Industry News

FDA Approves Ibrutinib Plus Obinutuzumab for CLL/SLL
On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Read the Janssen press release here.

Posted January 28, 2019

Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma
On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

Read the Adaptive Biotechnologies press release here.

Posted 1/23/2019

FDA Approves Cabozantinib for Previously Treated HCC
On January 14, Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Read the full Exelixis, Inc. press release here.

Posted 1/15/2019

FDA Approves Olaparib for Ovarian, Fallopian, Peritoneal Cancers

On December 19, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

Read the FDA press release here.

Posted 12/19/2018

FDA Approves Pembrolizumab for Merkel Cell Carcinoma

On December 19, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Read the FDA press release here.

Posted 12/19/2018

CMS Assigns Unique HCPCS Code for Imfinzi

Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System and Quality Reporting Program:
- J9173: Injection, durvalumab, 10 mg (APC 9492, SI G, Payment Rate $73.971*)
* The payment rate is the average sales price (ASP) per 10mg of Imfinzi as documented by the CMS Hospital Outpatient PPS Addendum A. Effective from January 1, 2019 through March 31, 2019.

Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement. Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims.

Posted 12/19/2018

CMS Assigns New J-Codes for Rituxan and Rituxan Hycela
Effective January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) has assigned new J-codes for Rituxan and Rituxan Hycela (Genentech, Inc.):
- J9312: Injection, rituximab, 10 mg (replaces J-code J9310)
- J9311: Injection, rituximab 10 mg and hyaluronidase
These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements.

Read more about the new J-codes for Rituxan and Rituxan Hycela here.

Posted 12/7/2018

FDA Approves Atezolizumab for Metastatic NSq NSCLC
On December 6, 2018, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

Read FDA announcement.

Posted 12/7/2018

FDA Approves Gilteritinib for Acute Myeloid Leukemia

On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

Read the full FDA press release here.

Posted 11/28/2018

FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion
On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

Read the full FDA press release here.

Posted 11/27/2018

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