Reason for request

First assessment

Key points

Favourable opinion for reimbursement for parental vitamin replacement when oral or enteral nutrition is impossible, insufficient or contraindicated, VIANT being indicated in adults and children aged 11 years and older.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

 Role in the care pathway?

Apart from the supply of proteins and energy in the form of carbohydrates and fats, parenteral nutrition requires the supply of trace elements, electrolytes and vitamins. Vitamins are an essential component of nutrition. They help maintain the body’s integrity and normal functions. The parenteral administration of vitamins prevents the clinical sequelae of vitamin deficiencies when foods cannot or must not be taken orally.

Three multivitamin complex products are currently available in France: CERNEVIT, VITALIPIDE and SOLUVIT (see Annex for the composition of the three proprietary medicinal products). To supply fat-soluble and water-soluble vitamins, it is possible to use either CERNEVIT, which contains water-soluble and fat-soluble vitamins and no vitamin K1, or to combine VITALIPIDE ADULT (fat-soluble vitamins) and SOLUVIT (water-soluble vitamins).

Role of the medicinal product in the care pathway

VIANT represents an alternative to the proprietary medicinal products already available in France to supply vitamins in the context of parenteral nutrition in adults and children aged 11 years and older.

 

 

 

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of VIANT, powder for solution for infusion is substantial in the MA indication.


Clinical Added Value

no clinical added value

The Transparency Committee considers that VIANT powder for solution for infusion provides no clinical added value (CAV V) for parental vitamin replacement in adults and children aged 11 years and older.


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