WHAT IS COST-SHARE ASSISTANCE?
Health care innovations made possible by biologic therapies, and new uses for IVIG, have improved the lives of thousands of patients living with chronic diseases and complex immune disorders. Unfortunately, due to the complicated manufacturing process, these new therapies can be incredibly expensive. As a result, many patients are unable to access these treatments, despite desperately needing them to manage debilitating illness. To provide relief and increase access to these medications, many manufacturers have created co-pay assistance programs to help patients manage the financial burden by covering a portion of the patient’s cost.
THAT SOUNDS GREAT, WHAT'S THE ISSUE?
Cost-share assistance programs can be used to incentivize prescribing habits. For example, in order to encourage patients and physicians to select a more expensive brand over the generic, the manufacturer might issue a cost-share coupon. Though the coupon might reduce the cost to the patient, the health plan would still pay full price for the brand-name drug.
In order to prevent excessive government spending, the Federal Anti-Kickback Statute prohibits pharmaceutical manufacturers from providing cost-share assistance to beneficiaries of government-subsidized health plans. So, while patients with commercial health plans are eligible to receive financial relief from these programs, patients on government funded plans are not.
THERE ARE NO GENERIC BIOLOGICS
Conventional medications are created using a chemical formula, so, using the original recipe, other companies can create generic drugs which act exactly like the original. Biologics, however, are much more complex medications, which are made in living cells. This high level of complexity makes it impossible to create a “generic” version of biologics.
Biologics are typically prescribed when a patient has exhausted every other option. Because there are no less expensive, equally effective alternatives, providing cost-share assistance to patients requiring these treatments should not be considered an excess cost to a Federal program, nor should it be considered a purposeful inducement.
Comparing the manufacturing process of a biologic to that of a traditional oral medication is like comparing the assembly of an airplane to that of a bicycle. Both are intended to provide transportation, but one requires a much higher level of detail, sophisticated engineering, and extensive research to ensure safety and efficacy.
SO, WHAT IS THE SOLUTION?
THE ANSWER IS SIMPLER THAN YOU MIGHT EXPECT
NICA has requested that the Office of Inspector General (OIG) issue new guidance, clarifying whether manufacturer cost-share assistance programs for biologics, IVIG, and other specialty medications paid for by federal health plans are considered a violation of the federal anti-kickback statute, given that there are no less expensive, equally effective alternatives for these medications. A statement of safe harbor would allow pharmaceutical manufacturers to make these funds available to thousands of vulnerable patients who struggle with the high cost of the medications they so desperately need.
WHAT CAN YOU DO?
NICA is building a coalition to support these efforts to ensure that some of our nation’s most vulnerable patients can access the medication they need but otherwise cannot afford without cost-share assistance. We will be coordinating a conference call for more information. If you are interested in joining our coalition, please contact us using the form below.
We will also be putting together a petition for health care providers and patients to sign a letter to the OIG. We ask that you support the efforts by sharing information with you providers and patients in your network and encouraging them to take action.