-Merger Product Review in Drug Compendia

IndustryDrug Compendia
ProblemTwo pharmaceutical manufacturers who recently merged sought a review of their products in the drug compendia following their merger to ensure no inconsistencies existed in the compendia.
PHSL SolutionUsing their expertise in the compendia, PHSI performed an independent review and examined four different drug compendia for any inconsistencies with the client’s products regarding packaging, pricing, and the active status of the products.
ResultsBy reviewing the compendia, PHSI was able to provide insight into selected products with discrepancies and recommended communications and corrections to the various drug compendia. For the remaining products, the client was assured that there were no identifiable differences between the drug product label and the compendia listing. This enabled the client to prevent any issues with prescribing, product selection, and reimbursement for their drug products.

Assistance Listing Devices in the Drug Compendia

IndustryDrug Compendia
ProblemA device manufacturer was launching an updated and enhanced version of their diabetes device. The new product was scheduled to have a different name, but the device manufacturer wanted to ensure that the different versions were distinguishable to prescribers in their e-prescribing systems. The device manufacturer was also seeking information on how their product would appear when compared to competitors.
PHSL SolutionPHSI reviewed the 510(k) approval letter, device user guide, and analogue device listings within the major drug compendia providers. Using the information gathered, PHSI hypothesized which products would share the same category with the newly-launched device. PHSI then drafted compendia submission forms for the device manufacturer and guided them through the compendia submission process.
ResultsThe device manufacturer’s product was successfully listed in all of the drug compendia. It was listed with unique naming that differentiated it from previous versions of the device, aiding in accurate prescribing and dispensing.

Monitoring Drug Compendia Listings of Competition

IndustryDrug Compendia
ProblemA generic pharmaceutical manufacturer required additional insights on products in their pipeline. The focus was their competitor listings in the drug compendia to understand market changes so they could continually update financial projections and determine profitable product launches.
PHSL SolutionPHSI created alerts in the drug compendia for the select products to provide monitoring of new launches, labeler changes, and NDC inactivations. Alerts are reviewed daily and an assessment of the impact of the changes is sent to the manufacturer.
ResultsThe pharmaceutical manufacturer used these to refine their product launch decisions and determine viable drug products to commercialize.

Manufacturer Sought Insight on Inner-Pack NDC Compendia Listing

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer faced lost sales with both prescribers and pharmacies based upon their inner-pack and outer-pack national drug code (NDC) product listing in drug compendia. The client desired to identify and align classifications of their product listing in the drug compendia to resolve issues on various EHR and pharmacy dispensing software systems impacting the prescribing, distribution, and dispensing process.
PHSL SolutionPHSI analyzed the drug compendia NDC package file definitions for inner-pack and outer-pack NDCs. PHSI prepared actionable next steps for the manufacturer at both the wholesaler and pharmacy level to clarify the client’s product listing. PHSI prepared a concise summary clarifying the use of outer-pack NDCs for ordering and dispensing as well as the purpose for the inner-pack NDC for patient safety. PHSI provided actionable recommendations for drug compendia modifications and clarification steps to communicate with suppliers, EHR system companies, and community pharmacies to ensure proper prescribing and dispensing of their product.
ResultsPHSI insight addressed the problems the client faced and removed potential barriers to improve efficiency in product prescribing and distribution process. The client understood NDC package drug characteristics and impact on different channel stakeholders from the product’s listing in drug compendia. The manufacturer implemented PHSI’s recommendations at the pharmacy level, and the dispensing issues previously seen at pharmacies were greatly reduced.

Drug Compendia Product Submission

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer with a new product lacked experience working with drug compendia and desired to have their drug listed properly before launch. The client had drug compendia challenges with previous launches and wanted to minimize issues with their new product.
PHSL SolutionPHSI prepared and led an onsite training program for the brand team and management from several operational areas including finance, regulatory, and sales. The training provided foundational knowledge about the role and importance of drug compendia, as they are used by prescribers with EMR systems, pharmacies for product selection, and payers for claims adjudication. PHSI assisted the client with drug compendia form completion and submission to Medi-Span, First Databank, Gold Standard, Cerner Multum, and Red Book. Finally, PHSI monitored these compendia publications to ensure there were no inconsistencies with how the new product was listed in the various compendia.
ResultsClient was better prepared to launch their new product and lowered their risk of drug compendia issues impacting prescribing and distribution. They integrated the compendia activities into their product launch plans and factored in the time for the new drug information to reach pharmacies, payers, and especially EHR systems. This ensured the product was available to e-prescribe almost immediately post product launch. The compendia process has become a best practice and will be included in launch planning for all new future products.

