2016 ASH Advocacy Efforts to Ensure Access to Safe and Effective Hematologic Drugs

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 in the U.S. House of Representatives and the U.S. Senate (H.R. 2739/S. 1566, the Cancer Drug Coverage Parity Act) 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. Currently, there are 123 cosponsors on the House bill and 20 on the Senate bill; a number of the cosponsors on each of the bills have come about as a direct result of ASH’s advocacy efforts. Though the bills continue to gain cosponsors, neither has thus far seen any additional movement through the legislative process. Though it is unlikely the bills will be passed before the end of the 114^th Congress in December 2016, sponsors of the legislation in both the House and Senate remain committed to the issue and are working to gain more cosponsors and urge committees in both the House and Senate to hold hearings on the issue.

• State Legislation – Although only federal legislation will ensure coverage for all cancer patients, 42 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, Alabama, and North Carolina.
  • Alabama: 2016 marked the first attempt to pass oral parity legislation in Alabama. ASH has been working as part of a coalition (the Alabama Cancer Treatment Fairness Coalition) since early fall 2015 to prepare for the 2016 legislative session. The 2016 legislative session began in early February, with oral parity legislation introduced in the House on the second day of the session. However, the chair of the House Insurance Committee refused to hear the bill and bring it up for a vote, effectively ending efforts to pass legislation in Alabama in 2016. The Alabama coalition is currently regrouping to plan for the 2017 legislative session; ASH will continue to work with the coalition to identify the most opportune times for the Society to weigh-in with state lawmakers and will continue to engage ASH grassroots advocates within the state of Alabama.
    
    
  • Michigan: As with efforts in other states, ASH continues to work as part of a larger coalition of patient and provider organizations to seek pass of oral parity legislation in Michigan. The 2015-2016 legislative session marks the third attempt to pass oral chemotherapy legislation in Michigan. The bill (SB 625) was officially read-in on December 1, 2015 and passed the Senate in May 2016. Following Senate passage of the bill, ASH sent a letter of support to the Chair of the House Insurance (Representative Leonard), which must discharge the bill before it may be considered by the full House. Though only a few legislative days remain following the November elections, supporters of SB 625 remain hopeful that the bill will pass the House and be signed into law before the end of 2016. ASH will continue to work with the Michigan coalition partners to activate ASH’s grassroots advocates in Michigan at necessary points throughout the legislative process.
    
    
  • Tennessee: In Tennessee, ASH has been working as part of the Tennessee Fair Access to Cancer Treatment Coalition. House and Senate bills were introduced in January and the Tennessee Senate Commerce & Labor Committee held several hearings on the issue. ASH identified several grassroots advocates in the state and engaged them in the Coalition’s advocacy activities in support of this legislation. However, the bill was defeated by a vote of 3-6 in the Senate Commerce & Labor Committee, ending the chances for passage of the legislation. As with Alabama, the Tennessee coalition is currently regrouping to plan for the 2017 legislative session; ASH will continue to work with the coalition to identify the most opportune times for the Society to weigh-in with state lawmakers and will continue to engage ASH grassroots advocates within the state of Tennessee.
    
    
  • Alaska: Legislation was also introduced in Alaska in late January 2016 directing health plans in the state that currently cover cancer treatments to apply the same cost-sharing for oral therapies as those that are administered intravenously or by injection. The legislation passed both the state House and Senate in April and was signed into law in July.
    
    
  • Pennsylvania: After passing the House in February 2015, HB 60 finally passed the Senate at the end of June 2016 and was signed into law in July 2016, making Pennsylvania the 42^nd state to enact an oral parity law.
    
    
  • North Carolina: Despite enjoying broad bipartisan support and passing the House in 2015, oral parity legislation stalled in the Senate in 2016 after facing opposition from insurers and the business community. The North Carolina Oral Chemotherapy Fairness Coalition is regrouping for the 2017 legislative session to resume efforts to pass oral parity legislation.

Prescription Drug Specialty Tiers

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.

• Federal Legislation – As part of the Coalition for Accessible Treatments, ASH has advocated for legislation in the U.S. House of Representatives (H.R. 1600, the Patients' Access to Treatment Act) that would significantly limit how much consumers pay for Tier 4 drugs (including biologics and other drugs for diseases and conditions such as cancer and anemia). The legislation, introduced in March by Representatives David McKinley (R-WV) and Lois Capps (D-CA) and cosponsored by 105 additional House members, 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.
  
  

  As with the federal oral parity legislation, H.R 1600 has continued to gain cosponsors but there has not yet been any additional movement on this bill through the legislative process. The ASH Committee on Practice advocated for the legislation during its Capitol Hill day on May 24, 2016. Representatives McKinley and Capps remain committed to the legislation and getting the bill passed and signed into law. ASH and other organizations are also working to find a champion to introduce companion legislation in the Senate.

Work with the Food and Drug Administration (FDA)

• In 2016, ASH continued to partner with the U.S. Food and Drug Administration (FDA) to offer the following educational programs:

  • ASH/FDA webinar series that features an unbiased discussion of newly approved hematology therapies. The 2016 webinars focused on the approval, accelerated approval, or new indications for Venetoclax; Nivolumab; Ixazomib; Daratumumab; von Willebrand factor (Recombinant); Idarucizumab; and Elotuzumab; Eltrombopag. The Webinars are archived and free to stream on ASH On Demand.

  • 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 in 2016 and the most recent program focused on novel cell therapies for untreatable diseases: chimeric antigen receptors for therapy of refractory hematologic malignancies.

• In late September, ASH submitted comments to the Food and Drug Administration (FDA) supporting the Agency’s draft guidance for Next Generation Sequencing (NGS)-based tests for germline diseases. ASH’s comments ask for clarification and make additional recommendations for important aspects worth including in the final guidance so that NGS-based tests can be effectively designed, developed and validated for various hematologic diseases. ASH’s recommendations also built on the Society’s 2015 letter to the FDA on this topic, which call for the Agency to clarify its review and approval of NGS-based tests for germline diseases; provide its regulation of other types of NGS-based tests (i.e., tumor genome sequencing) that are valuable for the identification of structural genetic alterations; address variant interpretation; and develop a complimentary guidance for somatic diseases.

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, and FDA alerts about newly approved therapies and updated safety information. In 2016, ASH added a new section focused on hematology-relatedRisk Evaluation and Mitigation Strategies, which provides information about safety programs to manage the serious risks that can arise from certain drugs or biological products.