The Formulary – Your Key to Mexican Market Access
Zuzanna Fimińska interviews Edith Lemus Carmona, Health Economics Manager at Novartis Mexico, about the need for new guidelines on what to include on the mexican national formulary.
“We need to find a way to prioritize by considering what the main public health concerns are, what drugs or treatments will change disease history in terms of mortality and morbidity, and what things as a country we need to search for."
“When a company wants to start selling in the public market, the next step after the registry is to be listed in the national formulary, only then they can go to another institution, and get another listing, but that listing would be specific to the particular institution,” Edith Lemus Carmona explained the importance of the list.
A national formulary is a publication aimed to provide prescribers, pharmacists, and other healthcare professionals with up-to-date information about the use of medicines. It includes key information on selection, prescribing, dispensing, and administration of drugs. Information on drugs is drawn from the manufacturers' product literature, medical and pharmaceutical literature, health departments, regulatory authorities, and professional bodies. Advice is constructed from clinical literature and reflects, as far as possible, an evaluation of the evidence from diverse sources. To be included on the formulary means that pharmacists and prescribing physicians are aware of a given drug and are therefore more likely to prescribe it, driving product sales.
“To get put on the national listing you need to provide information about cost-effectiveness, safety, clinical effectiveness – most of the guidelines of these national formularies are close to the WHO on national listings,” Lemus Carmona added.
The process is very general. It requires that the company seeking to have their product included on the formulary present economic and clinical information, but the regulations guiding decision-makers are limited, and it’s about time that changed. “We need to give certain weights to certain pieces of data. We recognize that having a cost-effective drug is a very good point, but sometimes it's not enough, e.g. when safety profile is not the best one, and that should be included in the evaluation. We need a more evidence-based approach, even though, at the end of the day, decision-making is a soft process.”
Additionally, more attention needs to be paid to local epidemiological data. “We need to find the top disease [that affects Mexicans], and then check how it develops relative to the growth of other diseases, as some of them have been growing a lot, others have been decreasing in prevalence.” Being informed about the evolution of disease is key, and knowing what will happen if you do nothing is an important piece of data to have.
“Then you need to find a consensus about the top diseases in the country, carrying in mind that some diseases aren’t costly from the medical perspective, but are very costly from the socio-economic point of view, from the patients' point of view. Examples would include neurological diseases that are easy to manage at hospitals, but difficult for patients are carers. Then you have to have to think about what kind of disease will receive priority, preferably using local data.”
There might be similar products on the list already, and then, regardless of the quality of those products – in many cases they might not be a golden standard – the new medicine must be compared against those already included
Preparing national listings is a challenge, and keeping them up-to-date is even more difficult. As a result, the list includes drugs which are not used anymore, and others which do not respond to the key public health challenges ahead. A new approach is needed to improve the situation. Lemus Carmona explains:
“The first thing we need to consider is which products on the national formulary can achieve our objective. There might be similar products on the list already, and then, regardless of the quality of those products – in many cases they might not be a golden standard – the new medicine must be compared against those already included, even when the evidence is weak or there’s no evidence at all. If the new products has got more or better quality evidence, it works in its favor.”
The bottom line is that patients need to be provided with the best possible treatment with minimum risk of adverse effects, and the highest likelihood of benefits from new medications and technologies. At the same time, drug evaluations need to address the needs of payers, as they are in charge of the big national social security institutions, and they need to decide what would be best use of the resources. “Access to drugs and sales are a measure of success of the improved, evidence-based approach,” Lemus Carmona concluded.
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