Understanding EHR Systems and Drug Compendia Databases

IndustryDrug Compendia
ProblemA pharmaceutical manufacturer contacted PHSI to gain a better understanding of electronic health records (EHRs), the compendia that EHR vendors use for drug product information, and typical ePrescribing habits. The manufacturer wanted to make sure that ePrescribing physicians and dispensing pharmacists could clearly identify their drug products to ensure safe and accurate prescriptions for patients.
PHSL SolutionPHSI partnered with Think Patients LLC to develop a unique training program for the client’s internal use. This partnership allowed the client to obtain insightful information regarding the most utilized EHRs and the impact of drug compendia in EHRs, pharmacy dispensing systems, and ePrescribing modules. The program focused on how products are listed in various databases and common physician practices such as computerized physician order entries.
ResultsBy utilizing the training program, which included visual mock-ups of electronic health records, the client was better able to build relationships with prescribers and address potential barriers for prescribing their product. By identifying key drug characteristics to address during product launch such as indication, dosage form, or packaging, the client was able to understand potential areas of differentiation in the different drug compendia and learned how physicians make decisions during the prescribing process. The knowledge gained on the role of naming structure and product identification will allow the client to effectively launch new products and optimize their use among prescribers.

Post-Launch Drug Compendia Review

IndustryDrug Compendia
ProblemA brand pharmaceutical manufacturer with a newly launched product wanted to examine how the product was listed in the four major drug compendia, Medi-Span, First Databank, Gold Standard, and Cerner Multum. An additional objective was to determine if the compendia classifications were in alignment with the information presented in the product’s prescribing information (PI).
PHSL SolutionPHSI provided the manufacturer with drug compendia listings from the four major providers, along with an easy-to-read-summary worksheet. PHSI compared these listings to the drug’s published PI in order to identify any inconsistencies.
ResultsPHSI identified that one drug compendia had the product incorrectly categorized. PHSI worked with the manufacturer and the drug compendia provider to correct the error, which was updated in a timely fashion.

Manufacturer Sought Insight on Package Size Compendia Listing Issue

IndustryDrug Compendia
ProblemPHSI’s pharmaceutical manufacturer client’s topical preparation product was listed with the incorrect billing quantity by one of the drug compendia. This issue caused billing and payment problems for pharmacies and claims processors who began to contact the manufacturer.
PHSL SolutionThe PHSI team used their understanding of the NCPDP Billing Unit Standard and the drug compendia to research the issue and to provide a concise explanation to the client along with the necessary steps toward a resolution. PHSI monitored the actions of NCPDP Work/Task Group responsible for adjudicating these issues with the compendia to ensure the proper outcome. PHSI helped the client communicate with the compendia providers so that proper and accurate information was provided to PHSI’s pharmaceutical manufacturer client’s suppliers, and that the information was consistent with the NCPDP Billing Unit Standard.
ResultsThe eventual correction of the billing quantity by the compendia resulted in smoother claims submission and proper payments to pharmacies.

Conversion from Multiple Platforms to a Single New Claims Processing System: GCN to GPI Crosswalk

IndustryDrug Compendia
ProblemA growing PBM needed to coordinate several books of business under a single claims processing software system using a service bureau arrangement. Previously, the claims processor used First Databank (FDB) as their drug compendia, but the new processor uses Wolters Kluwer’s Medi-Span drug compendia. Plan edits and formularies using FDB identifiers needed to be converted to Medi-Span GPI (Generic Product Identifier) codes.
PHSL SolutionPHSI analyzed the formulary and plan edits to isolate FDB codes that required conversion to Medi-Span codes. PHSI created a one-time compendia crosswalk based on NDC matches. GCN (Generic Code Number), and GSN (GCN Sequence Number) codes were converted to Medi-Span GPI codes. PHSI also converted therapeutic class GC3 codes to GPI codes.
ResultsThe client leveraged PHSI expertise to meet the aggressive conversion schedule and experienced a smooth transition. In the process, the client consolidated several high maintenance formularies and plan edits into more efficient GPI wildcard lists that reduced ongoing maintenance efforts, while understanding the limitations of this one-time crosswalk file.