Cost and Clinical Analysis of Autologous Hematopoietic Stem Cell Mobilization with G-CSF and Plerixafor Compared to G-CSF and Cyclophosphamide

Article Outline

• Abstract
• Introduction
• Patients and Methods
  • Patients
  • Mobilization Regimens
  • Cost Determination
  • Statistical Analysis
• Results
  • Patient and Control Characteristics
  • Mobilization Outcomes
  • Mobilization Costs
  • Transplantation Outcomes
• Discussion
• Acknowledgments
• References
• Copyright

Plerixafor plus granulocyte-colony stimulating factor (G-CSF) has been shown to mobilize more CD34⁺ cells than G-CSF alone for autologous hematopoietic stem cell transplantation (HSCT). However, many centers use chemotherapy followed by G-CSF to mobilize CD34⁺ cells prior to HSCT. We performed a retrospective study of patients who participated in the expanded access program (EAP) of plerixafor and G-CSF for initial mobilization of CD34⁺ cells, and compared outcomes to matched historic controls mobilized with cyclophosphamide 3-5 g/m² and G-CSF at 2 centers that participated in the EAP Control patients were matched for age, sex, disease, disease stage, and number of prior therapies. Mobilization costs were defined to be the costs of medical procedures, resource utilization, and medications. Median national CMS reimbursement rates were used to establish the costs of procedures, hospitalization, provider visits, apheresis, CD34⁺ cell processing and cryopreservation. Average sale price was used for G-CSF, plerixafor, cyclophosphamide, MESNA, antiemetics, and antimicrobials. A total of 33 patients from the EAP and 33 matched controls were studied. Two patients in the control group were hospitalized for neutropenic fever during the mobilization period. Apheresis started on the scheduled day in 33 (100%) study patients and in 29 (88%) control patients (P = 0.04). Sixteen (48%) control patients required weekend apheresis. There was no difference in number of CD34⁺ cells collected between the groups, and all patients proceeded to HSCT with no difference in engraftment outcomes. Median total cost of mobilization was not different between the plerixafor/G-CSF and control groups ($14,224 versus $18,824; P = .45). In conclusion, plerixafor/G-CSF and cyclophosphamide/G-CSF for upfront mobilization of CD34⁻ cells resulted in similar numbers of cells collected, costs of mobilization, and clinical outcomes. Additionally, plerixafor/G-CSF mobilization resulted in more predictable days of collection, no weekend apheresis procedures, and no unscheduled hospital admissions.

Key Words: Plerixafor, Mobilization, Cost analysis, Autologous transplant

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Introduction 

High-dose chemotherapy and autologous hematopoietic stem cell transplantation (HSCT) is an integral part of treatment for patients with multiple myeloma (MM), relapsed Hodgkin’s disease (HD), and non-Hodgkin lymphoma (NHL) 1, 2, 3. Mobilization of hematopoietic stem cells (HSC) into the peripheral blood using chemotherapy and/or cytokines followed by apheresis is the most common method used by many centers for autologous HSC collection 4, 5, 6. Prior studies have shown that more HSC are mobilized following chemotherapy and cytokine administration compared to cytokine administration alone 7, 8, 9, 10. Some patients who receive chemotherapy as part of standard therapy can also have HSC collected as they recover from their standard therapy. However, there may be greater toxicity or risk of infection following chemotherapy mobilization [8]. The method used for HSC mobilization has not been shown to affect overall transplantation outcomes, and choice of method may be more dependent on institutional practice 4, 7, 8, 9, 10, 11.

Plerixafor is a small molecule that reversibly inhibits chemokine stromal cell derived factor 1 alpha (SDF-1alpha) binding to CXC chemokine receptor 4 (CXCR4), resulting in increased HSC migration into peripheral blood circulation [12]. Randomized studies have shown that the combination of granulocyte colony stimulating factor (G-CSF) and plerixafor mobilizes more HSC in fewer apheresis sessions compared to G-CSF alone in MM and NHL patients 13, 14. However, many centers continue to use chemotherapy followed by G-CSF for HSC mobilization, and no prospective randomized studies comparing the mobilization efficacy of G-CSF + chemotherapy and G-CSF + plerixafor have been published.

The expanded access program (EAP) was a study using G-CSF + plerixafor for the front-line mobilization and collection of peripheral blood stem cells for autologous HSCT in patients with NHL, HD, and MM. The EAP created a database of clinical outcomes using plerixafor-based mobilization at multiple transplant centers. Two centers that participated in the EAP also had similar chemotherapy mobilization processes that allowed for this retrospective review of patients mobilized with G-CSF + plerixafor compared to matched controls mobilized with G-CSF + chemotherapy. Because the efficacy of G-CSF and plerixafor for mobilization has been previously established, the primary objective of this study was to compare the costs and logistical issues of autologous HSC mobilization between the 2 methods.

