[vc_row][vc_column][vc_column_text]Medical and pharmaceutical technologies have key differences which have important implications for how they are evaluated, both clinically and economically. As such, a thorough understanding of the differences that exist within both the industry and the technology is required to accurately assess the benefits associated with them.
The MedTech industry is diverse and medical procedures involving devices can be therapeutic, diagnostic, prognostic or pathological. The companies that make medical devices also differ from pharmaceutical companies in both size and number. While pharmaceutical companies tend to be large, the median size of a medical device company is less than 50 people (in the US). Medtech companies also often provide much more support to the health care providers or surgeons to ensure technical standards are met and the device is used effectively.
Medical technology is characterised by a high rate of innovation, often resulting in shorter life cycles than pharmaceuticals. This key difference can limit the opportunity for generation of clinical evidence to support marketing approval and reimbursement of devices. Innovation is often based on feedback from medical practitioners and their patients to improve an existing technology’s functionality.
There are inherent constraints in clinical trials design for devices to prove efficacy. The large-scale, blinded, randomised, placebo-controlled trials common for pharmaceuticals are often difficult or unrealistic to perform for medical devices, particularly surgically implantable devices.
Most clinical trials also have limited patient recruitment capacity since devices typically have smaller numbers of potential end users and even fewer eligible clinical trial candidates than a typical pharmaceutical clinical trial.
Another common limiting factor is that many devices require specialised training or skills to install or monitor them. Success of the implantable device may be dependent on the skill of the surgeon implanting it, not on the performance of the device alone.
Care must also be taken when assessing the benefit and harm profile of devices compared with pharmaceuticals. The effect of a medical device is physical whereas the effect of a pharmaceutical is chemical; this poses differences in addressing adverse events. The risk posed by the device remaining in the body must be weighed against the risk of removal. Often the implants are introduced into the body via surgery and these procedures contribute to the complication of evaluation of the implants, while adverse events related to a pharmaceutical can be addressed by discontinuation of treatment or changes in dosing.
All the issues described above mean a pragmatic approach is required when assessing medical devices for reimbursement. Data may be more limited while clinician hands-on experience with the devices may be more relevant. Nonetheless, it is important that the benefit/risk profile of the devices is evaluated and an assessment is made of the value to patients and the healthcare system.
The original version of the February 2017 Prostheses Guide identified that there are differences between medical devices and pharmaceuticals and that this would be taken into account by committees and advisory groups assessing sponsor applications. Unfortunately, this was removed from the latest version published in June. As demonstrated above, the differences between devices and pharmaceuticals are very clear, and must be recognised in HTA assessment if the Prostheses List process is to be an effective enabler of patient access to valuable technology.
|Over 80% small and medium-sized companies
|Very large multinationals dominate
|Majority of new products bring added functions and clinical value based on incremental improvements
|Usually large step innovation
|Limited patient recruitment capacity due to smaller numbers of potential end users and eligible clinical trial candidates
|Large-scale, blinded, randomised, placebo-controlled trials
|Addressing adverse events
|Risk posed by device remaining in the body must be weighed against risk of removal
|Discontinuation of treatment or change in dosing