2017 ASH Advocacy Efforts to Ensure Patient Access to Care

Efforts to Repeal and Replace the Affordable Care Act (ACA)

ASH was very vocal on Congress’s repeated attempts to repeal and replace the Affordable Care Act (ACA). ASH opposed the legislation introduced in the House, the American Health Care Act, and the Senate, the Better Care Reconciliation Act, and the Graham-Cassidy Amendment, because of concerns that these pieces of legislation would reduce overall access to coverage and treatment and would negatively impact patients with hematologic diseases and disorders. ASH sent numerous letters to Congress outlining the Society’s priorities and expressing concerns with specific provisions of each of these pieces of legislation.

The Senate released new legislation in October, the Bipartisan Health Care Stabilization Act. ASH supports this proposed legislation as it will improve patient access to care by funding the cost-sharing reduction payments through 2019 and re-funding the education and outreach efforts to help boost enrollment in the marketplaces.

Oral Chemotherapy Parity

While oral and patient-administered forms of chemotherapy have become more prevalent and represent the standard of care for many types of cancers for their convenience, efficacy, and low rate of side effects, they are covered differently than IV drugs, leaving many patients responsible for unsustainable high monthly co-payments.

• Federal Legislation. As part of the Patients Equal Access Coalition (PEAC), ASH has advocated for legislation to ensure that cancer patients have equality of access (and equality of insurance coverage) to all approved anticancer regimens including, but not limited to oral and intravenous drugs. In early March, Representatives Leonard Lance (R-NJ) and Brian Higgins (D-NY) reintroduced the Cancer Drug Parity Act (H.R. 1409), which currently has 114 bipartisan cosponsors. Senator Al Franken (D-MN) remains committed to reintroducing a companion bill in the Senate and is currently seeking a Republican Senator to lead the effort with him. (Senator Mark Kirk from Illinois had been the bill’s lead Republican sponsor in the past two congresses; however, he lost his reelection bid in November and did not return to the Senate for the 115^th Congress.)

• State Legislation. Although only federal legislation will ensure coverage for all cancer patients, 43 states plus the District of Columbia have passed legislation to limit patient out-of-pocket costs for oral anti-cancer medications. ASH has supported legislative efforts at the state level and will continue to work with stakeholders and advocacy groups to support ongoing legislative efforts in a number of additional states, including Michigan, Tennessee, and North Carolina.
  
  
  • Michigan: As with efforts in other states, ASH continues to work as part of a larger coalition of patient and provider organizations to seek passage of oral parity legislation in Michigan. Legislation was reintroduced in June 2017, marking the fourth attempt to pass oral chemotherapy legislation in Michigan. In October, the bill passed the Senate by a vote of 36-1. However, the legislation must still pass the House, where it faces substantial hurdles. ASH will continue to work with coalition partners to pass the bill and have it signed into law in Michigan.
  • Tennessee: Legislation was reintroduced in the Tennessee General Assembly in early February to institute insurance coverage parity for oral chemotherapy agents. The bill successfully passed the House Insurance Subcommittee in mid-March and was scheduled to be considered by the full House Insurance & Banking Committee in April. However, facing opposition in the Senate, the bill’s sponsor pulled the bill from further consideration. The Tennessee coalition is currently working to develop a strategy to pass the legislation in 2018.
  • North Carolina: Legislation passed the House in April 2017 by a vote of 90-22 and has since been sent to the Senate for consideration, where movement has stalled. The legislative session for 2017 in North Carolina has technically ended; however, due to a court order requiring the state legislature to redraw district lines, both chambers have been convening periodic special sessions. The North Carolina coalition is urging the Senate to consider the legislation in the next special session that will begin in January 2018.
  • Arkansas: Oral parity legislation was introduced in the Arkansas House in mid-February and very quickly passed through the full House. The legislation cleared the state Senate in mid-March and was signed into law by Governor Asa Hutchinson at the end of March, making Arkansas the 43^rd state to pass oral parity legislation.

Prescription Drug SpecialtyTiers

Many insurance companies have divided prescription medications and treatments into "tiers," generally based on cost. For drugs in Tiers 1, 2, and 3, most health plans charge fixed co-pays, such as $10, $25 and $50, respectively. But increasingly, insurers are moving certain drugs into a "specialty tier" (Tier 4 or Tier 5). Instead of a copay for specialty tier drugs, patients are responsible for coinsurance, meaning they pay a percentage of the actual cost of the drug – sometimes as much as 25 percent or even 50 percent.

As part of the Coalition for Accessible Treatments, ASH has advocated for legislation in the U.S. House of Representatives (H.R. 2999, the Patients' Access to Treatment Act) that would significantly limit how much consumers pay for drugs in Tier 4 or above (including biologics and other drugs for diseases and conditions such as cancer and anemia) by requiring a fixed co-pay for specialty tier drugs that is in line with Tier 3 drugs. The legislation, reintroduced in the 115^thCongress in June by Representatives David McKinley (R-WV) and G.K. Butterfield (D-NC), would end the practice of "discriminating between medications" by requiring a fixed co-pay for specialty tier drugs that is in line with Tier 3 drugs. Representatives McKinley and Butterfield, along with ASH and other organizations in the Coalition for Accessible Treatments, are also working to find a champion to introduce companion legislation in the Senate.

In February, the ASH Officers’ presented Representative McKinley with the 2016 ASH Public Service Award to thank him for his commitment to ensuring that patients have access to the treatments and cures through his sponsorship of this legislation.

Work With the Food and Drug Administration (FDA)

In 2017, ASH continued to partner with the U.S. Food and Drug Administration (FDA) to offer the following educational programs:

• The ASH-FDA Speaker Series, a program where ASH brings experts to the FDA to educate their staff on important topics in hematology, continued to be well received. The most recent program focused on epigenetic therapies, with insights from studies in myeloid malignancies, presented by Ross Levine, MD (Memorial Sloan Kettering).

• ASH and FDA are co-sponsoring two programs at the ASH Annual Meeting that will feature drugs recently approved to treat hematologic disorders. FDA product-reviewers will discuss the safety and efficacy issues from the products' clinical trials and toxicity studies. The programs will also include clinicians who will discuss their perspectives on the use of the products in the real-world setting.
  •  ASH-FDA Joint Symposium on New Drug Approvals in Acute Lymphoid Leukemia and Non-Hodgkin Lymphoma
  •  ASH-FDA Joint Symposium on New Drug Approvals in Acute Myeloid Leukemia

The FDA will also host a patient advocate session at the ASH Annual Meeting to encourage dialogue between FDA leadership and reviewers and patient advocates.

• ASH served as one of the supporting organizations for FDA’s Oncology Center of Excellence’s first annual Partners in Progress: Cancer Patient Advocates and FDA meeting. The goal of the meeting was to provide patient advocates with training on the role of the FDA and cancer patient advocates in oncology product development.

ASH Strengthens Drug Access Resources

ASH continues to enhance the content on the Society’s drug resource webpage, which includes resources to help clinicians and patients access high-cost hematologic drugs, information about hematologic drug shortages, FDA alerts about newly approved therapies and updated safety information, and hematology-related Risk Evaluation and Mitigation Strategies.

ASH will present a new biosimilars webcourse series in late November through early December entitled Biosimilars: A New Era of Hematology/Oncology Management Considerations. The two-part series will present practical, foundational information on biosimilars, while also addressing issues and barriers most commonly encountered in the clinical setting.