Horizon Scanning Centre January Apremilast for psoriasis SUMMARY NIHR HSC ID: 2652
|
|
- Lorena Wilson
- 5 years ago
- Views:
Transcription
1 Horizon Scanning Centre January 2013 Apremilast for psoriasis SUMMARY NIHR HSC ID: 2652 This briefing 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 or commissioning without additional information. Apremilast is intended to be used as therapy for the treatment of moderateto-severe psoriasis in adults who have had an inadequate response, a contraindication, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen with UVA treatment. If licensed, it will provide an additional treatment option for this patient group. Apremilast is a small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE- 4). The prevalence of psoriasis in England is estimated to be around 1.63% (644,000), of whom approximately 20% (129,000) have moderate to severe disease. Plaque psoriasis is the most common form, affecting 80-90% of people with the disease. The visible nature of psoriasis can create a sense of stigmatisation amongst those affected and the negative impact on healthrelated quality of life is comparable to that of ischaemic heart disease, diabetes, depression and cancer. Psoriasis is associated with considerable morbidity and an increased incidence of metabolic syndrome, heart disease, Crohn s disease, lymphoma, obesity and type 2 diabetes. Current treatment options include topical treatments, phototherapy, systemic therapies (for severe or refractory disease) and biologics (for patients intolerant, contraindicated or refractory to other treatments). Apremilast is currently in phase III clinical trials comparing its effect on psoriasis severity against treatment with etanercept and placebo. These trials are expected to report in This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Centre, University of Birmingham nihrhsc@contacts.bham.ac.uk Web:
2 TARGET GROUP Psoriasis: moderate to severe - in adults who have had an inadequate response, or a contraindication, or are intolerant to other systemic therapies, including ciclosporin, methotrexate and psoralen with UVA treatment (PUVA). TECHNOLOGY DESCRIPTION Apremilast (CC-10004) is a small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4) that subsequently down-regulates the production of multiple pro-inflammatory mediators including interleukin-2 (IL02), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and nitric oxide synthase (NOS). In clinical trials, apremilast was administered orally at 30mg twice daily 1. Apremilast is in phase III clinical trials for ankylosing spondylitis and psoriatic arthritis, and in phase II trials for Behcet s syndrome. INNOVATION and/or ADVANTAGES If licensed, apremilast will provide an additional treatment option for this patient group. DEVELOPER Celgene. AVAILABILITY, LAUNCH OR MARKETING In phase III clinical trials. PATIENT GROUP BACKGROUND Psoriasis is defined as a chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations 2. It typically follows a relapsing and remitting course 3 and is characterised by thickened, red, scaly skin lesions in the form of patches, papules, or plaques which arise due to 4 : Hyperproliferation of the epidermis. Dilation and proliferation of blood vessels in the dermis. Accumulation of inflammatory cells, particularly neutrophils and T-lymphocytes. The visible nature of psoriasis can create a sense of stigmatisation amongst those affected and the negative impact on health-related quality of life is comparable to that of ischaemic heart disease, diabetes, depression and cancer 5. 2
3 NHS or GOVERNMENT PRIORITY AREA This topic is relevant to The National Service Framework for Long-term Conditions (2005). CLINICAL NEED and BURDEN OF DISEASE The estimated prevalence of psoriasis in England is around 1.63% (644,000) 6, of whom approximately 20% (129,000) have moderate to severe disease 2. Plaque psoriasis is the most common form, affecting 80-90% of people with psoriasis 2. Onset may occur at any age but peaks in the second and third decades of life 5. Acute flares or relapses of plaque psoriasis may evolve into more severe disease, such as pustular or erythrodermic psoriasis and up to 10-20% of people with plaque psoriasis also experience psoriatic arthritis 7. Psoriasis is associated with considerable morbidity, with metabolic syndrome and heart disease causing the greatest increase in mortality a. Psoriasis is also associated with an increased incidence of Crohn s disease, lymphoma, obesity and type 2 diabetes 2. Life expectancy in men and women with severe psoriasis is reduced by 3.5 and 4.4 years respectively 5. In , there were 13,456 hospital admissions for psoriasis (ICD10 L40) in England, accounting for 14,094 finished consultant episodes and 23,195 bed days 8 and in 2011, 34 deaths were registered in England and Wales 9. PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance NICE technology appraisal. Ustekinumab for the treatment of adults with moderate to severe psoriasis (TA180). September NICE technology appraisal. Adalimumab for the treatment of adults with psoriasis (TA146). June NICE technology appraisal. Infliximab for the treatment of adults with psoriasis (TA134). January NICE technology appraisal. Etanercept and efalizumab for the treatment of adults with psoriasis (TA103). July NICE clinical guideline. Psoriasis: The assessment and management of psoriasis (CG153). October NICE quality standard in development. Psoriasis. Expected Autumn NICE interventional procedure guidance. Grenz rays therapy for inflammatory skin conditions (IPG236). November Other Guidance The Canadian Guidelines for the Management of Plaque Psoriasis. Consensus guidelines for the management of plaque psoriasis American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions SIGN. Diagnosis and management of psoriasis and psoriatic arthritis in adults a Expert personal communication. 3
