Spotlight on Market Access

Pharma manufacturers are facing both internal and external pressures when it comes to demonstrating value and securing reimbursement. Many are restructuring their health economics and outcomes research (HEOR) teams within organizations while at the same time grappling with industry pressures such as the Inflation Reduction Act (IRA) and state prescription drug affordability boards (PDABs). AIS Health, a division of MMIT, spoke with Avalere Health Advisory’s Taylor Schwartz, a managing director, and Amy Schroeder, R.Ph., a principal research scientist, about how companies are successfully managing these pressures.

When deciding how to cover Stelara (ustekinumab) and its recent spate of follow-on products, prominent PBMs and payers are favoring Biocon Biologics Ltd.’s Yesintek and their own private-label biosimilars — including one that has been the target of litigation. 

Cigna Healthcare, a division of The Cigna Group, on May 15 issued a new drug-coverage policy that prefers branded Stelara, Yesintek, Alvotech/Teva’s Selarsdi and ustekinumab-ttwe, a biosimilar manufactured by Cigna subsidiary Quallent Pharmaceuticals. 

The Trump administration on May 22 revealed multiple initiatives to improve health care price transparency, including updating guidance for health plans to publish data and seeking public input via requests for information (RFIs). Kolton Gustafson, an Avalere Health principal, tells AIS Health the announcements are “very significant for both plans and pharmaceutical manufacturers,” although he notes it is still to be determined whether they will lead to lower prices for health care services and prescription medications.  

The administration said the moves by HHS, along with the Labor and Treasury departments, will strengthen the Transparency in Coverage (TiC) rule, which was finalized in November 2020 and required health insurance companies to publicly post in-network rates, out-of-network allowed amounts and other data, as well as the Hospital Price Transparency rule, which was finalized in November 2019 and required hospitals to publicly disclose gross charges, cash prices, negotiated rates and other information.  

As expected, President Donald Trump signed an executive order on May 12 that would revisit the idea of implementing most-favored nation (MFN) pricing. 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.

In the order, Trump noted that while the U.S. has less than 5% of the population in the world, it “funds around three quarters of global pharmaceutical profits,” an “egregious imbalance…orchestrated through a purposeful scheme” by pharma manufacturers “deeply discount[ing]” their drugs in foreign markets and charging “enormously high prices” in the U.S. to “subsidize” the lower prices outside the country.

In April, New Jersey became the 21st state to sign into law legislation mandating coverage of biomarker testing for state-regulated plans. But gaps still exist in coverage: 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.

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.”