Spotlight on Market Access

The pharmaceutical industry continues to bring innovative therapies to market, but payers are continuing to grapple with how they can manage their financial impact. And while the Inflation Reduction Act (IRA) may bring some relief to Medicare beneficiaries in the form of lower drug prices and out-of-pocket costs, uncertainties remain about how that legislation could impact commercial payers, according to speakers at AHIP’s 2024 Medicare, Medicaid, Duals & Commercial Markets Forum, held March 12 through 14 in Baltimore.

During a March 13 session, titled “Trends in Prescription Drug Affordability, Innovation and Access,” a large part of the panel discussion focused on the IRA, which put “a lot of pressure on all parts of our health care system, but pharma got the brunt of it,” observed Rena Conti, Ph.D., associate professor at Boston University’s Questrom School of Business. While much of the focus from pharma and politicians has been on the drug price negotiation process, the Medicare Part D redesign “is actually a really big thing, because that’s what’s going to lower prices for seniors,” she asserted. “And it also will put a fair amount of pressure back on plans to manage this benefit.”

If providers charged the same price as specialty pharmacies for specialty medications, $13.1 billion in spending on health insurance premiums and premium equivalents could have been avoided in 2024, according to a new analysis from the consulting firm Oliver Wyman, commissioned by AHIP.

Provider-administered drugs can be delivered directly to clinicians from specialty pharmacies — known as white bagging — or providers can purchase the drugs directly and store the drugs until they are needed for patient care, which is called “buy and bill.” When the “buy and bill” method is utilized, the providers can charge a markup for the drug that is passed through to the patient’s bill.

A drug that the FDA first approved more than a decade ago was recently approved for the first-line treatment of an aggressive blood cancer. One clinical trial showed that people on the agent experienced complete remission more than twice as often as those on a comparator therapy.

On March 19, the FDA gave accelerated approval to Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.

In March, the FDA approved Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, which could further boost the already-strong sales for the GLP-1 weight-loss medication.

Specifically, Wegovy is now approved to reduce risk of “major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke” in adults who are either overweight or obese and have established cardiovascular disease, per a Novo press release.