Paying For Innovative Therapies
Keys to Understanding Chronic Hepatitis C Access and Reimbursement in Latin America
Hepatitis C (HCV) affects millions of people across the world and leads to the death of hundreds of thousands every year. Until the launch of the first generation direct acting antivirals, Incivo and Victrelis in the early 2010s, physicians had a very limited arsenal of drugs available for the treatment of chronic HCV, and dual therapy with Peg-IFN + ribavirin was the standard of care. However, even with the addition of those DAAs to peg-IFN + ribavirin, cure rates were very low, and the side effects particularly nefarious. As a result, many patients discontinued treatments or preferred to wait until new treatments were available.
Starting in 2013, the world saw an avalanche of game changing drugs for the treatment chronic HCV. Drugs such as Sovaldi, Olysio, Daklinza, Viekira Pak or Sunvepra, became available and widely known, allowing physicians treating chronic HCV to prescribe treatment regimens with smaller treatment periods, but above all, treatments that offered high efficacy and safety, and the possibility of discarding interferon. With treatment periods as short as three months, most patients were cured, and the progression of the disease stopped, preventing the development of cirrhosis and/or cancer associated with the disease. However, those treatments came with a hefty price; as a result, payers were forced to decide whether to offer those treatments or not, and if so, which patients should be prioritized. More recent agents like Harvoni, Epclusa or Zepatier, offer properties such as pangenotypic activity, even shorter treatment periods, and only one pill a day regimens, but brought with them additional pressure to payers and healthcare systems across the world.
The Pan American Health Organization (PAHO) estimates that up to 2.6-4.2 million people in Latin American are viremic, and that nearly 55,000 die every year from HCV, or cirrhosis/hepatocellular carcinoma caused by the disease. As explored in recent DRG Access & Reimbursement content here and here, in Argentina, Brazil, Colombia and Mexico (the four major Latin American pharmaceutical markets focus of this blog) treatment of chronic HCV is the responsibility of the public healthcare system. Although, a variable percentage of patients seek medical attention in the private setting, which complements to different extent coverage offered by public systems. All four countries have approved several second generation DAAs; unsurprisingly, in all of them, medical and patient associations lobby for the rejection of patents for the molecules included in those drugs.
Each country offers distinct landscapes that make it stand out among their peers. Brazil, for instance, can be considered a pioneer among Latin American countries, since it provides coverage to second generation DAAs since 2015, and offers treatment to a higher number of patients than the United Kingdom. However, the public healthcare system (SUS) ferociously negotiates the acquisition price of the agents that are covered, and recent developments in the analysis of Sovaldi’s patent have led some to fear that a patent will not be granted. In Colombia, after many years of oblivion, the government has recently focused on the management and treatment of the disease and created the national plan for control of hepatitis C. Moreover, the upcoming changes to the coverage process in the public setting may lead to important improvements in access to the newer treatments. In Mexico, DAAs are not included in the public treatment guidelines, but access to second generation DAAs will change soon with the recent major purchase of Harvoni and Viekira Pak by the IMSS. And what to say about Argentina, who, despite evaluating a patent request for Sovaldi, has allowed a local laboratory to manufacture and distribute its own version of sofosbuvir, called Probirase? What are payers and physicians’ opinions about this local version, and how does it impact the uptake of Sovaldi? More important, can this set a precedent for the local production of other DAAs?
It is critical to have a deep understanding of each market in order to achieve success. Whatever factors lead to the success of a drug in one country will not necessarily lead to success in other country, where the drug may stumble. The treatment of chronic HCV varies between the different countries, and it reflects the different availability of drugs, and the impact of payers’ policies in access. Each market offers its own access barriers, which have to be understood and overcome, in addition to stakeholders that need to be identified to ensure that the proper message is being transmitted.
For a more in-depth analysis of the Access and Reimbursement for HCV in Argentina, Brazil, Colombia and Mexico, please see our recent contents:
Follow Nuno on Twitter @NunoAntunesDRG.
About Access & Reimbursement
DRG’s Access & Reimbursement module helps you understand the access and reimbursement environment so you are better equipped to develop strategies that help you overcome potential barriers to access and help your brands thrive. With DRG’s Access & Reimbursement module, you can stay up to date on restriction policies: gauge payer and prescriber attitudes toward specific therapies; identify opportunities where brands can capture patient share through market access, and maximize opportunities for emerging therapies by learning how predecessor brands gained favorable reimbursement—or why they stumbled. Find out more: Access & Reimbursement
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