Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2021-06-11
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33600000: Pharmaceutical products
Estimated value: 26000000 NOK

Technical requirements: On behalf of the health authorities, Sykehusinnkjøp HF (the Norwegian Hospital Procurement Trust) intends to enter into a framework agreement with Chiesi Pharma AB applicable from and including 1 September 2021 for delivery of the medicine Procysbi (cysteamine as mercaptamine) for treatment of the disease nephropathic cystinose.
Nephropathic cystinose is a rare, serious disease that, if left untreated, causes serious manifestations in, among other things, the eyes, brain, liver, kidneys, muscles, lungs and bone substance. Untreated, 95 % of the patients experience kidney failure before puberty. The patients are currently primarily children. The treatment is life long.
There are two medications on the market in Norway with the active ingredient cysteamine for systemic treatment of this disease. The advantage of Procysbi is that the medication is only administered two times per 24 hours. This means significantly improved quality of life for both the patient and relatives. The patients achieve more stable plasma concentration of cysteamine. The patients also experience fewer problems from the gastrointestinal tract and the need for tube feeding is reduced. Also, the patients do not need to be woken during the night in order to take the medication, which gives a better nights sleep for parents and children.
The framework agreement has a duration of one year, with the possibility of extending for up to 12 months.
Based on market surveys there is only one marketing authorisation in the EU/EEA for medication with the active ingredient cysteamine (as Mercaptamine) that is administered two times daily, and therefore safeguard's the patient need in a satisfactory manner. The pharmaceutical design is patented until January 2027. The contracting authority believes that there is a legal basis to sign a contract without a contest in accordance with the procurement regulation §13-4 first section letter b) no. 3. The framework agreement is planned to be signed ten days after publication of the prior information notice.
On behalf of the health authorities, Sykehusinnkjøp HF [the Norwegian Hospital Procurement Trust] intends to enter into a framework agreement with Chiesi Pharma AB applicable from and including 1 September 2021 for delivery of the medicine Procysbi (cysteamine as mercaptamine) for treatment of the disease nephropathic cystinose.
Nephropathic cystinose is a rare, serious disease that, if left untreated, causes serious manifestations in, among other things, the eyes, brain, liver, kidneys, muscles, lungs and bone substance. Untreated, 95 % of the patients experience kidney failure before puberty. The patients are currently primarily children. The treatment is life long.
There are two medications on the market in Norway with the active ingredient cysteamine for systemic treatment of this disease. The advantage of Procysbi is that the medication is only administered two times per 24 hours. This means significantly improved quality of life for both the patient and relatives. The patients achieve more stable plasma concentration of cysteamine. The patients also experience fewer problems from the gastrointestinal tract and the need for tube feeding is reduced. Also, the patients do not need to be woken during the night in order to take the medication, which gives a better nights sleep for parents and children.
The framework agreement has a duration of one year, with the possibility of extending for up to 12 months.
Based on market surveys there is only one marketing authorisation in the EU/EEA for medication with the active ingredient cysteamine (as Mercaptamine) that is administered two times daily, and therefore safeguard's the patient need in a satisfactory manner. The pharmaceutical design is patented until January 2027. The contracting authority believes that there is a legal basis to sign a contract without a contest in accordance with the procurement regulation §13-4 first section letter b) no. 3. The framework agreement is planned to be signed ten days after publication of the prior information notice.


Winner: Chiesi Pharma AB
Award value: 26000000