This article was originally published by 

The proliferation of biosimilars, which has accelerated in recent years, has the chance to lower the cost of prescription drugs across countless conditions for millions of individuals. Medications for chronic diseases are often coupled with significant price tags and cause long-term financial stress, which makes managing the conditions even more burdensome. Not only can biosimilars reduce prices for myriad drugs, but they can also improve patient access to medications and make prescribing easier for the pharmacist.

Still, many providers harbor a reluctance to prescribe biosimilars because of their lack of comfort with their efficacy or safety compared with a reference biologic. There are also complex hurdles and restrictions created by the FDA regulating the use of biosimilars, which can make it difficult for patients and providers to understand which treatments are available for them and at what price.

The ability to designate biosimilars as “interchangeable” (those that demonstrate enhanced clinical similarity with a reference product) has allowed pharmacists greater flexibility. Still, interchangeability rules vary by state and only apply to a handful of treatments. Pharmacists must educate not only themselves but other members of the patient care team as well as patients on regulations, feasibility, and processes surrounding biosimilar substitution.

Interchangeable biosimilars must satisfy multiple conditions to be automatically substituted for an original reference biologic. The conditions include the following

It must be a biosimilar approved by the FDA.

It must produce the same clinical outcomes as the reference product in any patient for any approved indication.

If a biosimilar is given more than once to the same patient—whether switching or alternating with the reference product—it must sustain similar efficacy and have no greater risk of adverse events.

Although the FDA is responsible for deeming biosimilars interchangeable, it is the responsibility of pharmacists to properly select biosimilars they know are available and as effective as the reference biologic.

States have varying regulations surrounding the automatic substitution from a reference biologic to an interchangeable biosimilar. However, the FDA allows pharmacists to substitute a reference product without the approval of a prescribing physician. Despite the lack of uniformity, 46 of the 50 states allow for that FDA standard (the exceptions are Alabama, Indiana, South Carolina, and Washington).

 Pharmacists should ensure they are complying with specific state laws regarding biosimilar interchangeability and maintain sustained communication and accurate recordkeeping at an individual patient level.

Pharmacists cannot freely substitute a reference biologic for a biosimilar product without an FDA interchangeability designation. These cases require that a prescription for the biosimilar is written specifically by a prescriber, indicating it is safe to switch from the reference product. Proper awareness of which medications are considered interchangeable is an essential component of pharmacist biosimilar management.

Navigating insurance coverage is another critical aspect of biosimilar prescribing. Insurance companies typically provide coverage for biosimilars, but pharmacists should ensure they understand all relevant individual considerations for a patient’s coverage of biosimilars. Some factors to consider when deciding on a biosimilar for a patient are the type of insurance plan the patient is enrolled in and their formulary coverage, which can significantly affect biosimilar eligibility.

Pharmacists can consult directly with plan providers for patients on Medicare and Medicaid to discuss their eligibility for biosimilar coverage. Beyond communicating directly with insurance providers, pharmacists can educate and empower patients regarding manufacturer co-pay cards and programs to help patients pay for their insurance, which could help reduce the financial burden that may be associated with the cost of biosimilars.

Choosing which biosimilar to use for a patient’s condition can be challenging. Pharmacists in all spaces, whether community or health system pharmacists, should educate themselves about the biosimilars that have been approved by the FDA thus far as well as those that are further down the pipeline but expected to become available. Pharmacists can review resources to stay current on approved biosimilars of proven indications and can provide important input into decisions regarding the proper use of biosimilars in health facilities.

With a unique position as members of the patient’s multidisciplinary team, pharmacists can appropriately evaluate biosimilars based on each patient’s concerns and requests. Pharmacists in the clinical setting can provide a holistic view of the biosimilar products’ clinical profile and other important considerations, including proper storage, shelf life, and other aspects relating

Pharmacists play an important role in the substitution of biosimilars and patient education surrounding their use. The role of pharmacists in this space will only continue to grow as more biosimilars gain FDA-approved interchangeability status.

1. Okoro RN. Biosimilar medicines uptake: the role of the clinical pharmacist. 

 2021;1:100008.doi:10.1016/j.rcsop.2021.100008

2. Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. 

