Thought Leadership

Ever since the Inflation Reduction Act (IRA) became law, pharma companies have struggled to identify how these changes will affect their business. In many ways, the IRA is forcing a marriage of necessity between product development and market access, as manufacturers must now be more focused on anticipating future market states for their potential and existing pipeline.

Since the passing of the Inflation Reduction Act (IRA) last fall, pharma companies have been bracing for the impact of its provisions. The main healthcare-related IRA policies are the out-of-pocket spending cap, the Medicare Drug Price Negotiation Program, and the penalty for increasing drug prices faster than inflation.

In the past few years, real-world data (RWD) has become an increasingly important element of a successful market access strategy. By blending claims and lab data with clinical pathway and payer coverage data, pharma companies can get full visibility into what’s happening in the market.

Dallas Mavericks owner and venture capitalist Mark Cuban is taking aim at drug prices with his discount prescription drugs startup, Mark Cuban Cost Plus Drug Company. However, payers are divided on whether they want to work with the company, according to new MMIT research. By leveraging direct sourcing, Cost Plus Drugs’ goal is to eliminate excessive markups on prescription drugs. Cost Plus’ online pharmacy sells directly to consumers, and the firm is registered as a pharmaceutical wholesaler with the FDA.

In an effort to lower the cost of specialty drugs, many payers have initiated site-of-care optimization strategies. By encouraging patients to receive therapies in more cost-effective settings — such as physician offices, infusion clinics, or at home — payers can reduce unnecessary expenses while ensuring members receive clinically appropriate care.

Even though we knew it was coming, the end of the COVID public health emergency (PHE) on May 11, 2023, still took the healthcare industry by surprise. While the end of the PHE resulted in the rollback of many COVID-19 programs, it also changed the ways that Medicare patients can access oral therapies from community oncology clinics.

Preliminary data indicates that 2023 may prove to be the most volatile year for health plan enrollment in a decade. The convergence of major market disruptions—namely the Inflation Reduction Act (IRA) and the end of the Public Health Emergency—is sparking tremendous shifts in the individual and public exchange market.

In the past, rare disease manufacturers often assumed that any therapy they launched would automatically be covered by most health plans. But the rising cost of many rare disease drugs has increased payer sensitivity to the expense of these therapies, even those with orphan drug designation. Many rare disease treatments are placed in the highest cost-sharing tier, and intensive utilization management (UM) restrictions are common.

The FDA approved the first biosimilar more than eight years ago, and the agency continues to give the green light to multiple agents per year. In fact, 2023 could well be a landmark year in launches, spurred by multiple biosimilars of AbbVie’s Humira (adalimumab) entering the U.S. market. While the upcoming launches are a boon for biosimilar manufacturers, it’s important to note that FDA approval will not guarantee automatic market access for these products. Given the various state regulations in play, biosimilar manufacturers will need to handle managed care differently for different patients and insurers. They must adjust their commercialization strategies based on each state’s regulations, as what works for one team in Ohio may not work for another managed access team in California.

Developing the first and only FDA-approved treatment for a particular indication is no longer a guarantee of market access. Before the launch of its first commercial product, one small biotech company was concerned about restrictive utilization management policies. How would its sales team combat barriers to patient access?