CONSULTATION REQUEST

South Australian Formulary Committee (SAFC)

To SA Health Drug and Therapeutic Committees PO Box 287,

Rundle Mall
EMR Adoption Manager ADELAIDE SA 5000
ABN 97 643 356 590
SA Health Acute / Chromic Pain Services Heads of Unit
Chairperson SAFC
SA Health Haematology / Oncology Heads of Unit Dr Tilenka Thynne
tilenka.thynne@sa.gov.au
SA Health Palliative Care Heads of Unit
Executive Officer SAFC / Senior Pharmacist
SA Health Rehabilitation Heads of Unit Lisa Robertson (08) 8204 8998
Health.SAFC@sa.gov.au
SA Health Rheumatology Heads of Unit
www.sahealth.sa.gov.au/SAFC
From South Australian Formulary Committee (SAFC)
Date 21 March 2019

New Formulary Request: Tapentadol SR and IR tablets

The South Australian Formulary Committee (SAFC) has received a request for the addition of
tapentadol sustained release (SR) 50mg, 100mg, 150mg, 200mg and 250mg tablets for chronic
severe disabling pain unresponsive to non-opioid analgesics as per PBS criteria for the South
Australian Medicines Formulary (SAMF). Consultation with key stakeholders is an important aspect
of the formulary process.
Tapentadol provides benefits over the comparators oxycodone and tramadol; with less adverse
effects, lower risk of interactions and less risk of diversion and addiction. Tapentadol is less cost
effective to currently listed formulary alternatives with no generic brand to enable procurement
opportunities.
It is acknowledged tapentadol may provide therapeutic advantages over the comparators in some
patient populations; however there are concerns of the significant financial impact if these
populations are not clearly defined.
Additional annual expenditure is estimated at $30 000 per annum statewide, calculated on the
percentage of patients changed from comparators (20% oxycodone SR 10% tramadol SR) to
tapentadol SR. The below table provides financial impact at individual Local Health Networks (LHN).
Local Health Network Additional Annual Expenditure for Tapentadol SR
CHSA $2,000
CALHN $18,000
NALHN $6,000
SALHN $10,000
WCHN nil

SAFC is requesting your support for the following recommendations for use.
• Do you foresee any issues including financial, medication safety or Quality Use of
Medicines (QUM) with the proposed recommendations?
• Do you believe there should any further restrictions for the use of this agent?
SA Health Drug and Therapeutic Committees are requested to consider the financial
implications for their Local Health Network.

Restricted Formulary Inclusion

Tapentadol sustained release (SR) 50mg, 100mg, 150mg, 200mg and 250mg tablets
• Adult patients under the care of Acute and Chronic Pain services, Palliative Care,
Rehabilitation, Haematology / Oncology, Rheumatology for chronic severe disabling pain
unresponsive to non-opioid analgesics as per PBS criteria when oxycodone and/or tramadol
not appropriate.
Note: Slow-release opioids are not recommended for use in the management of patients with
acute pain

cc Dr Roger Hunt
SAFC has also received a request for the addition of tapentadol immediate release (IR) 50mg
tablets to the South Australian Medicines Formulary. This medicine is currently available via
streamlined non formulary approval process for the following criteria:
• Short term inpatient use only AND
• Complex acute pain patients with severe incident pain as part of multimodal analgesia that
includes immediate release opioids AND
• The patient has contraindications to tramadol AND
• Plan for analgesia requirements for discharge has been considered and documented if
required.

In addition to the financial impact tapentadol IR has the disadvantage over the immediate release
comparators as it is not available on the Pharmaceutical Benefits Scheme (PBS). SAFC is currently
reviewing the usage this formulation and appropriateness of above criteria for access.
Additional annual expenditure is estimated at $175 000 per annum, calculated on the
percentage of patients changed from comparators (20% oxycodone IR 10% tramadol IR) to
tapentadol IR. The below table provides financial impact at individual Local Health Networks.
Local Health Network Additional Annual Expenditure for Tapentadol IR
CHSA $8,000
CALHN $88,000
NALHN $30,000
SALHN $49,000
WCHN nil

SAFC is requesting your advice how the requirements for the immediate release tablets would
be managed with the addition of tapentadol sustained release?
Please review the proposed recommendations and provide any comments to SAFC Executive
Officer, SAFC, Health.SAFC@sa.gov.au in writing by Friday 19 April 2019

Yours sincerely

Dr Tilenka Thynne
Chair, South Australian Formulary Committee