Pharmaceutical Industry & Distribution II

A reimbursement pathway for innovative medicines with a price below a certain threshold (45k EUR/QALY) and a budget impact assessment (SF/HICs methodics) for broader launch. This pathway includes budget caps for 3-5 years and restrictions on target patient populations and specialized centers.

A temporary reimbursement pathway (3+2 years) for highly innovative drugs, regardless of their cost-effectiveness. It involves an agreement with payers on the budget impact and a local clinical registry (optional) to collect real-world evidence (RWE).

A reimbursement pathway for orphan drugs (rare diseases) with no specific cost-effectiveness threshold. It involves a separate process for decision-making and direct involvement of patients (PAG) and professional medical associations.

An independent evaluation group that assesses the cost-effectiveness of new drugs and provides recommendations for reimbursement.

A measure of the cost-effectiveness of a drug, calculated as the cost per quality-adjusted life year (QALY). A QALY is a year of life in perfect health.

A method for assessing the budget impact of a drug, taking into account the potential cost savings and increased efficiency.

A group of patients who provide input and feedback on drug development, clinical trials, and access to treatment.

Real-world evidence (RWE) is collected from clinical practice to complement data from clinical trials and assess the long-term effectiveness and safety of drugs.

A program that allows for the reimbursement of expensive, rare drugs on a case-by-case basis, considering factors such as patient need, effectiveness, and cost-effectiveness.

A set of regulations and guidelines defining the reimbursement process for drugs designated as 'orphan drugs,' which are intended for rare diseases. The framework aims to ensure these drugs are accessible to patients who need them.

A specific drug category that targets uncommon diseases with a limited number of affected patients. These drugs are often developed by pharmaceutical companies to fill unmet medical needs.

The process of reviewing and evaluating a new drug for potential reimbursement based on clinical evidence, patient need, cost-effectiveness, and societal impact. The evaluation involves various stakeholders, such as patients, healthcare professionals, payers, and government representatives.

The United States is considered more attractive for pharmaceutical research and development due to factors such as a strong regulatory environment, robust intellectual property protection, and a large, well-funded healthcare system.

The ability of the pharmaceutical industry to develop, manufacture, and distribute drugs effectively, meeting patient needs while minimizing environmental impact.

A situation where a drug needed by patients is not available in sufficient quantities. Shortages can be caused by various factors, including manufacturing issues, supply chain disruptions, and regulatory challenges.

This legal protection grants exclusive rights to a company to sell a drug during a specific period, preventing competition from generic versions.

The process of evaluating whether a new drug is cost-effective, considering its clinical benefits and its price compared to other treatment options.

An obligation for manufacturers to maintain a certain amount of their product in stock to prevent shortages in the market.

A label applied to products with limited availability, indicating potential shortages.

A list of products where distributors must hold a reserve stock to ensure continuous supply to pharmacies.

The obligation of manufacturers, distributors and pharmacies to report their stock levels of products with the 'Limited Availability' symbol.

The act of exporting a product that is in short supply in the origin country, potentially causing shortages.

A regulation prohibiting the distribution of products with the 'Limited Availability' symbol outside of the intended market.

Pharmaceutical companies' practice of supplying their sister companies with products, potentially compromising the transparency of stock reports.

A requirement for distributors to submit reports on the quantities of medicine distributed and the beneficiaries of those distributions.

SÚKL evaluates the availability of medicines in Czech Republic and assesses the risk of shortages. They consider if a drug can be replaced with another similar medicine.

Sales and brand management are key functions in pharmaceutical companies, focusing on marketing and reaching healthcare professionals.

Legal and Compliance ensures that all activities are legal and ethical.

The EMA (European Medicines Agency) is a European body responsible for the evaluation and supervision of medicines.

The FDA (Food and Drug Administration) is a U.S. government agency that regulates food, drugs, and medical devices.

AIFP is the Association of Innovative Pharmaceutical Companies in the Czech Republic.

ČAFF is the Czech Association of Pharmaceutical Firms.

The Czech Statistical Office collects and analyzes data on health care in the Czech Republic.

Certain medications, like seasonal vaccines and Covid treatments, are exempt from the required safety stock regulations due to their unique characteristics. This means they do not need to be kept in reserve by pharmacies and hospitals.

Direct to Pharmacy (DTP) and Direct to Hospital (DTH) models are alternative distribution pathways, allowing manufacturers to supply medications directly to pharmacies or hospitals, bypassing traditional wholesalers.

The Czech government aims to restrict the possibility of exporting medicines to other countries, primarily due to the risk of shortages for Czech patients.

Re-exporting medications involves purchasing them in a country with a lower price and selling them in a country with a higher price for profit. This practice often occurs with drugs where the Czech price is lower than the international price.

Although a complete ban on drug exports is desirable to ensure sufficient supply, it is prevented by the EU principle of free trade, which generally applies to medicines. Restrictions or bans are only possible for specific drugs that could endanger the health of patients in the Czech Republic.

The Czech Republic has a complex system to ensure the availability of medicines. This system involves collaboration between various institutions including the State Institute for Drug Control (SUKL) and the Ministry of Health.

The State Institute for Drug Control (SUKL) provides information related to the availability of medicines through online resources. Users can access this information directly on the SUKL website.

The Ministry of Health of the Czech Republic is responsible for providing information about the availability of medicines and also plays a role in enforcing export bans.