Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Manufacturers should be prepared for a period of uncertainty and potential disruption in vaccine policy. The recent overhaul of the CDC’s Advisory Committee on Immunization Practices (ACIP) signals a shift that could affect vaccine recommendations, public trust, and payer coverage decisions.
After Robert F. Kennedy Jr. was sworn in as the new secretary of the U.S. Department of Health and Human Services in February, the agency has taken several steps that could undermine confidence in vaccines. Manufacturers must remain transparent and proactive…
As biosimilars continue to redefine the specialty drug landscape, payers and their associated pharmacy benefit managers (PBMs) are executing new strategies to capture a larger share of revenue. PBMs are partnering with manufacturers to co-develop and commercialize their own private-labeled biosimilar products. This coordinated approach provides value to both parties, as it enables them to siphon off market share from originator therapies and their competitors.
In this article, we explore how the fragmented rollout of Humira biosimilars exposed the drawbacks of…
Over the next five years, 88 biologics—including several blockbuster agents like Eliquis, Keytruda, Opdivo, and Darzalex—are facing a loss of exclusivity, representing an estimated market of more than $100 billion. After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab).
While Stelara is used in fewer indications than Humira, it commands a large market share in its therapeutic areas, most notably in plaque psoriasis,…
As high-cost specialty treatments become more common, manufacturers are turning to innovative contracting to boost coverage for their products. Many cell and gene therapies, orphan drugs, and oncology therapies are prohibitively expensive, with costs ranging from several hundred thousand to millions of dollars.
Warranty-based agreements help mitigate the risk of paying for these therapies, as they offer payers financial protection if a patient must stop treatment for clinical reasons. If a therapy fails to work as intended, manufacturers agree to reimburse…
In 2024, biotechs were behind almost two-thirds of the FDA’s new drug approvals. Many biotechs are choosing to commercialize their products themselves, rather than partnering with Big Pharma players. Many fail, but some market factors are now in biotech’s favor.
A recent Evaluate report, Going Solo: Commercializing Biotech, analyzes the dynamics that are enabling biotech companies to bring their own therapies to market. The report explains the advantages small players can have over larger companies, and shares tips on how to…
For pharma companies, securing favorable coverage for a new asset is far more complicated than it used to be. Indications are more competitive, and the market is full of specialized niche therapies for smaller patient populations. While market access data has never been easy to parse, we’ve seen an evolution in the amount and type of information that’s needed to understand a product’s positioning.
A decade ago, our pharma clients were interested primarily in coverage binaries: is a product covered, or…
This article was originally published in Drug Channels.
To chart a clear path to commercialization, a manufacturer must begin with the end in mind. Early market research helps pharma companies understand which clinical endpoints and differentiators an asset will need to succeed at launch.
Today, one-third of pharma companies start market access planning in Phase I, and 80% start by Phase III. Manufacturers were once reluctant to invest in market research during development, when an asset’s future is uncertain. But the questions raised…
As the 340B Drug Pricing Program continues to grow in size and importance, its operations are being scrutinized more than ever. Pharma manufacturers, who have long noted issues with this program, have made various attempts at reform.
Their latest strategy — which would move away from up-front discounts to a rebate model — is currently in limbo as the courts weigh in. If drugmakers are successful in their efforts, however, findings from a recent MMIT survey indicate they would be advised…
Over the past decade, health systems have seen a rapid influx of private equity, with a six-fold increase in acquisitions totaling $10 trillion. As private equity firms continue to explore new methods of investment in health care, the recent announcement that Walgreens Boots Alliance will be acquired by Sycamore Partners seems to be a natural progression in strategy.
What does the introduction of private equity into one of the largest pharmacy chains in the U.S. mean for the industry? While this…
To speed patient access to potentially life-saving therapies, the FDA established expedited approval pathways for selected drugs that fill unmet needs or treat serious conditions. For patients in need, these pathways serve an essential purpose. But many payers and providers are concerned that expedited pathways do not require sufficient safety and efficacy data.
Their concerns impact coverage decisions, reimbursement models, and ultimately, patient access. The four key approval pathways are as follows:
Fast track: Manufacturers apply for this designation, which is…
