Abatacept (Orencia) for active rheumatoid arthritis. August 2009

Size: px
Start display at page:

Download "Abatacept (Orencia) for active rheumatoid arthritis. August 2009"

Transcription

1 Abatacept (Orencia) for active rheumatoid arthritis August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The Research Programme is part of the National Institute for Health Research

2 Abatacept (Orencia) for active rheumatoid arthritis Target group Rheumatoid arthritis (RA): adults; active; inadequate response to DMARDs and/or a tumour necrosis factor (TNF) inhibitor. Technology description Abatacept (Orencia, CTLA4Ig, BMS ) is an immunosuppressant that selectively modulates the CD86 and CD28 co-stimulatory signal required for T-cell activation. Abatacept is administered intravenously (IV) 10mg/kg every 2 weeks for the first month and monthly thereafter. Abatacept is currently licensed in combination with methotrexate (MTX) for the treatment of moderate to severe active RA in adults who have had an insufficient response or intolerance to DMARDs, and at least one anti-tnf inhibitor. Abatacept is in phase III clinical trials for Crohn s disease, systemic scleroderma, and ulcerative colitis; phase II/III clinical trials for systemic lupus erythematosus and phase II clinical trials for psoriatic arthritis. Innovation and/or advantages Abatacept has a novel mechanism of action and will provide an alternative treatment option for patients with an inadequate response to traditional DMARDs and/or an anti- TNF inhibitor. Developer Bristol-Myers Squibb Pharmaceuticals Ltd. Availability, launch or marketing dates, and licensing plans: In phase III clinical trials. NHS or Government priority area This topic is relevant to the Musculoskeletal Services Framework (2006) and the National Services Framework for Older People (2001). Relevant guidance NICE technology appraisal in development. Tocilizumab for the treatment of rheumatoid arthritis. Expected date of issue October NICE technology appraisal in development. Certolizumab pegol for the treatment of rheumatoid arthritis. Expected date of issue February NICE technology appraisal in development. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis after failure of a previous TNF-α inhibitor. Expected date of issue to be confirmed 3. NICE technology appraisal. Abatacept for the treatment of rheumatoid arthritis (refractory) NICE technology appraisal. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis NICE technology appraisal. Rituximab for the treatment of rheumatoid arthritis (refractory)

3 NICE technology appraisal. The clinical effectiveness and cost effectiveness of etanercept and infliximab for rheumatoid arthritis and juvenile poly-articular idiopathic arthritis NICE clinical guideline. Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults The British Society of Rheumatology. Updated guideline for the management of Rheumatoid Arthritis (first 2 years) The British Society of Rheumatology. Updated guidelines for prescribing TNFα in adults with rheumatoid arthritis The British Society of Rheumatology. Guidelines on standards of care for persons with rheumatoid arthritis The British Society of Rheumatology. Guidelines for prescribing anakinra in adults with rheumatoid arthritis SIGN. Management of early rheumatoid arthritis Clinical need and burden of disease RA is the most common inflammatory polyarthropathy in the UK, affecting around 1% of the population (over 400,000 people in England and Wales), with the disease being severe in about 15% of patients 8. RA affects three times as many women as men and has a peak age of onset of years 8. The life expectancy of people with RA is reduced by 5-10 years compared with that of people without the condition, and 35-50% of this excess risk is accounted for by cardiovascular mortality 8. Existing comparators and treatments The clinical management of RA includes physical therapy, surgical interventions, and a range of pharmacological treatments including: Non-biologic therapies Corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). DMARDs, including MTX, sulphalazine, leflunomide and azathioprine. Usually administered within three months of diagnosis to stabilise joint function, either as monotherapies or in combination with biologic therapies. Biologic therapies Guidelines recommend the use of anti-tnf inhibitors such as etanercept, infliximab and adalimumab in combination with MTX. If MTX is unsuitable, adalimumab and etanercept may be administered as a monotherapy 5. Rituximab is also recommended in combination with MTX for patients with severe active RA who have failed one or more anti-tnf therapies 6. Efficacy and safety Trial 029 ATTAIN; abatacept vs placebo; phase III. 102 AIM; abatacept vs placebo; phase III. 102 AIM extension; abatacept vs placebo; phase III. Bristol-Myers Squibb Pharmaceuticals Ltd. Sponsor Bristol-Myers Squibb Pharmaceuticals Ltd. Bristol-Myers Squibb Pharmaceuticals Ltd. Status Published 14. Published 15. Published 16. Location EU and USA. EU (inc UK), USA and South America. EU (inc UK), USA and other countries. 3

