OBR Daily Commentary - Lymphoma (includes NHL, HL, CNS Lymphoma)

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FDA Alerts More Doctors Of Rare Cancer With Breast Implants

(Fox News/Associated Press) Feb 7, 2019 - U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease.

William McGivney, PhD (Posted: February 11, 2019)

quotesBreast Implants; Déjà Vu All Over Again Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”. For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage. The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer. It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers. quotes

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FDA Approves First-Line Treatment For Peripheral T-Cell Lymphoma Under New Review Pilot

(FDA.gov) Nov 16, 2018 - The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly. “The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.

T Cao (Posted: November 16, 2018)

quotesIt seems too early to approve this drug.quotes

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U.S. Medicare Sets Outpatient Rate For Yescarta Reimbursement

(Reuters) Apr 5, 2018 - Medicare, the U.S. government healthcare program for the elderly and disabled, will pay hospitals close to its standard mark-up rate for administering cell therapy Yescarta for cancer outpatients, who will have a co-payment of nearly $80,000, according to the Centers for Medicare & Medicaid Services (CMS).

Winston Wong, PharmD (Posted: April 09, 2018)

quotesCMS has set the reimbursement for their near normal outpatient rate, thus CMS is treating the CAR-T therapies as an outlier, since the normal hospital reimbursement would be based upon the DRG. Given the co-pay cap, there seems to be little margin for the institution. Need to watch can see what will happen with the additional service reimbursement request.quotes

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Tomasz M. Beer, MD, FACP

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