4 British Association of Dermatologists and Primary Care Dermatology Society. Clinical guideline: Recommendations for the initial management of psoriasis British Association of Dermatologists' guidelines for biologic interventions for psoriasis American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics EXISTING COMPARATORS and TREATMENTS Current treatment options for plaque psoriasis include 14,23,24,25,b : Topical (alone or in combination) Corticosteroids: betamethasone dipropionate. Vitamin D analogues: calcipotriol, calcitriol, tacalcitol and tazarotene (with or without phototherapy). Tars (with or without phototherapy). Dithranol (with or without phototherapy). Salicyclic acid. Tacrolimus ointment (not licensed for this indication). Phototherapy Narrow band UVB or psoralen and UVA combination (PUVA). Systemic therapies (for the treatment of patients with severe or refractory psoriasis) Oral retinoids: acitretin (with or without phototherapy). Hydroxycarbamide (not licensed for this indication). Fumaric acid esters: monoethylfumarate and dimethylfumarate (licensed in the EU but not in the UK). Drugs affecting the immune response: ciclosporin, methotrexate, azathioprine and mycophenolate mofetil. Biologics (for the treatment of patients intolerant, contraindicated or refractory to other treatments) 26 Drugs affecting the immune response: Anti-tumour necrosis factor: etanercept, infliximab and adalimumab. Anti-interleukin 12/23: ustekinumab. EFFICACY and SAFETY Trial NCT , CC PSOR-010, ; apremilast vs etanercept vs placebo; phase III. ESTEEM 1, NCT , CC PSOR-008; apremilast vs placebo; phase III. ESTEEM 2, NCT , CC PSOR-009; apremilast vs placebo; phase III. Sponsor Celgene Corporation. Celgene Corporation. Celgene Corporation. Status Ongoing. Ongoing. Ongoing. b Expert personal communication. 4
5 Source of information Trial registry 27, manufacturer. Trial registry 28, manufacturer. Location EU, USA and Canada. EU (inc UK), USA and Canada. Design Randomised, active- and Randomised, placebocontrolled. placebo-controlled. Participants n=240 (planned); aged 18 n=844 (planned); aged 18 years and older; plaque years and older; plaque psoriasis; chronic, psoriasis; chronic, moderate to severe; moderate to severe. inadequate response, intolerance, or contraindication to 1 systemic agent for psoriasis; no previous biologic treatment. Schedule Randomised to apremilast, oral, 30mg twice daily with placebo, subcutaneous injection (SC) once weekly; or etanercept, SC, 50mg once weekly with placebo, oral, twice daily; or placebo, oral, twice daily with placebo, SC once weekly. At week 16, all participants receive apremilast for remainder of 2 yr trial. Follow-up Active treatment period 2 yrs. Placebo controlled phase: randomised to apremilast, oral, 30mg twice daily, or placebo. Maintenance phase: placebo group switched to receive apremilast, oral, 30mg twice daily. Participants maintain this dose to week 32. Randomised withdrawal phase: At week 32, responders re-randomised to maintain apremilast, oral 30mg twice daily or placebo (treatment withdrawal). Upon relapse/lost response, treatment resumes with apremilast, oral, 30mg twice daily. For subjects originally randomised to placebo dosing at baseline, all participants maintain apremilast, oral, 30mg twice daily. Follow-up up to 4 yrs. Trial registry 29, manufacturer. EU, USA and Canada. Randomised, placebocontrolled. n=413 (planned); aged 18 years and older; plaque psoriasis; chronic, moderate to severe. Placebo controlled phase: randomised to apremilast, oral, 30mg twice daily, or placebo. Maintenance phase: placebo group switched to receive apremilast, oral, 30mg twice daily. Participants maintain this dose to week 32. Randomised withdrawal phase: for participants originally randomised to apremilast at baseline, responders re-randomised to maintain apremilast, oral, 30mg twice daily, or placebo (treatment withdrawal). Upon relapse/lost response, treatment resumes with apremilast, oral, 30mg twice daily. Participants originally randomised to placebo at baseline will maintain apremilast, oral, 30mg twice daily. Follow-up up to 4 yrs. Primary outcome Secondary outcomes PASI c score. PASI score. PASI score. Disease severity score; spga d ; change in affected body surface area (BSA); DLQI e ; SF-36 f ; LS-PGA g. spga; BSA; pruritus Visual Analogue Scale (VAS); psoriatic arthritis disease activity VAS; skin discomfort/pain VAS; spga; BSA; pruritus VAS; psoriatic arthritis disease activity VAS; skin discomfort/pain VAS; global assessment of psoriasis c PASI: Psoriasis Area and Severity Index. d spga: Static Physician s Global Assessment of overall disease severity. e DLQI: Dermatology Life Quality Index. f SF-36: 36-item Short-form Health Survey. g LS-PGA: Lattice System Physician s Global Assessment. 5
