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IPD experts take you through the basics of how P&T Committees work to plan their formularies.

Topics in this episode include:
P&T Committee goals, members, and purpose
Clinical and financial reviews
Formulary tiering
Payer formulary planning trends
Manufacturer timing and communication strategies for formulary inclusion

In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months...​

Our Executive Clinical Pharmacy Team discusses Authorized Generics (AGs) and their impacts across the marketplace.

Topics in this episode include:
Differences between AGs and traditional generic drugs
Manufacturer motivations for launching AGs
Examples of current AGs, positioning tactics, and potential launches
Impact on price erosion and uptake
Forecasting implications
Payer considerations for various lines of business
And more

Our Executive Clinical Pharmacy Team discusses 505(b)(2) products and how they compete in the marketplace alongside brand and generic drugs, tackling pricing, market access, and stakeholder implications.

Specific topics included in this episode:​
Background on Approval Pathways
505(b)(2) Pathway
Interchangeability
Potential Barriers to Uptake
Payer Implications
Provider Implications
Manufacturer Motivations for 505(b)(2) Pathway
Coding and Reimbursement
Manufacturer Pricing and Formulary Access Considerations
Development Considerations
Prescriber Pushback

Our Executive Clinical Pharmacy Team discusses the basics of generic and brand drug pricing and reimbursement, covering:
Brand Pricing Terms and Acronyms
- WAC
- AWP
- U&C
- PBM
Brand Pricing Differences Based on Dispensing Method
- Retail
- Mail Order
- Specialty
Spread Pricing
- Generic Pricing Terms and Acronyms
- Authorized Generic
- Authorized Biologic
- MAC
- Preferred Pharmacy Networks
MAC Lists
NDC Codes
Medically Covered Drugs
Methodologies for Medical Drug Reimbursement

Our Executive Clinical Pharmacy team talks through strategies for maximum revenue capture at a time when hospitals are trying to keep up with COVID-19 related admissions, while seeing less revenue coming in from elective procedures and changes to the 340B program are looming.
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Topics included in this episode:
Revenue Capture Strategies
Pharmacy Teams
Revenue Cycle Management Teams
340B Program Background
Pricing and Margin Implications
Recent Changes
Pass-through and Non-pass-through
Biosimilars
Drugs with No ASP Pricing
Exemptions
Litigation
Potential Changes for 2021

In this report, IPD explores recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date...”

In this report, we explore recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date...”

Our Executive Clinical Pharmacy team talks through the basics of patient financial assistance programs and their impacts on the healthcare space.

Topics included in this episode:
Overview and Basic Definitions of Patient Financial Assistance Programs
Coupons or Copay Programs
Free-Trial Programs
Bridge Programs
Patient Assistance Programs
Payer Strategies
Accumulator and Maximizer Programs
Program Impacts on Payers
Regulatory Implications of These Programs

IPD Analytics’ 360° Insights help you analyze products and companies from every angle with aggregated, synchronous updates across our multiple platforms. Together, the full reports from each platform provide a comprehensive, 360° view of the market landscape...

In IPD’s latest report, Brand Drugs with Expected Generic Competition in Canada in 2H 2022–2024, our Canadian legal and regulatory analysts identify 36 brand-name small-molecule drugs covered by data protection or patent portfolios for which the generic competition likely would begin during 2H 2022–2024...

As the affordability of prescription drugs continues to be a top concern for consumers in the United States, drug importation, the practice of importing prescription drugs from another country, has been proposed as an approach to reducing drug costs...

IPD Analytics’ 360° Insights provide a comprehensive analysis to help you examine products and companies from every angle. These synchronous reports across IPD’s multiple platforms aggregate our analyses of intellectual-property protection, clinical data, payer reimbursement, and financial outlook, providing a 360° view of the market landscape...

In this report, IPD Analytics provides an outlook for potential approvals and launches across the biosimilar landscape over the 2023–2026 horizon. Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database...

Cognitive behavioral therapy (CBT) is a type of psychotherapy that focuses on changing current behavior without attempting to determine or evaluate why the behavior exists. CBT is effective in treating depression, anxiety disorders, addiction, eating disorders, and even digestive conditions such as irritable bowel syndrome (IBS). CBT can be provided via several modes of delivery, including face-to-face, telehealth, internet-based delivery, and now, DTx...

The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the United States. The FDA grants the Orphan Drug designation (ODD) to products that could be used to treat a rare disease. While drugs receiving the ODD can qualify for special incentives, they are still subject to the typical FDA review process.

​This report highlights 24 rare disease drug approvals from 2022, including three gene therapies. These products span eight therapeutic areas, with the most common being oncology.

