The European Medicines Agency (EMA) offers scientific advice and protocol assistance in parallel with health-technology-assessment (HTA) bodies. This procedure aims to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value as efficiently as possible.
Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region. In countries where health technology assessment is in place, payers, pricing and reimbursement agencies or HTA bodies rely upon these assessments to:
- determine reimbursement status;
- provide information on benefits and harms of new treatments compared to available treatment options;
- support the price negotiation process.
The assessment criteria used by HTA bodies differ between Member States, in accordance with regional and national legislation.
Parallel scientific advice from regulators and health-technology-assessment bodies is a multi-stakeholder procedure. A close interaction between regulators, HTA bodies and other relevant bodies is critical to enable patient access to important new medicines and hence for the benefit of public health. This aims to reduce developmental resources, by re-shaping and focusing medicine development programmes to generate data relevant for regulators, HTA bodies and other stakeholders.
For more information on HTA bodies and EMA's interaction with them, see Partners & networks: Health-technology-assessment bodies.
The parallel procedure has four stages:
- Pre-notification: applicants engage in early informal discussions with HTA bodies and EMA, describing their aims for the procedure, the medicine, timeframe and which HTA bodies will participate.
- Pre-submission: includes a teleconference with HTA bodies to discuss the scope, wording and clarity of the questions, and whether the material provided is sufficient to answer the questions posed. Applicants circulate their own documents throughout the procedure directly to all participants including HTA bodies.
- Evaluation: a face-to-face meeting between all stakeholders, lasting a maximum of four hours.
- Advice/Outcome: meeting minutes are circulated by the applicant within five working days after the evaluation meeting. EMA's Committee for Medicinal Products for Human Use (CHMP) provides regulatory scientific advice in a letter which the sponsor may share with participating HTA bodies. HTA bodies will provide their written answers directly to the applicant within fifteen working days from the face-to-face meeting or in the format preferred by the respective HTA body.
EMA's scope and the fees it charges for this procedure are the same as for standard scientific advice. For more information see:
- EMA Guidance for applicants seeking scientific advice and protocol assistance
- Fees payable to the European Medicines Agency
The remits of individual HTA bodies differ based on national or regional regulation and other factors, which will contribute to their decisions on whether to take part in individual procedures.
If a company is developing a medicine that falls outside the remit of an HTA body in a specific country or region, for example a vaccine or lifestyle product, they may invite the relevant national advisory body to participate in the parallel scientific advice procedure, following the same principles and procedures.
To support applicants, EMA has collated information on a number of relevant organisations operating in the European Economic Area:
Applicants should contact these organisations directly for any further information.
Best practice guidance
The best practice guidance for the parallel scientific advice procedure with health-technology-assessment bodies highlights ideal timelines and actions for each party and guidance for applicants on how to apply. The current version of the guidance, published in March 2016, takes into account extensive stakeholder feedback:
- Best practice guidance for the parallel regulatory-HTA scientific advice procedure
- Consultation questions
- Specific comments on best practice guidance
Together with the guidance, EMA has published a common briefing document template, which companies should use for circulating information and questions to EMA and HTA bodies as part of the procedure:
EMA launched the parallel scientific advice procedure with HTA bodies with a pilot project in 2010. Since then, the Agency has been receiving an increasing number of requests from pharmaceutical companies who wish to obtain simultaneous feedback from the two parties. The requests cover a variety of therapeutic areas, including rare conditions. EMA has published a report on the pilot project on parallel scientific advice from regulators and HTA bodies:
EMA publishes statistical information on the parallel scientific advice procedures it conducts with HTA bodies in its annual reports.
