Spotlight on Market Access

While CRISPR gene editing continues to hold promise, excitement around it has waned over the last couple of years due to various issues, including challenges with patient access and funding. But a reset of the approach to developing these agents, including the idea of using them as modular therapies that can be built upon for various diseases, is underway, leading to a potential turnaround within the industry, said speakers during a March 26 Endpoints Catalysts webinar.

“Gene editing once seemed primed to revolutionize medicine,” said moderator Ryan Cross, senior science correspondent at Endpoints News. “Although the science remains promising, many companies behind these genetic treatments are losing value and stepping back from some of the rare conditions that CRISPR seemed most poised to tackle.”

Health Care Service Corporation (HCSC) is the parent company of five large, member-owned Blues insurers: Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas. The five subsidiaries enroll more than 17 million lives across the spectrum of health insurance products, though much of their membership is concentrated in Illinois and Texas. Originally founded in 1936 in Chicago as a prepaid insur­ance plan for hospital care, HCSC now enrolls more than half of all insured lives in Illinois. In March 2025, HCSC completed its acquisition of The Cigna Group’s Medicare business, which includes Medicare Advantage (MA) plans serving about 700,000 members. Cigna will continue to provide pharmacy benefit management and other services for Medicare members through its Evernorth health services arm.

As Medicare Advantage insurers seek ways to maximize revenue in a fiscally challenging environment, the accurate and complete capture of diagnosis codes is paramount. That’s because their reimbursement is dependent on the documented health of their enrollees and related risk scores. But risk adjustment comes with inherent compliance risks, demonstrated by pending lawsuits involving the use of chart review and addenda programs and a recent settlement involving whistleblower Teresa Ross, a former MA plan employee who spoke at the 2025 RISE National conference.

“It’s a very isolating and lonely time. The whole time the company is gaslighting you. You say too much, so then you get excluded from meetings,” said Ross. At one point, her employer sent a mental health counselor to her office “to try to tell me that I was wrong for not going along,” she recalled.

The America First Policy Institute, a think tank founded by former advisers to President Donald Trump, recently released a paper that blamed foreign countries for pharmaceutical “global freeloading” and outlined several policy options to end it. Options included most-favored nation pricing and international reference pricing — two proposals raised during Trump’s first term.

The paper argued that this pharmaceutical freeloading occurs when other wealthy countries implement price controls that allow them to “have their cake and eat it too — to get lifesaving drugs for their citizens without paying the necessary costs to develop them.” It deprives drug manufacturers of billions of dollars and comes at the cost of new treatments for patients in the U.S. and abroad, the paper said.

Having a successful product launch and securing payer coverage come well before FDA approval of a drug. But some drugmakers face an uphill battle after launch because they fail to engage with both payers and patients in a timely fashion, as well as provide them with truly useful information.

To engage payers effectively, pharma companies should individualize their value propositions with a focus on what’s important to each one rather than a one-size-fits-all tactic, says Dominic Galante, M.D., chief medical officer at Precision AQ. He also recommends that manufacturers think beyond traditional pricing models and “adopt flexible pricing strategies and innovative reimbursement models that align with payer budgets and value-based care initiatives.”