Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, MSc, PhD; Hye-Young Kwon, PhD1,6
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Abstract: |
The recent GaBI Journal manuscript by Bertolani and Jommi comprehensively assessed the implications of a range of policies including education, benchmarking and financial incentives, implemented by the different healthcare organisations (HCOs) among the regions in Italy to increase the use of biosimilars as a way to conserve resources. This included both prospective and retrospective analyses of shifts in prescribing behaviour among the different regions and potential savings generated as well as how the savings generated were used [1].
We linked the findings of the Bertolani and Jommi paper [1] with other recent studies in an attempt to stimulate ongoing debate regarding potential ways to enhance the future use of biosimilars as well as how best to utilize the considerable resource savings produced [2, 3] without compromising care.
The Bertolani and Jommi study is seen as particularly important as a source of information that can be used to provide future guidance as there have only been a limited number of studies to date that assessed differences in regional policies to enhance the prescribing of biosimilars in the ambulatory care setting where biologicals are increasingly being used [4]. A response rate of 38% to the survey is seen as acceptable [5, 6], especially since the regions surveyed covered 93% of the Italian population [1].
The need to leverage competition from biosimilars will only increase since without a major increase in the use of biosimilars global expenditure on medicines is projected to reach US$1.5 trillion by 2023 [7–9]. This growth will be primarily driven by increased expenditures on specialty biological medicines, including new medicines for chronic, complex, or rare diseases, such as cancer and orphan diseases. Global expenditure for these medicines is likely to reach 50% of total medicine expenditures in the near future [7, 10]. Such expenditures are difficult to sustain, especially in countries with universal healthcare systems that need to fund a growth in the use of medicines driven by increasing rates of non-communicable diseases, changes in clinical practice, and the continual launch of new, high-priced medicines that address areas of unmet need [11–14]. There are additional concerns raised about some new, high-priced medicines for cancer and orphan diseases, for which funding appears driven more by the emotive nature of these diseases than by their proven clinical benefits [15–18]. Their value is being increasingly questioned as more medicines advocated in guidelines become available as low cost, multi-sourced medicines or biosimilars [19–21].
Biological medicines under increasing scrutiny include Humira® with global sales of US$19.9 billion in 2018. Although Humira® sales are now being decreased, especially in Europe, through increasing use of lower priced biosimilars as well as by the fact that AbbVie lowered the price of Humira® to compete [22–26]. For example, among Danish hospitals, expenditures for adalimumab decreased by 82.8% following the availability of biosimilars with almost total replacement by biosimilars (95.1% utilization). In the UK, expenditure on adalimumab is envisaged to fall by 75% following the availability of biosimilars [23, 25]. Such reductions are welcomed, especially among lower- and middle-income countries, including Central and Eastern European countries, where the use of biologicals has been limited by available governmental resources as well as by high patient co-payments [27–29]. Biosimilar switching programmes have been shown to conserve resources by a number of studies that also were unable to demonstrate meaningful differences in effectiveness or safety between biosimilars and originators. Such studies have included infliximab and other biologicals across a range of indications [30–38]. There have, however, been some concerns requiring patient monitoring [39, 40]. Such concerns could be exacerbated by multiple modifications in the manufacturing of originator biological drugs that can occur without companies being required to undertake clinical studies to assess the effect of such changes on clinical outcomes in actual practice, even with major manufacturing changes [41, 42].
Other biological medicines of special interest to health authorities across Europe and beyond include rituximab, infliximab and etanercept with current global sales of US$7.9 billion, US$5.9 billion and US$ 5.8 billion in 2017, respectively [43–45]. These concerns persist despite the fact that these sales are being reduced as the result of the increasing use of lower cost biosimilars [38, 39, 45-49]. Global sales of Herceptin® (trastuzumab) were stable in 2019 at US$7 billion due to increasing use of biosimilar trastuzumab. The use of biosimilar trastuzumab is expected to continue to increase globally. Trastuzumab biosimilars have already captured 45% of the European market [50–52]. However, these savings are being offset by growing expenditures on pertuzumab in combination with trastuzumab; with annual sales of US$2.8 billion in 2019 as well as by the use of Kadcyla® (trastuzumab emtansine), which is expected to reach annual sales of US$4.94 billion by 2023 [50, 53].
