Trump Administration Issues Proposed Rule on Importation of Prescription Drugs
On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)
Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.
Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.
FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer
On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.
Read the FDA announcement.
Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner
On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).
FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC
On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Read the corporate announcement.
Read FDA announcement.
Posted 12/04/2019; updated 12/06/2019
FDA Approves Reblozyl for Anemia in Adults with Beta Thalassemia
On Nov. 8, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.
Read the FDA announcement.
FDA Approves New Treatment Option for CLL Under International Collaboration
Nov. 21, 2019, the U.S. Food and Drug Administration (FDA) - as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada - granted supplemental approval to acalabrutinib (Calquence ) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
Read FDA announcement.
Read AstraZeneca corporate press release.
CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers
On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.
The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:
- Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
- Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.
CMS fact sheet on final rule.
Access final rule.
CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees.
If finalized, the "Transparency in Coverage" proposed rule would require health plans to:
- Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.
Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.
Access a CMS fact sheet on the proposed rule.
Access the proposed rule.
More details are available in the HHS press release.
FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma
On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
FDA granted this application priority review and zanubrutinib received orphan product and breakthrough therapy designations for treatment of MCL.
Read FDA announcement.
FDA Office of Hematology Oncology Products, Now Called Office of Oncologic Diseases
On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.
The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).
Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.
Read FDA press release.
CMS Issues RFI on Oncology Care First Model
Late Friday, Nov. 1, the Center for Medicare and Medicaid Innovation (the Innovation Center) released an informal Request for Information (RFI), on value-based payment to support high-quality oncology care. In the Nov. 1 announcement the Innovation Center stated they hope to gather feedback during today's Public Listening Session that will outline a potential Oncology Care First (OCF) Model.
The Innovation Center stated Friday at the Nov. 4 Public Listening Session and in submitted written feedback, they hope to solicit stakeholder input on the following targeted topics:
- The potential OCF Model would seek to improve health outcomes and quality of care for Medicare beneficiaries with cancer. How could the potential model support participants’ care transformation through practice redesign activities? Specifically, how could the potential model build on lessons learned from the implementation of the practice redesign activities included in the Oncology Care Model (OCM)? What revisions or additions should be made to the OCM practice redesign activities in the potential model?
- We welcome feedback on the potential payment methodology, including the structure and design of the monthly population payment and the performance-based payment. We are considering the inclusion of additional services in the monthly population payment, such as imaging or lab services, and seek feedback on adding these or other services to the monthly population payment.
- We encourage feedback on the conceptualized risk arrangements, in particular, how a downside risk arrangement might be best constructed in terms of the level of risk.
We invite feedback on the interest of physician group practices (PGPs) and hospital outpatient departments (HOPDs) in participating in a potential OCF Model. We are particularly interested in hearing from PGPs and HOPDs about the conceptualized participation eligibility parameters (e.g., the grouping concept), and whether they think that meeting those parameters would be feasible. We also invite feedback from potential payer partners, including commercial payers and state Medicaid agencies. We welcome suggestions about the model concept that would better incentivize participation in the potential model.
Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference. REGISTER HERE.
CMMI Public Listening Session on Potential Oncology Payment Model
Monday, Nov. 4, 2019
1:00 to 4:00 PM EST