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Improved Consumer Medicine Information template

TGA CMI Template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously registered medicines must adopt the new format by 30 December 2025.

 

For any enquiries or assistance with CMI formatting, please get in touch with our experienced Regulatory Services team at [email protected]

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Pandemic disruption and a new MA code update; what for patient programs in this new era?

covid19

COVID-19 has taught us that in times of uncertainty, people seek information and reassurance.

With everyone affected by the current pandemic, there are many people around Australia living with chronic and debilitating conditions, impacted by these unprecedented changes and requiring medicines and support for managing their illnesses. People are skipping appointments and missing crucial treatments, whilst communication and reassurance is more necessary than ever to continue keeping vulnerable people safe and well.

Amongst the distractions caused by this novel coronavirus, the long-awaited Medicines Australia (MA) Code Edition 19 was released. But what does this new edition mean for patient programs moving forward, and how can we continue to support patients in a time when they need information more than ever before?

 

  1. Whilst Edition 19 moves towards a ‘principles-based’ approach (and incidentally a lot less pages!) there are still specific requirements MA members are required to uphold surrounding patient support and access programs.
  2. Edition 19 still permits support for patients, albeit usually via third parties who provide patient services. There are a great many wonderful patient support services, and health consumer organisations operating in Australia today. The rapid uptake of technology and communication channels seen since self-isolation measures have been implemented will truly bring lagging demographics into the digital age and complement the many ways in which support and education can be delivered. Edition 19 now treats all channels (digital and traditional) with the same approach, no more distinctions between social or owned media.
  3. A support program is still an activity to help patients get the maximum benefit of their therapy, aimed at improving outcomes via education of appropriate administration of treatment and condition or disease lifestyle management to aid compliance. In recent years patient programs have become more holistic and sophisticated, demonstrating measurable improved outcomes and integrating treatment and lifestyle advice seamlessly. We see these programs as more important now than ever before.
  4. We won’t miss the terminology ‘PFP programs’ which is completely absent from Edition 19. That doesn’t mean familiarisation programs are no more, it means the formulaic requirements including how many patients can participate and the protocols are gone. Now referred to as ‘programs for the provision of medicines at no cost or reduced cost’ they still require a legitimate need and clear clinical rationale, and must withstand public scrutiny with regard to how long they run and how much stock is provided.
  5. Third parties are still paramount in enabling companies to deliver services to patients, providing de-identified data on outcomes that improve compliance, and critically support ongoing Adverse Event monitoring for new medicines. Aligning your Medical Information and Pharmacovigilance requirements internally with the opportunity to provide patient programs will continue to be a pathway to successful access and support programs for patients in need, creating healthier outcomes for all.

 

To find out how patient engagement programs can support your pharmaceutical marketing post Edition 19 and throughout COVID-19 into the future, contact [email protected]

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Hand sanitiser – What do you need to know to supply in Australia?

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories have been impacted even day to day.

COVID-19 hand Sanitiser

One of the areas with significant change is hand sanitisers; while washing hands with soap is still considered to be the most effective way to practice good hand hygiene, hand sanitisers can play an important role in keeping hands as free from harmful microorganisms as possible.

Shortages of hand sanitisers are here already, and the inventive, creative and sometimes concerning ways to overcome these potential shortages can pose a risk to the community.

Traditionally, hand sanitizers have been regulated as either ‘cosmetics’ or ‘therapeutic goods’, based on the types of claims made and the ingredients used.

 

To ease the burden of these shortages, from the 28th of March this year the Therapeutic Goods Administration (TGA) has introduced an additional category. Two formulations that were previously regulated as ‘therapeutic goods’ are now excluded from the TGA process requirements for the duration of the COVID-19 pandemic. This was enacted through the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020. It should be clear however that although certain hand sanitisers do not need to be lodged to the TGA, there are still specific requirements in the Determination that must be met before the product can be supplied through this route.

For anyone looking to import or produce hand sanitisers locally it is very important to be aware of the requirements to ensure your product is compliant for supply within Australia. The COVID-19 specific measures implemented by the TGA are creating an ever-evolving complex regulatory environment.

If you need assistance with determining the requirements for supply of hand sanitiser please contact our Regulatory Services team at [email protected]

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(NOT) BUSINESS AS USUAL

We live in unprecedented times.

