Oncology News in Brief:


FDA Approves KEYTRUDA® for Patients with Certain Bladder Cancer

On May 18, 2017, Merck announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In the second-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read the full press release here.

Additional resources:
Prescribing Information
Medication Guide
Safety Information

Posted 6/16/2017


KEYTRUDA® Now approved for Adult and Pediatric Patients with Unresectable or Metastatic MSI-H or dMMR Solid Tumors

On May 25, 2017, Merck announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for a first-of-its-kind indication: the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient, solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Read the full press release here.

Additional resources:
Prescribing Information
Medication Guide
Indication Brochure

Posted 6/16/2017


FDA Approves KEYTRUDA® For Several New Indications

On May 18, 2017, Merck announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.In the second-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read the full press release here.

Additional resources:
Prescribing Information
Medication Guide

Merck is also pleased to announce that KEYTRUDA is now approved for 200-mg fixed-dose administration in patients with unresectable or metastatic melanoma.

Safety information can be found here.

Posted 6/1/2017


KEYTRUDA: Now approved in combination with Carboplatin/Pemetrexed (CARBO/PEM)

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.

Read the full announcement letter here.

Additional resources:
Prescribing Information
Medication Guide

Posted 5/17/2017


Important information regarding Herceptin®

Genentech would like to make you aware of an upcoming change to Herceptin (trastuzumab). Recently, the FDA approved a revised USPI for Herceptin (dated 04/2017) that lists a new 150mg singe-dose configuration, along with additional label changes to meet updated FDA guidance. The new 150mg single-dose vial configuration for Herceptin will be introduced on May 30, 2017.

Important information for you to know:

An overview of Herceptin access aolutions services, billing, and coding can be found here.

Genentech is committed to delivering Herceptin to providers and patients. Decisions on how we manufacture and package our medicines are taken very seriously and all of our medicines, including all configurations of Herceptin, are packaged to meet FDA regulations and specifications. If you have any questions, please contact me or call the Genentech Customer Service Department at 1-800-551-2231, Monday through Friday, 6:00AM to 5:00PM PST.

Posted 5/10/2017


Pfizer announces a new, expanded indication for IBRANCE® (palbociclib)

Pfizer Oncology is proud to announce that IBRANCE may now be prescribed in combination with any aromatase inhibitor for the initial treatment of postmenopausal women with HR+/HER2- metastatic breast cancer (MBC), expanding options for your patients.

IBRANCE is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:

Read the full Pfizer press release and prescribing information here.

Posted 4/6/2017


REVLIMID® (lenalidomide) Receives Approval for use as Maintenance Therapy for MM Patients After auto-HSCT

Celgene Corporation is pleased to announce the new approval for the use of REVLIMID® (lenalidomide) as maintenance therapy for MM patients after autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is indicated as maintenance therapy in patients with multiple myeloma (MM) following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Read the full Celgene Corporation release here.

Posted 3/31/2017


KEYTRUDA Approved for Refractory or Relapsed classical Hodgkin Lymphoma (cHL)

KENILWORTH, N.J., March 14, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today 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.

Read the full MERCK press release here.

Posted 3/21/2017


BMS Recieves FDA Approval for Opdivo in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma

On Thursday, February 2, 2017, the Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read the BMS press release here.

Posted 2/6/2017


CMS assigns permanent Healthcare Common Procedure Coding System (HCPCS) code specific to IMLYGIC®

AMGEN in pleased to announce that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) code specific to IMLYGIC® (talimogene laherparepvec).

INDICATION
IMLYGIC® is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases

The new code, J9325, is defined as “injection, talimogene laherparepvec, per 1 million plaque forming units.” This code is effective January 1, 20171.

IMLYGIC® was the first oncolytic virus approved by the U.S. Food and Drug Administration on October 27, 20152. IMLYGIC® is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.

