Thursday, May 13, 2010

HTA Agencies: Industry Perspective

What is HTA?

The International Network of Agencies for Health Technology Assessment (INAHTA) defines Healthcare Technology assessment as:

  • Healthcare technology is defined as prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained.
  • Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.

(Source:; May 2010)

One important word above is implication. Since no technology will bring the same implications in two or more different settings, there is a need for HTA reports to adequately reflect their local scenarios and realities.

Industry perspective

HTA agencies all around the world are becoming more connected than ever, and an overseas report about your product may quickly influence the Payors’ decision in your market. Nobody wants to be caught by surprise and hear from their sales reps that the new product is no longer being reimbursed because of a decision taken by Agency X in country Y.

Although it is vital to monitor HTA reports and appraisals across the globe; the decision to proactively apply for an HTA evaluation in your market depends upon other factors.

First, you need to make sure you have strong clinical and economic data, demonstrating effectiveness in the local scenario. This is usually not the case when a product has just been launched, so it is ideal to have a plan covering which countries will be the first to have local economic analysis initiated.

Second and final, there is a unique risk-benefit situation. In case you apply and everything goes well, the product will likely be reimbursed or at least validated in the whole market. On the other hand, if the appraisal is negative doors will be closed for the product. Although there is a myriad of possibilities between fully negative and fully positive indications (for instance: approved for use in only X,Y and Z conditions, or approved only for X days etc), the worst-case scenario must always be considered.

In summary, if the decision is to go for an HTA submission, and all studies and data are good, then it is always prudent to have a Plan B. What should your company/department do if the HTA report is completely negative? A good start is to check what similar products where approved/not approved and why. The reasons may be used against a potential negative decision.

One market, many decision-makers?

Depending on the level of autonomy of its regions, a country may have a few or even many relevant HTA agencies. While these agencies may claim autonomy from each other, there is always a level of influence from one regional agency to another. This is the case of Spain and Italy.

Another parallel situation occurs in the private market. Brazil has a single public health care system, which translates into a single HTA agency. However, some private health plans in Brazil perform their own HTA evaluations independently from the government. Again, many HTAs agencies.

The best situation, particularly for new products, is to always apply for regional HTA evaluations. Also important is to understand the level of influence from one region on others, and decide for the best bottom-up approach which will allow your company to gather small victories towards a more solid submission for larger regional and/or national agencies. The “low-hanging fruit” rationale also applies here.

When considering HTA submissions, one cannot be too cautious. A couple of years ago, a decision in France would not reflect much in the US, but this is not the reality anymore. Of course, this is a tougher situation for “smaller global companies” that sell products across many countries, but cannot afford to have people watching all markets. In these cases consultants may become of great help, but it is always better to have an in-house HTA surveillance.

Should I stay or should I go

If you have three things: 1) enough strong and local data (clinical/economic); 2) a sequence of action to decide with agencies to target first, and 3) a plan in case of a complete negative appraisal, then go for it. Again, if you start small and target minor agencies, it will all become much easier to move further or to respond to negative recommendations.

Finally, I strongly believe in HTAs as a professional but also as a covered individual. Of course, most of the agencies (if not all) recognize their limitations and are attempting to be as fair and cautious as possible with their reports; but I also see the need for industry to become more involved with them. At the end, this has everything to become a win-win situation for all stakeholders, starting with patients.

Wish you success with your submissions!

Ernesto M. Nogueira