6 Expected reporting date gloval assessment of psoriasis disease activity VAS; DLQI; SF-36; PHQ- 8 h ; EQ-5D; WLQ-25 i ; clinically significant changes in physical examination, vital signs, electrocardiogram, clinical lab findings, psoriasis flare/rebound; pharmacokinetics. Q Q Q disease activity VAS; DLQI; SF-36; PHQ-8; EQ-5D; WLQ-25; clinically significant changes in physical examination, vital signs, electrocardiogram, clinical lab findings, psoriasis flare/rebound; pharmacodynamics. Trial NCT , CC PSOR-005; apremilast vs placebo; phase II. NCT , CC PSOR-005E; apremilast; phase II extension. NCT , CC PSOR-003; apremilast vs placebo; phase II. Sponsor Celgene Corporation. Celgene Corporation. Celgene Corporation. Status Published. Complete. Complete Source of information Publication 30, trial registry 31, manufacturer. Trial registry 32, manufacturer. Publication 33, trial registry 34, manufacturer. Location USA and Canada. USA and Canada. EU and Canada. Design Randomised, placebocontrolled. Non-randomised. Randomised, placebocontrolled. Participants n=352; aged 18 years and older; plaque psoriasis; chronic, moderate to severe. Schedule Randomised to apremilast, oral, 10mg, 20mg or 30mg twice daily, or placebo twice daily for 16 weeks followed by randomly assigned apremilast 20mg or 30mg twice daily. Follow-up Active treatment period 24 weeks; 4 weeks follow-up. n=209; aged 18 years and older; plaque psoriasis; chronic, moderate to severe; completed study NCT Participants continue same apremilast dose they were receiving at the end of the core study without interruption. Active treatment period 28 weeks; 4 weeks follow-up. n=260; aged 18 years and older; plaque psoriasis, moderate to severe. Randomised to apremilast, oral, 20mg once or twice daily, or placebo, oral, once or twice daily. Active treatment period 12 weeks; 4 weeks follow-up. Primary outcome Secondary outcomes Key results PASI score at week 16. Safety. Efficacy. spga; BSA; DLQI; SF-36; pruritus VAS; time to achieve PASI-50 or PASI- 75; vital signs; physical examination; lab findings; electrocardiograms; psoriasis flare; pharmacokinetics. For apremilast 10mg, 20mg, 30mg and placebo respectively (p value vs placebo): PASI-75 achieved at week Efficacy; PASI scores; BSA; spga; DLQI; SF-36. Safety; quality of life. - For apremilast 20mg once daily, twice daily and placebo respectively (p value vs placebo): PASI-75 achieved at week 12 (%), h PHQ-8: Patient Health Questionnaire. i WLQ-25: Work Limitations Questionnaire. 6
7 Adverse effects (AEs) Expected reporting date 16 (%),11 (p=0.19), 29 (p<0.0001), 41 (p<0.0001), 6; median time to PASI-75 (days), 70.0 (95% CI ), 83.0 (95% CI ), 44.0 (95% CI ), 57 (95% CI ); median time to PASI-50 (days), 41.0 (95% CI ), 42.0 (95% CI ), 30.0 (95% CI ), 45.5 (95% CI ); median time to PASI-90 (days), 50.5 (95% CI ), 87.0 (95% CI ), 58.0 (95% CI ), 57.0 (95% CI ); physicians global assessment score of 0 or 1 (%), 10, 24 (p=0.0425), 33 (p=0.0012),13; cleared or minimal disease at week 24 (%), 13, 24, 34 (placebo arm not reported); mean difference in DLQI score at week 16, -3.2, -5.9 (p<0.0001), -4.4 (p=0.0047), -1.9; clinically important improvement in DLQI score (%), 34, 49 (p=0.001), 44 (p=0.011), 25. AEs 5%, for apremilast 10mg, 20mg, 30mg and placebo respectively (%): nausea, 11, 15, 18, 8; upper respiratory tract infection, 10, 14, 16, 6; diarrhoea, 7, 7, 14, 5; nasopharyngitis, 10, 8, 6, 8; headache, 6, 9, 10, 6; tension headache, 3, 2, 16, 7; viral upper respiratory tract infection, 2, 8, 8, 8; gastroenteritis, 1, 5, 6, 3; dyspepsia, 1, 6, 5, 2; arthralgia, 1, 2, 2, 7; vomiting, 0, 3, 5, , 24.4 (p=0.023),10.3; PASI-50 achieved at week 12 (%), 27.6, 57.0 (p<0.001), 23.0; mean reduction in PAI score at week 12 (%), 30.3 (p=0.021), 52.1 (p<0.001), 17.4; relapse during followup (%), 24.2, 26.4, 21.7; mean change from baseline in overall spga at week 12, -0.8 (p=0.755), (p<0.001), -0.7; mean change from baseline in overall BSA, (p=1.104), (p<0.001), AEs >2%, for apremilast 20mg once daily, twice daily and placebo respectively (%): headache, 18.4, 12.9, 10.3; nasopharyngitis, 13.8, 14.1, 13.8; diarrhoea, 10.3, 5.9, 2.3; nausea, 3.4, 5.9, 0; vomiting, 2.3, 2.4, 0; upper abdominal pain, 2.3, 1.2, Q Q Trial NCT , CC PSOR-005LTE; apremilast vs placebo; phase II extension. NCT , CC PSOR-001; apremilast; phase II. NCT , CC PSOR-004; apremilast, phase II. Sponsor Celgene Corporation. Celgene Corporation. Celgene Corporation. Status Ongoing. Complete. Complete. 7
