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Public Submissions to the August 2018 PBAC Special Meeting – Part 1

In the first of a two-part series, we provide insights into opinions from 28 public submissions to the August 2018 PBAC Special Meeting held on 17 August 2018 regarding considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types

 

28 public submissions were received regarding the PBAC considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types.

 

  • Consumer organisation/research
  • Government HTA agency
  • Patients/individuals
  • Pharmaceutical industry
  • Professional organisation
  • Research and other – PBAC evaluation group



Opinions from the Public Submissions


Should the PBAC set aside one of its meetings each year to consider only PD-1 or PD-L1 inhibitors for cancer

Potential advantages of the PBAC’s consideration:

  • Timely & equitable access
  • Provides clinicians with flexible treatment options
  • Efficiency gains in the assessment & evaluation of data
  • Reduces PBAC workload
  • Budget certainty for government & sponsors
  • Opportunities for innovative pricing arrangements
  • Maintain reputation as a world leader in HTA & delivery of innovative medicines to Australians
  • Social justice

 

Potential disadvantages of the PBAC’s consideration:

  • Uncertainty with efficacy & safety data, cost-effectiveness & budget impact
  • Facilitating access to treatments that may be ineffective and/or harmful – opportunity cost
  • Accessibility to biomarker testing
  • Indication leakage
  • Timing may be premature given the number of ongoing trials, putting further PBAC applications at risk of heavy scrutiny
  • Equity across therapeutic areas
  • Increasing financial burden & burden on evaluation of cost-effectiveness
  • Limitations of current regulatory framework

What is the minimum level of evidence of effectiveness you think should be required before PD-1 and PD-L1 checkpoint inhibitors are considered for subsidy for a particular kind of cancer?

Aside from commenting on flexibility or responses not published/provided, five public submissions all stated that earlier phase, single-arm evidence should be made acceptable. Four submissions stressed the importance of subgroup analyses according to diagnostic assays such as biomarker expression.

The three government HTA agencies who provided public submissions had differing views: no minimum level of evidence should be required, single-arm evidence should be acceptable, or there should not be any difference in the level of effectiveness required for treatment subsidy in any therapeutic area.

Other views included evidence development and managed entry agreements rather than extrapolating evidence across tumours, with real-world data collected prospectively to confirm the biological rationale and effectiveness. A few submissions commented on a pay for performance model in the case of rare cancers, where effectiveness would be determined at the level of the individual.

Tune in next week for Part 2 of this series.




Abbreviations: PBAC = Pharmaceutical Benefits Advisory Committee; PD-1 = programmed cell death-1; PD-L1 = ligand of PD-1 receptor; HTA = Health Technology Assessment; MSAC = Medical Services Advisory Committee; IFNγ = Interferon gamma; TMB = Tumour Mutational Burden; dMMR = deficient mismatch repair; MSI-H = High Microsatellite Instability

Source: Pharmaceutical Benefits Scheme

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

This article was written by Michelle Yassa, Market Access Consultant.

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PBAC Special Meeting – August 2018

The August 2018 PBAC special meeting is scheduled for 17 August 2018 to consider options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple tumours (pan-tumour indications) on the PBS. Here, the Commercial Eyes Market Access team provides an overview of previous PD-1 and PD-L1 inhibitors submissions, including an additional analysis conducted on post listing utilisation.

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms. 

 

One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications.  All listed medicines must now use the permitted indications on offer or apply to add a new permitted indication to the list.  There will be no grandfathering of current claims. No permitted indications will reference prohibited or restricted representations as per the Therapeutic Goods Advertising Code 2015.  For medicines listed prior to 6 March 2018, sponsors must submit a grouping application to remove free text and ensure that only current permitted indications are used. 

 

But it’s not all bad news, there is a 3 year window to update claims and labels –  before TGA starts cancelling products under section 30 – and for the first 18 months (until 6 September 2019) the TGA fees will be waived.

