Process followed by Kela after Hila has issued its decision

The Social Insurance Institution of Finland (Kela) is charged with implementing decisions issued by the Pharmaceuticals Pricing Board (Hila) on the reimbursement status of pharmaceuticals; i.e. paying reimbursements to clients in accordance with the Hila decisions.

Kela is the implementing body for all Hila decisions. However, Kela has a separate process it uses to implement Hila decisions on restricted reimbursement status. After the process has concluded, Kela’s decision becomes effective, and clients can be reimbursed either on the basis of a personal entitlement to reimbursement or a note made on the prescription. The full process takes around seven weeks.

Timeline of decisions on the reimbursement status of pharmaceuticals

Decisions of the Pharmaceuticals Pricing Board (Hila)

The Pharmaceuticals Pricing Board (Hila) operates in affiliation with the Ministry of Social Affairs and Health. It is tasked with issuing decisions on the reimbursement status of pharmaceutical products. Hila may restrict reimbursement status to certain indications, for example a severity of illness, or to certain groups of patients. Kela can only provide reimbursement for a medication if it is used in accordance with Hila’s decision.

How Kela prepares its decisions

Pharmaceutical experts at Kela draw up a proposal on reimbursement entitlements. Kela’s role is to define in greater detail the medical criteria that must be fulfilled for a client to be included in the group of patients outlined in the Hila decision. Kela also decides on the documentary requirements for proving the fulfilment of the medical criteria and sets the maximum period of time for which clients can be granted a reimbursement entitlement.

Recommendation of the Pharmaceutical Section

The Pharmaceutical Section of Kela’s Socio-Medical Delegation reviews the reimbursement entitlement proposal drawn up at Kela. The Section is a statutory body with medical and health insurance expertise whose members represent Kela and outside organisations. Based on the proposal, the Pharmaceutical Section issues a recommendation laying out the criteria for granting a reimbursement entitlement.

However, the criteria are not finalised until they have been incorporated in approved Kela decisions.

Decisions issued by Kela

Decisions issued by Kela, and any revisions made to them, are approved at Kela by a director and a director of benefits. The revisions made are based on Hila decisions, preparatory work done at Kela, and recommendations put forward by the Pharmaceutical Section.

Kela issues three types of decisions on pharmaceuticals:

  • decision concerning medicines with restricted basic reimbursement status
  • decision concerning medicines with restricted special reimbursement status
  • decision concerning medical conditions entitling the patient to special reimbursement.

These decisions cover the entire spectrum of existing reimbursement entitlements.

Notification of decisions

Kela posts a notice of forthcoming revisions on its website a few weeks before they are scheduled to take effect.

Effective date of decisions

Decisions issued by Kela become effective simultaneously with the Hila-issued decision. Once the decision is effective, clients can obtain a reimbursement for medicines with restricted reimbursement status. The reimbursement is provided either on the basis of the reimbursement entitlement or a note made on the prescription, as specified in the Kela decision.

Clients can apply to Kela for the entitlement to reimbursement by submitting a doctor's statement B. Kela grants the entitlement if it appears from the statement that the requisite medical criteria are fulfilled.

In certain cases, Kela has made the decision to allow the doctor to indicate the fulfilment of the medical criteria by making a specific note on the prescription. This makes it possible for the client to obtain the reimbursement at the pharmacy without having to apply for the reimbursement entitlement.

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