 2023;29:SP545-SP548. doi:10.37765/ajmc.2023.89419

3. Overview of biologics and biosimilar products. American Pharmacists Association. Accessed February 19, 2025. 

https://www.pharmacist.com/Advocacy/Issues/Biosimilars

4. Interchangeable biosimilars: pharmacist’s guide to frequently asked questions. American Pharmacists Association. 2024. Accessed February 19, 2025. 

https://www.pharmacist.com/Advocacy/Issues/Biosimilars/Biologics-and-Biosimilar-Drug-Products-Pharmacist-Guide-to-Patients-Frequently-Asked-Questions

Pharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications.

As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are Paramount

Luke Halpern

This article was originally published in The American Journal of Managed Care

 Biosimilars provide an opportunity for a more sustainable and cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential financial impact of implementing a formulary change from reference to biosimilar natalizumab (NTZ) from the US commercial payer perspective.

 The budget impact of transitioning to biosimilar NTZ for the treatment of relapsing-remitting MS (RRMS) was estimated over a 3-year time horizon based on real-world dosing. Additional scenario analyses were conducted by varying the price differential of biosimilar NTZ.

 The target population was estimated from a 1-million-member hypothetical commercial health plan. Model inputs were drug acquisition costs and treatment-related and patient coinsurance costs. Budget impact and cost savings per member per year were calculated by assuming a biosimilar uptake of 10% in year 1 to 20% in year 3.

 Over 3 years, 255 patients were estimated to be treated with high-efficacy disease-modifying therapies for RRMS. The inclusion of biosimilar NTZ onto a formulary would result in cumulative cost savings to payers of $452,611 over 3 years, with mean savings per treated member per year of $1179, $1769, and $2359 in years 1, 2, and 3, respectively. One-way sensitivity analyses indicated that budget impact results were most sensitive to drug acquisition costs of both reference and biosimilar NTZ.

 Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS.

Disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis have been available for more than 25 years, yet DMT-related costs continue to be a concern, especially with the advent of biologic DMTs. We estimated the financial impact of implementing a formulary inclusion of biosimilar natalizumab from a US payer perspective:

The inclusion of biosimilar natalizumab onto a formulary would result in mean savings per treated member per year of $1179, $1769, and $2359 in years 1, 2, and 3, respectively.

Annualized costs for a biosimilar natalizumab can be lower than those for reference high-efficacy DMTs when considering real-world dosing patterns.

Multiple sclerosis (MS) is a chronic disease characterized by neural inflammation, demyelination, and neurodegeneration, mainly affecting young adults around the world. Most individuals with MS experience a variety of debilitating symptoms with periodic neurological relapses that impact their quality of life, employment, social relationships, and productivity.

 The global incidence and prevalence of MS is rising; in 2020, 2.8 million individuals were living with MS compared with 2.3 million in 2013.

 The US is among the countries with the highest prevalence of MS, with 288 MS cases per 100,000 individuals,

 and a recent study reported that approximately 1 million adults are living with MS nationwide.

 MS disproportionately impacts women; it is nearly 2 to 3 times more prevalent in women than men.

 MS can occur at any age, and the mean age of diagnosis is 32 years.5 The peak MS prevalence was observed among both male and female patients aged 45 to 49 years,

 and the peak incidence was observed in patients aged 25 to 29 years.

 MS also has a strong racial and ethnic component and disproportionately affects more individuals with northern European ancestry and Black individuals.

Relapsing-remitting MS (RRMS) is the most common phenotype, accounting for approximately 85% of cases.1

 Patients with RRMS experience episodic flare-ups of symptoms followed by periods of remission.

 Disease-modifying therapies (DMTs) are used to treat MS and significantly reduce clinical relapses, slow disease disability and progression, minimize MRI lesion activity, and improve patient quality of life.

 High-efficacy DMTs such as natalizumab (NTZ), ocrelizumab, and alemtuzumab are biologic therapies commonly given in infusion centers and are known for average relapse reduction of more than 50%.

 MS is one of the costliest chronic diseases for payers in the US. Its estimated total economic burden was $85.4 billion in 2019 in both direct and indirect costs to patients.

 Based on one large payer’s analysis, the MS drug category ranks fourth in spend, behind the autoimmune, cancer, and HIV drug categories.

 A study by Bebo et al estimated the economic burden of MS in the US and found that the direct medical cost for a patient with MS was $65,612 per year, with the majority of that being the cost of DMTs (53.6%).

