May 30, 2019
The Annual Report to the Nation on the Status of Cancer released on May 30, finds that for all cancer sites combined the overall cancer death rate continued to decrease in U.S. men, women, and children from 1999 to 2016. In men, the overall cancer incidence rates decreased from 2008 to 2015, after increasing from 1999 to 2008. Cancer incidence rates were stable in women from 1999 to 2015.
This year's report includes a special section on cancer rates and trends in adults ages 20 to 49. Among adults 20-49 years, researchers report that incidence and death rates were lower among men than women. The most common cancers in this age group were:
The report is jointly issued by the Centers for Disease Control and Prevention (CDC), the North American Association of Central Cancer Registries (NAACCR), the American Cancer Society (ACS), and the National Cancer Institute (NCI).
Access highlights and the full report on the CDC website here . Read NCI press release here .
Posted 5/30/2019
May 28, 2019
On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). Read FDA announcement .
Posted 5/28/2019
May 28, 2019
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Read FDA announcement .
Posted 5/28/2019
May 24, 2019
On May 24, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) for adults and pediatric patients ≥12 years of age. It is the first and only FDA-approved treatment for this indication. Read the Incyte press release here .
Posted 5/24/2019
May 23, 2019
Since April 19, a proposed rule titled "Potential Model Updates" has been under Office of Management and Budget review. Healthcare stakeholders and members of the oncology community are speculating that this proposed rule could offer the public a more finalized look into a radiation oncology specific alternative payment model (APM) that Administration healthcare leadership has been hinting at since last year.
Stakeholders anticipate that more information about the RO-APM will come either in this proposed rule or in the larger Medicare outpatient prospective payment system proposed rule later this summer. Posted 5/23/2019
May 23, 2019
The Trump Administration's spring regulatory agenda, released on May 22, shows a slow down of next steps for regulatory action on two pivotal drug-pricing reform measures: the International Pricing Index (IPI) model and the revamping of the rebate system.
The IPI model was outlined last fall in an advance notice of proposed rulemaking from the Department of Health and Human Services (HHS). The rule, originally expected this spring, is now slated to be proposed in August .
The regulatory agenda also indicates that Administration's proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system are now scheduled to be released later than originally anticipated. Source: Inside Health PolicyPosted 5/23/2019
May 23, 2019
On May 17, the Centers for Medicare & Medicaid Services (CMS) abruptly announced a delay in its release of a Medicare National Coverage Determination (NCD) for CAR T-cell therapy, which was due to be published that same day. The agency statement did not provide an explanation for the delay.
In a meeting with reporters on Wednesday, May 22, CMS Administrator Seema Verma said that the agency is taking care with the NCD because not only is the technology "new ground" for CMS, but also application of CAR-T therapy is expected to expand to other types of cancer beyond lymphoma. “So we want to make sure that we’re doing this appropriately, dotting our i’s and crossing our t’s. It’s just taking a little bit more time because it’s not a routine type of decision,” Verma said. Source: Inside Health PolicyPosted 5/23/2019
May 17, 2019
On May 16, the Centers for Medicare & Medicaid Services(CMS) released their final rule titled “Modernizing Part D and MedicareAdvantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Highlightsfrom this final rule include:
The ACCC policy team will continue to analyze this rule andprovide a more detailed analysis at a later date. Readthe CMS final rule here .
Posted 5/17/2019
May 15, 2019
On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination. Read the Genentech press release .
Posted 5/15/2019
May 15, 2019
On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. Read the Pfizer press release .
Posted 5/15/2019
May 13, 2019
On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars. Read statement from acting FDA Commissioner Ned Sharpless, MD.
Posted 5/13/2019
May 10, 2019
On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.
Read the FDA press release here .
Posted 5/10/2019
May 3, 2019
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1) (Kadcyla, Genentech Inc.) for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (Herceptin) and chemotherapy. Read the TargetedOnc article here .
Posted 5/3/2019
May 3, 2019
On May 2, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Read the FDA press release here .
Posted 5/3/2019
May 2, 2019
On May 2, the American Urological Association (AUA) released a new clinical guideline for the diagnosis and treatment of early-stage testicular cancer, the most common cancer among men aged 20 to 40. The new clinical guideline makes 45 recommendations, including recommendations for scrotal ultrasound, obtaining serum tumor markers, and sperm banking prior to orchiectomy. Read the AUA press release .
Read Diagnosis and Treatment of Early State Testicular Cancer: AUA Guideline (2019).
