Following the first approval of biosimilar filgrastim in the USA in June 2015 (used in oncology as supportive care), as of 2016, the FDA approved biosimilar versions of immunotherapies infliximab, etanercept, and adalimumab.7 In Europe, biosimilar filgrastim and biosimilar infliximab have been available since 2008 and 2013, respectively.8 Despite the inclusion of a tailored licensure pathway for biosimilars in the US health care reform legislation, the introduction and uptake of biosimilar products in the USA have been slow, mainly due to a lack of statutory guidance,9 higher hurdles to entry compared with generic products,10 and a general lack of familiarity with biosimilar products. Recent FDA guidance regarding nonproprietary naming of biologic products has provided some clarity. Each biosimilar is assigned a core name consistent across the originator biologic, any related biologic products, and biosimilars, with a suffix of four lower-case letters unique to each biosimilar or related biologic product of the originator biosimilar.11 Important unanswered questions remain, notably around the issue of interchangeability and the extent to which patients treated with a biologic might be switched to a biosimilar, or whether biosimilar uptake will primarily be in treatment-naïve patients.12
The objective of this review was to evaluate the progress made toward achieving health care reform since the passage of the ACA, the role of biosimilars in facilitating the aims of the ACA in terms of containing health care costs and improving disease management and outcomes, and possible barriers to biosimilar uptake, including a lack of awareness and financial disincentives relating to reimbursement.
Achievements of the ACA since enactment
Following the introduction of the ACA, ~20 million additional Americans gained health insurance.2,3,13,14 The ACA-related reforms, including transformed health care payment systems, contributed to a sustained period of slow growth in per-enrollee health care spending.2 Cost reductions were particularly evident for Medicare and Medicaid,13 and Medicare spending per beneficiary declined on an inflation-adjusted basis through 2014.3
In addition to saving costs, the ACA has improved the quality of health care delivery, as evidenced by improved health outcomes. For example, an estimated reduction of 3.4% in the share of nonelderly adults with fair or poor health has been reported.2 The ACA has also led to the formation of Accountable Care Organizations (ACOs). ACOs comprise physicians, hospitals, and other providers who aim to deliver cost-effective, coordinated care to Medicare beneficiaries and to take responsibility for overall provision, cost, and quality of patient care.15 It has been estimated that 23.5 million Americans are now served by an ACO. Some ACOs have resulted in improvements in health service quality measures, including clinician communication, timely access to physicians, and overall patient satisfaction.14
Despite these advances, a full accounting of the ACA to date has yet to be undertaken, and there remain major opportunities for US health care reform and health care improvement.2 For example, there is a lack of comprehensive, robust data on health outcomes before and after the ACA.3,13 Although more people have health insurance post-ACA, the level of individual coverage is still low. Many enrollees select bronze-level insurance plans, which essentially provide only catastrophic coverage.16 Adequate coverage is still unaffordable to many, and out-of-pocket costs have increased. Medicaid and Medicare Advantage coverage has expanded, and employer-sponsored plans have remained at the expense of state-sponsored exchange plans.3,16 Some insurance companies (eg, Dartmouth17 and UnitedHealthcare18) are dropping out of “ObamaCare” exchanges, as these are viewed as financially unattractive, and key stakeholders are withdrawing from the ACO market. Expanded health insurance coverage of high-risk patients and pressure to reimburse expensive cancer treatments and immunotherapy-based therapies have resulted in costs that have not been offset by enrollment of less expensive younger healthier patients, which has been low.14 In order to manage costs, health plans may consolidate, which would reduce competition and potentially drive up prices for consumers. Health care providers must address these and future challenges, such as rising costs, to ensure the continued success of the ACA.
Potential role of biosimilars in supporting US health care reform
Health care cost reduction
Controlling drug expenditure will be key to preventing future health care cost inflation and ensuring the viability of the ACA. The former US President, Barack Obama, highlighted lowering prescription drug costs as an area for improvement.2 Specialty medicine is one of the fastest growing areas, expected to expand considerably in the next 10 years, as new biologics and high-cost therapies become available. Biologics, most of which are in the specialty medicine category, are often more expensive and it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic options. Although biologics increase drug costs, they have demonstrated significant improvements in patient care that can avoid more expensive interventions such as hospitalizations. More information about the overall budget impact and cost-effectiveness of biologics is required.
Biosimilars, highly similar to biologics, are less expensive than the originators (discounts vary by market and product),19,20 offering the potential to reduce prescription drug costs while providing equivalent care. The Centers for Medicare and Medicaid Services (CMS) noted that biosimilars may provide an option for Part D (prescription drug benefit) sponsors to control costs while ensuring access to needed medication.21 The Rand Corporation22 reported that the use of biosimilars is estimated to result in US health care system cost savings of $44.2 billion (range, $13–$66 billion) between 2014 and 2024 (~4% of total biologic spending), from reductions in direct spending on biologics.
The introduction of competition from biosimilars may also create a downward pressure on biologic drug prices. In Europe (Scandinavia, in particular12), competition among biosimilars has resulted in discounts of up to 69% on the price of some originator biologics.23–25 In Japan, discounts are up to 67%, and in South Korea, although the biologics market as a whole is growing, originator biologics are rapidly losing market share.25 In Europe, biosimilars (available since 2006) of many biologics are priced between 10% and 30% lower than the originator.26 These discounts, however, are not in place in all markets or among all types of biosimilars, such as the newer monoclonal antibody and fusion protein biosimilars.12,27
Reductions in health care costs to payers arising from biosimilar availability as an alternative to the originator biologic will have maximum benefit to multiple stakeholders if translated into lower premiums and reduced out-of-pocket costs for patients, which could increase patient access to biologics (originators and biosimilars). For example, previously uninsured young adults with inflammatory bowel disease, a condition most effectively managed by biologics,28 may now have better access to these agents through health care coverage under the ACA. A clinical practice study from Italy’s Lazio region found increased use of filgrastim biosimilar after its introduction, resulting in estimated annual granulocyte-colony stimulating factor expenditure reduction of ~5%.29 Furthermore, a simulation of cost savings in major European countries found that the use of biosimilar filgrastim could result in not only potential cost savings, but also budget availability for greater access to important cancer therapies such as rituximab and trastuzumab.30
One large US pharmacy benefits manager has taken advantage of lower pricing and replaced filgrastim with its biosimilar in its formulary management strategy.31 If biosimilars are increasingly used in place of originator biologics when the originators are more expensive, then cost savings may be analogous (albeit perhaps not as substantial) to those seen with generic substitution of small-molecule drugs. For example, after closure of the Medicare Part D coverage gap (the “donut hole”), patients’ out-of-pocket spending significantly decreased among Medicare beneficiaries, mainly due to reduced spending on brand-name drugs and increased generic drug utilization.32 It remains to be seen how biosimilar availability will affect pricing and drug utilization covered under Medicare Part B. For example, the payment allowance limits of US CMS Part B drug (based on average sales price methodology) for the second quarter of 2017 were lower for filgrastim biosimilar, but higher for infliximab biosimilar than for their respective originators.33