NCL health policy updates | Health Advisory Council Newsletter | 2017 Q3

NCL health policy at work

Defending the ACA, Medicare, and Medicaid

As part of the Protect Our Care coalition, NCL continues to be actively engaged in the nationwide effort to protect the Affordable Care Act, Medicare, and Medicaid through statements, letters, and social media channels. Like many of you, we are working with our colleagues in the consumer, patient, and public health communities to support a bipartisan effort that will strengthen and improve the Affordable Care Act and shore up, not undermine, the healthcare marketplace.   

Generic drugs

On September 15, NCL submitted comments to FDA in follow-up to the FDA’s July 18, 2017 public meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” NCL’s comments focused on the following areas: pay-for-delay agreements; product hopping; Citizen Petitions; REMS requirements and generics; and reducing the generic drug backlog at the FDA.

Biosimilar biological products

On July 13, NCL Executive Director Sally Greenberg testified in support of biosimilars at the FDA Oncologic Drugs Advisory Committee meeting consideration of Mylan’s biosimilar to Genentech’s HERCEPTIN (trastuzumab) for the treatment of HER2-positive breast cancer and gastric cancer.       

On September 6, NCL submitted comments to CMS on the CY 2018 Medicare Physician Fee Schedule biosimilar payment policy. We urged CMS to include language that assigns each biosimilar product its own unique reimbursement code in order to preserve the physician-patient decision-making relationship and ensure robust biosimilar research and development.  

Alzheimer’s Disease

NCL is proud to be a partner in WomenAgainstAlzheimer’s We Won’t Wait Campaign, which seeks to unite women in a widespread effort to define Alzheimer’s as the 21st Century’s primary economic justice issue and health crisis for women. The Campaign promotes advocacy, education, and action on 5 key pillars: public funding; sex-based research; economic justice; diagnosis and treatment; and brain health.    

In August, NCL facilitated a meeting for advocates including Jill Lesser, President of WomenAgainstAlzheimer’s, and Dr. Lindsay Chura, Chief Scientific Officer of AARP’s Global Council on Brain Health, with Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), and other CDER staff. The group discussed the state of the Alzheimer’s drug pipeline and ways to encourage the development of Alzheimer’s treatments. We were pleased to hear FDA Commissioner Gottlieb speak on the topic and indicate that FDA would be clarifying the Guidance for the development of safe and effective Alzheimer’s treatments. 

In preparation for Open Enrollment, NCL worked with America’s Health Insurance Plans (AHIP) to update and add new content to our joint website, a comprehensive online tool that informs, educates, and engages consumers to better understand how health insurance works. The site provides consumers with easy-to-access, straightforward information to determine the health insurance coverage that is right for them and how to best use it to meet their personal health needs.    

FDA Appropriations

This month, NCL participated with more than 20 members of the Alliance for a Stronger FDA in the Alliance’s September Advocacy Day on the Hill. NCL met with the offices of Senate Appropriations Ranking Member Leahy (D-VT), Agriculture, Rural Development, FDA, and Related Agencies Subcommittee Chairman Hoeven (R-ND) and other Subcommittee members to thank the Senators for supporting the FDA in the FY 18 appropriations cycle and to lay the groundwork for the FY 19 cycle.