On April 30, AUA and the American Society for Radiation Oncology (ASTRO) announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new published research related to adjuvant radiotherapy. Read the AUA press release .
Read Adjuvant and Radiotherapy after Prostatectomy: ASTRO/AUA Guideline .
Posted 5/2/2019
May 2, 2019
A new study by researchers from the American Cancer Society (ACS) finds that approximately 137 million adults in America (56 percent) reported having medical financial hardship in the past year. Highlights of the report include:
2017 ACCC Annual Achievement Award winner Barbara McAneny, MD, president of the American Medical Association, says of the study in the Los Angeles Times , "People are trying hard to do the right thing, but care is being prices out of their reach." Read the ACS press press release . Read the Los Angeles Times article .
Read "Prevalence and Correlates of Medical Financial Hardship in the USA" in the Journal of General Internal Medicine .
Posted 5/2/2019
April 25, 2019
The American Heart Association (AHA) has published a scientific statement in the journal Circulation outlining the need to develop and test cardio-oncology rehabilitation programs for patients at high risk for cardiac dysfunction during and after cancer treatment. The statement outlines the process for identifying at-risk patients and the infrastructure needed to address the unique exposures and complications related to cardiac rehabilitation. Read the AHA journal article here .
Posted 4/25/2019
April 23, 2019
On April 23, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year (FY) 2020.
In the IPPS proposed rule, the agency proposes to:
The agency fact sheet specifically addresses CAR-T therapy in the context of applications for new technology add-on payments for FY 2020. In the proposed rule, CMS presents 17 new applications for new technology add-on payment for FY 2020, and proposes to continue the new technology add-on payments for 10 of the 13 technologies currently receiving the add-on payment (3 technologies will no longer be in their newness period in FY 2020). Two of the technologies CMS is proposing to continue payments for are types of chimeric antigen receptor (CAR) T‑cell therapy.
The ACCC policy team is analyzing the proposed rule and will provide a more in-depth analysis to members shortly.
Read the agency fact sheet . Access the proposed rule .
Posted 4/23/2019
April 22, 2019
On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Read the full FDA press release here .
Posted 4/22/2019
April 17, 2019
The National Institutes of Health (NIH)/National Cancer Institute (NCI) have announced a funding opportunity RFA-CA-19-035 , titled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-Up Care (RO1 Clinical Trial Required)"
The Funding Opportunity Announcement (FOA) solicits applications that develop and test models of care for adult survivors of cancer who are transitioning from active treatment to follow-up care. Through this FOA, the NCI intends to support multi-level interventions that enhance communication, collaboration, and coordination among oncology and non-oncology providers to improve cancer survivor outcomes.
Interventions that focus on the needs of racial/ethnic minority or medically underserved adult survivors and/or those receiving care in community settings (including, but not limited to, community-based cancer centers) are not required but strongly encouraged. NCI seeks to fund applications that represent a broad spectrum of cancer survivors (e.g., variability in demographics, cancer type, clinical characteristics) and care delivery settings (e.g., community settings, integrated healthcare settings).
KEY DATES
Open Date (Earliest Submission Date): May 28, 2019
Letter of Intent Due Date(s): 30 days prior to the application due date
Application Due Date(s): June 28, 2019, by 5:00 PM local time of applicant organization.
DATE FOR PRE-APPLICATION WEBINAR for RFA-CA-19-035May 3, 20191:00 PM - 2:00 PM (ET)
On Friday, May 3, 2019 from 1:00 - 2:00 PM (ET), NCI will hold a pre-application webinar for RFA-CA-19-035 entitled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care (R01 Clinical Trial Required)."
NCI staff members involved in this FOA will provide orientation and technical assistance to potential applicants to the above-referenced FOA by explaining the goals and objectives for the proposed FOA and answer questions from webinar attendees. Potential applicants are encouraged to submit their questions to NCIHDRP@mail.nih.gov by 12 pm ET on May 1, 2019.
To join the webinar, pre-registration is required through Webex . Specific webinar information will be provided upon registration.
Posted 4/17/19
April 17, 2019
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care, in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents. The update also suggests that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent. Read the ASCO and ASH press release here.Read the updated ESA guideline here.
Posted 4/17/2019
April 12, 2019
On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication. Read the full FDA press release here.
Posted 4/12/2019
April 12, 2019
On April 11, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test. Read the FDA press release here.
Posted 4/12/2019
April 5, 2019
On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. Read the full FDA press release here .
Posted 4/5/2019