News, Research, Treatments

PBAC Recommends all restrictions to be removed to TPORAs

The PBAC recommends removing restrictions to make it easier for ALL ITP Patients to access TPORAs.

Throughout the last couple of years, ITP Australia has been collaborating with various stakeholders, to provide access to TPORAs, better known as Eltrombopag (Revolade) and Romiplostim (NPlate) to all ITP Patients without the need for splenectomy. Progress in this area would not have been possible without our key Medical Advisors, the Thrombosis and Haemostasis Society of Australia and New Zealand and pharmaceutical companies Novartis and Amgen.

No longer requiring a splenectomy to access TPORAs would put Australian medical practices in line with other countries including the United State of America, the United Kingdom and most of Europe.

During 2020 and 2021, ITP Australia participated in the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia. Our submission focussed on the inequitable access to TPORAs for patients living with Immune Thrombocytopenia.  In 2021  Danielle Boyle, CEO and Founder of ITP Australia, followed this submission by participating in the Parliamentary Public Hearing for this inquiry. She gave a first-hand account of living with ITP, being able to access TPORAs and real-world insight into accessing treatments that are less invasive than surgery.

After this involvement, the THANZ ITP Treatment Guidelines for Adults were published in October 2021. These guidelines were driven by several of Australia’s leading ITP Clinicians, including  many on the ITP Australia Medical Advisory Board.

On Friday 17 June 2022, the Pharmaceutical Benefits Advisory Committee (PBAC) announced recommendations regarding PBS coverage of TPORAs. After consulting with our key stakeholders to clarify these recommendations, ITP Australia is excited to announce and endorse PBAC’s recommendations.

The recommendations of the PBAC were as follows:

The PBAC recommended changes to the restrictions of Romiplostim and Eltrombopag on the PBS align with current treatment guidelines. The PBAC recommends that:

  • switching between Eltrombopag and Romiplostim be allowed at anytime and working in the restriction about switching within 24 weeks be removed to mitigate confusion among prescribers;
  • the requirement for prior splenectomy or contraindication to splenectomy use be removed;
  • children be included in the updated restrictions by removing age limits;
  • restrictions on platelet count specified in continuing treatment be removed, and treatment be allowed to continue if the patient can maintain a platelet count sufficient to prevent clinically significant bleeding;
  • the requirement to stimulate toxicity to corticosteroid and immunoglobulin be removed.

While these are just recommendations, and there are still a number of steps to go before these recommendations can be accepted by the government and the PBS, we encourage all patients to:

  • Download a copy of the recommendations and present them to their clinician;
  • Write a letter to the Hon Mark Butler MP, Minister for Health and Aged Care advocating for these recommendations to proceed without delay;
  • Write a letter to your local Federal MP, advocating for these recommendations to proceed without delay.

 

Review the outcomes of the meeting here (last page).

Review the ITP Australia Submission for the Inquiry into approval processes for new drugs and novel medical technologies in Australia.

 

NPlate and Revolade

 

Publish Date: June 20, 2022

 

 

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