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Patients and Methods 

Patients 

The EAP was approved by the institutional review boards (IRBs) at the Texas Transplant Institute and the Rocky Mountain Blood and Marrow Transplant Program, and all patients were provided written informed consent. Retrospective analysis for all patients and controls was separately approved by the IRBs at both institutions.

The EAP patients were accrued to the study from July 2008 through January of 2009 and were consecutively treated during this time frame. Eligibility criteria for the EAP included patients with NHL, MM, or HD, who were otherwise eligible for autologous HSC transplantation and had not undergone prior stem cell mobilization or autologous or allogeneic HSC transplantation. Study patients also had to be at least 4 weeks from prior chemotherapy and 2 weeks from prior cytokine therapy, and have <20% bone marrow involvement with disease. Controls for the EAP patients treated at each institution were matched from the same institution for age, sex, diagnosis, prior therapy, and stage of disease at time of transplantation. Control patients also could not have undergone prior stem cell mobilization or autologous or allogeneic HSC transplantation. The controls were chosen without knowledge of mobilization outcomes, other than they subsequently proceeded to autologous transplantation. This was to avoid selecting any controls who failed mobilization and thus would not have allowed for valid cost comparisons because of their lack of apheresis procedures.

Mobilization Regimens 

Control patients received cyclophosphamide (CTX) 3-5 g/m² with equal doses of MESNA, and G-CSF (10 μg/kg subcutaneously [s.c.]) daily was initiated the following day. Apheresis was scheduled for 10 days after starting G-CSF in the control patients, but the actual start of apheresis was based on the peripheral blood CD34⁺ cell count reaching ≥10 cells/μL (Figure 1). Patients in the EAP received G-CSF (10 μg/kg s.c.) daily for 5 days and plerixafor (0.24 mg/kg s.c.) on the evening of day 4, 11 hours prior to the initiation of apheresis the next day. Plerixafor, G-CSF, and apheresis were repeated daily, for up to 4 additional apheresis, or until a minimum of 5 × 10⁶ CD34⁺ cells/kg were collected for NHL or HD patients and 6 × 10⁶ CD34⁺ cells/kg were collected for MM patients (Figure 2).

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• Figure 1 

  Chemotherapy mobilization dosing regimen (control patients).

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• Figure 2 

  Perixafor mobilization dosing regimen (EAP study patients).

Cost Determination 

Data on costs incurred from mobilization and apheresis were analyzed for all patients in the study and control groups. Individualized costs were identified per patient in both groups including all reimbursable procedures and charges along with complete costs of all medications during mobilization. A subanalysis was performed to evaluate the cost of mobilization in the study and control groups by capping all costs once a threshold of 3 × 10⁶ CD34⁺ cells/kg was reached for NHL patients, and 6 × 10⁶ CD34⁺ cells/kg was reached for MM patients. Another subanalysis evaluated the cost of mobilization for each apheresis day. Mobilization costs were divided per treatment phases into preapheresis and periapheresis costs. The procedures and costs related to these 2 phases are outlined in Table 1 and are adjusted to reflect 2009 dollars. Costs bundled with chemotherapy included drug acquisition costs, administration, and catheter placement and removal. Mobilization costs included acquisition cost of mobilizing agents, administration, routine lab monitoring, and apheresis-related costs. Apheresis-related costs included the apheresis procedure, flow cytometry, and immunohistochemistry and related materials. Mobilization-related hospitalization costs were based on a flat cost per day of hospitalization. This analysis was designed to estimate the potential costs of mobilization procedures from the perspective of the facility or institution. Procedure charges are variable and reflect institutional overhead and profit margin, making charges less useful when trying to define the costs or value associated with offering a service. Alternatively, institution-specific overhead and direct costs associated with procedures and services are proprietary, not released to the public domain, and cannot be generalized. We chose to avoid the problems associated with charges and institution-specific costs by estimating the institutional cost and value of mobilization using a standard set of reimbursements for specific procedures set by the United States (US) Department of Health and Human Services Centers for Medicaid Services (HHS/CMS). The US HHS/CMS database was used to estimate the average reimbursement for procedures based on national carrier data and was applied to reimbursable procedures associated with mobilization (http://www.cms.gov/PhysicianFeeSched/) [15]. Median national CMS reimbursement rates were used to value mobilization and hospitalization-related procedures, provider visits, apheresis procedures, CD34⁺ cell processing, and cryopreservation costs. Procedures or outcomes that were not reimbursable by CMS were derived from other cost-methodology studies [16] and adjusted by 3.5% yearly for inflation from the year noted in the publication.