Another important biological is long acting insulin glargine used for patients with Type 1 diabetes. The insulin glargine market was valued at approximately US$3.88 billion in 2018; and is envisaged to reach US$9.26 billion by 2025 [54]. However, potential savings associated with the introduction of biosimilar insulin glargine have been hampered by the limited price reductions seen in practice in a number of countries. There are also concerns with switching because differences in devices between manufacturers could increase the rate of hypoglycaemia [55–58]. These concerns have resulted in some health authorities advising against switching, despite similar effectiveness and safety being demonstrated in studies comparing the originator and a biosimilar [55, 56, 59-62]. The situation is however changing, at least in the US where a biosimilar insulin glargine reached over 40% of market share in the US Medicaid programme in 2018. There are also a number of initiatives and publications pushing for increased use of biosimilars among European countries including those encouraging new patients to be started on a biosimilar [49, 63-66].
A number of published studies have shown the potential for considerable savings from biosimilars. These results are pushing health authorities to employ initiatives to enhance their use [3, 9, 38, 49, 51, 67-70]. Winegarden (2019) in the US estimated annual savings of up to US$7 billion from the use of a range of biosimilars, and that these savings are likely to grow as more biosimilars become available [3]. However, for maximum savings, both supply- and demand-side measures are needed [21, 69]. This has been shown in studies of oral generic medicines comparing potential policies and savings in Korea with those in the UK [71–74]. Multiple demand- and supply-side measures in Scotland resulted in a considerable reduction in expenditure on lipid lowering medicines and proton pump inhibitors despite appreciably increased volumes [73, 74]. Moorkens et al. (2017), Rémuzat et al. (2017) and Vogler et al. (2017) have all recently summarized ongoing demand-side measures in Europe to enhance the use of biosimilars. Simoens et al. (2018) also provided guidance on additional demand-side measures that could be introduced to further realize the benefits of biosimilars [75–78]. There are European countries where some lower-cost biosimilars now account for the total market, e.g. erythropoietin (EPO) and granulocyte colony-stimulating factor (G-CSF) [79], and countries such as France and the UK are actively working to increase biosimilar penetration rates [80, 81].
Brill in the US has recently discussed the benefits of shared savings to enhance biosimilar use among State Medicaid programmes [10]. Siu et al. (2019) documented ongoing activities to enhance the use of biosimilars in both the private and public sectors in Canada [70]. These activities include preferential coverage by private insurers for increasing use of biosimilars, the pan-Canadian Oncology Biosimilars Initiative to enhance adoption of biosimilars in oncology (an attempt to address concerns with funding in oncology), as well as the British Columbia Biosimilars Initiative in May 2019 that promotes switching, with the savings used to lower premiums and co-pays where pertinent [70]. In addition, Biosimilars Canada has recently developed a centralized patient support service platform to assist manufacturers and patients with increasing the use of biosimilars [70]. Such activities are needed to promote the use of biosimilars because originator manufacturers have been appreciably lowering prices of their originators just before patent expiry to dissuade biosimilar companies from entering the market [22, 44, 79]. Suggestions have been made that originator companies should automatically lower their prices following patent expiry, thereby negating the need for biosimilars to interfere with the market in the first place [82]. Methods are needed to counter other behaviours of originator companies such as developing new formulations just before patent expiry to create a barrier to biosimilars mirroring other evergreening tactics [79, 83].
It was impressive to see that 89% of HCO surveyed by Bertolani and Jommi had implemented policies to enhance the use of biosimilars [1]. Educational activities were particularly prominent, increasing in recent years, including information on market access pathways for biosimilars as well as the results of tenders. Educational activities are crucial to allay fears regarding the effectiveness and safety of biosimilars. These fears are illustrated in Italy by the seven scientific Italian societies that recently expressed concerns about the Regional Administrative Court of Piemonte promoting the automatic substitution of biologicals in terms of therapeutic continuity for patients and concerns with the freedom of prescribing clinicians [84]. Despite this, benchmarking of biosimilar prescribing among physicians was already taking place among 75% of HCOs surveyed and this is likely to grow since such benchmarking of physician prescribing is working well in other countries [1, 85]. The 62% of HCOs that also provided physicians with prescribing targets for biosimilars is similar to what has been seen in other countries and regions [86–88], with 68% and 24% respectively, introducing incentives and sanctions to improve prescribing rates. Sanctions include monetary sanctions and potentially removal of the right to prescribe [1].
A concern though is that patients were involved in educational/information programmes among only 22% of the HCOs surveyed [1]. This is a potentially important weakness since all key stakeholders need to be convinced about the value of biosimilars in order to reduce any potential nocebo effects [89, 90].
