№ files_lp_4_process_3_082775
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Formal appeal document challenging the conclusions of a health technology appraisal regarding the clinical criteria, cost-effectiveness, and regulatory processes for abiraterone use in high-risk metastatic prostate cancer.
Year:
2020
Region / Country:
United Kingdom
Subject:
Health technology appraisal, oncology, prostate cancer
Document Type:
Legal/administrative appeal
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
Janssen Pharmaceuticals
Target Audience:
Healthcare regulators, appraisal committees, oncology specialists
Treatment Indication:
Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer in adult men
Therapy Discussed:
Abiraterone in combination with androgen deprivation therapy (ADT)
Procedural History:
Referral in 2016, European Commission approval in 2017, Final Appraisal Determination issued 19 June 2020
Patent Status:
Patent expiration expected September 2022, generic versions available in the USA
Appeal Grounds:
Clinical benefit assessment, quality of life considerations, cost-effectiveness evaluation, procedural fairness
Price: 8 / 10 USD
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Year:
2020
Organization:
National Institute for Health and Care Excellence (NICE)
Corresponding Group:
British Uro-Oncology Group (BUG)
Document Type:
Final Appraisal Document
Subject:
Abiraterone, Hormone-Sensitive Metastatic Prostate Cancer
Recipient:
STAMPEDE Trial Chief Investigator
Date of Letter:
21 July 2020
Period Covered:
Initial appraisal and appeal process regarding abiraterone
Appeal Grounds:
Unreasonableness of recommendations based on submitted evidence
Key Topics:
Clinical effectiveness, cost-effectiveness, follow-on treatments, quality of life, impact of COVID-19
Document Format:
Letter with appraisal commentary and appeal guidance
Year:
2017
Region / City:
UK
Theme:
Oncology / Pharmaceutical
Document Type:
Service Outline
Organization:
NHS Scotland
Author:
NHS Board
Target Audience:
Healthcare professionals, pharmacists
Period of Validity:
2017–2027 (subject to patent status)
Date of Approval:
12/10/2015
Date of Last Revision:
13/08/2012
Patent Expiry Date:
2018 (possible extension until 2027)
Service Type:
Patient access and prescription management for Zytiga®
Description:
This document provides a service outline and governance checklist for the supply, prescription, and patient management of Zytiga® (abiraterone acetate) within NHS Scotland, focusing on its usage in treating metastatic castration-resistant prostate cancer.
Year:
2021
Region / City:
Not specified
Topic:
Clinical study, oncology, prostate cancer
Document Type:
Study Protocol
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Medical professionals, clinical researchers
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Region / city:
Netherlands
Topic:
Cancer treatment, Abiraterone, Prostate cancer
Document type:
Research study
Institution:
Ziekenhuis Gelderse Vallei, Radboudumc
Author:
Indy Murdoch, Emmy Boerrigter, Arnold Baars, Floor Lubberman
Target audience:
Healthcare professionals, Researchers
Period of validity:
N/A
Date of approval:
February 4, 2022
Date of changes:
N/A
Year:
2020
Organization:
National Institute for Health and Care Excellence (NICE)
Corresponding Group:
British Uro-Oncology Group (BUG)
Document Type:
Final Appraisal Document
Subject:
Abiraterone, Hormone-Sensitive Metastatic Prostate Cancer
Recipient:
STAMPEDE Trial Chief Investigator
Date of Letter:
21 July 2020
Period Covered:
Initial appraisal and appeal process regarding abiraterone
Appeal Grounds:
Unreasonableness of recommendations based on submitted evidence
Key Topics:
Clinical effectiveness, cost-effectiveness, follow-on treatments, quality of life, impact of COVID-19
Document Format:
Letter with appraisal commentary and appeal guidance
Year:
2020
Region / City:
United Kingdom
Topic:
Prostate Cancer, Oncology, Drug Evaluation
Document Type:
Appeal Hearing Transcript
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
Various panel members, including Heather Blake, Professor Nicholas James, and others
Target Audience:
Healthcare professionals, decision-makers, cancer advocacy groups
Effective Period:
September 2020
Approval Date:
3 September 2020
Date of Changes:
None
Year:
2026
Study type:
Supplementary material
Cohort size:
93 patients
Disease:
Metastatic melanoma
Methods:
Multiplex immunofluorescence, image cytometry, Cox regression, LASSO analysis
Data type:
Tables and figures
Variables analyzed:
Clinicopathologic characteristics, cell density, proximity measurements, immune biomarkers
Statistical software:
R
Target population:
Patients with metastatic melanoma
Follow-up period:
5 years
Year:
2024
Region / city:
Global
Theme:
Oncology, Endometrial Cancer, Pharmaceutical Submissions
Document Type:
Medical Submission
Organization / Institution:
AstraZeneca Pty Ltd
Author:
AstraZeneca Pty Ltd
Target Audience:
Medical professionals, regulatory bodies, pharmaceutical companies
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Australia
Topic:
Oncology, Pharmaceutical Submission
Document Type:
Pharmaceutical Resubmission
Organization:
AstraZeneca Pty Ltd
Author:
Not specified
Target Audience:
Medical Practitioners
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A pharmaceutical resubmission document outlining the use of osimertinib as a first-line treatment for locally advanced or metastatic EGFRm non-small cell lung cancer (NSCLC) in Australia, including previous PBAC considerations and clinical trial data.