4 Design Randomised, placebocontrolled. Randomised, controlled. Open label extension. Participants and schedule n=391; active RA; inadequate response to anti- TNF therapy with n=652; active RA with inadequate response to MTX. Randomised to abatacept Continued with allocated therapy on a monthly basis. etanercept or infliximab or both. Randomised to abatacept 10mg/kg or placebo, on days 1, 15, and 29 and every 28 days thereafter up to and including day 141, in addition to at least one DMARD. 10mg/kg body weight oncemonthly infusion, or placebo. Follow-up 6 months. 1 year. 2 years. Primary outcomes ACR a 20, 50, and 70; HAQDI b. 6-month and 1 year ACR20, 50, and 70; clinically meaningful improvements in Progression of structural damage; mtss. Key results Adverse effects (AEs) At 6 months, abatacept all groups vs placebo respectively: ACR % vs 19.5% ACR % vs 3.8% ACR % vs 1.5% (p=0.003). HAQDI 47.3% vs 23.3% (p<0.001). AEs and peri-infusional AEs - abatacept: 79.5% and 5.0%; placebo group: 71.4% and 3.0%. Serious infections 2.3% in each group. physical function; mtss c. For abatacept vs placebo respectively: 6-months ACR % vs 39.7% ACR % vs 16.8% ACR % vs 6.5% (p<0.001). 1 year ACR % vs 39.7% ACR % vs 18.2% ACR % vs 6.1% (p<0.001). No progression, 56% vs 45%. Physical function improved, 63.7% vs 39.3% (p<0.001). Abatacept vs placebo: AEs 87.3% vs 84.0%; prespecified serious infections 2.5% vs 0.9%; acute infusion reactions, 8.8% vs 4.1% and peri-infusional, 24.5% vs Mean change in mtss scores 1.07 units in year 1 to 0.46 units in year 2. Year 2 66% had no progression with abatacept vs 56% on placebo. - a ACR: the American College of Rheumatology criteria comprise a core set of six outcome variables for the assessment of clinically important improvement: physical global assessment of disease activity; patient/parent global assessment of overall well-being; functional ability; number of joints with active arthritis; number of joints with limited range of motion; erythrocyte sedimentation rate. ACR20, ACR50, and ACR70 represent a 20%, 50%, and 70% improvement in at least three response criteria (and with no more than one response variable worse by greater than 30%). b Health Assessment Questionnaire Disability Index (HAQDI). c Modified Total Sharp Score (mtss) is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. 4

5 16.9%. Trial 064 ARRIVE; abatacept wash out vs direct switch from anti-tnf; phase III. 043 ATTEST, NCT ; abatacept or infliximab vs placebo; phase III. Sponsor Bristol-Myers Squibb Pharmaceuticals Bristol-Myers Squibb Pharmaceuticals Ltd. Ltd. Status Published 17. Published 18. Location EU (inc UK) and USA. USA and other countries. Design Open label. Randomised, double-blind, placebo-controlled. Participants and schedule n=1,046; active RA; inadequate response to anti-tnfs. 'Washout' patients (n=449) discontinued anti-tnf therapy (2 months before first abatacept dose); 'direct-switch' patients (n=597) began abatacept 10mg/kg at their next scheduled anti-tnf therapy administration. Follow-up 6 months. 1 year. Primary outcomes Key results Adverse effects (AEs) Clinically meaningful improvements in physical function; Mean change from baseline in DAS28 d (CRP e ); LDAS f ; PCS g and MCS h ; safety. At 6 months, washout vs direct-switch patients respectively: similar clinically meaningful improvements in DAS28 (CRP), 59.5% vs 53.6%; LDAS, 22.5% vs 22.3%; DAS28-defined remission,12.0% vs 13.7%; Physical function improvement, 46.3% vs 47.1%; Health-related QoL, PCS 5.5 vs 6.1, and MCS, 4.8 vs 5.4. At 6 months washout vs direct-switch patients: AEs 78.0% vs 79.2%, serious AEs (SAEs) 11.1% vs 9.9%. Discontinuations due to AEs 3.8% vs 4.0% and SAEs 2.0% vs 1.3%. n=431; active RA; inadequate response to MTX. Randomised to abatacept 10 mg/kg every 4 weeks or infliximab 3mg/kg every 8 weeks or placebo, in addition to MTX. DAS28 (ESR) i ; ACR 20, 50 and 70; LDAS; EULAR j responses; HAQDI; PCS and MCS; and safety. At 6 months, abatacept, infliximab and placebo respectively (p values vs placebo): mean change in DAS28 (ESR) 2.53 (p<0.001), 2.25 (p<0.001) and Abatacept and infliximab, respectively at 1 year: DAS28 (ESR) 2.88 vs 2.25; ACR % vs 55.8%; ACR % vs 36.4%; ACR % vs 20.6%; LDAS, 35.3% vs 22.4%; DAS28-defined remission 18.7% vs 12.2%; EULAR responses 32.0% vs 18.5%; HAQ-DI, 57.7% vs 52.7%; Mean changes in PCS, 9.5 vs 7.6, and MCS, 6.0 vs 4.0. For abatacept vs infliximab AEs 89.1% vs 93.3%, SAEs 9.6% vs 18.2%, serious infections 1.9% vs 8.5%. Discontinuations due to AEs 3.2% vs 7.3% and SAEs 2.6% vs 3.6%. d Disease Activity Score (DAS) 28-joint assessment for swelling and tenderness. e DAS28 based on C-reactive protein (CRP) for assessment of disease progression in patients with RA. f Low disease activity score (LDAS). g Physical component summary (PCS). h Mental component summary (MCS). i DAS28 based on erythrocyte sedimentation rates (ESR) for assessment of disease progression in patients with RA. j EULAR: the European League Against Rheumatism (EULAR) response criteria are based on the assessment of disease activity using the DAS, a statistically-derived index consisting of number of tender joints, number of swollen joints, erythrocyte sedimentation rate, and global disease activity. The EULAR response criteria include not only change in disease activity but also current disease activity. To be classified as responders, patients should have a significant change in DAS and also low current disease activity. Three categories are defined: good, moderate, and non-responders. 5

