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Commercial Eyes appoints Simon Higgins to head up new Commercialisation Services division

Commercial Eyes Pty. Ltd., one of Australia’s most successful health technology commercialisation companies, is pleased to announce the appointment of Simon Higgins to head up it’s new Commercialisation Services division.

Simon joins Commercial Eyes with over 20 years’ experience in the healthcare industry most notably as Director of Business Operations and the Commercial Lead for Pfizer, and more recently as heading up Bristol Myers Squibb’s Access, Policy and Advocacy division.

The new Commercialisation Services division offers a comprehensive and focused range of consulting services across the company’s existing offering of Market Insights, Market Access, Pricing and Policy as well as Medical Communications and Patient Engagement. It will also complement the company’s Medical Services division.

“In an increasingly complex environment we continue to see a need to provide integrated and comprehensive commercialisation services that allow medicines and other treatments to get to patients as quickly as possible,” Commercial Eyes’ founder and Managing Director, Andrew Carter said.

We saw Simon’s background and experience as the perfect fit for this role which draws on his broad experience in market access and commercialisation of novel pharmaceuticals and in the growth of established technologies.

Established in 2001, Commercial Eyes has rapidly grown to become a leading pharmaceutical and medical device commercialisation business with almost 90 people across four countries. Comprised of experienced subject matter experts with substantial real-world experience and a pragmatic, solutions-oriented approach, the company delivers tailored advice and services to those with a commercial interest in getting medicines to market.

On his appointment, Simon commented, “What has impressed me most is the passion the Commercial Eyes team has in partnering with our clients to get their health technology to patients that can benefit. This is across an incredibly broad offering, including understanding the local market dynamics, navigating the most appropriate regulatory and reimbursement pathway, communicating the value and benefits of product innovation, through to assisting sponsors to meet their post market safety requirements.

“Commercial Eyes is also setting a high standard in the industry with its workplace culture. While they have a commitment to delivery high-quality outcomes, this is achieved in a co-operative and supportive environment. There is a strong focus on community engagement, flexibility and wellbeing in the workplace which really appeals to me.”

I am looking forward to working together with the Commercial Eyes team and our clients to fulfil their objectives within the Australian and New Zealand health systems, leveraging the expertise from right across the Commercial Eyes business.

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Leukaemia Foundation – Raising Awareness of Blood Cancers

September is Blood Cancer Awareness month

Through various parts of our business including market access and insights, regulatory services and medical communications, Commercial Eyes works with a number of organisations involved in improving and extending the lives of people living with leukaemias and other blood cancers.

At a recent staff event, we were able to hear Patrick Devine share his story. Patrick was diagnosed with a rare blood cancer 10 years ago and with the help of clinical trials, is defying the usual life expectancy of his cancer type.

We were also pleased to provide the Leukaemia Foundation with a $5000 donation to support their bold goal to achieve Zero Lives Lost to Blood Cancer by 2035.

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PHARMAC prepares to take over the procurement of medical devices

Access to medical devices in New Zealand is changing

 

The Therapeutic Products Bill will be published shortly, resulting in PHARMAC assuming responsibility for the procurement and funding of medical devices in addition to their current brief of medicines. This is due to the establishment of a joint regulatory scheme to incorporate all therapeutic products (medicines including cell and tissue products and medical devices). This Bill replaces the Medicines Act that has been in place since 1981.

 

It is widely acknowledged that PHARMAC has implemented policies that have resulted in the procurement of the lowest priced drugs in the OECD. However, PHARMAC has also implemented policies have resulted in significant delay in access to new medicines, primarily due to working with a fixed yearly budget.

 

Professional medical societies agree that the Medicines Act 1981 is outdated and no longer fit for purpose but have expressed concern regarding the potential change in patients’ access to medical devices.

 

Considering the potential impact of disruptions to the supply chain and reduced availability of medical device products, it is critical to have a practical and thorough understanding of the challenges to market access in New Zealand to successfully navigate the increasingly complex PHARMAC reimbursement system. 

 

The Commercial Eyes Market Access team is highly experienced in developing reimbursement strategy and funding applications for consideration by PHARMAC. For assistance in navigating the PHARMAC reimbursement and pricing landscape, please contact Tenille Manuele (Director, Market Access & Pricing): [email protected]

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No CE mark? No problem.

CE Mark

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia.

Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device or IVD on the ARTG. Waiting for the European CE mark to be granted often resulted in delayed entry of devices into the Australian market.

In August 2018, a change was made to the legislation that permits the TGA to accept certification from a number of other markets with similar regulatory systems.  Acceptable certification includes decisions of the United States Food and Drug Administration (US FDA), approvals and licences issued by Health Canada, pre-market approvals from Japan and Certificates and reports issued under the Medical Device Single Audit Program (MDSAP).

The change has removed the reliance on the European notified bodies’ EC certificates, providing greater flexibility for sponsors, especially those based in North and South America.

If you’re looking at bringing a medical device to Australia the absence of a CE mark may no longer be an issue.

If you need assistance with medical devices in Australia, please contact our Regulatory Services team.

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PHARMAC issues a call for funding applications for medicines for rare disorders

PHARMAC Call for Funding

Applications will be accepted until 5pm on the 5th of August 2019 and will be considered by the Rare Disorders Subcommittee at their meeting scheduled for the 24th of September 2019.

 

Eligibility criteria:

  • The medicine must have been approved by Medsafe or an approved international regulatory authority for the identified indication;
  • The disorder is a clinically defined disorder affecting an identifiable and measurable patient population with a prevalence of less than 1:50,000 in NZ;
  • The medicine is only registered for the treatment of the rare disorder, or if it is registered for other disorders (or is part of Phase 3 clinical trials for other disorders), the cumulative prevalence across all indications is still less than 1:50,000 in NZ.

 

Additionally, applications should still meet the requirements of a full funding application, addressing the Factors for Consideration, as per standard PHARMAC submissions.

 

For assistance in the preparation of an application to PHARMAC, please contact [email protected]

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International Women’s Day Celebrations

International Women’s Day (March 8) is a global day celebrating the social, economic, cultural and political achievements of women. The day also marks a call to action for accelerating gender parity.

On IWD we celebrated our amazing woman and we considered the role gender imbalance plays in Domestic Violence, and thought about what we can each do for #BalanceforBetter.

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Are you ready for the mandatory transition to eCTD for prescription medicines?

Mandatory Transition to eCTD

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new biological entity, biosimilar and new combination medicine applications; with a proposed implementation by first quarter 2019. The timelines for Stage 2 (other Category 1 applications) and Stage 3 (variations and other types of applications) are 1 October 2019 and 1 July 2020, respectively.

The TGA consultation on the Transition to eCTD only for prescription medicines closes on 4 December 2018 and it is an opportunity to provide feedback on how the staged transition to eCTD will impact your organisation.

The transition to eCTD may seem daunting for companies who have not “taken the plunge”, and with valid reason, as it is not a simple project. Acquiring eCTD software will require considerable planning and resource before you are up and running. Some of the key steps to consider in planning your transition include defining your publishing requirements, investigating software solutions, selecting a vendor, procuring software, preparing IT systems, installing software and training.

Full or partial outsourcing of eCTD publishing is an alternative option which can support your transition to eCTD. Outsourcing can provide a cost and time effective solution for accessing eCTD software and publishing expertise. Partial outsourcing is also an option for increasing publishing capacity and access to local publishing resources in the same time zone can assist with meeting short deadlines.

 

To discuss how Commercial Eyes can assist you with all your eCTD outsourcing needs, contact our Regulatory Services team at [email protected]

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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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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 [email protected]

 

  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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