ONCOLOGY NEWSFEED

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

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

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

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

The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.

Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.

The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.

Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.

The proposed rule will be open for public comment for 90 days after publication. Read the FDA press release . View the proposed rule .

Posted 3/27/2019

On March 19, the FDA approved atezolizumab (Tecentriq ^® , Genentech) in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Read the Roche press release here . Read the FDA press release here . Download the Tecentriq ES-SCLC Day 1 Letter here .

Posted 3/19/2019

On March 14, the Centers for Medicare & Medicaid Services (CMS) updated its Drug Spending Dashboards with data for 2017. The dashboards add information on manufacturers that are responsible for price increases and includes pricing and spending data for drugs across Medicare Parts B and D and Medicaid.

The dashboards focus on average spending per dosage unit for prescription drugs paid under Medicare Parts B and D and Medicaid, and tracks the change in average spending per dosage unit over time. Information is also provided on drug uses and clinical indications, so patients and physicians can compare the list prices of different medications for a given condition.

In 2017, total gross spending on prescription drugs was $154.9 billion in Medicare Part D, $30.4 billion in Part B, and $67.6 billion in Medicaid.

Click here to access the CMS Drug Spending Dashboards .

Posted 3/14/2019

On March 12, Health and Human Services Secretary Alex Azar told Congress that Norman "Ned" Sharpless, director of the National Cancer Institute (NCI), will become acting commissioner of the Food and Drug Administration (FDA), succeeding Scott Gottlieb. Gottlieb announced his April departure in the first week of March.

Doug Lowy, current NCI Deputy Director, will serve as acting director of the NCI upon Sharpless' transition to the FDA. Read news coverage from STAT here .

Posted 3/12/2019

On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera ^™ ), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read the Pfizer press release here .

Posted 3/12/2019

On March 8, the FDA approved atezolizumab (Tecentriq, Genentech Inc.) plus nab-paclitaxel (Abraxane, Celgene) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC). Read OncLive news coverage here .

Posted 3/8/2019

In a March 6 press release , the Centers for Medicare & Medicaid Services (CMS) announced that the agency's issuance of a request for information (RFI) soliciting recommendations on "how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines."

The press release states that the RFI builds on President Trump’s October 12, 2017, Executive Order, “Promoting Healthcare Choice and Competition Across the United States” instructs the administration to facilitate the purchase of health insurance coverage across state lines.

The RFI will be open for public comment for 60 days. View the RFI here .

Posted 3/6/2019

On February 28, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech Inc.) for the treatment of HER2-overexpressing breast cancer.

On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Read the Taiho Oncology press release here .

Posted 2/25/2019

On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Read the FDA press release here .

Posted 2/19/2019

On February 14, the American Society of Breast Surgeons (ASBS) released a consensus guideline advising that genetic testing should be made available to all patients diagnosed with breast cancer, including patients who had previously been tested. ASBS developed this recommendation because it believes current guidelines regarding genetic testing for breast cancer to be too restrictive.

ASBS also recommended that genetic testing should be made available to patients without a history of breast cancer who meet NCCN guidelines. Read the ASBS consensus guideline here .

Posted 2/15/2019

On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.

With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”

Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].

Posted 2/15/2019
Updated 2/28/2019

The Association of Cancer Care Centers (ACCC) joined with more than 60 organizations in a January 31, 2019, letter to CMS Administrator Seema Verma expressing concern over recent developments in the agency's interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer .

An overarching concern is that, although the NCD was requested for a somatic-based test, the new interpretation will result in Medicare Administrative Contractors (MACs) applying the NCD's terms to both somatic and germline NGS-based testing for patients with cancer. As a result, patient access to medically necessary and relevant testing of germline mutations in patients with cancer would be restricted, as would NGS-based testing (both somatic and germline) for Medicare beneficiaries with early-stage cancer. Read the Letter . Posted 1/4/2019

On January 31, Health and Human Services Secretary Alex Azar proposed a rule to remove safe harbor protections for drug rebates paid by manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations. Through the removal of these protections, HHS and the Trump Administration continue their attempts to lower prescription drug prices and out-of-pocket costs. The proposal would also create new safe harbor protection for fixed fee service arrangements between manufacturers and PBMs.

Read the proposed rule here . Read the HHS press release here and the HHS fact sheet here .

Posted 2/1/2019

On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Read the Eli Lilly and Company press release here .

Posted 1/31/2019

The Center for Medicare & Medicaid Innovation (CMS Innovation Center) is hosting a webinar to provide a basic overview of the Part D Payment Modernization Model . CMS will host two sessions including the same content, which will take place on Thursday, January 31, 2019 at 1:00 p.m. EST , and on Wednesday, February 6, 2019 at 1:00 p.m. EST .

If you previously registered for the Part D Payment Modernization Model webinar originally scheduled for Tuesday, January 29, 2019 please re-register for one of the new dates.

During the webinar, CMS subject matter experts will provide information about The Part D Payment Modernization model, which tests the impact of modernized Part D program design and improved incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs. The model is open to eligible standalone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans that are approved to participate, is voluntary, and will last 5 years, beginning with the 2020 plan year.

As part of the model, CMS will provide participants with additional programmatic tools, including Part D rewards and incentives programs, to increase engagement with enrollees, with the goal of promoting better enrollee understanding of: (1) their Part D benefit, including out-of-pocket and total drug costs; and (2) clinically equivalent therapeutic options.

Register for the Thursday, January 31, 2019 webinar here .

Register for the Wednesday, February 6, 2019 webinar here .

Posted 1/29/2019

On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Read the Janssen press release here .

Posted January 28, 2019

On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing. Read the Adaptive Biotechnologies press release here .

Posted 1/23/2019

On January 18, the Centers for Medicare & Medicaid Services (CMS) announced that its Center for Medicare and Medicaid Innovation (CMMI) will test a new model for Part D plans and an update to the Medicare Advantage Value-Based Insurance Design (VBID) model that the agency launched in 2017.

The Part D model, titled the Part D Payment Modernization model, is voluntary as is the MA VBID update model, meaning that certain Medicare Advantage and Part D plans can choose to participate, and patients can choose to enroll in participating plans.

The Part D Payment Modernization model will begin in January 2020. The model is intended to test the impact of a revised Part D program design and incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs.

The voluntary, five-year Part D Modernization model will be open to eligible standalone Prescription Drug Plans (PDPs) and Medicare Advantage-Prescription Drug Plans (MA-PDs) that are approved to participate.

The CMS fact sheet on the Part D Modernization model states: "Through this model, CMS is testing the impact of a modernized Part D payment structure that increases and better aligns Part D plan sponsor liability with the costs paid for by CMS and Medicare beneficiaries. Ultimately, this model will allow CMS to address the high list price of drugs covered by Medicare Part D and evaluate the impact on cost and quality for Medicare beneficiaries."

Read CMS fact sheet on Part D Modernization Model here .

More information is available on the CMMI website here .

The CMS press release is available here .

Posted 1/18/19

On January 14, Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read the full Exelixis, Inc. press release here .

Posted 1/15/2019