Strategic, Market, Access, Advisory
For Pipeline Assets – EVA helps companies understand the current market and payer dynamics along with current and likely competition to help prepare inputs for TPP optimisation, Using sophisticated methods gauge payer “willingness to pay” and conduct analogue analysis and therapy area price evolution to help establish price-access implications for pipeline assets in Asia-Pacific including ANZ.
Payer Value dynamics and product value perception mapping – EVA helps companies understand the implications of broader pricing policies and evolving payer dynamics to help prioritise assets and indication for Asia Pacific and ANZ markets. Within this context, we can also help frame country level feedback on behalf of the operating company for regional and global inputs to help shape internal discussions around price and evidence requirements. In addition, we can also assist with data generation plans to improve evidence base for access and reimbursement based on competitors evidence plans and most likely comparators (see integrated evidence generation panning and support for more information)
Launch readiness – In order to improve launch readiness and cut time to patient access, we work with our clients to assess the market potential based on most likely label and gauge the unmet need within therapy areas using patient characterisation studies and map the clinical trial results to the label population in real world settings to help generalise clinical trial findings and reduce payer uncertainty. Using competitive dynamics alongside evolving payer needs help our clients recalibrate the market access strategy and work up a well aligned value proposition prior to launch. Based on the clinical trial evidence (Phase 3) and using the most current product profile gauge the likely payer acceptance of the evidence and price potential based on historical decisions, comparator price evolution / erosion since the last assessment, review current pricing guidance and in country reimbursement policies and funding priorities. This ensures that our clients have most up to date and realistic estimate of time to reimbursement to help guide other investment activities for commercial launch readiness.
Environment shaping – A sound access strategy doesn’t just revolve around developing an HTA submission or simple market assessment, best practice approach requires optimising both evidence and market conditions to improve chances of gaining reimbursement and accelerate uptake at launch. To help improve the launch effectiveness, EVA works with clients to help shape policy and practice, improve disease perception, identify the right stakeholder and engagement strategies to ensure successful launch that is both evidence-based and supported by key stakeholders such as Patient advocates and Key opinion leaders.
Integrated Evidence Generation Planning and Support
Targeted evidence generation aligned to stakeholder needs to improve value demonstration is no longer optional but a necessity. Often data generation is an afterthought or generated purely to plug gaps in clinical trial evidence. But savvy market access practitioners anticipate data requirements ahead of time based on superior understanding of key stakeholder’s evolving needs and are not afraid to challenge the status quo and inertia with compelling evidence to deliver access for patients.
At EVA, we are committed to bringing you most up to date evidence generation planning and execution tools which are tailored to products/services and we collaborate with our clients and stakeholders with a view to improve existing data generation plans and tailor it based on evolving payer needs in pre-launch, launch readiness and post launch scenarios. Our mission is to give your innovation the best chance for speedy reimbursement and patient access with best evidence generation strategy.
Policy and Advocacy
Health Policies and Payer dynamics can impact the size of the opportunity and the ability to capture optimal value for innovation. We work with our clients to help navigate the complex policy environment, develop credible policy asks in an evidence-based manner to help streamline access barriers and improve resource allocation for promising health technologies. With our deep insights and policy development experience, coupled with external affairs expertise, EVA along with its partners help create political advocacy campaigns that are credible and generate access solutions that are pragmatic and implementable.
New Product Planning
Most companies do not put a brand team in place until closer to launch however each product may have unique challenges that need to be addressed much earlier in the commercialisation planning e.g. evidence needs, disease perception, stakeholder value perceptions and environment shaping (policy and funding). Most New product planning (NPP) teams are stretched and only able to support a limited number of assets in-depth and light touch on others. This is not ideal and could have negative consequences for the business potential of certain assets. A better practice requires that the NPP team have superior understanding of the unique challenges of each product and potential implications much earlier in the assets commercialisation journey to guide the internal discissions at regional and global levels and address the gaps and if required resource certain activities ahead of time and lay solid groundwork to improve access and business certainty for pipeline assets.
EVA and its trusted partners collaborate with clients “upstream” as a natural extension to the NPP teams and provide an efficient and low-cost support option to free up valuable resources and provide robust market assessment (unmet need, place in therapy, patient population, and comparator selection), payer value perception, price evolution and pricing opportunity within the therapy areas. This helps NPP teams guide the internal discussions on ways to improve value proposition based on facts rather than instincts. We work across the spectrum to highlight the evidence needs, ways to improve potential value capture and access certainty. This force multiplier effect can make a critical difference in achieving optimal commercial outcomes.
Australian Sponsorship and Regulatory Support
EVA Healthcare is an Australian registered company that can act as a third-party sponsor for companies by:
- Sponsoring companies that do not have an established legal entity in Australia
- Submitting an application to add a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
- Maintaining sponsorship after registration or listing on the ARTG
- Undertaking ongoing legal responsibilities once the therapeutic good is on the ARTG and fulfilling the obligations of the sponsor
Sponsors have ongoing legal responsibilities once a therapeutic good is on the ARTG including:
- Obtaining information from the manufacturer when requested by the TGA
- Providing information to the TGA on request and within required legislative timeframes
- Ensuring all manufacturers hold a relevant manufacturing licence, clearance, certification or conformity assessment certificate, as required
- Ensuring the information supplied to the TGA is complete and correct
- Paying annual charges to maintain the ARTG entry while the therapeutic good is supplied on the ARTG
- Applying to, or notifying, the TGA of any changes to the therapeutic good, if required
- Complying with:
- any conditions imposed on the supply of the therapeutic goods
- the requirements for advertising therapeutic goods
- requirements for records of distribution and supply
- pharmacovigilance requirements
- Notifying the TGA of adverse events or problems with the therapeutic goods they sponsor
- Notifying the TGA of an issue that requires corrective action, such as a recall
- Undertaking recall actions relevant to the therapeutic goods supplied, where necessary
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