IL HB3268

Department of Healthcare and Family Services cannot make coverage recommendations more restrictive than FDA labeling requirements for drugs treating rare diseases (as defined by the Orphan Drug Act of 1983) or genetically targeted therapies.

Department must implement an open and transparent review process with clear guidelines for public comment on rare disease drugs and genetically targeted therapies.

Illinois Drug and Therapeutics Advisory Board must develop and maintain a list of external experts with scientific or medical training in rare diseases to provide consultation on coverage policies, utilization management, prior authorization, and treatment access issues.

All external expert recommendations must be provided in writing to board members, summarized at public hearings, and posted on the Department website; provisions affecting beneficiary drug access must be made available in user-friendly and searchable format.

For new rare disease and genetically targeted therapy drugs, the Advisory Board is exempt from the standard 6-month review moratorium and must review drugs at the next regularly scheduled meeting or within 90 days of FDA approval, with case-by-case access granted according to FDA labeling requirements prior to formal review.