Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Endometriosis

Initial treatment

Patient must have experienced moderate to severe pain associated with endometriosis; AND

The condition must be visually proven; AND

Patient must have received an inadequate response to, or be intolerant to, previous first line therapies for this condition, including at least one of the following: (i) hormonal contraceptives, (ii) analgesics; AND

Patient must not have undergone surgery for this condition in the last 3 months; or

Patient must not commence this treatment until 3 months post-surgery; AND

Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND

Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND

Patient must be pre-menopausal; AND

Patient must be at least 18 years of age.

Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Endometriosis

Continuing treatment

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must not have undergone surgery for this condition in the last 3 months; AND

Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND

Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND

Patient must be pre-menopausal.

The prescriber must only request for this treatment phase for the patient if ongoing treatment with this drug is likely to result in an adequate response.

Details of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) for continuing treatment beyond 6 months if under 41 years of age must be documented in the patient's medical record.

Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.