Year:
2025
Date:
October 30, 2025
Time:
5:00 PM
Field:
Oncology; Surgery
Topic:
Tumor-Infiltrating Lymphocyte (TIL) Therapy; Metastatic Melanoma
Document Type:
Continuing Education / Continuing Medical Education Activity Description
Organizing Institution:
Ascension
Accrediting Bodies:
Accreditation Council for Continuing Medical Education; Accreditation Council for Pharmacy Education; American Nurses Credentialing Center
Credit Designation:
1.50 IPCE credits; 1.50 ANCC contact hours
Target Audience:
Interdisciplinary healthcare team; Oncology and Surgery specialties
Faculty:
Jatandra Birney, PharmD, BCOP
Activity Coordinator:
Tari Hopper, BSN
Commercial Support:
None
Conflict of Interest Disclosure:
No relevant financial relationships disclosed
Year:
2026
Region / City:
Not specified
Topic:
Cancer genomics, epigenetics, prostate cancer
Document type:
Supplementary material
Institution:
Not specified
Authors:
Chennan Li et al.
Target audience:
Researchers in oncology and molecular biology
Sample type:
Plasma and buffy coat
Methods:
ctDNA sequencing, 5mC/5hmC methylomics, clonal reconstruction
Timepoints:
Baseline, restaging, progression, off-study
Genes analyzed:
AR, BRCA2, erythroid markers, platelet/megakaryocyte markers, globins
Data included:
Sequencing metrics, methylation percentages, gene-level events, survival analysis
Associated figures:
8 supplementary figures, 2 supplementary tables
Statistical analyses:
Spearman correlation, Kruskal-Wallis test, Mann-Whitney U test, Kaplan-Meier survival estimates, log-rank test
Year:
[Insert year]
Region / city:
[Insert region/city]
Subject:
Medical treatment request
Document type:
Authorization request letter
Institution:
[Insert institution name]
Author:
[Physician’s name]
Target audience:
Medical/Pharmacy Director
Effective period:
[Insert effective period]
Approval date:
[Insert approval date]
Date of modifications:
[Insert modification date]
Diagnosis:
[Insert diagnosis]
Treatment:
ERLEADA® (apalutamide)
Clinical trial:
TITAN trial
Clinical guidelines reference:
NCCN Guidelines®, AUA/SUO Guidelines
Patient history:
[Insert patient history]
Risk of disease progression:
[Insert risk]
Adverse reactions:
Rash, hot flush, hypertension, arthralgia, pruritus
Publication reference:
Journal of Clinical Oncology
Study data source:
Precision Point Specialty (PPS) Analytics, Komodo Research Database
Study design:
Retrospective, longitudinal, head-to-head analysis
Outcome:
Overall survival at 24 months
Year:
2021
Location:
University of Virginia, USA
Topic:
Metastatic prostate cancer, precision medicine
Document type:
Conference transcript / Grand Rounds presentation
Institution:
University of Virginia Health System; Memorial Sloan Kettering Cancer Center
Speaker / Author:
Karen Autio, MD, MSc
Target audience:
Medical professionals, oncology researchers
Date of presentation:
June 8, 2021
Focus:
Clinical updates, research studies, biomarker-driven therapy
Key terms:
Castration-resistant prostate cancer, androgen deprivation therapy, immune checkpoint inhibitors, PSA, prostate-specific membrane antigen
Year:
2025
Organization:
NICE Technology Appraisal Committee
Document type:
Interests Register
Region:
United Kingdom
Subject:
Conflicts of interest in health technology appraisal
Participants:
Peter Wheatley Price, Warren Linley, David McAllister, Professor Suneil Jain, Rhiannon Owen, Holly Knight
Date of publication:
TBC
Relevant period:
2025
Financial interests:
Pfizer, AstraZeneca, Bayer, Astellas, Johnson & Johnson, Boston Scientific, Teleflex, Accord, Molli Surgical, BXT Nanotherapy
Professional roles:
Committee members, clinical expert, patient expert
Access to trial data:
Yes
Appraisal ID:
4004
Record type:
Committee disclosures
Year:
2020
Organization:
National Institute for Health and Care Excellence (NICE)
Corresponding Group:
British Uro-Oncology Group (BUG)
Document Type:
Final Appraisal Document
Subject:
