CMS to Release Permanent J-Code for Phesgo™ Injection

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™, Genentech) injection for subcutaneous use will be issued a permanent J-Code that can be used starting January 1, 2021.

This single code (J9316) is to be used for all PHESGO patients and dosage strengths. 

Indications

Early Breast Cancer 
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for

• The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC); and

• The adjuvant treatment of adult patients with HER2-positive early breast cancer (EBC) at high risk of recurrence.

Select patients for therapy based on an FDA-approved companion diagnostic test.

Metastatic Breast Cancer  
Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic test.

See prescribing information.

Posted on 11/19/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients. 

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021.

Read press release. 

Posted on 10/29/2020.

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

Exelixis Access Services® EASE

Exelixis Access Services^® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx^®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey. 

Posted 10/02/2020

Cabozantinib Prescribing Information and Resources

Exelixis has issued prescribing information for cabozantinib (Cabometyx^®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice. 

Access Prescribing Information and Resources.

Posted 10/02/2020

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 Release, Fact 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

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