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Patient support program – the key driver of better health outcomes

patient support program

Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices. They provide significant value to patients through the accessibility of information and support.

Each program run by a pharmaceutical company is managed under strict ethical guidelines and for a specific medicine. Participation is only available to patients who have already been prescribed a medicine and supported by their healthcare professional.

Programs can provide information to patients about their condition, how to better manage their health, or encourage adherence to the medicines they have been prescribed. They are aimed to complement the important roles their doctors and pharmacists play in the management of their condition.

Companies must ensure that all aspects of a program including written materials or verbal interactions are patient focused and are not in any way promotional nor have the intention of promoting a prescription medicine to members of the general public.

A rationale must be developed for each program which describes the clinical significance of the program, the anticipated number of patients to be enrolled, the type of educational/informational material to be provided to a patient, the number of interactions (if any) that may be had with a patient and the duration of the program. Any communication with a patient considering enrolling in a patient support program should clearly identify the company, what materials or calls the patient may receive and their rights under the program. Companies have a duty of care to ensure that patients are fully aware how their privacy and confidentially is maintained and that they can elect to opt out of a program at any time. Patients should also be advised how and who will be holding their data and assurances given that data will not be used for purposes other than for the designed program. At specified intervals companies should evaluate whether a program is delivering on its initial objectives including improvements in compliance and patient wellbeing.

The importance of reporting adverse events identified through interactions with patients enrolled in patient support programs cannot be over emphasised. Careful monitoring of programs ensures accurate and timely reporting of de-identified product safety related information. It also aids our understanding of medicines in the post market environment.

Medicines Australia Code of Conduct has detailed provisions on how such programs should be administered and recognises that they offer important support to patients and have a key role to play in delivering positive health outcomes.

 

Our Medical Services team has extensive experience in patient focused programs. Call us on +613 9251 0777 to discuss how we can assist.

This article was written by Terence Khoo, from our Medical Services team.




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Commercial Eyes Recruiting: Regulatory Services Manager

Regulatory Services Manager

Commercial Eyes has a great opportunity for a Regulatory Services Manager

Reporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services business unit.

 

To be successful in this role, you will have…

  • A degree in science, pharmacy or a related discipline.
  • A minimum of 10 years of experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
  • Ability to develop sound strategies to resolve complex regulatory problems.
  • Good working relationships with relevant TGA staff and experience with TGA pre-submission meetings.
  • Experience in the review, critical evaluation and presentation of clinical data.
  • Good knowledge of TGA legislation, regulations, guidelines and working procedures.
  • High level written and oral communication skills.
  • Proven ability to manage projects.
  • Experience or aptitude for mentoring and leadership
  • Experience in staff management in a regulatory environment.
  • Ability to deal with high level of confidentiality.

 

Key responsibilities include:

  • Manage regulatory projects and staff to ensure optimum project outcomes.
  • Ensure agreed financial and organisational targets are met.
  • Undertake key account management and day-to-day liaison with clients as agreed with the Director, Regulatory Services.
  • Undertake business development and assist the Director, Regulatory Services to develop business development and other growth strategies.
  • External Representation of the business unit where possible
  • Attract new talented regulatory professionals to join the business.
  • To provide support to clients on the registration and listing of pharmaceuticals and medical devices in Australia and New Zealand.
  • Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.

 

In return….

This role is a rewarding one that will offer a competitive salary to the right candidate and a rare opportunity to lead a dynamic and successful team. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies. 

Becoming part of the CEPL team will also provide you with a strong sense of teamwork, job satisfaction and achievement whilst working in a well-known professional services organisation that recognises talent and expertise as one of its biggest assets. 

 

For more information about this role, please visit our Seek ad.

Please contact Jeanette Lodge on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad. 




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Commercial Eyes Recruiting: Senior Market Access Consultant

Market Insight Manager

Commercial Eyes has a great opportunity for a Senior Market Access consultant

to join our dynamic Market Access team. Reporting to the Health Economics and Market Access Manager, this senior consulting role offers the successful candidate the opportunity to gain valuable market access experience across a wide variety of projects for the pharmaceutical, medical device and wider health care industry.

