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Health Technology Assessment Unit

 
The Health Technology Assessment (HTA) Unit assists in the decision making process as regards the inclusion of new medicines on to the Government Formulary List, and hence is indirectly involved in the reimbursement procedure for pharmaceutical products. This unit provides supportive technical information and cost calculations with respect to medicinal products under review by the two consultative committees: the technical committee GFLAC (Government Formulary List Advisory Committee) and the financial committee ACHCB (Advisory Committee for Health Care Benefits).  The HTA Unit is involved in the pre and post committee procedures, and in drawing up technical reviews of the medicines being assessed.
Applications requesting the inclusion of new medicinal products or new indications on to the formulary are received at DPA, from either the Marketing Authorisation Holders (MAHs) or clinical consultants working within the Government Health Services, in line with Legal Notice LN 58/09 which transposes EU directive 89/105/EEC. The applications consist of forms T01 for MAHs or T02 and T02/P for consultants, and are submitted together with all the supportive documentation. Once an application form is received at our office, an acknowledgment is immediately issued to the applicant confirming receipt. Subsequently the requests are validated in line with the entitlement criteria as per Social Security Act Cap 318 Art 23 and licensing principles currently in place.  The applicant will be informed in writing whether the request has been accepted or not. If accepted, the request will eventually be passed on to a reviewer for a thorough appraisal of the medicine and the drawing up of a report summarising the pros and cons of the medicinal product, with special emphasis on its cost effectiveness. The place of the medicine being assessed is considered within an integrated care pathway encompassing the medical condition involved.   This report will then be discussed by the two committees.
The HTA unit follows up the outcomes of the discussion and the final decisions are ultimately disclosed to the applicants. If the medicine is recommended for approval and inclusion on the formulary, the procurement section is notified to initiate the tendering procedure.