8 Source of Trial registry 35. Publication 36, trial Trial registry 38. information registry 37. Location USA and Canada. USA. USA. Design Non-randomised, placebocontrolled. Non-randomised, single arm. Non-randomised, single arm. Participants n=56 (planned); aged 18 years and older; plaque psoriasis; chronic; moderate to severe; completed study NCT n=19; aged years; plaque psoriasis; severe. n=31; aged 18 years and older; plaque psoriasis; chronic; inadequate response, intolerance or contraindication to 1 standard systemic therapy for psoriasis. Schedule Follow-up Primary outcomes Secondary outcomes Participants who received 20mg or 30mg twice daily in prior study continue to receive the same dose. Participants who received 10mg twice daily in prior study randomised to apremilast, 20mg or 30mg twice daily. Active treatment period up to 4 yrs; 4 weeks follow-up. AEs; long-term safety. PASI; BSA; spga; DLQI; SF-36. All participants received apremilast, oral, 20mg once daily. Active treatment period 29 days; 4 weeks follow-up. Pharmacodynamic effect in reducing epidermal thickness. PASI; spga; BSA. No quality of life measures included. Key results - 20% reduction in epidermal thickness, 53.3% (95% CI ); mean reduction in epidermal thickness from baseline to day 29, 20.5%; 50% reduction in PASI score, 17.6%. Adverse events (AEs) Expected reporting date All participants received apremilast, oral, 20mg twice daily. Nonresponders (based on PASI-75) were allowed to increase to apremilast, oral, 30mg twice daily, responders remained on apremilast, oral, 20mg twice daily. Active treatment period up to 24 weeks; 4 weeks follow-up. Safety and tolerability. Pharmacodynamic effects; PASI; quality of life % reported at least one AE; most common were headache (5 participants) and nausea (3 participants). - Not reported. - Not reported. - ESTIMATED COST and IMPACT COST The cost of apremilast is not yet known. The costs of selected treatments for plaque psoriasis are summarised below 39 : 8
9 Drug Dose Unit cost Adalimumab 80mg SC, then 40mg on alternate weeks starting one week after initial dose (40mg, prefilled syringe) Etanercept 25mg SC twice weekly or 50mg once (25mg, prefilled syringe) weekly. Infliximab 5mg/kg IV repeated at 2 and 6 weeks, then (100mg vial) every 8 weeks. Ustekinumab 45mg SC, then 45mg 4 weeks after initial dose, then 45mg every 12 weeks (45mg, prefilled syringe) IMPACT - SPECULATIVE Impact on Patients and Carers Reduced mortality/increased length of survival Reduced symptoms or disability Other: No impact identified Impact on Services Increased use of existing services Decreased use of existing services: oral therapy Re-organisation of existing services Need for new services Other: None identified Impact on Costs Increased drug treatment costs Reduced drug treatment costs Other increase in costs: Other reduction in costs: Other: uncertain unit cost compared to existing treatments None identified Other Issues Clinical uncertainty or other research question identified: clinical expert notes that current biologic agents are less effective for heavier patients at conventional doses, and is concerned to know whether dose adjustment will be required for these patients. REFERENCES None identified 1 ClinicalTrials.gov. A phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis. Accessed 5 December Menter A, Korman NJ, Elmets CA et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Journal of the American Academy of Dermatology 2011;65(1) National Institute for Health and Clinical Excellence. Psoriasis: final scope. London: NICE; December Clinical Knowledge Summaries. Psoriasis background information. Accessed 5 November Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. National clinical guideline 121. Edinburgh: SIGN; October
10 6 National Institute for Health and Clinical Excellence. Adalimumab for the treatment of adults with psoriasis. Costing template and report. London: NICE; June Lui H and Mamelak AJ. Plaque Psoriasis. Medscape reference: Drugs, diseases and procedures. March Accessed October NHS Hospital episode statistics. NHS England HES data Office for National Statistics. Mortality statistics: deaths registered in 2011 (Series DR) Table National Institute for Health and Clinical Excellence. Ustekinumab for the treatment of adults with moderate to severe psoriasis. Technology appraisal TA180. London: NICE; September National Institute for Health and Clinical Excellence. Adalimumab for the treatment of adults with psoriasis. Technology appraisal TA146. London: NICE; June National Institute for Health and Clinical Excellence. Infliximab for the treatment of adults with psoriasis. Technology appraisal TA134. London: NICE; January National Institute for Health and Clinical Excellence. Etanercept and efalizumab for the treatment of adults with psoriasis. Technology appraisal TA103. London: NICE; July National Institute for Health and Clinical Excellence. Psoriasis: The assessment and management of psoriasis. Clinical guideline 153. London: NICE; October National Institute for Health and Clinical Excellence. Psoriasis. Quality standard in development. Expected Autumn National Institute for Health and Clinical Excellence. Grenz rays therapy for inflammatory skin conditions. Intervention procedure guidance IPG236. London: NICE; November Hsu S, Papp KA, Lebwohl MG et al. Consensus guidelines for the management of plaque psoriasis. Archives of Dermatolology. 