 

To be successful in this role, you will have…

  • Minimum undergraduate qualifications in economics or a life sciences discipline.
  • Preferably post graduate qualifications in health economics, statistics, or health sciences.
  • Minimum 6 years commercial life sciences experience.
  • Excellent numerical, verbal reasoning and written communication skills.
  • Excellent problem solving and project management skills.
  • Proficiency in building productive relationships and networks.
  • A keen interest in the practice of consulting.

 

Key responsibilities include:

  • Providing high quality expert consulting services to clients, in the key areas of reimbursement strategy, health economics, statistics, submission development and private/public market pricing.
  • Working with existing and potential clients in the life sciences sector to understand their business needs and identify areas or activities with which CEPL may be able to assist.
  • Translating these conceptual discussions into concrete project proposals which provide a realistic description of the scope of work to be undertaken and a competitive cost estimate for this.
  • Delivery of strategically and technically sound submissions, reports and presentations according to agreed deadlines and client requirements.
  • Building strong interpersonal networks across the life sciences sector and drawing on these to identify potential short and long term business opportunities for CEPL.
  • Working with the Manager and other stakeholders to identify important skills and knowledge gaps in the current CEPL reimbursement and pricing service offering; and to implement solutions to these service gaps; e.g. mentoring and developing junior consulting staff, negotiating access to key information sources, and identifying/working with new/existing partner organisations.

 

In return….

This role is a rewarding one that will offer a competitive salary to the right candidate. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies. 

Becoming part of the CEPL team will also provide you with a strong sense of teamwork, job satisfaction and achievement whilst working in a well-known professional services organisation that recognises talent and expertise as one of its biggest assets.

 

For more information about this role, please visit our Seek ad.




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Warning: This medical device literature review may contain traces of LBS

Medical Device Literature Review

With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in conjunction with the existing Australian Regulatory Guidelines for Medical Devices (ARGMD).

Clinical evidence for devices can vary depending on the class of the medical device. It is common for manufacturers to provide a CER derived from a variety of sources, such as clinical trials, literature reviews and/or post-market data for the proposed device. It is also common to collate data from equivalent or similar devices as long as there is an explanation of how evidence for the equivalent or similar device is applicable to the proposed device. Most of the time, literature reviews form a part of the CER.

The features of a literature review provided in this draft clinical evidence guideline closely resemble those for a literature-based submission (LBS) for medicines, such as:

  • A documented methodology, which captures published and unpublished scientific literature, both favourable and unfavourable,
  • A search protocol, which would include the database searched, search terms and limits used, inclusions/ exclusion criteria, to ensure the search can be replicated,
  • A selection strategy, which involves examining the quality of the literature, including the design of the study/ investigation, quality and completeness of the data reported, its scientific impartiality, and validity of any conclusions drawn in the paper,
  • Critical analysis of the data by an expert in the therapeutic area, rather than a summary of each literature article and a general conclusion at the end.

Some of the common errors made in CERs have also been highlighted by the TGA in this draft guideline.  Errors tend to relate to the proposed literature search strategy, such as the lack of a comprehensive literature review with documented methodology, an inadequate demonstration of substantial equivalence between reference device and the device under review, absence of critique or discussion of the evidence or its validity.

There is no need to obtain prior TGA approval for the proposed search strategy, however based on the above criteria, the TGA will be expecting a CER that delivers strongly on the quality of data.

The TGA consultation for the draft clinical evidence guideline closes COB on 10 June 2016, so make sure you take a look and provide input where necessary.

 

For assistance developing a suitable CER for your product, please contact our expert Regulatory Services team on +61 3 9251 0777.

This article was written by Wai Zin Wong, from our Regulatory Service team.




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Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market

exploding-idea

As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding the right resources to help us make informed decisions that suit our needs.  Building a successful commercialisation strategy for a new medicine is no different and requires a plan that must include the right resources and knowledge.

Introducing a novel treatment into Australia requires the sponsor to align with governance factors that shape the local pharmaceutical industry. An in-depth understanding of the current regulatory and reimbursement environment is critical for success. As such, planning for product launch should begin with the development of a cohesive strategy that occurs long before the submission of a regulatory registration dossier or government reimbursement application.

