Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative

Participants, interventions, and outcomes: Eight counties have been non-randomly selected for inclusion in the study. Initially, Novartis Access medicines will be sold solely to the Mission for Essential Drugs and Supplies (MEDS), the main supplier for the large network of private (often faith-based) non-profit health facilities in the country, and also a key supplier for public facilities in several counties. Of the 47 total counties in Kenya, 17 counties were excluded because they do not purchase medicines from MEDS, and an additional 15 counties were excluded that had not purchased at least 10 million KES worth of medicines through MEDS in the previous year. Three counties were excluded due to security concerns, and four additional counties were excluded to eliminate shared borders in the final sample, to minimize the risk of contamination between intervention and control counties. When considering counties with shared borders, those with the lower volume of MEDS purchases in the previous year were excluded.

In Kenya, NCD services are provided in the public and private non-profit sectors at level 2 dispensaries up through level 6 hospitals. Not all counties have a level 6 hospital, and for this reason they are excluded from the study. Counties have on average: five public and private non-profit level 5 county referral hospitals; three public level 4 sub-county hospitals; 15 public and private non-profit level 3 health centers; and 85 public and private non-profit level 2 dispensaries. All 184 eligible level 3-5 facilities will be included in the study, and 200 level 2 dispensaries will be randomly selected for inclusion. For each facility included in the study, one private drug seller identified as the main alternative for that facility will be identified and included. Private drug sellers include pharmacies, drug stores, and dispensing doctors.

A total sample of 800 households will be randomly selected from the eight study counties (400 from Novartis Access counties; 400 from control counties) using a two-stage sampling procedure. In the first stage, 10 enumeration areas (EAs) will be selected in each county with probability proportional to size based on data from the most recent census. Then, in the second stage, 10 eligible households will be randomly selected in each EA and recruited into the study. All households in the EA will be listed in a random order, and enumerators will proceed down the list until 10 eligible households are identified. Households will be eligible if at least one member at least 18 years old has been previously diagnosed and prescribed medicine for NCDs addressed by Novartis Access, including diabetes, hypertension, breast cancer, and asthma. All members of the household who fit that criterion will be recruited for the study. Based on the prevalence of the relevant NCD conditions in Kenya, 20% of all households will meet the inclusion criterion.

In intervention counties, public and private non-profit health facilities will be allowed to purchase subsidized Novartis Access NCD medicines through MEDS. The Novartis Access portfolio includes 15 medicines to treat diabetes, hypertension, breast cancer, and asthma. While the portfolio includes patented medicines usually marketed and sold under the Novartis brand and generics under the Sandoz brand, all medicines sold through the initiative will be packaged with the new Novartis Access brand. The medicines will be sold directly to MEDS at an average cost of 150 Kenyan Shillings (KES), around US$1.50, per monthly dose. Facility-level administrative data on NCD medicine purchases obtained from MEDS will be used to monitor the implementation of the intervention.

The primary outcomes of interest are medicine availability and price at health facilities, and medicine availability, price, and expenditures at patients' households. Availability at facilities is defined as the proportion of Novartis Access medicines and equivalents in stock on the day of data collection. Availability at households is defined as the proportion of prescribed Novartis Access medicines and equivalents in the home on the day of data collection. The price of NCD medicines sold by private for-profit drug sellers is an important secondary outcome. Patient perceptions of NCD medicine access will also be explored. Data will be collected at facilities and households using a structured questionnaire at baseline prior to the implementation of Novartis Access, at midline after one year, and at end line after two years. At each of these interviews, a subsample of facilities and households will also be administered a qualitative interview. Additional data will be collected quarterly from facilities and a randomly selected subsample of households using a structured questionnaire administered over the phone.