Our clinical pharmacists and and former Federal Circuit Clerks take you through the basics of skinny labels and off-label drug use.

Topics included in this episode:
Definition and motivations behind skinny labels
Examples of skinny labels in the market
Small molecule drugs vs. biosimilars
Payer, provider, manufacturer, retailer, and patient implications
Off-label use regulation

What does a recent case decided by the Federal Circuit Court mean for brand and generic manufacturer strategy in the future? Our Insight Brief reveals a subplot with potentially high stakes for payers, providers, and patients alike...

Our Executive Clinical Pharmacy team explains manufacturer life-cycle management strategies, including specific examples of successes and failures.

Topics included in this episode:
Additional indications
New formulations
Next generation products
Different strengths
Bundling
Brand over generic strategies
Reimbursement incentives and coding strategies
Distribution channels
Co-pay assistance programs
Strategic partnerships
Authorized generics

Over the past several years, the pharmaceutical industry has shifted away from traditional small-molecule drugs to focus more on complex formulations and specialty agents. The additional market complexities that are accompanying this shift have impacted stakeholder strategies for all drugs facing loss of exclusivity...

Authorized generic (AG) drugs have existed for more than 40 years and have long been utilized as a life-cycle management strategy by manufacturers to compete with generics...

Our Executive Clinical Pharmacy is back to add more insight on limited distribution drugs and their networks. As the specialty drug landscape has expanded, payers and providers have struggled to stay up to date on shifting limited distribution networks, making it harder to provide these critical medicines to patients. IPD's team discusses this complexity and why it's important to track limited distribution networks.

Topics included in this episode:
Understanding Limited Distribution Networks and Why they Exist
Specialty Pharmacies
Manufacturers and Specialty Drug Launches
Tracking Limited Distribution Networks
Limited Networks versus Specialty Drug Distributors

Our Executive Clinical Pharmacy is back to add more insight on limited distribution drugs and their networks. As the specialty drug landscape has expanded, payers and providers have struggled to stay up to date on shifting limited distribution networks, making it harder to provide these critical medicines to patients. IPD's team discusses this complexity and why it's important to track limited distribution networks.

Topics included in this episode:
Understanding Limited Distribution Networks and Why they Exist
Specialty Pharmacies
Manufacturers and Specialty Drug Launches
Tracking Limited Distribution Networks
Limited Networks versus Specialty Drug Distributors

This is the second issue of a recurring series to track the market potential of select products that are likely to impact the market in the coming years...

The FDA’s Priority Review Voucher (PRV) program was designed to incentivize the creation of medications for unmet needs and underserved disease areas...

In this report, our legal and regulatory analysts provide a background on patenting antibodies at the European Patent Office (EPO) and its member states. We then synthesize and analyze multiple case studies involving the validity and potential infringement of broad, functionally defined antibody patents...

The Inflation Reduction Act of 2022 is a budget reconciliation bill that addresses drug prices, corporate taxes, climate change, and energy security. It was passed by the U.S. Senate on August 7, 2022, passed by the U.S. House of Representatives on August 12, 2022, and signed into law on August 16, 2022, by President Biden...

Our Executive Clinical Pharmacy team talks through the complement inhibitor drug class and pipeline.

Topics included in this episode:
Overview and Basic Definitions of Complement Inhibitors
Complement Inhibitor Examples
Current Approvals
Side Effects
Current Complement Inhibitor Pipeline
Complement Inhibitor Class Management
Manufacturer Challenges
Implications and Final Notes

The utilization of digital therapeutics (DTx) has increased in recent years, especially since the start of the COVID-19 pandemic. With the growing interest in DTx, manufacturers have increased their investments in this space, and there is a robust pipeline of DTx products...

The 2023 launch of biosimilar versions of AbbVie’s Humira (adalimumab) will represent the largest loss-of-exclusivity event in the history of pharmaceuticals (based on Humira’s annual sales of over $20B) and one of the most important formulary management and financial decisions for payers, pharmacy benefit managers (PBMs), and hospitals in recent memory...

Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol; formerly AMX0035) is an oral, fixed-dose combination therapy approved by the FDA on September 29, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). Relyvrio is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways. Amylyx is also investigating AMX0035 for the potential treatment of Alzheimer's disease and Wolfram syndrome...

In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months. Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database...

​Use this report as a companion to our online Payer & Provider Insights and Clinical Development Tracker areas, which provide up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.

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Drug shortages are an often unpredictable challenge that can be a result of multiple issues along the supply chain. Oncology drugs, including both chemotherapeutics and supportive care medications, are often affected. Oncology drug shortages can result in delayed chemotherapy treatments, changes in dosing, use of alternative regimens, or even missed doses, if one or more drugs required as part of a treatment regimen is not available...