At Commercial Eyes, we focus our efforts on supporting clients in the regulated therapeutics industry get their products to the patients who need them, when they need them. We are conscious of the critical role many of our clients are playing, and will play in the current environment. Indeed, we have had a number of enquiries for direct support in addressing COVID-19 related issues.

Like many companies across Australia and around the world, our teams have quickly transitioned to working remotely.

Our investment in business processes, systems and hardware enabled us to act quickly last week, and our teams have set up seamlessly to be 100% working remotely for all our client requirements. For our work, that means we are relying on technology more than ever to support our clients.

We take matters of public health safety seriously, as well as the potential impact on our employees, business partners and much valued clients.  We will continue to monitor developments and the advice of expert authorities, and our thoughts remain with those affected by the virus.

 

So, for Commercial Eyes, we are well and truly open for business. However, as many of our clients have identified, this is anything but business as usual.

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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

Brexit

 

The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020

A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition period, with the current regulations for therapeutic goods continuing to apply.

The TGA have recently published guidance for sponsors and the main impact on the supply of medical devices and medicines in Australia will occur after the end of the transition period.

 

Medical devices

The TGA will continue accepting conformity assessment documents issued by UK notified bodies (under MHRA oversight) for medical devices currently on the ARTG, meaning products may continue to be imported and/or supplied in Australia.

The TGA are currently amending legislative instruments to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies.

It should be noted that some UK-based device manufacturers are transferring EU certificates from UK notified bodies to EU notified bodies. In this situation sponsors will need to submit variations to update the manufacturers evidence or in some cases submit a device change request if the ARTG entry is impacted.

 

GMP clearances

Sponsors are strongly encouraged to submit extension applications prior to expiry of current GMP clearances for UK manufacturing sites that are supported by MHRA desk-top assessments.

 

Medicines

There is minimal impact to medicines, as Australia and the UK have signed a Mutual Recognition Agreement (MRA) guaranteeing continuity of the existing mutual recognition arrangements when the transition period ends.

Sponsors will need to consider the impact of changes to the supply chain if manufacturing steps such as ‘release for supply’ to the Australian Market are transferred from a UK-based site to EU-based manufacturing sites, to ensure replacement sites are GMP cleared and registered on the ARTG. In this situation, forward planning will be imperative to minimising the impact on medicine supply and avoiding medicine shortages.

 

If you need assistance with assessing the impact of Brexit or navigating your regulatory strategy, please contact our Regulatory Service team at [email protected].

 

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TGO 91 and TGO 92 – are your labels ready?

TGO 91 and TGO 92

Following the 4-year transition period, the medicine labelling Therapeutic Goods Orders (TGOs), TGO 91 for prescription medicines and TGO 92 for non-prescription medicines, will become mandatory on 1 September 2020.

Medicines that are released for supply on or after 1 September 2020 must comply with either TGO 91 or TGO 92, whichever is relevant.

Sponsors should check that their medicine labels comply with the relevant TGO and if not, applications to update the labels should be submitted now to ensure they are approved in time for use in stock released after 1 September 2020.

 

For assistance in undertaking a review or updating and developing medicine labels that comply with TGO 91 or TGO 92, please contact our expert Regulatory Services team on +61 3 9251 0777

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PBAC Outcomes – November 2019

The November 2019 PBAC Meeting Outcomes were published recently

With 61 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making for this meeting, compared to the past 5 years of outcomes.

Of note, the November 2019 meeting had the highest recommendation rate of any of the major PBAC meetings (March, July or November) for the past 5 years.  Overall, 74% of the 61 submissions were recommended. This compares to an average of 60% between March 2015 and the November 2019 meeting.

Fourteen Sponsors made more than one submission to the PBAC, with Roche and Orpharma topping the list with four submissions each. One submission came from the National Aboriginal Community Controlled Health Organisation (NACCHO) for Prednefrin® Forte eye drops (Allergan Australia Pty Limited) indicated for severe inflammation of the eye. NACCHO, the national peak body representing Aboriginal Community Controlled Health Services, were given a positive recommendation by the PBAC with a Restricted Benefit listing for severe eye inflammation following cataract surgery for patients who identify as Aboriginal and Torres Strait Islander.

The majority of positive recommendations were based on cost-minimisation economic analyses (n=19), as reported by the PBAC. Thirteen of 45 positive recommendations related to oncology indications, while two positive recommendations were for biosimilars.

