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November 2018 PBAC Meeting Agenda

The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type.

 

 

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: Regulatory Services Associate

Recruiting: Regulatory Services Professional

Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas…

 

The role…

Operating within the Regulatory Services Business Unit at Commercial Eyes, and reporting to the Regulatory Services Manager, this role will prepare routine regulatory submissions and be part of teams to deliver major submissions, such as Category One (1) Applications and New Medicine Applications.

 

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

  • Undergraduate qualifications in the pharmaceutical sciences or other
    scientific discipline.
  • 2+ years relevant industry and regulatory experience.
  • A basic working knowledge of TGA and Medsafe regulatory pathways.
  • Reasonable computer literacy.
  • Proven experience dealing with a high level of confidentiality.
  • Ability to work to deadlines and attention to detail.
  • Ability to work effectively in project teams.
  • Excellent written and spoken communication and interpersonal skills.
  • Interest in consulting.

 

The Regards…

At Commercial Eyes we work with and support the industry’s best and believe in doing what is right. 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
  • Be a member of a team who supports and cares for each other
  • Be part of an inclusive and diverse working environment
  • Access workplace flexibility that fits your life and the customer’s needs
  • 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 +61392510777.




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Patient programs for improved patient outcomes

In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes. With the ease of online access to tools such as patient forums, advocacy groups and self-assessment sites to name a few, patients are well informed and able to play a strong role in the dialogue of their own health care matters. This has ultimately led to a feeling of empowerment among the patient community, as well as an expectation to be heard.1

This shift in perspective is leading pharmaceutical companies to focus on patient centric services and technology-based solutions. In a survey of over 200 patient services executives from the US and European industries (Accenture 2016), 85% of companies said they would be raising their investment towards a patient-centric approach over the next 18 months (Figure 1).2

Figure 1

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

 

In the same survey, 95% of respondents said they would be planning to invest in patient engagement technologies during the next 18 months (Figure 2), showing the industry trend towards alignment with the ever more technology-focused patient.

Figure 2

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Accenture. The patient is in pharma’s growing opportunity in patient services. 2016

Of the top ten patient services cited by surveyed patients as ‘extremely valuable’ (Accenture 2016), those which received the highest patient value included:

  • Medication delivery/support (85%)
  • Benefit coverage and access support (79%)
  • Remote monitoring (79%)
  • Patient outreach, reminders, scheduling (79%)
  • Adherence program management (77%)

 

Based on these figures it is not surprising that Pharmaceutical companies are focusing more and more closely on patient programs as initiatives to improve access to, usage of and adherence to medicines. Spending on these solutions has increased by nearly threefold in recent years as companies strive to deliver improved patient outcomes.3

In response to the top two patient rated services above – medication and access support – pharmaceuticals companies are looking towards medicines access programs (MAPs) to allow for a deferred cost of, or cost-free or subsidised access to medicines which do not have the relevant funding in place. For example, free access to medicines for indications which are not included within a funded scheme, e.g. clinical trial, and usually involving life-threatening conditions (compassionate access programs) or free access to medicines which are TGA-approved, however have not yet reached government reimbursement via the Pharmaceutical Benefits Scheme (PBS) (patient access programs).4 These are examples of the types of patient programs we can expect to see continued industry growth and investment in.

How can we help?

At Commercial Eyes, we have expertise in the development of online and paper-based patient programs, including compassionate access programs, patient access programs, product familiarisation programs (PFPs), patient support programs (PSPs) which can also involve the use of nurse support. We have collaborated with centralised pharmacies to allow for supply management direct to patient and have worked on nominated pharmacy models alike. We are passionate and excited about the upward trend towards patient services and can provide advice, support, assistance and expert project management for programs tailored to our clients’ needs.

For more information on how we may be able to help you develop a successful compliant Patient Program please contact medcomms@commericaleyes.com.au

 

  1. Therapeutic Innovation & Regulatory Science 2017, Vol. 51(4) 460-467
  2. The patient is in pharma’s growing opportunity in patient services. 2016. Online access July 2018
  3. Patient Support Programs That Deliver Results. 2015. Online access July 2018
  4. Managing Medicines Access Programs. 2015. Online access July 2018




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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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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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