Radar on Drug Benefits

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. 

As nonpreferred products, Cigna’s new policy lists Formycon/Fresenius’ Otulfi, Celltrion’s Steqeyma and Sandoz/Samsung’s Pyzchiva. Regarding Pyzchiva, the policy notes that patients will instead be “directed to ustekinumab-ttwe,” Quallent’s unbranded version of the drug. 

Amid policymakers’ ongoing scrutiny of the PBM industry, an April report from a key Senate committee likely added more fuel to the criticism by highlighting how vertically integrated health care giants like CVS Health Corp. reap increasing profits from the 340B Drug Pricing Program.  

Further complicating matters, a new court ruling thwarts — at least temporarily — a rebate model created by drugmakers that one expert says could have added much-needed transparency to PBMs’ role in 340B. 

The percentage of people affected by Medicare Part D insurers leaving their geographic market this year significantly increased from previous years, according to a study published on May 14 in JAMA. The results add to the growing literature showing the impact of Part D changes that were part of the Inflation Reduction Act (IRA) and took effect starting this year.  

Health policy experts tell AIS Health, a division of MMIT, that the IRA-mandated shifts have contributed to more people choosing Medicare Advantage Prescription Drug (MA-PD) plans rather than stand-alone Prescription Drug Plans (PDPs), but they say it remains to be seen how potential policies from Donald Trump’s administration will impact the market. 

The FDA will facilitate development of drug importation applications by individual states and Indian tribes in an effort to revive the largely dormant program, reversing years of resistance to the idea at the agency.

The program does not change the existing rules governing state efforts to import cheaper prescription drugs from Canada, which set a high bar for states and tribes interested in submitting importation program proposals to FDA for review and authorization.

The FDA program allowing drug importation from other countries was enacted in 2000 and updated in 2003. The agency established a regulatory framework for importing cheaper drugs in September 2020.

The budget reconciliation package that House Republicans passed on May 22 includes multiple PBM reform measures. In Medicaid, the bill would ban spread pricing and require drug retailers and some non-retail sellers to participate in the National Average Drug Acquisition Cost survey. In Medicare Part D, the legislation would require PBMs to provide detailed information to plan sponsors and HHS about pricing and discounts, and it would force PBMs to “delink” their compensation from the cost or utilization of drug, instead getting paid a set fee. The Congressional Budget Office estimates that the Medicaid PBM restrictions would save about $3 billion over 10 years, but it has not published estimated savings for the Medicare-related PBM provisions.