Industry News

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

FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment
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

FDA Expands Palbociclib Use to Include Male Breast Cancer Patients
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

HCPCS Assigns J-Code and ASP for Imfinzi

Imfinzi (durvalumab) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and average sales price (ASP) by the Centers for Medicare & Medicaide Services (CMS). The following code can be used to identify Imfinzi when billing across settings of care:
- J9173: Injection, durvalumab, 10 mg (vial size 500mg/10 mL, billing unit 50 units, NDC 0310-4611-50)
- J9173: Injection, durvalumab, 10 mg (vial size 120mg/2.4 mL, billing unit 12 units, NDC 0310-4500-12)
Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement. Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims. Imfinzi is listed in the April 2019 ASP Pricing File:
- J9173: Inj., durvalumab, 10 mg (HCPCS code dosage 10MG, payment limit $73.778).
Posted 12/19/2018

FDA Approves Atezolizumab for Small Cell Lung Cancer
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

FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin
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

FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC
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

FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer
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.

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Industry News

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

FDA Approves First-Line Pembrolizumab for Metastatic or Unresectable HNSCC

FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

FDA Approves Alpelisib for Metastatic Breast Cancer

FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

FDA Approves Avelumab Plus Axitinib for Advanced RCC

FDA Approves Ramucirumab for HCC

FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment

FDA Expands Palbociclib Use to Include Male Breast Cancer Patients

HCPCS Assigns J-Code and ASP for Imfinzi

FDA Approves Atezolizumab for Small Cell Lung Cancer

FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin

FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC

FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer