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LAtAm HTA harmonisation and centralised procurements: A feasible possibility?

26 October 2015 Angelica Kershaw

While attending the 5th ISPOR Latin American Conference that took place in Chile last month, my attention was drawn to the variety of regional initiatives that aim to implement centralised procurement of high-cost medicines and harmonise health technology assessments across the region.

Unasur and Mercosur to negotiate centralised procurement of high-cost medicines
The Union of South American Nations (UNASUR) at its annual meeting in April proposed the creation of a fund to negotiate centralised purchase of high-cost medicines. The initiative seeks to use the negotiating power of the UNASUR intergovernmental block to secure discounts in these high-cost treatments for its member states, which are Argentina, Brazil, Bolivia, Colombia, Chile, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela.

A similar initiative was presented by another sub-regional bloc in June, when the Southern Common Market (Mercado Común del Sur: Mercosur) healthcare authorities (Argentina, Bolivia, Brazil, Chile, Paraguay, Peru, Uruguay, and Venezuela) signed an agreement to facilitate the centralised purchase of high-cost medicines by member states' healthcare authorities.

The latest big development of these two initiatives was announced at the end of September when UNASUR and Mercosur agreed to work together on the two above-mentioned initiatives. Thus, with support from the Pan-American Health Organization (PAHO), UNASUR and Mercosur have created an ad hoc committee in charge of the first round of regional price negotiations for a joint procurement of four high-cost medicines: hepatitis C virus treatments Gilead Sciences' Sovaldi (sofosbuvir), BMS' Daklinza (daclatasvir), Janssen-Cilag's Olysio (simeprevir); and the HIV treatment Prezista (darunavir, Janssen-Cilag).

Latin America's High Cost Medicines Observatory (MAIF)
Another interesting regional initiative discussed during ISPOR was the joint effort of Colombia, Ecuador, and Mexico through the 'generation of information for improving efficiency in the management of medicines with high financial impact' project to achieve common guidelines and co-ordination in the cost-effectiveness analyses carried out by national HTA agencies.

As a result of this project, the governments of Colombia, Ecuador, and Mexico, together with Colombia's Institute for Drug Research in Health Systems (IFARMA), have created a regional institution called the High Cost Medicines Observatory (Observatorio MAIF) which focuses on administrative and online platforms to provide a single database of drug prices and patent protection information pertaining to the 20 medicines of highest financial impact in Colombia, Ecuador, and Mexico. Additionally, the MAIF has published health technology assessments for 10 of these 20 high-cost medicines, applying common guidelines agreed between the three countries.

Promising yet challenging landscape
The fact that the Latin America region is taking real steps towards harmonisation of healthcare policies in terms of HTA, prices and procurement of medicines is very positive for patient access to healthcare. These cooperative efforts, which take advantage of similarities across the region in terms of epidemiologic profile, language and budget constraints, have the potential to bring considerable benefits to the region.

The MAIF is already working as a key tool to facilitate and harmonise national reimbursement decisions by the respective healthcare authorities in Colombia, Mexico, and Ecuador. Additionally, it helps to search and compare medicine prices, as well as to exchange patent data.

However, the introduction of the regional initiative to introduce HTA - carried out by a centralised body, with technical training in cost-effectiveness and health policies -could negatively affect the pharma industry. Common HTA could add another step to the already-complicated process of obtaining funding for innovative medicines in Colombia, Ecuador, and Mexico. This could potentially slow down reimbursement decisions, since HTAs often take a long time to conduct, and often lead to negative decisions.

Similarly, the advances in the joint procurement are not good news for the pharma industry that is acutely aware that market access is likely to become increasingly competitive in terms of price, although those successful in winning tenders and contracts would have large guaranteed volumes. Furthermore, this centralised procurement of medicines could be used by some governments to pressure pharma companies to reduce prices, as they become aware of lower prices being paid by other countries in the region.

Finally, although the progress achieved with these two regional co-operative initiatives is undeniable, the path to full harmonisation in HTA and price negotiations in Latin America seems complex and challenging. The high number of UNASUR and Mercosur member states could be a challenge to further harmonisation, because despite some similarities, they have strong differences in their regulatory systems, political background and policy approaches to healthcare and pharmaceuticals.

Angelica Kershaw is a life sciences analyst for IHS
Posted 26 October 2015

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