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

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 ß [aß] 0·05, 95% CI -0·01 to 0·10; p=0·096) or their price (aß 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).

Perceptions of Kenyan adults on access to medicines for non-communicable diseases: A qualitative study.

In Kenya, noncommunicable diseases (NCDs) account for 27% of all deaths. Adult Kenyans have an 18% chance of dying prematurely from cancers, diabetes, cardiovascular diseases or chronic respiratory diseases. A Novartis Access Initiative is making medicines available to treat cardiovascular diseases, diabetes, chronic respiratory diseases, and breast cancer in 30 countries, including Kenya. Little is known about patients' perceptions of access to medicines for NCDs in Kenya. The study objective was to understand patients' perceptions of access to medicines; as well as barriers and facilitators at the household, community, and healthcare system level. A baseline qualitative study was conducted in eight of 47 counties as part of an evaluation of the Novartis Access Initiative in Kenya. The 84 patients interviewed through a household survey had been diagnosed and treated for an NCD. Although medicines at government facilities were free or cheaper than those sold in private pharmacies, the availability of medicines presented a constant challenge. Patients often resorted to private pharmacies, where NCD medicines cost more than at public facilities. Participants with an NCD took their health seriously and strove to get the medicines, even under difficult circumstances. Buying NCD medicines put a strain on the household budget, especially for the lower-income participants. Some actions to overcome affordability barriers included: borrowing money, selling assets, seeking help from relatives, taking on extra work, buying partial dosages, leaving without the medicines, or resorting to non-medical alternatives. In conclusion, access to NCD medicines is a major challenge for most adults in Kenya. As a result, they engage in complex interactions between public, private facilities and pharmacies to overcome the barriers. The government should ensure well-stocked public sector pharmacies and subsidize prices of medicines for lower-income patients. Integration of industry-led access to medicine programs may help governments to obtain low cost supplies.