SCIENTIFIC CONSULTATIONS ON METHODOLOGICAL ISSUES OF PREPARING A DOSSIER FOR THE STATE ASSESSMENT OF MEDICAL TECHNOLOGIES
The State Expert Center of the Ministry of Health of Ukraine provides scientific consultations on preparing the dossier for state health technology assessment (in accordance with para. 11 of the Procedure for Conducting State Health Technology Assessment, approved by Resolution of the Cabinet of Ministers of Ukraine of 23 December 2020 No. 1300 (as amended and supplemented) (hereinafter – the Procedure).
The purpose of the consultations is to provide methodological assistance to applicants on the choice of the comparison technology (comparator) when preparing the dossier for state HTA, as well as to establish effective interaction between the authorized body and stakeholders and to improve performance indicators during state HTA.
Initiation of the Consultation, contract, payment
The State Expert Center of the Ministry of Health of Ukraine (hereinafter, the Center) provides consultations as a consulting service under the terms of the Contract concluded between the Applicant and the Center, in the standard form (Ukrainian\English versions) posted on the official website of the Center at the link
The consultation begins at the initiative of the Applicant. The Applicant or its representative (hereinafter – the Applicant) submits to the “Service Center of the State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the Service Center) a draft Agreement in two copies with the package of documents required for its conclusion, together with a cover letter specifying the list of documents submitted and their number.
The further procedure for verifying the compliance of data and the validity of documents, and for approval (endorsement) of the Agreement during its conclusion, is in accordance with the established procedure.
The Service Center issues the Applicant a signed copy of the Agreement, after which the applicant sends to the e-mail address dec@dec.gov.ua the Application in the prescribed form together with a cover letter.
If necessary, additional materials may be provided with the Application in electronic form (for example, publications, clinical guidelines, instructions, a marketing analysis of the market for medicinal products/other medical technologies, etc.).
The Center's accounting department prepares and issues to the Applicant an invoice-specification for payment of the cost of providing the service.
- Before paying for the Consultation, the Applicant may receive assistance with concluding the contract, paying for the service, and procedural issues of organizing the Consultation.
- The Agreement is concluded and payment is made before the Application is reviewed.
After receipt of funds, the Center's Accounting Department checks the payment status of the issued invoices-specifications and informs accordingly the HTA Department, which is responsible for providing the Consultation.
The start of the Consultation is considered to be its 100% prepayment, as specified in the Agreement, according to the established cost of consulting services
- If payment for the consultation service is not made, the Application is left without consideration
After receiving the Application and documents, the HTA Department designates the experts responsible for preparing and providing the Consultation.
The result of providing the consultation is that the Conclusion of the authorized body based on the results of scientific consultations is sent to the Applicant
The consultation period is up to 60 calendar days from the day the Center receives payment for it under the terms of the Agreement.
- The opinion of the authorized body based on the results of scientific consultations specifically on the choice of the comparison technology (comparator) may be used by the Applicant for the purposes of proper preparation of the HTA dossier and submitted to the authorized body together with the application and the dossier for state HTA in accordance with the Procedure. The opinion based on the results of scientific consultations is not binding on the applicant and has no legal consequences for the state assessment of medical technologies, in particular the expert evaluation of the medical technology concerned. At the same time, the goal of the Consultation is achieved when the Center has no comments, following the state HTA, regarding the Applicant’s justification of the choice of the comparison technology in accordance with the provisions of paragraph 4 of the general section of the requirements for the content of the dossier for state health technology assessment, defined in Annex 2 to the Procedure, and provided that the results of the Consultation are taken into account in the dossier.
The applicant receives the Conclusion of the authorized body based on the results of scientific consultations with a cover letter, signed and registered in the EDMS, by e-mail.
- If, through the Service Center, the Applicant submits a request for issuance of the Opinion of the authorized body based on the results of scientific consultations in paper form, a paper copy of the cover letter with the Report with recommendations is transferred to the Service Center for handing over to the Applicant in person against signature.
The Center’s Accounting Department prepares and transfers the signed and sealed acceptance certificates for work performed (services rendered) to the Service Center for issuance to the applicant.
Clarifications regarding the Opinion of the authorized body based on the results of scientific consultations may be provided to the Applicant upon its request by e-mail to dec@dec.gov.ua, by a reply letter in paper or electronic form, or during a face-to-face meeting or an online meeting with employees of the HTA Department.
Providing explanations to applicants regarding the Opinion of the authorized body based on the results of scientific consultations is not included in the total term for providing the consulting service in accordance with the terms of the Agreement concluded between the Applicant and the Center.
