June 14, 2019
On June 13, 2019, Amgen and Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved Kanjinti ™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin ® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Read corporate press release .
Posted 6/14/2019
June 13, 2019
The Association of Community Cancer Centers (ACCC) has joined with oncology stakeholder organizations in a comment letter to the Centers for Medicare & Medicaid Services (CMS) on National Coverage Determination (NCD) 90.2 for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).
Section 90.2 of NCD describes conditions of coverage for NGS. The section is being interpreted to apply to NGS tests for somatic and germline mutations. Additionally, Section 90.2 of the NCD states criteria that patients must meet to qualify for NGS testing, and stipulates specific requirements that the diagnostic laboratory test using NGS must meet.
The comment letter to CMS cites specific concerns regarding the potentially deleterious effect of the Section 90.2 NCD on access to germline testing. The stakeholder letter recommends to CMS "that NCD 90.2 be revised to indicate that NGS-based germline genetic tests are exempt from the policy. This National Coverage Determination should specifically apply to somatic mutation testing and be renamed:National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) for Somatic."Read the comment letter .
June 11, 2019
The Association of Cancer Care Centers (ACCC) joined the American Cancer Society Cancer Action Network, the American Lung Association, the American Society of Clinical Oncology, the Cancer Support Community, and a number of other oncology clinical, professional, and patient advocacy organizations in a June 6, letter of support for S. 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019 .
The legislation is aimed at eliminating barriers in patient access to cancer clinical trials, with a special emphasis on decreasing disparities in cancer clinical trials. Read the letter .
June 10, 2019
On June 10, Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to polatuzumab vedotin-piiq (Polivy TM ) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Read the Genentech press release .
Posted 6/10/2019
June 6, 2019
On Wednesday, June 5, a bipartisan group of legislators introduced the “Improving Seniors’ Timely Access to Care Act of 2019” (H.R. 3107) . The bill would require the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorizations by Medicare Advantage (MA) plans in order to streamline the current MA prior authorization system.
The bill also calls for increased transparency in the prior authorization process and would require MA plans to report the extent of their prior authorization use to CMS, as well as their rate of approvals or denials.
Cosponsors of the bipartisan bill include Rep. Roger Marshall, MD (R-Kan.), Rep. Mike Kelly (R-Pa.), Rep. Ami Bera, MD (D-Calif.), and Rep. Suzan DelBene (D-Wash.).
Posted 6/6/2019
June 6, 2019
On June 6, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) seeking new ideas from the public to continue the administration's Patients over Paperwork initiative. The RFI will be published in the Federal Register on June 11.
The RFI invites patients and their families, the medical community, and other healthcare stakeholders to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and healthcare system’s resources from paperwork to high-quality care that improves patient health.
According to the agency's press release, CMS is seeking innovative ideas to relieve burden and improve:
Comments must be submitted by August 12, 2019.
Posted 6/6/2019
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