Consequently, resourcing and investing in accurate market insight advice specific to the Australian market can be invaluable. Government authorities are demanding more data than ever before, so coordinating relevant activities in the lead-up to launch cannot be underestimated. Market insight advice can formulate valuable assessments that will ensure any key gaps in various inputs are identified and filled which is critical to strategic decision-making. Market Insight professionals are similar to a knowledgeable party planner who meticulously researches and plans to bring the most useful and relevant resources together to set the scene and create a successful event.

Of course, it does not stop there, optimising a planned strategy also requires timely and appropriate execution. There is no point in the DJ arriving three days before the party, just as it can be fruitless to attempt a cost-effectiveness analysis with incomplete data or an unconfirmed indication. At the same time, it is also wise to show up a little early to scope the scene and identify where information is missing. As the demand for detailed clinical and economic evidence increases, a timely market access strategy allows a sponsor to paint a clear picture of the new treatment’s value offering to decision-makers at the earliest feasible point, having addressed any previously identified shortcomings in the acquired data.

Capturing clinical data that encapsulates the needs of both a regulatory and PBAC application is a worthwhile consideration prior to the drafting of a TGA/PBAC parallel process submission. Each individual TGA and PBAC application should be well structured and complement the other to form a compliant, comprehensive and cohesive submission for the proposed product. The timing of these types of submissions requires effective pre-planning and communication, a process that is significantly strengthened by synergy between the Market Access and Regulatory Services experts involved.

Just as a party host should be checking in to make sure that hot food is continuously available for guests, for commercialisation, inputs should be checked for accuracy and completeness. As a medicine gets closer to launch, marketing strategy development, pricing considerations, and cost effectiveness modelling help support reimbursement goals. When accessed through a single source such as Commercial Eyes, coaction is assured between the experts working within these distinct workflows, helping to harmonise and strengthen each of the applications required to achieve the optimal launch of a medicine on the Australian market.

Early implementation of a well-conceived strategy, specific to the needs of the product, will benefit both registration and reimbursement applications. As with any successful event, a commercialisation strategy must be well planned and properly executed to achieve optimal results. Engaging Commercial Eyes opens a specialised avenue to multiple experts in all areas of Market Insights, Market Access, and Regulatory Services. As a unified team, we can offer an integrated approach to any product launch and help you effectively manage the entry of your new drug into the Australian marketplace.

 

Commercial Eyes offers a full and integrated suite of consulting services across Market Insights, Market Access, and Regulatory Services. Call us on +61 3 9251 0777 for our insights into commercialisation strategies for healthcare products.

This article is co-written by our Market Access team and Matthew Douglas from our Market Insights team




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Data and Safety Monitoring of Clinical Trials

Safety Monitoring

Randomised clinical trials for medicines and medical devices are progressively being monitored for safety and other interim results by both Sponsors and Contract Research Organisations (CROs). There are a variety of methods to aid in proactive monitoring and gauging of patient safety and risk, including the utilisation of independent panels of expert physicians and biostatisticians, or what are known as Data Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs).

DSMBs/DMCs have as their top priority the ongoing assessment of subject safety during the course of a trial where subjects are exposed to heightened risks of trial participation due to the use of experimental medicines and/or medical devices.

The importance and growing popularity of monitoring panels has been recognised, evidenced by the FDA’s guidance and recommendations to Sponsors regarding when such committees should be convened as well as a general operational framework for each member’s role and responsibilities.  In order to maintain an independent unbiased role in their oversight of a trial, the physicians and biostatisticians of a DSMB/DMC may not have any fiduciary association with the Sponsor and may not be operationally involved in the trial as steering committee members, investigators or as the active study biostatistician.

A common example of when a DSMB/DMC panel may be convened surrounds central adverse event adjudication. Another area where DSMB/DMC panels play a key role is concerning trial protocols. Before a trial protocol is finalised for regulatory approvals, the DSMB/DMC may participate in a review of the trial protocol to provide feedback to the Sponsor as to operational characteristics that may be problematic and lead to subject safety and/or trial scientific integrity concerns. If there are formalised interim stopping rules defined in the trial protocol, these will be reviewed so that all parties understand the timing and mechanisms by which these decisions will be made.