The number of service units billed will be based on the IMLYGIC® dosage strength administered. When administering the 1 million PFU per 1 mL vial (106 PFU/mL), bill 1 service unit/per vial. When administering the 100 million PFU per 1 mL vial (108 PFU/mL), bill 100 service units/per vial.

Please see full Important Safety Information and link to Prescribing Information below.

IMPORTANT SAFETY INFORMATION
Contraindications

Warnings and Precautions
Adverse Reactions

Please click here for the IMLYGIC® Full Prescribing Information and Medication Guide.

Posted 1/3/2017


Avastin for Intravenous Infusion Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Genentech is excited to share the news of a new FDA approval. Avastin® (bevacizumab) solution for intravenous infusion is NOW FDA APPROVED in platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Indication

Please see Day 1 Announcement, as well as full Avastin Prescribing Information, including Boxed WARNINGS, for additional important safety information.

IMPORTANT SAFETY INFORMATION
Boxed WARNINGS


Gastrointestinal (GI) perforation

Hemorrhage

Additional serious adverse events
Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs control included:

Pregnancy warning

Most common adverse events

Indication-specific adverse vents

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information, including Boxed WARNINGS, for additional important safety information.

Posted 12/13/2016


KEYTRUDA Approved for 1st-Line Treatment of
mNSCLC with high PD-L1 Expression (TPS ≥50%)

Merck is pleased to announce that KEYTRUDA is now the only anti–PD-1 approved for first-line treatment of mNSCLC with high PD-L1 expression (TPS ≥50%). In the KEYNOTE-024 study, KEYTRUDA demonstrated superior survival in the first-line treatment of mNSCLC vs platinum-containing chemotherapy in patients whose tumors expressed high levels of PD-L1 (TPS ≥50%).

Read the full announcement here.

Posted 11/16/2016


FDA Approves Opdivo Injection for Squamous Cell Carcinoma of the Head and Neck

On November 10, 2016, the U. S. Food and Drug Administration approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

Read the FDA announcement here.

Posted 11/11/2016


Understanding Claims Submission for Office-administered Products with a Miscellaneous J Code

This video is a 5- minute educational video that includes animation, process flow icons, and audio to provide guidance on how to submit claims using miscellaneous J codes.

Posted 11/7/2016


Announcing FDA Approval of a New Treatment in Previously Treated Metastatic Non-Small Cell Lung Cancer

Genentech is excited to share the news of a new FDA approval. TECENTRIQ® (atezolizumab) is NOW FDA APPROVED for the treatment of patients with previously treated metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.

IMPORTANT SAFETY INFORMATION
Serious Adverse Reactions

Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

Most Common Adverse Reactions

The most common adverse reactions (rate ≥20%) included fatigue (46%), decreased appetite (35%), dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain (22%), and constipation (20%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1.888.835.2555.

Please see full Prescribing Information for additional Important Safety Information.

Posted 10/21/2016


Announcing a unique C-code for a Genentech BioOncology(R) product

The following is important information regarding a unique C-code that was recently assigned to TECENTRIQ™ (atezolizumab) by the Centers for Medicare & Medicaid Services (CMS). The C-code for TECENTRIQ is C9483 (Injection, atezolizumab, 10 mg).

The unique C-code goes into effect on October 1, 2016. Payers may require its use until a permanent J-code is assigned. The permanent J-code is expected to be available for use starting on January 1, 2018.

The C-code is used primarily in the Medicare hospital outpatient setting. However, some payers accept this C-code instead of unclassified J- or C-codes when billing for TECENTRIQ. Please check with your payers to verify codes and special billing requirements.

The TECENTRIQ Billing and Coding Flash Card, which contains additional information about coding and billing, can be found here.

You may seek assistance from one of the dedicated Specialists at TECENTRIQ Access Solutions at
(888) 249‐4918, or visit Genentech-Access.com/TECENTRIQ for more information.

