Real World Pharma – Affordability vs. Cost Effectiveness. Impressions from 18th ISPOR in Milan

Attending ISPOR when keeping your ear to the ground in Market Access matters is non-negotiable. And this year was no exception. Noticeable to us was that many presentations and workshops revolved around two important and related concepts: affordability and uncertainty. Here is some background.

Affordability is very different from cost effectiveness. Cost effectiveness is often based on long-term models accruing savings over multiple years, while affordability depends on the short-term budget impact at time “t”.

This means that these days many therapies that are seen as cost effective might not actually be affordable for health systems. This is especially true for therapies that project to be curative, and therefore are priced very high compared to chronic treatments. Most have probably followed the controversy surrounding Sovaldi pricing in Hep C in recent years, as just one example of many.

This year uncertainty in assessing value was a particular hot topic. It is increasingly difficult for payers to assess the real value of therapies based on the data provided at the time of price negotiations. We see increasing splicing of the market with many products now approved rapidly on small studies. While it remains easy for payers to say “no” to coverage, in the case of positive decisions it is increasingly difficult to say “how much”. As a result, payers are looking for Adaptive Pathways including not only regulatory but also reimbursement and pricing decisions.

What does this mean? As part of this discussion, ISPOR participants also debated the topic of Coverage with Evidence Development (CED) vs. individual pay for performance.  The latter is perceived as difficult and costly to implement on a large scale. A CED approach allows for the identification of outstanding value uncertainties at the end of regulatory and to link coverage for the overall target population to answering of these questions. However, CED requires enforcing post-marketing evidence requirements, something which is poorly done at present.

To us the implication for the industry is to evolve payer evidence generation from a “hunter gatherer” approach to a planned and considered “farmer” approach where evidence targeted to answer payers’ questions can be produced quickly, regularly and with adaptability, or a combination of the two.

To find out how groupH is already assisting its customers with this in mind, please click on the links below;

How groupH can assist in developing Market Access strategies