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: http://www.inahta.org/HTA; 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 

5 simple things to consider in Market Access

Still time to wish you a very happy New Year!

Thank you for visiting my blog. May 2010 be as prosperous and exciting as you wish.

As the year approaches its end, I’m resuming my posts in this blog. Look forward to readers’ comments! 

Market Access to whom?

The term “Market Access” is very often used by the World Trade Organization to define the conditions agreed by governments for the entry of specific goods into their markets.

In Health Care, it defines the processes through which companies access (sell to) specific markets. Note that I use “specific markets” and not countries, governments or regions because you may find several different markets within the same geographic location. For instance, while the National Health Service (NHS) embraces the three health care systems in Great Britain, health care delivery and improvements are decided by local Primary Care Trusts (PCTs). And there are more than 30 PCTs in London only.

The point here is that you may have a good idea of what Market Access is. But you won’t be able to develop any solid Market Access strategy before knowing who your specific market is.

Patient population

Every day companies target patients with market campaigns and strategies. The issue is the fact that not all patients are the same. I remember a large campaign to promote blood glucose monitors for Diabetic patients. As part of the team, I raised some questions that, although seemed obvious, had yet not been considered.

• Are we targeting Diabetic patients type 1 or 2? (easy one…)
• In the public or private market? (started to get a little bit complex)
• At what stage of the Diabetes?
• With or without co-morbidities?

As a former colleague used to say…”obvious things must be said twice, at least”.

None of the individuals in the team could go beyond the 3^rd question, which clearly meant they didn’t know to whom they were attempting to sell their products.

It is crucial to know your patient population, and the first step to do it is to understand the disease and how it affects people. When I was working in a Hepatitis Vaccine project for Substance Abusers, the first thing I noticed was that not all Substance Abusers were the same (again, pretty obvious, but…). Injection-drug users were much more likely to be infected by Hepatitis than alcohol abusers, for instance, and that meant a completely different Access strategy.

Stakeholders

Once you understand the disease and your patient population, everything becomes very linear. The next step is to define the relevant stakeholders and what they value in health care.

This is a very important step for those working with Value Dossiers. Quick question: can you develop Value Dossiers if you don’t know what value means for your relevant stakeholders?

(And yes…You cannot define the relevant stakeholders unless you know your patient population.)

Let’s take the example of a minimally invasive surgery (MIS) versus open surgery. Under the patient perspective, a minimally invasive approach results is less scaring and shorter length of stay in the hospital.

On the other hand, MIS tend to be more expensive than open surgeries. If speaking to a health plan, should we promote its aesthetical benefits? Sure patients value that, but is this valued by these payers? On the other hand, the shorter length of hospital stay as compared to open surgeries may translate into economic benefits, as health plans will pay for fewer room days. Eventually, this benefit may overcome the cost of surgery, making the MIS overall (surgery + hospital stay) cheaper than open procedures.

This is a very basic, but real, example. I’m not saying we should all look for the ONE single powerful value. On the contrary, we need to assess different stakeholders with different values, and approach each of them independently. This is the real Value Dossier mission.

In a nutshell

1)     Understand the disease

2)     Define the patient population

3)     Identify relevant stakeholders

4)     Assess patients and stakeholders values

5)     Develop your Value Proposition

The future?

It is always good to write about the future at the brink of an ending year.

About two weeks ago I was asked what I thought about the future of Market Access. I found this a very interesting question, especially because I worked for several years in Marketing only.

I inverted the question to answer it. In my opinion, the future of Health Care is Market Access.

More and more expensive health care technologies are launched each year, populations get larger and older, new diseases occur and many other aspects take place over limited financial resources to guarantee access to care for everyone. It doesn’t take much effort to see that the traditional Marketing efforts will not work anymore in a few years.

In a few words, I’m happy to be a Market Access professional. There is no doubt that my (our) expertise is becoming more and more valued each day. And if there is something certain about the future of Health Care, is that we won’t have enough money to pay for everything for everyone.

And this is where the ultimate mission of Market Access comes: to enable patients access to health care. We’ll talk more about this.

Happy New Year!!!

Ernesto M. Nogueira 

Winning in Emerging Markets

Last Post Review

A LONG time ago I posted my last blog feed about one of my favorite topics: Evidence-Based Marketing; or the use of Marketing Strategies reinforced by evidence and data. Another way to describe it (and which may sound more familiar) is Value-Based Strategies. In both cases, it means emphasizing the value offered by a certain health care product, and not only its benefits. After all, not all benefits turn into value, right?

