Inclusion on The Prescribed List (PL) provides for reimbursement of a medical device in Australian private hospitals. Devices receive separate payment by insurers which is over and above the fee that insurers pay private hospitals for admissions. It is primarily for implanted devices. It is difficult to compete in the private sector without inclusion on the PL.
Pitfall 1
Make sure your device is eligible for inclusion. This may sound basic, but many companies are so anxious for their product to be included that they apply when there is little, or no chance of their products being included. The inclusion criteria are summarised below:
The medical device:
(a) must be an implantable medical device, or an active implantable medical device, that is designed to:
(i )replace an anatomical body or
(ii) combat a pathological process or
(iii) modulate a physiological process or
(b) must:
(i) be specifically designed as an integral single use aid and be essential for implanting a device mentioned in paragraph (a) and
(ii) be designed for use for the patient in whom the device mentioned in paragraph is intended to be implanted or
(c) must be:
(i) critical to the continued functioning of an implanted device mentioned in paragraph (a) and
(ii) only suitable for use by the patient in whom the device mentioned in paragraph (a) is implanted.
The Medical Devices and Human Tissue Advisory Committee (MDHTAC) who evaluate PL applications interpret these criteria very narrowly, so if you are not sure if you are eligible, get expert advice. Application are time consuming, and fees are expensive, so it is best to be sure of your eligibility.
There are some exceptions to these criteria. Generally single use implantable devices are included on Part C of the PL. It is very difficult to be successful in a Part C application and clinical evidence must be exceptional. The Part C process is paused at present for review.
Pitfall 2
Insufficient clinical evidence.
This is usually an issue for TGA Class III medical devices but can be for some Class II devices as well. Peer reviewed published clinical evidence is required for Class III devices. There are specific evidence requirements for different types of devices which are listed in the Prescribed List Guide. Proof of acceptance for publication is also sufficient to include a paper in the application.
If your evidence is not published, it is best to wait as the application will more than likely be rejected and possibly receive more scrutiny on resubmission.
Pitfall 3
Treating the application as a regulatory submission.
While there is some information common to both a regulatory submission and a PL application, they are not the same. The decision is different, a regulatory approval allows your product to be supplied. A reimbursement decision is whether it is eligible to be paid for. There are nuances in a PL application that are important, particularly for higher risk devices. These can relate to clinical effectiveness, utilisation and outcome measures. If you are not sure how to approach an application, seek expert advice.
Pitfall 4
Treating the application as a marketing exercise.
Many applicants expound on the features and benefits of their device, describing how different and better their device is to existing (comparator) devices on the PL. Often non-objective marketing language is used. All of this is a mistake. Inclusion on the PL is based on comparative clinical effectiveness to a device already included on the PL. So, unless you are applying for a higher clinical benefit or a new clinical category (which requires a substantial and compelling amount of clinical evidence), it is best to say how similar your device is to its comparator in unemotive and simple language.
Pitfall 5
Including unnecessary information.
It is best to make the job of evaluating your application as easy as possible for the assessors. There are hundreds of applications each application round and Department of Health staff are overloaded. Only supply information that is directly relevant to your application. Irrelevant attachments, lengthy discourse on matters that are unrelated to the questions posed in the application make your application harder to assess.
Use the ‘additional information’ section to describe the highlights of your clinical evidence or to clarify any issues you may think are difficult to understand. Don’t add superfluous information that does not directly address the questions asked in the application. It is best to keep language, succinct, very clear, and unemotive. It can be difficult to craft language that is easy to read yet get the relevant points across without wearying the reader. Seek expert advice if necessary.
Conclusion
Securing inclusion on the Prescribed List is essential for Medical Device organisations looking to compete in the Australian private hospital sector, but the process is complex and highly scrutinized. Avoiding these five common pitfalls—ensuring eligibility, providing robust clinical evidence, distinguishing reimbursement from regulatory approvals, avoiding marketing language, and keeping applications clear and concise—can significantly improve the chances of success. Given the rigorous evaluation process, seeking expert guidance can make all the difference in navigating the application process efficiently and effectively. A well-prepared application not only saves time and resources but also increases the likelihood of achieving reimbursement, ultimately ensuring patient access to medical devices and technologies.
If you believe your device should be considered for Part C, it may be worth applying (noting the current pause in Part C assessments) However, keep your expectations realistic and ensure you have compelling clinical evidence.
At MedTechnique Consulting, we have a proven track record of successfully listing hundreds of products on the Prescribed List (PL). As policies continue to evolve and systems are refined, it is crucial to have accurate and timely advice to ensure your products are included without delays.
For more information about the Prescribed List (PL), visit our Prescribed List Applications page on our website, where you’ll find a video and articles covering recent reforms and the application process HERE – Prescribed List Applications – Medical Device Reimbursement & Market Access Experts
Why Choose MedTechnique Consulting?
- Expertise: With extensive experience in navigating the Prescribed List process, we understand the intricacies and challenges involved.
- Strategic Guidance: We provide tailored advice to help you meet the specific evidence requirements and streamline your application.
- Comprehensive Support: From initial consultation to final submission, we provide expert, tailored guidance.
Get in Touch
If you need more information about the Prescribed List, assistance with your application or market access for your medical device, please contact us directly. We’re here to answer your questions and provide the support you need to succeed.
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Email Us: info@medtechnique.com.au
Call Us: + 61 448 058 600.
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About the Author
Sarah Griffin, Director of MedTechnique Consulting. Sarah is an experienced health economist, reimbursement strategist, health policy advocate and speaker. Connect with Sarah Griffin on LinkedIn.
If you would like to learn more about Sarah’s speaking experience for your next event please email: Kim MacDonald, Spindrift Marketing