ASH Policy Statement in Support of Patient Access to Safe and Effective Drugs

ASH Policy Statement in Support of Patient Access to Safe and Effective Drugs

As an organization of physicians and scientists who care for desperately ill patients, including those with blood cancers such as leukemia, lymphoma, and myeloma, as well as those with non-malignant conditions such as sickle cell disease, thalassemia, hemophilia, thrombophilia, and various anemias, the American Society of Hematology (ASH) is supportive of efforts to ensure patients have access to safe and effective hematologic drugs. High drug prices continue to be a major issue facing patients with hematologic conditions and ASH continues to identify and advocate for ways to limit patient out-of-pocket expenses. Over the past several years, ASH has supported legislative efforts that would address this issue in several different ways.

Oral Parity
ASH is supportive of efforts to provide insurance parity for all approved evidence-based cancer treatments

Traditionally, intravenous (IV) and injected treatments were the primary methods of chemotherapy delivery and were covered under a health plan’s medical benefit; the patient was only required to pay a small office visit co-pay. Today, patient-administered chemotherapy has become more prevalent and is the standard of care for many types of blood cancer. This is due to their efficacy, convenience, and low rate of side effects. Patient-administered chemotherapy also accounts for approximately 35% of drugs in the oncology development pipeline. More importantly, many patient-administered anti-cancer medications do not have IV or injected alternatives and are the only option for some blood cancer patients.

Insurance coverage has not kept pace with innovation in medicine and the growing trend towards patient-administered chemotherapy. When a patient-administered treatment is determined most effective, patients are sometimes forced to make their treatment choice based on cost, rather than efficacy. This can be a large financial burden on patients and potentially a life or death decision.

While IV treatment is typically paid for as part of a health plan’s medical benefit, patient-administered anticancer drugs, including oral drugs like Gleevec (imatinib, used to treat patients with leukemia), Revlimid (lenalidomide, used to treat patients with multiple myeloma, mantle cell lymphoma, and MDS), and Jakafi (ruxolitinib, used to treat patients with myelofibrosis, a type of myeloproliferative disorder that affects the bone marrow,[2][3] and for polycythemia vera (PCV), as well as patient self-injectable drugs, are often only covered as a prescription benefit at a much lower rate. As a result, many patients are responsible for extremely high and unmanageable co-pays, which can be hundreds or even thousands of dollars per month. Though physician-administered intravenous and injected medications can be as expensive as (or even more expensive than) oral and other patient-administered therapies, the higher cost-sharing generally required of patients for patient-administered medications makes them much less affordable and, as a consequence, almost 10% of patients choose not to fill their initial prescriptions for these anti-cancer medications. As these medications become more prevalent in cancer treatment, they must be made as affordable as their IV counterparts.

Every cancer patient should have access to the approved evidence-based treatments recommended by his or her physician. Patients should not suffer from cost discrimination based on the type of therapy provided or the mechanism for the delivery of that therapy. Health plans offering IV chemotherapy benefits to plan subscribers should be required to provide parity for patient- administered (both oral and self-injectable) anticancer chemotherapy medications.

Despite the fact that a number of states have adopted coverage parity laws, more needs to be done to ensure that parity is applied to all insurers. While ASH supports efforts by individual states to address this issue, there remains a need for federal legislation to ensure coverage parity for patients throughout the United States. Congress should pass this legislation to require coverage parity for anticancer regimens and supportive therapies regardless of delivery method including, but not limited to oral and intravenous drugs, injections, surgery, radiation, cellular therapy, and transplantation.

Prescription Drug Specialty Tiers
Most private health insurers charge fixed co-payments for different categories, or tiers, of medications: generic (Tier 1) name brands (Tier II) and nonpreferred brand medications (Tier III). For example, co-pays might be set at $10/$20/$50 respectively, for medications in the three tiers.

However, some commercial insurers have established a fourth, or specialty, tier that includes biologics and other drugs. These specialty tier drugs typically require extremely high patient cost-sharing, with patients paying a percentage of the cost of these drugs, from 25% to 33% or more in coinsurance, rather than a fixed co-payment. Treatments for a number of blood diseases and disorders, including drugs like Gleevec—used to treat patients with leukemia—and treatments for hemophilia known as clotting factor therapies are frequently placed in the specialty tier. The cost of many of these treatments can exceed $10,000 a month, resulting in extremely high and unmanageable out-of-pocket costs for many patients.

Placing drugs in a specialty tier makes these medically necessary treatments unaffordable for most Americans. The intent of requiring higher patient cost-sharing for drugs and biologics is to reduce reliance on these expensive drugs and incentivize patients to choose lower-cost generic alternatives. However, there are no generic alternatives to many of these therapies. People with cancer or bleeding disorders who cannot afford specialty tier pricing may delay or go without treatment, resulting in a disability and other complications that can lead to increased long-term health care costs.

Patients should not be denied fair access to all effective drugs. ASH supports bipartisan legislation that would prevent private health insurance plans from requiring higher cost-sharing (co-payments and coinsurance) for medications in the specialty drug tier(s) than what is charged for drugs in a nonpreferred brand drug tier. The Society calls on Congress to pass this important legislation that will increase access to life-saving drugs by removing the burden of excessive cost-sharing, benefiting people with leukemia, lymphoma, and bleeding and other hematologic disorders, and others with high-cost chronic conditions.

Medicare Prescription Drug Price Negotiation
In 2022, the Inflation Reduction Act (IRA) was signed into law, allowing the federal government to lower drug costs for Medicare beneficiaries paid under Part D through the Medicare Drug Negotiation Program. Through this program, the Centers for Medicare & Medicaid Services (CMS) can directly negotiate prices with the pharmaceutical industry. Negotiating prices covered under Medicare Part D allows for drugs to be more affordable for patients. ASH supports this program and the Federal government’s ability to negotiate direct drug prices with pharmaceutical companies.

Benefits covered under Part D should remain the most effective drug of choice for the patient, and not be limited due to excessive costs. Allowing patients to receive the most efficacious treatments can increase the likelihood of lower health care costs in the future, as the patient will be receiving the best care possible.