Opportunity to comment on Amgen’s Romosozumab Submission to the PBAC
Opportunity to comment on Amgen’s Romosozumab Submission to the PBAC: After two unsuccessful applications, Amgen has made a further submission to the PBAC seeking PBS listing of romosozumab for patients with severe osteoporosis. A PBS listing similar to teriparatide is being sought.
The romosozumab application will be considered at the March 2020 PBAC meeting. On 24 December 2019 the PBAC will invite consumer comments on the submission. The closing date for consumer comments is 12 February 2020.
ANZBMS Therapeutics Committee is currently preparing a detailed response which will be sent to all ANZBMS members. We encourage ANZBMS members to make their own submissions, as researchers, and clinical practitioners. You may also wish to advise patients and patient groups that you are in contact with about the submission; the PBAC is interested in gauging public and patient interest as well as seeking clinical and scientific insight.
PBAC is most interested in the impact of new medicines on patient care. They receive a comprehensive overview of the efficacy and safety of a new medicine from the Sponsor company. Suggested areas for discussion are:
The high unmet clinical need for an additional bone forming therapy, for example:
Severity of disease
Challenges with medical management of patients
Limitations of current treatment options.
Brief opinion on the efficacy and safety of romosozumab
Why romosozumab is needed in addition to already available treatment options.
Benefits to patients of having romosozumab available on the PBS.
Between 24 December 2019 and 12 February 2020, comments can be made via an email or letter. There is also an online form, which includes questions geared more towards patients. The contact information is provided below. All correspondence should include reference to: “Consumer comments for the romosozumab submission at the March 2020 PBAC meeting”.
Online: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-consumer-comments or http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form
Mail: PBAC Secretariat, MDP 952, Department of Health and Ageing, GPO Box 9848, ACT, 2601
Fax: 02 6289 4175. Attention PBAC Secretariat
Publication Date : 15 January 2020