MBR Consulting S.C. – your partner in Reimbursement

Pricing & reimbursement decisions are made on the national level and published in the official journal (Obwieszczenie Ministra Zdrowia).

Reimbursement Process

Our Team can support you with the reimbursement approval process performed by the Ministry of Health (Ministerstwo Zdrowia, MoH):

• Support in the process of preparing Reimbursement dossiers;

• Preparing impact on budget analysis for reimbursement purposes (in-house service) and clinical analysis, economic rationalization analisis (using external consultants);

• Submit Reimbursement dossier and monitor the progress;

• Support in meeting with MOH;

There are several levels of reimbursement: 0% (non-reimbursed), 50%, 70% and fixed fee and 100% with price limits within international names groups and therapeutic groups. Besides the open reimbursement with mentin leveles, Marketing Authorisation Holader can apply for reimbursement in Teheapeutic Program or in Chemiotherapy Program.

The new Act on the Reimbursement of Medicinal products, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices came into effect from the beginning of 2012.

The mains changes with respect to the previous reimbursement rules include:

* official prices and reimbursement of products being decided by individual decisions of the Minister of Health; the applicant will have the right of appeal in an ordinary administrative process

* extending the scope of the reimbursement to cover food for special medical purposes

* introducing fixed (instead of maximum) selling prices and fixed wholesaler's and retailer's margins

* reducing the wholesaler's margin and changing the way the retailer's margin is calculated

* introducing risk-sharing arrangements into pricing and reimbursement decisions, including payment by results and price-volume arrangements

* introducing a reimbursement 'tax' (3% of the annual value of the reimbursed product, based on the net selling price)

* introducing a "payback" mechanism under which applicants who received decisions on reimbursement of their products will be obliged to compensate to the National Health Fund (the amount to be returned will be calculated according to a set formula) the costs of the increase in expenditure for reimbursement over the reimbursement budget

* introducing administrative fines (varying in amount according to factors such as the value of the annual reimbursement of the product) for failures such as applying inappropriate price or inappropriate wholesaler's or retailer's margin or not using the required risk-sharing instrument

* requiring applicants to accept enforcement measures (e.g. the excess amount and the reimbursement tax) in a notarial deed which they must submit before receiving a the decision on reimbursement.

Pricing Approval Process

The prices for non-reimbursed drugs are determined by the manufacturer ("free pricing").

If a Marketing Authorisation Holder seeks for reimbursement, the price for the product will be set through a negotiation with the Ministry of Health.

Our Team can support you with the price approval process performed by the Ministry of Health (Ministerstwo Zdrowia, MoH):

• Support in the process of preparing Price Application;

• Submit Application and monitor the progress;

• Support in meeting with MOH;