The study of Bertolani and Jommi adds to a number of examples of successful multiple demand-side measures including preferentially encouraging the prescribing of multi-sourced medicines versus originators and patented medicines in a class without compromising care [91–93]. Monies saved can subsequently be used to fund new more expensive medicines as well as other healthcare services such as diagnostics. Ninety-three per cent of HCOs also provided physicians with information retrospectively or prospectively on potential savings from increased use of biosimilars, with 25% of HCOs also participating in post-marketing studies to help further fears with biosimilars [1]. However, only 21% of HCOs systematically estimated the proportion of potential patients not receiving biosimilars, with only rare perceptual surveys among patients and other healthcare professionals. This situation may need to change given the stated concerns of the seven scientific Italian societies [84].
In conclusion, Bertolani and Jommi, have provided a comprehensive review of ongoing policies among HCOs in the different regions of Italy and their potential to influence on future directions. This information is useful for other countries where demand-side measures can be localised to meet future goals, with the potential for localities to learn from each other. This is important to stimulate increasing use of biosimilars in a way that addresses the accelerating resource challenges brought about by the expanding use of medicines in ageing populations as well as the need to pay for new, high-priced medicines that address areas of previously poorly or untreatable diseases.
There was no funding for this paper.
Competing interests: The authors have no conflicts of interest to declare.
Provenance and peer review: Commissioned; internally peer reviewed.
Brian Godman1,2,3, BSc, PhD
Eleonora Allocati4, BSc, MSc
Evelien Moorkens5, MSc, PhD
Hye-Young Kwon, PhD1,6
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK
2Division of Public Health Pharmacy and Management, School of Pharmacy, Faculty of Health Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa
3Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden
4Istituto di Ricerche Farmacologiche ‘Mario Negri’ IRCCS, Milan, Italy
5KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium
6College of Pharmacy, Seoul National University, Seoul, Korea
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Author for correspondence: Brian Godman, BSc, PhD; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK; Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden |
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Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective
Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc
Abstract:
Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to enhance savings from biosimilars to improve the affordability of biologicals.
Submitted: 9 September 2019; Revised: 12 September 2019; Accepted: 12 September 2019; Published online first: 25 September 2019
Brian Godman, Eleonora Allocati and Evelien Moorkens review the paper by Siu et al. regarding the evolving regulatory and reimbursement landscape in Canada [1], and subsequently link these within the broader global context of biosimilar market access to stimulate future activities and debates in this important area. This includes the current and potential market value of biosimilars, their regulatory and reimbursement environments as well as ongoing initiatives across countries to enhance their utilization to maximize potential savings. In addition, the potential sustainability of appreciable discounts among both originator and biosimilar manufacturers is discussed.
Siu et al. point out that biologicals are now commonly prescribed medicines for a wide variety of disease areas including diabetes, immunological diseases such as arthritis, inflammatory bowel disease and psoriasis, as well as for a number of cancers [1–4]. The high prices for new cancer medicines coupled with the growing prevalence of patients with cancer have resulted in growing (and now considerable) sales for oncology medicines across Europe and globally. Worldwide sales of cancer medicines, many of which are biologicals, was US$107 billion in 2015 and rising [5, 6]. The global anti-tumour necrosis factor (ant-TNF) market was valued at US$40.4 billion in 2017, and expected to expand at 2.54% per year with Europe and the US currently accounting for 87.70% of sales [7]. Within this, worldwide sales of adalimumab were US$17.6 billion in 2017, rising to nearly US$20 million in 2018 thereby making it the world’s best-selling medicine, with infliximab sales at US$5.9 billion in 2017 and etanercept at US$5.8 billion in 2017 [8, 9]. In Canada in 2017, biologicals accounted for 21.60% of overall public healthcare expenditure with the anti-TNF medicines accounting for 8.20% of total expenditure [1]. This compares with the US where biologicals currently account for 37% of net drug spending [10]. In the UK, anti-TNF medicines are also one of the highest spend areas within high-cost medicines, with GBP 780 million spent in England in 2018 [11], and in Germany, adalimumab was the top-selling medicine in 2017 with net costs to the statutory health insurance system of Euros 975 million [12]. Consequently, the introduction of biosimilars, especially in oncology and immunological diseases, should be of considerable interest to payers of health care and patients worldwide. We have seen limited use to date of biological medicines in many Central and Eastern European countries versus Western European countries due to their high costs and co-payments [13–15]. Consequently, biosimilars should help address this as prices fall. A competitive market should also bring down the cost of biosimilar insulins, helping many patients in low- and middle-income countries currently denied such treatments [16].
As a result of the current and envisaged sales of biological medicines coupled with ongoing initiatives, we are seeing considerable growth in the availability and use of biosimilars especially in China and Europe [17–20]. This will help increase their worldwide sales from approximately US$4 billion in 2018 [21]. Competition, with the resultant impact on overall expenditures, should intensify as many biological medicines that are currently used first- or second-line in treatment regimens lose their patent benefitting patients and payers [22].
