Welcome to Justin Stindt Consultants, a global consulting agency adept at navigating the intricacies of the Pricing and Reimbursement dossier Spain landscape. In the Iberian Peninsula, the procedure for pricing and reimbursement of medicines is rooted in a comparative evaluation, emphasizing therapeutic and economic aspects. This ensures decisions are based on rigorous evaluations of scientific evidence, including the clinical benefit and cost-effectiveness of the drug. Our international team of experts specializes in articulating the added benefit of products in the Spanish Pricing & Reimbursement dossier, leveraging insights from the AEMPS and the General Directorate of Common Portfolio of Services of the National Health and Pharmacy System (DGCYF). Trust Justin Stindt Consultants as your dedicated partner in achieving optimal market positioning and access in Spain.
Understanding the Procedure for Medicines Pricing and Reimbursement in Spain: An Overview of Key Regulatory Steps and Bodies
The procedure for pricing and reimbursement (P&R) of medicines in Spain is established in articles 92 and 94 of Royal Legislative Decree 1/2015, of July 24.
After the assignment of the national code by the AEMPS, the P&R process is started by the Ministry of Health through the General Directorate of Common Portfolio of Services of the National Health and Pharmacy System (DGCYF).
In Spain, the decision-making for the pricing and reimbursement of medicines is based on a comparative evaluation, both in therapeutic and economic terms, and ensures the best decision-making based on an objective and rigorous evaluation of the available scientific evidence in fundamental aspects, such as the clinical benefit of the drug, its added value, and its cost-effectiveness in comparison with existing financed therapies (whether or not these are medicines) and in the context of the epidemiology of the disease. The outcome of the evaluation is the cornerstone of the pricing and reimbursement negotiations.
Key Components and Decision-Making in Spain’s Drug Pricing and Reimbursement: The Role of CIPM and the Value Dossier
The value dossier presented by the manufacturer and the therapeutic positioning report (IPT) developed by the SNS Drug Evaluation Network (REvalMED) are key inputs for this evaluation. The Interministerial Commission on Drug Prices, hereinafter CIPM, is the competent body for setting drug prices in Spain. The CIPM is made up of national and regional public authorities: representatives of the Ministry of Health, the Ministry of Industry, Commerce and Tourism, the Ministry of Economic Affairs and Digital Transformation and the Ministry of Finance and Public Function, and representatives of the regions. For medicines for hospital use that are acquired outside the NHS, the CIPM also sets the so-called notified price. Once the price has been agreed upon at the CIPM, the decision to reimburse the medicine in Spain is formalized by means of an express resolution of inclusion or no inclusion in the provision. If included, this resolution establishes the financing and price conditions within the scope of the National Health System.| What? | Who? |
|---|---|
| Application for regulatory marketing authorization | Marketing Authorization holder of the drug |
| Regulatory evaluation of drug efficacy, quality and safety (benefit/risk balance) |
|
| Drug marketing authorization |
|
| Application for the marketing of the drug to the AEMPS | Marketing Authorization holder of the drug |
| Conformity analysis in accordance with the requirements established by law | AEMPS |
| Marketing authorization and national code assignment | AEMPS |
| Start, ex officio, of study of pricing and reimbursement of the drug | DGCYF (Start Unit) |
| Presentation of the informative dossier of the drug and financial offer | Marketing Authorization holder of the drug |
| Comparative technical evaluation (incremental clinical benefit and budgetary impact, among others, to determine the value of the drug in the context of Spain). | DGCYF (Evaluation Unit) |
| Pricing and reimbursement decision |
|
| Resolution of inclusion/non-inclusion of the drug in public financing | DGCYF (Unit of Resolutions) |
Expert Consulting for Spain's Healthcare Sector: Justin Stindt Consultants on Pricing & Reimbursement Dossiers and Market Access
Justin Stindt Consultants is your global consulting agency with the right experts in supporting the preparation of pricing and reimbursement dossiers for the Spanish market.
Our services for pharma, biotech and medtech companies include (not limited to):
- Comprehensive project planning with clear timelines and milestones
- Strategic review of drug positioning
- Dossier writing, both Spanish original and English translations
- Dossier validation with Key Opinion Leaders, ex-members of the AEMPS or CIPM and regional payers
- Submission process guidance and support
- Hearing preparation and support
- Strategic advice and participation in price negotiations
- Effective project management and communication throughout the process
At Justin Stindt Consultants, our team of experts has extensive experience in providing our clients with tailored support to provide access to Spanish patients as soon as possible at sustainable pricing and reimbursement conditions. If your company is looking for a vendor to support your Spanish Pricing & Reimbursement dossier, select a service provider that will go the extra mile to enable HTA endorsement and sustainable pricing for your product. More than just a dossier supplier, Justin Stindt Consultants will partner with you and upon your firm’s request can provide full-service support including engagement with the authorities and price negotiations.
Let Justin Stindt Consultants be your trusted agency partner in unlocking pricing & reimbursement (P&R) opportunities for your market access product in Spain.
Contact us today to learn how we can tailor our services to meet your unique needs and make your market access goals a reality.
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