One third of rejected submissions related to oncology indications. Reasons for rejection were varied, and related to the uncertain cost-effectiveness of the intervention, financial estimates that were unacceptably high, uncertain and/or inadequately justified, unclear or immature clinical evidence and in one case, an unacceptable nominated comparator (Polivy® for diffuse large B-cell lymphoma).

Two out of four deferred outcomes were related to oncology indications. Deferred submissions were related to requests for revisions to economic models, estimated financial implications and/or proposed Risk Sharing Arrangements, one unacceptable price advantage (Trulicity® for type 2 diabetes mellitus) and one cost-minimisation analysis unable to proceed until the comparator is listed (Keytruda® for melanoma).

Of the 61 submissions assessed by the PBAC in November 2019, 15 (25%) were resubmissions of which 74% were recommended, compared to a 5-year average recommendation rate for resubmissions of 50%. Oncology medicines accounted for nine (60%) resubmissions.

Publication of the Public Summary Documents from the November meeting on 6th March 2020 (for positive and subsequent rejections) and 20th March 2020 (for first time rejections and deferrals) will provide some additional context for the implications for PBS expenditure from this meeting.

 

The Commercial Eyes Market Access & Pricing 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.

This article was written by Michelle Yassa and Ian Teichert, from our Market Access & Pricing team

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Pharmac reverses controversial brand switch decision

Pharmac has been placed in the spotlight over their decision earlier in the year to fund only one brand of anti-epileptic medication, lamotrigine, instead of the previously funded three lamotrigine brands.

Prior to the switch, Medsafe warned Pharmac that the switch posed a “significant safety issue” and was “against international consensus on switching brands of anti-epileptic medicines”.

Despite the Medsafe warnings, Pharmac proceeded to approve an agreement with Mylan New Zealand Pty Ltd to only supply a single brand of lamotrigine, ‘Logem’, the switch aimed at recouping a supposed $30 million in savings over five years.

From October 1st 2019, Pharmac ceased funding of the two major brands, Lamictal and Arrow-Lamotrigine, used by 90 percent of New Zealand patients with epilepsy. As a result, these patients were forced onto the generic version, Logem, impacting an estimated 11,000 people.

Since the brand switch decision, four deaths and 50 adverse reactions have been reported to the Centre for Adverse Reactions Monitoring.

The Health and Disability Commissioner, Anthony Hill, is calling for an inquiry into the decision claiming that patient rights have been breached with many patients unaware their medication had been changed.

In a mea culpa, Pharmac recently reversed their controversial decision, backing down on the switch and enabling patients to obtain funding for their preferred medicine if supported by their GP.

Pharmac’s backflip provides a warning to funders that the benefits and harms to patients must be managed carefully when embarking on cost-savings measures.

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ARCS Australia appoints Commercial Eyes Founder and Managing Director to Board.

ARCS Australia, a leading, membership-based organisation focused on the development and growth of the Australian healthcare sector, has appointed Commercial Eyes Founder and Managing Director, Andrew Carter, to its Board of Directors.

With nearly 30 years’ experience in the medicines and medical device industry, Andrew is a highly qualified and skilled business leader and company director, with a strong track record in leadership, strategy, business structuring, growth and delivering financial stability.

This along with Andrew’s nearly twenty years of governance experience in both the private and public sector will bring a depth of knowledge to the ARCS Board as they work to shape the future of the organisation, with a continued focus on their mission of providing education, career pathways, professional development and advocacy to those working in the sector.

In a recent announcement ARCS President, George Papadopoulos, welcomed Andrew and other newly elected members to the Board and thanked outgoing Board members for their contributions to ARCS and the healthcare sector.

 

For more information on ARCS Australia, please click here.

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Commercial Eyes receives marketing award for product launch campaign


Congratulations to Associate Director, Dianne Gill and our Medical Communications & Patient Engagement team for receiving a Diamond Award from Consumer Healthcare Products Australia.

The team took home the marketing award for Best Healthcare Professional Initiative, after delivering a successful product launch strategy and campaign for one of our clients.

The brief for Commercial Eyes was to assist the client to launch a product into a competitive market, while avoiding cannibalisation of the client’s existing products in that market. Our Medical Communications & Patient Engagement team were able to do this by considering the positioning of the entire product range and developing engaging educational material to support healthcare professionals with appropriate patient selection.

We always appreciate recognition for the work that we do and know that we can help make a difference in the lives of patients.

For more information on the services and programs that our Medical Communications & Patient Engagement team offer, please click here.

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