The prevalence of rheumatoid arthritis (RA) is higher in Argentina and Mexico than in most Latin American countries and comparable to rates found in mature pharmaceutical markets. Biologics from several drug classes are available in these markets to treat RA, and most of them are covered/reimbursed by healthcare providers in each country. The high-cost of RA treatment with biologics imposes a financial burden on the public healthcare systems in this region.
- Biologic agents are usually recommended after the failure of conventional disease-modifying antirheumatic drugs (synthetic) and in cases of active and structurally progressive disease; both are prescribed to halt the destructive course of RA and prevent debilitating joint damage.
- Anti-tumor necrosis factor-alpha (Anti-TNF-α) agents are usually recommended as the initial biologic (Amgen/Pfizer’s Enbrel [etanercept], AbbVie’s Humira [adalimumab], Janssen/Merck’s Remicade [infliximab] and Simponi [golimumab], and UCB/Astellas’s Cimzia [certolizumab pegol]), but biologics with different mechanisms of action are also available for use in first-line biologic treatment (Bristol-Myers Squibb’s Orencia/Ohrencia [abatacept]) and/or in second or later lines of biologic treatment (Bristol-Myers Squibb’s Orencia/Ohrencia [abatacept], Roche’s MabThera [rituximab] and Actemra/RoActemra [tocilizumab]).
- In Mexico, there are three copies of RA biologics approved by COFEPRIS (two of etanercept and one of rituximab) that are already being prescribed by our surveyed physicians. There are no non-innovator copies of biologics for RA currently available in Argentina.
- Pfizer’s Xeljanz (tofacitinib) and Eli Lilly/Incyte’s baricitinib, both oral janus-activated kinase inhibitors, are in development in Latin America. Studies seem to show that Xeljanz and baricitinib offer strong efficacy against the signs and symptoms of RA, with a convenient oral formulation.
Our report covers the prescribing and coverage/reimbursement environment for these therapies in Argentina and Mexico, and compares attitudes of physicians and payers, to assess how the RA market access landscape will evolve in the next two to three years as the treatment armamentarium for RA expands and biosimilars increase their penetration.
Questions Answered in This Report:
Understand the impact of pricing and access/reimbursement on the use of current biologics for RA:
What are the key market access challenges in each country? How do coverage/reimbursement status and resulting restrictions impact on-label and off-label prescribing of drugs for RA in Argentina and Mexico? How does the impact of payer policies vary among drugs and among private and public patients? How do access/reimbursement constraints rank against other barriers to use of biologics in these markets? Which of these agents is included in drug formularies of government-sponsored and/or social security programs? What procedures must patients and providing institutions follow in order to receive drugs listed, and not listed, in the drug formularies? In several discount scenarios, how much power would price discounts have to shift prescribing? Are government initiatives under way to expand access? How do multinational corporation (MNC)-led patient assistance programs influence access? How will access to currently marketed and emerging agents shift by the end of 2016?
Understand physician and payer perspectives on emerging brands and biosimilars:
What are the market access hurdles emerging agents for RA will need to overcome in Argentina and Mexico? How will the health technology assessment (HTA) requirements differ between the markets and among national/government versus institutional HTA bodies (in Mexico)? How do payers and prescribers perceive the emerging brands? How will payer policies in Argentina and Mexico impact uptake of emerging brands over currently approved drugs? How will inclusion in government reimbursement/coverage guidelines impact uptake of emerging therapies for public and private patients? How do clinicians expect to be able to prescribe the emerging brands? What clinical and commercial factors would be most likely to convince payers to grant emerging biologics formulary coverage or advantaged positioning? Among the high-cost brands available in Argentina and Mexico by 2016, which agent has the strongest probability for inclusion in the government and institutional therapeutic formularies?
This Emerging Markets Physician & Payer Forum explores the dynamics that affect sales of high-cost brands and biosimilars used to treat RA in Argentina and Mexico. The report is based on a survey of 104 prescribers (rheumatologists) and interviews with 7 payers. Interviewed payers have influence in patient access to drugs at a national or regional level and include the following:
- Argentina: Pharmacoeconomist analyst at IECS (Instituto de Efectividad Clínica y Sanitaria); Purchase director for Chronic Diseases Department at OSPRERA (Obra Social del Personal Rural y Estibadores de la República Argentina ); Purchase manager for the High Cost Program at PAMI (Programa de Atención Médica Integral); Government advisor, Division of Scientific and Technological Activities, Department of Economic Development (Ministry of Health).
- Mexico: Purchase director at a major private HMO; Director and coordinator of the IMSS’s Compulsory Program; Director at Seguro Popular, Health Services Management.