First-of-its-Kind Randomized Trial Studies Medication Access

A study through the Boston University School of Medicine is the first of its kind to use a randomized trial design to produce thorough evidence on the impact of a pharmaceutical industry-led medicines access program.

Published in Lancet Global Health, the study evaluated Novartis Access, a Novartis social business program in Kenya to contribute to the public evidence base on strategies for improving access to medicines globally. Novartis Access currently offers a portfolio of non-communicable disease (NCD) medicines at a wholesale price of $1 per treatment per month.

The investigators evaluated the effect of the first 15 months of Novartis Access in Kenya, the first country to use the system. Four Kenyan counties received the Novartis Access intervention, with public and non-profit health facilities purchasing Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Households in these counties were also eligible if they had at least 1 adult patient who had been diagnosed and prescribed medicines for one of the NCDs targeted by the program: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer, according to the press release.

The study analyzed NCD medication access over the first 15 months within the 4 Kenyan counties and with access to 4 other counties with similar demographics and health variables. The authors combined household and facility data collection with repeated, in-depth interviews of patients and the medicine providers. The investigators were also able to collect information monthly from households and facilities on NCD medicine availability and prices due to the high levels of cell phone ownership in Kenya.

The results indicating that the program significantly increased the availability of 2 medications, the hypertension drug amlodipine and the type-2 diabetes drug metformin, yet the program did not affect the prices of the drugs or increase availability in households.

"Access programs operate within complex health systems and reducing the wholesale price of medicines might not always or immediately translate to improved patient access," explained Veronika Wirtz, MSc, PhD, co-author of the study.

The researchers also found that although patients were usually diagnosed with an NCD in the public or faith-based mission sector, most patients obtained their NCD medicines from the private sector, according to the press release.

"This first-of-its-kind study demonstrates that it is possible to evaluate access programs undertaken by major pharmaceutical companies using robust, 'gold standard' methods," said study co-author Richard Laing, MBChB, MSc (CHDC) MD.