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.

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)
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 (no details)	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.

Operational Information

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

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