Last week I participated in a two-day seminar held by the Consejo de Salubridad General of Mexico. The topic was “Farmacoeconomia: una nueva era en la toma de decisiones,” (“Pharmacoeconomics: a new age for decision making.) The conference’s subtitle was important, “una vision internacional.”
The “internacional” part consisted of myself, Michael Drummond, Professor of Health Economics (University of York), Professor Jacques Lelorier, Chief of the Pharmaco-economics and Pharmaco-epidemiology research unit at the University of Montreal, and Kalipso Chalkidou, Acting Director of Policy Consulting at NICE.
The seminar was designed to debate and discuss Mexico’s new pharmaco-economic guidelines for their national formulary. And there was as much debate as discussion. (The audience was comprised of about 100 members of various Mexican government health authorities – and they were not passive observers.) The opening remarks by Stephano Bertozzi (Instituto Nacional de Salud Publica) set the tone for the event, “We need to spend more and spend more wisely.”
Michael Drummond’s presentation was a primer on the various types of evidence used in healthcare technology assessments. Nothing new – but a valuable view into the soul of HTA. Dr. Drummond’s take-away message was that decisions made via HTA are economic decisions – not necessarily medical ones. He also pointed out that using RCTs as the mainstay of comparative effectiveness measures was a flawed proposition and that other evidence – such as observational studies and real-time outcomes data needed to become part of the broader HTA equation.
I was up next, and the gist of my talk was that decisions should be made on patient-centric rather than cost-based platforms – and that reimbursement choices based on short-term budgetary considerations can have expensive (for the government) and dire (for the patient) consequences. My presentation can be found here.
Third on the agenda was Professor Jacques Lelorier who gave a very provocative presentation on the gaming of the comparator issue in general and by Canadian authorities (CDR) in particular – which does not tell the innovator company what comparator it has chosen and then, once a decision has been made, won’t share the data used in the process. He made the point (echoed by others during the course of the event) that when a particular HTA review finds a product to be outside of the selected cost-effectiveness parameters, “the answer is no,” but when the parameters fall within the selected criteria, “the answer is maybe.”
Kalipso Chalkidou gave an overview of NICE – making a point of the fact that NICE is not a reimbursement agency and does not deny access to pharmaceuticals. She also discussed the pending policy (in the UK) of providing physicians with financial “incentives” if they move patients from on-patent medicines to generic alternatives “Incentive” -- such a nice word when a government uses it. Can you imagine what it would be called if this same technique was used by an innovator company? (Hint – “bribery.”) Dr. Chalkidou also noted this policy is “pending” because it is being challenged in court. She also pointed out (vis-à-vis statins) that if there was “any proof” that an on-patent product was “better” than a generic that NICE would be glad to reconsider its current position on the matter. I will shortly send her a link to the BMJ-published THIN study that shows why switching patients from on-patent atorvastatin (Lipitor) to off-patent simvastatin (generic Zocor) has proven to be very expensive to the British healthcare system because of its disastrous and deleterious impact on patient health. (For more on the THIN study, see here.)
Day Two of the seminar was comprised of Mexican health officials and academics presenting their views on pharmaco-economics and HTA. Some worthwhile and representative remarks:
“Developing guidelines is one thing -- making disastrous implementation mistakes is something else. We must have confidence in the people doing our HTA reviews and understand the relative strengths and weaknesses of the data. We must have clarity about appeal guidelines. A good economic analysis is not a faultless crystal ball. HTA has threats as well as opportunities.” (Atanacio Valencia, Institudo Nacional de Salud Publica)
“HTA isn’t a decision – it is the evidence to assist in making a decision.” (Maria Cristina Gutierrez Delgado, Secretaria de Salud). Her presentation was on a Mexican HTA analysis of the HPV vaccine – an analysis that showed the vaccine not to be cost-efficient. The Health Minister, however, decided to go against that recommendation.
Stephano Bertozzi spoke about the need to create a formalized training program for those who prepare HTA studies as well as for those who will make the final reimbursement decisions.
Octavio Amancio Chassin (Consejo de Salubridad General), made the excellent point that HTA must go “beyond the QALY,” taking into careful consideration a variety of factors such as the financial impact associated with caregivers.
Being able to participate in this event and to view the Mexican public health community discuss and debate how to set up an HTA authority convinces me of five things:
1. HTA can be a valuable tool when the right tools are used the right way;
2. HTA must be a combined and collegial effort of government officials, trained academics, physicians and pharmaceutical companies;
3. A variety of evidence must be considered – from RCTS to observational studies to outcomes data;
4. HTA must be as much a patient-centric proposition as a cost-effectiveness mechanism;
5. All aspects of HTA – from the design to the decision to the appeals process must be open and transparent
As we in the United States begin to think seriously about HTA we absolutely must remember that it’s more than just “comparative effectiveness.” And a good way to start having a serious conversation about the issue would be to convene experts and discuss the right way to move forward.
I respectfully suggest to Senator Baucus and Senator Conrad, before they offer legislation setting up an American comparative effectiveness body (within AHRQ or anywhere else), that they look at the process being used by our NAFTA neighbors to the South and carefully consider the warning of Professor Atanacio Valencia, “Don’t make the remedy worse than the disease.”
