Industry News

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.
- Read the agency's press release on the proposed 2020 OPPS
- Read the agency's fact sheet on the proposed 2020 OPPS rule.
- Access the proposed OPPS rule. The rule is scheduled for publication in the August 9 Federal Register. The deadline for submitting comments on the proposed rule is September 27, 2019.
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.
- Read the agency's press release on the proposed 2020 PFS and Quality Payment Program (QPP) rule.
- Read the agency's fact sheet on the proposed 2020 PFS rule.
- Read the 2020 QPP Proposed Rule Fact Sheet.
- Access the proposed PFS and QPP rule. The proposed PFS rule is scheduled for publication in the August 14 Federal Register. The deadline for submitting comments on the proposed rule is September 27, 2019.
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

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Industry News

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

CMS Releases Proposed 2020 OPPS and PFS Rules

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

ACCC Summary of RO Model Highlights Key Considerations

Administration Withdraws Proposed Drug Rebate Rule

CMS Releases Proposed Radiation Oncology Model Rule

FDA Approves Selinexor for Multiple Myeloma

Information on Keytruda Dosing & Testing Requirements

FDA Approves Pembrolizumab for Metastatic SCLC

FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications