PSORIASIS DRUGS IN EUROPE - MARKET ACCESS DECISIONS IN COMPARISION BASED ON THE PRISMACCESS DATABASE
|
|
- Jean Stokes
- 6 years ago
- Views:
Transcription
1 PSORIASIS DRUGS IN EUROPE - MARKET ACCESS DECISIONS IN COMPARISION BASED ON THE PRISMACCESS DATABASE Lutz Vollmer 1,3, Daniel Dröschel 1,4, Bruno de Paz 2, Stefan Walzer 1,5 1 MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany 2 Prioritis SA, Paris, France 3 University of Applied Sciences Rottenburg / Neckar, Rottenburg, Germany 4 SRH Mobile University Riedlingen, Germany 5 State University Baden-Württemberg Lörrach, Germany ISPOR EUROPE Glasgow, November 2017
2 Psoriasis Long-lasting autoimmune disease characterized by raised, red, scaly patches of abnormal skin. Typically affects the outside of the elbows, knees or scalp, though it can appear on any location. A non-curable disease; however, treatment options help to control the disease for many patients. Psoriasis can be mild, moderate or severe. Severity is based on how much of the body is affected by psoriasis. However, the severity of psoriasis is also measured by how psoriasis affects a person's quality of life. This study provides information on the current reimbursement situation with biological agents in various European countries, which are part of the treatment plans of moderate to severe Psoriasis.
3 Methods The international HTA database Prismaccess includes over worldwide decisions by market access authorities. This study includes the decisions of : France Transparency Committee Haute Autorité de Santé TC HAS / CEESP England National Institute for Health and Care Excellence - NICE Scotland Scottish Medicines Consortium - SMC Germany Federal Joint Committee - G-BA, IQWIG Sweden The Dental and Pharmaceutical Benefits Agency, TLV As therapeutic area Psoriasis was chosen. Investigation period was from 2011 to October For comparison, the decision scale was transformed in to a traffic light system.
4 Added benefit in comparison France TC HAS - ASMR Germany G-BA - Added benefit Sweden TLV - Cost-Effect. England NICE - Cost-Effect. Scotland SMC - Cost-Effect. Recommended without limitations ASMR IV and higher in all subgroups Added benefit in all subgroups Recommended Accepted Accepted Recommended with limitations ASMR V / Insufficient in at least one subgroup No added benefit in at least one subgroup Recommended with restriction / and condition Accepted (with limitations) Restricted Not recommended / not reimbursed Insufficient Lesser benefit Not recommended Not recommended Not recommended
5 Overall development 66 decisions 27 drugs 15 active ingredients Total / 1 TC / CEESP 7 / 4 IQWIG / G-BA
6 Drug therapies Established Therapies Adalimumab - HUMIRA Betamethasone Brodalumab Calcipotriol Calcipotriol / Betamethasone Clobetasol Etanercept - ENBREL Fumaric acid esters Infliximab - REMICADE Methotrexate Mometasone Ustekinumab - STELARA New upcoming therapies / Biologics Apremilast - OTEZLA Dimethyl Fumarate - SKILARENCE Brodalumab - KYNTHEUM Ixekizumab - TALTZ Secukinumab - COSENTYX
7 France Overall: 24 decisions with an SMR of Substantial in 23 subpopulations Moderate in 2 subpopulations Insufficient in 10 subpopulations And mostly no improvement in the added benefit
8 France Focus on new therapies (4 decisions) Decision for an insufficient benefit increased. Also added benefit for an ASMR of IV increased.
9 Sweden 14 decisions incl. re evaluations Majority is approved and no negative recommendation New therapies (Apremilast, Brodalumab, Ixekizumab, Secukinumab) all approved with restriction (and condition)
10 Scotland Total 10 decisions with the majority restricted. Not recommended due to nonsubmission. New therapies: only Apremilast was considered as cost-effective and accepted without limitations.
