Growth hormone deficiency - paediatric patients Program in Pharmaceutical Benefits Scheme (PBS) 012-63030010

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Question: How do patients access GH medicines through the PBS?

Answer: Patients must meet PBS criteria to receive an approved PBS authority prescription for their GH medicine from their treating medical practitioner.

Patients may have their GH medicines dispensed by an approved supplier of their choice. These include:

• approved pharmacists (community pharmacies)
• approved hospital authorities (private or public hospital pharmacies), and
• approved medical practitioners (dispensing doctors)

Not all approved suppliers will have GH medicines in stock. Patients or their carers need to notify their selected pharmacy in advance to ensure their GH medicines are available.

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Question: Are Department of Veterans Affair (DVA) patients eligible to access GH under the PBS?

Answer: Yes. DVA patients can access the GH Program. PBS authority approval may be granted.

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Question: How do prescribers obtain PBS authority approval to prescribe GH?

Answer: Patients must meet current PBS restriction criteria. Prescribers may apply for PBS GH authority approval by:

• accessing the Online PBS Authorities (OPA) system
  
• uploading the written authority application via the form upload function in Health Professional Online Services (HPOS), or
• posting the written GH authority application to the Complex Drugs Team

2

Question: How do prescribers calculate the dosage and quantity?

Answer: Prescribers should use the most recent version of the:

• Growth hormone program dose and cartridge quantity calculator for SOMATROPIN ONLY, or
• Somatrogon prescribed maximum quantity by weight

The above are published on the Department of Health and Aged Care’s website; Attachment to Growth Hormone Program (Paediatric Use) FAQs - Dose and Quantity Calculator (updated 1 October 2022).

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Question: Can prescriptions be written for brand-specific GH medicines?

Answer: Yes. The prescriber must specify in the application form and on the authority prescription the brand of somatropin (including the form and strength) that is to be prescribed for the patient. They do not need to specify the brand of somatrogon.

Note: for computer generated prescriptions, the prescriber must put the active ingredient first, followed by the brand (including the form and strength). The same brand (including the form and strength) must be dispensed for both the original and the repeat supplies. If the brand needs to be changed during the treatment period, this will require a separate authority approval from Services Australia.

4

Question: Can a prescriber re-issue an approved authority?

Answer: No. If a prescriber requires a re-issue of an approved authority prescription, they need to contact the Complex Drugs Team.

The Complex Drugs Team can only re-issue approved GH prescriptions where the patient’s GH information has not changed.

Prescribers need to provide the following for a re-issue:

• Authority prescription number
• Quantity
• Repeats
• Weekly dose, and
• Reason for the re-issue

The Complex Drug Team must communicate to the prescriber that the original approved authority prescription will be invalid as it has been replaced by the re-issued authority prescription. The invalid authority prescription cannot be presented for supply at the pharmacy.

5

Question: Can a prescriber save a partially completed authority application and return to complete the application later?

Answer: Yes. A prescriber can partially complete an application and save the application. The Prescriber can complete the application later and submit for assessment.

6

Question: Can a prescriber’s clinical delegate partially complete GH applications?

Answer: Yes. The delegate must be an approved delegate for the prescriber. The delegate can partially complete the application and save the application for the prescriber to complete and submit. A delegate cannot submit an Authority Application.

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Question: Why does a prescriber have to provide the biological sex if the patient’s gender has been provided through the Medicare Card details?

Answer: Eligibility under the GH Program is based on the patient’s biological sex and not their identified gender.

It is clinically inappropriate to provide a patient with GH treatment in a manner not related to their biological sex because of the effect of biological sex on growth plates. Patient health and safety in terms of growth supports assessment on biological sex.

8

Question: What should prescribers use as the date of prescribing?

Answer: The date of prescribing is the date the GH authority application is requested. The date of the prescription must be the same date the application is requested on OPA.

Backdating of authority prescriptions is not permitted.

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Question: Can a prescriber make amendments to a GH authority once it has been created in Online PBS Authorities (OPA) system?