Siu et al. point out appreciable changes in the regulatory and Health Technology Assessment (HTA) domains in the biosimilar environment in Canada in recent years to enhance their availability and promote their uptake [1]. This includes Health Canada in 2015 launching a pilot programme to provide manufacturers with the ability to discuss their biosimilar with Health Canada. In 2017, Health Canada laid out a Regulatory Review of Drugs and Devices which included a project to improve access to biologicals (biosimilars and non-biosimilars) by increasing their regulatory review capacity [1]. This should result in a more secure supply of biological drugs and more affordable biologicals. In addition, Health Canada and HTA organizations in Canada as well as the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec began collaborating in 2018 to better align review processes including biosimilars to reduce duplication and time lags between regulatory approval and reimbursement [1]. Heath Canada also intends to implement an updated naming convention for biologicals including the product’s brand name, International Nonproprietary Name (INN), and the Drug Identification Number (DIN), to support a clear distinction between biologicals including biosimilars to enhance adverse event tracking [1]. There have also been initiatives in other countries to enhance earlier access to biosimilars [20, 21, 23–26] although further developments are being proposed [27]. Interestingly, whilst modifications to the manufacturing process of originator biological drugs are common, regulators have very rarely required clinical studies to assess similarities even in the case of major manufacturing changes [28, 29].
With respect to reimbursing biosimilars, a number of significant changes have taken place recently in Canada to ease the situation. In Canada, the CADTH (Canadian Agency for Drugs and Technologies in Health) Common Drug Review (CDR) plays an important role in deciding whether medicines will be eligible for public reimbursement, with the provinces subsequently typically making the final decision based on CDR recommendations [30]. In May 2019, CADTH announced that as of 1 June 2019, it would no longer routinely review biosimilars via its CDR and pCODR (pan-Canadian Oncology Drug Review) programmes to streamline access [1]. A similar situation is seen in Quebec with INESSS. The pan-Canadian Pharmaceutical Alliance (pCPA) subsequently uses its combined purchasing power to improve access and increase the cost-effectiveness of medicines, similar to cross country collaborations in Europe [31–34]. In 2016, pCPA launched a more comprehensive biosimilar policy and in 2018 released a Biologics Policy Directive in which biological drugs for which biosimilars are already reimbursed as well as any new biosimilar will not be considered for reimbursement unless there are transparent price reductions to the lowest list price, providing an exemplar to others [1]. In addition, the potential for tiered pricing in certain therapeutic areas, which is likely to lead to increasing discounts as more biosimilars are launched. Manitoba was the first Canadian Province to instigate tiered arrangements in which biological-naïve patients must first be prescribed a biosimilar or an approved biological where no biosimilar exists [1]. Private insurers in Canada are also now offering preferential coverage for biosimilars leading to average savings of CA$8,500 per participating member per year [1]. Such initiatives should help boost the use of biosimilars in Canada along with educational, awareness and other initiatives, with biosimilar use currently lagging behind Europe [1, 19].
Biosimilars Canada has also recently developed a centralized patient support service platform to assist manufacturers and patients [1]. Policies regarding switching should also help enhance the use of biosimilars in Canada along with collecting real-world evidence to help ally current fears [1]. There have been considerable concerns with patients being switched between an originator biological medicine and a biosimilar across countries as well as indication extrapolation especially with respect to the risk of immunogenicity-related safety issues and diminished efficacy [17, 35]. However, an appreciable number of studies have now shown that such risks are unchanged when switching between an originator and a biosimilar [11, 21, 36–44]. As a result, patient and physician organizations in Canada are now supporting non-medical switching [1], similar to initiatives among European countries such as France [45]. The growing body of evidence for biosimilars is also leading to suggestions to modify the current lengthy approval process and costs to enhance earlier access and strengthen competition [46]. There are though still concerns with switching among physicians that need to be addressed with education as these can negatively impact on their future utilization [47–49]. Additional monitoring of patient outcomes in routine clinical practice should help further reduce possible concerns as well as potentially reduce the need for comparative clinical efficacy evidence as more originators lose their patents. This should reduce the investment needed for developing new biosimilars, and combined with developments in manufacturing [50], should help reduce future prices.
A number of other initiatives have also recently been undertaken in Canada to enhance the utilization of biosimilars. This includes the pan-Canadian Oncology Biosimilars Initiative to enhance successful adoption of biosimilars in oncology. British Columbia launched its Biosimilars Initiative in May 2019 promoting switching, with the savings used to lower premiums and co-pays where pertinent [1]. Other provinces are likely to follow.
