FDA Approves New Treatment for Hairy Cell Leukemia

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

Read the full FDA announcement here.

Posted 8/20/2018

FDA Approves Nivolumab for Previously Treated SCLC Patients

FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

On August 16, 2018, the Food and Drug Administration approved lenvatinib  (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival.

Read the full FDA press release here.

Posted 8/17/2018

FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

FDA Approves Nivolumab Plus Ipilimumab for Metastatic Colorectal Cancer

CMS Posts MIPS Final Scores, Performance Feedback for Review

On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website. The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.

MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review. 

If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018. The following are examples of circumstances in which you may wish to request a targeted review:

• Errors or data quality issues on the measures and activities you submitted
• Eligibility issues (e.g., you fall below the low-volume threshold and should not have received a payment adjustment)
• Being erroneously excluded from the APM participation list and not being scored under APM scoring standard
• Not being automatically reweighted even though you qualify for automatic reweighting due to the 2017 extreme and uncontrollable circumstances policy

You can access your MIPS final score and performance feedback and request a targeted review by:

• Going to the Quality Payment Program website
• Logging in using your Enterprise Identity Management (EIDM) credentials; these are the same EIDM credentials that allowed you to submit your MIPS data. Please refer to the EIDM User Guide for additional details.

CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:

• MIPS Performance Feedback Fact Sheet: Offers an overview of what performance feedback is, who receives the feedback, and how to access it on the Quality Payment Program website.
• Targeted Review of the 2019 MIPS Payment Adjustment Fact Sheet: Details what a targeted review is and when and how to request a targeted review.
• Targeted Review of the 2019 MIPS Payment Adjustment User Guide: Provides an overview of the targeted review process, and how to access and complete the targeted review request form.
  

For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).

FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer

Pfizer’s Biosimilar Retacrit® Receives Q-Codes

On May 15, 2018 the U.S. Food and Drug Administration approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen^®/Procrit^® (epoetin alfa). Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) in the United States and is approved for the same indications as Epogen/Procrit.

CMS has granted two Q-codes for Retacrit effective July 1, 2018:

Q5105: Injection, epoetin alfa, biosimilar, (Retacrit) (for esrd on dialysis), 100 units

Q5106: Injection, epoetin alfa, biosimilar, (Retacrit) (for non-esrd use), 1000 units

View Codes on CMS Website

FDA Approves Pembrolizumab for Treatment of PMBCL