Listings: Palliative care PBS changes

Changes were made to the PCS for opioids for acute severe pain and chronic severe pain.

Acute severe pain – new items

On 1 June 2021, new Authority Required (Streamlined) listings for hydromorphone and morphine were added to the Pharmaceutical Benefits Scheme (PBS) Palliative Care Schedule (PCS) (Tables 1 and 2).¹

To receive subsidised treatment for severe pain with hydromorphone or morphine, patients must be undergoing treatment for palliative care and:¹

• have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics, or
• be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

A maximum of two packs and one repeat can be prescribed.¹ Authority approval for increased quantities and/or repeats can be requested from Services Australia for up to one month supply per prescription through the Online PBS Authorities System or the telephone. Further, up to three months treatment (up to one month quantity and sufficient repeats) will be available through the Online PBS Authorities System or in writing.²

See the PBS website for complete details for each item

Table 1: New hydromorphone items for severe pain¹

^a Can be prescribed by nurse practitioners.

Table 2: New morphine items for severe pain¹

^a Can be prescribed by nurse practitioners.

See the PBS website for more information on nurse practitioner PBS prescribing

Chronic severe pain – new items

On 1 June 2021, new Authority Required listings for fentanyl, hydromorphone, methadone, morphine, oxycodone and oxycodone + naloxone were added to the PBS PCS (Tables 3–8).¹

To receive subsidised treatment for severe disabling pain with fentanyl, hydromorphone or methadone, patients must be undergoing treatment for palliative care and:¹

• not be opioid-naïve, and
• have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics, or
• be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

Patients maybe opioid-naïve to receive subsidised treatment with morphine, oxycodone and oxycodone + naloxone. However, they must still be undergoing treatment for palliative care and:¹

• have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics, or
• be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

For each of these medicines, no repeats are specified in the listing.¹ However, authority approval for increased quantities and/or repeats can be requested from Services Australia for up to one month supply per prescription through the Online PBS Authorities System or the telephone. Further, up to three months treatment (up to one month quantity and sufficient repeats) will be available through the Online PBS Authorities System or in writing.²

The new items on the PCS do not include a requirement for annual review for authorities for increased maximum quantities and/or repeats, unlike the equivalent opioid items for chronic severe pain on the General Schedule.^1-3

See the PBS website for complete details for each item

Table 3: New fentanyl items for severe disabling pain¹

^a Can be prescribed by nurse practitioners.

Table 4: New hydromorphone items for severe disabling pain¹

MR: modified release

^a Can be prescribed by nurse practitioners.

Table 5: New methadone items for severe disabling pain¹

^a Can be prescribed by nurse practitioners.

Table 6: New morphine items for severe disabling pain¹

MR: modified release

^a Can be prescribed by nurse practitioners.

Table 7: New oxycodone items for severe disabling pain¹

MR: modified release

^a Can be prescribed by nurse practitioners.

Table 8: New oxycodone + naloxone items for severe disabling pain¹

MR: modified release

^a Can be prescribed by nurse practitioners.

See the PBS website for more information on nurse practitioner PBS prescribing

Chronic severe pain – amended items

Buprenorphine patches

On 1 June 2021, changes were made to buprenorphine listings on the PBS PCS (Table 9).¹

The changes affect the following buprenorphine medicines (brands Bupredermal, Buprenorphine Sandoz and Norspan).¹

• 5 microgram/hour patch, 2 (Item 10957Q)
• 10 microgram/hour patch, 2 (Item 10948F)
• 15 microgram/hour patch, 2 (Item 10953L)
• 20 microgram/hour patch, 2 (Item 10970J)
• 25 microgram/hour patch, 2 (Item 10964C)
• 30 microgram/hour patch, 2 (Item 10949G)
• 40 microgram/hour patch, 2 (Item 10959T)

To receive subsidised treatment for severe disabling pain, patients are still required to have pain that is inadequately controlled by non-opioid analgesics. While the listed number of repeats has reduced to zero, authority approval for increased quantities and/or repeats can be requested from Services Australia for up to 1 month supply per prescription through the Online PBS Authorities System or the telephone. Further, up to 3 months treatment (up to 1 month quantity and sufficient repeats) is available through the Online PBS Authorities System or in writing.^1,3

The amended items on the PCS do not include a requirement for annual review for authorities for increased maximum quantities and/or repeats, unlike the equivalent opioid items for chronic severe pain on the General Schedule.^1-3

See the PBS website for complete details for each item

Table 9: Buprenorphine Palliative Care Schedule amendments^1,3

Morphine MR tablet

On 1 June 2021, changes were made to morphine modified release (MR) on the PBS PCS (Table 10).¹

The changes affect morphine sulfate pentahydrate 200 mg MR tablet, 28 (Item 5391R; brand MS Contin).¹

To receive subsidised treatment for severe disabling pain, patients are still required to have pain that is inadequately controlled by non-opioid analgesics. The listed number of repeats has been reduced to zero and the maximum quantity that can be prescribed has increased.^1,3 Authority approval for increased quantities and/or repeats can be requested from Services Australia for up to one month supply per prescription through the Online PBS Authorities System or the telephone. Further, up to three months treatment (up to one month quantity and sufficient repeats) is available through the Online PBS Authorities System or in writing.²

The amended items on the PCS do not include a requirement for annual review for authorities for increased maximum quantities and/or repeats, unlike the equivalent opioid items for chronic severe pain on the General Schedule.^1-3

See the PBS website for complete details for each item 

Table 10: Morphine Palliative Care Schedule amendments^1,3

May be prescribed by nurse practitioners¹

Authorised nurse practitioners may prescribe the above buprenorphine patch and morphine MR tablet items.

