Industry News

  • FDA Grants Acalabrutinib (Calquence) Breakthrough Therapy Designation

    AstraZeneca announced August 14 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to acalabrutinib (Calquence) for chronic lymphocytic leukemia (CLL).

    The FDA granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials, which will serve as the foundation for regulatory submissions later this year.

    FDA Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. Use of acalabrutinib in adult patients with CLL is not yet FDA-approved.

    Read press release.

    Posted 8/15/2019



  • CMS Finalizes NCD for CAR T-Cell Therapy

    On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.  

    Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.

    The NCD     continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

    In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." 

    Read the CMS Decision Memo.

    Download CMS Decision Memo.

    Posted 8/07/2019


  • HHS Issues Plan Outlining 2 Paths for Prescription Drug Importation

    The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.

    Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.

    Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. 

    Read the HHS press release.
    Read the administration's Action Plan.

    Posted 7/31/2019


  • FDA Approves Pembrolizumab for PD-L1 Positive Advanced SCC of Esophagus

    On July 31, Merck announced U.S. Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    Read the corporate press release    .

    Posted 7/31/2019


  • CMS Releases Proposed 2020 OPPS and PFS Rules

    On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) proposed rule and the CY 2020 Physician Fee Schedule (PFS) and Quality Payment Program proposed rule.

    CMS states that the OPPS proposed rule puts forward price transparency requirements that will increase competition among all hospitals by requiring them to make pricing information publicly available.

    According the agency, the policy changes included under the proposed 2020 PFS rule align with the administration's aims to reduce providers' paperwork burden, remove unnecessary reporting measures, and reward clinicians for time spent with patients.

    The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.

    Posted 7/29/2019



  • FDA Approves Ruxience (rituximab-pvvr) for Adult NHL, CLL, Some Auto-Immune Conditions

    Pfizer Inc. announced on July 23, the U.S. Food and Drug Administration (FDA) approval of Ruxience™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

    Read the corporate press release.

    Posted 7/24/2019



  • ACCC Summary of RO Model Highlights Key Considerations

    On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (“RO Model”). As proposed, the model would make fundamental (but temporary) changes to the way that Medicare pays for radiation therapy in certain randomly chosen geographic areas. Under the proposed model, Medicare would pay providers a pre-determined, site-neutral bundled rate for most services provided in a 90-day episode of radiation therapy, rather than paying for each service individually. The proposed model would be mandatory for providers selected to participate and is intended to incentivize providers to deliver radiation therapy services more cost-effectively while maintaining or improving the quality of care delivered.

    The Association of Community Cancer Centers has released a summary of the proposed RO Model, including potential implications for providers and manufacturers offering radiation therapy services and products. The summary covers top-of-mind consideration for this model, as proposed, and outlines questions for further analysis going forward as ACCC works with stakeholders to further evaluate the proposal.

    Based on the proposed rule’s anticipated date of publication date in the Federal Register, comments on the proposal will be due September 16, 2019.

    Posted 7/16/2019



  • 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


  • Information on Keytruda Dosing & Testing Requirements

    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.

    Information on Dosing and Testing Requirements for Keytruda (pembrolizumab) is available here.

    Posted 7/2/2019


  • 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


  • FDA Approves First-Line Pembrolizumab for Metastatic or Unresectable HNSCC

    On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

    Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test. The FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting patients with HNSCC for treatment with pembrolizumab as a single agent.

    Read the FDA announcement.

    Posted 6/11/2019


  • FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

    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


  • FDA Approves Alpelisib for Metastatic Breast Cancer

    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


  • FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

    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


  • FDA Approves Avelumab Plus Axitinib for Advanced RCC

    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



  • FDA Approves Ramucirumab for HCC

    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


  • FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

    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



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