Drug Class Review: Long-acting muscarinic antagonists (LAMAs) for treatment of chronic obstructive pulmonary disease (COPD)

Transcription

1 Drug Class Review: Lng-acting muscarinic antagnists (LAMAs) fr treatment f chrnic bstructive pulmnary disease (COPD) Cmprehensive Research Plan: Pharmacepidemilgy Unit April 10 th, 2014

2 ODPRN Drug Class Review Prpsal Pharmacepidemilgy Unit Study Title: Epidemilgic analyses f lng-acting muscarinic antagnists (LAMA) in the management f patients with Chrnic Obstructive Pulmnary Disease (COPD) Objective: T examine trends in LAMA use acrss Canada, and t describe characteristics f patients prescribed LAMA prducts (either as single, dual r triple therapy) Objective 1a: Natinal and prvincial trends in COPD Therapies Design: Time series analysis with quarterly time intervals Study perid: Natinal and prvincial trends (IMS Cmpuscript): Octber 2009 t December 2013 Ppulatin: All prvinces Prescriptin Drug Data Surce: IMS Cmpuscript: aggregated data fr all prescriptins dispensed at retail pharmacies acrss Canada Study Ppulatin: Outcme(s) f Interest: Inclusin Criteria: All privately and publically-funded prescriptins dispensed in Canada fr LAMAs Nte that the Pharmacepidemilgy Reprt n ICS/LABA cmbinatin prducts will prvide mre details n trends in use f ther prducts used in COPD Measured ver entire study perid (quarterly): Number f prescriptins dispensed Ttal cst f prescriptins Reprt: Overall rates f use by prvince Distributin f prescriptins by payer (public, private, cash, NIHB) Limitatins: Infrmatin fr privately funded prescriptins is nly available at the prescriptin and unit level. Objective 1b: Trends in publically-funded LAMA utilizatin in Ontari

3 Design: Time series analysis with quarterly time intervals Study perid: Octber 2009 t March 2014 Ppulatin: Ontari Prescriptin Drug Data Surce: Ontari Drug Benefit Database (ODB): individual level data fr all publically funded prescriptins dispensed in Ontari. Study Ppulatin: Outcme(s) f Interest: Inclusin Criteria: All publically-funded prescriptins fr LAMA prducts dispensed in Ontari (titrpium-spiriva, glycpyrrnium brmide-seebri Breezhaler) Measured ver entire study perid (quarterly): Number f prescriptins dispensed Number f units (puffs) dispensed Ttal cst f prescriptins Number f users Cst per user Reprt: Overall rates f use Distributin f prescriptins by LAMA (titrpium, glycpyrrnium brmide) Distributin f prescriptins by age (<65, 65+) Limitatins: Aclidinium (Tudrza Genuair) is nt listed n the Ontari public drug frmulary; we are therefre unable t btain utilizatin infrmatin n this drug Objective 2: Trends in Indicatin f Use f LAMAs Design: Crss-sectinal analysis with annual time intervals Study perid: April 2000 t March 2013 Prescriptin Drug Data Surce: Ontari Drug Benefit Database (ODB) Study Ppulatin: Inclusin Criteria: All publically-funded prescriptins fr LAMA prducts (titrpium) dispensed in Ontari Adults aged 35+ at time f LAMA dispensing

4 Outcme(s) f Interest: Measured ver entire study perid (quarterly) Prprtin f LAMA prescriptins dispensed t disease chrts: COPD + Asthma COPD nly Asthma nly Neither asthma nr COPD Stratify all analyses by: Age (<65, 65+) Limitatins: COPD and Asthma diagnsis defined via validated datasets develped at ICES. Althugh these datasets have 85% and 84% sensitivity and 78% and 76% specificity, respectively, there may be sme misclassificatin. COPD database is nly created fr thse aged 35 and lder. Glycpyrrnium brmide (Seebri Breezhaler) was added t the prvincial frmulary in August 2013; therefre, use f this drug will nt be captured in this analysis. We cannt extend the study perid t capture glycpyrrnium use since the COPD and Asthma databases are nly updated t March Aclidinium (Tudrza Genuair) is nt listed n the prvincial drug frmulary. Objective 3: Characteristics f COPD Patients treated with LAMA Prducts in Ontari Design: Crss-sectinal analysis Study perid: April 2012 t March 2013 Prescriptin Drug Data Surces: Ontari Drug Benefit Database (ODB) Study Ppulatin: Inclusin Criteria: All publically-funded beneficiaries f Ontari with a diagnsis f COPD wh are prescribed a LAMA prduct (titrpium) Chrt #1: Adults aged 36+ at time f LAMA dispensing Chrt #2: Adults aged 66+ at time f LAMA dispensing

