Forget location. It’s timing, timing, timing when it comes to escaping the first round of U.S. Medicare price negotiations due to pending biosimilar competition. Under the Inflation Reduction Act (IRA), only single-source drugs that have been approved for a specific length of time are subject to the forced negotiations, which focus on drugs with the biggest Medicare spend, not necessarily the highest price tag. Since the IRA gives biologics a 12-year safe harbor from negotiations, which aligns with the biologic exclusivity provided by the Biologic Price Competition and Innovation Act, it creates a scenario in which the innovator could be facing negotiations just as its first biosimilar competition prepares to launch. That creates a lot of what-ifs.
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations.
The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations with the Centers for Medicare & Medicaid Services as part of the Inflation Reduction Act of 2022, U.S. Senate and House Republicans are firing back, calling the imposed “price-controls set by Washington bureaucrats” part of a scheme that “will lead to higher prices for new drugs coming to market, stifle the development of new cures and destroy jobs,” ultimately driving up costs for seniors.
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
With the U.S. Centers for Medicare & Medicaid Services soon expected to publish the list of 10 drugs selected for the first round of the Inflation Reduction Act’s (IRA) price negotiations, Astrazeneca plc is the latest to file a challenge. It’s the first non-U.S.-headquartered company to do so and, unlike the other challenges, Astrazeneca’s complaint focuses on the impact to the Orphan Drug Act (ODA). In a statement, the Cambridge, U.K.-based firm said the “drug price negotiation provisions of the IRA run headlong into the goals” of the ODA.
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S.
The U.S. Centers for Medicare & Medicaid Services has proposed to terminate the coverage with evidence development requirement for the use of positron-emission tomography (PET) imaging for patients suspected of suffering from beta amyloids, a marker of Alzheimer’s disease (AD). However, CMS is also considering a removal of the coverage policy that limits each patient to a single PET scan per lifetime, although the proposal to allow Medicare administrative contractors (MACs) to determine coverage is drawing fire from industry and physician groups alike.
Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service (IRS) said they intend to issue proposed regulations to implement the tax.
RSS