The “internacional” part consisted of myself, Michael Drummond, Professor of Health Economics (University of York), Professor Jacques Lelorier, Chief of the Pharmaco-economics and Pharmaco-epidemiology research unit at the University of Montreal, and Kalipso Chalkidou, Acting Director of Policy Consulting at NICE.
The seminar was designed to debate and discuss Mexico’s new pharmaco-economic guidelines for their national formulary. And there was as much debate as discussion. (The audience was comprised of about 100 members of various Mexican government health authorities – and they were not passive observers.) The opening remarks by Stephano Bertozzi (Instituto Nacional de Salud Publica) set the tone for the event, “We need to spend more and spend more wisely.”
Michael Drummond’s presentation was a primer on the various types of evidence used in healthcare technology assessments. Nothing new – but a valuable view into the soul of HTA. Dr. Drummond’s take-away message was that decisions made via HTA are economic decisions – not necessarily medical ones. He also pointed out that using RCTs as the mainstay of comparative effectiveness measures was a flawed proposition and that other evidence – such as observational studies and real-time outcomes data needed to become part of the broader HTA equation.
I was up next, and the gist of my talk was that decisions should be made on patient-centric rather than cost-based platforms – and that reimbursement choices based on short-term budgetary considerations can have expensive (for the government) and dire (for the patient) consequences. My presentation can be found here.
Third on the agenda was Professor Jacques Lelorier who gave a very provocative presentation on the gaming of the comparator issue in general and by Canadian authorities (CDR) in particular – which does not tell the innovator company what comparator it has chosen and then, once a decision has been made, won’t share the data used in the process. He made the point (echoed by others during the course of the event) that when a particular HTA review finds a product to be outside of the selected cost-effectiveness parameters, “the answer is no,” but when the parameters fall within the selected criteria, “the answer is maybe.”
Kalipso Chalkidou gave an overview of NICE – making a point of the fact that NICE is not a reimbursement agency and does not deny access to pharmaceuticals. She also discussed the pending policy (in the UK) of providing physicians with financial “incentives” if they move patients from on-patent medicines to generic alternatives “Incentive” -- such a nice word when a government uses it. Can you imagine what it would be called if this same technique was used by an innovator company? (Hint – “bribery.”) Dr. Chalkidou also noted this policy is “pending” because it is being challenged in court. She also pointed out (vis-à-vis statins) that if there was “any proof” that an on-patent product was “better” than a generic that NICE would be glad to reconsider its current position on the matter. I will shortly send her a link to the BMJ-published THIN study that shows why switching patients from on-patent atorvastatin (Lipitor) to off-patent simvastatin (generic Zocor) has proven to be very expensive to the British healthcare system because of its disastrous and deleterious impact on patient health. (For more on the THIN study, see here.)
Day Two of the seminar was comprised of Mexican health officials and academics presenting their views on pharmaco-economics and HTA. Some worthwhile and representative remarks:
“Developing guidelines is one thing -- making disastrous implementation mistakes is something else. We must have confidence in the people doing our HTA reviews and understand the relative strengths and weaknesses of the data. We must have clarity about appeal guidelines. A good economic analysis is not a faultless crystal ball. HTA has threats as well as opportunities.” (Atanacio Valencia, Institudo Nacional de Salud Publica)
“HTA isn’t a decision – it is the evidence to assist in making a decision.” (Maria Cristina Gutierrez Delgado, Secretaria de Salud). Her presentation was on a Mexican HTA analysis of the HPV vaccine – an analysis that showed the vaccine not to be cost-efficient. The Health Minister, however, decided to go against that recommendation.
Stephano Bertozzi spoke about the need to create a formalized training program for those who prepare HTA studies as well as for those who will make the final reimbursement decisions.
Octavio Amancio Chassin (Consejo de Salubridad General), made the excellent point that HTA must go “beyond the QALY,” taking into careful consideration a variety of factors such as the financial impact associated with caregivers.
Being able to participate in this event and to view the Mexican public health community discuss and debate how to set up an HTA authority convinces me of five things:
1. HTA can be a valuable tool when the right tools are used the right way;
2. HTA must be a combined and collegial effort of government officials, trained academics, physicians and pharmaceutical companies;
3. A variety of evidence must be considered – from RCTS to observational studies to outcomes data;
4. HTA must be as much a patient-centric proposition as a cost-effectiveness mechanism;
5. All aspects of HTA – from the design to the decision to the appeals process must be open and transparent
As we in the United States begin to think seriously about HTA we absolutely must remember that it’s more than just “comparative effectiveness.” And a good way to start having a serious conversation about the issue would be to convene experts and discuss the right way to move forward.
I respectfully suggest to Senator Baucus and Senator Conrad, before they offer legislation setting up an American comparative effectiveness body (within AHRQ or anywhere else), that they look at the process being used by our NAFTA neighbors to the South and carefully consider the warning of Professor Atanacio Valencia, “Don’t make the remedy worse than the disease.”