Posted 10/5/2016


Pharmacyclics announces an expanded IMBRUVICA® (ibrutinib) label

Pharmacyclics is pleased to announce an expanded IMBRUVICA® (ibrutinib) label. Please view this letter for the following:

Overall survival data in previously untreated Chronic Lymphocytic Leukemia (CLL)
New indication for Small Lymphocytic Lymphoma (SLL) patients
Combination dosing IMBRUVICA® with Bendamustine and Rituximab (BR) for CLL/SLL patients

Posted 10/5/2016


Merck Announces EMEND for Oral Suspension is Now Available

Merck is pleased to announce that EMEND for oral suspension is now available.

Please use the links below for additional information:

Prescribing Information
Patient Information
Instructions for Use

Posted 9/9/2016


FDA Approves Pembrolizumab for Head and Neck Squamous Cell Carcinoma

On August 5, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval of pembrolizumab (Keytruda injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Under the FDA’s accelerated approval program, this indication for Keytruda is approved based on tumor response rate and durability of response.

Read FDA announcement here. Read the company press release here.
Posted 8/8/16; updated 8/9/16.

Posted 8/29/2016


KEYTRUDA’s KEY+YOU Support Program

The KEY+YOU Support Program provides patients and their caregivers with support 24/7 throughout their treatment with KEYTRUDA® (pembrolizumab) injection 100 mg. The program gives patients and caregivers the option of talking with an experienced nurse who offers support by telephone and/or receiving resources by e-mail.

KEY+YOU nurses can provide general information about KEYTRUDA. Enrollees are notified that the information provided through the KEY+YOU Support Program does not take the place of talking to their doctor or health care team, and are actively instructed to contact their health care team if treatment questions are asked.

Please click on the link below or call 85-KEYTRUDA (855-398-7832) for information about the KEY+YOU Patient Support Program from Merck.

KEY+YOU Support Program

Posted 8/26/2016


Portrazza Injection Assigned Product-Specific C-Code

Eli Lilly and Company announced the assignment of a product‐specific C‐code for Portrazza® (necitumumab) injection. The Centers for Medicare & Medicaid Services (CMS) released the April 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS), which included designation of C9475 for Portrazza with the effective date of April 1, 2016.

Portrazza was approved by the FDA on November 24, 2015. Portrazza is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for the treatment of nonsquamous NSCLC. For more information, click here.

Posted 6/13/2016


CMS Publishes Preliminary Decision on HCSPCS Application for Unique J Code for Bendeka® (bendamustine HCl) Injection

On April 19, 2016, the Centers for Medicare & Medicaid Services (CMS) published a preliminary decision on the HCSPCS application for a unique J code for Bendeka® (bendamustine hydrochloride) Injection, a ready-to-dilute solution, low-volume (50 mL) bendamustine formulation. CMS ruled that the current J code for Treanda® (bendamustine HCl) (J9033) appropriately describes Bendeka.

This is a preliminary decision and the final CMS decision is expected in the fourth quarter. If a unique J code is recommended at that time for Bendeka, the effective date would be Jan. 1, 2017.

As a result of this preliminary ruling, it is anticipated that some payers may reimburse Bendeka using either the J9999 or the J9033 code. You must adhere to the payer recommendations to determine which code to use for Bendeka patients. Whatever your decision is regarding coding, it will be important to ensure that the Bendeka NDC is used on every claim.

Click here for more information on Bendeka.

Posted 6/8/2016


FDA Approves Atezolizumab for Urothelial Carcinoma

On May 18, 2016, the U. S. Food and Drug Administration (FDA) gave accelerated approval to atezolizumab injection (Tecentriq™, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody.

Read the FDA announcement here.

Posted 5/20/2016


Register for 2016 Best of ASCO Meetings

Attend a Best of ASCO Meeting and experience the relevant and novel scientific and educational highlights from the world's premier oncology event, the ASCO Annual Meeting, condensed into a two-day program. Connect with experts in the field who will review the latest compelling research in cancer care.

