Market Access 101: Formulary and Medical Exceptions
Beginning with the basics, our Market Access 101 blog series has addressed how manufacturers can improve formulary placement for pharmacy benefit drugs, secure coverage and assess the need for contracting for medical benefit therapies. In this final post, we’ll explore what it means to request a formulary exception or medical exception for a non-covered therapy. […]
Market Access 101: Key Factors in Medical Benefit Contracting
Welcome back to our Market Access 101 blog series, which began with the basics of market access and covered how to improve formulary placement and secure coverage under the medical benefit. In this post, we’ll dive deeper into the medical benefit, explaining how payer/PBM contracting works—and why it’s increasingly necessary. Essentially, all pharma companies want […]
Key Trends in Medical Benefit Contracting
The rising cost of specialty pharmaceuticals has motivated payers to implement tighter restrictions and seek both traditional and value-based contracts. As manufacturers are already contracting with GPOs, distribution networks and medical practices, most would prefer to avoid contracting with payers and PBMs for their medical benefit products. Yet the data reveals that medical benefit contracting […]
Removing Access Barriers for Long-Acting Injectables
The past few years have seen an increase in the number of long-acting injectable (LAI) therapies for a variety of disorders and diseases, including schizophrenia, bipolar disorder, and HIV. These LAI antipsychotics and antiretroviral therapies include brand-name drugs such as Invega Sustenna (paliperidone palmitate by Jannsen), Abilify Maintena (aripirazole by Otsuka), and Cabenuva (cabotegravir/rilpirivine by […]
Market Access 101: Securing Coverage Under the Medical Benefit
Welcome back to MMIT’s Market Access 101 blog series. Our first post, Understanding the Basics, covered the difference between the pharmacy and medical benefit structure, while our second, Improving Your Drug’s Formulary Placement, discussed how to overcome access barriers. In this post, we’ll discuss what manufacturers should know about drugs covered under the medical benefit. […]
Market Access 101: Understanding the Basics
For many pharmaceutical companies, planning for commercialization only begins in earnest when a drug has been submitted for FDA approval—which is far too late. Ideally, a company’s commercial and market access teams should be fully functional long before the approval stage, as many decisions must be made in the early phases of the drug development […]
New HCPCS Codes for Generics: What Payers and Manufacturers Should Know to Ensure Accurate Reimbursement
As if medical billing and coding wasn’t challenging enough, 2023 brings a new layer of complexity: the establishment of unique HCPCS codes for generic drugs. Specifically, the new codes affect generics approved under the FDA’s 505(b)(2) new drug application (NDA) and biologics license application (BLA) pathways. In its Q3 2022 HCPCS Coding Cycle documentation, CMS […]
From Buy-and-Bill to White Bagging: The Future of Reimbursement Under the Medical Benefit
Pharmaceutical manufacturers that are nearing the commercialization stage of pre-approval planning are faced with a lot of realities about managed markets. Manufacturers are so engrossed in the details of a clinical trial, and its eventual success, that beginning to plan for commercialization can be daunting. However, for physician-administered therapies or IV therapies, understanding and navigating […]
Will New Approaches to Medical Benefit Contracting Help Control Specialty Drug Spend?
Pharmacy benefit contracting has always been a mechanism for payers to offset the cost of small-molecule therapeutic areas. Payers have looked to manufacturers to negotiate contracts that would prevent their products from being placed on a restrictive tier, or subject them to step edits or an NDC block. But with the emergence of biologics driving […]