2015 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. The Committee on Practice advocated for the legislation during its Capitol Hill day on May 19, 2015 and the ASH Advocacy Leadership Institute participants also educated Congressional members and staff on this legislation during its Capitol Hill day on October 29, 2015. Currently, there are 35 co-sponsors on the House bill and 6 on the Senate bill. Though the bills continue to gain cosponsors, neither has thus far seen any additional movement through the legislative process. Sponsors of the legislation in both the House and Senate remain committed to the issue, however, and are working to gain more cosponsors and urge committees in both the House and Senate to hold hearings on the issue, with the ultimate goal of passing the bills before the conclusion of the 114th Congress in December 2016.
• State Legislation – Although only federal legislation will ensure coverage for all cancer patients, 40 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, North Carolina, and Pennsylvania.

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 94 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. 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 2014, the ASH-FDA Speaker Series was launched and there were three speaker series programs in 2015. For these seminars, ASH brings specialists to the FDA to educate their staff on important topics in hematology. The 2015 programs focused on BCR-ABL1 testing in chronic myelogenous leukemia; novel cell therapies for untreatable diseases, with a focus on gene therapy for inherited immunodeficiencies and coagulopathies; and iron overload and iron chelation therapy in myelodysplastic syndrome and other hematologic malignancies.
• In early October, an ASH representative served as a panelist at the U.S. Food and Drug Administration's (FDA) meeting on "Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access." The ASH representative addressed the impact of REMS on the practice of hematology and patients with hematologic conditions, while also noting that REMS programs should continue to ensure patient safety and the highest quality of care.
• The ASH Annual Meeting program will include a new session entitled ASH/FDA Joint Symposium on Late-Breaking Drug Approvals, which will feature drugs that received FDA approval in November 2015. The FDA product-reviewers will discuss the safety and efficacy issues from the products' clinical trials and toxicity studies. The program will also include clinicians who will discuss their perspectives on the use of the products in the real world setting.
• In late October, ASH submitted a letter to the FDA in response to the Agency’s draft guidance on the Nonproprietary Naming of Biological Products. ASH’s comments noted support for the FDA’s decision to require biologics and biosimilars to have unique names that would include a suffix, indicating that unique names will minimize inadvertent substitution of products not determined to be interchangeable by the FDA; facilitate proper and safe use of these treatments; and enable better tracking of prescriptions and any adverse events associated with these products. ASH also encouraged the FDA to develop a policy that requires notification to the prescribing physician and patient prior to any substitution being made of any type of biosimilar, including those deemed to be "interchangeable."

ASH Advocacy with United States Pharmacopeial Convention
In June, ASH submitted a comment letter to the United States Pharmacopeial Convention (USP) in response to its re-published General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. The Society commented on the original version of Chapter <800> in July of 2014, due to the concern of an ASH practice member who alerted the Society to the impact of this proposal on the preparation of drugs provided through chemotherapy. Despite some changes to the document, ASH’s original concerns remain and are included in the new letter. The Society noted that the proposal was redundant, as existing regulations protect staff from exposure to hazardous drugs in the practice setting. ASH requested that the USP provide the scientific rationale for the development of the proposed regulations. The Society also raised a particular concern about whether the risk assessments performed on storage and handling areas should exempt biologic therapies, which are commonly used by hematologists.

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. ASH most recently added sample appeal letters to help improve access to Interferon.