Hotel Reservation and Early Registration Deadlines:
Chicago: May 18 at 11:59 pm (EDT)
Washington DC: June 8 at 11:59 pm (EDT)
San Diego: June 29 at 11:59 pm (EDT)

Visit boa.asco.org to register, reserve your hotel, and to view the program.

Posted 5/18/2016


FDA Approves Venclexta Tablets for CLL Patients

On April 11, 2016, the U. S. Food and Drug Administration (FDA) approved venetoclax (Venclexta tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

Read the FDA announcement here.

Posted 4/13/2016


FDA Approves Xalkori for Metastatic NSCLC

On March 11, 2016, the U.S. Food and Drug Administration (FDA) approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. 

Read the FDA announcement here.

Read the corporate press release here.

Posted 3/21/2016


New HCPCS Code for Blincyto®

Amgen Inc. announced the assignment of a HCPCS code for Blincyto® (blinatumomab) for injection for intravenous use. The Centers for Medicare & Medicaid Services (CMS) assigned HCPCS code J9039 for Blincyto (Injection, blinatumomab, 1mcg) which became effective on January 1, 2016.  

Blincyto was approved by the FDA on December 3, 2014, for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Posted 3/10/2016


ACCC Expresses Strong Opposition to CMS Proposed Medicare Part B Payment Model Rule

On March 8, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the anticipated proposed rule to test new models for how Medicare Part B pays for prescription drugs. According to a CMS fact sheet, the proposal “is designed to test different physician and patient incentives to do two things: drive the prescribing of the most effective drugs, and test new payment approaches to reward positive patient outcomes.”

Under the proposal, CMS will choose a group of Part B providers based on Primary Care Service Areas (PCSAs), and instead of paying physicians and hospital outpatient departments for drugs at the current ASP +6 percent, the model would drop the add-on payment to 2.5 percent plus a flat fee payment of $16.80 per drug per day to test whether this “changes prescribing incentives and leads to improved quality and value.”

CMS proposes to update the flat fee at the beginning of each year by the percentage increase in the consumer price index for medical care for the most recent 12-month period. The agency plans to begin the test in fall 2016 (no earlier than 60 days after the rule is finalized). In January 2017, CMS will require providers to use value-based purchasing tools such as indication-based pricing, reference pricing, and clinical decision support tools to receive Part B payments.

Last week, the Association of Community Cancer Centers (ACCC) joined with the American Society of Clinical Oncology (ASCO), the Community Oncology Alliance (COA), and approximately 100 other organizations in a letter to HHS Secretary Sylvia Burwell and Acting CMS Administrator Andy Slavitt expressing “strong concern” about the agency’s plans to put forward a proposed rule for the Medicare Part B Drug Payment Model and asking the agency not to proceed with the initiative.

The rule is scheduled to be published in the March 11 Federal Register. Comments on the proposed rule are due by May 9.

Read letter here. Read the ACCC press release here.

Read the CMS proposed rule here. Read CMS fact sheet here.

Posted 3/9/2016


FDA Approves Gazyva Injection for Previously Treated Follicular Lymphoma

On Feb. 26, 2016, the U. S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.

Read the FDA announcement here.

Read the corporate press release here.

Posted 3/7/2016


Pfizer Receives Expanded FDA Approval For Ibrance (Palbociclib)

On Feb. 19, 2016, the U. S. Food and Drug Administration (FDA) approved palbociclib (Ibrance Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Read the FDA announcement here.

Read the corporate press release here.

Posted 2/26/2016


FDA Approves Merck’s Single-Dose Emend® (fosaprepitant dimeglumine) for Injection

On February 4, 2016, Merck's Emend® for injection received another approval from the U.S. Food and Drug Administration (FDA). Emend for injection 150 mg is now indicated in adults in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and repeat courses of MEC. The approved dosage in adults is a single 150-mg intravenous (IV) infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy on Day 1.

Read the corporate press release here.

Posted 2/12/2016


FDA Approves Expanded Indication for Keytruda®

On December 18, 2015, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Merck's Keytruda® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for Keytruda, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status.

