FDA Approves TECENTRIQ® (atezolizumab) for first-line (1L) treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Tecentriq Patient Assistance & Reimbursement Information:

https://www.tecentriq-hcp.com/small-cell-lung-cancer.html

Full Prescribing Information:

https://www.gene.com/download/pdf/tecentriq_prescribing.pdf

FDA Approves TECENTRIQ® (atezolizumab) for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

TECENTRIQ in combination with paclitaxel protein-bound* is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells [IC] of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). *Paclitaxel protein-bound is also referred to as nab-paclitaxel (nab-pac).

Also Genentech is excited to share the news of a new 840 mg vial and new FDA-approved indication for a Genentech therapy. TECENTRIQ® (atezolizumab) is now available in a new 840 mg single-dose vial and has a new dosing schedule.

Please see the attached TECENTRIQ 840 mg Now Available Flashcard, as well as the TECENTRIQ full Prescribing Information, for additional Important Safety Information.

Full Prescribing Information:

https://www.gene.com/download/pdf/tecentriq_prescribing.pdf

TECENTRIQ Flashcard

New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

KEYTRUDA is also indicated for the treatment of patients with unresectable or metastatic melanoma.

·    PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1.

KEYTRUDA® (pembrolizumab) Prescribing Information

The Medication Guide also is available.

UDENYCA™ (pegfilgrastim-cbqv) Q-code Assigned

On November 21, 2018 CMS released their HCPCS Quarterly Update. Included in that update was a new Q-code for  UDENYCA™ (pegfilgrastim-cbqv):

HCPCS Code     Long Descriptor

Q5111           Injection, Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg.

For More Information on billing UDENYCA™ go to: 

www.coheruscomplete.com

Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test - Favorable Draft LCD

Epic Sciences and Genomic Health Announce Favorable Draft Local Coverage Determination (LCD) on Medicare Coverage for Use of the Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test in Patients with Metastatic Castration-Resistant Prostate Cancer.

Medicare Draft Coverage Supports Clinical Utility of the Oncotype DX AR-V7 Nucleus Detect Test, Providing 25,000 Medicare Patients with Coverage Once LCD Is Finalized Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer (mCRPC) may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.  


"The Oncotype DX AR-V7 Nucleus Detect test is the first and only predictive and prognostic test in prostate cancer that can identify which patients will no longer benefit from ARSi therapies, such as enzalutamide and abiraterone, and need to switch to chemotherapy or start another type of therapy in order to extend life," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer." 

LONSURF® Receives New FDA Approval

On February 25, 2019 Taiho Oncology, Inc. announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.  

Click Here to read the entire press release.

https://www.taihooncology.com/us/newsroom/press-releases/2019-02-25-LON-PM-US-1213-FDA-Approves-Gastric

 

IMFINZI® Assigned Unique HCPCS Code J9173

AstraZeneca is pleased to announce that IMFINZI® (Durvalumab) injection has been assigned a unique HCPCS code by the Centers for Medicare & Medicaid Services (CMS).

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 and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs available at:


https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-24243.pdf

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. 

AstraZeneca Access 360™ can help with questions you may have about coding and reimbursement. For additional assistance, please contact your Reimbursement Counselor at 1-833-360-4357, Monday through Friday from 8 AM to 8 PM Eastern Time, or visit www.MyAccess360.com.

References: 1. Centers for Medicare & Medicaid Services. Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. November 2, 2018.

New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

·    PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information

The Medication Guide also is available.