See the PBS website for more information on nurse practitioner PBS prescribing.

Changes were made to PCS and General Schedule for diclofenac and indomethacin,⁴ non-steroidal anti-inflammatory drugs (NSAIDs) that are used in palliative care for pain and also malignancy-related fever.⁵

Diclofenac

On 1 June 2021, diclofenac suppository and tablet items were deleted from the PBS Palliative Care Schedule (PCS).⁴

Both formulations continue to be listed on the General Schedule for palliative care. The General Schedule listings for the tablet formulation have changed from Restricted Benefits to Unrestricted listings, with the same maximum quantity and repeats.^3,6 See Table 11.

See the PBS website for complete details for each item

Table 11: Diclofenac: deleted PCS items, amended and unchanged items on the General Schedule

^a Supply only: items/brands are available on the PBS for dispensing but not for prescribing, usually for a period of up to 12 months from when they are deleted.

^b Can be prescribed by nurse practitioners.

^c Can be prescribed by dental practitioners.

^d Can be prescribed by midwives.

Indometacin

On 1 June 2021 the indometacin suppository item was deleted from the PBS PCS.⁴

However it continues to be listed on the General Schedule for prescribing as an Unrestricted Benefit with same maximum quantity and repeats as it had in the PCS item.^1,3 See Table 12.

See the PBS website for complete details for each item

Table 12: Indometacin: deleted PCS item and unchanged item on the General Schedule

^a Supply only: items/brands are available on the PBS for dispensing but not for prescribing, usually for a period of up to 12 months from when they are deleted.

^b Can be prescribed by nurse practitioners.

^c Can be prescribed by dental practitioners.

Items for bisacodyl enemas, suppositories and tablets were deleted from the PCS.

Bisacodyl

Bisacodyl is a stimulant laxative prescribed for patients receiving palliative care who are experiencing constipation.⁵

On June 1 2021, bisacodyl enema, suppository and tablet items were deleted from the Palliative Care Schedule (PCS).⁴

However they continue to be listed on the General Schedule for patients receiving palliative care with the same restriction and similar maximum quantity packs and repeats as they had in the deleted PCS items.^1,3 See Table 13.

See the PBS website for complete details for each item

Table 13: Bisacodyl: deleted PCS items and unchanged items on the General Schedule

^a Supply only; items/brands are available on the PBS for dispensing but not for prescribing, usually for a period of up to 12 months from when they are deleted.

^b Maximum quantity has been determined to match the manufacturer's pack. These packs cannot be broken and the maximum quantity should be supplied and claimed.

^c Can be prescribed by nurse practitioners.

Changes were made to the PCS for clonazepam, haloperidol and metoclopramide for various indications for palliative care.

Clonazepam

Clonazepam is a benzodiazepine used in palliative care for the treatment of seizures, multifocal myoclonus, dyspnoea, intractable hiccups, acute agitation and altered mental state, pain associated with skeletal muscle spasm and rigidity in end-stage Parkinson disease.⁵

On 1 June 2021, the following changes were made for clonazepam on the PCS:⁴

• New item: Clonazepam injection 1 mg/mL injection, 5 x 1 mL ampoules (item 12534Q^a) was listed as a Restricted Benefit for patients receiving palliative care (1 maximum quantity / 1 repeat).
• Amended items; existing PCS listings for: Clonazepam tablets and oral liquid were changed from Authority Required to Restricted Benefits and the indication was broadened from myoclonus to palliative care. See Table 14.

See the PBS website for complete details for each item

Table 14: Clonazepam: amended PCS items

_a Can be prescribed by nurse practitioners.

Haloperidol

Haloperidol is an antipsychotic medicine used in palliative care for delirium, acute agitation and altered mental state and sedation and, as a dopamine antagonist, for nausea and vomiting.^5,7

On 1 June 2021, a new item, haloperidol 5 mg/mL injection, 10 x 1 mL ampoules (12519X) was listed as a Restricted Benefit on the PBS PCS for use in patients receiving palliative care (maximum quantity 1 / 2 repeats). Nurse practitioners can prescribe this medicine on the PBS PCS.^1,4

See the PBS website for complete details for each item

Metoclopramide

Metoclopramide is a dopamine antagonist used in palliative care for nausea and vomiting, and anorexia.⁵

On 1 June 2021 the following changes were made to the PBS PCS for metoclopramide:^1,4

• New item: metoclopramide 10 mg, 25 tablets (item 12507G) was listed as a Restricted Benefit for use in patients receiving palliative care (maximum quantity 4 / 5 repeats).
• Amended item: metoclopramide 10 mg/2 mL injection, 10 x 2 mL ampoules (item 10762K^b), maximum quantity 4, was increased from no repeats to 2 repeats.

Nurse practitioners can prescribe this medicine on the PBS PCS.^1,4

See the PBS website for complete details for each item