Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial

Lancet Global Health
Apr 2019  Volume 7Number 4e385-e532
http://www.thelancet.com/journals/langlo/issue/current

Articles
Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: a cluster-randomised controlled trial
Peter C Rockers, Richard O Laing, Paul G Ashigbie, Monica A Onyango, Carol K Mukiira, Veronika J Wirtz
Summary
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).

Research in context
Evidence before this study
In 2016, we conducted a systematic review to identify published evaluations of pharmaceutical industry-led access programmes in low-income and middle-income countries and to assess the quality of the available evidence on the effect of these programmes. First, we developed a list of industry-led access programmes by reviewing the Health Partnerships Directory of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Information from the directory was supplemented with information from reports published by the Access to Medicine Index and annual and corporate social responsibility reports for non-IFPMA companies. On May 1, 2016, we searched PubMed, Google Web, and Google Scholar for published evaluations of identified access programmes, using as search terms the name of the programme, the name of the company, the focus disease, and the focus countries. We did not set restrictions on the publication date of evaluations. We identified 120 access programmes that fit our criteria, seven of which had at least one published evaluation. We reviewed all of the published evaluations and assessed their quality using the GRADE system. None of the evaluations were rated as high quality and three were rated as moderate quality. We found no previous evaluations that used a randomised controlled trial design. None of the published evaluations provided clear evidence on the effect of a price reduction programme similar to Novartis Access.
Added value of this study
To our knowledge, this study is the first randomised controlled trial assessing the effect of a pharmaceutical industry-led access to medicines programme. We found that Novartis Access, a programme offering a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in Kenya, had little effect during its first year on the availability of medicines at facilities. Although the programme significantly increased the availability of amlodipine and metformin at health facilities, there was no effect on medicine prices or on availability at patient households. The study contributes to the public evidence base on strategies for improving access to non-communicable diseases medicines in low-income and middle-income countries. The study also contributes to ongoing discussions on the role of measurement and transparency in establishing accountability for private sector social programmes.
Implications of all the available evidence
Novartis Access is one of a growing number of pharmaceutical industry-led access programmes. Few of these programmes have been rigorously evaluated, and little is known about their effect or which strategies work best to improve access. This study suggests that offering a portfolio of medicines at a reduced price might not lead to immediate improvements in patient access. In order to build a more robust evidence base on this important topic and ensure accountability, rigorous measurement and transparent reporting should be adopted as a standard for pharmaceutical industry efforts to improve access to medicines globally. This study demonstrates that pharmaceutical companies can use robust, high-quality methods to evaluate their access programmes.