For more information on the Merck Access Program for Keytruda, please visit merckaccessprogram-keytruda.com.

Posted 1/19/2016


New HCPCS Code for Keytruda®

A product-specific Healthcare Common Procedure Coding System (HCPCS) code is now available for Merck & Co.'s Keytruda® (pembrolizumab) for injection.

The new code, J9271, is defined as Injection, pembrolizumab, 1 mg. This code became effective January 1, 2016.

For more information on the Merck Access Program for Keytruda, please visit merckaccessprogram-keytruda.com.

Posted 1/5/2016


Alecensa® Now FDA Approved for Treatment of Metastatic ALK+ NSCLC

On December 11, 2015, the U.S. Food and Drug Administration (FDA) approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).

Read the FDA press release here.

Posted 12/28/2015


FDA Approves Portrazza™ for the Treatment of Metastatic Squamous NSCLC

On November 24, 2015, the U.S. Food and Drug Administration (FDA) approved Portrazza, an epidermal growth factor receptor (EGFR) antagonist, indicated in combination with gemcitabine and cisplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for the treatment of nonsquamous NSCLC.

Read the corporate press release here.

Posted 12/14/2015


FDA Approves Bendeka (bendamustine hydrochloride) Injection

On Dec. 8, 2015, Teva Pharmaceuticals Industries Ltd. and Eagle Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved approved Bendeka, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. Bendeka is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

Read the corporate press release here.

Posted 12/9/2015


Sign Up Today for Next Week's ASCO MACRA Webinar

Be sure to join ASCO for a free webinar, MACRA: Learn the Basics, Get Ready for a Post-SGR World on Tuesday, December 15, 2015 from 4:00-5:30 p.m. EST. Presented by ASCO Senior Director of Clinical Affairs Stephen Grubbs, MD, and ASCO Director of Coverage and Reimbursement Sybil Green, JD, RPh, this webinar will feature a high-level overview of the Medicare Access and Chip Reauthorization Act of 2015 (MACRA). Find out how the upcoming changes to reimbursement and reporting activities will affect your program or practice. Register for the webinar here.

Posted 12/9/2015


New HCPCS Code for Cyramza®

Eli Lilly and Company announced the assignment of a product-specific Healthcare Common Procedure Coding System (HCPCS) code for Cyramza® (ramucirumab) for injection.

The new code, J9308, is defined as Injection, ramucirumab, 5 mg. This code is effective January 1, 2016.

For more information, please visit www.cyramzahcp.com. For full Prescribing Information, please click here.

Posted 12/4/2015


FDA Approves Elotuzumab in Combination Regimen for Previously Treated Multiple Myeloma Patients

On Nov. 30, 2015, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Read the FDA announcement here.

Read the FDA press release here.

Posted 12/1/2015


FDA Approves Nivolumab for Advanced Renal Cell Carcinoma

On Nov. 23, 2015, the U. S. Food and Drug Administration (FDA) approved nivolumab (Opdivo Injection) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

Read the FDA announcement here.

Read FDA press release here.

Posted 11/25/2015


FDA Approves Cotellic as Part of Combination Regimen for Advanced Melanoma

On Nov. 10, 2015, the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

Read the FDA announcement here.

Posted 11/20/2015


FDA Expands Approved Use of Opdivo in Advanced NSCLC

On Oct. 9, 2015, the U.S. Food and Drug Administration approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.

Read FDA press release here.

Read manufacturer press release here.

Posted 10/13/2015


FDA Approves Keytruda for Advanced NSCLC

On Oct. 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

Read FDA announcement here.

Posted 10/6/2015


FDA Approves Nivolumab in Combination with Ipilimumab for BRAF V600 Wild-Type Melanoma

On September 30, 2015, the U. S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.

This is the first FDA approval of a regimen of two immuno-oncology agents in cancer.

Read the FDA announcement here.

Read the Bristol-Myers Squibb announcement here.