6 Estimated cost and cost impact For a patient weighing kg the average maintenance doses of abatacept for the first year of treatment and for subsequent years are 10,898 and 9,445 respectively (cost estimate from the company). The costs of other licensed biologic treatments are: Drug Dose Annual cost 19 Adalimumab 40mg pre-filled syringe; alternate weeks. 9,295 Etanercept 25mg vial; twice weekly. 9,295 Infliximab 3mg/kg IV infusion at weeks 0, 2, and 6; 8 weekly 6,713 k thereafter. Potential or intended impact speculative Patients Reduced morbidity Quicker, earlier or more accurate diagnosis or identification of disease Reduced mortality or increased length of survival Other: Improved quality of life for patients and/or carers None identified Services Increased use Service reorganisation required Staff or training required Decreased use Other: None identified Costs Increased unit cost compared to alternative New costs: given to a wider patient group References Increased costs: more patients coming for treatment Savings: Increased costs: capital investment needed Other: 1 National Institute for Health and Clinical Excellence. Tocilizumab for the treatment of rheumatoid arthritis. Technology appraisal in development. Expected date of issue October National Institute for Health and Clinical Excellence. Certolizumab pegol for the treatment of rheumatoid arthritis. Technology appraisal in development. Expected date of issue February National Institute for Health and Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis. Technology appraisal in development. Expected date of issue to be confirmed. 4 National Institute for Health and Clinical Excellence. Abatacept for the treatment of rheumatoid arthritis (refractory). Technology appraisal TA141. London: NICE; April National Institute for Health and Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis. Technology appraisal TA130. London: NICE; October National Institute for Health and Clinical Excellence. Rituximab for the treatment of rheumatoid arthritis (refractory). Technology appraisal TA126. London: NICE; August National Institute for Health and Clinical Excellence. The clinical effectiveness and cost effectiveness of etanercept and infliximab for rheumatoid arthritis and juvenile poly-articular idiopathic arthritis. Technology appraisal TA36 (partially replaced by TA130). London: NICE; March National Institute for Health and Clinical Excellence. Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults. Clinical guideline CG79. London: NICE; February The British Society of Rheumatology (BSR) updated guideline for the management of rheumatoid arthritis (first 2 years). July The British Society of Rheumatology (BSR) updated guidelines for prescribing TNFα in adults with rheumatoid arthritis. July k Costing based on average weight 67.5kg (men and women) and average surface area 1.7m 2 6

