Pharmaceutical Manufacturer

Order Set Preparation for Product Awaiting Approval

IndustryPharmaceutical Manufacturer
ProblemA manufacturer wanted assistance reviewing their draft Prescribing Information (PI) before the drug’s PDUFA date. They were seeking help drafting an order set, or a protocol on how to use the newly launched product, which could be provided to healthcare systems and hospital P&T Committees.
PHSI SolutionPHSL reviewed the supporting literature and labeling provided by the client and provided a draft order set for the manufacturer’s review and approval. Standard order set sections were drafted to include, but not limited to, the following: concomitant medications, take home medications, nursing orders, pre-medications, laboratory monitoring, drug instructions, and more. PHSL conducted a conference call to review the draft order set with the manufacturer to address question related the order set.
ResultsPHSL provided two draft revisions prior to the final submission. Having a standardized order set available enabled the manufacturer to quickly provide a protocol to hospitals and healthcare systems, helping to mitigate delays in P&T committee evaluation and review. This allowed for faster uptake of their product in hospital systems and helped to ensure the drug was used correctly.

Evaluation of Free Samples vs Vouchers for Newly Approved Medication

IndustryPharmaceutical Manufacturer
ProblemA brand pharmaceutical manufacturer wanted to evaluate when its pipeline product is approved whether samples of the product should be dispensed at a doctor’s office or if patients should be given a voucher to present at the pharmacy to receive the initial trial of the medication.
PHSI SolutionPHSL reviewed the pros and cons of each approach which may include cost, ease of use, packaging (bottle vs unit dose), insurance coverage, as well as the benefits the type of packaging affords both prescribers and patients. PHSL also reviewed the qualitative and quantitative benefits of using vouchers, which allow the manufacturer to have more detailed data on the product's use compared to samples.
ResultsPHSL provided straightforward, sufficiently detailed information to the manufacturer to enable them to make an informed decision as to which approach they should take regarding sample medication.

Manufacturer Seeks Redesign of Return Goods Policy

IndustryPharmaceutical Manufacturer
ProblemA manufacturer was looking to review their current Return Goods Policy. They wanted to create an up-to-date policy with additional insights on how it can be improved, while addressing new trends in the industry.
PHSI SolutionPHSL identified ten manufacturers of similar size and business to review their return goods polices for best practices. With this information, PHSL created an Excel grid comparing and contrasting key areas of the Return Good Policy. The findings were presented to the client, with PHSL’s recommendations based off the constructive portions of the newer policies, and PHSL provided redlined suggestions.
ResultsThe manufacturer updated their Return Good Policy using PHSL’s guidance to create a new, effective return goods policy. The client has now implemented an up-to-date policy that aligns with industry standards and addresses new trends.

Seasonal-Use Product Reimbursement Trend Analysis

IndustryPharmaceutical Manufacturer
ProblemA manufacturer that markets a seasonal product felt their sales underperformed for the recently completed season. They wanted to research potential reasons why this occurred and implement strategies to improve sales during the next season.
PHSI SolutionPHSI conducted market trend analyses for the manufacturer reviewing patient, pharmacy, and competitor perspectives. PHSI also looked at the utilization of copay cards and how their use impacted patient behaviors.
ResultsThe manufacturer gained an understanding of the market trends that impacted their product's performance. The manufacturer is revising its marketing approach for the following season to improve its market success.

Assess Physician Prescribing Practices Through Market Research

IndustryPharmaceutical Manufacturer
ProblemA generic pharmaceutical manufacturer was looking to predict future physician prescribing preferences after a drug shortage disrupted the market. The generic manufacturer had many Authorized New Drug Applications (ANDAs) available in the same therapeutic class and in similar classes and wanted to determine which products they should produce to meet the new market needs.
PHSI SolutionPHSI crafted a 10-question closed-ended survey to assess physician preferences and future prescribing practices. The manufacturer-approved survey was distributed to a geographically diverse group of physicians that specialize in the affected disease state. PHSI collected and tabulated the results into a concise PowerPoint summary.
ResultsThe generic manufacturer better understood physician preferences and was able to pinpoint which drug classes and which specific medications were preferred by specialists. The results provided the manufacturer with a key data point to help them shape their future manufacturing decisions.

Understanding Impact of Trade Agreements Act (TAA) Compliant Pharmaceutical Products

IndustryPharmaceutical Manufacturer
ProblemA generic pharmaceutical manufacturer contacted PHSI to evaluate their competitors’ compliance with the Trade Agreements Act (TAA). TAA compliance fosters fair and open international trade and requires that the United States government prioritize TAA compliant products. The client desired a review of their competitors’ products to determine the TAA compliance to make strategic decisions about their own products.
PHSI SolutionPHSI researched the client requested products to identify the country of manufacturing. The TAA compliance of that country was classified for each product. PHSI provided the client with comprehensive report detailing each drug, the number of TAA compliant and non-compliant competitors, and listed the manufacturers and countries in each group.
ResultsThe generic manufacturer gained the timely TAA compliance status for their competitors’ products. The client’s knowledge of competitor TAA compliance was a key resource to make strategic decisions on specific products regarding their own manufacturing location and compliance with TAA.

Monitoring Drug Compendia Listings of Competition

IndustryPharmaceutical Manufacturer
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.
PHSI 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.

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.

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.