 Among individuals using DMTs, annual DMT costs ranged from $57,202 to $92,719.

 In a survey among patients with RRMS, high out-of-pocket (OOP) costs were frequently reported as a DMT access barrier.

There is evidence in the US of health care cost savings following the entry of generic MS drugs. For example, the launch of generic glatiramer acetate coincided with a decline in gross sales of glatiramer acetate injection from approximately $4.5 million (2015) to approximately $2.5 million (2019); glatiramer acetate injection accounted for 33% and 32% of total DMT prescriptions in 2015 and 2019, respectively.

 In a similar manner, the introduction of a biosimilar for the treatment of RRMS could help address issues of high spending and access barriers to high-efficacy MS therapies.

 Sandoz Inc’s biosimilar NTZ is the first biosimilar NTZ approved in the US.

 A confirmatory phase 3 study demonstrated the matching efficacy and safety of biosimilar NTZ to that of the reference medicine.

 The purpose of this economic analysis was to estimate the potential financial impact from the payer perspective of the inclusion of biosimilar NTZ onto a drug formulary.

A budget impact model was developed in Excel (Microsoft) to estimate the financial impact of introducing biosimilar NTZ to the high-efficacy DMT space for treatment of adult patients with RRMS in a hypothetical 1-million-member US commercial health plan over a 3-year time horizon. The model was developed according to Modeling Good Research Practices guidance from ISPOR—The Professional Society for Health Economics and Outcomes Research.

 A schematic of the model structure is shown in 

The patient population of interest was adult patients with RRMS who were treated with high-efficacy infused DMTs, aged 20 to 64 years, and covered by commercial insurance. Three high-efficacy DMTs—NTZ, alemtuzumab, and ocrelizumab—were included in the analysis to represent the technology mix of high-efficacy infused DMTs in the US as recommended by the ISPOR budget impact analysis guideline.

 The model estimated expected total cost and budget impact on an overall and per-member basis with and without the introduction of biosimilar NTZ onto a formulary. The main model parameters are outlined in 

The model inputs included estimates of epidemiological data, relapse rates, dosing, utilization rates, and costs. Costs to payers included drug acquisition, administration, monitoring, relapse, and adverse event (AE) management costs. All costs were obtained from literature and adjusted to 2021 US$. In accordance with recommended practice for short-term budget impact analyses, we did not apply discounting on costs to derive present values.

 Although biosimilar NTZ has the same indications as reference NTZ, this model focused on the most common phenotype of MS: RRMS. The population of interest was patients with RRMS (treatment-naive patients and patients with existing treatment) aged 20 to 65 years who were currently being treated with or newly started on infused high-efficacy DMTs.

The annual incidence and prevalence rates of MS were assumed to be constant over the 3-year time horizon of the analysis. RRMS incidence and prevalence were age adjusted by age groups from US census data, age-specific incidence and prevalence of MS, and the proportion of patients with RRMS in the US.

 The analysis was conducted from a US commercial payer perspective. Analysis of the budget impact from a Medicare perspective is presented separately in eAppendix Section C.

 In the base-case analysis, we assumed dosing frequency derived from published real-world studies.

 The findings from multiple studies indicate that clinicians in the US are prescribing and administering NTZ less frequently than the FDA-labeled dosing (theoretical setting), which is associated with a reduction in the risk of progressive multifocal leukoencephalopathy.

 In addition, patients receiving ocrelizumab and alemtuzumab in real-world settings were observed to require more doses than on label to control relapses, as highlighted by Nicholas et al.

 The total number of doses administered in a year are given in 

 Drug acquisition costs were derived from wholesale acquisition costs (WACs) from IBM Redbooks(dated July 1, 2021), similar to other recent budget impact analysis studies.

 The base-case WAC price for biosimilar NTZ was assumed to be 15% lower than the cost of reference NTZ based on the historical experience of other biosimilar launches in the US.

 The WAC drug price for each drug is shown in 

Costs associated with administration, monitoring, and pretreatment for the included DMTs were obtained from a study conducted in 2020 by Kozma et al

AE treatment costs were obtained from a study by Chirikov et al.

 AE management costs for each DMT are shown in eAppendix Section B and were utilized to obtain the total AE cost for the treatment-naive and existing patients.

Relapse management costs of $3116 per episode were derived from literature (shown in eAppendix Section B).