Posted 10/2/2015


FDA Provides List of Compatible Devices for Treanda Injection

On March 10, 2015, the U.S. Food and Drug Administration (FDA) issued a statement warning healthcare professionals not to use chemotherapy drug Treanda Injection (45 mg/0.5 mL or 
180 mg/2 mL solution) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

As an update, on September 4, 2105, the FDA provided information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection.

Read the Sept. 4 FDA notice here.

Read the Teva Pharmaceuticals’ Dear Health Care Provider letter here.

Posted 9/17/2015


CMS to Host “Virtual Office Hours” Session on PQRS & 2016 MPFS

The Centers for Medicare & Medicaid Services (CMS) is offering a Virtual Office Hours session on the 2016 PQRS and the 2016 Medicare proposed Physician Fee Schedule (PFS) rule on Thursday, September 3 from 2:00 pm – 3:00 pm ET.

To participate, please register here. Space is limited.

The session will allow stakeholders an opportunity to ask a CMS representative questions about the new proposed PQRS requirements for program year 2016. Also included will be information on the deadline for public comments, and the next steps for the 2016 PFS rule.

Posted 8/26/2015


Adcetris Approved for Classical Hodgkin Lymphoma Patients at High Risk for Relapse, Progression

On Aug. 17, 2015, Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. Read the press release here.

Posted 8/24/2015


FDA Approves Carfilzomib (Kyprolis) for Relapsed and Refractory Multiple Myeloma

On July 24, 2015, the U. S. Food and Drug Administration (FDA) approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Read FDA announcement here.

Posted 7/29/2015


Celgene Commercial Co-pay Program for Istodax®

Celgene has recently implemented a Celgene Commercial Co-pay Program for eligible patients taking Istodax® (romidepsin) for injection. To qualify for the program, a patient must: (i) have an annual household income of less than $100,000, (ii) maintain commercial or private health insurance, and (iii) reside in the United States or Puerto Rico. Certain qualifying patients may be eligible to reduce their out-of-pocket co-pay responsibility for Istodax to $0. Also, co-pay assistance may be available for patients who have Medicare, Medicaid, or other government- sponsored insurance through unaffiliated, independent, third-party organizations such as the Patient Access Network Foundation.

You can find out more about these programs and others by calling Celgene Patient Support® at 1.800.931.8691, Monday–Friday, 8 am – 7 pm ET.

Posted 7/22/2015


ACCC July 21 Conference Call on Proposed 2016 OPPS and Physician Fee Schedule Rules

Please join us on Tuesday, July 21, for an ACCC members-only conference call on the proposed 2016 Hospital Outpatient Prospective Payment System (OPPS) rule and proposed 2016 Medicare Physician Fee Schedule (PFS) rule. Find out how the proposed rules will affect your program or practice. Access call information here.

We will hear from legal experts Beth Roberts, Partner, and Beth Halpern, Associate, Hogan Lovells US LLP, with an in-depth look at CMS’s proposals for 2016.

Posted 7/13/2015


Updated Labeling for Pomalyst®

Celgene Corporation announced that the FDA approved updated labeling for Pomalyst® (pomalidomide).

Pomalyst is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Click here for more information.

Posted 7/8/2015


New C-Code for Blincyto™

Onyx Pharmaceuticals, an Amgen subsidiary, announced the assignment of HCPCS C-code for Blincyto™ (blinatumomab) for Injection for intravenous use1.  The Centers for Medicare and Medicaid Services (CMS) assigned a unique C-code for Blincyto which will become effective on April 1, 2015.  

HCPCS Code: C9449

Blincyto Long Descriptor: Injection, blinatumomab, 1 mcg
Strength:
35 mcg
Effective Date:
4/1/2015

Source: April 2015 Update to the Hospital Outpatient Prospective Payment System (OPPS) Source Link: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/C-Codes-Effective-04-01-15.zip.         

Please click here  to see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, for Blincyto.

