Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms

BURLINGTON, Mass., Aug. 21, 2014 /PRNewswire/ -- Decision Resources Group finds that, for the treatment of COPD,  physicians in Brazil and Mexico manage to follow clinical guidelines and commonly prescribe long-acting beta-agonist (LABA)- and long-acting muscarinic antagonist (LAMA)- containing regimens, although they do so within current severe cost/coverage constraints. Therefore, new brands of LABA/LAMA fixed-dose combinations (FDCs) that are expected to launch in these countries—which will considerably expand the chronic obstructive pulmonary disease (COPD) market—will compete with well-established marketed therapies, especially the twice-daily LABA/ inhaled corticosteroids (ICS) FDCs. New LABA/LAMA FDCs will also compete with recently launched once-daily Relvar/Relvare (GlaxoSmithKline/Theravance). According to payers, improvements in dosing and delivery of new FDCs of current drugs/drug classes are important but may not be enough to justify a premium price over comparator drugs or its separate components.

Other key findings from the Emerging Markets Physician and Payer Forum report entitled Positioning of Current and Emerging Agents for COPD: Physician and Payer Perspectives on the Prescribing and Patient Access Landscape in Brazil and Mexico include:

• Factors impacting formulary inclusion: In Brazil, CONITEC (Brazil's HTA agency) is restricting the incorporation of new COPD drugs in the coverage offered by the public healthcare system. Demonstration of superior comparative clinical and economic benefit, preferably using local data, is crucial to formulary inclusion.
• Exclusion of key agents: In Mexico, although the national drug formulary lists a comprehensive range of COPD drugs that can be covered by government-sponsored or Social Security programs, individual institutions have been excluding some key agents based on their own budgets.
• Private patients' access to treatment: The budgetary environment seems less restrictive in the private sector than in the public sector, but the lack of coverage in the outpatient setting in Brazil and of mandatory coverage in Mexico—together with expensive out-of-pocket costs in both countries—is limiting some eligible COPD private patients' access to treatment.

Comments from Decision Resources Group Director Andreia Ribeiro, Ph.D.:

• "Upon the launch of generic LABA/ICS FDCs (GlaxoSmithKline's Seretide and AstraZeneca's Symbicort) and LAMAs (Boehringer Ingelheim's Spiriva), their use is likely to be promoted, due to the tendering purchase models used in the public sector in both countries. COPD patients in Brazil and Mexico are already requesting currently available low-priced generics, according to our survey findings." 
• "Particularly in Brazil, state coverage and judicial actions are a powerful driver of access to costly agents, especially those not included in the formularies. Also, in some cases, patient assistance programs are the only way for patients to access drugs not covered under a specific public sector scheme, as in the case of Seguro Popular in Mexico. Manufacturers should explore these opportunities to best position their drugs in these markets."

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Decision Resources Group
Christopher Comfort
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SOURCE Decision Resources Group