The following healthcare-guidance and HTA organisations have already participated in parallel scientific advice procedures with EMA. Links are provided to the English language version of their websites if available:
- Agencia Española de Medicamentos y Productos Sanitarios (Spain)
- Agenzia Italiana del Farmaco (Italy)
- Agency for Health Technology Assessment and Tariff System (Poland)
- Agency for Health Quality and Assessment of Catalonia (Spain)
- Gemeinsamer Bundesausschuss (Germany)
- Haute Autorité de Santé (France)
- Hauptverband der Österreichischen Sozialversicherungsträger (Austria)
- National Institute for Sickness and Invalidity Insurance (Belgium)
- Institute for Quality and Efficiency in Health Care (Germany)
- National Institute for Health and Care Excellence (England)
- Norwegian Medicines Agency (Norway)
- Tandvårds- och Läkemedelsförmånsverket (Sweden)
- Zorginstituut Nederland (The Netherlands)
Frequently asked questions
This section addresses the questions that EMA is frequently asked about parallel scientific advice from regulators and HTA bodies. The answers provided are based on the Agency's best practice guidance for this procedure, which applicants should consult for more detailed information on how to apply and a comprehensive overview of all aspects of the procedure.
- When should I first contact EMA and what information should I provide?
Applicants should contact EMA in the pre-notification phase, approximately six weeks prior to the letter-of-intent deadline. This is approximately five months before the intended date for the face-to-face meeting if a pre-submission teleconference is planned, or fourth months if no teleconference is required.
Applicants should contact firstname.lastname@example.org providing the following details:
- product name;
- mechanism of action;
- desired date of the face-to face-meeting;
- details on HTA bodies to be targeted (if known);
- nature of questions (i.e. covering clinical matters only or also non-clinical and quality matters);
- if a pre-submission teleconference is required.
Following confirmation of the date of the face-to-face meeting, applicants then contact HTA bodies swiftly to request their availability for the desired face-to-face meeting date. Alternatively, EMA may make initial contact with HTA bodies to request their availability. For more information, see the section on the pre-notification phase in the best practice guidance.
- What documents should I submit?
Once EMA and participating HTA bodies have agreed to a timeline and confirmed the date of the face-to-face meeting, applicants should prepare and submit the following documents:
- letter of intent: a formal notification of the company's intent to request parallel scientific advice from EMA, which should include a brief description of the requested procedure. Companies should use EMA's template letter of intent;
- draft briefing document: an introduction to the medicine under development, together with the company's questions and positions. Each question or position can be addressed separately to EMA or the HTA bodies, or to both parties. The Agency strongly recommends that companies use the parallel scientific advice briefing document template, which includes guidance on compiling the briefing document and related annexes and references.
EMA and HTA bodies may comment and ask for clarification on certain points of the draft briefing document. The applicant needs to address these, regardless of whether a pre-submission meeting has taken place or not, and send the final briefing document (including annexes and references) to the relevant EMA scientific officer for validation.
Applicants should submit the final briefing document either as:
- a Word document with annexes and references (which may be separate files either in Word or PDF format);
- a PDF document containing all annexes and references.
Once validated by the EMA scientific officer, the applicant is responsible for circulating the validated final briefing document diectly to all EMA contacts and participating HTA bodies.
- What are the deadlines for presenting the necessary documentation?
Applicants should submit required documents in line with the submission deadlines and meeting dates of the Scientific Advice Working Party, which is responsible for coordinating the provision of EMA's scientific advice:
- The dates of 2016 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel EMA/HTA requests
Please note that deadlines may vary according to the applicant’s preferred type of procedure and whether a pre-submission meeting is requested.
The final briefing document must be delivered promptly to enable enable coordinators to review the document and prepare their first reports. A delay in submission may delay the procedure by a month.
- How do I circulate the validated final briefing document?
Once validated, the applicant is responsible for circulating the final briefing document directly to all participants in the procedure, including all appointed EMA coordinators and participating HTA bodies.
EMA only accepts the electronic submission of the final briefing document via Eudralink. Applicants should follow the instructions provided during the validation process.
Although HTA bodies generally have access to Eudralink, applicants should clarify the participating HTA bodies’ preferred means of communication during the procedure.
- Where do discussion meetings take place?
All discussion meetings take place at EMA's premises at the following address:
30 Churchill Place
London E14 5EU
For more information, see How to find us.
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