Proposed Project Plan

Transcription

1 Proposed Project Pln Comprison of triple conventionl synthetic disese-modifying ntirheumtic drugs nd biologic drugs or Jnus-ssocited kinse inhibitors for rheumtoid rthritis 28November 2018

2 BACKGROUND AND RATIONALE Rheumtoid rthritis (RA) is chronic, systemic inflmmtory disese chrcterized by inflmmtion of the synovil lining of the joints, tendons nd perirticulr structures. 1 RA ffects 0.5% to 1.0% of the popultion in Western countries. 2 Untreted, RA leds to joint destruction, functionl limittion nd severe disbility, nd hs significnt impct on helth-relted qulity of life. 3-6 Definitive tretments tht hve disese-modifying potentil include glucocorticoids, conventionl synthetic disese-modifying nti-rheumtic drugs (csdmards, such s methotrexte, sulfslzine, hydroxychloroquine nd leflunomide), biologic DMARDs [tumor necrosis fctor (TNF) inhibitors nd non- TNF inhibitors], or trgeted synthetic DMARDs [tsdmards, such s the Jnus ssocited kinse (JAK) inhibitors tofcitinib nd bricitinib]. The use of DMARDs leds to n improvement in pin nd function for ptients with RA, s well s more long-term outcomes such s less disese progression nd disbility Monotherpy conventionl synthetic DMARD (methotrexte preferred) is the drug of choice for tretmentnive ptients with erly or estblished RA for ny level of disese ctivity ccording to the Americn College of Rheumtology 2015 Guidelines. 11,12 When monotherpy with csdmard hs been ineffective or prtilly effective (disese ctivity remins moderte or high) or hve hd ssocited side effects, tretment options include other csdmards lone or in combintion, biologics (including biosimilrs) nd JAK inhibitors. 11,12 This proposed project will evlute the effectiveness nd sfety of triple csdmards compred with TNF inhibitors (nd biosimilrs), non-tnf inhibitors, nd JAK inhibitors. Tble 1: Policy Question Is it pproprite to require triple conventionl synthetic disese-modifying nti-rheumtic drug therpy for treting rheumtoid rthritis? Tbles 2 nd 3 describe the drugs vilble in Cnd tht re relevnt to this CADTH project. Tble 2: Conventionl Synthetic Disese-modifying Anti-rheumtic Drugs used s Triple Therpy Drug Clss Drug Brnd Nme Mnufcturer ntimlril, immunosuppressnt folte nlog metbolic Inhibitor, immunosuppressnt nti-inflmmtory, immunomodultor hydroxychloroquine Plquenil, generics Snofi-Aventis Cnd Inc., others methotrexte Metoject, generics Medexus Inc., others sulfslzine Slzopyrin, PMS- Sulfslzine combintion recommended by the Americn College of Rheumtology 2015 guidelines Pfizer Cnd Inc., Phrmscience Inc. Tble 3: Biologic Drugs nd Jnus-ssocited Kinse Inhibitors Drug Clss Generic Nme Brnd Nme Mnufcturer TNF Inhibitors TNF inhibitors Etnercept Enbrel Immunex Corportion Infliximb Remicde Jnssen For stkeholder feedbck 2

3 Non-TNF Inhibitors B lymphocyte-depleting drug (nti-cd20 therpy) Adlimumb Humir AbbVie Corportion Certolizumb pegol Cimzi UCB Golimumb Simponi Jnssen Rituximb Rituxn Roche T cell costimultory inhibitor Abtcept Orenci Bristol Myers Squibb IL-6 inhibitor Tocilizumb Actemr Roche Trgeted Synthetic DMARDs Srilumb Kevzr Snofi Genzyme Jnus-ssocited kinse inhibitor Tofcitinib Xeljnz Pfizer Biosimilrs Bricitinib Olumint Eli Lilly Biosimilr of infliximb CT-P13 Inflectr, Remsim Celltrion Helthcre SB2 Renflexis, Flixbi Smsung Bioepis Biosimilr of etnercept HD203 Dvictrel Hnwh Chemicl GP2015 Erelzi Sndoz Cnd Inc. SB4 Brenzys, Benepli Smsung Bioepis Unknown AnBiNuo Zhejng Hisun Phrmceuticl Co. Biosimilr of dlimumb ABP 501 Amjevit, Amgevit, Solymbic Amgen ZRC-3197 Exempti Zydus Cdil SB5 Hdlim b, Imrldi Smsung Bioepis DMARDs = disese-modifying nti-rheumtic drugs; TNF = tumour necrosis fctor brnd nme not vilble in Cnd b pproved but not mrketed in Cnd PROJECT DESCRIPTION The project will compre the clinicl effectiveness, sfety nd cost-effectiveness of triple csdmards with biologic drugs nd JAK inhibitors. The selection criteri for this project re described in Tble 4. For stkeholder feedbck 3

