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Oncology Newsfeed

  • Administration Withdraws Proposed Drug Rebate Rule

    On July 11, the White House announced withdrawal of its proposed drug rebate rule that would have removed rebates from government drug plans. 

    “Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” said White House spokesman Judd Deere. “The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline.”

    The controversial proposed rule fueled a rift in the Administration with HHS Secretary Alex Azar supporting the curbing of drug rebates and other White House officials in opposition due to the potential for the proposal to increase Medicare spending by nearly $200 billion.

    The proposed rule was considered central to the Administration's drug pricing reform plan. Withdrawal of the proposal likely signals an even greater focus by the Administration on its proposed International Pricing Index Model for Medicare Part B Drugs, which is currently undergoing review at the White House. 

    Posted 7/11/2019

  • CMS Releases Proposed Radiation Oncology Model Rule

    On July 10, 2019, the Centers for Medicare and Medicaid Services (CMS) released its proposal for a new mandatory Medicare Payment Model – the Radiation Oncology Model (RO Model) that seeks to promote the inclusion of radiation oncology in the evolution of value-based care arrangements in cancer care.

    This model would be conducted under the Center for Medicare and Medicaid Innovation (CMMI) at CMS, and is proposed as a four-year model, running from 2020 through 2024. The proposal seeks to include 17 cancer types in the RO Model that would make prospective episode-based payments to participants in a site-neutral manner. The RO Model would also be furnished to provide physicians the opportunity to participate in an Advanced Alternative Payment Model (APM) under the Quality Payment Program (QPP). Participation in the RO Model would be required based upon radiation therapy (RT) services furnished in randomly selected Core Based Statistical Areas (CBST).
    More details on the proposed model if available from CMMI here.

    The ACCC policy team is continuing to analyze the effect of this proposal across our entire membership. CMS is accepting comments from relevant stakeholders up to 60 days after the release of this proposed rule into the Federal Register.

    Posted 7/10/2019

  • FDA Approves Selinexor for Multiple Myeloma

    On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

    As a condition of accelerated approval, further clinical trials may be required to verify and describe selinexor’s benefit. FDA granted this application fast track designation and orphan drug designation. 

    Read FDA announcement.

    Posted 7/3/2019

  • FDA Approves Daratumumab in Combo for Multiple Myeloma Ineligible for ASCT

    On June 27, the  U.S. Food and Drug Administration (FDA) announced approval of daratumumab (Darzalex®) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

    Read FDA announcement

  • FDA Approves Bevacizumab-bvzr (Zirabev™) Avastin Biosimilar

    On June 28, Pfizer Inc. announced that the U.S. Food and Drug Administration(FDA) has approved Zirvabev™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

    Read corporate press release.

    Posted 6/28/2019

  • Senate HELP Committee Adds More Drug Pricing Reform Measures to S.1895

    On June 25, the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee leaders added bipartisan legislation to S. 1895 (116), the Lower Health Care Costs Act. In marking up the bill, legislators are expected to incorporate large-scale proposals to tackle drug pricing reform from Congress, including, surprise medical billing legislation, telehealth access legislation, generics competition legislation, and a tobacco 21 proposal.

    Posted 6/25/2019

  • President Trump Signs Executive Order Requiring Healthcare Price Disclosure

    On Monday, President Trump signed an executive order that aims to make hospital and other healthcare cost more transparent for consumers.

    The order calls for health officials to propose a regulation within 60 days that would ultimately require hospitals and hospital-employed physicians to post their charges — including the discounted rates they negotiate with insurers.

    Read Executive Order.

    Posted 6/25/2019

  • FDA Approves Pembrolizumab for Metastatic SCLC

    On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

    Read FDA announcement.

    Posted 6/18/2019

  • FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications

    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

  • ACCC Joins In Comment Letter on Medicare NGS NCD

    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.