Industry News

FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment
On April 11, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

Read the FDA press release here.

Posted 4/12/2019

FDA Expands Palbociclib Use to Include Male Breast Cancer Patients
On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

Read the full FDA press release here.

Posted 4/5/2019

HCPCS Assigns J-Code and ASP for Imfinzi

Imfinzi (durvalumab) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and average sales price (ASP) by the Centers for Medicare & Medicaide Services (CMS). The following code can be used to identify Imfinzi when billing across settings of care:
- J9173: Injection, durvalumab, 10 mg (vial size 500mg/10 mL, billing unit 50 units, NDC 0310-4611-50)
- J9173: Injection, durvalumab, 10 mg (vial size 120mg/2.4 mL, billing unit 12 units, NDC 0310-4500-12)
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. Imfinzi is listed in the April 2019 ASP Pricing File:
- J9173: Inj., durvalumab, 10 mg (HCPCS code dosage 10MG, payment limit $73.778).
Posted 12/19/2018

FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin
On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera^™), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Read the Pfizer press release here.

Posted 3/12/2019

FDA Approves Pembrolizumab for Melanoma
On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Read the FDA press release here.

Posted 2/19/2019

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 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

FDA Approves Glasdegib for Acute Myeloid Leukemia
On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/2018

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