BILL ANALYSIS Ó AB 1668 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 1668 (Calderon) As Amended August 15, 2016 Majority vote -------------------------------------------------------------------- |ASSEMBLY: |77-2 | (May 31, |SENATE: |38-0 |(August 18, | | | |2016) | | |2016) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: HEALTH SUMMARY: Authorizes the manufacturer of an investigational drug, biological product, or device (investigational drug) that is not yet approved by the United States Food and Drug Administration (FDA) to make the investigational drug available to a patient with a serious or immediately life-threatening disease, when that patient has considered all other treatment options currently approved by the FDA, has been unable to participate in a relevant clinical trial, and for whom the investigational drug has been recommended by the patient's primary physician and a consulting physician. Specifies other criteria and requirements for the use of investigational drugs. The Senate amendments clarify that a health benefit plan, except to the extent the plan provided coverage, is not liable for any outstanding debt related to the treatment or lack of insurance for the treatment. AB 1668 Page 2 FISCAL EFFECT: According to the Senate Appropriations Committee: 1)One-time costs of $20,000 and ongoing costs of $10,000 per year to review plan filings by the Department of Insurance (Insurance Fund). 2)One-time costs of $380,000 in 2015-16 to respond to requests for information about prior independent medical review decisions and ongoing costs of $210,000 per year to respond to consumer complaints and requests for independent medical review for access to investigational drugs by the Department of Managed Health Care (Managed Care Fund). 3)Uncertain impact on state-funded California Public Employees' Retirement System health care coverage (General Fund and special funds). (See previous fiscal analysis) COMMENTS: According to the author, this bill removes barriers to accessing potentially life-saving drugs for terminally-ill patients and doctors who believe an investigational drug could be their last hope for survival. The author further states that those patients that have exhausted all other treatment options, and are not eligible for clinical trials, often seek access to investigational new drugs but face a variety of hurdles. These patients may seek compassionate use exemptions from the FDA, but the process is cumbersome and approval comes too late for many. The author explains this bill removes barriers for patients who need to immediately obtain investigational treatments, while also protecting physicians, hospitals, and manufacturers from retribution. Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 00047360003206 AB 1668 Page 3