COMMITTEE ON LEGISLATIVE RESEARCH
OVERSIGHT DIVISION
FISCAL NOTE
L.R. No.:4258H.01I Bill No.:HB 1830 Subject:Mental Health; Drugs and Controlled Substances Type:Original Date:January 16, 2024Bill Summary:This proposal creates provisions relating to alternative therapies.
FISCAL SUMMARY
ESTIMATED NET EFFECT ON GENERAL REVENUE FUNDFUND
AFFECTED
FY 2025FY 2026FY 2027Fully
Implemented
(FY Unknown)
General Revenue($5,972,715 to
$8,572,715)
($18,800,982 to
$19,475,982)
($18,815,892 to
$19,490,892)
Likely to exceed
($25,466,502 to
26,141,502)
Total Estimated
Net Effect on
General
Revenue
($5,972,715 to
$8,572,715)
($18,800,982 to
$19,475,982)
($18,815,892 to
$19,490,892)
Likely to exceed
($25,466,502 to
$26,141,502)
ESTIMATED NET EFFECT ON OTHER STATE FUNDSFUND
AFFECTED
FY 2025FY 2026FY 2027Fully
Implemented
(FY Unknown)
Total Estimated
Net Effect on
Other State
Funds $0$0$0$0
Numbers within parentheses: () indicate costs or losses. L.R. No. 4258H.01I
Bill No. HB 1830
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ESTIMATED NET EFFECT ON FEDERAL FUNDSFUND
AFFECTED
FY 2025FY 2026FY 2027Fully
Implemented
(FY Unknown)
Total Estimated
Net Effect on
All Federal
Funds $0$0$0$0
ESTIMATED NET EFFECT ON FULL TIME EQUIVALENT (FTE)FUND
AFFECTED
FY 2025FY 2026FY 2027Fully
Implemented
(FY Unknown)
General Revenue
5 FTE5 FTE5 FTE5 FTE
Total Estimated
Net Effect on
FTE 5 FTE5 FTE5 FTE5 FTE
☒ Estimated Net Effect (expenditures or reduced revenues) expected to exceed $250,000 in any
of the three fiscal years after implementation of the act or at full implementation of the act.
☐ Estimated Net Effect (savings or increased revenues) expected to exceed $250,000 in any of
the three fiscal years after implementation of the act or at full implementation of the act.
ESTIMATED NET EFFECT ON LOCAL FUNDSFUND
AFFECTED
FY 2025FY 2026FY 2027Fully
Implemented
(FY Unknown)
Local
Government$0$0$0$0 L.R. No. 4258H.01I
Bill No. HB 1830
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January 16, 2024
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FISCAL ANALYSIS
ASSUMPTION
§§ 191.479, 191.480 and 192.950– Alternate therapies
Officials from the Department of Health and Senior Services (DHSS) state §192.950 of the
proposed legislation would require the DHSS to conduct clinical trials for alternative therapies in
collaboration with a hospital operated by an institute of higher education in Missouri or contract
research organizations conducting clinical trials approved by FDA. The following needs to be
considered while reviewing the information below:
1. Psychedelic drugs commonly used for the purposes mentioned in the proposed
legislation are MDMA, Psilocybin and Ketamine.
2. Section 192.950 states that DHSS shall conduct a study on the efficacy of using
alternative medicine and therapies, including the use of Psilocybin. Since other
alternative medicines and therapies are also listed, fiscal estimates provided are
for the three most common therapies used for this purpose.
3. FDA came up with new draft guidance for psychedelic drugs and the fiscal estimates
provided do not include any changes that might arise in the final guidance and
costs associated with the assessment abuse potential of drugs, particularly for
psychedelics where the abuse potential could be high.
The average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around $4, $13,
and $20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and
Drug Administration (FDA) of the United States cost a median of $41,117 per patient. These
cost estimates across therapeutic areas were reported by Aylin Sertkaya et al., in a report
submitted to the U.S. Department of Health and Human Services:
https://aspe.hhs.gov/sites/default/files/private/pdf/77166/rpt_erg.pdf (see Table 1) L.R. No. 4258H.01I
Bill No. HB 1830
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Since psychedelic drugs such as those mentioned in this legislation (MDMA, Psilocybin and
Ketamine) modulate brain cell activity, cost estimates were developed using the study costs for
the central nervous system therapeutic area (row #3). Furthermore, this report was developed in
2014 and cost estimates were inflation-adjusted using the consumer price index (CPI) inflation
calculator provided by the Bureau of Labor Statistics (BLS) available at: https://data.bls.gov/cgi-
bin/cpicalc.pl. For example: four million dollars (estimated cost of a phase 1 trial) in 2014 would
be $5,115,853.5 in 2023 – a 28% increase since 2014. This could go up when the legislation
actually takes into effect as the CPI calculator will not provide inflation-adjusted estimates for
2024 at this point.
