US drugmaker Biogen has had a setback in Argentina. As the country extends its Covid-19 lockdown, the Ministry of Health has removed Obligatory Medical Program (PMO) status from the company’s star product Spinraza after only 10 months, opening the path for an arduous process of negotiation.

As new generation medicines grow further out of reach for social security, Argentina’s Ministry of Health is sweeping the deck and dealing again with Biogen‘s high-cost Spinraza.

The drug had been included in Argentina’s Obligatory Medical Program (PMO for its initials in Spanish) in August 2019 under former health secretary Adolfo Rubinstein. The program establishes basic essential provisions that must be guaranteed by all social security healthcare providers and health insurance providers. Today Spinraza’s inclusion in the program was oficially revoked. See resolution in Spanish below.

The government published two resolutions, the second rescinding the 2019 agreement with Biogen. The company’s local head Maximiliano Gutiérrez will now find the issue at the top of his agenda folloing his recovery from coronavirus. See article.

The government has called on the Secretariat for Domestic Trade to guarantee provision of the drug at a «reasonable price for the entire health system.»

The decision of Argentina’s current Minister of Health Ginés González García to remove the drug’s PMO standing is based on a verdict reached by the National Comission for the Evaluation of Health Technologies (CONETEC) in November. The body decided it did «not recommend incorporation of the technology in the country’s obligatory cover» and that it should be considered for patients with spinal muscular atrophy (SMA) types I and II «only in the event of a considerable reduction in priceSee CONETEC report in Spanish.

The product, according to local regulator ANMAT, has a sales price to the public of ARS$9 millones (US$ 122,000) after the deal agreed with the drugmaker last year, but Argentina’s healthcare providers are finding that the cost of even a couple of cases among their patients are enough to stretch them to breaking point.

The decision is based on the verdict of evaluation commission CONETEC which advised against incorporating the technology in Argentina. 

The resolution published in Argentina’s official bulletin today instructs the Subsecretariat of Medicine and Strategic Information to draw up a project within 30 days to create a new National Program for the Supervision of Health Technologies. It also requests the collaboration of Argentina’s Secretariat for Domestic Trade to «guarantee provision of Spinraza on the Argentine market at a reasonable price for the entire health system.» See resolution in Spanish.

US$ 1 = ARS$ 73.77

English version 

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