Oncology Newsfeed

Nobel Prize in Medicine Awarded to Two Cancer Immunotherapy Researchers

The Nobel Assembly at Karolinska Institute announced on Monday, Oct. 1, the 2018 Nobel Prize in Physiology or Medicine was awarded to James P. Allison, PhD, of The University of Texas MD Anderson Cancer Center in Houston, and Tasuku Honjo, MD, PhD, Deputy Director-General and Distinguished Professor of Kyoto University Institute for Advanced Study in Japan, for their discovery of cancer therapy by inhibition of negative immune regulation.

Their work laid the foundation for a new class of cancer drugs, checkpoint inhibitors, and established a fourth pillar of cancer treatment—immunotherapy.

In a statement, the Nobel Assembly lauded the two Laureates for creating “an entirely new principle for cancer therapy.”

Read the Nobel Assembly statement.

Listen to Dr. Allison's remarks at a press briefing on Oct. 1 during the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference.

Posted 10/2/18

HHS OIG Report Raises Concerns About Medicare Advantage Step Therapy

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a report that raises concerns about the beneficiary impact of the Centers for Medicare & Medicaid Services’ (CMS) new “fail first” step therapy policy for Medicare Advantage (MA) beneficiaries beginning in 2019. The report's findings include:

• A “central concern” in the MA program is that plans have “potential incentives” to “inappropriately deny access to services and payment in an attempt to increase their own profit.”
• 75% of MA plans’ coverage or payment denials were overturned at the first level of appeal, and additional denials were overturned in later stages of appeal.
• Treatment disruptions and coverage delays that are already regularly taking place in the MA program will be exacerbated under the new “fail first” policy.
• Beneficiaries and providers appealed only one percent of denials by MA plans, which may be due to the “confusing and overwhelming” process for many beneficiaries. 
• MA plans’ inaccurate coverage denials are particularly difficult for the MA patient population, finding that treatment delays “may be especially burdensome for beneficiaries with urgent health conditions.”

FDA Approves NGS Test to Detect MRD in ALL and Myeloma

On September 28, 2018, the U.S. Food and Drug Administration announced that the agency is permitting marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients.

Read details in the FDA announcement.

Posted 10/1/18

FDA Approves Cemiplimab-rwlc for Cutaneous Squamous Cell Carcinoma

FDA Approves Dacomitinib for Metastatic NSCLC

House Approves Legislation Banning Pharmacist “Gag Clauses”

On Tuesday, September 25, 2018, the U.S. House passed by voice vote two Senate bills that ban so-called "gag clauses" which prevent pharmacists from informing consumers when it would cost less to pay out-of-pocket for prescriptions drugs instead of using their health insurance.

On Monday, the U.S. Senate passed two pieces of legislation that would prohibit such "gag clauses." The Patient Right to Know Drug Prices Act, S. 2554, impacts private health plans including those in the ACA marketplace, and the Know the Lowest Price Act of 2018, S. 2553, covers Medicare Advantage and Part D plans. 

FDA Approves Duvelisib for CLL/SLL, FL

ACCC Submits Comments to Proposed 2019 OPPS Rule

On September 24, 2018, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed CY 2019 Outpatient Prospective Payment System (OPPS) rule.

In its comments, ACCC recommends that CMS:

• Not finalize its proposal to reduce reimbursement to Wholesale Acquisition Cost (WAC) plus 3 percent for new drugs and biologicals that do not yet have adequate Average Sales Price (ASP) data;


• Not finalize its proposal to reduce payment for separately payable drugs purchased under the 340B program at nonexcepted hospital off-campus provided-based departments;


• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for certain clinic visits furnished at excepted off-campus provider-based departments;


• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for service-line expansions at excepted off-campus provider-based departments;


• Clarify how hospital should bill for furnishing certain outpatient services related to CAR T-cell therapies and ensure that hospitals are paid appropriately for furnishing these therapies; and


• Ensure that any model based on Competitive Acquisition Program (CAP) authority is voluntary for all participants, preserves patient access to treatment and provider flexibility, and promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.

Pfizer Announces Relief for Cancer Patients Affected by Hurricane Florence

Pfizer Oncology has announced emergency relief protocols to ensure that patients who receive their Pfizer Oncology medicines through the Pfizer Patient Assistance Program and are impacted by Hurricane Florence have continued access to their medications.

Hogan Lovells to Host Webinar on Legal Considerations of Telehealth

• Recent and proposed expansion of Medicare coverage of telehealth services
• State law considerations in providing telehealth
• Fraud and abuse issues in telehealth
• Innovations, future trends, and the evolution of what’s considered “telehealth”