11 England Overall 6 decisions Mainly accepted with limitations New therapies are all accepted with limitation Apremilast first submission not recom-mended because not costeffective
12 Germany Only new therapies were rated in the benefit assessment, with the majority of an added benefit.
13 Date of decision 02/12/2015 Moderate V 15/06/2015 Approved with restriction and condition 25/11/ /11/2016 Apremilast - OTEZLA Results ACT Patient population Clinical Data Not recommended Accepted with limtations Adalimumab/ Etanercept/Infliximab /Secukinumab/ Ustekinumab e.g. Methotrexate or biologic treatment BSC (Moderate) Biologics (Severe) 08/06/2015 Accepted Etanercept/Infliximab /Adalimumab/ Ustekinumab Moderate and severe who not responded... to other syst. therapies à 2 nd line, not 3 rd line Moderate and severe who not responded... to other syst. therapies Only severe disease (not Cost-Effective for moderate) Moderate and severe who not responded... to other syst. therapies Against Placebo -> moderate SMR! Against Placebo was accepted Against Placebo and NMA was accepted Against Placebo and NMA was accepted 06/08/2015 No added benefit proven Adalimumab/ Infliximab/ Ustekinumab Moderate and severe who not responded... to other syst. therapies Against Placebo was not accepted for benefit assessment
14 Date of decision 16/09/ /10/ /05/ /05/2016 Secukinumab - COSENTYX Results ACT Patient population Clinical data Substantial IV (Insufficient for other) Approved with restriction and condition Adalimumab/Apremilast/ Ciclosp./Etanercept/Inflix imab/ixekizumab/ Methotrexate/Ustekinum ab Etanercept/Adalimumab/ Infliximab/Ustekinumab Only severe chronic forms (3rd line treatment) and further failure of at least two treatments Moderate to severe who do not respond to systemic FIXTURE/ERA SURE/FEATUR E/JUNCTURE/ CLEAR + NMA FIXT./ERAS./ FEAT./JUNC./ CLEAR+NMA 22/07/2015 Accepted with limitations Biological treatments 08/06/2015 Restricted Etanercept/Infliximab/ Adalimumab/ Ustekinumab 27/11/ /08/2017 A Considerable (after resub.) B Considerable C Minor A)Fumaric acid esters/ cyclosporine/methotrexa te/phototherapy BC)/Adalimumab/ Infliximab/Ustekinumab Severe AND when failed to respond to standard systemic therapies When failed to respond to standard systemic therapies A) Moderate to severe plaque psoriasis who are eligible for systemic therapy BC) not responded adequ. FIXT./ERAS./ FEAT./JUNC./ + NMA FIXTURE,ERAS URE,FEATURE, JUNCTURE A) PRIME B)CAIN457A2 223/ERAS./FI XT/FEAT./JUN CT. + NMA
15 Date of decision 05/10/2016 Substantial V (Insufficient for other) 30/09/2016 Approved with restriction 26/04/2017 Accepted with limitations Ixekizumab - TALTZ Results ACT Patient Population Clincal data Secikinumab (the most) Adalim./Aprem./Ciclosp./ Etaner./Inflixi./Ixekizu./M ethotr./ Ustekinu./ Secikinumab (Indirect comparison) Other biological treatments 10/04/2017 Restricted Etanercept/Infliximab/ Adalimumab/Ustekinuma b 15/08/2017 A Considerable B Minor A) Fumaric acid esters/ /cyclosporine/methotrex ate/ phototherapy B) Adalimumab/ Infliximab/Ustekinumab Only severe chronic forms (3rd line treatment) and further failure of at least two treatments Moderate to severe who do not respond to systemic Severe AND when failed to respond to standard systemic therapies Moderate to severe who do not respond to systemic A) Moderate to severe who are eligible for systemic therapy B) Moderate to severe who do not responded adequate. UNCOVER 1,2,3 RHBS + Ind. comp. UNCOVER 1,2,3 + Indirect com. UNCOVER 1,2,3 + NMA UNCOVER 1,2,3 + NMA RHBZ RHBS
16 Date of decision Brodalumab - KYNTHEUM Results ACT Patient Population No information available yet 31/10/2017 Approved with restriction In development Ixekizumab and Secukinumab (indirect comparison) Only subsidized for patients who have been treated with TNF inhibitors or where this is not appropriate. Because not shown reasonable cost in relation to TNF inhibitor In development In development
17 Date of decision Dimethylfumarate - SKILARENCE Results ACT Patient Population No information available yet No information available yet 06/09/2017 Approved with limitations In development Placebo Fumaric acid esters severe and patients who failed to other systemic therapies Cost effective for severe subpopulation In development
18 Summary The MA label for moderate and severe patients for new biologic therapies is not fully implemented by all authorities. Range from full access (Germany) to 3 rd line treatment (France) The appropriate comparator therapy is different specified by each authority. In general clinical data was mostly accepted. Clinical data based on Placebo e.g. is assessed differently by each authority. Treatments are seen mostly as cost-effective to patients with severe psoriasis, and are a reason for restrictions.