7 11 The British Society of Rheumatology (BSR) guidelines on standards of care for persons with rheumatoid arthritis. July The British Society of Rheumatology (BSR) guidelines for prescribing anakinra in adults with rheumatoid arthritis. October Scottish Intercollegiate Guidelines Network (SIGN). Management of early rheumatoid arthritis. Publication 48. Edinburgh: SIGN December Genovese MC, Becker JC, Schiff M et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. New England Journal of Medicine. 2005;353: Kremer JM, Genant HK, Moreland LW, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of International Medicine. 2006;144: Genant HK, Peterfy CG and Westhovens R. Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial. Annals of the Rheumatic Diseases. 2008;67; Schiff MH, H Pritchard C, Huffstutter JE et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tnf therapy or were directly switched to abatacept: the ARRIVE trial. Annals of the Rheumatic Diseases Dec 15 (Epub). 18 Schiff MH, Keiserman M, Codding C et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Annals of the Rheumatic Diseases. 2008;67: British Medical Association, British National Formulary 57. London: BMA; March The National Institute for Health Research Research Programme is funded by the Department of Health. The views expressed in this publication are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health The, Department of Public Health and Epidemiology University of Birmingham, Edgbaston, Birmingham, B15 2TT, England Tel: +44 (0) Fax +44 (0)

Certolizumab pegol (Cimzia) for psoriatic arthritis second line

Certolizumab 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 information

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Abatacept (Orencia) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Ustekinumab (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) 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 information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium abatacept, 250mg powder for concentrate for solution (Orencia ) No. (400/07) Bristol Myers Squibb Pharmaceuticals Ltd 10 August 2007 The Scottish Medicines Consortium has

More information

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Adalimumab (Humira) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Horizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330

Horizon 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 information

Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line

Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line August 2011 This technology summary is based on information available at the time of research and a limited

More information

NIHR Innovation Observatory Evidence Briefing: November 2017

NIHR Innovation Observatory Evidence Briefing: November 2017 NIHR Innovation Observatory Evidence Briefing: November 2017 Upadacitinib for adults with moderate to severe active rheumatoid arthritis after conventional synthetic disease-modifying anti-rheumatic drugs

More information

Horizon Scanning Centre January Apremilast for psoriatic arthritis SUMMARY NIHR HSC ID: 3716

Horizon Scanning Centre January Apremilast for psoriatic arthritis SUMMARY NIHR HSC ID: 3716 Horizon Scanning Centre January 2013 Apremilast for psoriatic arthritis SUMMARY NIHR HSC ID: 3716 This briefing is based on information available at the time of research and a limited literature search.

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: abatacept_orencia 4/2008 2/2018 2/2019 2/2018 Description of Procedure or Service Abatacept (Orencia ), a

More information

RHEUMATOID ARTHRITIS DRUGS

RHEUMATOID ARTHRITIS DRUGS Rheumatology Biologics Criteria from the Exceptional Access Program RHEUMATOID ARTHRITIS DRUGS DRUG NAME BRS REIMBURSED DOSAGE FORM/ STRENGTH Adalimumab Humira 40 mg/0.8 syringe and 40mg/0.8 pen for Anakinra

More information

Abatacept: first T cell co-stimulation modulator for severe active RA

Abatacept: first T cell co-stimulation modulator for severe active RA Abatacept: first T cell co-stimulation modulator for severe active RA Steve Chaplin MSc, MRPharmS and Andrew Ostor FRACP PRODUCT PROFILE Proprietary name: Orencia Constituents: abatacept Dosage and method

More information

Horizon Scanning Research & Intelligence Centre. Baricitinib for moderate to severe rheumatoid arthritis. May 2015 SUMMARY NIHR HSRIC ID: 5270

Horizon Scanning Research & Intelligence Centre. Baricitinib for moderate to severe rheumatoid arthritis. May 2015 SUMMARY NIHR HSRIC ID: 5270 May 2015 Horizon Scanning Research & Intelligence Centre Baricitinib for moderate to severe rheumatoid arthritis SUMMARY NIHR HSRIC ID: 5270 This briefing is based on information available at the time

More information

Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195

Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195 Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195

More information

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis New Evidence reports on presentations given at EULAR 2012 Tocilizumab for the Treatment of Rheumatoid Arthritis Report on EULAR 2012 presentations Tocilizumab monotherapy is superior to adalimumab monotherapy

More information

Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480

Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480 Tofacitinib for moderate to severeere rheumatoid arthritis Technology appraisal guidance Published: 11 October 2017 nice.org.uk/guidance/ta480 NICE 2018. All rights reserved. Subject to Notice of rights

More information

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375 Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed Technology

More information

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008 Saxagliptin (BMS 477118) for type 2 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement

More information

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes May 2011 This technology summary is based on information available at the time of research and a limited literature search. It

More information

Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis New Evidence reports on presentations given at EULAR 2010 Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2010 presentations

More information

National Horizon Scanning Centre. Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer

