Colombia mulls extending Spinraza access

Colombia’s Ministry of Health (MINSALUD) is considering a number of mechanisms to improve spinal muscular atrophy (SMA) patients’ access to Biogen's Spinraza (nusinersen), including a shared risk model. Discussions with importer BIIB Colombia come as MINSALUD is pressured by the Sara and Sofía Colombia SMA Foundation (FAMECOL) to extend to all types of sufferers the orphan drug’s indication, which in April this year was approved to treat only 5q SMA in patients aged 6 years or less, as GBI reported.

Since then, MINSALUD’s Fund Administrator of the General Health Insurance System (ADRES) has only received a bill for three vials, which cost COP 374 million (USD 111,000) each. However, each patient requires six doses in the first year of treatment alone, which would amount to over COP 230 billion (USD 68 million) for the 103 sufferers registered in FAMECOL’s database.

According to Francisco Calderón, access manager at BIIB, it is unusual for regulatory agencies to limit Spinraza indications to a certain age range. He said that the company is in price negotiations with MINSALUD, currently discussing a shared risk agreement under which the firm would bear a percentage of the cost in cases where Spinraza does not meet treatment expectations.

Meanwhile, Aurelio Mejía, head of MINSALUD’s directorate of medicines and health technologies, commented that the institution has a number of budget safeguards, including drug price regulations and protocols for the use of high-cost medicines. He added that the decision to extend Spinraza’s indication will depend on a report by the Institute for Health Technology Evaluation (IETS).


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