№ lp_1_2_38151
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Clinical protocol governing shared prescribing, monitoring responsibilities, and dosing regimens for paliperidone palmitate long-acting injections in adult patients with schizophrenia across secondary and primary care services.
Document type:
Shared care protocol
Medicine:
Paliperidone palmitate long-acting injection
Indication:
Maintenance treatment of schizophrenia
Population:
Adults aged 18 years and over
Healthcare setting:
Secondary and primary care
Intended users:
NHS healthcare professionals
Initiation of treatment:
Secondary care mental health services
Shared care commencement:
After approximately 12 weeks when dose is optimised
Dosage forms:
1-monthly, 3-monthly and 6-monthly long-acting injections
Renal impairment restriction:
Not recommended in moderate or severe renal impairment (creatinine clearance <50 ml/min)
Version:
v4.0
Replaces version:
v3.0
Clinical content last reviewed:
January 2024
Next review date:
June 2026
Approving bodies:
GM CRG, GMMMG, CEGC
Approval dates:
14 May 2024; 13 June 2024; 20 June 2024
Geographical scope:
NHS Greater Manchester
Usage restriction:
Non-commercial, non-marketing use only
Price: 8 / 10 USD
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Year:
2026
Region / City:
United Kingdom
Subject:
Medicine Guidelines
Document Type:
Medical Guidelines
Organization:
NHS
Author:
Not specified
Target Audience:
Healthcare professionals (psychiatrists, pharmacists)
Effective Period:
Indefinite, for use with Trevicta®
Approval Date:
Not specified
Date of Changes:
Not specified
Context Description:
Medical guideline on the administration of Trevicta® long-acting injection for patients transitioning from Xeplion® in the UK, specifically for schizophrenia treatment.
Year:
2024
State:
Wisconsin
Country:
United States
Issuing Authority:
Department of Health Services, Division of Mental Health and Substance Abuse Services
Form Number:
F-24277
Legal References:
42 CFR 483.420(a)(2); DHS 134.31(3)(o); DHS 94.03 & 94.09; §§ 51.61(1)(g) & (h)
Document Type:
Informed Consent Form
Medication Category:
Atypical Antipsychotic
Medication Name:
Invega Trinza (paliperidone palmitate)
Dosage Information Last Revised:
05/09/2016
Administration Route:
Intramuscular injection
Intended Use:
Psychotropic medication treatment with DSM-5 diagnosis or diagnostic impression
Population:
Patients / Clients receiving mental health services
Record Status:
Maintained in client record and accessible to authorized users
Voluntary Status:
Completion voluntary; court order required if consent not given unless emergency
Year:
2026
Region / City:
United Kingdom
Subject:
Medicine Guidelines
Document Type:
Medical Guidelines
Organization:
NHS
Author:
Not specified
Target Audience:
Healthcare professionals (psychiatrists, pharmacists)
Effective Period:
Indefinite, for use with Trevicta®
Approval Date:
Not specified
Date of Changes:
Not specified
Context Description:
Medical guideline on the administration of Trevicta® long-acting injection for patients transitioning from Xeplion® in the UK, specifically for schizophrenia treatment.
Year:
2024
State:
Wisconsin
Country:
United States
Issuing Authority:
Department of Health Services, Division of Mental Health and Substance Abuse Services
Form Number:
F-24277
Legal References:
42 CFR 483.420(a)(2); DHS 134.31(3)(o); DHS 94.03 & 94.09; §§ 51.61(1)(g) & (h)
Document Type:
Informed Consent Form
Medication Category:
Atypical Antipsychotic
Medication Name:
Invega Trinza (paliperidone palmitate)
Dosage Information Last Revised:
05/09/2016
Administration Route:
Intramuscular injection
Intended Use:
Psychotropic medication treatment with DSM-5 diagnosis or diagnostic impression
Population:
Patients / Clients receiving mental health services
Record Status:
Maintained in client record and accessible to authorized users
Voluntary Status:
Completion voluntary; court order required if consent not given unless emergency
Type of document:
Pharmaceutical Benefits Advisory Committee (PBAC) submission and assessment report
Medicine:
Aripiprazole long-acting injectable (AOM)
Dosage forms/strengths:
Powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe; Powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe
Brand:
Abilify Maintena
Sponsor:
Lundbeck Australia Pty Ltd
Purpose of submission:
Request for General Schedule Authority Required (STREAMLINED) PBS listing of AOM pre-filled syringe dose form
Indication:
Treatment of schizophrenia
Comparator:
AOM modified release injection vial kit (therapeutic vial kits)
Regulatory status:
TGA registered 7 May 2018 for acute and maintenance treatment of schizophrenia in adults and maintenance treatment of bipolar I disorder (monotherapy)