National Horizon Scanning Centre. Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer Erlotinib (Tarceva) in combination with bevacizumab for advanced or metastatic non-small cell lung cancer This technology summary is based on information available at the time of research and a limited

More information

ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira ( adalimumab

ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira ( adalimumab ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents ORENCIA demonstrated comparable

More information

National Horizon Scanning Centre. Irbesartan (Aprovel) for heart failure with preserved systolic function. August 2008

National Horizon Scanning Centre. Irbesartan (Aprovel) for heart failure with preserved systolic function. August 2008 Irbesartan (Aprovel) for heart failure with preserved systolic function August 2008 This technology summary is based on information available at the time of research and a limited literature search. It

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION TOFACITINIB (Xeljanz Pfizer Canada Inc.) Indication: Rheumatoid Arthritis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that tofacitinib be listed, in combination

More information

Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy

Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy September 2008 This technology summary is based on information available at the time of research and a

More information

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel April 2009 This technology summary is based on information available at the time of research and a

More information

infliximab, 100mg, powder for concentrate for solution for infusion (Inflectra ) SMC No. (1007/14) Hospira UK Ltd.

infliximab, 100mg, powder for concentrate for solution for infusion (Inflectra ) SMC No. (1007/14) Hospira UK Ltd. infliximab, 100mg, powder for concentrate for solution for infusion (Inflectra ) SMC No. (1007/14) Hospira UK Ltd. 07 November 2014 (Issued 06 March 2015) The Scottish Medicines Consortium (SMC) has completed

More information

Rilonacept for cryopyrin associated periodic syndromes

Rilonacept for cryopyrin associated periodic syndromes Rilonacept for cryopyrin associated periodic syndromes August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007 Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer December 2007 This technology summary is based on information available at the time of research and a limited literature

More information

Orencia (abatacept) for Rheumatoid Arthritis. Media backgrounder

Orencia (abatacept) for Rheumatoid Arthritis. Media backgrounder Orencia (abatacept) for Rheumatoid Arthritis Media backgrounder What is Orencia (abatacept)? Orencia (abatacept) is the first biologic agent to be available in both an intravenous (IV) and a self-injectable,

More information

National Horizon Scanning Centre. Rituximab (MabThera) for chronic lymphocytic leukaemia. September 2007

National Horizon Scanning Centre. Rituximab (MabThera) for chronic lymphocytic leukaemia. September 2007 Rituximab (MabThera) for chronic lymphocytic leukaemia This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

National Horizon Scanning Centre. Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment

National Horizon Scanning Centre. Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment Ipilimumab (MDX-010) for unresectable stage III or IV metastatic melanoma - first or second line treatment April 2008 This technology summary is based on information available at the time of research and

More information

1 Executive summary. Background

1 Executive summary. Background 1 Executive summary Background Rheumatoid Arthritis (RA) is the most common inflammatory polyarthropathy in the UK affecting between.5% and 1% of the population. The mainstay of RA treatment interventions

More information

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis New Evidence reports on presentations given at EULAR 2011 Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2011 presentations Benefit of continuing

More information

Center for Evidence-based Policy

Center 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 information

Pharmacy Medical Necessity Guidelines: Orencia (abatacept)

Pharmacy Medical Necessity Guidelines: Orencia (abatacept) Pharmacy Medical Necessity Guidelines: Effective: October 23, 2017 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review SQ: RXUM/ RX / Pharmacy (RX) or

More information

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy Eribulin for locally advanced or metastatic breast cancer third line; monotherapy April 2009 This technology summary is based on information available at the time of research and a limited literature search.

More information

BRIEFING DOCUMENT. human, recombinant fusion protein: extracellular domain of CTLA-4 and Fc domain of human IgG1

BRIEFING DOCUMENT. human, recombinant fusion protein: extracellular domain of CTLA-4 and Fc domain of human IgG1 BRIEFING DOCUMENT Application Type BLA Submission Number 125118/0 Reviewer Name Team Leader Division Director Established Name (Proposed) Trade Name Applicant Formulation Dosing Regimen Indication Intended

More information

Annual Rheumatology & Therapeutics Review for Organizations & Societies

Annual Rheumatology & Therapeutics Review for Organizations & Societies Annual Rheumatology & Therapeutics Review for Organizations & Societies Comparative Effectiveness Studies of Biologics Learning Objectives Understand the motivation for comparative effectiveness research

More information

Orencia (abatacept) DRUG.00040

Orencia (abatacept) DRUG.00040 Market DC Orencia (abatacept) DRUG.00040 Override(s) Prior Authorization Quantity Limit Approval Duration 1 year Medications Comments Quantity Limit Orencia (abatacept) - AGP, VA MCD only 4 vials per 28