 The annualized relapse rates for NTZ, ocrelizumab, and alemtuzumab were 0.19, 0.22, and 0.17, respectively, calculated based on relative risks from the Institute for Clinical and Economic Review.

All treatment (non-DMT) costs obtained from literature were adjusted to 2021 US$ based on US Consumer Price Index inflation statistics.

 The overall budget impact was calculated by assuming a 10%, 15%, and 20% uptake of biosimilar NTZ from reference NTZ in years 1, 2, and 3, respectively. Our uptake assumption of biosimilar NTZ is consistent with 3-year market shares of past biosimilar launches in the US since 2013.

 The utilization rates of ocrelizumab and alemtuzumab were assumed to remain constant.

Analysis: Base-Case Analysis Using Real-World Dosing Pattern

The number of patients continuing and newly starting treatment for each year was estimated using patient-year calculations and stratified by patients who switched to biosimilar NTZ and those who remained on reference NTZ, ocrelizumab, and alemtuzumab. Results with FDA label dosing are presented in eAppendix Section D.

A 1-way sensitivity analysis was performed to assess the impact of varying each base-case parameter by ±25% on the model outcomes. Additional analysis of price sensitivity is reported in eAppendix Section E.

In the base-case analysis for a hypothetical 1-million-member health plan, 84 patients aged 20 to 64 years with RRMS (2 incident and 82 existing cases) were estimated to require high-efficacy DMT in year 1. Over the 3-year time horizon, it was estimated that 255 patient-years of high-efficacy DMTs would be provided (

In base-case analysis assuming real-world dosing patterns, the model estimates that the cumulative total cost of high-efficacy DMT over 3 years from the payer perspective is $21.1 million and can be reduced to $20.6 million with the inclusion of biosimilar NTZ. The formulary inclusion of biosimilar NTZ for RRMS could result in cumulative cost savings of $452,611 over 3 years, starting at $98,189 in year 1 and rising to $204,207 in year 3, as shown in 

Within this base-case analysis, payer cost savings were primarily driven by the decrease in drug acquisition costs due to the shift from reference NTZ to biosimilar NTZ, which we assume will have lower drug acquisition costs based on historical biosimilar experience.

Without biosimilar NTZ in the formulary for the commercial plan population, the per-member per-year (PMPY) cost was $6.90 in year 1 and up to $7.17 in year 3. The increased PMPY costs were due to the incorporation of annual population growth into the model. With biosimilar NTZ, PMPY costs were reduced to $6.80 in year 1 and $6.97 in year 3. The cost savings per treated member per year were $1179 in year 1, $1769 in year 2, and $2359 in year 3. The mean annual total cost per existing patient to the payer was found to be the lowest for biosimilar NTZ ($69,532) and higher for the other DMTs (reference NTZ [$81,262], ocrelizumab [$81,013], and alemtuzumab [$81,728]) (

From a Medicare perspective analysis, 10 patient-years of high-efficacy DMT would be provided over 3 years. The inclusion of biosimilar NTZ into the formulary would generate cost savings of $18,642 over 3 years, equivalent to a mean cost savings per treated member per year of $1192 in year 1, $1786 in year 2, and $2380 in year 3. Detailed results for Medicare are provided in eAppendix Section C.

The base-case results were most sensitive to the drug acquisition cost of reference NTZ and biosimilar NTZ (

). Results of price sensitivity analysis are reported in eAppendix Section E.

Biosimilar NTZ from Sandoz is the first biosimilar for the treatment of RRMS to be launched in the US. This budget impact model estimated that, assuming a 15% reduction between the WAC prices of reference NTZ and biosimilar NTZ, switching from the reference to biosimilar NTZ could result in savings of approximately $452,611 from a commercial payer’s perspective over a 3-year time horizon.

Our model assumed the lowest price differential between biosimilar and reference product from historical experience in the US; cumulative savings could be even higher if the price difference was at the historical maximum of 37%.

 Such savings to the US health care system would result in significant economic and social benefit to payers and patients. The 1-way sensitivity analysis revealed that the budget impact was most sensitive to variation in the WAC price of reference NTZ, followed by the predicted WAC price of biosimilar NTZ.