Following are some of the ongoing safety and scientific integrity questions that a DSMB/DMC may need to consider:

  • Are subjects being exposed to reasonable risks given the scientific research that is being conducted?
    • Are there unexpected events not initially envisioned at the outset of the trial?
    • Are there evolving safety signals that might suggest that subjects in the trial are being exposed to an elevated level of risk and, with an eye toward the future, is it reasonable to continue the trial given the projected risks to subjects yet to be enrolled?
    • If continuing the trial is reasonable, a DSMB/DMC may make recommendations to the Sponsor to communicate safety related issues to the study steering committee, the investigators and even the FDA to raise awareness
    • If the safety issues are material and the risks to subjects are no longer acceptable, the DSMB/DMC can make a recommendation to stop the study early due to these concerns
  • Are the a priori assumptions that led to the power and sample size calculations in the trial protocol still valid?
    • Is the observed data deviating from these assumptions, perhaps leading to the need for an interim sample size re-estimation which would most commonly be an increase in the enrolment target?
    • Can the new enrolment target be achieved?
  • Is there new data from an external source (e.g. a similar or clinically relevant trial) where the results that have become available suggest that it would be unethical to continue the trial being monitored?

In trials where there are formalised interim stopping rules, these must be pre-defined in the trial protocol. These stopping rules would be derived through detailed statistical methods.

  • Stopping for Safety
    • Predefined criteria for the incidence of serious adverse events, especially if they are deemed to be treatment emergent/related or are indicative of treatment failure. These are typically expected events, which are occurring at rates that raise questions about the risk/benefit balance of the treatment(s) under study
  • Stopping for Efficacy
    • Predefined criteria, which would demonstrate that the benefit observed in the treatment of interest is sufficiently large, that to continue the study to its logical conclusion would not alter or reverse this finding
    • Stopping the study for efficacy on an interim basis would have stricter than typical p value thresholds for statistical testing (e.g. p ≤0.001 as opposed to p ≤0.05) to control for false positive (Type I) errors, and would account for multiple looks at the data
    • Ifthe criteria are met, stopping would reduce the required sample size for the study, reducing risks to subjects not yet enrolled and address the ethical questions, for example, of continuing to treat subjects with an alternative that is now demonstrably inferior. It would allow the Sponsor to proceed to regulatory submissions earlier and at a lower cost than originally budgeted
  • Stopping for Futility
    • Predefined criteria that would indicate that there is a lack of a clinically meaningful benefit attributed to the treatment of interest. If the study were to continue to its logical conclusion, the probability that this finding would be altered or reversed to demonstrate a benefit is sufficiently low (typically <10%) as to raise ethical concerns to continue.

 

Commercial Eyes’ experienced Clinical Development team can help you navigate the data and safety monitoring requirements of your clinical trials. Call us on +61 3 9251 0777 to discuss your needs.

This article was written by Ric DeGaris, a member of our Clinical Development team.




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Are you eCTD ready?

eCTD in Australia

eCTD Submissions

Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an important milestone for the TGA in recognising eCTD as an acceptable (and preferable) submission format and is supportive of the broader government policy for digital transition.

 

Recent developments

As an incentive for sponsors to adopt the eCTD format, the TGA has recently commenced a pre‑submission pilot for certain types of new Category 1 applications (Type A and Type D) submitted as a validated eCTD sequence. The intention of the pilot is to decrease the pre‑submission workload for sponsors and to reduce the overall registration timeline by at least one month. Participation in the pilot is optional and represents an excellent opportunity to take advantage of an expedited evaluation pathway for eligible applications.

 

Advantages of eCTD

Electronic dossier formats (eCTD or NeeS) have a number of advantages over paper based submissions including:

  • Reduced costs associated with producing, checking and Storage of paper dossiers
  • Enhanced navigation between documents
  • Greater search functionality

Some additional benefits which are unique to eCTD include:

  • Lifecycle management of documents
  • Ability to reuse files
  • Cross-referencing to previous sequences

While the eCTD format is not currently mandatory in Australia, it is only a matter of time before the TGA joins other global regulators in mandating eCTD. Given the substantial benefits and advantages of moving to eCTD, and in order to start developing familiarity and experience, sponsors should strongly consider introducing it to their regulatory processes now to ensure that they are prepared in advance of any changes to TGA policy. 

