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PBAC Meeting Outcomes – July 2018

The July 2018 PBAC Meeting Outcomes were published on 17th August 2018. With 64 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including additional analysis conducted on biosimilar and oncology submissions.

 

PBAC Meeting Outcomes

 

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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Commercial Eyes Recruiting: Drug Safety Junior Associate

 

The Role…

If you have some experience in the medical, pharmaceutical, medical information, or drug safety areas, and are looking to build a career in pharmacovigilance this is a great role for you.  You will be processing and reporting adverse event cases and follow up, for a range of clients and products to ensure client and regulatory compliance.

  • Enter adverse event cases and follow up activities into GxP databases.
  • Work within the systems and processes designed to meet Good Pharmacovigilance (GVP) practice.
  • Process and support safety data as per SOP’s and client instructions in order to maintain client and regulatory compliance.
  • Prepare project reports and track agreed KPI’s in order to meet project deliverables.
  • Participate in internal and external audits.
  • Proactive contribution to improving business processes.

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

  • Health Science degree (Pharm, BioMed, PharmSci, etc).
  • Experience in a drug safety or equivalent role in a highly regulated industry (e.g. pharmaceutical or devices).
  • Understanding of the regulatory requirements for managing and reporting adverse events in Australia and New Zealand.
  • Highly developed service, communication, organisational and problem solving skills.
  • High level of attention to detail and computer literacy with experience in databases / systems.
  • Highly developed verbal and written communication, organisational and problem-solving skills. 

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

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au

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 39251 0777.




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Public Submissions to the August 2018 PBAC Special Meeting – Part 2

In the second part of this two-part series (Read Part 1 about here) we bring you further insight into opinions from the public submissions to the August 2018 PBAC Special Meeting.

Opinions from the Public Submissions


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

 

Do you think that different evidentiary requirements are appropriate for rare cancers?

 

YES – 64%   NO – 4%

No answer provided – 14%
Not published – 14%
Other* – 4%

 

* ”There are no set evidentiary requirements for applications seeking PBS listing of a drug, other than that the available data be presented systematically, in an unbiased manner and present evidence of comparative efficacy, safety and cost-effectiveness…”

 

How do you think cost-effectiveness should be established in this case?

A number of submissions commented on managed entry agreements and evidence development. A shared funded access mechanism could be applied where, after commencement, fit-for-purpose data could be collected prospectively to confirm the biological rationale and effectiveness of the product.

Multiple submissions stressed the generation of real-world outcome data for populations with rare and less common cancers as critical.

Do you think it is possible for the PBAC to satisfy itself that treatment with a PD-1 or PD-L1 checkpoint inhibitor is cost-effective without an economic model that is specific to that kind of cancer? How?

A number of submissions commented on the difficulties and challenges of determining cost-effectiveness without an economic model, or assessment of multiple indications within a single economic funding model. In the absence of multi-tumour data, there is significant uncertainty, and a greater tolerance of uncertainty may be justified in situations of high unmet need.

Some submissions provided possible approaches to establishing cost-effectiveness across cancer types:

  • Develop a separate model for each cancer type included in the multi-tumour list and perform separate cost-effectiveness analyses to identify the tumour type(s) where the drug is cost-effective
  • Develop a single, comprehensive model to simultaneously inform cost-effectiveness in multiple cancer types with the possibility of clustering different but related tumours types (e.g. similar natural progression, treatment approach). This model could allow estimation of incremental cost-effectiveness ratios (ICERs) of individual tumour types based on the relative prevalence and utilisation of the proposed drug in each tumour type
  • In the absence of an economic model, establish scores of clinical value (e.g. ESMO Magnitude of Clinical Benefit Scale (MCBS), ASCO value framework) and link price to scoring systems
  • Follow-on indication pathway: resources are devoted at the start of the agreement to define the populations and clarify expectations of the evidence and cost-effectiveness. For follow-on indications in the 3-year risk-sharing deeds, cost-effectiveness is verified at the end of the agreement period and this could be accomplished using a multi-indication model using pre-agreed principles
  • Rare cancer pathway: a pay-for performance type approach to medicines access should ideally not require the construction of, or evaluation of, a traditional PBAC-level economic model. This approach, in this population, controls expenditure and maximises value for public money by ensuring funds are spent when response (as a measure of effectiveness) is confirmed


FDA – 3 submissions referenced the FDA’s decision to consider pan-tumour indications and the approval of Keytruda® (pembrolizumab).

MA OIT – 4 submissions referred to the Medicines Australia’s (MA) Oncology Industry Taskforce’s (OIT) preliminary research into innovative international models for subsidy consideration across multiple indications. This found that there are various initiatives underway in overseas health systems (Belgium, Denmark, Netherlands, Germany and Italy). As per Medicines Australia: “While many of these agreements would not fit within the Australian legislative requirements, there are elements (e.g. initial horizon scanning of upcoming indications) that could be quite useful locally.” For further information, please refer to the submission by Medicines Australia: http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/august-2018-special-meeting/submission-27-medicines-australia.pdf

Outcomes of the PBAC’s considerations will be published through the PBS website scheduled for 28 September 2018.