19 Implications A one size fits all HTA is not recommendable for Europe given the significant differences in the application of HTA methods and preferences for analyses. Especially patients with moderate Psoriasis might suffer from different country-specific access to new treatments.
20 PSORIASIS DRUGS IN EUROPE - MARKET ACCESS DECISIONS IN COMPARISION BASED ON THE PRISMACCESS DATABASE Lutz Vollmer 1,3, Daniel Dröschel 1,4, Bruno de Paz 2, Stefan Walzer 1,5 1 MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany 2 Prioritis SA, Paris, France 3 University of Applied Sciences Rottenburg / Neckar, Rottenburg, Germany 4 SRH Mobile University Riedlingen, Germany 5 State University Baden-Württemberg Lörrach, Germany ISPOR EUROPE Glasgow, November 2017
21 Further Information Further information on the reimbursement status is available in the Prioritis Analysis Report Psoriasis Stop by at Stand 602, Hall 4 to drop your for a free version
22 HTA decisions Including regional decions from Italy and Spain
23 Timelines MA to HTA and Reimbursement
Background AN UPDATED LOOK AT TREATMENTS FOR PLAQUE PSORIASIS JULY 2018 PLAQUE PSORIASIS TARGETED IMMUNOMODULATORS AS A TREATMENT OPTION
JULY 2018 Background PLAQUE PSORIASIS Plaque psoriasis is a common disease affecting 3% of the US population that causes itchy, red, scaly, raised lesions on the skin, most commonly on the elbows, knees,
More informationREFERENCE CODE GDHC1170DFR PUBLICATION DATE M AY 2013
REFERENCE CODE GDHC1170DFR PUBLICATION DATE M AY 2013 BRODALUMAB (PSORIASIS) - Executive Summary Table below presents key metrics for brodalumab in seven of the nine major pharmaceutical markets covered
More informationPharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024
PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 PharmaPoint: Psoriasis - Global Drug Forecast and Market Analysis to 2024 BioPortfolio has been marketing business and market research
More informationREFERENCE CODE GDHC1174DFR PUBLICATION DATE M AY 2013
REFERENCE CODE GDHC1174DFR PUBLICATION DATE M AY 2013 XELJANZ (PSORIASIS) - Executive Summary Table below presents key metrics for Xeljanz (tofacitinib) in seven of the nine major pharmaceutical markets
More informationSingle Technology Appraisal (STA) Tildrakizumab for treating moderate to severe plaque psoriasis
Single Technology Appraisal (STA) Tildrakizumab for treating moderate to severe plaque psoriasis Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) Please
More informationREFERENCE CODE GDHC1114CFR PUBLICATION DATE M AY 2013
REFERENCE CODE GDHC1114CFR PUBLICATION DATE M AY 2013 PSORIASIS - Psoriasis - India Drug Forecast and Market Analysis to Executive Summary Sales for Psoriasis in India 2012 We estimate the 2012 PsO drug
More informationixekizumab 80mg solution for injection (Taltz ) SMC No. (1223/17) Eli Lilly and Company Ltd.