 

On the bright side, this is a great opportunity for Sponsors to clean up their TGA listings and ensure that the evidence to support their indications is current and compliant.

 

If your claim does not fit one of the permitted indications, there is good news for you too!  The TGA have released a new tier of listed medicines – the AUST L(A) –  Assessed Listed Medicines.  To be an assessed listed medicine, the product must comply with the requirements of a listed medicine, but can have intermediate, rather than low level indications.  AUST L(A) products will have all their indications assessed and will be issued with a claimer for the product label stating that it has been assessed by TGA.

 

So, there’s plenty of good news and significant opportunities for sponsors of listed medicines to strengthen claims, consolidate supporting data and ensure a compliant, future focussed product portfolio. If you need help with making the most of this opportunity, contact our expert consultants at [email protected]

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commercial eyes recruiting: business services associate

Recruiting: Business Services Associate

The role…..

The Business Services Associate reports to the Business Services Manager; and is responsible for administrative activities that facilitate the smooth running of the company. The role provides seamless support to the company’s large team of consultants across the week, during business hours. The culture and personality of the Business Services Associate has significant influence across the business and so it is essential that this role leads the way with a positive, dedicated, proactive and professional approach. The role is responsible for the Business Services function at times when the Manager is not in the office.

In this role, main duties will include:

  • Welcome visitors in person or by phone
  • Incoming & outgoing mail, courier bookings
  • Manage meeting room bookings and set up 
  • Staff & business event coordination & catering
  • Office facility management & coordinating office supplies
  • Administrative support across the company
  • Administration support of the company’s Quality Management System
  • Preparing company communications including, daily updates & the staff internal newsletter
  • Staff travel bookings

 

To be successful in this role, you will ideally possess…

  • 5 years’ relevant office administration experience
  • Bachelor’s degree or relevant qualification would be an advantage
  • Technical know-how – strong computer/ Technical skills; Microsoft Office, office equipment, business software
  • Confidence – enthusiastic, bright and friendly personality
  • Knowledge of standard administrative practices and fundamental business principles
  • Professionalism – well-presented and interacts with clients and staff professionally
  • A positive “can do” attitude, self-motivated
  • Adaptability – demonstrate flexibility regardless of changes in the work environment
  • Organisation skills that means you can balances conflicting priorities to get things done
  • Detailed attention to make sure ‘its right’
  • Communication skills –producing well thought out professional correspondence
  • A strong sense of confidentiality with demonstrated experience managing confidential and sensitive information

 

The rewards…

At Commercial Eyes we work with and support the industry’s best.  At Commercial Eyes you will:

  • Propel your professional development through a breadth of experience
  • Be assured of interesting & meaningful work that challenges, changes, and demands your best
  • Work for a company consistently delivering excellence
  • Deliver work that makes a difference to people’s lives through health

At Commercial Eyes we believe in doing what is right. At Commercial Eyes you will:

  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

Please note: to apply for this role you must be a permanent resident or citizen of Australia.  Commercial Eyes does not accept applications from recruitment agencies.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.

To apply, please submit your CV and cover letter to [email protected]

Please note Commercial Eyes does not accept applications from recruitment agencies.

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Stephanie Gaylard, Human Resources or for a private and confidential discussion on +61 (0)3 92510777.

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Sponsors struggle with Ministerial discretion

The 2017 Medicines Australia Strategic Agreement with the Australian Government extended the existing five-year anniversary statutory price reduction (SPR) of 5% for F1 medicines and introduced new SPRs for drugs that have been listed for ten years and fifteen years over the five-year term of the agreement (10% and 5%, respectively).

Sponsors were afforded the chance to apply for discretion from the Health Minister to avoid the price cut, based on relevant pricing or clinical factors, with the outcomes for eligible PBS items becoming known on 1 June 2018, when price reductions were implemented.

A Commercial Eyes analysis has identified items that received Ministerial discretion, showing a bleak picture for Sponsors who seek to avoid these newly legislated cuts. Out of 582 items eligible for Ministerial discretion, only 64 were able to avoid a price cut.

