Industry News

  • 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


  • Imfinzi Assigned Unique HCPCS Code for Reimbursement by CMS

    Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab, AstraZeneca) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs:

    • J9173: Injection, durvalumab, 10 m
    Read the full CY 2019 OPPS Final Rule here.

    Posted 11/20/2018


  • FDA Approves Pembrolizumab for Hepatocellular Carcinoma

    On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Read the Merck press release here.

    Posted 11/12/2018


  • FDA Approves Elotuzumab, Pomalidomide, Dexamethasone for Multiple Myeloma

    On November 6, Bristol-Myers Squibb Company announced that the Food and Drug Administration approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

    Read the Bristol-Myers Squibb press release here.

    Posted 11/7/2018


  • FDA Approves Lorlatinib for ALK+ Metastatic NSCLC

    On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    Read the full FDA press release here.

    Posted 11/5/2018




  • FDA Approves Pembrolizumab for First-Line Treatment of Metastatic Squamous NSCLC

    On October 30, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

    Read the full FDA press release here.

    Posted 10/31/2018


  • FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer

    On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.).

    Read the full FDA press release here.

    Posted 10/16/18



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