1.
A reimbursement scheme is introduced in Nye Metoder encompassing new PD-(L)1 inhibitors and extensions of marketing authorization of existing PD-(L)1 inhibitors. These can be introduced in the specialist health care, without a prior HTA, if the yearly cost of the product meets a predefined price level.
2.
Sykehusinnkjøp will prepare a price note, calculating the annual cost for a full year use of the pharmaceutical based on the approved dosage in the SmPC. The calculated annual cost remains unaffected by actual treatment duration in clinical trials or the clinical utilization of the drug. The price ceiling in the scheme has been established by considering the same terms and conditions across manufacturers, ensuring fairness and equity in the process.
3.
The scheme is scheduled to continue for four years. The unit prices referred to as “agreed prices” which serve as the basis for introducing indications throughout the scheme’s continuation, will also be applied for future indications.
4.
Indications for which an HTA has been previously commissioned by Bestillerforum (Ordering Forum), but where a decision has not yet been made, can be included in the scheme.
5.
Participation in the scheme is optional for the Companies.
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Once included in the hospital formulary, the drug may be subject to disease-specific tenders. A lower price may be offered in tenders.
The scheme allows introduction of PD-(L)1 inhibitors in indications used in monotherapy or in combination with generics/ biosimilars or inexpensive chemotherapy.
Note: If a Pd-(L)1 inhibitor is already included in the hospital formulary at price lower than the specified price ceiling, the existing price will be maintained for enrolment in the scheme.
Process in Nye metoder
1.
In order to enroll in the scheme, the manufacturer must send an e-mail to nyelegemidler@sykehusinnkjop.no and confirm that their intention to participate with their immune checkpoint inhibitor.
2.
When a new indication of an already reimbursed drug is granted marketing authorization (or when a marketing authorization for a new substance is issued for the first time), the supplier shall request an assessment from Nye Metoder, and inform that the drug is enrolled and registered in the scheme.
3.
The Secretariat of Nye metoder will assign an ID number and register the case on the agenda for the earliest available meeting in Bestillerforum.
4.
Bestillerforum commissions a price note from Sykehusinnkjøp (not an HTA).
5.
The price note cannot be prepared until an approved indication/posology is available through the regulatory process. The supplier must send the approved SmPC to Sykehusinnkjøp once it becomes available.
6.
Sykehusinnkjøp will control that the price ceiling is not exceeded. The yearly cost is calculated for a full year use of the pharmaceutical based on the approved dosage in the SmPC. The calculated yearly cost is independent of factual duration of treatment in clinical trials. Administration costs are not added.
7.
If the price ceiling is exceeded (e.g. due to a more intense dosage than previous indications), Bestillerforum will commission an HTA based on input from Sykehusinnkjøp.
8.
Beslutningsforum approves the introduction of the new indication in the specialist health care if the yearly cost is below the price ceiling. The date at which the pharmaceutical can be introduced upon a positive decision, depends on ongoing procurements and the Handbook as usual.
Exception
If an indication is previously introduced with a managed entry agreement that implies a lower price than required in the scheme, this specific therapeutic area is exempt from the scheme.
Indications where HTAs are already commissioned in Bestillerforum
Indications for which an HTA has previously been commissioned by Bestillerforum (Ordering Forum), but decision has not yet been made, may be included in the scheme if the PD-(L)1 inhibitor in question is used either in monotherapy or in combination with generics/ biosimilars or inexpensive chemotherapy.
Bestillerforum can consider recommissioning “simple price note”. If the supplier chooses to enroll in the scheme, they may contact Sykehusinnkjøp regarding indications that are relevant for recommissioning.