Radar on Specialty Pharmacy

The first biosimilars of Amgen Inc.’s Prolia (denosumab) and Xgeva (denosumab) have launched onto the U.S. market, with more expected to follow soon. On June 2, Sandoz said that it had launched Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz), with an eye on bringing a more cost-effective option to patients of the reference drugs, which have undergone more than 20 price increases since their approval. It remains to be seen whether the manufacturer will choose the private-label route favored by recent biosimilar launches.

Approved on March 5, 2024, the agents also are the only biosimilars of Prolia and Xgeva, respectively, with interchangeable status for all indications of the reference drugs.

During his first administration, President Donald Trump attempted to implement most-favored nation (MFN) pricing but was deterred by legal rulings. Undeterred, he again introduced the idea via an executive order (EO) on May 12. If implemented, the EO could have unforeseen, long-term impacts on the U.S. health care system, say industry experts. But it’s unclear whether implementation of the EO is the ultimate goal, they say.

While the proposal seems to be more extensive than his previous attempts at implementation of the model, it is scarce on details about how the process will go.

While it appears unclear whether the administration is intending for most-favored nation (MFN) pricing to apply to commercial health plans, most stakeholders agree that it would be extremely difficult to do. But if the administration is successful in putting MFN into effect in at least Medicare, private insurers could feel the impact. AIS Health, a division of MMIT, spoke to a handful of industry experts on how MFN pricing, as introduced in a May 12 executive order (EO), could affect the commercial market.

Michael Abrams, managing partner of Numerof & Associates: Lower domestic drug prices would reduce utilization costs for the 50% or so of patients across the country who are on some form of government insurance. And even though it may have no direct authority over reimbursement rates in the commercial insurance space, those prices are public, and they would inevitably become a data point influencing commercial reimbursement.

The advanced therapies market shows no signs of slowing, as scientific innovation continues to bring revolutionary new treatments out of the laboratory and onto the U.S. market. But some barriers to access, including the lack of patient caregiver support, payer hurdles and high costs, still remain and must be overcome if these agents are able to realize their potential and be even more impactful than they already are, according to a recent report from Cardinal Health.

Multiple advanced therapies — 22 cell and gene therapies (CGTs) and 22 ultra-specialty therapies — are available in the U.S., and that total is expected to more than quadruple by 2030. By that time, estimates find that more than 100,000 will have undergone treatment with them.

As the number of biomarker tests continues to rapidly grow, some health plans may struggle with coverage of them. A recent Zitter Insights survey found that 30% of commercial and Medicare payers do not provide coverage of companion diagnostics — a type of biomarker testing — for their members. But payer coverage of many of these tests can lead to lower health care costs. With that in mind, many states are mandating coverage of biomarker testing for state-regulated plans, with New Jersey recently becoming the latest one to do so.

On April 23, New Jersey Lieutenant Governor and Secretary of State Tahesha Way signed A-4163/S-3098 into law, mandating that state-regulated health insurance plans, Medicaid, the State Health Benefits Program and the School Employees’ Health Benefits Program cover “biomarker precision medical testing…for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition, excluding asymptomatic screening, to guide treatment decisions of a subscriber when the test is supported by medical and scientific evidence.”