 

Conversion to eCTD

Submitting the initial registration application in eCTD format is the most convenient and logical approach to maintain the full product history in a single electronic location. For currently registered products or applications under evaluation that have been submitted in formats other than eCTD, converting a dossier will involve planning, and the appropriate timing will depend on ongoing regulatory activities, the status of the dossier and other commercial priorities. Submission of an eCTD baseline is highly recommended by the TGA when converting from paper or NeeS format and the baseline sequence is essentially a reformat of previously submitted CTD documents. Creating an eCTD baseline is a valuable exercise from both a regulatory and compliance perspective.  Although initially it may seem daunting, the benefits to your regulatory maintenance program through improved document lifecycle management will quickly be realised.

 

To discuss how Commercial Eyes can assist you with all of your eCTD needs call us on +61 3 9251 0777.

This article was written by Danielle McLennan from our Regulatory Services team.

 




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Commercial Eyes Recruiting: Medical Information Assistant

Medical Information Assistant

Commercial Eyes has an exciting opportunity for a switched-on assistant

to join our team on a casual basis to provide administrative support to the Medical Information team in respect to meeting client demands and expectations.

 

To be successful in this role, you will have…

  • Tertiary qualification
  • Australian citizenship or permanent residency
  • Demonstrated computer experience with Microsoft Word, Excel, Access, PowerPoint and Outlook
  • Highly developed communication and customer service skills
  • Excellent organisational, time management and problem solving skills
  • Experience with database management (preferred)

Key responsibilities include:

  • Providing administrative support to ensure Medical Information operations are maintained in effective, up-to-date and accurate manner
    • Word processing, creating spreadsheets and presentations as required
    • Organising and storing Medical Information contact logs in client specific folders
    • Managing offsite document storage for Medical Information
    • Ensuring contact logs are printed and allocated to each team for daily enquiries
    • Preparing and sending outgoing faxes, mail and courier parcels
    • Transferring non-medical calls or collecting caller details to forward to other CEPL departments
    • Ensuring office stationery are always available for Medical Information
  • Assisting the Project Team Leaders with month end duties and reports
  • Maintaining a database of Medical Affairs activities
  • Providing basic support in processing of medical information enquiries
  • Performing other related duties as required
  • Billing a minimum of one third of work time to clients

 

In return…

This role is a rewarding one that offers all the traditional benefits of employment, such as a competitive salary, a supportive and respectful culture, a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

 

For more information about this role, please visit our Seek ad.


Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad.




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Multi-criteria decision making – How can non-health attributes be considered and valued?

Pressure is mounting on decisions to recommend and continue funding health technologies. Concerns around the rising cost of new medicines, an ageing population with greater resource utilisation, federal and state healthcare budgetary constraints, and an increasing dependency ratio (the ratio of individuals who are not in the labour force compared to those who are and paying tax) are significant contributors to that pressure.

Multi-Criteria Decision Making

As a developed country we are not alone facing the pressures of allocating increasingly limited resources to maximise health gains from our healthcare system. However debate in other countries with publically funded centralised healthcare systems has focused on refining how the value of new health technologies is assessed and translated into price. The premise of this has been to provide manufacturers with greater certainty around their investment and market access decisions.

Reforms in Australian healthcare policy have seemingly focused on the affordability of currently reimbursed products. The first of the 5% statutory price reductions began on April 1 2016 through the PBS Access and Sustainability Package for those molecules which have been in the F1 formulary for five years or more. This now adds a time component for which a molecule (irrespective of indication, timing of patent expiry or data exclusivity periods) can be listed before reductions in price are legislated, on top of price disclosure reductions legislated as the molecule shifts to the F2 formulary and generic medicines become available and compete for market share.

While policies that impact the affordability of medicines are applied post-listing, the initial benchmark assessment of value occurs during the submission phase. Demonstrating value to the PBS for new medicines is required throughout HTA processes, firstly through an assessment of the clinical effectiveness and safety of new medicines against a comparator in clinical trials. Then, depending upon these outcomes, the incremental clinical performance must be explained through a cost-minimisation or cost-effectiveness/utility analysis by considering health effects and healthcare resource implications.

Though attention has begun to turn to the inclusion of non-health attributes such as consumer experience/preference, it is not clear how these additional attributes will be incorporated into the decision making process. For example, whether they will be explicitly incorporated into a cost-effectiveness or cost-minimisation analysis or if they will be considered as additional criteria outside of the evaluation process. Perhaps there will be a standard framework for which information is assessed but how will that be standardised and communicated?

