№ lp_1_2_37099
File format: docx Character count: 55310 File size: 164 KB
Year: 2023
Region / City: Australia
Topic: Hidradenitis Suppurativa Treatment
Document Type: Submission for Pharmaceutical Benefits Scheme (PBS) Listing
Organ / Institution: Novartis Pharmaceuticals Australia Pty Limited
Author: Novartis Pharmaceuticals Australia Pty Limited
Target Audience: Medical professionals, Healthcare policymakers
Period of Validity: Not specified
Approval Date: Not specified
Date of Amendments: Not specified
Category / Program: General Schedule (Code GE)
Prescriber Type: Dental Medical Practitioners, Nurse Practitioners, Optometrists, Midwives
Restriction Type: Authority Required
Severity: Moderate to severe
Condition: Hidradenitis suppurativa
Treatment Phase: Initial treatment
Clinical Criteria: Hurley stage II or III grading, abscess and inflammatory nodule count ≥ 3, failure to respond to antibiotics
Treatment Criteria: Dermatologist supervision
Population Criteria: Adult patients
Administrative Advice: Subcutaneous injection
Prescribing Instructions: Must assess disease severity, first 4 weeks under restriction
Cost: $6,145.10 for 300 mg/2 mL pre-filled syringe/pen
Source: Table 1.1, p25; Table 1.6, p35; Table 1.7, pp36-37; Table 1.7, p38
Price: 8 / 10 USD
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secukinumab mPBPK-TE-MBMA model based on IL-17 pharmacokinetics and target engagement
Year: 2013
Model type: mPBPK-TE-MBMA
Drug: secukinumab
Based on: 2nd generation mPBPK-TE model for IL-17 (Cao & Jusko, JPKPD, 2013)
Author: JLee
Data file: IL17_mPBPK_NM_v01_LN.csv
Subroutines: ADVAN6
Compartment description: ABS, serum, muscle, leaky, skin, lymph, total IL17A serum, total IL17A skin
Parameters: CL, FA, KA, L, LS, L1, L2, VP, V1, V2, VS, VL, kdegSK, kdegSE, kintSK, kintSE, BSsk, BSse, KD, sSK, s1, s2, sL
Error model: combined additive and proportional, log-transform for serum and skin PK
Simulation: 1234 replicates, NSUBPROBLEMS=1, ONLYSIM
Output tables: sdtab1128, patab1128, catab1001, cotab1001
Target audience: pharmacometricians, modelers
Scope: pharmacokinetic and target engagement predictions for secukinumab in serum and skin compartments
The roles of IL-17A and IL-17F in hidradenitis suppurativa pathogenesis: evidence from human in vitro preclinical experiments and clinical samples
Year: 2021
Region / City: Slough, UK
Topic: Immunology, Dermatology
Document Type: Research Article
Organization / Institution: UCB
Author: Joseph Rastrick, Hannah Edwards, Alex S. Ferecskó, Gaëlle Le Friec, Avneet Manghera, Matthew Page, Stevan Shaw
Target Audience: Researchers, Healthcare Professionals
Period of Validity: Not specified
Date of Approval: Not specified
Date of Changes: Not specified
Context: The document is a research article presenting findings on the roles of IL-17A and IL-17F in hidradenitis suppurativa (HS), based on human in vitro and clinical experiments.
Letter of Medical Necessity for Dual Therapy in Hidradenitis Suppurativa
Year: 2023
Region / city: Not specified
Subject: Medical necessity of dual biologic therapy for hidradenitis suppurativa
Document type: Medical letter
Organization / institution: Not specified
Author: Dermatologist
Target audience: Insurance providers, healthcare professionals
Effective period: Not specified
Approval date: Not specified
Amendment date: Not specified
Context: Medical letter advocating for insurance approval of dual biologic therapy for a patient with severe hidradenitis suppurativa, citing clinical data and treatment history.
The roles of IL-17A and IL-17F in hidradenitis suppurativa pathogenesis: evidence from human in vitro preclinical experiments and clinical samples
Year: 2021
Region / City: Slough, UK
Topic: Immunology, Dermatology
Document Type: Research Article
Organization / Institution: UCB
Author: Joseph Rastrick, Hannah Edwards, Alex S. Ferecskó, Gaëlle Le Friec, Avneet Manghera, Matthew Page, Stevan Shaw
Target Audience: Researchers, Healthcare Professionals
Period of Validity: Not specified
Date of Approval: Not specified
Date of Changes: Not specified
Context: The document is a research article presenting findings on the roles of IL-17A and IL-17F in hidradenitis suppurativa (HS), based on human in vitro and clinical experiments.
Letter of Medical Necessity for Dual Therapy in Hidradenitis Suppurativa
Year: 2023
Region / city: Not specified
Subject: Medical necessity of dual biologic therapy for hidradenitis suppurativa
Document type: Medical letter
Organization / institution: Not specified
Author: Dermatologist
Target audience: Insurance providers, healthcare professionals
Effective period: Not specified
Approval date: Not specified
Amendment date: Not specified
Context: Medical letter advocating for insurance approval of dual biologic therapy for a patient with severe hidradenitis suppurativa, citing clinical data and treatment history.
Topics: Secukinumab Hidradenitis Suppurativa