2012;148: American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. July Accessed October British Association of Dermatologists & Primary Care Dermatology Society. Recommendations for the initial management of psoriasis. October PCDS%20Psoriasis%20reviewed% pdf Accessed 12 October Smith CH, Anstey AV, Barker JN et al. British Association of Dermatologists' guidelines for biologic interventions for psoriasis British Journal of Dermatology 2009;161(5): American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 4. guidelines of care for the management and treatment of psoriasis with traditional systemic agents. September Accessed October American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1 - Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. May Accessed October British Association of Dermatologists & Primary Care Dermatology Society. Recommendations for the initial management of psoriasis. October PCDS%20Psoriasis%20reviewed% pdf Accessed 6 December Map of Medicine (MoM), Psoriasis. International view. London: MoM; 2011 (Issue 4) Accessed 6 December British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BNF 62. London: BMJ Group and RPS Publishing, September National Institute for Health and Clinical Excellence. Plaque psoriasis commissioning algorithm. London: NICE; January ClinicalTrials.gov. Phase 3b safety and efficacy study of apremilast to treat moderate to severe plaque-plaque psoriasis. Accessed 21 December
11 28 ClinicalTrials.gov. Study to evaluate safety and effectiveness of oral apremilast (CC-1004) in patients with moderate to severe plaque psoriasis (ESTEEM 1). Accessed 21 December ClinicalTrials.gov. Study to evaluate safety and effectiveness of oral apremilast (CC-10004) in patients with moderate to severe plaque psoriasis. (ESTEEM 2). w_locs=y Accessed 21 December Papp K, Cather JC, Rosoph L et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. The Lancet 2012;380(9843): ClinicalTrials.gov. Efficacy and safety study of apremilast (CC-10004) in subjects with moderatesevere plaque-type psoriasis (core study). nk=1 Accessed 21 December ClinicalTrials.gov. Extension study of apremilast to evaluate safety and efficacy in subjects with psoriasis who completed the treatment phase of the core study CC PSOR (PSOR-005E). w_locs=y Accessed 21 December Papp KA, Kaufmann R, Thaci D et al. Efficacy and safety of apremilast in subjects with moderate to sever plaque psoriasis: results from a phase II multicentre, randomized, double-blind placebocontrolled, parallel-group, dose-comparison study. Journal of the European Academy of Dermatology and Venereology. Doi: /j x 34 ClinicalTrials.gov. Double-blind, randomized, placebo-controlled comparison of CC in subjects with moderate to severe plaque type psoriasis (PSOR-003). Accessed 21 December ClinicalTrials.gov. Long-term safety extension of apremilast (CC-10004) in subjects who completed the treatment phase of extension study CC PSOR-005E (PSOR-005LTE). Accessed 7 January Gottlieb AB, Strober B, Krueger JG et al. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis reated with an oral anti-inflammatory agent, apremilast. Current Medical Research and Opinion 2008;24(5): ClinicalTrials.gov. Open-label, single-arm pilot study to evaluate the pharmacodynamics, pharmacokinetics, safety, and preliminary efficacy of CC1004 in subjects with severe plaque type psoriasis (PSOR-001). Accessed 7 January ClinicalTrials.gov. Phase 2, open-label study to evaluated apremilast recalcitrant (not responded to therapy) plaque-type psoriasis. Accessed 7 January British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BNF 64. London: BMJ Group and RPS Publishing, September
Horizon 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 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 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 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 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 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 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 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 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 informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Psoriasis: the management of psoriasis 1.1 Short title Psoriasis 2 The remit The Department of Health has asked NICE: 'to produce
More informationHorizon Scanning Centre November Faldaprevir with BI for chronic hepatitis C infection, genotype 1 SUMMARY NIHR HSC ID: 7688
Horizon Scanning Centre November 2012 Faldaprevir with BI 207127 for chronic hepatitis C infection, genotype 1 SUMMARY NIHR HSC ID: 7688 This briefing is based on information available at the time of research
More informationHorizon 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 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 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 informationInfliximab (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 informationCertolizumab 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 informationAbatacept (Orencia) for active rheumatoid arthritis. August 2009
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