Besides reference and biosimilar NTZ, our model also included alemtuzumab and ocrelizumab as part of the treatment mix to provide additional context in this therapeutic area. In general, there is no uniform approach for DMT selection or sequencing for patients with RRMS, and product selection is influenced by patient preferences for efficacy, safety, tolerability, route of administration, and cost. Moreover, patients and their neurologists can switch from one DMT to another for any one of these reasons. There is, however, growing consensus that early use of higher-efficacy DMTs such as NTZ or ocrelizumab might be advantageous for improving long-term outcomes, and their use has increased.

 Although ocrelizumab has been demonstrated to be cost saving or more cost-effective vs NTZ, the emergence of a lower-cost, high-efficacy DMT, such as biosimilar NTZ, has the potential to produce significant cost savings for payers. We did not assume that NTZ (reference or biosimilar) would take market share from alemtuzumab or ocrelizumab within the short time frame of our analysis, although changes to the overall treatment mix between these high-efficacy DMTs are possible over the longer term.

Although reference NTZ is a high-efficacy DMT commonly used for the treatment of RRMS, since its approval in 2004, newer and less costly high-efficacy DMTs have been approved; these include ocrelizumab in 2017 and ublituximab in December 2022. Based on our model with lower biosimilar NTZ WAC prices and the use of real-world dosing patterns, our results (Table 3) showed that from the perspective of cost per treated patient per year, biosimilar NTZ would be on par with newer treatments such as ocrelizumab, especially after the first year of treatment. This in turn ensures continued patient access to highly efficacious DMTs and treatment alternatives within the drug class.

Despite the cost-saving advantages of biosimilars, there are many barriers to the entry of biosimilars in the US. The introduction of biosimilars in the US market is essential for increasing patient access and market competition and thus decreasing the overall treatment cost for both the government and payers. In the US, MS is associated with the highest OOP expenditure, including hospital and doctor bills, prescription drugs, and premiums, among the most common diagnoses such as diabetes, injuries, stroke, mental illnesses, and heart disease.

 With increasing global prevalence of MS, the utilization of DMTs has also increased because DMTs demonstrate high efficacy in reducing relapses, delaying disease progression, reducing disability, and improving the quality of life among patients with MS.

 However, despite the availability and proven efficacy of DMTs in patients with MS, affordability of DMTs remains a major challenge because of increasing costs.

 A recent cross-sectional study highlighted that nearly 70% of Medicare beneficiaries with MS were using a DMT and that for the patients who used DMTs consistently throughout the year, OOP costs were high.

 Although DMTs have been available to patients for more than 25 years, DMT-related costs continue to be high.

 Hence, health care plans should consider including the cost-saving treatments in their drug formulary, which could potentially reduce the financial burden.

This is the first study to assess from a US payer perspective the budget impact of introducing a high-efficacy DMT biosimilar into a formulary for the treatment of patients with RRMS. Our findings, however, should be interpreted with caution, as the estimated cost savings depend on many interrelated factors such as biosimilar price differential relative to the reference product, biosimilar uptake rate, and patient access to biosimilars. Biosimilars have been available in the US since 2015, and they have enabled the health care system to realize significant savings.

 The considerable potential savings on drug spending when patients switch from reference NTZ to biosimilar NTZ as observed in the present study are consistent with previous biosimilar literature (

As the promising cost savings due to biosimilars are emerging, a RAND study estimated total biosimilar savings of $38.4 billion from 2021 to 2025 in the US.

 Further, a report by IQVIA Institute for Human Data Science on biosimilars in the US projected an increased savings of $181 billion in 2023-2027, which will be more than 4 times the savings over the past 5 years ($40 billion), as newly approved biosimilars launch and existing biosimilars see continued uptake and price reduction.

 However, the potential role of biosimilars and their contribution to the health care system will not be realized until more policy makers and physicians support biosimilar usage by understanding their value proposition. In general, biosimilars are equally efficacious, offer the same dosing approach and schedule as reference medicines, and have potential to increase access while delivering cost savings in the US.

The results of this economic model are meant to provide an estimate of the potential costs that can be incurred and the savings realized from the perspective of a commercial health plan with the inclusion of biosimilar NTZ. Actual savings experienced by health plans will depend on their unique circumstances such as their covered population, treatment utilization rates, and pharmacy and medical costs.

