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.
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 then the launch team’s efforts will be in vain.
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.
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.
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.
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.
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.
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.