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 informationLiraglutide (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 informationHorizon 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 informationLacosamide (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 informationCilengitide (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 informationHorizon Scanning Centre March Denosumab for glucocorticoidinduced SUMMARY NIHR HSC ID: 6329
Horizon Scanning Centre March 2014 Denosumab for glucocorticoidinduced osteoporosis SUMMARY NIHR HSC ID: 6329 This briefing is based on information available at the time of research and a limited literature
More informationThey are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see:
bring together everything NICE says on a topic in an interactive flowchart. are interactive and designed to be used online. They are updated regularly as new NICE guidance is published. To view the latest
More informationTechnology 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 informationHorizon Scanning Centre November Enobosarm (Ostarine) for cachexia in patients with advanced non-small cell lung cancer first line
Horizon Scanning Centre November 2012 Enobosarm (Ostarine) for cachexia in patients with advanced non-small cell lung cancer first line SUMMARY NIHR HSC ID: 5206 This briefing is based on information available
More informationRoflumilast (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 informationHorizon Scanning Centre November Vinflunine (Javlor) monotherapy for advanced breast cancer SUMMARY NIHR HSC ID: 7887
Horizon Scanning Centre November 2012 Vinflunine (Javlor) monotherapy for advanced breast cancer SUMMARY NIHR HSC ID: 7887 This briefing is based on information available at the time of research and a
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 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 informationUSTEKINUMAB. London New Drugs Group APC/DTC Briefing Document. May 2009
Page 1 London New Drugs Group APC/DTC Briefing Document USTEKINUMAB Contents Summary 1 Background 4 Clinical efficacy 5 Cost implications 9 Reference list 10 Appendices 11 Produced for the London New Drugs
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 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 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 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 informationHorizon 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 informationInsulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes
Insulin degludec/insulin aspart (DegludecPlus) for type 1 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationBilaga 1.till rapport. Bilaga 1 Tabell över inkluderade studier/ Appendix 1 Description of included studies
Bilaga 1.till rapport Ljusbehandling och systemisk behandling av psoriasis, rapport nr 278 (2018) Bilaga 1 Tabell över inkluderade studier/ Appendix 1 Description of included studies Description of included
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 informationApixaban 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 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 informationFinal Appraisal Report. Etanercept (Enbrel. Pfizer Limited. Advice No: 0210 March Recommendation of AWMSG
Final Appraisal Report Etanercept (Enbrel ) Pfizer Limited Advice No: 0210 March 2010 Recommendation of AWMSG Etanercept (Enbrel ) is not recommended for use within NHS Wales for the treatment of chronic
More informationPasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line
Pasireotide Long-Acting Repeatable (Signifor) for acromegaly first and second line December 2010 This technology summary is based on information available at the time of research and a limited literature
More informationOlesoxime for amyotrophic lateral sclerosis first line
Olesoxime for amyotrophic lateral sclerosis first line May 2011 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to
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 informationClinical Trial Report Synopsis
Clinical Trial Report Synopsis A phase 2a, proof of concept trial, testing twice daily application of LEO 124249 ointment 30 mg/g in the treatment of mild to moderate inverse psoriasis Design of trial:
More informationBotulinum toxin A (Dysport) for hyperhidrosis of the axillae
April 2016 Horizon Scanning Research & Intelligence Centre Botulinum toxin A (Dysport) for hyperhidrosis of the axillae LAY SUMMARY This briefing is based on information available at the time of research
More informationThe Cosentyx clinical trial programme 1-11
The Cosentyx clinical trial programme 1-11 There are eight pivotal trials (four in psoriasis, two in psoriatic arthritis, two in ankylosing spondylitis) There are two head-to-head trials in psoriasis showing
More informationTRANSPARENCY 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 informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Single Technology Appraisal
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Single Technology Appraisal Apremilast for treating moderate to severe plaque psoriasis ID679 Consultee and commentator comment form Please use
More informationB-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 informationThank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS.