Our analysis did not take OOP maximums into consideration due to the wide variation in plan designs. Patients receiving care out of network are likely to have much higher OOP thresholds. Similarly, patients on original Medicare55 who have 20% Part B coinsurance without annual patient cost-sharing limits can benefit from the reduced drug price and resulting reduced co-pay for biosimilars. Additionally, we also did not assess the impact of potential deductibles, manufacturers’ co-pay assistance, or co-pay cards for commercially insured patients. We excluded these parameters because of the complexity and variety of payer and manufacturer benefit structures across the US.

The model assumed that patients starting alemtuzumab would stay on treatment for the rest of the model’s time horizon. However, this assumption did not have any significant impact on the results because alemtuzumab market share was assumed unchanged in both analysis scenarios. Real-world dosing patterns utilized in the base-case scenario were derived from the included studies but can still vary in other real-world settings. We also did not account for use of ofatumumab (not infused but high efficacy) or off-label rituximab, which is considerably less expensive.

Because biosimilar NTZ had not launched in the US at the time of this analysis, the price is currently an assumption based on historical market trends, and the base case price differential represents the most conservative scenario.

 The model assumed that the utilization of NTZ remained stable over the 3 years. Utilization rates were based on multiple references describing the proportion of patients treated with various DMTs. Some of the references may not reflect the current treatment population count, and individual payer utilization rates may be different.

Based on this 3-year analysis, the use of biosimilar NTZ is economically attractive and can potentially address high spending and access barriers to high-efficacy DMTs. Assuming a reduction in price, the value proposition of NTZ is expected to improve. Future analyses should be continually conducted to assess whether these short-term financial benefits can translate into more cost-effective care, increased access and earlier adoption of NTZ, and improved population-based outcomes.

All authors approved the final version of the manuscript and thank Nidhi Arora, PhD, of Sandoz Pvt Ltd in Hyderabad, India, for medical writing support.

 Sandoz Inc (EL, AC), Princeton, NJ; Novartis Corporation Sdn Bhd (AG), Selangor, Malaysia; Novartis Healthcare Pvt Ltd (SG), Hyderabad, India; Sandoz International GmbH (MS), Holzkirchen, Germany; College of Pharmacy, Oregon State University (DMH), Portland, OR.

 This study was funded by Sandoz International GmbH.

 Dr Li is employed by Sandoz and owns stock in Novartis. Mr Goh and Ms Gupta are employed by Novartis. Ms Schauf is employed by Sandoz International. Dr Chen is employed by and owns stock in Sandoz. Dr Hartung has consulted for the National Multiple Sclerosis Society and has provided expert testimony in litigation on behalf of Humana and the US Department of Justice.

 Concept and design (EL, AG, SG, MS, AC, DMH); acquisition of data (AG, SG); analysis and interpretation of data (EL, AG, SG, AC, DMH); drafting of the manuscript (EL, AC); critical revision of the manuscript for important intellectual content (AG, SG, MS, AC, DMH); statistical analysis (AG, SG); administrative, technical, or logistic support (AC); and supervision (MS).

 Anna Chen, PharmD, MS, Sandoz Inc, 100 College Rd W, Princeton, NJ 08540. Email: anna-1.chen@sandoz.com.

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26. Elsisi Z, Hincapie AL, Guo JJ. Expenditure, utilization, and cost of specialty drugs for multiple sclerosis in the US Medicaid population, 2008-2018. 

27. Romero-Pinel L, Bau L, Matas E, et al. The age at onset of relapsing-remitting multiple sclerosis has increased over the last five decades. 

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28. Nazareth TA, Rava AR, Polyakov JL, et al. Relapse prevalence, symptoms, and health care engagement: patient insights from the Multiple Sclerosis in America 2017 survey. 

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Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Budget Impact Analysis of Biosimilar Natalizumab in the US

Daniel M. Hartung, PharmD, MPH

All eyes in the world of biologics and biosimilars are on the Supreme Court as it decides a constitutional challenge to the Affordable Care Act (ACA) in 

 provisions of the ACA, at stake is the future of the Biologics Price Competition and Innovation Act (BPCIA), which was signed into law on March 23, 2010 as Title VII to the ACA and provides a pathway to market for biosimilar products. For biologic and biosimilar stakeholders, the focus is on whether the Supreme Court will let the BPCIA stand even if it finds provisions of the ACA to be unconstitutional.

