Another New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA is now the only anti–PD-1 approved in combination with carbo/pem for the first-line treatment of patients with nonsquamous metastatic NSCLC (mNSCLC) irrespective of PD-L1 expression. KEYTRUDA is also the only anti–PD-1 approved as first-line monotherapy for patients with nonsquamous and squamous mNSCLC whose tumors have high PD-L1 expression (TPS ≥50%) and are negative for EGFR and ALK genomic tumor aberrations.

Press Release

Announcement Letter

Webinar:First-line Treatment Options for Metastatic Non–Small Cell Lung Cancer (NSCLC)

Merck is sponsoring an interactive live webcast entitled: First-line Treatment Options for Metastatic Non–Small Cell Lung Cancer (NSCLC) 

Learning Objectives 

  •  Understand the clinical data associated with the first-line treatment options for metastatic NSCLC 
  •  Identify the appropriate patient with metastatic NSCLC eligible for first-line treatment option 

Click Here to read the Webcast invitation and for directions on registering for the event. 

New FDA Approval for KEYTRUDA®

On March 14, 2017, Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication is approved 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. 

Click Here to read the entire Press Release. 

Additional Information:


Announcement Letter

Approval Letter

Prescribing Information

Medication Guide

SUSTOL® Receives NCCN Category 1 Recommendation

On February 24, 2017, Heron Therapeutics, Inc. announced the inclusion of SUSTOL® (granisetron) extended-release injection as part of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis Version 1.2017. 

The NCCN has given SUSTOL a Category 1 recommendation, the highest level category of evidence and consensus, for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving HEC or MEC regimens. Importantly, the guidelines identify SUSTOL as a “preferred” agent for preventing CINV following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL. 

Click Here to read the entire Press Release

Click Here to read the NCCN Guidelines

Oncotype DX Press Release re: AJCC Cancer Staging Manual

REDWOOD CITY, Calif., Dec. 22, 2016 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that based on unparalleled clinical evidence, the American Joint Committee on Cancer (AJCC) incorporated the Oncotype DX® test in its recently published Eighth Edition AJCC Cancer Staging Manual. Representing a rigorous, multi-disciplinary assessment, the updated criteria identify Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on clinical evidence in more than 63,000 patients.

"For the first time, AJCC has added molecular signatures to complement the traditional anatomic features of the disease, transitioning cancer diagnosis and care to truly personalized medicine," said Steven Shak, M.D., chief scientific officer, Genomic Health. "We believe this groundbreaking milestone will enhance physicians' ability to deliver the excellent patient outcomes demonstrated across multiple prospective studies of the Oncotype DX test."

Effective January 2018, the new AJCC Prognostic Stage Groups will add the Oncotype DX Breast Recurrence Score™, hormonal status (ER, PR), and HER2 status to nodal status, tumor size, and tumor grade for staging breast cancer. For patients with node-negative disease or micrometastases in the nodes, a low Oncotype DX Recurrence Score (RS<11) classifies a patient as having the most favorable Prognostic Stage, regardless of tumor grade or tumor size (up to five centimeters).

As part of the implementation process, all AJCC partners, including the College of American Pathologists (CAP) and the National Comprehensive Cancer Network (NCCN), will develop and update protocols and tools to facilitate successful adoption of the required new staging system rules in 2018. The electronic version of the Eighth Edition AJCC Cancer Staging Manual is scheduled to be available the first quarter of 2017.

As stated in the AJCC publication1, "Based on the best available evidence at this time, the Expert Panel determined that it was appropriate to incorporate multigene molecular profiling to incorporate the Oncotype DX score into staging for the subgroup of patients defined by Arm A of the TAILORx study. These patients should be staged according to the AJCC Prognostic Stage Groups. The findings for the ODX (Oncotype DX) test are supported by Level I Evidence (large-scale prospective clinical trial data)."

The results of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) were published in The New England Journal of Medicine in 2015. Additionally, the Eighth Edition AJCC Cancer Staging Manual cites clinical outcomes data from tens of thousands of patients in the United States generated by the Surveillance, Epidemiology, and End Results (SEER) Registry program of the National Cancer Institute (NCI), demonstrating that patients with low Recurrence Scores have excellent breast cancer survival at five years.

Billing for the Administration of Onpro®

The new CPT code 96377 Application of on-body injector (includes cannula insertion) for timed subcutaneous injection. became effective January 1, 2017.

Certain commercial payors are paying on CPT 96377. 

However, CMS assigned this new code Status Indicator "I" (inactive) on the Medicare Physician Fee Schedule. As the status indicator is determined by CMS, individual Medicare contractors have no discretion to alter such a status.  

Although individual Medicare contractors can price the code (and many did quite a while ago), they cannot pay it. Any claim submitted with 96377 will be rejected since that is an invalid code.  

Last year, when this drug was first marketed packaged with the disposable pump, Noridian suggested to providers to bill as they usually would with the appropriate subcutaneous injection code, 96372. Noridian Medical Director, Richard Whitten, has confirmed that providers may bill for the administration of Neulasta® (pegfilgrastim) Onpro® with CPT 96372.

Below is a link to Noridian's current policy on billing for J2505

https://med.noridianmedicare.com/web/jeb/policies/coverage-articles/pegfilgrastim-neulasta-j2505.  

In light of this information from Noridian, providers may want to correct claims filed with the denied CPT 96377 using CPT 96372 in its place. 

New HCPCS Code for IMLYGIC

The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) code specific to IMLYGIC (talimogene laherparepvec).

The new code, J9325, is defined as injection, talimogene laherparepvec, per 1 million plaque forming units (PFU). This code is effective January 1, 2017. 

New HCPCS Code for Portrazza® (necitumumab)

Effective January 1, 2017 there is a a product‐specific Healthcare Common Procedure Coding System (HCPCS) code forPortrazza® (necitumumab) for injection.


The new code, J9295, is defined as “injection, necitumumab, 1 mg.” This code is effective January 1, 2017.