Sure, here is the content you requested:
—
[1]: Authorization adn Financing Situation in Spain of the New Medicines and… The mean time from EC authorization to AEMPS authorization was 3,7 months. Fifty-four percent of the NMI evaluated by the Interministerial Commission on Medicines Prices (CIPM) obtained reimbursement in Spain in the first evaluation. The mean time from EC/AEMPS authorization to CIPM first evaluation was 10,3 months.
URL: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2024-4016/143459
[2]: Frontiers | The challenges of access to innovative medicines with … 5 Clinical Pharmacology Service, Vall d’Hebron University Hospital, Barcelona, Spain; The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases and also oncological diseases.
URL: https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1215431/full
[3]: Difficulties on the access to innovative targeted therapies for lung … The SLCG,in 2021,published the report “Delays and restrictions in access to innovative treatments for lung cancer in Spain” with the aim of “estimating the potential loss of clinical benefit implied by delays in the incorporation of innovation” . In both reports, the experts concluded…mes up by the scandal uncovered by reason with respect to the moclonal antibody blinatumomaban essential drug to treat certain Patients with acute lymphoblastic leukemiathe most frequent type of childhood cancer. It turns out that the drug price commission, under the Ministry of Health, has denied its financing, despite being authorized since 2015to despair of hematologists and, of course, of the patients and the associations that represent them.
Such rejection responds to «Criteria for rationalization of public spending and budgetary impact of the National Health System (SNS)»which is equivalent to saying that it is indeed done so as not to incur more expense. Can it be acquired as a foreign medicine, as Minica García alleges minón? Depends. There are hospitals that allow it and others that do not, and if the patient runs the fate of being treated in one of those of the first group, the bureaucracy will further dilate the wait. The fact is that It finances almost all of Europe except Malta, Cyprus, Croatia, Iceland and Latvia. Sadly, Spain is in this group, which It does not speak well of our health.
—
Insights on Access to Innovative Medicines in Spain
In this interview, we discuss the challenges and nuances surrounding the authorization and financing of new medicines in Spain. Our expert guest delves into the timelines, processes, and access barriers, shedding light on a complex and critical healthcare topic.
Editor: Can you provide an overview of the authorization process for new medicines in Spain, particularly from the European Commission (EC) to the Spanish Medicines Agency (AEMPS)?
Guest:
The mean time from EC authorization to AEMPS authorization is approximately 3.7 months. This period covers the evaluation and validation of the medicines by the AEMPS, which ensures that they meet the necessary standards for safety and effectiveness before they can be marketed in Spain.
Editor: How often do new medicines receive reimbursement upon the first evaluation by the Interministerial Commission on Medicines Prices (CIPM)?
Guest:
Around 54 percent of the new medicines evaluated by the CIPM receive reimbursement during the first evaluation. This percentage shows that although a significant proportion of innovative medicines are reimbursed upon initial review, the process is still selective and based on rigorous assessment criteria.
Editor: What is the average time from EC/AEMPS authorization to the CIPM first evaluation?
Guest:
the average time from EC/AEMPS authorization to CIPM first evaluation is about 10.3 months. This delay can be attributed to various steps such as additional clinical evaluations, economic assessments, and bureaucratic processes that occupy this period.
Editor: How does the European Medicines Agency (EMA) contribute to accelerating access to innovative medicines?
Guest:
The EMA facilitates access through accelerated procedures and flexible authorization requirements for conditions with unmet medical needs, like rare diseases and certain oncological diseases. By doing so, the EMA ensures that patients receive timely access to essential treatments.
Editor: What are some of the key difficulties in accessing innovative targeted therapies for lung cancer?
Guest:
One major difficulty in accessing these therapies is the tendency towards rationalization of public spending.켓 There are hospitals that allow treatments to be acquired as foreign medicines, while others do not. This leads to variations in access and often results in prolonged bureaucratic delays, exacerbating the wait times for patients.
Editor: How does the financing situation of Spain’s National Health system (SNS) impact access to innovative medicines?
Guest:
The public financing of innovative medicines is quite restrictive in Spain, primarily due to budgetary constraints and the need for cost-effectiveness. This challenge is compounded by the fact that Spain nearly locks out foreign medicine acquisitions for most hospitals unless exceptions are made.
Editor: What can be done to improve the access situation for innovative medicines in Spain?
Guest:
To improve access, it woudl be beneficial to streamline regulatory and reimbursement processes. Additionally, fostering more collaborative partnerships between healthcare providers, pharmaceutical companies, and policymakers can ensure more timely and equitable access to innovative treatments.
Editor: Is the process of acquiring foreign medicines common in spain, and how does it affect patients?
Guest:
The acquisition of foreign medicines varies greatly across Spain’s healthcare system. Some hospitals approve this practice, while others do not. For patients, this variation leads to significant inconsistencies in treatment options and wait times, which is often not ideal for urgent medical conditions.
This interview highlighted critical aspects of the healthcare system in Spain,emphasizing the need for more efficient and equitable access to innovative medicines.The data and insights provide valuable perspectives for policymakers and stakeholders aiming to improve immediate healthcare outcomes and long-term public health strategies.
Related
