Daiichi Sankyo and AstraZeneca are excited to announce that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for a new indication.

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate that was recently approved for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.1

ENHERTU has Boxed WARNINGS for Interstitial Lung Disease/Pneumonitis and Embryo-Fetal Toxicity. Please see the Important Safety Information below and the full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

View a sample EMR treatment plan HERE and information for ENHERTU that reflects efficacy, safety, and clinical trial information HERE.

RECOMMENDED DOSAGE FOR LOCALLY ADVANCED OR METASTATIC GASTRIC CANCER

The recommended dosage of ENHERTU for locally advanced or metastatic gastric and GEJ cancer is 6.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Please see the full Prescribing Information for details on dose reductions and modifications.

PATIENT SELECTION CONSIDERATIONS

Select patients with locally advanced or metastatic gastric cancer based on HER2 protein overexpression or HER2 gene amplification. Reassess HER2 status if it is feasible to obtain a new tumor specimen after prior trastuzumab-based therapy and before treatment with ENHERTU.

ENHERTU4U ICD-10 CODES
Please update your organization’s systems to include relevant ICD-10 codes for gastric cancer. The ENHERTU4U website lists codes for your consideration: https://www.enhertu4u.com/hcp/coding-and-reimbursement.html

ENHERTU PACKAGE INFORMATION

Vial size1
NDC1
J-code3
One 100 mg single-dose vial
65597-406-01
J9358

Important Safety Information
Indication
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

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Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly
higher hematologic complete response rate in this rare and serious blood cell disorder

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.2,3 This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Read the Full Release HERE

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FOR IMMEDIATE RELEASE
December 23, 2020

 

STATEMENT FROM EXECUTIVE DIRECTOR: MICHAEL REFF
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email: kevin.scorsone@ncoda.org
www.ncoda.org

MOST FAVORED NATION: TEMPORARY RESTRAINING ORDER ISSUED

NCODA has been in opposition of the Most Favored Nation (MFN) model for Medicare patients since it was announced late last month. The model would negatively affect patient access to Part B drugs – the anti-cancer (oral and infused) treatments that are administered in oncology practices.

Today, it was announced that US District Court Judge Catherine Blake (Maryland) issued a two-week temporary restraining order (TRO) which delays the implementation of the MFN model. The two-week reprieve allows the court time to consider implementing a preliminary injunction against the MFN model.

This mandatory 7-year payment model would establish reimbursement to providers based on an MFN price for the 50 highest cost Part B drugs. The MFN price would be phased in to replace the current ASP reimbursement model and would be based on international pricing from other similar countries.

This model would create a potentially insurmountable challenge for oncology practices, and it would hurt the people who matter most – the patients. NCODA continues to oppose this model and will monitor and update our membership as progress is made on this decision.

Michael Reff, RPh, MBA
Founder & Executive Director | NCODA, Inc.

Read the full release HERE.

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FOR IMMEDIATE RELEASE
December 18, 2020
STATEMENT FROM EXECUTIVE DIRECTOR: MICHAEL REFF

Contact: Kevin Scorsone, NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email:
kevin.scorsone@ncoda.org
https://www.ncoda.org

MOST FAVORED NATION MODEL: NOT THE ANSWER FOR PATIENTS

NCODA is in opposition of the Most Favored Nation (MFN) model for Medicare patients that would negatively affect patient access to Part B drugs – the chemotherapy and infusion treatments that are administered in our community oncology member practices.

Scheduled to begin January 1, 2021, this mandatory 7-year payment model proposed to lower drug costs would establish reimbursement to providers based on an MFN price for the 50 highest cost Part B drugs.  The MFN price would be phased in to replace the current ASP reimbursement model and would be based on international pricing from other countries.

Under the MFN model, practices administering these drugs would be purchasing and administering these drugs at a cost exceeding the proposed MFN reimbursement.  These losses would be unsustainable and force practices to close their doors and send patients to more expensive treatment locations. Life-saving treatment options would not be as readily available to many seniors who would be forced to forgo treatment.

We are still in the midst of the COVID-19 pandemic which has resulted in thousands of deaths. The MFN model will promote additional limitations on seniors’ access to standard of care therapy for their cancer diagnoses.

NCODA does not support the implementation of this mandatory model on cancer patients and the oncology community. Not only would this model create a potentially insurmountable challenge for oncology practice it would hurt the people who matter most, the patient.

Our Passion for Patients is not just a statement it continues to be our Mission and focus.


Michael Reff, RPH, MBA
Founder and Executive Director

Full Press Release HERE

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FOR IMMEDIATE RELEASE
December 11, 2020
STATEMENT FROM EXECUTIVE DIRECTOR: MICHAEL REFF

Contact: Kevin Scorsone, NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email:
kevin.scorsone@ncoda.org
https://www.ncoda.org


SUPREME COURT RULES UNANIMOUS: REGULATES PHARMACY BENEFIT MANAGERS
Decision confirms that states will have the right to regulate; brings clarity and optimism

Yesterday, December 10, 2020, the United States Supreme Court (Rutledge, Attorney General of Arkansas VS Pharmaceutical Care Management Association) unanimously decided that states can regulate Pharmacy Benefit Managers. Pharmacy Benefit Managers (PBM’s) are companies that oversee the prescription drug benefits on behalf of insurance companies along with Medicare Part D drug plans.

NCODA believes that this decision by the Supreme Court marks a significant day for pharmacists and pharmacies everywhere. Most importantly, this ruling provides patients the ability to have complete transparency when dealing with Pharmacy Benefit Managers and track the cost of their medications.

Read the full press release here.

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