Description of Review Process

Description of the Review Process

Conduct of the review

The review was conducted in accordance with the administrative instructions and guidelines provided by the Convenor. It is understood the Convenor also provided copies of this information to the sponsor. The Convenor and reviewers agreed to regular scheduled time intervals for teleconferences and draft reports.

Attainment of additional material

In addition to the material supplied by the sponsor (outlined previously), a structured literature search was performed by identifying articles in three bibliographic computerized databases, MEDLINE, PubMed and EMBASE. The search was performed during August 2006 and was restricted to studies conducted with human patients and published in English language. The search terms used were “indirect data comparison”, “subgroup analysis”, and “teriparatide-mechanism of action”. Additional references were identified from the reference lists of the published articles.
The reviewers did not consider any new information or other information directly concerning the drug (teriparatide) that was not available to the PBAC. In particular, no unpublished clinical or scientific data was requested from the sponsor.

Consultation

No external consultation was agreed with the Convenor during the conduct of the review. The reviewers concurred that external consultation would not yield additional beneficial information to assist in the review process and was an inappropriate methodology to undertake if the independent nature of the review was to be maintained.

Recruitment and management of secondary reviewer

At the request of the principal reviewer, the Convenor was requested to recruit a secondary reviewer as the third matter of utility assessment was outside the expertise of the principal reviewer. The secondary reviewer was contracted on June 2, 2006 to assist with the evaluation of the matter related to the health utilities. The secondary reviewer received the same material from the sponsor (via the Office of the Convenor) as the principal reviewer.
The principal and secondary reviewer discussed the health utility matter (background information, facts and opinions) by weekly teleconference during July and August 2006. Interim written reports were also discussed.