Reimbursement

Establishing coverage and reimbursement is an essential requirement to ensuring market adoption and patient access for any medical device. Coverage and reimbursement decisions are complex, with stakeholders, decision-making bodies, and processes that are separate and distinct from the regulatory approval pathway. Even in the preclinical phase, assessments of the reimbursement landscape and evidence requirements can help developers plan for potential market access challenges that can be proactively addressed through early engagement with relevant stakeholders.

Since the initial transcatheter aortic valve replacement (TAVR) devices were commercially introduced in 2007 in Europe, the reimbursement landscape for the technology has evolved drastically.  From the outset, TAVR demonstrated great promise for patients with severe aortic stenosis (AS) as a new, less invasive technology for aortic valve replacement. However, the relatively high procedural costs and lack of long-term outcomes data limited coverage and reimbursement to specific subsets of patients.

Since then, improvements in valve design and procedural efficiency have resulted in better patient outcomes and lower costs thereby improving the economics and value of the technology (1,2). Moreover, multiple, rigorous health economic assessments have quantified and demonstrated these improvements across different patient populations (3-9).  This, in turn, has led to broad adoption, coverage, reimbursement and patient access to TAVR across many global health systems.

The Food and Drug Association (FDA) approved the first TAVR device in 2011 and the Centers for Medicare & Medicaid Services (CMS) subsequently issued a National Coverage Decision (NCD) in 2012. The TAVR NCD establishes coverage with evidence development for Medicare beneficiaries and outlines procedural and facility requirements in order for TAVR to be reimbursed by CMS. The NCD also includes facility infrastructure requirements (on-site cardiac catheterization and/or hybrid operating room, noninvasive imaging capabilities) and established procedural thresholds (≥50 total aortic valve replacements [AVRs] in the previous year prior to TAVR and 1,000 catheterizations per year including 400 percutaneous coronary interventions) that need to be maintained for TAVR certification and reimbursement (10).

While the NCD established coverage for Medicare beneficiaries, it did not specify reimbursement rates for TAVR.  For inpatient hospitalizations, Medicare reimburses providers using Medicare-Severity Diagnosis Related Group (MS-DRG) payments. MS-DRG payments are calculated and adjusted based on a national average of historical cost and resource utilization for specific procedures (11). Initially, TAVR was covered under the range of cardiac valve replacement MS-DRGs (216-221). However, in October 2014, CMS established two TAVR-specific MS-DRGs: DRG 266 and DRG 267 (12).

Even though Medicare is a national health care program, there is variation in the MS-DRG payment amounts received at individual hospitals for the TAVR procedure. MS-DRG base payments rates are adjusted at an individual hospital level to incorporate geographic adjustment factors (GAF) (13). In particular, GAFs reflect the geographic variation in wage and cost indices (i.e., urban vs. rural, high cost of living vs. low cost of living) and adjust the final payment amount to hospitals. As a result, a hospital in Florida and a hospital in New York may be paid drastically different amounts by the Medicare program for the same TAVR procedure.

This dynamic affects the financial viability for some hospitals in select geographies to perform TAVR procedures. As a relatively resource-intensive procedure with implant costs that do not vary considerably across geography, the Medicare payments for TAVR may not cover the direct costs to perform the procedure in certain regions and among certain hospital types. At a facility level, negative contribution margins may impact a hospital’s decision to offer the TAVR procedure or invest in a TAVR program – thereby reducing patient access to the therapy.

Germany is the largest TAVR market in the European Union with the highest rate of procedures per capita.  In 2011, it was estimated TAVR was performed in 36.2% of TAVR-eligible German patients (14). By 2015, TAVR represented 50% of all AVRs, including isolated and concomitant procedures (15). In Germany, all new inpatient procedures are explicitly covered and reimbursed by the German health care system, unless specifically excluded by the Federal Joint Committee. As a result, TAVR has been available in Germany since 2007 but did not have a specific payment rate until 2010.

Like the United States, German hospitals are reimbursed on a DRG payment system (called the G-DRG in the Germany). The G-DRG payment is an algorithm that factors in diagnoses, procedures and patient characteristics (16). Prior to 2010, TAVR procedure payments were grouped with the surgical aortic valve replacement (SAVR) G-DRGs. In 2010, however, the TAVR-specific G-DRG rate was established, at a rate higher than the SAVR G-DRGs (17). This favorable reimbursement rate coupled with early, widespread coverage has contributed to accelerated adoption of TAVR in Germany (18).

Moreover, the government has never formally assessed TAVR via a health technology assessment (HTA) in Germany.  In addition, there are no formal restrictions on the use of TAVR for severe AS patients.  Instead, German cardiac society guidelines have provided guidance and clinicians have broad discretion on selecting patients for TAVR (19).

Post CE mark approval in 2007, TAVR was available on a limited basis in the United Kingdom, typically funded through hospital budgets. However, there was no explicit, defined coverage or funding for the procedure by the National Health Service (NHS).

In 2012, the National Institute for Health and Clinical Excellence (NICE) performed an HTA and concluded that the efficacy for TAVR in patients unsuitable for SAVR was adequate. However, in patients at high risk for SAVR, NICE concluded the evidence for TAVR was inadequate and should only be used in “special arrangements for clinical governance, consent or data collection, or research” (20). As a result of NICE’s recommendations, the NHS instituted a policy in April 2013 covering and reimbursing TAVR for patients who are at “too high a risk for open heart surgery” as judged by a specialist team (21).

