case studies

In redefining Medical Affairs, CRC works on a variety of pre-launch to post market projects throughout the product lifecycle. From various traditional medical affairs, patient and healthcare professional activities through to market access, government relations, PR and commercialisation initiatives. Our approach to tailoring solutions is to look at each client project through multiple lenses, providing a diverse range of knowledge and expertise integrated in the one solution. Read how CRC produced the desired outcomes for each of the following project case studies, which required multi-functional expertise.


Case 1

Patient Survey Boosts Efforts Leading to Medical Device Reimbursement

Problem

Our client is a niche medical device company who sought State Government funding for an established consumable device proven to manage significant airway challenges and improve the quality of life of people in the community living with a laryngectomy (voice box removal). In all but one Australian State the device remained unfunded, despite various efforts over many years by individuals seeking reimbursement for this small population. Exacerbating the problem was lack of a national advocacy body or dedicated laryngectomy support group in most States to enable a coordinated effort. Yet it was imperative these people be “given a voice” for which our client would initially focus on seeking funding in two States before widening efforts nationally.

Proposal      

To overcome this longstanding issue, CRC planned and implemented a strategy involving a coordinated multi-pronged approach for a stakeholder communications and engagement program grounded on real-world local evidence. This was important to raise awareness and show government decision makers the quality of life and economic benefits of the consumable device in the Australian community setting.

Our strategy focused on:

  • Gaining solid insights into political and bureaucratic landscapes relevant to funding the device.
  • Building a broader advocacy/support base for reimbursement:
    • Increasing political awareness among State parliamentarians and bureaucrats.
    • Gaining the support of relevant healthcare professionals.
    • Mobilising existing local patient groups.
  • Raising general community awareness of the need for funding.
  • Generating Australian data as the basis for creating an economic case for the device, which we considered essential for government decision making.

Action Plan

Strategy implementation included:

  • Developing a patient survey for local real-world evidence of device user and non-user experiences, i.e. life after a laryngectomy, for insights into issues such as healthcare resource use, impact on daily activities, social interactions. The comparative results were then used to create key messages and an economic case for government and community stakeholders.
  • Preparing a stakeholder map of key parliamentarians and bureaucrats relevant to funding decisions about the device. This also included gathering key political insights and executing an accompanying engagement plan, which involved a series of meetings with select individuals informed by the stakeholder map.
  • Patient and healthcare professional engagement to build a solid advocacy/support base for device funding.
  • Conducting a local media campaign in each State to raise community awareness of the need for device funding, the device’s value and financial implications for the government budget.

Outcome

  • The survey results showed a lower percentage of device users compared with non-users were re-hospitalised due to complications after a laryngectomy and also spent less time in hospital. This enabled subsequent financial analysis forecasting government budget cost savings.
  • The evidence generated by the survey combined with the other strategy elements and a very strong patient advocate led to device funding in one State within 6 months of the project start, while it “opened the door” for the first time to progressing potential funding in the other State.
  • Our client has since leveraged the strategy, survey and communication materials we created to seek device funding in the other States. This would give laryngectomy patients across Australia equal access to a device that can ease their burden and improve quality of life.

Case 2

Market Opportunity Assessment Informs Potential Expansion Into Asia

Problem

Our client is a global biotech company specialising in blood disorders. Having successfully completed a prior market access project for their Australian affiliate, our client required a comprehensive assessment of the potential marketplace opportunity for its haemophilia therapies in Asia. The project involved an assessment of eight South East Asian countries and China, which was important to help inform our client’s decision making about future potential entry into these markets.

Proposal      

CRC aimed to give our client a comprehensive understanding of the healthcare and payer systems, stakeholders and competitor product landscape in each country, as well as quantify the market size opportunity. We therefore planned and conducted a series of assessments, which involved the research, collation, analysis and reporting of various information for each of the nine countries

Our assessment approach included country specific:

  • Healthcare system, structures and processes.
  • Therapy access/funding pathways.
  • Haemophilia epidemiology and demographics.
  • Use of plasma derived vs recombinant factor products, extent of prophylactic therapy and factor consumption per capita.
  • Factor product sales/marketing data.
  • Purchasing and distribution channels.
  • Key opinion leaders, treatment centres and patient advocacy groups.
  • Insights on the politics of haemophilia as a government/payer health priority.

Action Plan

  • CRC obtained information from a variety of sources:
    • Publications, government and other websites, commissioned sales data, conference materials, media content.
    • Intelligence via our networks not in the public domain or only available locally.
  • We produced separate country reports containing information from both published and unpublished data sources to capture all relevant intelligence and insights.
  • Each report quantified the size of the market opportunity for each country, where marketing data was available.
    • We presented to the client an accompanying slide deck containing key information for all countries, which also included a “country score card”. This rated each country on a number of factors to help inform the probability and priority order in potentially entering these markets.
    • From the findings, CRC provided the client a recommendation for each country and rated the market potential for future potential entry.