Posted 5/22/2015


Shared Voice: Individualizing Patient-Centered Communication for Advanced Lung Cancer Patients

Shared Voice brings together a distinguished panel of lung cancer and communication experts to explore how such patient-centered communication improves shared decision-making, patient understanding, and patient satisfaction for advanced lung cancer patients. These programs, sponsored by Lilly USA, LLC, are being held across the country, click here to find an event near you.

Posted 5/7/2015


UnitedHealtcare Oncology Prior Authorization Letter

Please click here for the announcement letter for UnitedHealthcare’s prior chemotherapy authorization process. This program has been tested in Florida since May 2014, and it will be national effective June 1, 2015.

The tool is designed to show all NCCN covered regimens for the patient’s specific clinical conditions. This feature has resulted in significantly fewer denials in the Florida pilot. 

Posted 4/21/2015


ACCC Members! April 22 Conference Call: The End of SGR—What It Means for Reimbursement

As you know, in an historic step, Congress this week approved H.R. 2, Medicare Access and CHIP Reauthorization Act (MACRA), putting an end to the sustainable growth rate (SGR) once and for all. MACRA will provide physicians with predictability in payments needed to continue to provide high-quality cancer care, while transitioning over a 10-year period to a new dual Medicare reimbursement system.

What will MACRA mean for providers and the future of oncology reimbursement?

Get answers and a detailed look at MACRA and the SGR aftermath. Join us for an ACCC members-only conference call with Dan Todd, former Senior Health Counsel, Senate Finance Committee, and a primary author of MACRA. Call-in information can be found here: http://ow.ly/LSmJ6.

Posted 4/20/2015


Senate Passes SGR Repeal!

Late on April 14, 2015, the U.S. Senate overwhelmingly by a 92-8 vote passed H.R. 2, legislation that permanently repeals Medicare’s sustainable growth rate (SGR) for physician reimbursements. The vote came just hours before a scheduled cut to physician' payments would have gone into effect.

The bill now goes to President Barack Obama, who has said he will sign it.

H.R. 2 would replace the current SGR formula with new value-based systems for setting the annual updates to payment rates for physician services provided to Medicare beneficiaries.

Posted 4/15/2015


No Senate Vote on SGR Until After Its Recess

The U.S. Senate recessed on Friday, March 27, without voting on SGR repeal legislation.

The Senate is recessed for two weeks, but is still expected to act on the permanent SGR repeal bill when it reconvenes on April 13.

Modern Healthcare reports that despite the fact that the current SGR “patch” will expire on April 1, physicians will not face a 21% pay cut as CMS “has indicated that it can delay processing claims for a period of time to keep the cut from being implemented.”

Posted 3/27/2015


SGR Bill Heads to Senate—Contact Your Senators Today!

On March 26, by a vote of 392-37 the U.S. House of Representatives overwhelmingly passed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015, legislation to permanently repeal and replace Medicare’s sustainable growth rate (SGR) formula for physician reimbursement. Read a summary of the legislation here.

Rep. Michael C. Burgess, MD, (R-Texas), the bill’s primary sponsor, said in a statement, “This is the work of a collaborative body. . . .It is time to end the SGR. Let us never speak of this issue again.”

On March 25, the White House expressed support for the bill.

The Senate is expected to vote on the bill March 27, before Congress recesses for two weeks.

Contact your Senators and ask them to support a permanent repeal of the SGR. As an expert in cancer care, they need to hear from you!

Posted 3/26/2015


House, Senate Leaders Introduce SGR Legislation

On Mar. 19, 2015, leaders in the U.S. Senate and House introduced bipartisan, bicameral legislation (HR 1470) to replace the broken Medicare Sustainable Growth Rate (SGR) formula with an improved payment system that rewards quality, efficiency, and innovation. The bipartisan, bicameral bill seeks to end the cycle of annual “doc fix” crises that have created uncertainty for millions of Medicare providers and beneficiaries for over a decade.

