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Cardiomyopathy (CM) Program in Pharmaceutical Benefits Scheme (PBS) 012-24041204



This document outlines details of PBS-subsidised mavacamten for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), and tafamidis for patients with transthyretin amyloid cardiomyopathy (ATTR-CM).

For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.

On this page:

Symptomatic obstructive hypertrophic cardiomyopathy (HCM) quick reference

Transthyretin amyloid cardiomyopathy (ATTR-CM) quick reference

HCM delayed assessment

Symptomatic obstructive hypertrophic cardiomyopathy (HCM) quick reference

Table 1

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

(First 12 weeks of therapy)

PB360 form

Written

Electronic

S85:

mavacamten

No

OPA

Must be treated by a:

  • cardiologist
  • consultant physician with experience in the management of HCM

Yes - immediate or delayed assessment (delayed if any free text option used)

Grandfather

PB361 form

Written

Electronic

S85:

mavacamten

No

OPA

Must be treated by a:

  • cardiologist
  • consultant physician with experience in the management of HCM

Yes - immediate or delayed assessment (delayed if any free text option used)

First continuing

(until at least 6 months on optimal dose is achieved)

Telephone

Electronic

S85:

mavacamten

No

OPA

Must be treated by a:

  • cardiologist
  • consultant physician with experience in the management of HCM

Yes

Subsequent continuing

(maintenance treatment)

Telephone

Electronic

S85:

mavacamten

No

OPA

Must be treated by a:

  • cardiologist
  • consultant physician with experience in the management of HCM

Yes

Transthyretin amyloid cardiomyopathy (ATTR-CM) quick reference

Table 2

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB358 form

Written

Electronic

S85:

tafamidis

No

OPA

Must be treated and prescribed by a:

  • cardiologist
  • consultant physician with experience in the management of amyloid disorders

Yes

Grandfather

PB358 form

Written

Electronic

S85:

tafamidis

No

OPA

Must be treated and prescribed by a:

  • cardiologist
  • consultant physician with experience in the management of amyloid disorders

Yes

Second and subsequent continuing

Telephone

Electronic

S85:

tafamidis

No

OPA

Must be treated and prescribed by a:

  • cardiologist
  • consultant physician with experience in the management of amyloid disorders

Yes

HCM delayed assessment

Delayed assessment due to:

  • contraindication and/or intolerance to prior therapies
  • patient taking a drug not specified in the listed options

Table 3: this table lists the details of what to check for the delayed assessment and common acronyms.

Service Officers to assess that free text is:

Examples

Outcome

Relevant to the question

  • A drug name
  • Heart condition
  • Worsened renal failure
  • Nausea and vomiting
  • Elevated or deranged etc. liver function test
  • Gastrointestinal toxicity

Approve

Random text

  • Happy Birthday
  • Patient did not want to take
  • Ikasditbn

Reject

Non-descriptive

Grade 3 (no detail of toxicity)

Toxicity

Reject

Common acronyms

  • LFT - Liver function tests
  • GI toxicity - Gastrointestinal
  • N+V - Nausea and vomiting

Escalate to a Pharmaceutical Adviser (PA) by phone if unsure of acronym used.