Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
After the FDA called for additional warning labels on anti-inflammatory drugs known as JAK inhibitors this September, pharma companies in the immunology space have been waiting with bated breath to see how payers will react to this news. Will insurers start requiring step-edits or prior authorization? Will payers alter their management strategies for rheumatoid arthritis and ulcerative colitis? What will potential restrictions mean for newly diagnosed patients or those who are seeing success with JAK inhibitors? What will the impact be…
When launching a new drug, especially one that addresses a high unmet need, the barriers to access are numerous. Cost, formulary placement, and prior authorization and step therapy restrictions can all prevent patients from picking up their medication at the prescription counter.
“It is very important that if a doctor makes a decision to place a patient on a therapy, that they have confidence that the ‘script-to-fill’ process is right,” said the vice president of market access at a small pharma…
There are many challenges that manufacturers face when launching a new drug: Will physicians prescribe the drug? Will they have any legal issues? Will patients request the drug? How should they market and distribute it?
The list goes on and on, but one of the most critical questions to answer is this: Will patients be able to access the drug? A manufacturer can have all other elements of a product launch accounted for, but if there are tight restrictions in place…
While payers’ formulary decisions can make or break a drug’s success, manufacturers within oncology face an additional obstacle to gaining market access: clinical pathways, or guidelines that determine which treatments and procedures should be prescribed along the patient journey. While pathways were developed to help standardize treatment and ensure quality care, oftentimes they limit physicians’ prescribing decisions by restricting their choices to the products on the pathway.
Why is this important for oncology manufacturers?
Consider Martha, a 68-year-old who started experiencing…
With payer coverage decisions around pharmaceuticals changing rapidly, simply being covered is no longer enough for getting patients on therapy quickly. Today, increasing market complexity and outsize payer influence have resulted in numerous hurdles to ensuring adequate access, from prior authorizations to step therapy to label restrictions.
To succeed at launch amid these higher stakes and ever-evolving market dynamics, pharma companies—especially those within the oncology or rare disease spaces—need a go-to-market strategy that tracks market access in real time.
Why timely…
John Griggs co-authored this article with Dinesh Kabaleeswaran. This article was originally published on Drug Channels.
Large healthcare conglomerates, or integrated delivery networks (IDNs), have long been fixtures in the market access landscape—a dynamic that has gone unchanged despite the disruption caused by COVID-19. While M&A activity slowed down during 2020, IDNs are seeing a bout of positive recognition: Many have received accolades on their ability to deliver quality coordinated care during a year of upheaval for healthcare. Partly thanks to this…
The COVID-19 pandemic has been an unrelenting trial—one that, in many ways, accelerated the pace of change in the life sciences industry. In the wake of breathtakingly fast novel vaccine development, an abrupt shift toward virtual care and a renewed focus on digital therapeutics, things look vastly different than they did less than two years ago.
But amid this industry-wide evolution, where does that leave specialty pharmacy? With roughly two-thirds of novel therapies approved as specialty drugs in 2019, it’s clear…
People often ask me how MMIT fits into the healthcare ecosystem. MMIT’s mission is to smooth and simplify access to therapies, affecting every part of the continuum from the pharmaceutical company to the payer, provider and patient.
Everyone knows someone who has had trouble accessing a life-saving or life-changing therapy because of communication problems between the pharma company, PBM, payer and provider. Sometimes providers prescribe a medication that isn’t covered by the payer, and other times may not prescribe a medication…
This article was originally published in FierceHealthcare.
While it has been over a month since the FDA announced its controversial decision to approve Biogen’s Alzheimer’s drug, Aduhelm, payers have been slow to make any decisions—and for good reason.
While the excitement around the approval is undeniable given the long-overdue unmet need for Alzheimer’s patients, there are still many questions stemming from the therapy’s stated efficacy and the FDA’s waffling over the label’s indication and usage section. With CMS’s recent move to open a…
