Dr Ira Klein Discusses Value-Based Care in Pharmaceutical Development

When looking at the value of a medication, pharmaceutical companies are looking at outcomes, including ones that encompass patient centricity, said Ira Klein, MD, MBA, FACP, senior director of healthcare quality strategy for the Strategic Customer Group at Janssen Pharmaceuticals.

When looking at the value of a medication, pharmaceutical companies are looking at outcomes, including ones that encompass patient centricity, said Ira Klein, MD, MBA, FACP, senior director of healthcare quality strategy for the Strategic Customer Group at Janssen Pharmaceuticals.

Transcript

What are pharmaceutical developers looking for out of value-based care?

The pharmaceutical industry is concerned with finding cures, alleviating illness, and serving a patient population that’s presently not well served through the therapeutic alternatives that they have today. A definition of value that I think is fairly universal is one that says we will measure the outcomes obtained over the resources inputted. Some people like to simplify this to say that it’s quality over cost but something about quality: you have to think about quality for whom?

So, when I think about the outcomes I think about not just things that were said in labelling discussions with the Food and Drug Administration, things like overall survival rate, progression free survival, attainment of certain laboratory metrics. But I think about the greater metrics that really encompass patient centricity. Those include: can a patient get out of bed, and feel like they can function on a daily basis? What are the ability of a drug to allow a person to work or care for another person or participate in activities that they were previously limited from participating in? So I think as we really expand the definition of quality in an overall definition of value, we have to think about the patient-reported outcomes and we have to think about a more general way of measuring the outcomes.

And on the cost-incurred side I think we have to be more broad. We need to think not just what is the wholesale price of a drug, we need to dig deeper and ask: is that the price really paid? Because it never is today. There are rebates and discounts there are other factors involved such as the price paid are often not the price reported. In addition to the resources spent, we have to think about what are the other resources deployed. If there is time and energy expended prior to therapy on taking care of other people or not having the ability to care for other people, not having the ability to work, and then those are returned then that probably should be factored into any type of costing and pricing in terms of costs.

I think our value definition is fairly holistic and it’s very patient centric. It’s something that you don’t see as simply an econometric statistic on an annual basis.