ixekizumab 80mg solution for injection (Taltz ) SMC No. (1223/17) Eli Lilly and Company Ltd. 10 March 2017 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and
More informationPsoriatic Arthritis- Second Line Treatments
Psoriatic Arthritis- Second Line Treatments Second line treatments for Psoriatic Arthritis (PsA) are usually prescribed by a Rheumatologist, Dermatologist, or in a combined clinic where both the Dermatologist
More informationCosentyx. Cosentyx (secukinumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.11 Subject: Cosentyx Page: 1 of 7 Last Review Date: September 20, 2018 Cosentyx Description Cosentyx
More informationOtezla. Otezla (apremilast) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Otezla Page: 1 of 5 Last Review Date: March 16, 2018 Otezla Description Otezla (apremilast) Background
More informationHorizon Scanning Centre March Tildrakizumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 6798
Horizon Scanning Centre March 2015 Tildrakizumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 6798 This briefing is based on information available at the time of research and a limited
More information2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Outcome High Priority
Quality ID #410: Psoriasis: Clinical Response to Systemic Medications National Quality Strategy Domain: Person and Caregiver-Centered Experience and Outcomes Meaningful Measure Area: Management of Chronic
More informationAnalyzing Health Technology Assessment (HTA) Decisions in Oncology
Analyzing Health Technology Assessment (HTA) Decisions in Oncology Funding for this research was provided by PhRMA. Avalere retained full editorial control. Avalere Health An Inovalon Company May 31, 2018
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Otezla (apremilast) Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Otezla (apremilast) Prime Therapeutics will review Prior Authorization requests Prior
More informationHorizon Scanning Centre March Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209
Horizon Scanning Centre March 2015 Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209 This briefing is based on information available at the time of research and a limited
More informationPsoriasis. Andrei Metelitsa, MD, FRCPC, FAAD Clinical Associate Professor, Dermatology, U of C Co-Director, Institute for Skin Advancement
Psoriasis Andrei Metelitsa, MD, FRCPC, FAAD Clinical Associate Professor, Dermatology, U of C Co-Director, Institute for Skin Advancement Copyright 2017 by Sea Courses Inc. All rights reserved. No part
More informationPsoriatic Arthritis- Secondary Care
Psoriatic Arthritis- Secondary Care Our Psoriatic Arthritis: First Line Treatments information sheet gives information on the treatments that can be prescribed by a GP, or that might be prescribed if the
More informationA Patient s Guide to. Treatments for Psoriatic Arthritis
A Patient s Guide to Treatments for Psoriatic Arthritis Who should read this guide? This guide is aimed at people with psoriatic arthritis (abbreviated as PsA), or those who care for a person with this
More informationCIMZIA (certolizumab pegol)
Pre - PA Allowance None Prior-Approval Requirements Age Diagnoses 18 years of age or older Patient must have ONE of the following: 1. Moderate to severe Crohn s Disease (CD) a. Inadequate response, intolerance
More informationRegulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 8 Last Review Date: March 16, 2018 Orencia Description Orencia (abatacept)
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1017-7 Program Prior Authorization/Notification Medication Cimzia (certolizumab) P&T Approval Date 1/2007, 6/2008, 4/2009, 6/2009,
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Health Technology Appraisal Dimethyl fumarate for treating moderate to severe Draft scope (pre-referral) Draft remit/appraisal objective To appraise
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 2104-4 Program Prior Authorization/Medical Necessity Medication Taltz (ixekizumab) P&T Approval Date 8/2016, 5/2017, 2/2018 Effective
More informationINFLIXIMAB Remicade (infliximab), Inflectra (infliximab-dyyb), Ixifi* (infliximabqbtx), Renflexis (infliximab-abda)
Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 6 years of age or older 1. Moderate to severe Crohn s disease (CD) a. Patient has fistulizing disease
More information13 Skin. In alphabetical order Product Manufacturer. NHS Lothian decision. Condition being treated. Date of NHS Lothian decision