Outcome

  • The country reports and accompanying presentation deck with country score card, market sizing and recommendations provided the client deep insights that substantially increased their understanding of each market. This provided the client a solid basis upon which they conducted further internal analysis to progress a decision about market expansion into Asia.

Case 3

Industry Paper to Support Australian Complementary Medicines in China

Problem

Our client is a multinational complementary medicines company with an established presence in Australia and growing global market reach. To support the company’s growing business in China it was recognised that stakeholder understanding and acceptance of Australia’s strong regulatory system and rigorous standards for producing high quality complementary medicines was essential. In particular, it was expected this can facilitate a future more streamlined process that would enable the company to meet increasing consumer demand for Australian complementary medicines in China.

Proposal

CRC prepared an industry paper (“Paper”) to help raise awareness in China of the strict regulatory standards and processes in Australia for registering and using complementary medicines. The activities undertaken included:

  • Development of a strategy for the Paper with a “multiple lens” approach to ensure the inclusion of accurate, balanced and compelling information for stakeholders that communicates Australian policy and regulatory standards for complementary medicines as a “consumer protection benchmark”.
  • Production of the Paper in both English and Chinese language, ensuring the accurate translation of key messages.
  • Conversion of the Paper into a professionally finished brochure (“Brochure”) with accompanying graphics.

Action Plan

  • We thoroughly researched and reviewed information from the Therapeutic Goods Administration website, published literature and other data sources to ensure capturing the entirety of information. This included relevant regulations, recent reforms and marketplace information that collectively shows a well-regulated ecosystem of product registration, promotion/advertising, healthcare professional/practitioner practice standards and the safe and responsible use of complementary medicines in Australia.
  • We devised the strategy from which a comprehensive Paper with compelling discussion was created to highlight Australia’s high standards and regulatory processes for complementary medicines as a benchmark for best practice regulation.
  • We produced English and Chinese versions of both the Paper and Brochure complete with graphics for a professional look and feel to further enhance stakeholder interest.

Outcome 

The client received the Paper and Brochure in both English and Chinese languages to use in educating key stakeholders and facilitating future robust discussion regarding a more streamlined process supporting the regulation and growing demand for Australian complementary medicines in China.

Case 4

Government engagement to progress market access opportunity

Problem

Our client is a niche biotech global company and relatively new to the Australian market. To progress reimbursement of two therapies treating similar diseases, for which the funding process was uncertain, our client required government engagement that would raise awareness about these conditions, the new therapies and the need for a timely reimbursement solution. As a new player, it was also important for our client to start building “share of voice” with key government stakeholders.

Proposal       

CRC prepared and executed a government relations strategy, which aimed to educate and engage key stakeholders for their support and buy-in to reimbursement for the new therapies and the need for a clear funding pathway. The proposal included:

  • Development of a stakeholder map identifying key individuals within government considered relevant to reimbursement decision-making;
  • A separate stakeholder engagement and implementation plan informed by insights and intelligence gathered from the stakeholder map, which would guide meetings with individuals both within and outside of government reimbursement processes;
  • Interactions with key healthcare professional and consumer advocacy representatives for their views, insights and support;
  • Creation of a value story for each therapy addressing patient need, health outcomes and government budget impact.

Action Plan

  • We produced the stakeholder map and implemented a series of in-person meetings with various government officials, managing all logistics, briefings and other communications.
  • We tailored the value story and key messages to each stakeholder’s needs and interests.

Outcome

  • Productive meetings informative for both the client and stakeholders, which led to follow-up engagement with select government officials.
  • Political support for reimbursement of the two therapies, whereas there was none previously, as well as funding pathway options proposed by government officials to the client. This gave the client both clarity and choice as to a reimbursement process to pursue.

Case 5

Glucose biosensor registration, reimbursement and commercialisation

Problem

Our client needed a global registration, reimbursement and commercialisation (RRC) strategy to bring a novel saliva based glucose biosensor to market. The glucose biosensor is a first in class, innovative non-invasive saliva based glucose monitoring solution intended for people with diabetes and, longer term, pre-diabetes.

The client as a new player in the marketplace did not have the in-house resources or infrastructure to meet its RRC objectives.

Proposal

  • We prepared a RRC strategy that considered the client’s commercial objectives and is based on a two-phase plan:
    • The first stage is a “discovery” phase to explore the regulatory and reimbursement pathway options, as well as gather necessary clinical and marketplace information/intelligence to inform an effective RRC strategy.
    • The second stage is an “implementation” phase to execute the strategy.

