FOR IMMEDIATE RELEASE
February 23, 2021

STATEMENT FROM – NCODA Legislative & Policy Advisory Committee
Contact: Kevin Scorsone | NCODA Legislative & Policy Liaison
Phone: (919) 903-2057
Email: kevin.scorsone@ncoda.org
www.ncoda.org

ANY WILLING PROVIDER – STILL A MAJOR ISSUE IN ONCOLOGY

As we begin to navigate 2021, it is important for the oncology community to speak up on issues that are still a focal point affecting patient care. The continuing issue of “Any Willing Provider (AWP)” is one that remains at the forefront of NCODA’s efforts as it relates to the Legislative & Policy Advisory Committee.

“Any Willing Provider” statutes, sometimes referred to as  “Any Authorized Provider,” are laws that require health insurance carriers to allow health care providers to become members of the carriers’ networks of providers if certain conditions are met. Such statutes prohibit insurance carriers from limiting membership within their provider networks based upon geography or other characteristics, so long as a provider is willing and able to meet the conditions of network membership set by the carrier. 1

NCODA serves patients by way of our vast membership. We are aware of issues that continue to face patients in various states, limiting their access to quality care, and in this instance with AWP limitations, negatively impacting patients’ ability to receive their medications in a timely manner.

While many of the issues that face the world of oncology are determined at the state level, we must look to the higher courts as we did earlier this year when the Supreme Court ruled to allow states to regulate Pharmacy Benefit Managers (PBM’s). NCODA believes that the ability to receive timely and quality care from pharmacies should not be determined by geographic location.

This is the call of the oncology community and we hope that the necessary steps are taken in order to correct issues such as AWP that continue to have detrimental effects on patient access to care.

[1] Courtesy of ncsl.org

 

Read the Full Press Release HERE

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FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%

  • Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials
  • This is the third approval for Libtayo in the U.S.

PARIS and TARRYTOWN, N.Y. – February 22, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

“The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, M.D., Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial. “Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

This is the third approval for Libtayo and follows a Priority Review by the FDA, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions. Earlier this month, Libtayo was approved as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease. In 2018, Libtayo was the first systemic treatment approved for adults with advanced cutaneous squamous cell carcinoma (CSCC) that is locally advanced or metastatic and who are not candidates for curative surgery or curative radiation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.

Read More HERE.

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