Chronic kidney disease (CKD) and its underlying conditions (diabetes and hypertension) are among the top causes of disability-adjusted life years in the Latin American region. Complications arising from CKD include renal anemia and mineral disorders such as hyperphosphatemia and secondary hyperparathyroidism that significantly increase the costs of treating CKD as the disease progresses. Hence, new, cost-effective drug treatments that can delay the progression of CKD are in high demand. Although several erythropoiesis-stimulating agents (ESAs) have been approved in Brazil and Mexico to treat renal anemia, access barriers to more recent and effective ESAs limit the majority of patients in the public sector to domestically produced ESA products. In addition, public CKD patients must meet strict requirements to be eligible for ESAs and other CKD therapies that are managed by nephrologists. In the private sector, a different access environment develops, but barriers still exist in both countries. All of these access barriers have created a need for oral drugs with new mechanisms of action, such as hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors (for example, roxadustat by AstraZeneca/FibroGen) and iron-based phosphate binders such as Velphoro and Auryxia.
Questions Answered in This Report:
- Current therapies for CKD in Brazil and Mexico: What are the current prescribing patterns for renal anemia and hyperphosphatemia? What is the current brand share of ESAs and phosphate binders? How will the treatment practices for renal anemia change in light of new therapies such as oral HIF-PH inhibitors poised to enter the Brazilian and Mexican markets?
- Market access opportunities and challenges of CKD drugs in Brazil and Mexico: What is the reimbursement landscape for ESAs, IV iron supplements, and phosphate binders in Brazil and Mexico? How does it impact current patient (or brand) shares for these agents? How does coverage compare in the public and private sectors? What factors most strongly influence and constrain physician prescribing of new agents over available treatments, including biosimilars in the case of the ESA class?
- Emerging therapies for CKD in Brazil and Mexico: What are payers’ views on the pricing and reimbursement landscape for emerging CKD drugs? What types of savings on direct and indirect costs do payers seek in CKD treatments? What are the factors that will shape the market with the advent of emerging therapies with new mechanisms for CKD? What therapies do payers expect to be included in formularies and treatment guidelines in the future? What market access levers can drug developers take advantage of to optimize positioning of their new brands? To what extent do emerging therapies address unmet clinical needs for CKD, and how do clinicians expect to prescribe these agents?
This Emerging Physician & Payer Forum report, entitled Market Access Challenges Facing Chronic Kidney Disease Treatments in Brazil and Mexico, surveys 104 nephrologists and interviews six payers in Brazil and Mexico. We assess how these stakeholders currently shape the renal space and how it will evolve in the next 2-3 years as disease burden increases, budgets tighten, and new products penetrate the market.
Markets covered: Brazil and Mexico.
Primary research: 104 nephrologists complete an online quantitative survey designed by therapeutic and country experts. Six payers/payer-advising thought leaders who have influence on patient access to CKD drugs at a regional or national level were interviewed and include:
- Medical auditor responsible for the disease and portfolio management in a major insurance company, member of the drug standardization committee of the institution.
- Head of pharmaceutical assistance programs at São Paulo State (reference to the MoH and CONITEC for development of protocols).
- Nephrologist KOL, professor at a university hospital, member of the drug standardization committee of the institution.
- Nephrologist at an ISSSTE hospital; prior Chief of Nephrology CMN "20 November" and General Hospital "Dr. Darío Fernández Fierro”; active member of the Mexican Institute of Nephrology Research.
- Nephrologist KOL, active member of the Mexican Institute of Nephrology Research.
- Chief of Nephrology in an IMSS’s hospital, director of a hemodialysis unit, member of the Board of Nephrologists of Mexico.
Nuno Tiago Giao Antunes, Ph.D.