Over the past decade, the life sciences industry has undergone transformative change that has disrupted everything from early drug discovery to post-launch treatment monitoring. Driven by the proliferation of real-world data (RWD) and technology like AI and machine learning, these innovations are changing our understanding of drug value and enabling life-saving medications to get into the hands of patients faster.

When it comes to medical reimbursement, there are several challenges that both payers and providers face in today’s rapidly changing regulatory environment. With new drugs and generics entering the market at breakneck speed and supply chain issues continuing to plague manufacturers, it can be difficult for stakeholders to keep up with the Healthcare Common Procedure Coding System (HCPCS), especially considering that July will mark the eighth consecutive quarterly update to HCPCS codes. While HCPCS codes used to be updated on an annual basis, more recently CMS has moved to a quarterly schedule, increasing the frequency with which providers and payers must check for new coding requirements.

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 to pipeline agents?

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.