BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
AB 159 (Calderon) - Investigational drugs, biological products,
and devices
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|Version: July 6, 2015 |Policy Vote: HEALTH 8 - 0, B., |
| | P. & E.D. 8 - 0 |
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|Urgency: No |Mandate: No |
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|Hearing Date: July 13, 2015 |Consultant: Brendan McCarthy |
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This bill meets the criteria for referral to the Suspense File.
Bill
Summary: AB 159 would authorize the manufacturer of an
investigational drug to make an investigational drug available
to a patient, under certain circumstances.
Fiscal
Impact:
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).
Onet-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).
Uncertain impact on state-funded CalPERS health care coverage
AB 159 (Calderon) Page 1 of
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(General Fund and special funds). (See below.)
Background: Under federal law and regulation, drug manufacturers must
apply to the federal Food and Drug Administration for permission
to market drugs. The application process includes a series of
clinical trials to demonstrate the safety and effectiveness of
new drugs. The clinical trial process includes a variety of
requirements regarding informed consent for participants and
reporting requirements on manufacturers. Current federal law
also includes a process whereby seriously ill patients can
access investigational drugs before they have been approved for
general use and without the patient needing to be a participant
in a clinical trial. In recent years, concerns have been raised
that the process for approving such requests is slow and
cumbersome for physicians, discouraging them from seeking such
access for their seriously ill patients.
Current state law generally prohibits the sale or giving away of
new drugs unless the new drug has been approved by the state
Department of Public Health or the drug has been approved for
use by the federal Food and Drug Administration (including
premarket approval). State law authorizes the experimental use
of drugs and requires certain patient protections, such as
oversight by a review committee and informed consent for the
patient.
Current state law authorizes patients to seek an independent
medical review when a health plan or health insurer denies
coverage for an experimental or investigational drug when the
patient has a life-threatening or seriously debilitating
condition, the patient's physician indicates that standard
therapies have not been effective, and the patient's physician
has recommended an experimental or investigational drug. If the
independent medical review finds that the required conditions
are met, the health plan or health insurer is required to
provide coverage for the experimental or investigational drug.
Statute governing the state's Medi-Cal program generally limits
the coverage for experimental drugs and prohibits coverage of
experimental drugs if the experimental drug costs more than
conventional therapies.
AB 159 (Calderon) Page 2 of
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Proposed Law:
AB 159 would authorize the manufacturer of an investigational
drug to make an investigational drug available to a patient,
under certain circumstances.
Specific provisions of the bill would:
Authorize a manufacturer of an investigational drug,
biological product, or device to make such product available
to an eligible patient;
Authorize a manufacturer to make an investigational product
available to a patient without compensation or to require the
patient to pay the costs of manufacturing the product;
Specify that the bill does not require a health plan or state
agency to provide coverage for the costs of an investigational
product;
Authorize a health plan to provide coverage for an
investigational product;
Prohibit a state regulatory board from taking disciplinary
action against a physician based on the physician's
recommendation that a patient use an investigational product;
Prohibit a state agency from taking regulatory action against
a health facility based on a facility's participation in
treatment using an investigational product;
Require a participating physician's institutional review board
or an accredited institutional review board to provide
information to the Department of Public Health, the Medical
Board, and the Osteopathic Medical Board on the use of
investigational drugs under the bill.
Related
Legislation:
SB 715 (Anderson) is substantially similar to this bill. That
bill is pending in the Senate Health Committee.
AB 149 (Stone) is substantially similar to this bill. That
bill is in the Assembly Business and Professions Committee.
Staff
Comments: The bill would authorize a manufacturer to make
investigational drugs available to patients under limited
circumstances. The bill itself does not require a patient's
AB 159 (Calderon) Page 3 of
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health plan to provide coverage for the cost of the
investigational drug. However, state law requires health plans
to provide coverage for investigational drugs under certain
circumstances. If a health plan denies coverage for an
investigational drug, an enrollee can request an independent
medical review of that decision. Based on the independent
medical review, a health plan may be required to provide
coverage for an investigational drug. It is possible that
patients could use the independent medical review process to
access coverage for investigational drugs provided by
manufacturers under this bill. To the extent that patients
enrolled in coverage provided by CalPERS do so, there could be
additional costs to the state and/or local governments.
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