Thank you for agreeing to give us a statement 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 informationHorizon Scanning Centre November 2012
Horizon Scanning Centre November 2012 Cangrelor to reduce platelet aggregation and thrombosis in patients undergoing percutaneous coronary intervention99 SUMMARY NIHR HSC ID: 2424 This briefing is based
More informationEverolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery
Everolimus (Votubia) for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis first line or post surgery April 2011 This technology summary is based on information
More informationHorizon Scanning Centre November Spheroids of human autologous matrix-associated chondrocytes (Chondrosphere) for articular cartilage defects
Horizon Scanning Centre November 2014 Spheroids of human autologous matrix-associated chondrocytes (Chondrosphere) for articular cartilage defects SUMMARY NIHR HSC ID: 8515 This briefing is based on information
More informationGuselkumab for treating moderate to severe plaque psoriasis [ID1075]
Guselkumab for treating moderate to severe plaque psoriasis [ID1075] 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 informationUpdate on systemic therapies and emerging treatments How do I choose a systemic agent?
Update on systemic therapies and emerging treatments How do I choose a systemic agent? Amy S. Paller, M.D. Walter J. Hamlin Professor and Chair of Dermatology Professor of Pediatrics Northwestern University
More informationKTE-C19 for relapsed or refractory mantle cell lymphoma
NIHR Innovation Observatory Evidence Briefing: July 2017 KTE-C19 for relapsed or refractory mantle cell lymphoma NIHRIO (HSRIC) ID: 11846 NICE ID: 9122 LAY SUMMARY Mantle cell lymphoma is an uncommon type
More informationNATIONAL 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 informationScottish 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 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 informationHorizon Scanning Centre March Cholic acid (Orphacol) for inborn errors of primary bile acid synthesis first line SUMMARY NIHR HSC ID: 9468
Horizon Scanning Centre March 2014 Cholic acid (Orphacol) for inborn errors of primary bile acid synthesis first line SUMMARY NIHR HSC ID: 9468 This briefing is based on information available at the time
More informationKEY MESSAGES. Psoriasis patients are more prone to cardiovascular diseases, stroke, lymphoma and non-melanoma skin cancers, and increased mortality.
KEY MESSAGES Psoriasis is a genetically determined, systemic immune-mediated chronic inflammatory disease that affects primarily the skin and joints. Psoriasis Vulgaris is characterised by well-demarcated
More informationCabazitaxel (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 informationCabozantinib for medullary thyroid cancer. February 2012
Cabozantinib for medullary thyroid cancer 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 be a definitive
More information2.0 Synopsis. Adalimumab R&D/04/118. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority
More informationinfliximab, 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 informationTechnology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta456
Ustekinumab for moderately to severelyerely active Crohn s disease after previous treatment Technology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta456 NICE 2017. All rights reserved.
More informationNational 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 informationOTEZLA (Apremilast) Showed Meaningful Improvements in Clinical and Quality of Life Measures of Psoriasis Beyond Those Captured by Assessing Skin Alone
OTEZLA (Apremilast) Showed Meaningful Improvements in Clinical and Quality of Life Measures of Psoriasis Beyond Those Captured by Assessing Skin Alone Patients with moderate to severe plaque psoriasis
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 informationRilonacept 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 informationA systematic review of treatments for severe psoriasis Griffiths C E, Clark C M, Chalmers R J, Li Wan Po A, Williams H C
A systematic review of treatments for severe psoriasis Griffiths C E, Clark C M, Chalmers R J, Li Wan Po A, Williams H C Authors' objectives To compare the effectiveness of currently available treatments
More informationEffect of Apremilast on Patient-Reported Outcomes in Patients With Moderate to Severe Plaque Psoriasis in the ESTEEM 1 Trial
1152 Effect of Apremilast on Patient-Reported Outcomes in Patients With Moderate to Severe Plaque Psoriasis in the ESTEEM 1 Trial April W. Armstrong, MD, MPH 1 ; Christopher E.M. Griffiths, MD 2 ; Tom
More informationClinical Policy: Secukinumab (Cosentyx) Reference Number: CP.PHAR.261 Effective Date: 08/16 Last Review Date: 08/17
Clinical Policy: (Cosentyx) Reference Number: CP.PHAR.261 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationInsulin 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 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 informationETANERCEPT Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL 18830 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid
More informationRiociguat for chronic thromboembolic pulmonary hypertension
Riociguat for chronic thromboembolic pulmonary hypertension 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 informationPediatric Use: Safety and effectiveness of Ustekinumab (STELARA ) in pediatric patients have not been evaluated.