Recommendations from the Lothian Formulary Committee (FC) following Scottish Medicines Consortium (SMC) advice, NICE MTA advice, (FAF3) unlicensed and off-label medicines and (FAF2) medicines not considered
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION IXEKIZUMAB (Taltz Eli Lilly Canada Inc.) Indication: Moderate to Severe Plaque Psoriasis Recommendation: The CADTH Canadian Drug Expert Committee
More informationNB Drug Plans Formulary Update
Bulletin # 995 March 27, 2019 NB Drug Plans Formulary Update This update to the New Brunswick Drug Plans Formulary is effective March 27, 2019. Included in this bulletin: Special Authorization Benefit
More informationDrug Class Prior Authorization Criteria Therapeutic Agents in Rheumatic and Inflammatory Diseases
Drug Class Prior Authorization Criteria Therapeutic Agents in Rheumatic and Inflammatory Diseases Line of Business: Medicaid P & T Approval Date: August 16, 2017 Effective Date: August 16, 2017 This policy
More informationStelara. Stelara (ustekinumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.04 Subject: Stelara Page: 1 of 9 Last Review Date: September 20, 2018 Stelara Description Stelara
More informationBiologics for Autoimmune Diseases
Biologics for Autoimmune Diseases Goal(s): Restrict use of biologics to OHP funded conditions and according to OHP guidelines for use. Promote use that is consistent with national clinical practice guidelines
More information3 rd Appraisal Committee meeting, 28 February 2017 Committee D
Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease modifying antirheumatic drugs Multiple Technology Appraisal 3 rd Appraisal Committee
More informationBiologic Immunomodulators Prior Authorization with Quantity Limit Program Summary
Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary Biologic Immunomodulators Prior Authorization with Quantity Limit (with a preferred option) OBJECTIVE The intent of the
More informationTechnology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta442
Ixekizumab for treating moderate to severe ere plaque psoriasis Technology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta442 NICE 2017. All rights reserved. Subject to Notice of rights
More informationRisankizumab (by subcutaneous injection) for moderate to severe chronic plaque psoriasis
NIHR Innovation Observatory Evidence Briefing: November 2017 Risankizumab (by subcutaneous injection) for moderate to severe chronic plaque psoriasis NIHRIO (HSRIC) ID: 9708 NICE ID: 9191 LAY SUMMARY Plaque
More information13 Skin. In alphabetical order Product Manufacturer. NHS Lothian decision. Condition being treated. Date of NHS Lothian decision
Recommendations from the Lothian Formulary Committee (FC) following Scottish Medicines Consortium (SMC) advice, NICE MTA advice, (FAF3) unlicensed and off-label medicines and (FAF2) medicines not considered
More informationScottish Medicines Consortium
Scottish Medicines Consortium ustekinumab, 45mg solution for injection (Stelara ) No. (572/09) Janssen-Cilag Ltd 15 January 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of
More informationTargeted Immunomodulators for the Treatment of Moderate-to- Severe Plaque Psoriasis: Effectiveness and Value
Targeted Immunomodulators for the Treatment of Moderate-to- Severe Plaque Psoriasis: Effectiveness and Value Condition Update Final Background and Scope January 9, 2018 Background Psoriasis is a common
More information2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Process
Quality ID #337: Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier National Quality Strategy Domain:
More informationADDING VALUE AND EXPERTISE FOR SUCCESSFUL MARKET ACCESS. Per Sørensen, Lundbeck A/S
ADDING VALUE AND EXPERTISE FOR SUCCESSFUL MARKET ACCESS Per Sørensen, Lundbeck A/S Market Access - price & reimbursement Situation today within psychiatric and neurological diseases Increased requirements
More informationCimzia. Cimzia (certolizumab pegol) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.11 Section: Prescription Drugs Effective Date: April 1, 2018 Subject: Cimzia Page: 1 of 5 Last Review
More informationRegulatory Status FDA-approved indications: Entyvio is an α4β7integrin receptor antagonist indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.12 Subject: Entyvio Page: 1 of 7 Last Review Date: September 20, 2018 Entyvio Description Entyvio