We have also seen initiatives among other countries to enhance the use of biosimilars. Moorkens et al. and Vogler et al. have summarized these for Europe as well as provided future guidance to further enhance their uptake [51, 52]. More recently, Simoens et al. gave guidance on additional measures that could be introduced in Europe to fully realize the potential of biosimilars [53]. We are also seeing prescribing targets for biosimilars among European countries including national frameworks [54–57]. However, there are still limited initiatives in some countries including Japan where currently no position statement regarding biosimilars has been included in treatment guidelines for any of the cancer societies [58]. This may change though with increasing pressure on resources and with the Japanese government now reviewing supportive measures for biosimilars [58]. Smeeding et al. recently highlighted a number of issues that payers in the US should consider as part of any strategy to increase the use of biosimilars [59].
Ongoing initiatives across countries, including both supply- and demand-side measures, have increased potential savings from biosimilars. Siu et al. suggest that by the third year of entry, potential savings from biosimilars in Canada could range from 13%–43% for acute use products such as granulocyte colony-stimulating factors (G-CSF) and erythropoietin (EPO) and 8%–43% for chronic-use products, e.g. anti-TNFs [1]. This is helped by price reductions for biosimilars in Canada ranging between 17% and 50% from the originator.
A number of European countries have introduced price-link policies for biosimilars to lower their prices and enhance savings, with other countries instigating measures, such as tendering to lower prices [52, 60, 61]. For instance, tendering among hospitals in Norway resulted in a 72% discount compared to its list price [60], and tendering in the UK will result in GBP 300 million (approximately US$386 million) savings from currently GBP 400 million-per-year (approximately US$514 million) spent on adalimumab [62]. In Germany, the current high use of adalimumab and anticipated savings resulted in biosimilars accounting for 28% of total prescriptions of adalimumab within eight weeks of launch [12]. In the US, it is estimated that biosimilars will reduce direct spending on biological drugs by US$54 billion from 2017 to 2026 [10, 63]; with savings likely to be higher with greater discounts than 20% to 30% currently seen [10]. Substantial discounts for biosimilars across Europe, greater than initial considerations [61], coupled with demand-side measures, have already resulted in their appreciably increased use in recent years. In some cases and countries in Europe, in view of their lower prices, biosimilars now account for the total market for EPO and G-CSF. This is especially the case among a number of Central and Eastern European countries [19].
However, there are concerns that originators are starting to substantially lower their prices potentially affecting future biosimilar availability and the sustainability of the marketplace as seen recently with adalimumab [9, 19, 64]. In addition, we are seeing originator companies defending manufacturing and other patents, as well as seeking to instigate hurdles in the US making it more difficult for insurers to place biosimilars on formularies in order to disrupt the biosimilar market [10, 65, 66]. Originator companies are also developing new formulations of their biologicals to try and further disrupt the biosimilar market building on previous evergreening tactics [19, 67]. There are also suggestions to lower the prices of originators in countries such as Belgium and the US over time, negating the need for biosimilars to further interfere with this market [68]. We will continue to monitor these developments and their implications.
In conclusion, Siu et al. have provided a comprehensive review of current and planned policies in Canada to enhance the use of biosimilars at competitive prices to benefit payers and patients. This is important for disease areas such as cancer with ever increasing prices for new medicines, which potentially threaten the sustainability of healthcare systems [69, 70]. It is also increasingly likely that health authorities will start reassessing prices and potential discounts for on-patent medicines for oncology and immunological diseases as more standard medicines used for pricing negotiations lose their patents [6, 71]. Siu et al. also remind key stakeholders to continually monitor developments with biosimilars including both supply- and demand-side initiatives as well as encourage countries to learn from each other to enhance their uptake. This is critical for health authorities with the instigation of disruptive tactics such as in The Netherlands with AbbVie and in the US with hurdles such as rebates and other strategies with insurers to limit biosimilar use. In addition, payers need to monitor the development of new formulations by originator manufacturers and plan for the implications.
Funding
There was no funding for this Commentary.
Competing interests: The authors have no conflicts of interest to declare.
Provenance and peer review: Commissioned; internally peer reviewed.
Authors
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK
2Division of Public Health Pharmacy and Management, School of Pharmacy, Faculty of Health Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa
3Department of Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden
4Istituto di Ricerche Farmacologiche ‘Mario Negri’ IRCCS, Milan, Italy
5KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium
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Author for correspondence: Brian Godman, BSc, PhD, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, UK
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