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 Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma

On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

Read the FDA Announcement.

Read the Bristol Myers Squibb Announcement.

Posted 10/5/2020 

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

Sanofi Announces Permanent J-Code for Isatuximab-irfc

On October 1, 2020, the isatuximab-irfc (Sarclisa^®, Sanofi Genzyme) healthcare common procedure coding system (HCPCS) level II J code (J9227) will be effective. 

Read the one pager. 

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.

Posted 9/16/2020

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

NGS Alert for Pegfilgrastim Product Claims