More informationustekinumab (Stelara )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationdimethyl fumarate 30mg and 120mg gastro-resistant tablets (Skilarence ) SMC No 1313/18 Almirall Limited
dimethyl fumarate 30mg and 120mg gastro-resistant tablets (Skilarence ) SMC No 1313/18 Almirall Limited 9 March 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationHorizon Scanning Centre May Brodalumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 5524
Horizon Scanning Centre May 2014 Brodalumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 5524 This briefing is based on information available at the time of research and a limited literature
More informationIxekizumab (plaque psoriasis)
IQWiG Reports Commission No. A17-07 Ixekizumab (plaque psoriasis) Benefit assessment according to 35a Social Code Book V 1 Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Ixekizumab
More informationCertolizumab pegol (Cimzia) for chronic plaque psoriasis in adults
NIHR Innovation Observatory Evidence Briefing: April 2017 Certolizumab pegol (Cimzia) for chronic plaque psoriasis in adults NIHRIO (HSRIC) ID: 2406 NICE ID: 9112 LAY SUMMARY Plaque psoriasis is the most
More informationUstekinumab for the treatment of moderate to severe psoriasis
DOI: 10.3310/hta13suppl3/10 Health Technology Assessment 2009; Vol. 13: Suppl. 3 Ustekinumab for the treatment of moderate to severe psoriasis E Gospodarevskaya, J Picot, K Cooper, E Loveman* and A Takeda
More information2017 Blue Cross and Blue Shield of Louisiana
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationCriteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or
Supplementary Material Table S1 Eligibility criteria (PICOS) for the SLR Criteria Inclusion criteria Exclusion criteria Population Adults (aged 18 years) with active PsA despite treatment with csdmards,
More informationStelara. Stelara (ustekinumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.04 Subject: Stelara Page: 1 of 6 Last Review Date: December 8, 2017 Stelara Description Stelara (ustekinumab)
More informationDrug Name (specify drug) Quantity Frequency Strength
Prior Authorization Form GEHA FEDERAL - STANDARD OPTION Autoimmune Conditions (FA-PA) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign
More informationRegulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Orencia Page: 1 of 9 Last Review Date: September 20, 2018 Orencia Description Orencia (abatacept)
More informationSiliq. Siliq (brodalumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.28 Subject: Siliq Page: 1 of 5 Last Review Date: December 8, 2017 Siliq Description Siliq (brodalumab)
More informationPsoriasis. Dr. Pablo de la Cueva Hospital Universitario Infanta Leonor Madrid
Psoriasis Dr. Pablo de la Cueva Hospital Universitario Infanta Leonor Madrid PSORIASIS Psoriasis News. Topical treatment Calcipotriene/Betamethasone Dipropionate (Cal/BD) foam: In the real-world, Cal/BD
More informationICER Public Meeting: Evaluating Emerging Therapies for Psoriasis and Endometriosis
ICER Public Meeting: Evaluating Emerging Therapies for Psoriasis and Endometriosis July 12, 2018 WIFI Network: Student Password: [Open network] Targeted Immunomodulators for Plaque Psoriasis: Effectiveness
More informationPATIENT CENTRIC MEASURES IN HTAs FOR AUTOIMMUNE DISEASES
PATIENT CENTRIC MEASURES IN HTAs FOR AUTOIMMUNE DISEASES Monday, November 12, 2018 Carlijn Hintzen, Rianne Ernst, Arun Chhikara, Cristina Ivanescu, Anke van Engen, Mary New Copyright 2018 IQVIA. All rights
More informationXeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 6 Last Review Date: March 16, 2018 Xeljanz Description Xeljanz, Xeljanz
More informationACTEMRA (tocilizumab)
Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 1. Active Polyarticular Juvenile Idiopathic Arthritis (PJIA) b. Patient has an intolerance or has experienced
More informationNHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 21 August 2018 at 14:30 in the Seminar Room, David Anderson Building PRESENT APOLOGIES APPROVED
NHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 21 August 2018 at 14:30 in the Seminar Room, David Anderson Building PRESENT APOLOGIES APPROVED Dr D Culligan (from item 8.4) Dr A MacDonald Ms A
More informationPsoriasis. and Biologic Treatments. Choose the best treatment to regain your quality of life. Edition 4
Psoriasis and Biologic Treatments Choose the best treatment to regain your quality of life. Edition 4 PSORIASIS, What is this disease? Psoriasis is a common disease, that affects up to 4% of the population.
