Cadth 2015 a2 hta challenges from an industry perspective j shin

Editor's Notes

• #3: Industry is the research and development of the Canadian health care system and the primary source of innovative solutions to unmet health care needs. Technologies that reduce patient length of stay, change site of care, or eliminate more invasive procedures bring patient value. However, the health care system’s perceived value of these benefits is often limited by organizational or structural factors. Devices can offer long-term gains but require substantial short-term investment that often exceeds short term fiscal budgets. This is the greatest issue that device manufacturers face. Unfortunately, this short-term view is very prevalent in many jurisdictions. The assessment itself demands evidence of effectiveness, not efficacy. Evidence of efficacy is derived from studies conducted under ideal conditions, as with randomized controlled trials [3]. Effectiveness studies, however, derive evidence from studies that more closely mimic usual health care circumstances to increase the generalizability of findings [3] and may include special patient populations or allow the use of common co-interventions. When escalating development costs are combined with short product life cycles (18-24 months for devices [6]), minimal patent protection, and an ever increasing demand for higher quality safety and efficacy data, the wariness of medical device providers to invest in speculative product concepts becomes understandable. The increasing complexity of devices and their use in chronic diseases such as obesity, arthritis, and heart disease have raised concerns around device performance and safety in the long-term. This has resulted in a call for further investment in clinical trials or registries that can follow patient outcomes after launch. Unlike drugs that may come to market with extensive randomized clinical trial data demonstrating clinical efficacy, devices are limited by confounding factors that can mask efficacy. One of the biggest confounders comes in the form of clinician competency. Factors such as patient selection, physician training, procedural learning curves, and patient management (before and after surgery) can all contribute to the measured effectiveness of a device independent of the device itself (Figure 1). Physician training and procedural learning curves in particular are a greater hindrance for devices over their drug counterparts. Unfortunately, the assessment of effectiveness can be conducted only after launch. As a result, many devices may be deemed unworthy of investment by decision makers, some of whom are unwilling to share the risk and investment associated with effectiveness studies. Devices also do not receive the more secure patent protection of their drug counterparts; they may be easily modified to produce similarly functioning devices that exist outside the patent protection of the originals.
• #4: Sedasys example wrt to budget framework Recommendation 4 – Accelerate the Shift to Strategic, Value-Based Procurement To better support development and adoption of innovation, a broad range of key stakeholders – including procurement officials and health professionals – will be engaged in defining health care procurement priorities and strategies on an early and ongoing basis. Stakeholders will focus on addressing health system priorities and population needs rather than the day-to-day purchasing of specific goods and services. In addition, individual health care providers will work with shared service organizations to efficiently procure innovative technologies. Finally, the health system will invest in the skills, knowledge and competencies needed to enable strategic procurement. Procurement in health care organizations has typically focused on generating short-term savings in meeting day-to-day needs. A more strategic, valuebased approach considers not only price but also other measures of value such as reduced service utilization (e.g., fewer hospital readmissions), increased quality of life, and economic benefits.17 By taking into account these wider dimensions of value, the Council believes strategic procurement can contribute to healthier populations, a more efficient health system, and the growth of Ontario’s health technology sector. Resistance to change: Innovative health technologies may change existing scopes of practice, or displace existing positions, which can result in resistance to adoption. Other factors include the complexity involved in learning and using the health technology, potential changes in workload, and perceptions concerning the value that new technologies add to existing practice. Lack of appropriate reimbursement mechanisms: If an innovative health technology does not fit under existing reimbursement arrangements, health care organizations and clinicians must absorb the costs of implementing the technology until reimbursement systems are updated. If reimbursement systems need updating, either costs are absorbed by the institution or not implemented at all
• #5: It may also be challenging for industry to navigate the many agencies conducting HTA in Canada and their sometimes inconsistent recommendations around a single technology. Canada has several HTA agencies operating at various levels (Table 1). Public health care is administered provincially, and there are several provincial and provincially affiliated academic HTA producers throughout the country, as well as units operating at the institutional level. However, a national prioritization system is still needed to drive timely and efficient device HTA without duplication. Currently, this patchwork of HTA agencies can result in a multitude of differing advisements for a single technology, resulting in wide variation in funding indications or patient access across the country. However, little is known about the efforts taken by each agency to harmonize device selection and priority setting across the country and how or if duplication is minimized. Manufacturers and decision makers alike would benefit from harmonization and increased transparency in the selection of HTA topics throughout the country. Transparency is particularly important with respect to policy and reimbursement decisions based on HTA at each level. This, and consistency in the use of HTA to inform policy decisions, are noted as weak areas in international HTA and fourth-hurdle frameworks [12,15]. Industry should have involvement in the HTA process both to improve transparency and to understand the needs of its customers. Industry will be better equipped to meet the needs of its customers if it can understand how the needs of customers are prioritized. The availability of transparent evaluation guidelines and criteria, similar to those provided for drugs, would go a long way toward improving the evidence base for health care devices. Manufacturers and decision makers alike have benefited from this risk-sharing approach to HTA. Other jurisdictions, both provincial and federal, would benefit from the industry partnerships that can be established through this approach. Manufacturers can feel that some of the risk associated with effectiveness evaluation is shared and manageable, while decision makers can design the studies needed to answer their specific questions about effectiveness  like OHTAC