Original Issue Date (Created): January 1, 2010 Most Recent Review Date (Revised): January 28, 2014 Effective Date: April 1, 2014 I. POLICY Preauthorization Requirements for Ustekinumab (STELARA ) Note:
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal (STA)
Thank you for agreeing to give us a statement 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 informationClinical Policy: Brodalumab (Siliq) Reference Number: CP.PHAR.375 Effective Date: Last Review Date: 05.18
Clinical Policy: (Siliq) Reference Number: CP.PHAR.375 Effective Date: 06.01.18 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationUstekinumab for the treatment of adults with moderate to severe psoriasis
Ustekinumab for the treatment of adults with moderate to severe psoriasis Issued: September 2009 guidance.nice.org.uk/ta180 NICE has accredited the process used by the Centre for Health Technology Evaluation
More information2.0 Synopsis. Adalimumab M Clinical Study Report R&D/04/900. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2. Synopsis Abbott Laboratories Name of Study Drug: Name of Active Ingredient: Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Phase
More informationErlotinib (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 informationTechnology appraisal guidance Published: 26 August 2015 nice.org.uk/guidance/ta352
Vedolizumab for treating moderately to severely erely active Crohn's disease after prior therapy Technology appraisal guidance Published: 26 August 2015 nice.org.uk/guidance/ta352 NICE 2017. All rights
More informationOral OTEZLA (apremilast) Approved by the European Commission for the Treatment of both Patients with Psoriasis and Psoriatic Arthritis
Oral OTEZLA (apremilast) Approved by the European Commission for the Treatment of both Patients with Psoriasis and Psoriatic Arthritis OTEZLA, a selective PDE4 inhibitor, is the first oral treatment in
More informationClinical Policy: Ixekizumab (Taltz) Reference Number: CP.PHAR.257 Effective Date: Last Review Date: 05.18
Clinical Policy: (Taltz) Reference Number: CP.PHAR.257 Effective Date: 08.01.16 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationThe role of current biologic therapies in psoriasis
: An Update on and IL-17 Inhibitors Joanna Dong, BA; Gary Goldenberg, MD PRACTICE POINTS The newest biologics for treatment of moderate to severe plaque psoriasis are and IL-17 inhibitors with unprecedented
More informationTechnology appraisal guidance Published: 23 September 2009 nice.org.uk/guidance/ta180
Ustekinumab for the treatment of adults with moderate to severe ere psoriasis Technology appraisal guidance Published: 23 September 2009 nice.org.uk/guidance/ta180 NICE 2017. All rights reserved. Subject
More informationSecukinumab for treating moderate to severe plaque psoriasis. Erratum
Aberdeen HTA Group Secukinumab for treating moderate to severe plaque psoriasis Erratum Completed 2 March 2015 This report was commissioned by the NIHR HTA Programme as project number 13/129/01 Contains
More informationSTELARA DATA SHEET NAME OF THE MEDICINE DESCRIPTION V L C L V H C H 1 C H 2 C H 3. Fab. F(ab)' 2. hinge
DATA SHEET NAME OF THE MEDICINE Ustekinumab (rmc). CAS Registry Number: 815610-63-0. DESCRIPTION (ustekinumab) is a human IgG1kappa monoclonal antibody with an approximate molecular weight of 148,600 daltons.
More informationTechnology appraisal guidance Published: 28 November 2018 nice.org.uk/guidance/ta547
Tofacitinib for moderately to severelyerely active ulcerative colitis Technology appraisal guidance Published: 28 November 2018 nice.org.uk/guidance/ta547 NICE 2019. All rights reserved. Subject to Notice
More informationEli Lilly and Company
Eli Lilly and Company Ixekizumab Phase 2 Psoriasis Data Investment Community Discussion April 10, 2012 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 3 October 2012
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 3 October 2012 REMICADE 100 mg, powder for concentrate for solution for infusion B/1 vial (CIP code: 562 070-1) Applicant:
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 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 informationNational 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 informationClinical Policy: Secukinumab (Cosentyx) Reference Number: ERX.SPA.165 Effective Date:
Clinical Policy: (Cosentyx) Reference Number: ERX.SPA.165 Effective Date: 10.01.16 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
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 information