Abiraterone, Hormone-Sensitive Metastatic Prostate Cancer
Recipient:
STAMPEDE Trial Chief Investigator
Date of Letter:
21 July 2020
Period Covered:
Initial appraisal and appeal process regarding abiraterone
Appeal Grounds:
Unreasonableness of recommendations based on submitted evidence
Key Topics:
Clinical effectiveness, cost-effectiveness, follow-on treatments, quality of life, impact of COVID-19
Document Format:
Letter with appraisal commentary and appeal guidance
Year:
2026
Region / city:
South San Francisco, CA, USA; Munich, Germany
Subject:
Oncology, Cancer Research
Document type:
Research Paper
Organization:
Amgen Research
Author:
Petra Deegen, Oliver Thomas, Olivier Nolan-Stevaux, Shyun Li, Joachim Wahl, Pamela Bogner, Famke Aeffner, Matthias Friedrich, Michael Z. Liao, Katja Matthes, Doris Rau, Benno Rattel, Tobias Raum, Peter Kufer, Angela Coxon, Julie M. Bailis
Target audience:
Researchers, oncologists, biotechnologists
Period of validity:
Not specified
Approval date:
Not provided
Date of changes:
Not provided
Year:
2020
Region / City:
United Kingdom
Topic:
Prostate Cancer, Oncology, Drug Evaluation
Document Type:
Appeal Hearing Transcript
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
Various panel members, including Heather Blake, Professor Nicholas James, and others
Target Audience:
Healthcare professionals, decision-makers, cancer advocacy groups
Effective Period:
September 2020
Approval Date:
3 September 2020
Date of Changes:
None
Year:
2023
Study Type:
Clinical trial, Phase 2
Document Type:
Supplementary data
Authors:
Samuel J. Klempner et al.
Intervention:
Zolbetuximab monotherapy, Zolbetuximab + mFOLFOX6, Zolbetuximab + Pembrolizumab
Population:
Patients with advanced or metastatic claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma
Sample Size:
54
Countries:
France, Italy, Japan, Korea, Taiwan, United States
Cohorts:
1A, 2, 3A
Age Range:
32–79 years
Median Age:
60–65 years
Sex Distribution:
Male 33, Female 21
Ethnicity:
Asian 43%, White 43%, Black 2%, Hispanic/Latino 6%
PK Sampling:
Zolbetuximab, mFOLFOX, Pembrolizumab
HRQOL Assessment:
Multiple cycles per cohort
Follow-up:
30-day safety, 90-day follow-up
Geographic Focus:
Eastern Asia, Central/Eastern Europe, United States, France
End Points:
Pharmacokinetics, health-related quality of life, patient demographics
Data Sources:
Clinical study data, GLOBOCAN 2020, literature references
Supplementary Materials:
Methods, Tables, Figures
Year:
2026
Region / City:
South West London, UK
Topic:
Medical referral for metastatic spinal cord compression
Document Type:
Referral form
Institution:
St George’s Hospital; Royal Marsden Hospital; Royal Surrey County Hospital
Author:
NHS Clinical Team
Target Audience:
Medical professionals, consultants, hospital staff
Date of Implementation:
2026
Referral Hours:
Mon-Thu 08:30-16:30, Fri 08:00-16:00
Contact Emails:
[email protected]; [email protected]; [email protected]
Purpose:
Patient referral and clinical information collection for suspected or confirmed metastatic spinal cord compression
Instructions:
Completion required prior to referral; all imaging studies must be available via SGH PACS
Year:
2026
Region / City:
Not specified
Topic:
Oncology / Pharmacology
Document Type:
Patient Information Leaflet
Institution:
Healthcare Provider / Pharmaceutical Guidance
Drug Name:
Palbociclib
Indications:
HR-positive, HER-2-negative advanced or metastatic breast cancer
Dosage:
125 mg orally once daily for 21 days, followed by 7 days off
Administration:
With food, do not crush or split tablets
Interactions:
Avoid grapefruit; consult before new medications
Side Effects:
Neutropenia, fatigue, nausea, hair loss, mouth sores, liver function changes
Precautions:
Pregnancy and contraception guidelines, handling of body fluids
Storage:
Room temperature below 25°C, keep away from children and pets
Target Audience:
Patients undergoing Palbociclib therapy
Source Type:
Medical guidance / pharmaceutical leaflet