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Industry News Archive

  • FDA Approves Two Liquid Biopsy Companion Diagnostics for Osimertinib

    On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne® Liquid CDx and Guardant360® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.


    See full prescribing information.

    About FoundationOne® Liquid CDx.

    About Guardant360® CDx.

    Posted 9/24/2020





  • CMS Releases RO Model Final Rule

    On Friday, September 18, 2020 the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Radiation Oncology (RO) Model. The RO Model seeks to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether bundled, prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The RO Model has a five-year Model performance period that begins on January 1, 2021 and runs through December 31, 2025. 

    For additional information on the final rule and the model, please visit the radiation oncology website. The following resource documents about RO may also be helpful: Press ReleaseFact Sheet, and Final Rule. For questions regarding the RO Model, please reach out to the RO Model Helpdesk by phone: 1.844.711.2664, option 5; or email: RadiationTherapy@cms.hhs.gov.

    Posted 9/18/2020

     

     



  • Lilly Announces Thyroid Cancer Testing Program

    Lilly announces their Thyroid Cancer Testing Program designed to provide access to molecular testing for appropriate advanced or metastatic medullary thyroid cancer (“MTC”) patients 12 years of age and older who require systemic therapy; and advanced or metastatic non-medullary thyroid cancer (“non-MTC”) patients 12 years of age and older who are radioactive iodine-refractory (if radioactive iodine is appropriate).

    Appropriate patients are eligible for one molecular test at no cost for the purpose of determining whether the patient has any actionable genetic alterations that may inform therapeutic decisions, without regard to purchase of any prescribed drug or any other product.*

    No patient, healthcare program, payer, or beneficiary shall be billed for any test ordered pursuant to the Thyroid Cancer Testing Program.

    To request a test for your patient <and understand further requirements>, you may download the Thyroid Cancer Testing Program Test Request Form.

    The Thyroid Cancer Testing Program is NOT available to New York State patients and facilities as the aforementioned NGS tests have not been approved by the New York State Department of Health.

    Posted 9/16/2020



  • CMS Issues FY2021 IPPS and LTCH Final Rule

    On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 Long-Term Care Hospitals. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent. 

    CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies.

    Also in the final rule, CMS approved a record number of 24 new technology add-on payments, which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.

    Read the fact sheet and final rule from the Federal Register.

    Posted 9/2/2020



  • FDA Approves Azacitidine for AML Continued Treatment

    On September 1, 2020 the U.S. Food and Drug Administration (FDA) approved Onureg® (azacitidine) for the continued treatment of patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.

    Read the Bristol Myers Squibb announcement.

    Read the FDA announcement.

    Posted 9/2/2020


  • CMS Releases CY 2021 OPPS and PFS Proposed Rules

    On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and council are reviewing these proposed rules and will be providing comments.

    Until this analysis is complete, read the proposed OPPS rule and the proposed PFS rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.


    Posted 8/6/2020



  • FDA Approves Tafasitamab-cxix + Lenalidomide for R/R DLBCL

    On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

    Read corporate press release.

    Read FDA announcement.

    Posted 8/3/20



  • FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

    MSI-H/dMMR testing is required prior to initiating treatment with Keytruda in these patients. For the MSI-H/dMMR indication, select patients for treatment with Keytruda as a single agent based on MSI-H/dMMR status in tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.

    Read prescribing information and medication guide

    Posted 7/17/2020



  • FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. 

    Read FDA announcement and prescribing information

     

    Posted 7/14/2020



  • Enhertu Receives Permanent J-Code

    Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) has a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.

    For full prescribing information, click here

    Posted 7/7/20



  • Update: COVID-19 Emergency Food Assistance Grant Amount Change

    Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.

    To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.  

    This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.

    Who is Eligible?

    Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.

    For more information, including application instructions, click here.  

    Posted 7/2/2020



  • FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

    Read FDA announcement.

    Posted 6/30/2020



  • FDA Approves Pembrolizumab for Recurrent or Metastatic cSCC

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

    Read the FDA announcement.

    Posted 6/24/2020



  • FDA Approves Cyramza for First-Line Treatment of Metastatic EGFR-Mutated NSCLC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab injection, 10 mg/mL solution (Cyramza®, Eli Lilly and Company) in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.

    Read the press release

    Posted 6/22/2020




  • FDA Approves Tabrecta for Metastatic NSCLC with METex14

    On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

    Read corporate press release

    Posted 6/22/2020



  • Pfizer Oncology Personalized Support

    At Pfizer Oncology Together, patient support is at the core of everything they do. From helping to identify financial assistance options to connecting patients to resources for emotional support, the needs of patients prescribed Pfizer Oncology medications are a top priority.

    Pfizer Oncology Field Reimbursement Managers (FRMs) can help address challenging or urgent Pfizer Oncology patient access cases. Click here for the FRM contact in Arizona.
     
    Posted 6/22/2020



  • FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

    On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

    Read the FDA announcement.

    Posted 6/17/2020



  • FDA Extends Indication of Gemtuzumab Ozogamicin to CD33-Positive AML Pediatric Patients

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.

    Read FDA announcement.

    Posted 6/16/2020



  • FDA Approves HPV Vaccine Gardasil 9 for Prevention of Certain Head & Neck Cancers

    On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

    Read the corporate press release.

    Posted 6/15/2020



  • CMS Issues Product-Specific J-code for Adakveo®

    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.

    Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (injection, crizanlizumab-tmca, 1 mg, hospital outpatient).

    See full prescribing information.

    Posted 6/12/20




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