What is a manufacturer’s role in managing a product’s ePI?
Plan for Success
Pay close attention to the language in your PI, compendia submissions, and marketing tactics to make sure both people and computers can clearly understand the key characteristics of your new product, including:
Brand and generic name
Dosage form
Route of administration
Strength/concentration
Package size and billing unit
Delivery devices and package descriptions
Indications and mechanism of action
Use your labeling and compendia submissions to influence ePI whenever possible, and follow compendia rules and industry standards to ensure consistency across all platforms.
Launch Better and Faster
Prepare your teams to act quickly once FDA approval is received.
You can’t “speed up” when your product will appear in EHRs. The timing is controlled by the EHR software supplier and their customers.
However, by preparing compendia submissions that follow each compendium’s practices, you can reduce the risk of delays caused by missing or unclear information.
Submit product information to pricing and clinical compendia within 1-2 days of FDA approval, or notify them if there are any delays.
Coordinate all other external messaging around when the product is expected to appear in compendia.
Strengthen Your Sales Teams
Prepare field teams to understand when and how product listings will appear in customer technologies, like EHRs.
Train teams on Health IT topics and set expectations based on compendia publication timing.
Offer ongoing support throughout the launch period.
Monitor EHRs at the end-user level to verify when the product appears in real-world settings.
Create a communication channel for field teams to report issues, challenges, and questions, so they can be addressed while field teams stay focused on sales.
Improve Access
Support payer decisions and formulary inclusion with proper product positioning.
Plan for and confirm each pricing compendium’s therapeutic category.
Balance opportunities for differentiation with the risk of step-edit positioning.
Enter payer negotiations with insights from each compendium’s unique market basket.
Support prescriber access in health systems by understanding and planning for P&T committee decisions, treatment protocols, and order sets.
Write Ads that Work
EHRs are clinical tools, so standard marketing messages won’t work.
Make sure your messages and banner ads deliver value in workflow.
Focus on helping prescribers understand when and how to use your product and how to get patients started.
Match all marketing materials to the electronic appearance of your product—not just the EHR ads.
Use language in your marketing that matches how compendia, EHRs, and other digital systems describe your product, or risk confusing your customers.
What sources and datasets contribute to a product’s ePI?
Product Naming
Something as simple as using capital vs. lowercase letters may seem like a style choice, but it can have a big impact on how a product appears on digital platforms.
Packaging Configurations
The way a product is packaged impacts the way it’s prescribed. It’s important to consider how things like billing unit standards can make it easier or harder to complete a prescription for the product.
Dosage Forms
Compendia may define a product’s dosage form differently than the manufacturer or the FDA, which can affect prescribing or cause confusion when the prescription is written, filled, and reimbursed
Competitive Set
Reviewing the ePI of other products, including competitors, helps identify opportunities and avoid challenges the product may face in digital systems like EHRs.
Therapeutic Categorization
A compendium’s unique method for product categorization can impact reimbursement, so relying only on expected FDA classifications isn’t enough to ensure market differentiation.
What sources and datasets contribute to a product’s ePI?
FDA-Approved Labeling
The product Prescribing Information (PI) and packaging provide the basic details needed to prescribe and use a product.
The PI is written for humans, but it must be converted into structured data before it appears in a healthcare provider’s software.
Manufacturers should consider this conversion when writing the PI, and shouldn’t depend on the to ensure it is optimized for digital translation.
Clinical Studies and Trial Data
It’s not just data from a drug’s clinical trials. Third-party studies, medical journals, and even clinical data from other drugs in the same class can affect a product’s ePI.
It’s important to keep track of information in the entire therapeutic area to fully understand a drug’s ePI.
Clinical Practice Guidelines
When respected organizations and agencies publish recommendations for a disease state, these guidelines can greatly affect a product’s place in therapy within healthcare organizations and providers.
Practice guidelines may not always align with a product’s FDA-approved indications and should be monitored closely for the potential impact on product use.
Pricing Compendia
Pricing compendia databases are no longer just for sharing a product’s price. They also provide the details needed to prescribe, dispense, and process claims for a drug (but don’t tell users when or how to use it).
These compendia provide the drug information that makes a product appear in EHRs, pharmacy systems, and other platforms.
In addition to industry standards, each compendium follows its own editorial policies when publishing product information.
Clinical Compendia
Clinical compendia editors use a product’s labeling, along with other published studies, to create recommendations for its use.
Although often accessed online, clinical compendia are also integrated into some EHRs, giving prescribers direct access to these recommendations and product overviews.
Brand Digital Media & Marketing
Since the manufacturer has the most control over this part of the ePI, it’s important to create brand messaging that matches and supports the product’s digital appearance, making it easy to understand within the clinical workflow.
Formularies, Protocols, and Order Sets
Decision makers, like payers and P&T committees, use product information to create their own datasets that guide product use.
Payer Formulary & Benefit Files show coverage information to prescribers and pharmacists.
Health system protocols and order sets can either encourage or limit the use of specific products.
EHRs & Prescribing Databases
EHRs use pricing compendia data to fill their prescribing databases. Products with optimized compendia listings are easier to find and prescribe in the EHR.
EHRs may also be used to implement and enforce local health system or practice policies.
Dispensing & Claims Software
The pharmacy is a key communication link between the prescriber and payer. Pharmacy software must be able to understand and translate prescription information to dispense the correct product and verify patient coverage.