Facebook Pixel
Pink piggy bank. Photo by Fabian Blank on Unsplash

The Therapeutic Goods Administration’s (TGA) Medicines Repurposing Program (MRP) aims to improve patient access to medicines in Australia by identifying new therapeutic uses for existing medicines and supporting sponsors in seeking the regulatory approval and subsidy of the new use.

The MRP, which launched on 1 March 2024, offers a pathway for the assessment of medications such as omalizumab, which, if approved through the Program, will help patients who do not currently meet eligibility for this medication and are accessing it “off-label” with their medical practitioner’s support.

While TAMS is already advocating directly with the relevant medication sponsor regarding omalizumab being included in the first round of applications for the MRP, your medical practitioners’ insights on the additional indications for omalizumab in the management of mast cell disorders will add helpful information to the considerations of the TGA in assessing this medications applicability to the MRP.

If you are currently using or have been suggested the use of omalizumab as a possible future treatment option, please forward this page to your medical practitioner and ask if they will consider nominating the medication, noting that the deadline for the first round of applications is Wednesday, 17 April 2024. Future rounds will be announced in due course.

By engaging with your medical practitioners to provide their insights directly, you are helping TAMS to advance informed discussions around improved access to a greater variety of treatments for those living with mast cell disorders.

Thank you for your support.

Email templates for your use

Please cut and paste the relevant email content into your email program, edit and send to your doctor. Be sure to include the email text for them to send to TAMS.

There are two email options available below:

  • Email for patients currently on omalizumab for “off-label” indications
  • Email for nomination of omalizumab for medicines repurposing program – seeking access for ineligible patients

Email for patients currently on omalizumab for “off-label” indications

 

Dear [Doctor’s Name],

I hope this message finds you well.

I’m writing to you following The Australasian Mastocytosis Society’s alert regarding the Therapeutic Goods Administration Medicines Repurposing Program (the Program). Established on 1 March 2024, the Program will consider new therapeutic indications of medicines registered on the Australian Register of Therapeutic Goods and consideration of these medications by the Pharmaceutical Benefits Advisory Committee for listings on the Pharmaceutical Benefits Scheme.

As I am currently on omalizumab for “off-label” indications for my mast cell disorder, I am seeking your consideration in nominating omalizumab for the Program to help provide a means for sustainable long-term access to the medication, possibly at a reduced cost.

Clinician nominations are confidential and do not require the disclosure of patient information. I kindly request your consideration regarding completing a nomination for omalizumab for inclusion in the first round of the Program. *Submissions for the first round must be received by Wednesday, 17 April 2024.

If you decide to nominate omalizumab or any other medications for the Program, I would also appreciate it if you could email The Australasian Mastocytosis Society (TAMS) using the wording below to inform them of your nomination. The information will help with TAMS’ ongoing work advocating for improved treatment options and accessibility for individuals affected by mast cell diseases in Australia. TAMS commits to upholding your confidence in disclosures.

Thank you for your attention to this matter.

Kind regards,
[Your Name]

 

*Please include the following text at the bottom of your email so your doctor can copy/paste their response to TAMS* 

Email to: info@mastocytosis.org.au

Dear TAMS,

I am writing to confirm that I have nominated [XXXX medication] for inclusion in the TGA Medicines Repurposing Program, as per your request.

Approximately [number of patients or estimate of frequency of use] patients under my care are currently accessing [XXXX medication] off-label for their mast cell disease management, OR would benefit from access if it was indicated mast cell diseases in Australia.

I [DO/DO NOT] grant consent to be contacted for updates and collaboration opportunities with The Australasian Mastocytosis Society regarding this and other access pathways for [XXXX medication] in Australia for the management of mast cell diseases.

Regards,
[Name] 

Email for nomination of omalizumab for medicines repurposing program – seeking access for ineligible patients

 

Dear [Doctor’s Name],

I hope this message finds you well.

I’m writing to you following The Australasian Mastocytosis Society’s alert regarding the recent launch of the TGA Medicines Repurposing Program (the Program). The Program, initiated on 1 March 2024, aims to assess medicines currently registered on the Australian Register of Therapeutic Goods for new therapeutic indications, and for consideration of these medications by the Pharmaceutical Benefits Advisory Committee for listings on the Pharmaceutical Benefits Scheme.

As you have suggested omalizumab may be useful in the management of my mast cell disorder, but I am not eligible to access it as it is currently not indicated for my symptoms. I am seeking consideration in nominating omalizumab for the Program so that if the medication is indicated for my management in the future it is readily available, possibly at a reduced cost.

Clinician nominations are confidential and do not require the disclosure of patient information. I kindly request your consideration regarding completing a nomination for omalizumab for inclusion in the first round of the Program. *Submissions for the first round must be received by Wednesday, 17 April 2024.

If you decide to nominate omalizumab or any other medications for the Program, I would also appreciate it if you could email The Australasian Mastocytosis Society (TAMS) using the wording below to inform them of your nomination. The information will help with TAMS’ ongoing work advocating for improved treatment options and accessibility for individuals affected by mast cell diseases in Australia. TAMS commits to upholding your confidence in disclosures.

Thank you for your attention to this matter.

Kind regards,
[Your Name]

 

*Please include the following text at the bottom of your email so your doctor can copy/paste their response to TAMS* 

Email to: info@mastocytosis.org.au

Dear TAMS,

I am writing to confirm that I have nominated [XXXX medication] for inclusion in the TGA Medicines Repurposing Program, as per your request.

Approximately [number of patients or estimate of frequency of use] patients under my care are currently accessing [XXXX medication] off-label for their mast cell disease management, OR would benefit from access if it was indicated mast cell diseases in Australia.

I [DO/DO NOT] grant consent to be contacted for updates and collaboration opportunities with The Australasian Mastocytosis Society regarding this and other access pathways for [XXXX medication] in Australia for the management of mast cell diseases.

Regards,
[Name] 

Share This