Answer: Yes. The prescriber can amend an assessed authority application through the ‘Revise Authority Application’ function.

An authority application can only be amended if the prescription has not previously been supplied, cancelled or re-issued.

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Question: Who may dispense, supply and claim GH medicines under the PBS?

Answer: PBS subsidised GH medicines can be dispensed by:

• approved pharmacists
• approved hospital authorities (private or public hospitals pharmacies), and
• approved medical practitioners (dispensing doctors)

Non-reform public hospitals are exempt from these arrangements, unless they have an agreement with an approved private hospital.

Note: prescriptions written for public patients of NSW and ACT public hospital clinics cannot be dispensed under the PBS, as these jurisdictions do not participate in the Pharmaceutical Reforms.

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Question: How will GH medicines be ordered by approved suppliers?

Answer: Approved suppliers may order GH medicines directly from the pharmaceutical manufacturer (or through a wholesaler).

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Question: How is the pricing of GH medicines calculated?

Answer: Remuneration for GH medicines is modelled on the pricing of Section 100 Highly Specialised Drugs (HSD) items at the applicable rate for the relevant approved supplier and is calculated using the ex-manufacturer price. Patients must pay the relevant PBS patient co-payment for each PBS supply.

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Question: Who do I contact if enquires are received about the Online PBS Authorities for GH medicines from the PBS General Enquiries line?

Answer: If the caller wants further assistance regarding the GH Program, follow escalation procedures to transfer to the Complex Drugs Team.

If callers wish to read more information regarding the program, refer them to the Department of Health and Aged Care and Services Australia websites located at the top of the Resources page.

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Question: What is the ‘Re-issue’ functionality?

Answer: A re-issue is a new authority prescription record, which is a created copy of all the details from an approved authority prescription (with the exception of one or more of the following editable fields) that does not go through the assessment engine for re-assessment:

• Authority prescription number
• Quantity
• Repeats
• Weekly dose, and
• Reason for the re-issue

Where an approved GH authority prescription is re-issued for a valid reason in the Online PBS Authorities (OPA) system, the original authority record is invalidated and the re-issue authority record becomes the valid authority record.

To re-issue, the existing authority must have either an ‘Approved’, or ‘Approved with changes’ or ‘Previously rejected/now approved’ status.

A new ‘Authority Approval Number’ and a new ‘Unique Authority Id’ is generated on the re-issued authority. The original authority is changed to a ‘Re-issue’ status.

When this functionality takes place, the original authority no longer has the option to be amended, cancelled or supplied at the pharmacy.

Service Officers can enquire and view a re-issued authority in Mainframe, however the functionality to re-issue an approved GH authority in Mainframe is not available.

The number or re-issues available for an approved authority is held in a parameter.

If a prescriber requires additional patient information to be updated (excluding the editable re-issue fields), the GH application becomes a new application and need to be reassessed within the system. This means the prescriber has two options moving forward:

1. Complete a new GH authority request in the OPA system, or
2. Complete the relevant GH PDF form and submit the form either through the form upload function in HPOS or post the form to the PBS Complex Drugs Programs

3

Question: What is the Save functionality?

Answer: The save functionality enables a partially completed authority application to be saved and completed later.

The Save button will not display unless the following minimum data set is entered:

• Prescriber ID
• Date of prescribing
• Patient Medicare Card number
• Authority Prescription Number
• Item code
• Prescribed quantity
• Prescribed repeats

The Save button will display on the following screens:

• Item Search
• Ingredient Selection
• Select Restriction
• Complex Criteria
• Answer Questions
• Authority Prescription

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Question: What is the Reject functionality?

Answer: The reject functionality enables a user to partially complete an authority application assessment and reject the application earlier in the application process rather than completing the whole application assessment when a reject is identified earlier. The Reject function is only available to internal OPA users.