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single Technology Appraisal (STA)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single Technology Appraisal (STA) Abatacept for the treatment of rheumatoid arthritis only after the failure of conventional disease-modifying anti-rheumatic drugs Thank you for agreeing to give us a statement on your organisation's view

More information

National Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy

National Horizon Scanning Centre. Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy Bevacizumab (Avastin) in combination with non-taxanes for metastatic breast cancer - first line therapy December 2007 This technology summary is based on information available at the time of research and

More information

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma September 2008 This technology summary is based on information available at the time of research and a limited literature

More information

B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma

B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma B-cell lymphoma vaccine (BiovaxID) for follicular non-hodgkin s lymphoma May 2010 This technology summary is based on information available at the time of research and a limited literature search. It is

More information

National Horizon Scanning Centre. Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation

National Horizon Scanning Centre. Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation Irbesartan (Aprovel) for prevention of cardiovascular complications in patients with persistent atrial fibrillation August 2008 This technology summary is based on information available at the time of

More information

New Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate

New Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits

More information

National Horizon Scanning Centre. GV1001 for advanced and/or metastatic pancreatic cancer. April 2008

National Horizon Scanning Centre. GV1001 for advanced and/or metastatic pancreatic cancer. April 2008 GV1001 for advanced and/or metastatic pancreatic cancer April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

M Schiff, 1 C Pritchard, 2 J E Huffstutter, 3 V Rodriguez-Valverde, 4 P Durez, 5 X Zhou, 6 T Li, 6 K Bahrt, 6 S Kelly, 6 M Le Bars, 7 M C Genovese 8

M Schiff, 1 C Pritchard, 2 J E Huffstutter, 3 V Rodriguez-Valverde, 4 P Durez, 5 X Zhou, 6 T Li, 6 K Bahrt, 6 S Kelly, 6 M Le Bars, 7 M C Genovese 8 The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial

More information

M Schiff, 1 C Pritchard, 2 J E Huffstutter, 3 V Rodriguez-Valverde, 4 P Durez, 5 X Zhou, 6 T Li, 6 K Bahrt, 6 S Kelly, 6 M Le Bars, 7 M C Genovese 8

M Schiff, 1 C Pritchard, 2 J E Huffstutter, 3 V Rodriguez-Valverde, 4 P Durez, 5 X Zhou, 6 T Li, 6 K Bahrt, 6 S Kelly, 6 M Le Bars, 7 M C Genovese 8 1 University of Colorado, Denver, Colorado, USA; 2 Rheumatology Specialty Center, Willow Grove, Pennsylvania, USA; 3 Arthritis Associates, Hixson, Tennessee, USA; 4 Hospital Universitario Marques De Valdecilla,

More information

The Hospital for Sick Children Technology Assessment at SickKids (TASK)

The Hospital for Sick Children Technology Assessment at SickKids (TASK) The Hospital for Sick Children Technology Assessment at SickKids (TASK) THE USE OF BIOLOGIC RESPONSE MODIFIERS IN POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Report No. 2010-01 Date: January 11,

More information

National Horizon Scanning Centre. Pregabalin (Lyrica) for fibromyalgia. September 2007

National Horizon Scanning Centre. Pregabalin (Lyrica) for fibromyalgia. September 2007 Pregabalin (Lyrica) for fibromyalgia September 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

National Institute for Health and Clinical Excellence SCOPE. Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults

National Institute for Health and Clinical Excellence SCOPE. Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults National Institute for Health and Clinical Excellence 1 Guideline title SCOPE Rheumatoid arthritis: the management and treatment of rheumatoid arthritis in adults 1.1 Short title Rheumatoid arthritis 2

More information

Lacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011

Lacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011 Lacosamide (Vimpat) for partial-onset epilepsy monotherapy This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a

More information

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine

More information

National Horizon Scanning Centre. Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory. January 2008

National Horizon Scanning Centre. Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory. January 2008 Temsirolimus (Torisel) for mantle cell lymphoma - relapsed and/or refractory January 2008 This technology summary is based on information available at the time of research and a limited literature search.