Now, after a few months away from my blog I decided to resume my activities putting some thoughts on emerging markets, under the perspective of Health Care business.

BRIC Power!

The first time I heard about the BRICs was in the 90s when still in high school; and frankly, much before Jim O’Neill from Goldman Sachs “created” the term. Brazil, Russia, India and China, although far from what they represent now, were expected to have such a fast development that they would become major players in the global Economy. At that time, few would believe it, and I wasn’t one of them despite my Brazilian heart.

Nowadays it is very easy to find numbers and analyses justifying the importance of the BRICs to the world economy, but this is just the tip of the iceberg. Emerging markets have dominated the scene for quite some time now, and the BRICs is on top of that given the market size and potential of these four countries.

This is not a blog about Economy, but my point is that emerging markets represent countries experiencing fast industrialization process, with people increasing their income and, therefore, consumption. When you combine an emerging economy with a huge population the effects are geometric: imagine if just 10% of China’s 1.3 Billion people start to relocate from rural to urban areas, earn more money and spend more in clothing, food, entertainment, health care…Imagine what this would represent in terms of market potential for new products and companies. Now stop imagining because this is happening every year, and at a faster rate of about 15.3% (source: The World Factbook, CIA).

The comparison is clear: where would you market your products: a) in a highly-competitive, saturated market, or b) somewhere else with just a few (if any) competitors and with a market that is eager to spend what it hasn’t spent for the past years?

According to the World Bank, on average the world is expected to grow its GDP at 2.7% and 3.0% in 2008 and 2009, respectively. The U.S. GDP is expected to grow at 1.1% and 1.9% in the same period. Now, what about the BRICs?

Brazil: (2008) 4.6%; (2009): 4.4%

Russia: (2008) 7.1%; (2009): 6.3%

India: (2008) 7.0%; (2009): 7.5%

China: (2008) 9.4%; (2009): 9.2%

Together, the BRIC countries represent almost 41% of the world’s population, and in a simple average is growing at 7%, or more than twice the average global growth rate. (For Math fans, the weighted BRICs growth average is even higher: 8%).

Implications for Health Care

As my returning post after a few months “in silence”, I just wanted to call your attention to a logical equation: should we invest where we can obtain higher returns? Let’s analyze the significance and implications of BRICs to Health Care.

The Health Care market, most noticeably Pharma industry, is experiencing a tough period. With blockbuster drugs losing patents and generics entering the market each day, the average product price has been falling steadily, and so are margins.

Well, a broken patent in Germany is also a broken patent in Brazil, so there is no safe place for old blockbuster drugs. However, these blockbuster formulas were initially created for individuals living in developed countries and with a very specific epidemiology. The list goes on diabetes, high cholesterol, obesity, stress, depression, cancer…with this last therapy area being very difficult and expensive to be replicated by generics.

Now, what about unexplored and untapped areas such as vaccines, infections, tropical diseases and severe digestive illnesses? Of course you’re thinking “well, there are a lot of vaccines out there” and that’s right! Out there, in the developed markets, there are a lot of vaccines for sure. And, by the way, one single disease may have different virus strains depending on the world’s region – U.S., Latin America, Africa, Asia etc. Now guess which regions are usually considered for vaccine development?

I’m not talking about “orphan” drugs or diseases, but about creating emerging market plans for health care products. It doesn’t help to say “well, China will grow about 9% this year, so we should be able to increase sales for our Bariatric surgery equipment there”. (Bariatric surgery is the procedure indicated for people with a certain minimum degree of excess body fat).

Mistake 1: Assume that China would be like anywhere else. Fact: obesity is not an issue there.

Mistake 2: Initially, GDP growth has nothing to do with health care sales increase, unless you create a plan for that.

I remember entering a director’s office in my company to report a project’s conclusion. He was sitting on his chair, reading the newspaper with a very serious expression on his face.

- “What happened?” I said.

- “Well, it says here that Brazil’s economy will be the 5^th in the world by 2030 and is growing at a very fast pace as compared to other emerging markets.”

- “And what’s the matter with that?”

- “Well…” and the director looked at me with very disturbed expression. “…headquarters are questioning why our sales are not growing at the same rate.”

(And this director’s region already had the highest sales growth in the world for his division.)

Ernesto M. Nogueira