Oncology Newsfeed

Verma: CAR-T NCD "New Ground" for CMS, Agency Needs More Time

On May 17, the Centers for Medicare & Medicaid Services (CMS) abruptly announced a delay in its release of a Medicare National Coverage Determination (NCD) for CAR T-cell therapy, which was due to be published that same day. The agency statement did not provide an explanation for the delay.

In a meeting with reporters on Wednesday, May 22, CMS Administrator Seema Verma said that the agency is taking care with the NCD because not only is the technology "new ground" for CMS, but also application of CAR-T therapy is expected to expand to other types of cancer beyond lymphoma. “So we want to make sure that we’re doing this appropriately, dotting our i’s and crossing our t’s. It’s just taking a little bit more time because it’s not a routine type of decision,” Verma said.

Source: Inside Health Policy
Posted 5/23/2019

CMS Releases Finalized Medicare Advantage & Part D Rule

On May 16, the Centers for Medicare & Medicaid Services (CMS) released their final rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Highlights from this final rule include:

• Reversal from the outlined proposed rule that would have allowed for significant change to the Medicare Part D six protected classes and coverage of these important therapies.
• Part D plan sponsors will be required to implement an electronic real-time benefit tool (RTBT) with the goal of increasing price transparency. This tool seeks to be capable of integrating with at least one prescriber's electronic prescribing system or electronic health record.

The ACCC policy team will continue to analyze this rule and provide a more detailed analysis at a later date.

Read the CMS final rule here.

Posted 5/17/2019

FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

FDA Approves Avelumab Plus Axitinib for Advanced RCC

On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

Read the Pfizer press release.

Posted 5/15/2019

FDA Issues Final Guidance to Manufacturers on Biosimilars' Pathway to Interchangeability

On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars.  

Read statement from acting FDA Commissioner Ned Sharpless, MD.

Posted 5/13/2019

FDA Approves Ramucirumab for HCC

On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

FDA Approves Ado-Trastuzumab Emtansine for HER2+ Breast Cancer

FDA Approves Ivosidenib for AML

AUA Releases New Guidance for Testicular Cancer, Radiotherapy after Prostatectomy

ACS: More than Half of Americans Report Medical Financial Hardship

A new study by researchers from the American Cancer Society (ACS) finds that approximately 137 million adults in America (56 percent) reported having medical financial hardship in the past year. Highlights of the report include:

• Adults aged 18 to 64 reported higher material (i.e. trouble paying medical bills), psychological (i.e. concern about medical bills), and behavioral (delaying or forgoing care because of cost) medical financial hardship than those aged 65 and older.
• Among adults aged 18 to 64, those with less education and more health conditions reported greater intensity of hardship.
• Women were more likely to report multiple domains of hardship than men.
• Uninsured adults were more likely to report multiple domains of hardship than those with public or private insurance.