A 2018 study published in the Journal of American Medical Association (JAMA) – Internal
Medicine reviewed pivotal clinical trial cost data from 59 therapeutic agents that were approved
by the Food and Drug Administration (FDA) from 2015 to 2016 and derived a median cost
estimate of $19.0 million (interquartile range, $12.2 million - $33.1 million). However, the cost
of pivotal clinical trials varied greatly by the number of participants and the duration of study.
The median cost for pivotal clinical trials with a duration of 26 weeks or greater was $51.7
million – closer to the number in the above table from the HHS report. Therefore, central
nervous system estimates in the table above adjusted for inflation were used to come up with cost
estimates for this proposed legislation.
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such
as psychotherapy or medications. Clinical trials are often conducted in four phases, not including
the FDA review process –
Phase 1 - Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months, Purpose – Safety and Dosage; L.R. No. 4258H.01I
Bill No. HB 1830
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Phase 2: Study Participants: Up to several hundred people with the disease/condition. Length of
Study: Several months to 2 years, Purpose - Efficacy and side effects;
Phase 3: Study Participants: 300 to 3,000 volunteers who have the disease or condition. Length
of Study: 1 to 4 years Purpose: Efficacy and monitoring of adverse reactions
Phase 4: Post-marketing studies, which are conducted after a treatment is approved for use by the
FDA Study Participants: Several thousand volunteers who have the disease/condition, Purpose:
Safety and Efficacy.
The proposed legislation is asking for a fiscal estimate for three years; therefore, the budget sheet
has estimates only for Phase 1 and Phase 2 clinical trials and not for the more expensive and time
intensive Phase 3 and Phase 4 clinical trials.
Phase 1 clinical trial for psilocybin (after inflation adjusted) = $5,115,854;
Phase 2 clinical trial for three drugs (after inflation adjusted) = $17,905,487.
While Phase 3 and Phase 4 clinical costs are not included in the budget sheet, the following is an
estimate for those phases for the psilocybin after successful completion of phase 1 and phase 2 at
the end of three years:
Phase 3 clinical trial for psilocybin (after inflation adjusted) = $24,556,097
FDA – New Drug Application (NDA) review phase (after inflation adjusted) = $2,557,927 * 3 =
$7,673,780
Phase 4 clinical trial for psilocybin (after inflation adjusted) = $17,905,487 * 3 = $53,716,462
The DHSS does not conduct clinical trials nor has any experience conducting clinical trials.
While the legislation clearly states that DHSS / Office of Epidemiology (OOE) would
collaborate with a hospital operated by an institute of higher education in Missouri or Contract
Research Organization (CRO’s), OOE would require at least three (3) FTEs to coordinate /
oversee clinical trials in collaboration with institutes of higher education. The 4 FTE request is
only for the first three years and to set up the clinical trials. Based on literature review of clinical
trials, it is estimated that the following minimum staff would be needed for the first three years:
Clinical Study Medical Writer (One FTE @ $74,600 annual salary) – The proposed legislation
requires quarterly as well as annual reports on the progress of trials to the legislature. A medical
writer would be needed to produce quarterly reports in conjunction with the entities conducting
trials.
Clinical Research Physician (One FTE @ $203,682 annual salary) – While the clinical trials will L.R. No. 4258H.01I
Bill No. HB 1830
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be conducted in collaboration with institutes of higher education, it is essential for DHSS to hire
a clinical research physician so that they can coordinate with the institutes on clinical trial plans
and update DHSS / legislature accordingly on the progress and handle any clinical questions /
issues from stakeholders / legislators on clinical trials.
