Open letter to the Medical Services Advisory Committee regarding TMS Item Number regulations

Abstract

Objective

To present the perspective of professionals working in the field of transcranial magnetic stimulation (TMS) regarding the regulations which impact the availability of government subsidisation via Australian Medicare Benefits Schedule Item Number rebates to patients with major depressive disorder (MDD) who are seeking TMS treatment.

Conclusions

We argue that three regulations should be withdrawn: (1) that patients who received TMS prior to 1 November 2021 are ineligible for TMS rebates after 1 November 2021; (2) that every person is subject to a limit of 50 TMS treatments in a lifetime; and (3) that rebates are not available for maintenance TMS. We also conclude that consideration should be given to the provision of rebates for TMS treatments when it is delivered as a first-line treatment for MDD.

Major depressive disorder (MDD) is a common, serious problem, while depression is the leading cause of ill health and disability worldwide. ¹ Transcranial magnetic stimulation (TMS) is an effective treatment, which has been used in clinical practice in Australia for the last three decades. At present, TMS is reserved for treatment-resistant depression (TRD), which is more difficult to bring to remission and more likely to relapse than standard MDD.

In Australia, Medicare Benefits Schedule (MBS) Item Numbers for TMS treatments became available on 1 November 2021. However, we believe several attached regulations lack justification and are preventing suffering patients from receiving this unique treatment. We will detail three regulations and make a further suggestion we believe worthy of consideration.

A first regulation for consideration is that patients who received TMS treatment prior to 1 November 2021 are not allowed rebates after 1 November 2021. We can think of no justification for this regulation, other than a cost saving measure.

If people received TMS at an earlier point in life and, at a later time, following relapse, seek further treatment, their early treatment was almost certainly successful or they would not be trying to access the service again.

So, we are talking about people suffering a severe, potentially life-threatening (suicide) condition, which they know is likely to respond to TMS, but are prevented from receiving.

A second regulation worthy of consideration is the lifetime limit of 50 rebated TMS treatments. Again, this rule is incomprehensible. A standard course of TMS is 35 treatment sessions. It is proven that TRD is frequently a relapsing disorder. ² The 50-session regulation means that a patient suffering this disorder can receive only one and a half treatment courses in a lifetime. In contrast, there is no limit on the number of electroconvulsive therapy (ECT) procedures that a patient can receive, and this regulation relating to TMS means some patients receive ECT unnecessarily. A possible alternative may be to allow each patient to receive 50 TMS treatment sessions annually.

A third regulation needing consideration is that maintenance TMS therapy is refused any rebates. Again, this should be repealed. The continuation of treatment which has resulted in remission is common in psychiatric practice (examples include antidepressant medication and ECT), especially when relapse has a high probability.

Psychiatrists around the world use maintenance TMS, when funds can be found. Two main forms have been described: ‘Cluster maintenance’ is five treatments delivered over 3–5 days and repeated at monthly or longer intervals, ³ while the other is a single TMS applied weekly or fortnightly. ⁴

The Australian Government Department of Health and Aged Care states, ‘Medical Services Advisory Committee (MSAC) found…there was a limited evidence base for maintenance treatment’.

The reason maintenance TMS has not yet achieved complete scientific acceptance is because it has not been subjected to placebo-controlled double-blind clinical trials – and this is due to the impracticality of such studies. To reach this form of proof, many patients would need to be involved (half, of course, receiving placebos) and this would need to be continued for at least a year to achieve statistical significance. There would be much cost, time, and travel for both active and placebo treatment groups. Thus, other forms of evidence should be considered.

While agreeing the preferred scientific proof is not yet available, expert groups have conducted systematic reviews and expressed support. ⁵ A meta-analysis has produced support. ⁶ A maintenance study using theta burst has revealed a positive outcome. ⁷ A randomised, double-blind, sham-controlled trial has been proposed, but no further information is available ⁸ – which may speak to the difficulties of placebo and double-blind studies in this field.

A multisite open randomised controlled trial of another form of maintenance TMS has been found beneficial in the management of TRD in adolescents. ⁹ Also termed ‘retreatment protocol’, patients are followed regularly and any evidence of deterioration in mood triggers a further short course of TMS.

A final topic which needs to be considered is whether TMS should be a first-line treatment of depression. Rebates for TMS are restricted in Australia to patients with depression which is unresponsive to medication. This limitation exists in many places around the world, arising because there appeared to be a huge differential in the cost of providing TMS versus antidepressant medication. However, many studies have demonstrated that TMS produces better outcomes at lower cost than antidepressants.^10–12

TMS has been recommended as a first-line treatment in paediatric depression. ¹³ Others state TMS should be implemented ‘early on’ in the treatment process. ¹⁴ Another authoritative group argued that, compared to other treatments, ‘TMS has similar efficiency, fewer side-effects, lower risk of serious adverse events, comparable compliance, the potential for more rapid relief, and cost-effectiveness’. It concluded by stating that TMS should ‘be considered a first-line treatment for adult major depressive episodes’. ¹⁵