A case for evidence-based healthcare policy
The Union government has made some serious commitments to improving health indicators and tackling disease in the country. The drive to eradicate multiple diseases and tame Kala-azar and filariasis by 2017, leprosy by 2018, measles by 2020 and tuberculosis by 2025 are all noble causes. IMR (infant mortality rate) is projected to come down from 39 in 2014 to 28 per 1,000 live births in 2019 and MMR (maternal mortality rate) from 167 in 2011-13 to 100 per 100,000 live births by 2018. The recent price caps on stents is also being seen as a measure to address the burden of heart disease in the
One applauds the government for taking these steps for improving the overall healthcare scenario in the country. But what is of concern is that while the goal is clearly defined, the road map often gets mired in a number of issues. The loftiness that elevates the intent proves to be a liability when applied to tactical issues. What’s especially a concern is that healthcare decision-making is often isolated from the rigour of evidence-based healthcare.
These views could be read as sweeping generalizations, but healthcare decision-makers, more often than not, have ignored integrating individual clinical expertise with the best available external clinical evidence from systematic research. Our health policies are skewed towards lowering costs through unilateral diktats and unscientific calculations. Public administrators are always struggling to separate evidence from speculation, balance economics and emotion, and reconcile policy and politics.
Many factors come in the way of formulating sound public policies. First, policymakers are often required to take decisions with very little reliable information, let alone evidence. Second, policymakers find themselves on shaky ground because many economists who advise them do not fully factor in the significance of history, culture and context. Third, to improve knowledge, policymakers often commission evaluations. They commonly tend to use two criteria to assess the quality of the evaluation report. The first is to match the findings with their own understanding of ground reality. If the findings coincide reasonably well, then it is a good report. The second is simply political expediency. If the report matches current ideology, it is kosher.
One recent case in point to explain what is happening all over is the February order by the National Pharmaceutical Pricing Authority (NPPA) for putting a price ceiling on cardiac stents. Many countries are, like India, struggling with a complex set of economic and ethical challenges in healthcare financing. Introduction of penalties, fines, and price caps have become common policy tools to address some of these dilemmas. The assumption is that creating such deterrence around decisions will moderate the behaviours of various actors.
However, with the rest of the ecosystem unchanged around these decisions, and the failure to even begin to address structural issues, such interventions lead to actions and decisions that may not be sustainable. The nature of the stents price-cap raises questions about the efficacy of such strategies. By being fixated on stents and ignoring the other factors that need to be controlled, what has been demonstrated is that the easiest course may often not be the best. And in this case, the course taken is also bereft of robust evidence.
The NPPA states that there is no evidence to price stents differently, and has therefore included all stents under the same price. The issue here is that medical device standards are just about evolving in India. Mechanisms of evaluation and evidence are based on standards borrowed from the drug industry. Medical devices are different, in the sense that they include additional elements of engineering, biomechanics, material science, etc. Just because available evidence does not factor in advances that go beyond conventional norms, the NPPA made a decision that, instead of opening the medical devices field, has possibly imploded it, to the detriment of the patient.
The very popular 85% price reduction in cardiac stents may create political capital, but it could run a nascent industry to the ground as device companies realize that the freedom of choice of what products to sell is not available to them. No wonder then that some stent companies are seething. On the one hand, the NPPA decided that all stents are the same, and on the other, it did not allow them to withdraw commercially unviable products. This is reflective of the dichotomy in healthcare decision-making, and makes the government look like a “big brother”. To a great extent, the device-makers have themselves to blame. The unreasonable, exorbitant margins had to go and they have, but the NPPA has thrown the baby out with the bathwater. This needs to be addressed as the government starts looking at implementing similar price controls on other devices.
India would do well to adopt a comprehensive health technology assessment that is a multidisciplinary process that handles and analyses information on medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. It would be a better approach to informed decision making on funding decisions leading to efficient access and use of technology.
Amir Ullah Khan is policy adviser at the Bill & Melinda Gates Foundation, visiting professor, ISB, and director, research, Aequitas Health Consulting.
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