PBS Treatments for Multiple Sclerosis (MS) - Potential Delistings

Question

1. What has triggered this price reduction and delisting process for high-efficacy treatment for MS? 2. Has the Department undertaken any patient impact assessment before progressing to a potential delisting pathway? If so, what were the key findings? 3. Can the Department confirm that approximately 28,000 Australians rely on high-efficacy MS therapies currently listed on the PBS? 4. What clinical advice has the Department relied on to conclude that non-medical treatment switching at scale would not pose risks such as relapse, disease reactivation, or disability progression for stable patients? 5. If a patient is receiving a treatment that can be administered at home (e.g. subcutaneous injection) and that product is no longer available on the PBS, will they be required to seek infusion treatments that are only available in a hospital? 6. Can the Department confirm that there is no clinical risk, including relapse, disease reactivation or disability progression, for patients who are stable on therapy and are required to switch treatments for administrative reasons? 7. What assessment has been made of the impact on regional and rural patients, and health service capacity, if patients are required to transition to infusion-based therapies? 8. When is PBAC likely to make a decision on this matter? 9. Who is the ultimate decision maker to delist a medicine? The Minister, PBAC or the Department?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002773.pdf (opens in a new tab)