FDA Approves Vitrakvi® (larotrectinib)

FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion1,2 

• First treatment with a tumor-agnostic indication at the time of initial FDA approval

• 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children (N=55)2

• Adverse events (AE) of any grade observed in 20% or more of patients, regardless of attribution, included increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%)2

Vitrakvi will be available in oral capsules as well as a liquid formulation for adults and children.2

Bayer to Provide Comprehensive Value and Access Programs

Bayer is committed to ensuring that patients in the U.S. who are prescribed Vitrakvi are able to access the medication and receive the support they may need. As part of this commitment, Bayer is providing two comprehensive programs, the Vitrakvi Commitment ProgramTM and the TRAK AssistTM patient support program. 

The Vitrakvi Commitment Program will refund the cost of Vitrakvi to payers, patients and third-party organizations paying on behalf of patients, in the event eligible patients do not experience clinical benefit within 90 days of treatment initiation. Eligible patients include those who have tested positive for an NTRK gene fusion, have not received clinical benefit within 90 days of treatment initiation, and received Vitrakvi from an in-network specialty pharmacy.

 

The TRAK AssistTM patient support program provides comprehensive reimbursement support and patient assistance services. For more information and eligibility requirements, please call 1-844-634-TRAK (8725) or www.vitrakvi.com .

Click Here to read the Press Release.

Click Here to read the Prescribing Information. 

New J Code for Rituxan

The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). 

Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. 

Click Here for the RITUXAN AND RITUXAN HYCELA J-Code Flash Card provided by Genentech. 

Apple Health (Medicaid) Provider Alert

What is changing? 

There is no change to the agency’s current process for hospice 5-day notification for Washington Apple Health (Medicaid) clients. 

When does the agency require a completed hospice 5-day notification?

The agency requires a completed hospice 5-day notification form (HCA/Medicaid Hospice Notification, HCA 13-746) when the client is enrolled in hospice and resides in a nursing home, or may be admitted to a nursing home, and is one of the following: 

  • A Medicare client whose Medicaid eligibility is pending or who has not yet applied for Medicaid; or
  • A dual-eligible client (currently enrolled in Medicare and Medicaid). 

Please review the HCA/Medicaid Hospice Notification (HCA 13-746) form for complete and valid information, including current attending physician. The agency will return incomplete or incorrect forms by fax. To download an agency provider form, go to HCA’s Billers and provider’s web page, select Forms & publications.

When does the agency NOT require a completed hospice 5-day notification? 

Do not send an HCA/Medicaid Hospice Notification form to the agency for anyone who is private pay and not enrolled in Washington Apple Health (Medicaid). 

New FDA Approval for TALZENNA®

Pfizer announced the FDA approval of TALZENNA® (talazoparib) on October 16, 2018. 

Prescribing Information: click here

FDA Approves a New Dosing Frequency for  KYPROLIS® (carfilzomib) and dexamethasone

On October 1, 2018 Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. 

Click Here to read the entire Press Release

Click Here for more information on Kyprolis

FDA Approval of LORBRENA® (lorlatinib)

Pfizer Oncology is proud to announce the FDA approval of LORBRENA® (lorlatinib) on Friday, November 2, 2018.

Click here  to read the Press Release.

Visit LORBRENA U.S. Physician Prescribing Information to read the full PI.

New FDA Approval for Empliciti

On November 6, 2018 Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Click Here to read the entire Press Release

Click Here to read the Prescribing Information

New FDA Approval for KEYTRUDA®

On October 30, 2018 Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial. In the pivotal Phase 3 trial of patients regardless of tumor PD-L1 expression status, KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017). This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.

Click Here to read the entire Press Release

Click Here for the Prescribing Information

Click Here for the Keytruda Medication Guide