Common issues patients face accessing their plasma-derived therapies

Written by guest contributor Matthew Delaney, Government Relations Manager of the National Bleeding Disorders Foundation.

Plasma-derived therapies are critical lifesaving, life sustaining treatments for thousands of people in the United States with primary immunodeficiency, bleeding disorders, alpha-1 antitrypsin deficiency, and neurological diseases. Despite their medical necessity, patients who rely on these drugs are faced with additional obstacles imposed by insurance companies and pharmacy benefit managers (PBMs), "middlemen" between the insurer and pharmacy that negotiates drug prices and benefits on behalf of a health plan. Often, PBM’s are responsible for decreased access to medications that are covered by insurance, or control the difficulty of accessing the drug prescribed.

Copay accumulators

Plasma- derived therapies are expensive to produce because of the cost of attaining and retaining plasma donors, and the purification process needed to keep therapies safe and effective. One tactic insurance plans and PBMS use is copay accumulator adjusters and alternative funding programs (AFP’s) which shift costs directly on to the patient. Alternative Funding Programs (SaveonSP is a large Alternative Funding Program) occur when an insurer does not classify a drug as an "Essential Health Benefit" under the Affordable Care Act. As a result, the insurer will not cover the drug until a patient enters a third-party "alternative funding program" that requires patient personal information, power of attorney, and other private financial and medical information. 

Copay accumulators allow insurance companies and PBM to collect copayment assistance offered by a product’s manufacturer or a nonprofit organization to patients without applying the funds to a patient’s out-of-pocket obligations—their deductible and out-of-pocket maximum. The American Plasma Users Coalition (APLUS) Coalition, a group 13 patient advocacy organizations representing American patients who rely on plasma-derived therapies in advocacy and policy, have helped lead legislation in Congress (S.864) and in states to ban these practices. To date, twenty-five states, Washington, D.C., and Puerto Rico have banned copay accumulators on state-regulated health plans, such as ACA Marketplace plans, but federal legislation or regulation is needed to ban these programs nationwide. 

 

Formulary restrictions  

While not all plasma-derived medications are interchangeable, insurance companies manage costs by implementing restrictive formularies of covered drugs, increased utilization management such as step-therapy or “fail first” programs that require a patient to “fail” on an alternative therapy before getting coverage for their prescribed drug, or not covering the drug as an “essential health benefit” under the Affordable Care Act. Patients may also be required to switch medications due to formulary changes, which jeopardizes the health of the patient and leads to worse health outcomes. 

Prior authorization  

One of the most prevalent barriers to access is the need for prior authorization for a therapy. Oftentimes, insurance companies require prior authorization from providers to justify that a therapy is “medically necessary” for the patient, resulting in treatment delays and significant wasted staff time at hospitals and treatment centers. Though recently big insurers have promised to cut down on this. 

H.R. 1 changes to Medicaid  

Many individuals who rely on plasma-derived therapies, due to the complexity of their condition and costs related to them, rely on insurance coverage through Medicaid. In bleeding disorders, for example, almost one-third of patients rely on some form of Medicaid coverage to maintain their treatment. As a result of H.R. 1, which was passed in July 2025, the Congressional Budget Office estimates that over 10 million Americans will lose coverage over the next nine years due to new bureaucratic obstacles, eligibility changes, and decreases in funding from federal and state governments. This can result in formulary changes and additional hurdles to retaining coverage.

Coverage confusion

Both patients and healthcare providers alike struggle with inconsistent insurance policies related to coverage for plasma-derived medications. Approval can change across insurers, or even in the same plan over time. Lack of transparency creates significant confusion and burden on patients, and delays treatment. 

We are here to help!

Patient organizations throughout the rare and chronic disease community are fighting tirelessly on the state and federal levels to reduce these insurance. For patients who rely on plasma-derived medications, access to timely and consistent treatment isn’t just a nice thing to have, it is essential to our health, dignity, and quality of life.

If you are interested in helping us fight these barriers, please reach out to your local organization to get involved in advocacy. We need your voice!