Working with confidential data in the FINOSE collaboration
In addition to publicly available material, the assessment is based on a company’s submission.
The company is asked to make identical submissions to DMC, Fimea, NoMA and TLV containing the information and data that are intended to be shared among the agencies. These identical sets of information, sent by the company to DMC, Fimea, NoMA and TLV with the intention to serve as a basis for the joint report, are called the common submission.
The basis of working with confidential data in the FINOSE collaboration is a waiver given by the company. The waiver allows the participating agencies to discuss the common submission covered by the waiver and to produce a joint report based on confidential data.
The joint report is used to support decisions on reimbursement on national level. The report can also be used to support price negotiations on national or Nordic level and for recommendations for use.
Therefore, the assessment report needs to be shared with the following organisations; Amgros I/S in Denmark, Representatives of the Finnish university hospitals participating in price negotiations, Sykehusinnkjøp HF, divisjon legemidler (LIS) in Norway and The new therapies council (NT-council) in Sweden.
In addition, the waiver includes persons deemed necessary by the parties, such as contracted experts and officials. The details are outlined in the wavier of confidentiality.
The company may also have data that is intended to be used only locally in one of the agencies and not to be shared among the agencies, e.g., data related to local pricing. In this case, the company has the possibility not include this data in the common submission butsubmit local data separately, in a submission to the agency in question, clearly indicating that this data is not intended for sharing among the agencies.
Before the joint report becomes public, the company has the possibility to note whether the draft joint report contains confidential data. In the published version of the assessment report, confidential information will be concealed. The company’s view on confidentiality is taken into consideration. Nevertheless, it should be noted that DMC, Fimea, NoMA and TLV work under national legislation on public access to information and secrecy, which determines access to information submitted to the agencies.
To avoid delays in the process, the clinical experts recruited for the assessment may receive the draft report prior to the checking of the confidential material.