Clinical Project Manager (One FTE @ $84,900 annual salary)- While the clinical trials will be
conducted in collaboration with institutes of higher education, it is essential for DHSS to hire a
clinical project manager as well who will work with the physician to ensure plans/protocols are
being implemented in accordance with the terms and conditions set forth for clinical trials,
handle unexpected issues that arise during clinical trials and to act as a liaison between DHSS /
clinical trial site staff to ensure clinical trials to meet scientific standards and government
regulations.
Administrative Support Professional (one FTE @ $47,990 annual salary) – While the clinical
trials will be conducted in collaboration with institutes of higher education, it is essential for
DHSS to hire an administrative support professional to coordinate the activities of the project
manager, medical writer and research physician.
Legal Counsel (unknown up to one FTE @ $82,999 annual salary) – There will be need for
research and review of grant/clinical study documents. DHSS does not otherwise conduct
clinical trials/studies and the program will need legal guidance as we navigate this new area. The
legal counsel need is unknown up to one (1) FTE.
Due to the risks associated with a clinical trial and the complexities of documentation review,
specialized outside legal counsel would be needed. Based on the following assumptions: Legal
consult team of 1-3 attorneys, estimated billing $300-$500 per hour (due to specialized field),
and estimated need of 500 hours (10 hours per week) for the first year for each attorney and 250-
500 hours per week for each attorney thereafter. The estimated cost of outside specialized
counsel is $150,000 - $750,000 for the first year and $75,000 - $750,000 thereafter.
At the end of three years, and if phase 2 clinical trials are successful, the staffing needs will
significantly increase because phase 3 trials are usually conducted at multiple sites in different
countries and will likely involve significant DHSS staff involvement/travel to ensure these trials
are conducted in compliance with the countries where these trials are conducted with respect to
human subject involvement and adverse event reporting. It is not possible to estimate DHSS
staffing needed for phase 3 and phase 4 at this time because of the uncertainty associated with
phase 2 clinical trials. Only 33% of phase 2 clinical trials move onto a phase 3 clinical trial.
Consideration needs to be given to the following notes with respect to this proposed legislation:
The three common psychedelics that are relevant to treating the conditions listed in the
legislation are – Ketamine, MDMA and Psilocybin. L.R. No. 4258H.01I
Bill No. HB 1830
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In Summary –
The state will effectively spend upwards of 200 million dollars (likely to go up) to conduct trials
for three alternative medicines that have already been extensively studied. Of the three:
- One has already been approved by FDA (ketamine)
- A new drug application (NDA) has already been filed with the FDA for the other one –
MDMA
- The third one – Psilocybin is already in phase 3 clinical trials on a global scale and
based on phase I and phase II studies shows promising results.
Oversight does not have any information to the contrary. Based on an internet search of the
average length of time for clinical trials, it is possible for them to go on for 10-15 years.
Therefore, for fiscal note purposes Oversight assumes costs could exceed the $53,716,462
provided by DHSS for Phase 4 Clinical Trials. It is unknown in what year the provisions of this
proposal would be concluded.
Oversight does not have information to the contrary and therefore, Oversight will reflect the
estimates as provided by the DHSS.
Oversight notes the provisions of §191.479.4 allows DHSS to provide grants for $2,000,000,
subject to appropriation. For fiscal note purposes, Oversight assumes costs of $0 to ($2,000,000)
to the General Revenue Fund for the research grants. Oversight notes that the proposal specifies
a total of $2,000,000 for grants.
Responses regarding the proposed legislation as a whole
Officials from the Office of Attorney General (AGO)
arising from this proposal can be absorbed with existing personnel and resources. However, the
AGO may seek additional appropriations if there is a significant increase in litigation.
Oversight does not have any information to the contrary. Therefore, Oversight assumes the
AGO will be able to perform any additional duties required by this proposal with current staff
and resources and will reflect no fiscal impact to the AGO for fiscal note purposes.
Officials from the Department of Commerce and Insurance, the Department of Mental
Health, the Department of Public Safety – Missouri Veterans Commission and the Office of
the State Courts Administrator
respective organizations. Oversight does not have any information to the contrary. Therefore,
Oversight will reflect a zero impact in the fiscal note for these agencies.
Officials from the University of Missouri System did not respond to Oversight’s request for a
statement of fiscal impact. L.R. No. 4258H.01I
Bill No. HB 1830
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FISCAL IMPACT – State
Government
FY 2025
(10 Mo.)