Forty-two secured full discretion, with 22 only receiving partial discretion. An overview of these outcomes, and a list of Sponsors receiving discretion for multiple items are presented below.

 

Commercial Eyes has completed a detailed report on Ministerial discretion outcomes, including analysis of the application of Ministerial discretion by:

  • Manufacturer
  • Therapy area
  • PBS Program; and
  • Manner of Administration

The report also includes an analysis of successful outcomes to identify trends and commonalities between items and can be purchased directly from Commercial Eyes. For additional information, or a customised report, contact Matthew Douglas, Market Access Consultant, at [email protected].

 

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The long road to PBS listing for Orkambi

Orkambi (lumacaftor and ivacaftor), a treatment for cystic fibrosis (CF), will go before the PBAC for a fourth time at the upcoming July 2018 PBAC meeting. So far, the road to reimbursement has been filled with multiple rejections, a strong voice from patient advocacy groups, increasing media interest, and the apparent ‘impossible position’ in which both Vertex Pharmaceuticals (the sponsor) and the federal government find themselves.

The sponsor, and patient advocacy organisations, contend that Orkambi is an essential medicine for cystic fibrosis patients that would help limit hospitalisations associated with CF and enhance ability to participate in school, employment, and the community. This view is buoyed by remarks from Health Minister Greg Hunt, who has encouraged Vertex to “give it another go” with the PBAC following an earlier rejection. In commentary from previous submissions, the PBAC supports this view and yet has rejected Orkambi three times “on the basis of unacceptable cost-effectiveness at the requested price and uncertainty around the longer term impact of lumacaftor/ivacaftor on lung function and survival beyond two years of treatment”.

The clinical benefit of Orkambi to cystic fibrosis patients appears to be have been demonstrated and accepted in previous PBAC submissions, with the barrier to recommendation continuing to rest on price, despite repeated proposals for risk-share arrangements and price caps. It is however unclear whether Vertex is seeking a Special Pricing Arrangement.

Recent history has shown that innovative high cost medicines often require multiple trips to the PBAC before being recommended and PBS-listed. Examples include Spinraza (for spinal muscular atrophy), Ibrance and Kisqali (for breast cancer), all requiring multiple submissions prior to recommendation. Celgene’s Otezla (apremilast) has abandoned seeking reimbursement entirely, following seven PBAC rejections.

With its recent stint on Sunrise, Orkambi is a high-profile example of what can occur when both the PBAC and the sponsor are unable to reach agreement on the value of a medicine. Could this evolution of the reimbursement environment extend to current pipeline medicines? Upcoming treatments for migraine might face similar hurdles, as currently available treatments are older, cheaper medicines and the potential patient population is large (equating to high cost to government).

The outcome of July’s meeting may demonstrate that three or four PBAC submissions for innovative high cost drugs has become ‘the new normal’ for gaining reimbursement in Australia.

 

The Commercial Eyes Market Access team has extensive experience in pricing and reimbursement and can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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PBAC Meeting Agenda – July 2018

The July 2018 PBAC Meeting is scheduled from 4 to 6 Jul 2018. Here, the Commercial Eyes Market Access team provides an overview of the meeting agenda, including submissions relating to biosimilars lodged for this meeting.

 

 

The Commercial Eyes Market Access Team can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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PBAC Meeting Outcomes – March 2018

The March 2018 PBAC Meeting Outcomes were published on 20th April 2018. With 71 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including an additional analysis conducted on oncology submissions which have dominated the meeting.

 

 

The Commercial Eyes Market Access Team can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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PBAC Meeting Agenda – March 2018

 

The Commercial Eyes Market Access can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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PBAC outcomes: a snapshot of 2017

 

The Commercial Eyes Market Access Team can help you navigate Australia and New Zealand’s sophisticated and mature systems of Health Technology Assessment. Contact us on (03) 9251 0777 to learn more about our PBAC Outcomes Database and let us help you envisage, achieve and defend the optimum market access outcomes for your business.

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