Similar issues arise in relation to existing consideration of life saving drugs and the role of the rule of rescue.

Over the next few months, the Guidelines Review Steering Committee will review the public consultation submissions issued in response to the new draft PBAC guidelines for the assessment of medicines. We can only hope that amongst their considerations they:

  • Review whether deliberative decision making is appropriate for consistent and transparent outcomes, and
  • Consider the array of decision making frameworks that fall under the umbrella of multi-criteria decision making (MCDA) which can be used to explicitly link different attributes, and effectively and transparently communicate outcomes.

As part of a broader process, it would be greatly advantageous to further consider, what relevant non-health attributes ought to be included; how they will be measured; how they will be valued; how the value of individual attributes will be aggregated and how this will be linked to an assessment of a medicines overall value.

 

The expertise and experience of the Commercial Eyes Market Access team is at your disposal to help you navigate the PBAC Guidelines for the assessment of medicines. Call us on +61 3 9251 0777.

This article was written by Peter Moore, our Health Economics and Market Access Manager.




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Keys to off-label communications

The TGA and the Medicines Australia Code of Conduct are very clear on the appropriateness and dissemination of off-label information to HCPs.

Off Label Communication

In a post-marketing setting many products gather a body of evidence surrounding their use outside of the approved labelling.  This evidence may include alternative indications, dosage, administration methods or target populations (e.g. paediatrics). This may be through an unexpected effect observed in a clinical trial, an excited letter to the editor from a surprised doctor, or a researcher attempting to fill a void in the market not adequately covered by existing therapies. Regardless of how or why the body of evidence is formed, it is essential for sponsors to know how to use this information to formulate responses to spontaneous requests from healthcare professionals. Here are some of the vital pieces of information you need to know:

  1. Know your regulations

    It is absolutely essential that company employees are aware that there are regulations and associated penalties with regards to the advertising of off-label information. The Therapeutic Goods Act is clear that it is an offence to advertise therapeutic goods for an indication that has not been accepted as part of its listing.

    Whilst advertising of off-label information is not permitted, the provision of information to HCPs is allowed through the Medicines Australia Code of Conduct (section 1.4) which describes who can respond.

  2. Differentiate solicited vs. unsolicited requests

    Off-label information is never to be promoted/advertised by a company.

    • Members of the commercial team, e.g. sales representatives, must not pursue any conversation regarding off-label use.
    • Company representatives must not offer, prompt or suggest off-label information.
    • Company representatives must pass the request to the appropriate Medical department for a response.
    • Companies must only respond to healthcare professionals.
    • All responses must be unique and directed to a specific healthcare professional (so no generic “Dear Doctor” letters are permitted).
  3. Respond through appropriate channels

    In all cases, responses for off-label information should be prepared and sent via the medical department. Under no circumstances should the information be supplied by a member of the commercial division (e.g. sales representatives or product managers). This makes it clear to an external observer that the company is not promoting the off-label use of their products.

  4. Use all of the Evidence

    In responding to a request, the medical department should consider the following in their response:

    • Use peer reviewed literature from recognised medical databases like Medline or Embase.
    • If summarising literature, clearly define the level of evidence in the paper. A body of evidence consisting of a single case study and an animal investigation must be presented as such.
    • Be neutral – present all studies regardless of outcome and eliminate bias in your response.
    • Do not conclude. The purpose of a response is for the healthcare professional to evaluate available evidence and form a clinical opinion. A conclusion may be viewed as a form of promotion.
  5. Disclaimers

    Whether you’re making a phone call or sending a letter, be sure to:

    • Include excerpts from, and a full copy of, the approved labelling (for example, the product information or instructions for use).
    • Clearly state what the product is approved for and that the information that is being provided is not approved.
    • Confirm that you are responding to an enquirers unsolicited request for information
    • Confirm that the use of the product in an unapproved way is at the clinical discretion of the healthcare professional, not a recommendation from the company.

 

Our medical department is highly experienced in responding to requests for off-label information. Call us on +61 3 9251 0777 to discuss your Medical Service’s needs.

This article was written by Anthony Anselmo from our Medical Services team.




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