More informationSubject: Guselkumab (Tremfya ) Injection
09-J2000-87 Original Effective Date: 09/15/17 Reviewed: 09/12/18 Revised: 01/01/19 Subject: Guselkumab (Tremfya ) Injection THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report November 2016 Drug Indication ustekinumab (Stelara) Injection The treatment of adult patients with active psoriatic arthritis alone or in combination with
More informationHorizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330
Horizon Scanning Centre November 2012 Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Secukinumab is a high-affinity fully human monoclonal antibody that antagonises
More informationapremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd.
apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd. 08 May 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1097-7 Program Prior Authorization/Notification Medication *Stelara (ustekinumab) *This program applies to the subcutaneous formulation
More informationCenter for Evidence-based Policy
P&T Committee Brief Targeted Immune Modulators: Comparative Drug Class Review Alison Little, MD Center for Evidence-based Policy Oregon Health & Science University 3455 SW US Veterans Hospital Road, SN-4N
More informationRegulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 9 Last Review Date: March 16, 2018 Simponi / Simponi
More informationCOSENTYX (secukinumab)
COSENTYX (secukinumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationTechnology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta368
Apremilast for treating moderate to severe ere plaque psoriasis Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta368 NICE 2015. All rights reserved. Contents 1 Guidance...
More informationSummary of Guidance on Health-Utility Measures by Selected Health Technology Assessment Agencies (Information Updated September 2017)
Summary of Guidance on Health-Utility Measures by Selected Health Technology Assessment Agencies (Information Updated September 2017) Country Agency Guidance Source Australia PBAC No specific utility instrument
More informationDrug Effectiveness Review Project Summary Report Biologics (Targeted Immune Modulators)
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationThis questionnaire was used both during the face-to-face interviews with the
Additional file 1: Primary research questionnaire This questionnaire was used both during the face-to-face interviews with the dermatologists and during the expert panel 1. During the last month, how many
More informationPublic observer slides
Public observer slides Lead team presentation Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease modifying antirheumatic drugs Multiple
More informationCost-effectiveness of apremilast (Otezla )
Cost-effectiveness of apremilast (Otezla ) alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis in adult patients who have had an
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Apremilast Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 Effective Date... 1/1/2018 Next
More informationUstekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)
Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research
More informationComparative Clinical Effectiveness of Treatment Options for Moderate-to-Severe Plaque Psoriasis
Comparative Clinical Effectiveness of Treatment Options for Moderate-to-Severe Plaque Psoriasis Research Protocol (Update) February 20, 2018 Institute for Clinical and Economic Review Institute for Clinical
More informationPsoriasis. and Biologic Treatments. Choose the best treatment to regain your quality of life.
Psoriasis and Biologic Treatments Choose the best treatment to regain your quality of life. PSORIASIS, What is this disease? Psoriasis is a common disease, that affects up to 4% of the population. It usually
More informationBritish Association of Dermatologists guidelines for biologic therapy for psoriasis 2017
British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017 IMPLEMENTATION TOOLKIT Table S1: SUMMARY OF LICENSED INDICATIONS AND POSOLOGY FOR BIOLOGIC THERAPY Table S2: DECISION
More informationPharmacy Accreditation
EASING THE PATIENT BURDEN OF PSORIASIS AND PSORIATIC ARTHRITIS: THE ROLE OF THE SPECIALTY PHARMACIST Claire Lee, PharmD, CSP, CPHQ Clinical Quality Improvement Supervisor Diplomat Flint, Michigan Pharmacy
More informationSecukinumab (plaque psoriasis)
IQWiG Reports Commission No. A17-08 Secukinumab (plaque psoriasis) Benefit assessment according to 35a Social Code Book V 1 (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the
