Pharmaceutical Industry & Distribution II
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What is the time frame for data aggregation and reporting in the new legal framework for reimbursement for orphan drugs?

  • 30 days for data aggregation and 30 days for reporting
  • 30 days for data aggregation and 110 days for assessment (correct)
  • 30 days for data aggregation and 6 months for reporting
  • 60 days for data aggregation and 110 days for assessment

    • Which stakeholder is involved in the appraisal process for orphan drug reimbursement?

  • Only healthcare professionals
  • Government only
  • Pharmaceutical companies only
  • Patients advisory groups (correct)

    • What is the focus of the committee's criteria for evaluating orphan drugs?

  • Efficacy of the drug alone
  • Cost-effectiveness solely
  • Individual patient needs exclusively
  • Societal perspective and impact (correct)

    • Which option is NOT a criterion considered in the appraisal process for orphan drugs?

    <p>Individualized treatment options</p> Signup and view all the answers

    What is the role of MoH in the appraisal process for orphan drug reimbursement?

    <p>To oversee the entire appraisal process</p> Signup and view all the answers

    Which medicinal products are excluded from the safety stock obligation?

    <p>Seasonal vaccines</p> Signup and view all the answers

    What is one condition under which an export ban on medications is possible?

    <p>The lack of the drug would endanger patient health.</p> Signup and view all the answers

    What is a key factor that affects the re-exportation of drugs?

    <p>The price of the drugs in the Czech Republic</p> Signup and view all the answers

    Which distribution model involves direct supply to hospitals?

    <p>DTH</p> Signup and view all the answers

    What is the typical profit margin associated with drug distribution?

    <p>2 - 4%</p> Signup and view all the answers

    Which of the following is NOT listed as a product where safety stock is not required?

    <p>Chemotherapy agents</p> Signup and view all the answers

    Which entity provides information on the availability of medicinal products?

    <p>SÚKL</p> Signup and view all the answers

    Why is a blanket ban on drug exports not feasible?

    <p>It violates the EU's principle of free trade.</p> Signup and view all the answers

    What is a key factor influencing the broad launch of innovative medicines?

    <p>Budget impact</p> Signup and view all the answers

    What is the purpose of the temporary reimbursement pathway for highly innovative drugs?

    <p>To provide immediate market access</p> Signup and view all the answers

    What is a consequence of a more restrictive definition of unmet medical need?

    <p>It affects the definition of high morbidity/mortality.</p> Signup and view all the answers

    What is the duration of the temporary reimbursement agreement for highly innovative drugs?

    <p>3+2 years</p> Signup and view all the answers

    Which of the following is a condition for exceptional reimbursement under §16?

    <p>It applies only to exceptional individual cases</p> Signup and view all the answers

    What is required for all products under shortage prevention plans?

    <p>Advance notification of shortages.</p> Signup and view all the answers

    Which statement is true regarding the WTP threshold for orphan drugs?

    <p>Orphan drugs do not require WTP thresholds</p> Signup and view all the answers

    Which of the following is NOT a focus of the new pharmaceutical legislation?

    <p>Reduction of research funding.</p> Signup and view all the answers

    How long do budget caps typically last for new innovative medicines?

    <p>3-5 years</p> Signup and view all the answers

    What role does regulatory data protection (RDP) play in pharmaceutical legislation?

    <p>It encourages innovation by protecting data.</p> Signup and view all the answers

    Who has a direct involvement in the appraisal process for innovative reimbursement pathways?

    <p>Professional medical associations</p> Signup and view all the answers

    What can cause the European Medicines Agency (EMA) to reject new medicines?

    <p>Environmental Risk Assessment results.</p> Signup and view all the answers

    What is the purpose of adjusting maximum prices in drug reimbursement?

    <p>To prevent surcharges for health insurance.</p> Signup and view all the answers

    What is a potential alternative to a local clinical registry in the reimbursement process?

    <p>Real-world evidence (RWE) collection</p> Signup and view all the answers

    Which of these adjustments is aimed at dealing with drug shortages?

    <p>Simplification of regulatory rules.</p> Signup and view all the answers

    What is the primary objective of the incentives in the pricing system for drugs?

    <p>To adjust reimbursement rates appropriately.</p> Signup and view all the answers

    What obligation does the holder have regarding the supply of a product after it has a shortage for one month?

    <p>Supply the market after a shortage of 1 month if the product is reimbursed or has a maximum price</p> Signup and view all the answers

    Under what condition is the holder exempt from the obligation to supply during a shortage?

    <p>If the product is not yet marketed for 12 months</p> Signup and view all the answers

    What types of products are generally exempt from the ‘Safety Stock’ obligation according to the decree?

    <p>Gene therapy and blood products</p> Signup and view all the answers

    What does the 'Limited Availability' symbol indicate?

    <p>The product is subject to special reporting and may have a supply risk</p> Signup and view all the answers

    What is the consequence for distributors that favor specific pharmacies when ordering medicines?

    <p>They are prohibited from favoring any pharmacy in their orders</p> Signup and view all the answers

    When must REG and DIS reports be submitted?

    <p>By the 5th day of the following month</p> Signup and view all the answers

    What must distributors keep as a reserve stock for certain products starting from January 1?

    <p>One month of supplies for each product</p> Signup and view all the answers

    What agency is responsible for labeling products with the 'Limited Availability' symbol?

    <p>SÚKL</p> Signup and view all the answers

    What role do medical representatives play in the innovative farm-industry?

