BRUSSELS, July 13 (APM) - Belgium and the Netherlands have announced that they have together reached an agreement with Biogen on the pricing and reimbursement of Spinraza (nusinersen), indicated for 5q spinal muscular atrophy.
This is the first time that the three-year-old international cooperation on negotiating with drug companies, known as BeNeLuxA, has delivered a positive outcome.
Negotiations began in February, and involved joint health technology assessment as well as three-way talks between Biogen and the Belgian and Dutch health ministries.
Spinraza will be reimbursed for specific groups of patients in both countries under similar conditions.
Giant step
Belgian health minister Maggie de Block, one of the instigators of BeNeLuxA, said in a Thursday statement that this demonstrated that countries can jointly negotiate the reimbursement of orphan drugs.It was "a giant step forward" to make this orphan drug available to patients barely one year after it received marketing authorisation, she added.
Dutch health minister Bruno Bruins said in the statement that the outcome is "a very clear and promising example of the benefits of working together on price negotiations and pharmaceutical policy. "
He complimented Biogen on its readiness to engage in a process that he said "can offer swift access in several markets at the same time."
"I hope more companies will follow this example," he said.
Patient population
The list price for Spinraza is €83,300 per injection, and six injections are needed in the first year - at a cost of €499,800 - and three per year subsequently, at a cost of €249,900.Bruins did not reveal the negotiated price, but said it has been reduced "to an acceptable level", and that the drug will be made available for 80 young children with spinal muscular atrophy from 1 August.
In Belgium, reimbursement will commence as from the beginning of September, thanks to "an excellent collaboration" at an acceptable price.
The agreement will run until the end of 2020, and during that time, De Block said, Biogen will collect real world data about the medicine in clinical use, and explore its effect in sub-types of the disease.
The Belgian reimbursement organisation, INAMI, will re-examine the agreement on the basis of the data collected.
Expanding Beneluxa
The BeNeLuxA initiative, initiated by Belgium and the Netherlands to give health agencies better leverage in negotiations with international drug firms, has expanded to embrace Luxembourg, Austria and, most recently, Ireland (APMMA 58650).It is not the first time that the countries have attempted joint negotiations, but previous discussions on other products did not result in an agreement.
BeNeLuxA says it has "several pilots ongoing", and it aims to expand future negotiations with other Beneluxa partners.
It says it is planning to enhance efficiency by streamlining reimbursement processes in several countries.
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