Parallel Processing of PBS

Applications and Regulation of

Drugs

Dr Teresa Nicoletti

Partner, Piper Alderman

Senior Member, Administrative Appeals Tribunal

Phone : 02 9253 9946

Email: tnicoletti@piperalderman.com.au

Outline of Presentation

Why implement new framework?

Operation of new framework

Have the reforms worked?

Case examples

Issues to resolve

Why implement new framework?

Previous TGA and PBAC Processes

Registration and reimbursement processes

were initially undertaken sequentially

Lengthy process of obtaining regulatory

approval first and then applying for PBS

listing

Statutory time for regulatory approval

process is 255 working days (does not

include clock stops)

Previous TGA and PBAC Processes

PBAC submission could be lodged only after

receipt of Delegate’s Overview

17 weeks from lodgement until consideration

by PBAC

Negotiations with PBPA if positive

recommendation made

Operation of the new framework

Objectives of reform

Timely access to medicines

Affordability of medicines

Certainty in regulatory process and

timeframes

Have the reforms achieved this?

TGA Business Process Reforms

Streamlined submission process

Pre-submission planning form

Election of 30 day or 60 day timeframe to

respond to consolidated list of s31 questions

7 month period from lodgement to Delegate’s

Overview

Additional month for consideration by ACPM

Additional month for final registration decision

> Includes PI and CMI consideration

Registration Timeline

Source: http://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-

introduction-of-parallel-TGA-and-PBAC-processes

The Memorandum of Understanding

Parallel processing introduced following

signing of MoU between DoH and MA

Signed on 10 September 2010

Kick-off on 1 January 2011

TGA-PBAC parallel process

PBAC submission can be lodged any time after

date of submission of TGA registration dossier

BUT

> PBAC lodgement process has stayed the same

> PBS listing cannot occur prior to ARTG

registration

> PBAC recommendation will not be published

before TGA decides that the product is registrable

– Must have at least the Delegate’s Overview

Possible scenarios

PBAC meeting precedes receipt of

delegate’s overview

PBAC meeting is after Delegate’s Overview

but before ACPM consideration

PBAC meeting is after ACPM consideration

but before registration decision

PBAC meeting is after registration decision

TGA-PBAC parallel process

Recommendation that PBAC process begin

during 5th month of TGA registration process

Sponsors permitted to submit Delegate’s

Overview up to one week before PBAC meeting

Products may still receive positive

recommendation from PBAC prior to ACPM

resolution and final conditions of registration

being known

Have the reforms worked?

Source: Pretium Drug Tracker, March 2014

Number of regulatory approvals 2010 - 2013

Approval to PBS listing timeframess

Source: Pretium Drug Tracker, March 2014

Time from regulatory approval to PBS listing

PBAC Recommendations

0

10

20

30

40

50

60

70

80

90

100

2008 2009 2010 2011 2012 2013

Nu

mb

er

of

Su

bm

iss

ion

s

Year

PBAC Recommendations

Major Submissions

Positive Recommendations

Potential issues faced by PBAC

TGA delegate’s overview may be

significantly delayed

> PBAC may be ready but cannot make any

recommendation until the delegate’s overview

Indications and the population study change

substantially between PBAC submission and

TGA outcome

> Need to re-evaluate increases the evaluation

workload

Consequences of submitting too early

Possible mismatch between the final TGA-

approved indication and PBS indications

Possible non-identification of key issues by

PBAC, such as risk of adverse events or action

required to mitigate risk (e.g. diagnostic tests)

Positive recommendation will not be made in

absence of Delegate’s Overview

Probability of deferral or rejection of submission

May lead to unnecessary resource wastage

General issues

Streamlined submission process is too rigid

Must elect 30 day or 60 day timeline to

respond to consolidated s31 questions

Generic products follows the same process

Sponsor expected to submit a complete

dossier

Only opportunity to submit additional data is

in response to consolidated s31 questions

General issues

Evaluators and Delegate have limited time to

properly consider submissions

If evaluators or delegate raise other issues,

no opportunity to respond

Sponsors have less dialogue and

interchange with evaluators

More likelihood of rejection of applications

Appeals on the increase

Case examples

Application for an injectable solution

Pre-submission planning form lodged

No untoward issues identified

Application lodged

Consolidated list of s31 questions received

along with chemistry evaluation report

No untoward issues raised

Sponsor responded to consolidated questions

Application for an injectable solution

Evaluation report for responses concluded

that there were no objections to registration

At the end of the evaluation process, TGA

raised impurity issues

But TGA said it would not accept additional

data to respond to the issues

Sponsor submitted the data anyway

But TGA rejected application 2 days later

Application for a generic product

Application submitted for a generic product

Subsequent submission of PBAC application

(minor process)

Complications with TGA evaluation

Delegate’s decision delayed – potential

safety issues identified

Decision not available before TGA

consideration

Application deferred by PBAC

Application for a generic product

By next meeting, TGA had still not made a

decision

Application not reconsidered

TGA decided not to issue bioequivalence

statement

Company decided not to proceed with PBS

listing

Application withdrawn

Issues to resolve

Issues to resolve - TGA

Reforms have shortened time from

evaluation to approval to 9 months

But statutory time frame is still 255 working

days

TGA “drops out” of SSR if it can’t meet its

deadlines

Why can’t the sponsor?

Issues to resolve - TGA

Shorter time for generics not considered by

ACPM

Other options for shorter evaluation

Circumstances when evaluation time should

be lengthened

Issues to resolve - PBAC

In theory, parallel submission process should

shorten time to PBS listing

But process can be hampered by progress of

TGA evaluation

Works well if SSR is fixed and product

approved

Process failures when TGA decisions

delayed