Pharmaceutical Manufacturer

Understanding Impacts of an Authorized Generic Product

IndustryPharmaceutical Manufacturer
ProblemA brand pharmaceutical manufacturer faced a competitor that launched an Authorized Generic (AG) prior to patent expiry. This competitor hoped its AG strategy would spur sales of a “generic” alternative with both favorable formulary coverage and reduced costs for patients. The client needed to understand how prescribers, pharmacies, payers and patients may perceive and react to an AG launch without additional generic competitors from a tactical perspective.
PHSI SolutionPHSI analyzed the impact of this authorized generic product upon different entities such as prescribers, pharmacies, and PBMs. A key component of this analysis was the listing of the authorized generic in the drug compendia. The analysis examined pharmacy claims to determine how different PBMs/MCOs were covering the target brand and its AG. PHSI provided the client with a landscape overview of the authorized generic’s impact on formularies, prescribers, pharmacies, reimbursement, PBM and third party payors.
ResultsPHSI provided senior management of the pharmaceutical manufacturer with a better understanding of how the competitor’s AG may impact their own product.

Specialty Generics Competing With Orphan Brands

IndustryPharmaceutical Manufacturer
ProblemA pharmaceutical manufacturer client was preparing for approval and first to market launch of a specialty generic drug for a small, sensitive patient population. The brand manufacturer for this drug had a limited distribution network of specialty pharmacies. It was unknown whether the brand manufacturer would continue to compete in this space post Loss of Exclusivity (LOE) by offering discounts and rebates to the contracted specialty pharmacies and/or launch their own authorized generic. The client needed to understand how the brand manufacturer marketing tactics could impact their own pricing, support, and contracting strategies.
PHSI SolutionPHSI developed several different strategies and “what if” scenarios for the client to consider. These strategies were based on the number of generic competitors and how the brand manufacturer would attempt to compete post LOE with discounts and rebates to the specialty pharmacies. PHSI performed additional analysis and developed correlating strategies depending on the client’s decision of how they would contract with specialty pharmacies. Some options included contracting with specialty pharmacies owned by PBMs, independent specialty pharmacies, or MCOs whose specialty pharmacies never had access to the brand product.
ResultsPHSI provided the forecasted scenarios and strategies to the client, which gave them insight to make informed decisions when finalizing their marketing and pricing strategies.

Manufacturer Sought Insight on Inner-Pack NDC Compendia Listing

IndustryPharmaceutical Manufacturer
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.
PHSI 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.

Loss of Exclusivity (LOE) Brand Strategy Playbook

IndustryPharmaceutical Manufacturer
ProblemA pharmaceutical manufacturer desired a compilation of product retention strategies to consider for their brand products approaching LOE. The client’s brand teams sought to extend product sales by delaying brand erosion, keeping revenue opportunities open, and retaining a portion of brand sales after LOE.
PHSI SolutionPHSI researched recent brand patent expirations and conducted interviews with national and regional pharmacy chains. PHSI compiled a detailed playbook of brand loss of exclusivity strategies for client and brand team consideration to slow brand erosion and retain brand product sales.
ResultsPHSI provided the client a resource for their brand teams to review and consider for branded products as they prepared for future brand LOE events. Two brand teams used multiple tactics from the playbook provided by PHSI to delay generic conversion, slowing the sales decline immediately post loss of exclusivity.

Drug Compendia Product Submission

IndustryPharmaceutical Manufacturer
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.
PHSI 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

IndustryPharmaceutical Manufacturer
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.
PHSI 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.

Manufacturer Seeks Pre-Launch Rebate Level Forecasting

IndustryPharmaceutical Manufacturer
ProblemA pharmaceutical manufacturer client needed to forecast the potential rebates that would be required to compete with generics to a competing product in the same therapeutic category. The manufacturer needed a model that estimated future costs to assist with scenario planning.
PHSI SolutionPHSI identified four potential scenarios that could impact the not-yet-launched brand product. For each scenario, PHSI identified the assumptions, variables, and calculations to determine the investment in rebates for the brand to be competitive in each scenario.
ResultsPHSI’s model revealed a range of potential rebates and included a dynamic model that permits the manufacturer to adjust the variables to test additional scenarios. The manufacturer used the model to assist with their strategic pricing decisions during pre-launch planning.

Clinical Services Review for Manufacturer

IndustryPharmaceutical Manufacturer
ProblemA pharmaceutical manufacturer was receiving field team inquiries about Medication Therapy Management (MTM) and patient counseling. The client had a particular interest in understanding the roles of the pharmacist and the ways a pharmaceutical manufacturer might be able to provide educational support materials.
PHSI SolutionThe client requested that PHSI explain the differences between patient counseling and MTM in an easily understandable format. PHSI’s staff relied on their pharmacist expertise to design a PowerPoint presentation to highlight the unique aspects of both services. PHSI included details about major MTM companies, pertinent laws such as the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) and the Medicare Modernization Act (MMA) and how these influenced the practice of pharmacy. Furthermore, PHSI provided details on how MTM can improve healthcare outcomes for patients on the manufacturer products.
ResultsPHSI’s presentation allowed the manufacturer’s staff to learn and ask questions. The PowerPoint was provided to the client as training materials for new employees. The information from PHSI helped the client get a better understanding of the clinical services being provided in pharmacy practice.

Post-Launch Drug Compendia Review

IndustryPharmaceutical Manufacturer
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).
PHSI 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.

Retail Immunization Process

IndustryPharmaceutical Manufacturer
ProblemThe client wanted to understand the process used by retail pharmacies and retail clinics to identify candidates for immunizations. The client wanted to understand the opportunities that retail healthcare professionals have to engage with patients about their immunization needs.
PHSI SolutionPHSI reviewed the client material and developed a discussion guide to identify the process used to identify candidates for immunizations and the delivery process for administering vaccines. PHSI conducted market research with retail pharmacists, nurse practitioners, and physician assistants.
ResultsPHSI provided in-depth analysis of the retail processes and patient interactions identifying patients for immunizations by retail pharmacists and retail clinic personnel.