NHS’s policy doesn’t completely restrict TAVR to the inoperable (unsuitable for SAVR) severe AS population. The procedure is funded by NHS at a minimum of 25 per million residents and there is discretion at the local administrative level and the clinician level to justify funding treatment in high surgical risks patients (22). However, the global TAVR evidence base has evolved markedly since 2012 and the current NHS policy doesn’t reflect contemporary technology, practice, or evidence. NICE is planning a review of TAVR, which could broaden access for patients in the United Kingdom.

TAVR was first approved by Australia’s regulatory agency – the Therapeutic Goods Administration – in 2013.  However, to date, there is no coverage, reimbursement, or funding provided through Australia’s primary public payer – Medicare.  Australian Medicare is funded through tax revenue and provides a base level of coverage for all Australian citizens.  Forty seven percent (47%) of Australians also have supplemental private insurance which provides additional access to hospitals and providers (22). However, the lack of TAVR coverage, reimbursement or funding by Medicare severely limits availability to the technology in Australia.

A request for a Medical Services Advisory Committee (MSAC) evaluation of TAVR was submitted in May 2013 and completed in March 2016. The evaluation concluded with MSAC supporting Medicare Benefits Schedule (MBS) listing of the TAVR procedure for use in patients determined to be at high risk for SAVR or non-operable. Payment levels for the TAVR procedure are below SAVR, which may continue to limit the availability of this technology to patients.

Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency provided regulatory approval for TAVR in 2013. Currently, TAVR is covered and reimbursed under Japan’s Public Health Insurance System, which provides universal primary coverage to all Japanese citizens (22). This widespread coverage coupled with an aging Japanese population, makes Japan an attractive growth opportunity for THV manufacturers (23).

Due to recent budget constraints, MHLW is piloting a more formal HTA of medical technologies with high impact to national health expenditures. The first MHLW HTA pilot included seven drugs and six medical devices, one of which is a THV (24). The pilot is still ongoing, and it remains to be seen how the results will influence future decision making, but it is a sign that scrutiny on cost effectiveness and value may be more of a focal point for MHLW decisions going forward.

Establishing coverage and reimbursement is essential to the success of any medical technology but is also incredibly challenging and complex. The multitude of stakeholders, differences in evidence requirements, and the variability in HTAs around the world make the processes both time consuming and resource intensive. As health care spending increases, the scrutiny on new medical technologies will only continue to grow with all stakeholders – payers, providers, patients – demanding value (in terms of clinical outcomes, cost offsets, etc.) for each dollar invested. It is imperative for any developer to evaluate HTA requirements in key markets throughout product development to inform overall market potential and commercial strategies.

Looking forward, a few specific considerations should be considered for new market entrants:

— Quantifying burden of illness: Illustrating the unmet need and the economic impact of a disease is a foundational element to establishing the value of a new technology to an HTA. Cost burden analyses quantify the budgetary and societal cost of a disease that – in some cases – may augment or complement the overall value story in an HTA submission. These analyses are essential to putting the value of the technology in the appropriate context of the disease, the affected patients and the economic consequences of the status quo.

— Evidence requirements: Randomized controlled trials are the gold standard of clinical evidence but generating that evidence may not be an option for new market entrants or new device generations within existing approved indications. Communicating and demonstrating improvements in clinical outcomes as a result of new technology and evolving clinical practice is important to ensure HTA decisions are made with the most contemporary, relevant evidence.

— Cost effectiveness as a specific requirement: As health care budgets are constrained, and payers balance affordability with access to new technologies, the incremental value of new medical technologies will only increase in importance. Japan is experimenting with a new HTA process and in the United States – while HTAs are not explicitly required for coverage and reimbursement – provisions in the 2010 Affordable Care Act call for realigning reimbursement incentives to favor high value procedures and technologies (25). Conducting landscape assessments, proactively planning access strategies, and modeling product cost effectiveness relative to the standard of care during product development is important to gauge potential coverage and market adoption post regulatory approval (26).

— Documenting the “learning curve” for cost-effectiveness evaluations: The “learning curve” is a unique characteristic of medical device markets. As an operator’s skill and experience with a device improves, so do the device outcomes (22). However, HTAs may prioritize and evaluate outdated evidence that doesn’t incorporate this characteristic or the related impact on outcomes. In the case of TAVR, rapid iterations in device technology, advances in patient selection, and enhanced procedural skills resulted in significantly improved outcomes over time. Nonetheless, many HTAs relied heavily on evidence from early, outdated studies that did not accurately reflect current clinical practice or outcomes. To accurately assess cost effectiveness, it is important that HTAs consider the impact of the learning curve on clinical outcomes and cost.  Furthermore, it is incumbent on developers to document and quantify the learning curve impact (if applicable) as a component of any HTA submission.

— Reducing procedure cost and improving efficiency: To justify the incremental cost of a new technology, it is important to consider the cost offsets resulting from the technology relative to the standard of care. The ability to demonstrate reduced resource utilization (i.e., lower hospital length of stay, reduced procedure time) and quantifying the impact is an important foundation to any value assessment. Cost offsets may not be readily apparent when a new technology is introduced. In the case of TAVR, increased operator and facility experience coupled with treating patients in lower cost settings have led to a dramatic decrease in procedure cost over time (27,28). The ability to document and communicate the improvements over time is important to consider when developing an evidence base required for coverage and reimbursement decisions.