Abbreviations: PBAC = Pharmaceutical Benefits Advisory Committee; PD-1 = programmed cell death-1; PD-L1 = ligand of PD-1 receptor; ICER = Incremental Cost-Effectiveness Ratio; ESMO = European Society for Medical Oncology; MCBS = Magnitude of Clinical Benefit Scale; ASCO = American Society of Clinical Oncology; FDA = Food and Drug Administration; MA = Medicines Australia; OIT = Oncology Industry Taskforce

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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Commercial Eyes Recruiting: Medical Information Associate

The Role…

This role is a great opportunity to take your career to the next level, through exposure to medical information across a range of companies and products. Join a great team, providing Med Info services on behalf of a range of clients (pharma, med device, local & global) to enquirers including; healthcare professionals, consumers, and the client’s internal staff.

Duties……

  • Receive, assess and respond to medical information enquiries in a timely and compliant manner.
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database.
  • Respond to customer queries using various medical databases and research strategies, including performing literature reviews.
  • Perform literature searches using Pubmed or similar databases to answer enquiries.
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures and regulations.
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities.

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

  • Health Science degree (Pharm, BioMed, PharmSci, etc).
  • 3+ years’ experience in medical information.
  • Knowledge of the principles of medical information.
  • Ability to conduct basic literature searches using Pubmed or Embase.
  • Technical writing skills.
  • Knowledge of prescription, medical device and/ or complementary medicines.
  • Knowledge of Australian and NZ & key overseas regulations in medical information and drug safety reporting.
  • Highly developed verbal and written communication, organisational and problem-solving skills.

The rewards…

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

  • 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.

  • 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 recruitment@commercialeyes.com.au.  If you want to know more information call Stephanie Gaylard, HR on 61 3 92510777.




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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 regulatory@commercialeyes.com.au




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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 recruitment@commercialeyes.com.au

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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Commercial Eyes Recruiting: Medical Information Manager

Recruiting: Regulatory Associate

 

The role…

The Medical Information Manager is responsible for the overall management of client outsourced medical information services, as well as ensuring resources and staff are managed to ensure each client’s medical information service is delivered in accordance with their specific requirements and Commercial Eyes quality standards and policies, regulations, and guidelines.

 

Client Management & Medical Information

  • Ensure delivery of high quality medical information and associated services within agreed time frames.
  • Manage assigned clients, ensuring clarity of expectations, open and effective communication, stakeholder engagement, and enduring positive relationships.
  • Monitor project activities and report against client and internal KPIs and timelines.
  • Ensure Adverse Events (AEs) and Product Complaints (PCs) are reported as required.
  • Work as part of a team, providing back up and coverage and sharing responsibility for the completion of tasks.

Leadership & Management

  • Manage a team of department professionals in accordance with the Vision, Purpose and Values.
  • Manage resource allocation and monitor team achievement to targets.
  • Complete people management processes such as recruitment, induction, performance management, coaching and knowledge development, identification of progression opportunities, and staff welfare issues.  
  • Assist team members with important client activities and act as direct client contact to address and resolve client concerns when escalated by the team.
  • Provide assistance and support to the Director in areas of the business unit management.

Business Development

  • Work with existing and potential clients in the life sciences sector to understand their business needs and identify areas or activities with which Commercial Eyes may be able to assist.
  • Translate these conceptual discussions into concrete project proposals including scope and cost estimates.
  • Build strong networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes.
  • Work closely with the Director to implement and develop strategic plans to expand the medical services practice and support development of strategic plans to drive the development and growth of the business unit.

 

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

  • BPharm or relevant scientific or biomedical qualification
  • 8+ years’ experience in a Medical Information / Medical Affairs roles in industry
  • 3+ years people and project management experience
  • Experience with TGA prescription, medical device and complementary medicines
  • Thorough knowledge of global medical information and drug safety reporting requirements 
  • Excellent people management skills and highly developed communication skills
  • Strong knowledge of medical literature and drug information databases
  • Excellent written and oral communication skills including communication of scientific data
  • Knowledge of Industry Codes and requirements for safety reporting in Australia and New Zealand
  • Previous consulting experience or a keen interest in the practice of consulting
  • Australian Permanent Resident or Citizen

 

The rewards…

At Commercial Eyes we work with and support the industries 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 support and care for each other
  • Be part of an inclusive and diverse working environment
  • Join a company that is generous to the community

 

To apply, please submit your CV and cover letter to recruitment@commercialeyes.com.au

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

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

 

If you are interested in this position or are keen to discuss other possible opportunities at Commercial Eyes please contact Stephanie Gaylard, Human Resources on +61392510777.




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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 matthew.douglas@commercialeyes.com.au.

 




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