Peter C Rockers1, Richard O Laing2, Paul G Ashigbie3, Monica A Onyango3, Carol K Mukiira4, Veronika J Wirtz3. 1. Department of Global Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: prockers@bu.edu. 2. Department of Global Health, Boston University School of Public Health, Boston, MA, USA; School of Public Health, Faculty of Community and Health Sciences, University of Western Cape, Cape Town, South Africa. 3. Department of Global Health, Boston University School of Public Health, Boston, MA, USA. 4. Department of Demography and Population Studies, University of the Witwatersrand, Johannesburg, South Africa.
Abstract
BACKGROUND:Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme. METHODS: We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095). FINDINGS: On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted β [aβ] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aβ 0·48, 95% CI -1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569). INTERPRETATION:Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis's efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally. FUNDING: Sandoz International (a subsidiary of Novartis International).
RCT Entities:
BACKGROUND: Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme. METHODS: We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095). FINDINGS: On March 8, 2016, we randomly assigned eight clusters to intervention (four clusters; 74 health facilities; 342 patients) or control (four clusters; 63 health facilities; 297 patients). 69 intervention and 58 control health facilities, and 306 intervention and 265 control patients were evaluated after a 15 month intervention period (last visit February 28, 2018). Novartis Access significantly increased the availability of amlodipine (adjusted odds ratio [aOR] 2·84, 95% CI 1·10 to 7·37; p=0·031) and metformin (aOR 4·78, 95% CI 1·44 to 15·86; p=0·011) at health facilities, but did not affect the availability of portfolio medicines overall (adjusted β [aβ] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aβ 0·48, 95% CI -1·12 to 0·72; p=0·500). The programme did not affect medicine availability at patient households (aOR 0·83, 95% CI 0·44 to 1·57; p=0·569). INTERPRETATION: Novartis Access had little effect in its first year in Kenya. Access programmes operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access. The evidence generated by this study will inform Novartis's efforts to improve their programme going forward. The study also contributes to the public evidence base on strategies for improving access to medicines globally. FUNDING: Sandoz International (a subsidiary of Novartis International).
Authors: Paul G Ashigbie; Peter C Rockers; Richard O Laing; Howard J Cabral; Monica A Onyango; John Mboya; Daniella Arends; Veronika J Wirtz Journal: Health Policy Plan Date: 2021-05-17 Impact factor: 3.344
Authors: Veronika J Wirtz; Edson Servan-Mori; John Mungai; John Mboya; Peter C Rockers; Monica A Onyango; Zana Wangari Kiragu; Richard Laing Journal: Int J Health Plann Manage Date: 2021-10-21
Authors: Paul G Ashigbie; Peter C Rockers; Richard O Laing; Howard J Cabral; Monica A Onyango; John Paul Likalamu Buleti; Veronika J Wirtz Journal: BMJ Open Date: 2020-05-15 Impact factor: 2.692
Authors: Brian Godman; Debashis Basu; Yogan Pillay; Julius C Mwita; Godfrey Mutashambara Rwegerera; Bene D Anand Paramadhas; Celda Tiroyakgosi; Patrick Mbah Okwen; Loveline Lum Niba; Justice Nonvignon; Israel Sefah; Margaret Oluka; Anastasia N Guantai; Dan Kibuule; Francis Kalemeera; Mwangana Mubita; Joseph Fadare; Olayinka O Ogunleye; Larry A Distiller; Enos M Rampamba; Jeffrey Wing; Debjani Mueller; Abubakr Alfadl; Adefolarin A Amu; Zinhle Matsebula; Aubrey Kalungia; Trust Zaranyika; Nyasha Masuka; Janney Wale; Ruaraidh Hill; Amanj Kurdi; Angela Timoney; Stephen Campbell; Johanna C Meyer Journal: Front Pharmacol Date: 2020-03-20 Impact factor: 5.810