    <p>Sell medicinal products and connect with healthcare professionals.</p> Signup and view all the answers

    What is the main focus of SÚKL's evaluation process regarding medicines?

    <p>Assessing the risk of insufficient supply and substitutability of drugs.</p> Signup and view all the answers

    Which function is responsible for ensuring all activities meet legal and ethical standards?

    <p>Legal &amp; Compliance.</p> Signup and view all the answers

    What is a key responsibility of brand management in the innovative farm-industry?

    <p>Shaping the brand throughout the product life-cycle.</p> Signup and view all the answers

    What type of function is described as supportive, non-branded, and non-commercial?

    <p>Supportive function.</p> Signup and view all the answers

    In the innovative farm-industry, omnichannel campaigns are primarily prepared by which role?

    <p>Brand management.</p> Signup and view all the answers

    Which entity's evaluations take into account the substitutability of particular drugs?

    <p>SÚKL.</p> Signup and view all the answers

    The role of sales in the innovative farm-industry typically includes what?

    <p>Engaging directly with healthcare providers to sell medicinal products.</p> Signup and view all the answers

    Study Notes

    Pharmaceutical Industry & Distribution

    • The presentation discusses the pharmaceutical industry and distribution within the context of social and clinical pharmacy.
    • It covers topics such as industry innovation, orphan drugs, EU regulations, drug shortages, distribution, and roles/job functions within the industry.

    Content

    • The presentation will cover industry innovation and generic drugs.
    • It will also look into orphan drugs, EU pharma legislation, drug shortages, and distribution, as well as roles within the pharmaceutical industry.

    Research and Development - Farm Industry

    • The average time from molecule synthesis to launch of a new innovative medicine is 12-13 years.
    • The average cost of developing a new medicine is approximately $2.5 billion.
    • Only 1 in 10,000 molecules/substances will be successful in the market.
    • The development process includes phases such as screening, patent application, pre-clinical development, and clinical trials.

    Costs of Drug Development

    • The cost of developing one single drug exceeds 30 billion koruna.
    • The stages of research, discovery, pre-clinical testing, clinical trials, and regulatory approval have varying timeframes and costs.
    • There are various stages of drug development, each with their own associated costs and time commitments.

    Pharmaceutical Spending in Healthcare

    • In the period 2017-2021, the proportion of expenditure on pharmaceuticals in healthcare decreased.
    • The figures show a downward trend in the proportion of pharmaceutical costs within total healthcare spending for the years 2017 to 2021.

    Roles for Original and Generic Companies

    • Original drug companies bring innovation and ensure real innovation reaches patients.
    • They often use tools like risk-sharing and evidence-based reimbursement strategies.
    • Generic companies focus on significant price reductions, extensions for all patients, and quick generic entries to the market. Their tools include reference prices, access provisions, and volume guarantees.

    Orphan Drugs

    • Orphan drugs are for rare diseases, with prevalence less than 5 in 10,000 people.
    • The European Medicines Agency (EMA) is central in facilitating the development and authorisation of medicines for rare diseases.
    • The development time takes a maximum of 90 days from validation.

    Availability and Reimbursement of Orphan Drugs

    • Between 2015 and 2020, only 57% of EMA-registered orphan drugs were delivered to Czech patients, while only 29% were officially reimbursed.
    • Reimbursement schemes differ, with varying success rates for orphan medicinal products.
    • As of January 2022, a new legal framework for orphan drugs facilitates innovative medicines, primarily focusing on ICER (Incremental Cost-Effectiveness Ratio) below 45k EUR/QALY.
    • Innovative reimbursement pathways for innovative drugs are also provided.
    • The framework also includes exceptional reimbursement provisions.

    Drug Shortages

    • Drug shortages were a significant issue in 2022 and require systemic solutions.
    • There is no universal solution; rather, the focus is on preventing and mitigating shortages through various regulatory and industrial measures.

    Dealing with Drug Shortages

    • Simplifying regulations, improving pricing and reimbursement models, and streamlining procedures are key to addressing drug shortages.
    • Rationalizing drug supply chains and protecting intellectual property are also important to encourage product diversification and availability.

    Amendment to the Act on Pharmaceuticals

    • The amendment introduces a "safety stock" requirement for products that could face supply issues, while exemptions exist for certain products.

    List of Medicinal Products

    • There is a list of products deemed exempt from the safety stock requirement, encompassing seasonal vaccines, Covid medications, and diagnostic/radiopharmaceutical agents.

    SÚKL Information on Availability

    • The State Institute for Drug Control (SÚKL) offers information on medicinal product availability.

    Ministry of Health Information

    • The Ministry of Health provides information on availability and export bans on medicinal products.

    Distribution

    • Drug distribution in the Czech Republic involves direct distribution to hospitals and pharmacies. There are restrictions on exporting and re-exporting medicinal products.
    • Several distribution companies are highlighted, indicating a network of distribution channels in the country

    Re-exports

    • Re-export of drugs occurs when the Czech price is lower than abroad.
    • Legal restrictions on re-exports exist but specific restrictions for certain medicines are possible if justified by insufficient domestic supply issues and patient health concerns.

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    Description

    Test your knowledge on the new legal framework for orphan drug reimbursement. This quiz covers critical aspects such as the appraisal process, criteria for evaluation, and stakeholder involvement. Dive into the specifics of drug distribution and export regulations related to orphan drugs.

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