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Thursday, 30 August 2001
Page: 30734

Dr Lawrence asked the Minister for Health and Aged Care, upon notice, on 27 February 2001:

(1) Does he recognise that hormone replacement therapy (HRT) can provide significant medical benefits for women who (a) require relief for the symptoms of menopause, (b) have undergone partial or complete hysterectomies and (c) are at risk of, and/or suffering from osteoporosis.

(2) Does he acknowledge that due to negative side effects many women who have had a hysterectomy are unable to take alternative forms of hormone replacement therapy such as Estraderm or Premarin.

(3) Is he aware that oestrogen implants are not available on the Pharmaceutical Benefits Scheme (PBS).

(4) Why are women ineligible for oestrogen implants under the PBS whilst under certain circumstances, men are eligible for testosterone implants under the PBS.

(5) Will he consider the inclusion of oestrogen implants for PBS listing.

Dr Wooldridge (Minister for Health and Aged Care) —The answer to the honourable member's question is as follows:

(1) (a) HRT can provide significant benefits in terms of symptom relief for women suffering from both natural and surgically induced menopause. The benefits may include reduction in hot flushes and sweating, improvement in urinary symptoms, improved mood and reduction in sleep disturbance;

(b) Women who have undergone partial or complete hysterectomies can benefit from HRT providing they are menopausal; and

(c) There is also good evidence to show that HRT has a protective effect against bone mass loss and thus may be an aid in the prevention of osteoporosis. There is some evidence to suggest that in women who have developed osteoporosis, HRT will increase bone mass density.

(2) Negative side effects are formulation specific and whether a woman has had a hysterectomy or not, or has undergone natural or surgically induced menopause is not considered to have a bearing on their tolerance to treatment. Generally, the choice of oestrogen dosage form by a prescribing doctor will depend on a number of factors, including the indication for treatment, the risks associated with the particular condition and side effects experienced by an individual patient. A variety of oestrogen dosage forms such as oral tablets, transdermal patches, vaginal creams and pessaries, and implants are on the Australian Register of Therapeutic Goods, to meet the various needs of patients.

However, there is a high, long term risk of osteoporosis in patients who have undergone surgical menopause and therefore, it is necessary to ensure long term treatment and compliance with HRT, often at higher doses. In this group of patients intolerance to oestrogen may pose a significant clinical dilemma. The focus in these cases would be toward a multidisciplinary approach that includes, weight-bearing exercise, cessation of smoking, reduction in alcohol use, diet and calcium supplementation.

(3) Yes

(4) Before a medicine can be subsidised via the PBS, it must be both recommended for listing by the Pharmaceutical Benefits Advisory Committee (PBAC) and a suitable price for listing agreed with the Pharmaceutical Benefits Pricing Authority.

At its September 1996 meeting, the PBAC recommended that oestrogen implants be listed as pharmaceutical benefits for postmenopausal symptoms and where oral oestrogens are not tolerated. However, negotiations between the Government and the pharmaceutical company for a mutually acceptable price have not been successful and consequently listing has not eventuated.

In the case of testosterone implants, listing on the PBS was implemented on 1 November 1996 following a positive recommendation from the PBAC and the successful completion of price negotiations with the manufacturer.

(5) In order to progress the PBAC recommendation, there must be a satisfactory outcome on price; the Government hopes that negotiations will continue, with a view to agreeing a price which allows the listing of oestrogen implants on a basis which is cost effective.