Other Updates

Takeda Update: 

Takeda, following alignment with the U.S Food and Drug Administration, has announced that EXKIVITY (mobocertinib) is no longer commercially available in the U.S. market.

EXKIVITY was previously indicated for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease had progressed on or after platinum-based chemotherapy.

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information

The Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. October 7, 2021. More Information:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-recognizes-memorial-sloan-kettering-database-molecular-tumor-marker-information

CIGNA ​Medication Administration Site of Care Coverage Policy Update Expands Prior Authorization Requirements

Effective 2/15/21, CIGNA has implemented a drug and biologic coverage policy update ​expanding prior authorization requirements for certain oncology drugs to include a medical necessity review of the site of care. Learn more:

https://static.cigna.com/assets/chcp/pdf/coveragePolicies/pharmacy/ph_1605_coveragepositioncriteria_site_of_care.pdf

Urgent News: Incorrect Denial for Pegfilgrastim and Biosimilars Claims

Date Reported: 8/5/2020
Status: Open
Provider Type Impacted: Jurisdiction 6 and Jurisdiction K Part A outpatient providers
Reason Codes: AA500, AA501
Claim Coding Impact: J2505, Q5108, Q5111

Description of Issue
Pegfilgrastim and Biosimilars claims are denying in error due to an internal systems issue.

National Government Services Action
The Business Support Operations Department is in the process of reviewing the cause of the errors and will determine the action NGS will take.

Provider Action
No provider action is necessary at this time, however, please continue to check the Production Alerts section of our website and future Email Updates for additional information regarding this issue.

Proposed Resolution/Fix
Mass adjustments will be done once the issue has been resolved.

Bristol Myers Seeks to Diversify Trials With $300 Million Pledge

Bristol Myers Squibb Co. will train hundreds of racially and ethnically diverse clinical investigators and set up trial sites in under-served communities as a part of a multimillion-dollar push to improve the way it serves minorities.

The combined $300 million in commitments are part of a broad five-year effort to expand its diversity and inclusion efforts announced on Wednesday by the pharmaceutical company and its foundation. A primary focus will be improving diversity in clinical-trial participation, Chief Executive Officer Giovanni Caforio said in an interview.

https://www.bloomberg.com/news/articles/2020-08-12/bristol-myers-seeks-to-diversify-trials-with-300-million-pledge

The Medically Unlikely Edit Value for KEYTRUDA(R) (pembrolizumab) Has Been Modified as of July 1, 2020

A Medicare Medically Unlikely Edit (MUE) value has been modified for KEYTRUDA^® (pembrolizumab), effective July 1, 2020.

A list of quarterly Procedure-to-Procedure and MUE version update changes from CMS can be found here.

Payer coding and coverage requirements may vary or change over time, so it is important to regularly check with each payer as to payer-specific requirements. The use of this information does not guarantee payment or that any payment will cover your costs. You are solely responsible for determining the appropriate codes and for any action you take in billing.

You can find useful resources at merckaccessprogram.com.

FDA approves new dosing regimen for pembrolizumab

Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen. April 28, 2020.

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-dosing-regimen-pembrolizumab

BAVENCIO dosage modification

On October 19, 2018, the FDA approved modification to the Recommended Dosage section of the PI for BAVENCIO as follows:

 “The recommended dosage of BAVENCIO is 800mg administered as an intravenous infusion over 60 minutes every 2 weeks until diseases progression or unacceptable toxicity.”

Please  refer to the Full Prescribing Information for BAVENCIO  for complete Dosage and Administration information.

NOTE:   There is no change to how BAVENCIO is supplied.  BAVENCIO is supplied as a single-dose vial of 200mg/10mL (20mg/mL) individually packed (11-digit NDC is 44087-3535-01). 

IMFINZI® (durvalumab) is the first immunotherapy to demonstrate significant overall survival benefit in unresectable, Stage III lung cancer

IMFINZI reduced the risk of death by nearly one-third compared to placebo in the Phase III PACIFIC trial

Updated data reaffirm unprecedented improvement in progression-free survival of more than 11 months

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of IMFINZI® (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine. September 25, 2018

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2018/imfinzi-durvalumab-is-the-first-immunotherapy-to-demonstrate-significant-overall-survival-benefit-in-unresectable-stage-iii-lung-cancer-09252018.html#!

Genomic Health Expands Offering to Prostate Cancer Patients with Launch of Oncotype DX® AR-V7 Nucleus Detect™ Test to Predict Treatment Response in Metastatic Disease

New Liquid Biopsy Test Helps Physicians Select Most Effective Treatment, Prolonging Lives of Men with Metastatic Castration-resistant Prostate Cancer

REDWOOD CITY, Calif., Feb. 26, 2018 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced the U.S. commercial launch of the Oncotype DX^® AR-V7 Nucleus Detect™ test. The first and only liquid biopsy test of its kind, the Oncotype DX AR-V7 Nucleus Detect test was developed by Epic Sciences to help prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by accurately detecting a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTCs). Knowledge of a patient's AR-V7 status enables physicians to confidently decide whether men treated with an androgen receptor-signaling inhibitor (ARSI) therapy, such as enzalutamide and abiraterone, need to start another type of ARSI or switch to chemotherapy.