More informationDERMATOLOGY. The Changing Landscape of Psoriasis Treatment ABSTRACT
WHITE PAPER PRESENTED BY PREMIER RESEARCH The Changing Landscape of Psoriasis Treatment ABSTRACT Over the past two decades, biologic therapies have revolutionized the treatment of psoriasis, with more
More informationTechnology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta455
Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people Technology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta455 NICE 2017. All rights
More informationSubject: Ixekizumab (Taltz ) Injection
09-J2000-62 Original Effective Date: 06/15/16 Reviewed: 09/12/18 Revised: 10/15/18 Subject: Ixekizumab (Taltz ) Injection THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION
More informationMedication Policy Manual. Topic: Otezla, apremilast Date of Origin: May 9, 2014
Medication Policy Manual Policy No: dru342 Topic: Otezla, apremilast Date of Origin: May 9, 2014 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1, 2015 IMPORTANT
More informationLIST OF FIGURES INTRODUCTION
SUPPLEMENT: 2017 INTRODUCTION This document is a supplement to the PMPRB publication Market Intelligence Report: Biologic Response Modifier Agents, 2015 1 produced under the NPDUIS initiative. The supplement
More informationBiologics and Psoriasis: The Beat Goes On
Biologics and Psoriasis: The Beat Goes On Mark Lebwohl, MD Waldman Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai Mark Lebwohl is
More informationWhen researchers discovered in 1979 that the immunosuppressant
The Evolving Landscape of Psoriasis Treatment April W. Armstrong, MD, MPH,* Kenneth B. Gordon, MD, M. Alan Menter, MD, and Jashin J. Wu, MD Abstract The process of discovering new drugs for plaque psoriasis
More informationcertolizumab pegol (Cimzia )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationCertolizumab pegol (Cimzia) for psoriatic arthritis second line
Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
More informationBioLingus GmbH BUY SIDE PORTFOLIO SELECTION. Strong Potential: Transforming the way medicines work. Investment Highlights
18 December 2017 Research Update Biotechnology Strong Potential: Transforming the way medicines work Alpha Deal Group considers BioLingus GmbH, as a unique opportunity to benefit from strong and growing
More informationJosephine Mauskopf Miny Samuel Doreen McBride Usha G. Mallya Steven R. Feldman
PharmacoEconomics (2014) 32:395 409 DOI 10.1007/s40273-014-0130-5 SYSTEMATIC REVIEW Treatment Sequencing After Failure of the First Biologic in Cost-Effectiveness Models of Psoriasis: A Systematic Review
More informationMedicare Part C Medical Coverage Policy
Step Therapy: Part B Medications Origination: December 19, 2018 Review Date: December 19, 2018 Next Review: December 2020 Medicare Part C Medical Coverage Policy DESCRIPTION OF PROCEDURE SERVICE Step Therapy
More informationIxekizumab for treating moderate to severe plaque psoriasis [ID904]
Thank you for agreeing to make a submission on your organisation s view of the technology and the way it should be used in the NHS. Healthcare professionals can provide a unique perspective on the technology
More information1 P a g e. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
LENGTH OF AUTHORIZATION: Initial: 3 months for Crohn s or Ulcerative Colitis; 1 year for all other indications. Renewal: 1 year dependent upon medical records supporting response to therapy and review
More informationPredicting the Response to Phototherapy for Psoriasis Patients
A*STAR-NHG-NTU Skin Research Grant Joint Workshop 17 October 2015 Predicting the Response to Phototherapy for Psoriasis Patients Is it possible? Dr Eugene Tan Consultant Dermatologist National Skin Centre
More informationBrodalumab for treating moderate to severe plaque psoriasis [ID878]
Brodalumab for treating moderate to severe plaque psoriasis [ID878] Thank you for agreeing to give us your organisation s views on this technology and its possible use in the NHS. You can provide a unique
More information1 x weekly 50 mg. Consumption:
Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in
More informationBreakthrough Drugs in Dermatology. Mark Lebwohl, MD
Breakthrough Drugs in Dermatology Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai LIFE CHANGING
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 13 May 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 13 May 2009 STELARA 45 mg, solution for injection B/1 x 0.5 ml vial (CIP code: 392 586-2) JANSSEN-CILAG Ustekinumab
More information