5 Variable(s) f Interest: Fr each chrt, measure: Number f patients Number f new LAMA users Age Gender Histry f asthma COPD Severity Residence in LTC Drug plan cverage (Senirs, Ontari Disability Supprt Prgram, Ontari Wrks, Lng-Term Care, Hmes fr Special Care, Trillium, Hme Care, Special Drugs Prgram, Other) [based n first prescriptin dispensed ver the study perid) Urban vs. rural residents Sciecnmic status Average annual cst f LAMA prescriptins per persn Past COPD maintenance therapy (1 year; ICS, LABA, ICS/LABA cmbinatin prducts, SABA, SAMA, thephylline) Past treatment fr COPD exacerbatins (1 year) Stratify by: Age (<65, 65+) Limitatins: COPD and Asthma diagnsis defined via validated datasets develped at ICES. Althugh these datasets have 85% and 84% sensitivity and 78% and 76% specificity, respectively, there may be sme misclassificatin. COPD database is nly created fr thse aged 35 and lder. Glycpyrrnium brmide (Seebri Breezhaler) was added t the prvincial frmulary in August 2013; therefre, use f this drug will nt be captured in this analysis. We cannt extend the study perid t capture glycpyrrnium use since the COPD and Asthma databases are nly updated t March Aclidinium (Tudrza Genuair) is nt listed n the prvincial drug frmulary. Objective 4: a. Prevalence f single, dual and triple LAMA therapy Design: Crss-sectinal analysis Study perid: April 2012 t March 2013 Prescriptin Drug Data Surces: Ontari Drug Benefit Database (ODB)

6 Study Ppulatin: Inclusin Criteria: All publically-funded beneficiaries f Ontari with a diagnsis f COPD wh are prescribed an LAMA prduct (titrpium) Adults aged 35+ at time f LAMA dispensing Outcmes f interest: Type f LAMA Therapy DEFINITION OF ONGOING USE Define nging use f LAMA therapy accrding t receipt f a subsequent prescriptin within 180 days f the prir prescriptin. Fr each individual, als define a perid f cntinuus use f: LABA LAMA ICS ICS/LABA cmbinatin prduct Define individuals as single, dual r triple therapy based n whether they have verlapping perids f cntinuus use fr mre than 30 days as fllws: Single Therapy: LAMA with n verlapping use f ther therapies Dual Therapy: LAMA with verlapping use f LABA r ICS Triple therapy: LAMA with verlapping use f either ICS/LABA cmbinatin prduct r verlapping use f bth ICS and LABA prducts Nte: if peple have multiple different types f therapy ver the study perid, assign them t the highest categry. Reprt the fllwing: Number f individuals receiving each type f therapy Stratify by age (<65 vs. 65+) Stratify by COPD severity Stratify by dual therapy (LAMA+ICS, LAMA+LABA) Objective 4: b. Adherence t single, dual, and triple LAMA therapy Design: Crss-sectinal analysis Study perid: April 2008 t March 2013 Prescriptin Drug Data Surces: Ontari Drug Benefit Database (ODB)

7 Study Ppulatin: Inclusin Criteria: All publically-funded beneficiaries f Ontari with a diagnsis f COPD wh are prescribed an LAMA prduct (titrpium) Adults aged 66+ at time f LAMA dispensing Outcmes f interest: Type f LAMA Therapy DEFINITION OF ADHERENCE Define nging use f LAMA therapy accrding t receipt f a subsequent prescriptin within 180 days f the prir prescriptin. Fr each individual, als define a perid f cntinuus use f: LABA LAMA ICS ICS/LABA cmbinatin prduct Define individuals as single, dual r triple therapy based n whether they have verlapping perids f cntinuus use fr mre than 30 days as fllws: Single Therapy: LAMA with n verlapping use f ther therapies Dual Therapy: LAMA with verlapping use f LABA r ICS Triple therapy: LAMA with verlapping use f either ICS/LABA cmbinatin prduct r verlapping use f bth ICS and LABA prducts Nte: if peple have multiple different types f therapy ver the study perid, assign them t the highest categry. Reprt the fllwing: Number f individuals receiving each type f therapy (single, dual, triple) Stratify by COPD severity Stratify by dual therapy (LAMA+ICS, LAMA+LABA) Median duratin f therapy (days) Stratify by therapy type (single, dual, triple) Stratify by COPD severity Stratify by dual therapy (LAMA+ICS, LAMA+LABA) Kaplan Meier curves f time t discntinuatin f therapy Stratify by therapy type (single, dual, triple) Stratify by COPD severity Stratify by type f dual therapy (LAMA+ICS vs. LAMA+LABA) Objective 5: a. Rapid Review f Relevant Literature

8 Objective: Review f ppulatin-based studies n cmparative effectiveness and safety f LAMA prducts amng patients with COPD Study Ppulatin Adults with COPD Observatinal studies Cmparative effectiveness studies Safety studies Study Inclusin Criteria Interventins 1. Canadian ppulatin 2. English Language 3. Published in last 10 years LAMA prducts (in single, dual r triple therapy) Cmparatrs Any COPD therapy Outcmes Any reprted utcmes General Limitatins Tw new LABA+LAMA cmbinatin prducts [indacaterl + glycpyrrnium (Ultibr) and vilanterl + umeclidinium (Anr Ellipta)] were apprved fr marketing in Canada in early There is therefre n utilizatin data available fr these prducts during the study perid; as a result, these prducts will nt be captured in this analysis.