BILL ANALYSIS                                                                                                                                                                                                    

                                                                    AB 1668

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          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.


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          FISCAL EFFECT:  According to the Senate Appropriations  

          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  

          Analysis Prepared by:                                             
                          Rosielyn Pulmano / HEALTH / (916) 319-2097  FN:  


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