Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
This article was originally published in Drug Channels.
Given the growth of specialty pharmaceuticals, manufacturers will need to develop more aggressive contracting strategies to secure optimal market access for their medical benefit drugs. Shifting market dynamics, driven in part by the influx of lower cost biosimilars on the pharmacy benefit, will require pharma companies to focus more on rebating and cost minimization.
Understanding Market Forces Under the tiered design of a PBM, drugs covered under the medical benefit are directly impacted…
Many manufacturers are interested in which factors can give them an edge on obtaining preferred coverage with payers. This is especially true given the increasing competition in saturated categories such as immunology, diabetes care and breast cancer.
We scoured recent MMIT research to gain a better grasp on the factors that are top of mind for payers—those that will truly move the needle in terms of coverage determination. Our findings show that payers consider three main factors when evaluating therapies:
Cost…
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 life cycle.
According to Deloitte, the average cost of bringing a pharmaceutical asset to market is $2 billion, yet more than a third of all product…
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 issued 36 new HCPCS Level II codes to identify these products, effective Jan. 1, 2023. The agency also declared its intention to review additional 505(b)(2) drugs…
Despite the challenges of the pandemic, the pharma industry has enjoyed steady growth during the past two years, which is expected to continue in 2023. The global pharmaceutical market is forecast to expand at a CAGR of 5.7% between now and 2028. Hundreds of products are currently awaiting FDA approval, and new modalities, including cell and gene therapies, have increased to 21% of the drug development pipeline.
Of course, plenty of existing hurdles remain, along with several new challenges and opportunities.…
The FDA has created a number of pathways to bring drugs for serious conditions onto the market sooner than the traditional approval process would allow. These include priority review, accelerated approval, fast track and breakthrough therapy designations, as well as emergency use authorizations, which are used in emergency situations, such as the COVID-19 pandemic.
One of the most popular routes is accelerated approval, which allows the agency to approve drugs using surrogate endpoints that are thought to predict a clinical benefit.…
According to the National Institutes of Health (NIH), approximately 80% of research studies fail to meet their enrollment goals within the stated timeframes. Recruitment and trial design challenges can prolong the timeline for phase III studies, driving up costs and delaying market entry.
While many sponsors use aggregated data and predictive analytics to improve the trial process, one data source is often overlooked: lab data. By analyzing normalized lab data sourced from both commercial and inpatient labs, pharma companies can optimize…
With rebates now a common pharma practice, and generics and biosimilars launching in oncology, payer management of once-untouchable cancer drugs is growing. As the FDA continues to approve a large number of cancer drugs, resulting in increased competition in various tumor types, and spending on these agents continues to rise, PBM and payer formularies are now excluding some oncolytics while designating others as preferred.
Not so long ago, oncology was fairly off-limits for utilization management, but that is no longer the…
This article was originally published in BioPharma Dive.
In the competitive pharma marketplace, physician engagement plays a critical role in a drug manufacturer’s commercialization strategy. However, before manufacturers can promote a new therapy directly to providers, they must first determine which physicians treat the relevant patient population. By investing in timely lab data, manufacturers can identify specific providers to target—before a diagnosis or prescribing decision is made.
Broadly speaking, lab data refers to any type of diagnostic test that passes through a…
When it comes to biosimilars, there seem to be far more questions than answers, specifically when it comes to interchangeability. Now that the FDA has granted three biosimilar products “interchangeable” status—with more to come, surely—how will this development affect the biosimilars market? What do pharma manufacturers, payers and physicians need to know about this designation? And, crucially, how might interchangeability affect biosimilar uptake in 2023 and beyond?
To learn more, we sat down with Cathy Humphries, a Senior Consultant on MMIT’s…