According to a U.S. Senate Finance Committee press release, the legislation is nearly identical to bills introduced last year in the House and Senate. This proposal will:

Read Senate Finance Committee press release.

Posted 3/19/2015


FDA Approval Opdivo for Patients with Previously Treated Metastatic Squamous NSCLC

On March 4, 2015, the U. S. Food and Drug Administration (FDA) granted approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Nivolumab was previously approved in December 2014, for the treatment of previously treated unresectable or metastatic melanoma. Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.

Read FDA announcement here.

Read Bristol-Myers Squibb fact sheet here.

Posted 3/9/2015


Medicare to Cover Lung Cancer Screening with LDCT, CMS Issues Final NCD

On Feb. 5, the Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) that provides for Medicare coverage of screening lung cancer with low dose computed tomography (LDCT). The coverage is effective immediately.

Medicare will now cover lung cancer screening with LDCT once per year for Medicare beneficiaries who meet all of the following criteria:

Medicare coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening. The NCD also includes required data collection and specific coverage eligibility criteria for radiologists and radiology imaging centers, consistent with the National Lung Screening Trial protocol, U.S. Preventive Services Task Force recommendation, and multi-society multidisciplinary stakeholder evidence-based guidelines.

Access the Lung Cancer Decision Memo here.

Posted 2/17/2015


New Liquid Formulation of Keytruda

Merck has announced the availability of a liquid formulation of Keytruda (pembrolizumab). Merck expects to make this product available on or after February 16, 2015. Check with your authorized distributor for details. This 100-mg liquid vial will replace the 50-mg lyophilized formulation, which was launched as a transition image until the liquid formulation was available. The price per mg has not changed with the introduction of this image.

Merck plans to no longer make the 50-mg lyophilized powder formulation available to authorized distributors as of February 16, 2015. We suggest you deplete any 50-mg lyophilized formulation you may have in inventory prior to switching to the 100-mg liquid vial, carton NDC number 0006-3026-02. As a reminder, when billing for the 50-mg lyophilized formulation, please use the carton NDC number 0006-3029-02.

Read the full announcement here.

Posted 1/26/2015


Coding Information for Keytruda

Merck Sharp & Dohme Corp. (Merck), a subsidiary of Merck & Co., Inc., is pleased to announce
that Keytruda (pembrolizumab) has been assigned a Level II HCPCS C code, effective 1/1/2015. This code applies to Medicare hospital outpatient claims for dates of service on or after 1/1/2015.

Read the full announcement here.

Posted 1/20/2015


FDA Approves Cyramza to Treat Aggressive NSCLC

On Dec. 12, 2014, the U. S. Food and Drug Administration approved Cyramza Injection (ramucirumab) (Eli Lilly and Company) for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab.

Ramucirumab was previously approved as a single agent and for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma after disease progression on first line therapy.

Read FDA press release here.

Read FDA announcement here.

Posted 1/9/2015


CMS to Hold 2015 Date-of-Service Claims for Services Paid Under the MPFS for Two Weeks

In a Dec. 29, 2014, MLN Connects Provider eNews, the Centers for Medicare & Medicaid Services (CMS) states that in order to implement corrections to technical errors discovered after publication of the 2015 Medicare Physician Fee Schedule (MPFS) rule and process claims correctly, Medicare Administrative Contractors will hold claims containing 2015 services paid under the MPFS for the first 14 calendar days of January 2015 (i.e., Thursday Jan. 1 through Wednesday Jan. 14). According to CMS, the hold should have minimal impact on provider cash flow as, under current law, clean electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt.

MPFS claims for services rendered on or before Wednesday Dec. 31, 2014, are unaffected by the 2015 claims hold and will be processed and paid under normal procedures and time frames.

Read announcement here.

Posted 1/8/2015


FDA Approves Opdivo for Advanced Melanoma

On Dec. 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs.

Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.

Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.

Read FDA press release here.

Bristol-Myers Squibb Opdivo fact sheet here.

Posted 1/8/2015