Sekce: Daily overview

Selection from Decision-Making Practice - 8

The State Institute for Drug Control (SÚKL) has rejected a request by the marketing authorization holder (MAH) of an orphan medicinal product (OMP) to suspend the proceedings on the setting of the...
Pharmeca a.s. 04/23/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 7

Use of Subjective Parameters in Administrative Proceedings
Pharmeca a.s. 04/17/2025
Sekce: Daily overview

Ministry of Health Opinion on Medicines for Rare Diseases

The Ministry of Health of the Czech Republic has published its opinion on the use of a medicinal product for rare diseases (LPVO) with reimbursement granted under Section 39da as a comparator in...
MZ ČR 04/10/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 6

Removal of the Prescription Symbol “A”
Pharmeca a.s. 04/09/2025
Sekce: Focused on

Fully Reimbursed Medicinal Products in the Czech Health Insurance System

Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is based on the Public Health Insurance Act, which aims to...
Pharmeca a.s. 04/02/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 5

The Institute may not conduct its own pharmacoeconomic analyses
Pharmeca a.s. 04/02/2025
Sekce: Daily overview

VZP Requests Submission of EMDN Codes

VZP requests that all applicants submit EMDN codes for all medical devices (ZÚM) listed in the VZP Reimbursement Catalogue.
VZP 04/01/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 4

Ensuring the Right to Full Reimbursement for Medicinal Products Listed in Annex No. 2
Pharmeca a.s. 03/26/2025
Sekce: Focused on

Roles of Key Stakeholders in the Drug Reimbursement Process in the Czech Republic

The process of determining the reimbursement of medicinal products in the Czech Republic is complex and involves several key stakeholders who collectively influence the final decision. In our...
Pharmeca a.s. 03/21/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 3

Health Insurance Companies' Statement on the Unacceptability of Budget Impact.
Pharmeca a.s. 03/19/2025
Sekce: Focused on

Cost-Effectiveness Assessment of Pharmaceuticals: Key Questions

Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis,...
03/14/2025
Sekce: Daily overview

Selection from Decision-Making Practice - 2

The State Institute for Drug Control questioned the cost-effectiveness presented in the administrative proceedings.
Pharmeca a.s. 03/12/2025
Sekce: Focused on

Impacts of the New SUKL Decision-Making Practice on the Reimbursement of Innovative Medicines

The pharmaceutical market in the Czech Republic is undergoing a gradual shift in decision-making practices, which may significantly impact pricing and reimbursement regulations as well as the...
03/07/2025
Sekce: Daily overview

Selection from Decision-Making Practice

Multiple reimbursement levels for JAKi in reimbursement review.
Pharmeca a.s. 03/05/2025
Sekce: Daily overview

Opinion of the Ministry of Health of the Czech Republic on the impact on the system when setting prices and reimbursements.

The Ministry of Health of the Czech Republic has published an opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and...
MZ ČR 02/24/2025
Sekce: Daily overview

EMA Launches New Platform to Monitor Medicine Shortages

The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
Pharmeca a.s. 01/31/2025