FY 2026FY 2027Fully
Implemented
(FY Unknown)
GENERAL REVENUE
FUND
Costs – DHSS (§191.479)
grants for research on
use/efficacy of psilocybin p.5
$0 to
($2,000,000)$0 $0 $0
Costs – DHSS (§192.950) –
clinical trial p.
Likely to
exceed...
Personal service($411,809)($504,054)($514,136)($514,136) Fringe benefits($222,196)($270,466)($274,374)($274,374) Equipment and expense($72,856)($45,975)($46,895)($46,895) Legal Consultant($150,000 to
$750,000)
($75,000 to
$750,000)
($75,000 to
$750,000)
($75,000 to
$750,000)
Contracts – Phase 1($5,115,854)$0$0$0 Contracts – Phase 2$0($17,905,487)($17,905,487)$0 Contracts – Phase3+$0$0$0($24,556,097)Total Costs - DHSS($5,972,715
to
$6,572,715)
($18,800,982
to
19,475,982)
($18,815,892
to
$19,490,892)
($25,466,502
to
$26,141,502) )
FTE Change - DHSS5 FTE5 FTE5 FTE5 FTEESTIMATED NET EFFECT
ON THE GENERAL
REVENUE FUND($5,972,715
to
$8,572,715)
($18,800,982
to
$19,475,982)
($18,815,892
to
$19,490,892)
Likely to
exceed
($25,466,502
to
$26,141,502)
Estimated Net FTE Change on
the General Revenue Fund5 FTE5 FTE5 FTE5 FTE L.R. No. 4258H.01I
Bill No. HB 1830
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FISCAL IMPACT – Local
Government
FY 2025
(10 Mo.)
FY 2026FY 2027Fully
Implemented
(FY
Unknown)
$0$0$0$0
FISCAL IMPACT – Small Business
No direct fiscal impact to small businesses would be expected as a result of this proposal.
FISCAL DESCRIPTION
As specified in this bill, any person who acquires, uses, produces, possesses, transfers, or
administers psilocybin for the person's own therapeutic use will not be in violation of state or
local law and will not be subject to a civil fine, penalty, or sanction so long as the person meets
the certain conditions.
The DHSS must prepare and submit to the Governor, Lieutenant Governor, and the General
Assembly annual reports on any information collected by the Department on the implementation
and outcomes of the use of psilocybin.
This bill specifies that, a physician will not be subject to criminal or civil liability or sanction
under the laws of this State for providing documentation that a person suffers from posttraumatic
stress disorder, major depressive disorder, or a substance use disorder or requires end-of-life
care, and no State agency or regulatory board shall revoke, fail to renew, or take any other action
against a physician's license issued under Chapter 334, RSMo based solely on the physician's
provision of documentation that a person suffers from posttraumatic stress disorder, major
depressive disorder, or a substance use disorder or requires end-of-life care.
This bill also requires the Department, in collaboration with a hospital operated by the an
institution of higher education in this state or contract research organizations conducting trials
approved by the United States Food and Drug Administration in Missouri, to conduct a study on
the efficacy of using alternative medicines and therapies, including, but not limited to, the use of
psilocybin for the treatment of patients suffering from post-traumatic stress disorder, major
depressive disorder, substance use disorders, or who require end-of-life care. The bill specifies
that such study shall include a clinical trial of psilocybin, as well as a literature review and the
submission of various reports. No person participating in the clinical trial shall be subjected to
criminal or civil liability or sanction for the participation in the clinical trial, except in cases of
gross negligence or willful misconduct.
The Department must maintain the confidentiality of any personally identifiable protected
information collected during the clinical trial. A physician will not be subject to criminal or civil L.R. No. 4258H.01I
Bill No. HB 1830
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liability or sanction under the laws of this state for referring a patient to the clinical trial under
this section, and no state agency or regulatory board shall revoke, fail to renew, or take any other
action against a physician's license based solely on the physician's referral of a patient to the
clinical trial under this section. (§192.950)
This legislation is not federally mandated, would not duplicate any other program but would
require additional capital improvements or rental space.
SOURCES OF INFORMATION
Attorney General’s Office
Department of Commerce and Insurance
Department of Health and Senior Services
Department of Mental Health
Department of Public Safety –
Missouri Veterans Commission
Office of the State Courts Administrator
Julie MorffRoss StropeDirectorAssistant DirectorJanuary 16, 2024January 16, 2024