Thank you for agreeing to add your family to the letter being led by The Little Hercules Foundation. The letter will outline the need for the following provisions under Ohio law:
- State programs must provide access to drugs approved under the FDA’s accelerated approval pathway based on the Medicaid rebate agreement, according to CMS Directive No. 185
- Rare disease treatments must be covered from the outset, once a product comes to market, according to its FDA-approved use.
- States choosing to review an approved rare disease therapy and to develop prior authorization criteria must do so within 90 days of approval while providing coverage during that time according to the FDA-approved use.
- Review of an approved therapy must not utilize state resources to reassess the safety and effectiveness as it would be redundant to and could conflict with the responsibilities of the FDA under the FDCA.
- Coverage policies must be made public within 90 days and conform to the medically accepted indication and FDA-approved label.
- State Medicaid decision-making bodies must include a disease specialist, as well as a patient/family participant as members and make accommodations for patient testimony to be provided via telephone and/or webcast when a representative is unable to attend a P&T meeting in person.
Please fill in the details below to oficially sign on.