4 Tble 4: Project Scope Popultion tretment-experienced dults with moderte to severe, ctive RA who hve filed or re intolernt to methotrexte (indequte responders) Intervention triple csdmards Comprtors biologic drugs, biosimilrs nd JAK inhibitors my include combintion therpy with methotrexte Outcomes disese severity (ACR 50) disese ctivity (DAS/ DAS-28) remission (DAS-28 remission) WDAEs SAEs Reserch Questions 1. Wht is the clinicl effectiveness nd sfety of triple csdmards compred with TNF inhibitors (nd biosimilrs)? 2. Wht is the clinicl effectiveness nd sfety of triple csdmards compred with non-tnf inhibitors? 3. Wht is the clinicl effectiveness nd sfety of triple csdmards compred with JAK inhibitors? 4. Wht is the cost-effectiveness of triple csdmards compred with biologic drugs or JAK inhibitors? ACR = Americn College of Rheumtology; csdmards = conventionl synthetic disese-modifying nti-rheumtic drugs; DAS = disese ctivity score; JAK = Jnus-ssocited kinse; RA = rheumtoid rthritis; SAEs = serious dverse events; TNF = tumour necrosis fctor; WDAEs = withdrwl due to dverse events Definitions Moderte rheumtoid rthritis: Ptients with moderte disese ctivity s defined by the Americn College of Rheumtology guidelines Severe rheumtoid rthritis: Ptients with high disese ctivity s defined by the Americn College of Rheumtology guidelines Tretment-experienced: Ptients previously treted for rheumtoid rthritis. Tretment intolernce: Intolernce to tretment due to n dverse event or contrindiction to tretment. Tretment filure: Less thn optiml response to tretment due to lck of efficcy (i.e., ptient does not ttin low disese ctivity). Indequte responders: Ptients with tretment intolernce or tretment filure. KEY PROJECT COMPONENTS In order to ddress the questions described bove, this HTA project my include the following key components. A Science Report: A systemtic review of the evidence on clinicl efficcy nd sfety. This my include n indirect comprison in the form of network met-nlysis. The informtion used for the clinicl evlution will borrow from the dt generted in the Drugs for the Mngement of Rheumtoid Arthritis published in Mrch A review of economic studies. An economic evlution (depending on the results of the systemtic nd economic reviews). Summry of ptient group input: Ptient experience, expecttions nd perspective obtined for the project Drugs for the Mngement of Rheumtoid Arthritis my be of use in the selection of outcomes relevnt for ptients, nd in the contextuliztion of the evidence. A Recommendtions Report or Policy Options Report: A Recommendtion Report or Policy Options Report my be produced bsed on the Science Report. Determintion of whether such recommendtions or policy options re developed will be bsed on CADTH jurisdictionl customers needs. For stkeholder feedbck 4

5 STATUS OF THE DOCUMENT This proposed project scope is posted for 10 business dys for stkeholder feedbck. The feedbck will be considered s we finlize the project pln. A list of included studies nd project protocol my be posted on CADTH s website if required. REFERENCES 1. Lee DM, Weinbltt ME. Rheumtoid rthritis. Lncet (London, Englnd). 2001;358(9285): Wong Re. Prevlence of rthritis nd rheumtic disese round the world. A growing burdent nd implictions for helth cre needs. University Helth Network; Lubeck DP. Ptient-reported outcomes nd their role in the ssessment of rheumtoid rthritis. PhrmcoEconomics. 2004;22(1): Odegrd S, Finset A, Kvien TK, Mowinckel P, Uhlig T. Work disbility in rheumtoid rthritis is predicted by physicl nd psychologicl helth sttus: 7-yer study from the Oslo RA register. Scndinvin journl of rheumtology. 2005;34(6): Yelin E. Work disbility in rheumtic diseses. Current opinion in rheumtology. 2007;19(2): Kvien TK, Uhlig T. Qulity of life in rheumtoid rthritis. Scndinvin journl of rheumtology. 2005;34(5): Csh JM, Klippel JH. Second-line drug therpy for rheumtoid rthritis. The New Englnd journl of medicine. 1994;330(19): Finckh A, Ling MH, vn Herckenrode CM, de Pblo P. Long-term impct of erly tretment on rdiogrphic progression in rheumtoid rthritis: A met-nlysis. Arthritis nd rheumtism. 2006;55(6): Pincus T, Ferrccioli G, Sokk T, et l. Evidence from clinicl trils nd long-term observtionl studies tht disese-modifying nti-rheumtic drugs slow rdiogrphic progression in rheumtoid rthritis: updting 1983 review. Rheumtology (Oxford, Englnd). 2002;41(12): Strnd V, Singh JA. Improved helth-relted qulity of life with effective disese-modifying ntirheumtic drugs: evidence from rndomized controlled trils. The Americn journl of mnged cre. 2008;14(4): Singh JA, Sg KG, Bridges SL, Jr., et l Americn College of Rheumtology Guideline for the Tretment of Rheumtoid Arthritis. Arthritis & rheumtology (Hoboken, NJ). 2016;68(1): Smolen JS, Lndewe R, Breedveld FC, et l. EULAR recommendtions for the mngement of rheumtoid rthritis with synthetic nd biologicl disese-modifying ntirheumtic drugs: 2013 updte. Annls of the rheumtic diseses. 2014;73(3): Fleischmnn R, Tongbrm V, vn Vollenhoven R, et l. Systemtic review nd network metnlysis of the efficcy nd sfety of tumour necrosis fctor inhibitor-methotrexte combintion therpy versus triple therpy in rheumtoid rthritis. RMD open. 2017;3(1):e Scott DL, Ibrhim F, Frewell V, et l. Rndomised controlled tril of tumour necrosis fctor inhibitors ginst combintion intensive therpy with conventionl disese-modifying ntirheumtic drugs in estblished rheumtoid rthritis: the TACIT tril nd ssocited systemtic reviews. Helth technology ssessment (Winchester, Englnd). 2014;18(66):i-xxiv, For stkeholder feedbck 5