Patient access to investigational drugs outside of clinical trials

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Patient access to investigational drugs outside of clinical trials


A new state law on investigational drugs, biologics or devices ("investigational devices") for terminally ill patients went into effect on Oct. 1. ConnectiCare does not cover investigational devices outside of clinical trials or any costs associated with their use. This policy does not prevent your patients from seeking such treatment, however.

If an individual should choose to use investigational devices, the following eligibility requirements must be met under state law:

  1. The patient must have considered all other treatment options currently approved by the FDA.
  2. The patient must be unable to participate in a clinical trial for the relevant terminal illness that is 100 miles or less from the patient's home or the patient must have been declined participation in a clinical trial not more than one week after completing a clinical trial application.
  3. The patient's treating physician must have recommended treatment with the investigational item.
  4. The patient (or parent or guardian, if the patient is a minor or lacks mental capacity to consent) must have given written, informed consent for use of the investigational treatment. The state law defines consent in detail.
  5. The patient's treating physician must give the patient written documentation that the patient meets all of these requirements.

The consent document must be signed by the patient and verified by the patient's treating physician and a witness. Physicians should send signed and verified documents to:

175 Scott Swamp Road
P.O. Box 4050
Farmington, CT 06034-4050