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 assessment of the medicine
and preparation of HTA, 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.