Previous PBAC consideration:
400 mg AOM PFS recommended July 2018; recommendation rescinded March 2023
Pricing basis:
Cost-minimisation versus AOM vial kit with equivalent pricing (no price premium)
Price levels referenced:
DPMQ, PTP, AEMP (current as of 1 June 2025)
Estimated PBS usage:
400,000 to <500,000 scripts over first six years (Year 1 10,000–<20,000; Year 6 100,457)
Indication listing conditions:
Authority Required (Streamlined); prescriber types include medical practitioners and nurse practitioners; general schedule (Code GE)
Version number:
6.0
Approved by:
Medicines Committee
Ratified by:
Medicines Committee
Date ratified:
June 2023
Original author:
Luton & Bedfordshire Lead Pharmacist
Executive Director lead:
Chief Medical Officer
Implementation Date:
July 2023
Last Review Date:
June 2023
Next Review Date:
June 2026
Services:
Trustwide, Mental Health and LD, Community Health Services
Type of document:
Policy
Scope:
Long-acting antipsychotic injections, typical and atypical
Target audience:
Clinicians, pharmacists, mental health services staff
Document structure:
Includes guidance on initiation, choice, and monitoring of depot injections, adverse effect reporting, and appendices with forms and rating scales
Year:
2010
Region / City:
Connecticut
Subject:
Pharmaceutical practice, Collaborative practice agreements, Antipsychotic therapy
Document Type:
Legal agreement, Clinical protocol
Organization / Institution:
Connecticut Department of Consumer Protection, University of Connecticut School of Pharmacy
Author:
C. Caley, PharmD, BCPP, Clinical Professor
Target Audience:
Pharmacists, Physicians, Healthcare providers in Connecticut
Effective Date:
October 1, 2010
Date of Approval:
Not specified
Date of Review:
Annual review completed
Date of Modification:
Not specified
Year:
not specified
Language:
English
Topic:
HIV-1 treatment
Therapeutic regimen:
Long-acting injectable antiretroviral therapy
Medication:
Cabenuva (cabotegravir and rilpivirine)
Drug classes:
Integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor
Route of administration:
Intramuscular gluteal injection
Dosing schedules:
Every 4 weeks; every 8 weeks
Target population:
Adults with HIV-1 infection
Eligibility criteria:
Virologically suppressed patients without relevant drug resistance
Exclusion criteria:
Pregnancy, breastfeeding, specific drug interactions, hypersensitivity
Monitoring requirements:
HIV viral load, CMP, CBC
Clinical setting:
Clinic-administered therapy
Healthcare roles:
Provider, case manager, registered nurse, pharmacy
Regulatory reference:
FDA labeling
Source adaptation:
Ward 86 Long-Acting Injectable ARV Protocol
Year:
2021
Region / City:
United States
Subject:
Medicine, Pharmacology
Document Type:
Drug Information
Agency / Institution:
Food and Drug Administration (FDA)
Author:
FDA
Target Audience:
Healthcare professionals, physicians, pharmacists
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Revisions:
Not specified
Year:
2023
Region / City:
Global
Topic:
Pharmacology, Psychiatry
Document Type:
Medical Guidelines
Organization / Institution:
Unspecified
Author:
Unspecified
Target Audience:
Healthcare Professionals, Psychiatrists
Duration of Validity:
Indefinite
Approval Date:
Unspecified
Date of Changes:
Unspecified
Year:
2024
Region:
Massachusetts, USA
Subject:
Healthcare billing, Antipsychotic medications
Document Type:
Policy / Instruction
Organization:
MassHealth
Audience:
In-state acute inpatient hospital providers
Effective Date:
5/15/2024
Reference:
Sections 5.B.4.g of the MassHealth Acute Hospital Request for Applications
Medication Covered:
Long-Acting Injectable (LAI) Antipsychotics
Billing Codes:
National Drug Code (NDC), HCPCS
Submission Requirements:
Professional claims (Claim Types M and B), Direct Data Entry for IC drugs, invoice attachment from distributor/manufacturer
Payment Methodology:
Fee schedule in 101 CMR 317.00 or Individual Consideration (IC)
Documentation:
Attachments via Provider Online Service Center (POSC)
Compliance Notes:
Failure to follow instructions may result in inaccurate payment
Instruction Updates:
May be updated from time to time
Year:
2024
Region / City:
Massachusetts
Topic:
Long-Acting Injectable Antipsychotic Medications
Document Type:
MassHealth Drug List Update
Institution:
MassHealth
Author:
MassHealth
Target Audience:
Healthcare providers, inpatient psychiatric service providers
Effective Period:
May 15, 2024
Approval Date:
May 15, 2024
Update Date:
Ongoing updates
Applicable Policy:
Long-Acting Injectable Antipsychotic Medication Payment and Reimbursement Policy
J-Codes:
J0401, J0402, J1631, J1943, J1944, J2358, J2426, J2427, J2428, J2680, J2794, J2798, J2799, J2801
Billing Instructions:
Available on the MassHealth website