More information

apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd.

apremilast 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 information

Roflumilast (Daxas) for chronic obstructive pulmonary disease

Roflumilast (Daxas) for chronic obstructive pulmonary disease Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

certolizumab pegol (Cimzia )

certolizumab 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 information

Research Article. Efficacy and safety of abatacept therapy for rheumatoid arthritis in routine clinical practice

Research Article. Efficacy and safety of abatacept therapy for rheumatoid arthritis in routine clinical practice Research Article Efficacy and safety of abatacept therapy for rheumatoid arthritis in routine clinical practice Aim: To evaluate treatment of rheumatoid arthritis with abatacept in the real-life clinic

More information

Coverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication

Coverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Kineret (anakinra subcutaneous injection) Commercial HMO/PPO/CDHP

More information

Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373

Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 NICE 2017. All rights reserved.

More information

James R. O Dell, M.D. University of Nebraska Medical Center

James R. O Dell, M.D. University of Nebraska Medical Center Not everyone in the world needs a biologic: Lessons from TEAR and RACAT James R. O Dell, M.D. University of Nebraska Medical Center Disclosure Declaration James O Dell, MD Advisory Board for Crescendo,

More information

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta466

Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta466 Baricitinib for moderate to severeere rheumatoid arthritis Technology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta466 NICE 2017. All rights reserved. Subject to Notice of rights

More information

Certolizumab pegol (Cimzia) for chronic plaque psoriasis in adults

Certolizumab 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 information

Concise report. Additional supplementary data are published online only. To view these fi les please visit the journal online ( bmj.

Concise report. Additional supplementary data are published online only. To view these fi les please visit the journal online (  bmj. Additional supplementary data are published online only. To view these fi les please visit the journal online (http://ard. bmj.com) 1 Department of Rheumatology, University of Colorado School of Medicine,

More information

10 Musculoskeletal and Joint Diseases

10 Musculoskeletal and Joint Diseases 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 information

Report on New Patented Drugs - Orencia

Report on New Patented Drugs - Orencia Report on New Patented Drugs - Orencia Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the Board s Excessive

More information

Apixaban for stroke prevention in atrial fibrillation. August 2010

Apixaban for stroke prevention in atrial fibrillation. August 2010 Apixaban for stroke prevention in atrial fibrillation August 2010 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory 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 information

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) DERBYSHIRE JOINT AREA PRERIBING COMMITTEE (JAPC) Derbyshire commissioning guidance on biologic drugs f the treatment of Rheumatoid arthritis with methotrexate This algithm is a tool to aid the implementation

More information

CADTH Therapeutic Review Panel

CADTH Therapeutic Review Panel Therapeutic Review Panel Final Recommendations Biological Response Modifier Agents for Adults with Rheumatoid Arthritis July 2010 RECOMMENDATIONS The Therapeutic Review Panel (TRP) recommends that in adult

More information

National Horizon Scanning Centre. Ampligen for chronic fatigue syndrome. December 2007

National Horizon Scanning Centre. Ampligen for chronic fatigue syndrome. December 2007 Ampligen for chronic fatigue syndrome December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive

More information

Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children

Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children Insulin glulisine (Apidra) for type 1 diabetes mellitus in adolescents and children December 2008 This technology summary is based on information available at the time of research and a limited literature

More information

Infliximab (Remicade) for paediatric ulcerative colitis - second line

Infliximab (Remicade) for paediatric ulcerative colitis - second line Infliximab (Remicade) for paediatric ulcerative colitis - second line September 2011 This technology summary is based on information available at the time of research and a limited literature search. It

More information

TRANSPARENCY COMMITTEE OPINION. 26 April 2006

TRANSPARENCY COMMITTEE OPINION. 26 April 2006 TRANSPARENCY COMMITTEE OPINION 26 April 2006 REMICADE 100 mg powder for concentrate for solution for infusion Box of 1 (CIP code: 562 070.1) Applicant : laboratoires Schering Plough List I Drug for hospital

More information

Technology appraisal guidance Published: 22 February 2012 nice.org.uk/guidance/ta247

Technology appraisal guidance Published: 22 February 2012 nice.org.uk/guidance/ta247 Tocilizumab for the treatment of rheumatoid arthritis Technology appraisal guidance Published: 22 February 2012 nice.org.uk/guidance/ta247 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

PRODUCT INFORMATION. ORENCIA (abatacept) (LYOPHILIZED POWDER FOR IV INFUSION) (SOLUTION FOR SUBCUTANEOUS ADMINISTRATION)

PRODUCT INFORMATION. ORENCIA (abatacept) (LYOPHILIZED POWDER FOR IV INFUSION) (SOLUTION FOR SUBCUTANEOUS ADMINISTRATION) PRODUCT INFORMATION ORENCIA (abatacept) (LYOPHILIZED POWDER FOR IV INFUSION) (SOLUTION FOR SUBCUTANEOUS ADMINISTRATION) NAME OF THE MEDICINE ORENCIA (abatacept (rch)) ORENCIA (abatacept (rch)). Abatacept