Action Plan

  • We consulted with key regulatory authorities and payers to understand the data needed to support registration and reimbursement for the biosensor.
  • We also conferred with other stakeholders to further inform the various clinical and commercial activities that would be undertaken in implementing the RRC strategy.

Outcome

The client received a RRC strategy with a clear pathway that balanced therapeutic positioning, speed to market and reimbursement opportunities, as well as being a foundation for future potential applications of the biosensor technology.

Case 6

Glucose biosensor communication to maximise audience reach

Problem

Our client required a new publication for electronic platforms to communicate in a few short minutes the development of a first in class, innovative non-invasive saliva based glucose monitoring solution focused on improving the quality of life of people living with diabetes.

Proposal

It was essential the short piece contain key messages about the biosensor that multiple audiences could understand (e.g. consumers, healthcare professionals, investors, payers) and which were grounded on complete information and relevant insights from key speakers representing different viewpoints. Therefore, to increase audience awareness, understanding and interest in the biosensor, CRC created strategy to tell the story from ‘multiple lenses’, i.e. scientific, medical and humanistic perspectives, i.e. the biosensor inventor, the clinician and individuals with diabetes, respectively.

Action Plan

A six-minute video clip included the following story chapters:

  • Diabetes disease and economic burden
  • Importance of glucose monitoring
  • Problem with the current self-monitoring blood glucose method (e.g. invasive, painful, inconvenient)
  • Need for a non-invasive, accurate, easy and convenient way to monitor glucose levels
  • Glucose biosensor as the solution and its clever technology
  • Other potential future applications of the biosensor platform
  • Glucose biosensor representing a new revolution in diabetes care

The clip was released during National Diabetes Week in Australia for maximum impact and accompanied by a blog article about glucose monitoring in diabetes that also discussed the glucose biosensor, which was published around the same time.

Outcome

Our client advised the clip has proven to be a very useful education and engagement tool for a wide range of stakeholders that has substantially increased its share of voice.

Case 7

State of the art inaugural presentation at the World Oncology Congress

Problem

The introduction of our client’s novel first in class targeted cancer therapy at the World Cancer Congress required a state of the art presentation focused on a body of pre-clinical evidence. This therapy is a collection of monoclonal antibodies that inhibit parathyroid hormone-related hormone (PTHrP) in cancer cells and so it was important to achieve share of voice for its debut at a major scientific meeting.

Proposal

  • We developed and executed a tailored communications plan focused on generating awareness and interest in the new therapy.
  • Key audience messages included the role of PTHrP in cancers, solid in vivo and in vitro evidence of the therapy’s inhibitory effects of breast cancer, melanoma and prostate cancer tumours and the therapy’s potential to treat a multitude of cancers leading to improved patient outcomes and survival rates.

Action Plan

  • Data verification, validation and referencing to source was conducted.
  • A slide deck presentation containing key messages and compelling pre-clinical evidence was delivered to the congress audience.
  • Medical media strategy to increase audience reach beyond the Congress was implemented, which included KOL speaker interviews and post congress news articles.
  • A market assessment report for the therapy was prepared in advance of the presentation. This generated relevant insights about unmet needs in the oncology market and, based on the evidence, the potential of the new therapy to address these needs for a range of cancers with initial focus on breast cancer.

Outcome

  • Audience feedback confirmed the debut presentation was well received and generated much interest.
  • The volume of media output exceeded expectations and contained all the key messages.

Based on these two outcomes, a solid initial share of voice was established for the therapy.

Case 8

Maximising life cycle value for a portfolio of products

Problem

The reimbursement potential of a portfolio of medical device hardware and consumables products had not previously been explored by the client who was looking to maximise their value, most of which were mature non-funded products.

Proposal

CRC proposed conducting a portfolio review of the devices. This involved:

  • thorough assessment of each product to evaluate potential eligibility for inclusion in existing funding schemes and
  • comprehensive investigation into potential funding pathways via information and insights gathered from various published sources, as well as communications with stakeholders in both public and private sectors.

Action Plan

  • CRC conducted a desktop search for relevant information on potential reimbursement pathways, from which a couple of potential reimbursement pathways not previously considered by the client were identified as warranting further exploration.
  • These pathways required communications with public and private sector payers and also healthcare professionals with knowledge or experience of funding processes. A stakeholder engagement plan involving numerous in-person meetings was subsequently developed and implemented to gather necessary informal intelligence for insights that would not be possible from public information sources.
  • The combination of published and unpublished information enabled us to prepare a report of the findings, pathway options and recommended strategy for pursuing the pathways found.

Outcome

Based on the review, the client received a clear strategy for increasing the portfolio’s value, which was subsequently included in planned activities for their new budget cycle.

CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.

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