Industry News
The following section is additional information posted from our Corporate members to supplement product announcements.
2020
- Janssen Oncology shares five resources:
Medicare Part D For Patients with Prostate Cancer, Medicare Part D Extra Help/Low-Income Subsidy (LIS) for Patients with Prostate Cancer,
2021 Medicare Open Enrollment MEDIGAP Considerations, Medicare Advantage and Part D Prescription Drug Coverage, and Health Plans in the Insurance Marketplace.
- Bristol Myers Squibb announces that on September 1, 2020, the FDA approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy. AML is one of the most common acute leukemias in adults. More information. September 1, 2020.
- Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (DECITABINE AND CEDAZURIDINE) tablets, oral hypomethylating agent (HMA) therapy for intermediate and high-risk MDS and CMML. Click for more information.
- Merck announces a change from CMS regarding ONTRUZANT®(trastuzumab-dttb), for injection, for intravenous use 21 mg/mL, which has a Q-code of Q5112. As of July 2020, Centers for Medicare & Medicaid Services (CMS) has issued a Corrected Addendum B to update the non-payable status for ONTRUZANT (Q5112) to Status Indicator “K”, which allows for Medicare reimbursement and is retroactive to April 15, 2020. Click to read Addendum A and Addendum B from CMS. Click here to review the "July 2020 Correction" for Addendum B.
- Merck announces that the FDA has approved KEYTRUDA® (pembrolizumab) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). Click here for more information.
- Genentech announces that TECENTRIQ® (atezolizumab), in combination with bevacizumab, has been approved by the FDA for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment. Click for information on TECENTRIQ and AVASTIN. Click here for important safety information. Click
- Merck announces that a Medicare Medically Unlikely Edit (MUE) value has been modified for KEYTRUDA® (pembrolizumab). The MUE for KEYTRUDA was modified effective July 1, 2020. A list of quarterly Procedure-to-Procedure and MUE version update changes from CMS can be found here.
- Merck announces that KEYTRUDA® (pembrolizumab) injection 100 mg has been approved by the FDA for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Click here for more.
- AstraZeneca and Daiichi Sankyo, Inc. announce permanent Jcode effective July 1st for ENHERTU. Click here for more.
- Pfizer is announcing preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen for potential publication. Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers. More information.
- Genentech, Inc. announces that on June 29, 2020, the Food and Drug Administration (FDA) approved PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. PHESGO is a fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase,
an endoglycosidase.1 More information.
- EMD Serono and Pfizer Inc. announces that on June 30, 2020 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication. BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc. Please refer to the revised Full Prescribing Information for BAVENCIO.
- Johnson & Johnson: Key Takeaways: FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule: Chimeric Antigen Receptor (CAR) T-Cell Therapy and Hospital Market-Based Data Reporting. Comments due July 10, 2020. Click here for more information.
- Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg. The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types. Click here for more information. June 15, 2020.
- Bristol Myers Squibb announces that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. More information. May 26, 2020
- Merck Sharp & Dohme Corp. ("Merck") announces that ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use 21 mg/mL, a biosimilar* to Herceptin® (trastuzumab), is available through specialty distributors and wholesalers. Please contact your specialty distributor or wholesaler to confirm product availability. More Information. April 21, 2020.
- AstraZeneca Pharmaceuticals announces a webinar entitled "IMFINZI® (durvalumab) in Combination with Chemotherapy for the Treatment of ES-SCLC, on April 21, 2020, Find out more.
- AstraZeneca Pharmaceuticals announces IMFINZI® (durvalumab) sample treatment plan template for the first-line treatment of adult patients with extensive-stage small cell lung cancer in combination with etoposide and either carboplatin or cisplatin as an example of an Electronic Health Record (EHR) order set, Find out more.
- Pfizer Oncology is pleased to announce that IBRANCE® (palbociclib) is transitioning from capsules to tablets. Click here for more.
- Novartis is pleased to announce that, effective April 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific C-code, C9053 for 100 mg/10 mL (10 mg/mL) solution in a single-dose vial of ADAKVEO® (crizanlizumab-tmca) for IV infusion. Click here for more.
- On February 18, 2020, 106 organizations representing patients, providers, medical researchers, survivors, and families joined together to urge Congress to include the bipartisan CLINICAL TREATMENT Act (H.R. 913) in the upcoming ‘must pass’ healthcare extenders package, which is expected to pass this spring. Find out more
- Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for POLIVY™ (polatuzumab vedotin-piiq). POLIVY received FDA approval on June 10, 2019: Click here for more.
2019
2018
- Gennetech - The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Click here for more.
- Genentech announced the FDA granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. The Genentech press release including Important Safety Information is linked here. Click here for prescribing information.