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Health Technology Appraisal Secukinumab for treating ankylosing spondylitis after inadequate response to non-steroidal anti-inflammatory drugs

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: golimumab_simponi 8/2013 2/2018 2/2019 3/2018 Description of Procedure or Service Golimumab (Simponi and

More information

Clinical Policy: Certolizumab (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid

Clinical Policy: Certolizumab (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Clinical Policy: (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Coding Implications Revision Log Description (Cimzia ) is a tumor necrosis

More information

New Evidence reports on presentations given at ACR Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab

New Evidence reports on presentations given at ACR Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab New Evidence reports on presentations given at ACR 2009 Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab From ACR 2009: Rituximab Rituximab in combination with methotrexate

More information

National Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007

National Horizon Scanning Centre. Sunitinib (Sutent) for advanced and/or metastatic breast cancer. December 2007 Sunitinib (Sutent) for advanced and/or metastatic breast cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

Technology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340

Technology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340 Ustekinumab for treating active psoriatic arthritis Technology appraisal guidance Published: 4 June 2015 nice.org.uk/guidance/ta340 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

National Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007

National Horizon Scanning Centre. Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer. December 2007 Vandetanib (Zactima) for locally advanced or metastatic medullary thyroid cancer December 2007 This technology summary is based on information available at the time of research and a limited literature

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium infliximab 100mg powder for intravenous infusion (Remicade ) No. (364/07) Schering-Plough UK Ltd 6 April 2007 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

Horizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007

Horizon Scanning Technology Summary. Liraglutide for type 2 diabetes. National Horizon Scanning Centre. April 2007 Horizon Scanning Technology Summary National Horizon Scanning Centre Liraglutide for type 2 diabetes April 2007 This technology summary is based on information available at the time of research and a limited

More information

National Horizon Scanning Centre. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids.

National Horizon Scanning Centre. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids. Mepolizumab (Bosatria) for hypereosinophilic syndrome first line in combination with corticosteroids May 2008 This technology summary is based on information available at the time of research and a limited

More information

National Horizon Scanning Centre. Decitabine (Dacogen) for myelodysplastic syndrome. April 2008

National Horizon Scanning Centre. Decitabine (Dacogen) for myelodysplastic syndrome. April 2008 Decitabine (Dacogen) for myelodysplastic syndrome April 2008 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be

More information

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012

Cilengitide (Impetreve) for glioblastoma multiforme. February 2012 Cilengitide (Impetreve) for glioblastoma multiforme February 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Medication Policy Manual. Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013

Medication Policy Manual. Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013 Medication Policy Manual Policy No: dru289 Topic: Xeljanz, tofacitinib Date of Origin: January 21, 2013 Committee Approval Date: January 19, 2015 Next Review Date: January 2016 Effective Date: April 1,

More information

National Horizon Scanning Centre. Dronedarone (Multaq) for atrial fibrillation and atrial flutter. December 2007

National Horizon Scanning Centre. Dronedarone (Multaq) for atrial fibrillation and atrial flutter. December 2007 Dronedarone (Multaq) for atrial fibrillation and atrial flutter December 2007 This technology summary is based on information available at the time of research and a limited literature search. It is not

More information

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid

More information

London, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8

London, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8 London, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8 1. Introduction Infliximab is a chimeric human-murine IgG1κ monoclonal antibody, which binds

More information

Scottish Medicines Consortium

Scottish 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 information

National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008

National Horizon Scanning Centre. Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class III. April 2008 Oral and inhaled treprostinil for pulmonary arterial hypertension: NYHA class April 2008 This technology summary is based on information available at the time of research and a limited literature search.

More information

Psoriatic Arthritis- Second Line Treatments

Psoriatic 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 information

Technology appraisal guidance Published: 14 December 2011 nice.org.uk/guidance/ta238

Technology appraisal guidance Published: 14 December 2011 nice.org.uk/guidance/ta238 Tocilizumab for the treatment of systemic juvenile idiopathic arthritis Technology appraisal guidance Published: 14 December 2011 nice.org.uk/guidance/ta238 NICE 2018. All rights reserved. Subject to Notice

More information

Extended report. Colorado, USA; 2 Pontificial Catholic University, School of Medicine, Porto Alegre, Brazil; Oklahoma City, Oklahoma, USA;

Extended report. Colorado, USA; 2 Pontificial Catholic University, School of Medicine, Porto Alegre, Brazil; Oklahoma City, Oklahoma, USA; Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate

More information