The Little Blue Pill That Can Protect Your Heart?

By Karlena Luz Sep. 9, 2016

Pulmonary Arterial Hypertension (PAH) is a life-threatening condition that makes it harder for blood to flow due to narrow or blocked arteries. As a result, the heart has to work harder to pump blood, which eventually makes it weaker and increases the risk of heart failure.

Incidentally, the drug sildenafil, originally tested for heart problems on the basis of its vasodilatory effects (which widens the blood vessels), can become a treatment for PAH patients. Despite its original intentions, in its first decade (1998-2008), the focus of the drug shifted from treating angina (chest pain), of which the treatment outcome was not satisfactory, to treating erectile dysfunction. As such, it became one of the most commercially successful drugs in the world. Its commercial successes did not incentivize companies to also register it for the indication to treat PAH despite many subsequent experiments, studies, randomized controlled trials, and clinician reports that say the little blue pill may actually be a good if not better treatment for PAH relative to other drugs.

In the case of Indonesia, an estimated number of 500 cases of PAH were reported in 2015. Currently, beraprost is the only available treatment approved for PAH by Indonesia’s national formulary. Local clinicians regard sildenafil as clinically more effective than beraprost. However, sildenafil is not listed in the national drugs formulary due to pharmaceutical companies’ non-registration of the product for the PAH indication. Some doses of sildenafil, e.g. 20 mg, for PAH indication is also not available in Indonesia Additionally, it is not included in the Indonesian benefits package of Jaminan Kasehatan Nasional (JKN).

To investigate its practical use in the Indonesian context, Indonesia’s Health Technology Assessment (HTA) Committee had commissioned a team to conduct a model-based economic evaluation and a budget impact analysis for using sildenafil as a first line treatment for PAH patients. This study was completed in the last quarter of 2015. There are reports that the government is considering allowing access to sildenafil for PAH through a Special Access Scheme.

In this effort, the Health Intervention and Technology Assessment Project (HITAP) Thailand, on behalf of the International Decision Support Initiative (iDSI) provided technical support to the team conducting the study. By embarking on this study, there is hope to providing better access to medicines in the country. We would like to acknowledge the Access and Delivery Partnership (ADP) for their support.