The Reject button will not display unless the following Minimum data set is entered:

• Prescriber ID
• Date of prescribing
• Patient Medicare Card number
• Authority Prescription Number
• Item code
• Prescribed quantity
• Prescribed repeats

The Reject button will display on the following screens:

• Item Search
• Ingredient Selection
• Select Restriction
• Complex Criteria
• Answer Questions
• Authority Prescription

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Question: Can the Complex Drugs Team override a GH assessment result?

Answer: Yes. With the exception of the following hard rejects where a rejected status cannot be overridden to an approved status.

• Current Data Date
• 6 Month Data Date
• 12 Month Data Date
• Intracranial Lesion Diagnosis Date
• Intracranial Lesion Completion Date
• Treatment Completion Date for the condition for which intracranial irradiation was received
• Structural Lesion Diagnosis Date
• Structural Lesion Completion Date
• Bone Age Date
• Bone Age Date prior to commencement
• Data Date prior to commencement
• 6 month Data Date prior to commencement
• 12 month Data Date prior to commencement, and
• Date of transplant

These data dates are required to perform data validation checks. If the data date is unavailable, the relevant calculations cannot be performed.

If no valid values are found in the relevant reference data table, the system assessment will return a ‘null’ value, which then prevents the system performing the assessment.

Specific reason codes will return and display on the screen explaining why the GH application was rejected.

In addition to the hard rejects, the existing override functionality applies. For example, the application cannot be overridden if the prescription has been supplied or if the authority application has a status of ‘duplicate’.

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Question: Does the ‘Too Soon’ policy apply to GH?

Answer: No. Due to GH date driven clinical criteria, the ‘Too Soon’ policy rule is not assessed by the system.

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Question: Are increased quantities and repeats allowed under the GH Program?

Answer: No. The quantity is determined using the ‘paediatric dose and cartridge quantity calculator’ published on the Department of Health and Aged Care’s website.

Prescribers can only request up to the maximum listed number of repeats. For GH, this is set at one repeat.

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Question: Do GH authority applications refer back to patient history as part of the system assessment?

Answer: No. GH policy advice is that each GH authority application is assessed as a stand-alone application.

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Question: Can a GH authority application be referred by a prescriber from the Online PBS Authorities (OPA) system to the Complex Drugs Team?

Answer: No. Prescribers should contact the Complex Drugs Team directly with all queries.

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Question: Can the date of prescribing for a GH authority application be changed by the Complex Drugs Team to the date the prescription was written?

Answer: Yes. This function is only available to internal OPA users entering authority applications into the Online PBS Authorities (OPA) system, which have been received via the post or through the HPOS form upload.

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Question: How does the Complex Drugs team assess a GH authority application for a patient who commenced treatment overseas?

Answer: The patient must be in Australia at the time to access their PBS treatment.

Prescribers will need to ensure that patient eligibility for access to PBS subsidised GH can be met, e.g. through provision of a Medicare Card or through a reciprocal health care agreement. Once this has been determined, the patient may be considered eligible where the prescriber is able to demonstrate that the patient:

• would have met the initial restriction criteria prior to commencing GH treatment, and
• is currently meeting restriction criteria for continuing GH treatment phases (or equivalent if reclassification is appropriate).

In these circumstances, the fact that they have not received previous access to treatment under the s100 GH Program will not preclude determination of their eligibility.

This policy advice does not apply to patients that received previous GH treatment through a clinical trial. These patients should be referred to the program area to manage with the Department of Health and Aged Care.

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Question: What are the rules regarding treatment dose and skeletal maturity for Prader-Willi (PW) patients?

Answer: PW has 2 possible treatment dose units:

• mg/m2/week (M2), or
• mg/kg/week (KG)

Where the patient has not reached skeletal maturity (SM), the Weekly Dose (WD) must be in M2.

Where the patient has reached SM, the WD must be in Kilogram (KG).

For continuing treatment, the Previous Treatment Dose must always be provided.

For a detailed explanation see the below User Guide ‘Diagram plus rules and statements for Prader Willi and Skeletal Maturity’.