The Constitutional Challenge: Can Congress Require a Tax of Zero Dollars?

The ACA was intended to lower insurance premiums and overall health care costs by broadening the insurance pool with the individual mandate, which required individuals to maintain insurance coverage or pay the Internal Revenue Service a “shared responsibility payment.”

National Federation of Independent Business 

, the Supreme Court in 2012 upheld the ACA’s individual mandate under the taxing power of Congress. But in 2017, Congress amended the ACA to set the shared responsibility payment to $0. A number of states and private citizens sued. They argued that the now nonexistent shared responsibility payment cannot be a constitutional exercise of Congress’s power to tax. But that is not the end of the line for the BPCIA. If the individual mandate is unconstitutional, the Supreme Court will have to decide whether it can be “severed” from the rest of the ACA, allowing other provisions of the ACA, including the BPCIA, to remain in place.

Severability, a doctrine that goes back at least to Chief Justice John Marshal in the early 1800s, allows a court to save statutes with unconstitutional provisions by cutting out the invalid part of the law. The basic question is whether Congress would have intended the entire statute to remain without the unconstitutional provision. During Justice Amy Coney Barrett’s recent confirmation hearing, she explained that severability is like a game of judicial Jenga. Once a court identifies an unconstitutional provision, the court must pull out that unconstitutional block. But if the statutory “tower” cannot stand without that block, then the court cannot use severability to save the remainder of the statute.

Many conservative justices have questioned how the severability doctrine can be applied to the ACA. The late Justice Scalia is one example. In a dissent in the NFIB case, he stated that the ACA was not severable, comparing the ACA to a Christmas tree with each member of Congress adding ornaments, making it impossible to discern what should remain if the tree were taken away.

Oral Argument: Playing “Gotcha” With the BPCIA?

There was almost no mention of the BPCIA during the Supreme Court’s oral argument Tuesday in 

. Counsel for the state of California did raise, however, the biosimilar provision in passing as one provision in the statute on which the public relies. Although not the focus of the argument, that reference will not go unnoticed, especially in light of an amicus brief focused directly on the severability of the BPCIA filed by the Association for Accessible Medicines.

Justice Barrett did not show her cards during oral argument. She had, however, stated during her confirmation hearing that she held in a moot (simulated) court competition for law students that the individual mandate could be severed from the ACA. Although a moot court judge’s hypothetical ruling in an academic exercise is not a good basis to predict how she will rule in the actual case, 2 of the conservative-leaning justices made strong statements Tuesday about severability during oral argument.

Chief Justice John Roberts asked whether Congress would “want the rest of the law to survive if the unconstitutional provision were severed.” The chief justice said that there was “compelling evidence on the question,” namely that in 2017 when Congress set the shared responsibility payment to $0, “Congress left the rest of the law intact.”

Justice Brett Kavanaugh also seemed inclined to sever the individual mandate. In an earlier case, he, wrote “Constitutional litigation is not a game of gotcha against Congress, where litigants can ride a discrete constitutional flaw in a statute to take down the whole, otherwise constitutional statute.”

 During the argument by counsel for the House of Representatives, who echoed that thinking, Justice Kavanaugh stated that the severability question was “very straightforward under [Supreme Court] precedents, meaning that we would excise the mandate and leave the rest…in place.”

If Chief Justice Roberts and Justice Kavanaugh side with Justices Stephen Breyer, Sonia Sotomayor, and Elena Kagan, who are widely expected to vote for severability if the court says that the ACA is unconstitutional, then the BPCIA could survive this latest challenge to the ACA. After oral argument, the initial consensus has been that severability is likely if the court holds the individual mandate of the ACA unconstitutional. But as veteran court watchers know, it is not unheard of for the justices to make statements in favor of a position only to vote against it later. Biosimilar manufacturers should continue to advance contingency plans for a post-BPCIA world, just in case the Supreme Court yells “Jenga!”

1. Barr v Am. Ass’n of Political Consultants, Inc

Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).

Legal Opinion: BPCIA Is Likely to Survive Latest ACA Challenge

Drew Hillier JD

This was originally published in Pharmacy Times

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.

Common Patient Questions About Insulin Biosimilars Pertain to Classification

Chase Ibia is a PharmD candidates at the Daniel K. Inouye College of Pharmacy at the University of Hawai’i at Hilo.

Authors