Wednesday, June 3, 2015
Implementing Antibiotic Incentives
OK. Let’s say that somehow, someone, somewhere comes up with several billion dollars to provide the upfront payments for new antibiotics to fight resistant pathogens. How will this incentive be implemented? Here are a few considerations in this regard. I’m sure I have missed many other issues that some of you may be able to point out.
1. If this is to be a one-time upfront payment of a lump sum as suggested by O’Neill’s report, what is the term of obligation of the pharmaceutical company to supply the new product at low price or free of charge?
a. The term should be linked to the exclusivity of sales of the product in some way. At the same time, therefore, there must be a way for the company to transition to charging some price once exclusivity has expired. This will incentivize generic companies to produce the product and will help keep prices low after the period of exclusivity.
2. Who will be responsible for distributing the product to hospitals and other healthcare facilities?
a. The pharmaceutical company. They have the systems in place to provide this service whereas governments are generally not equipped to take this on.
3. Who will decide what kinds of antibiotics are needed and which might be candidates for the incentive payment?
a. I think that this question will have to be dealt with within each market individually. In the US, it might be a committee of experts including the Infectious Diseases Society of America, the FDA and perhaps others. In Europe, there might be different answers from different markets within Europe. For example Greece and Spain might have different needs than the Netherlands. Here – Europe would actually have to hang together on the financial front (good luck on that).
4. De-linkage? I agree with many that the idea of de-linkage could be a good thing. With an upfront payment for a new antibiotic, the need for marketing to garner sales and perhaps encouraging unnecessary over-use of antibiotics is no longer present or is at least greatly diminished. But no one is talking about education. That is, when a new product, especially a pharmaceutical product, hits the market, there is a considerable educational need such that physicians understand how and when it is appropriate to use the new product. With no incentive for the pharmaceutical company to carry out this important educational function – who will do this and how? Will this be left to professional societies like the Infectious Diseases Society of America? Will the CDC take this on? If they do – who is paying for that effort? As much as I admire these lofty and important organizations, I do not think they are prepared for this. And if this is the plan, will these organizations be held to the same restrictions on what they can say (don’t stray from the regulatory label) as a company would? And how will they reach all the US physicians? In the US, almost 80% of US hospitals have less than 200 beds and over 50% have less than 100 beds. Who will reach out to those hospitals and how? Did I hear you say, “Webinars?” That won’t work in my hospital (less than 100 beds). In my hospital, someone will actually have to come and provide a continuing education seminar. Then there will have to be follow-up contacts with the ID physician and the pharmacy. Who is doing that? I don’t have this answer. Do you?
I am vehemently in favor of the kind of incentives included in the O’Neill report. But I do not yet see a clear path to implementing them. Lets have some help here.