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  • CMS: Medicaid NPRM Aims to Foster VBP Models for Prescription Drugs

    On June 17, the Centers for Medicare & Medicaid Services (CMS) released the "Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-P)."

    The agency states that the proposals put forward support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. The proposed rule also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse.

    Read the CMS fact sheet on the proposed rule.  

    Access the proposed rule

    Read HealthAffairs blog by CMS Administrator Seema Verma.

    Posted 6/17/2020



  • FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

    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.

    Posted 6/17/2020



  • FDA Extends Indication of Gemtuzumab Ozogamicin to CD33-Positive AML Pediatric Patients

    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.

    Posted 6/16/2020



  • FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC

    On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 6/16/2020



  • FDA Approves HPV Vaccine Gardasil 9 for Prevention of Certain Head & Neck Cancers

    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.

    Posted 6/15/2020



  • FDA Approves Pegfilgrastim-apgf) Biosimilar to Pegfilgrastim

    On June 11, 2020, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegilgrastim). Nyvepria is indicated to decrease incidence of infection as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

    Read corporate press release.

    Posted 6/12/2020


  • CMS Issues Product-Specific J-code for Adakveo®

    Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.

    The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.

    Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (injection, crizanlizumab-tmca, 1 mg, hospital outpatient).

    See full prescribing information.

    Posted 6/12/20



  • FDA Approves Nivolumab for Previously Treated Advanced Esophageal SCC

    On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 6/11/2020



  • ASTRO Releases New Clinical Guideline for RT to Treat Nonmetastatic Cervical Cancer

    June 10, 2020, the American Society for Radiation Oncology (ASTRO) released a new clinical guideline that provides recommendations for radiation therapy to treat patients with nonmetastatic cervical cancer. The guideline, ASTRO's first for cervical cancer, was published online in Practical Radiation Oncology.

    Included within the recommendations are indications and best practices for external beam radiation therapy and brachytherapy in the postoperative and definitive settings. Recommendations also address other treatments including chemotherapy and surgery when used in combination with radiation.

    Read ASTRO press release.
    Access the clinical guideline.

    Posted 6/10/2020


  • ACS Updates Diet and Physical Activity Guideline

    On June 9, the American Cancer Society (ACS) released updated recommendations for diet and physical activity for cancer prevention. The ACS guideline was last updated in 2012. Changes to the guideline reflect the latest evidence on the impact of lifestyle on cancer risk. Approximately, 18 percent of all cancer cases in the U.S. are related to a combination of diet and physical activity factors, the ACS states. 

    The new guideline includes recommendations for more physical activity, eating less (or no) processed and red meat, and avoiding alcohol or drinking less.

    The updated American Cancer Society Guideline for Diet and Physical Activity for Cancer Prevention  was published online on June 9, in CA: A Journal for Cancer Clinicians.

    Access the full article here.

    Posted 6/9/2020



  • Imbruvica® + Rituximab vs. FCR National Broadcast

    Redefining Approaches in Frontline Chronic Lymphocytic Leukemia (CLL) Treatment     

    Wednesday, June 17
    7:30 PM ET and 9:30 PM ET
    6:30 PM and 8:30 PM CT
    4:30 PM and 6:30 PM PT

    Register today to participate in a national broadcast: Imbruvica® + Rituximab vs. FCR: Data From a Head-to-Head Trial in 1L CLL/SLL. For details or to register, click here


    Read corporate announcement.

    6/09/2020



  • FDA Approves Atezolizumab for Adult Patients with Metastatic NSCLC

    On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®, Genentech), as a single agent, for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1–stained ≥50% of tumor cells [TC ≥50%] or PDL1–stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. 

    Read corporate announcement.

    Read prescribing information

    Posted 6/5/2020



  • CMMI Adds New Flexibilities & Adjustments to Oncology Care Model

    On Wednesday, June 3, the Center for Medicare & Medicaid Innovation (CMMI) announced that, in response to the COVID-19 public health emergency (PHE), CMMI is providing new flexibilities and adjustments to current and future Innovation Center models. The announcement included the following changes specifically for Oncology Care Model (OCM). 


    Payment Methodology:

    • Option for OCM practices to elect to forgo upside and downside risk for performance periods affected by the PHE.
    • For OCM practices that remain in one- or two-sided risk for the performance periods affected by the PHE, remove COVID-19 episodes from reconciliation for those performance periods.

    Quality Reporting:
    -Make the following optional for the affected performance  periods:

    • Aggregate-level reporting of quality measures
    • Beneficiary-level reporting of clinical and staging data

    -Remove the requirement for cost and resource utilization  reporting and practice transformation plan reporting in  July/August 2020.

    Timeline: Extend model for 1 year through June 2022.                         
    The CMS Innovation Center will host a call on Friday, June 5, 2020, from 2:00 PM – 3:00 PM ET to provide an overview of the Oncology Care Model adjustments and flexibilities and answer your questions.

    When: Friday, 06/05/2020 from 2:00 PM – 3:00 PM ET
    Register Here.

    View information on the CMMI website here.
    Read a Health Affairs blog post by CMS Administrator Seema Verma.

    Posted 6/3/2020



  • FDA Approves Atezolizumab + Bevacizumab for Previously Untreated Advanced HCC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with bevacizumab (Tecentriq and Avastin, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

    Read full FDA announcement

    Tecentriq prescribing information and billing/coding for HCC.

    Avastin prescribing information and billing/coding for HCC.

    Posted 6/2/2020



  • FDA Approves Ramucirumab + Erlotinib for First-Line Treatment of Metastatic NSCLC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

    Read full FDA announcement.

    Posted 6/2/2020


  • FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC

    On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    Read full FDA announcement.

    Posted May 27, 2020



  • FDA Approves Pomalidomide for Patients with AIDS-Related KS

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) approved pomalidomide (Pomalyst®, Bristol Myers Squibb) capsules for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. 


    Read corporate announcement.


    Posted 5/26/2020



  • FDA Approves Brigatinib for ALK-Positive Advanced NCSLC

    On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

    On the same day, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic for brigatinib.

    Read full FDA announcement.

    Posted 5/26/2020



  • FDA Approves Olaparib + Bevacizumab as Maintenance Treatment for Advanced Ovarian Cancer

    On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic test.

    Read the corporate press release.

    Read the Lynparza PAOLA-1 Testing Medical Policy Considerations.

    Posted 5/21/2020



  • FDA Approves Olaparib for HRR Gene-Mutated mCRPC

    On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

    On the same day, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib.  

    Read full FDA announcement.

    Posted 5/20/2020