Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) has a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.
For full prescribing information, click here.
Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.
To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.
This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.
Who is Eligible?
Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.
For more information, including application instructions, click here.
On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Read FDA announcement.
Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. CMS released the July 2020 Quarterly Healthcare Common Procedural Coding System File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.
Read corporate announcement.
On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read the FDA announcement.
On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Read corporate press release.
At Pfizer Oncology Together, patient support is at the core of everything they do. From helping to identify financial assistance options to connecting patients to resources for emotional support, the needs of patients prescribed Pfizer Oncology medications are a top priority.
Pfizer Oncology Field Reimbursement Managers (FRMs) can help address challenging or urgent Pfizer Oncology patient access cases. Click here for the FRM contact in New York.
On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.
Read the FDA announcement.
On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.
Read FDA announcement.
On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
Read the corporate press release.