Table 1. Procedure Costs

Preapheresis
Chemotherapy associated costs	Chemotherapy i.v. infusion 1 h $143.44 Additional hour of chemotherapy $32.74 Catheter insertion $875.53 Place needle in vein $23.65 Catheter removal $352.02
G-CSF–associated costs	Immunotherapy injections $12.29 Observation hospital same date $165.70 per day
Plerixafor-associated costs	Immunotherapy injections $12.29
CD34+ (flowcytometry + immunohistochemistry)	$76.49 + $55.71
Resource utilization (provider visits)	$165.70 per visit
Room costs	$943.02 per day
Transfusion costs (platelet and PRBC), includes administration	$538.46 each (platelet and PRBC)
Complete blood count (CBC), Chem-7, microbiology lab costs	$101.67 each (CBC, Chem-7, microbiology)
Periapheresis
Apheresis	$2,048.32
CD34+ (flowcytometry + immunohistochemistry)	$76.49 + $55.71
Cryopreservation bag storage, supplies, preparation	$1361.54 for initial bag and $28.00 per each subsequent bag

PRBC indicates packed red blood cells; G-CSF, graulocyte-colony stimulating factor.

Chemotherapeutic agents (cyclophosphamide), mobilizing agents (G-CSF and plerixafor), and supportive medications (antimicrobials, antiemetics, and MESNA) were included in the cost analysis. Average wholesale price (AWP) was used to establish medication acquisition costs and AWP figures were derived from the Redbook 2009 edition, using July pricing updates; AWP was then adjusted to estimate the average sale price (ASP) that was applied to all medications. ASP was used for medication pricing to account for lower than AWP prices observed in larger institution purchasing groups after applying incentives, rebates, and volume discounts [17]. There is no centralized source for ASP, so conversion of AWP to ASP was required for this analysis using a simple calculation: ASP = AWP – (AWP × 0.2); reflecting an estimated 20% margin of difference between the 2 price indicators. The ASP used in this study for medications related to mobilization is listed in Table 2 and adjusted to reflect 2009 dollars.

Table 2. Average Sale Price (ASP) Medication Costs

p.o. indicates orally; i.v., intravenously, s.q., subcutaneously; G-CSF, graulocyte-colony stimulating factor.

Statistical Analysis 

Patient data was electronically recorded in a relational database and aggregated for clinical and cost comparisons. All statistical calculations were performed with JMP version 8.0.2 by SAS Institute (Cary, NC). Patient baseline demographic characteristics were defined with descriptive statistics. Tests for central tendency were selected after reviewing distributions. Means and standard deviations were applied to normally distributed variables, and medians were used for nonnormally distributed variables. Analysis of variance (ANOVA) and the t test was applied to linear variables that were normally distributed. Wilcoxon/Kruskal-Wallis rank-sum was used to compare medians. Prespecified statistical analysis with Pearson’s chi-squared or Fisher’s exact test was used for proportional comparisons as appropriate. All P values were 2 sided, and alpha values ≤0.05 were considered significant.

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Results 

Patient and Control Characteristics 

The characteristics of the study and control patients are listed in Table 3. Nine study patients were matched with 9 controls at the Texas Transplant Institute, and 24 study patients were matched with 24 controls at the Rocky Mountain Blood and Marrow Transplant Program. The majority of patients and controls treated at both centers had MM (61%) and the remainder had NHL (39%). The study and control patients were well matched for age, sex, disease, disease stage, and lines of prior therapy, with no significant differences between the groups. Prior therapy in MM patients included lenalidomide in 11 (33%) EAP patients and 5 (15%) control patients (P = .15). Prior radiation therapy was delivered to 4 (12%) EAP patients and 2 (6%) control patients (P = .67).

Table 3. Patient Characteristics

	Plerixafor/G-CSF n = 33	Chemo/G-CSF n = 33	P Value
Age median N (range)	58 (41-66)	59 (41-69)	.22
Gender N (%)
Male	17 (51.5)	17 (51.5)	1.00
Female	16 (48.5)	16 (48.5)	1.00
Diagnosis N (%)
MM	20 (60.6)	20 (60.6)	1.00
NHL	13 (39.4)	13 (39.4)	1.00
Lines of prior therapy N (%)
1	20 (60.6)	21 (63.6)	.80
2	10 (30.3)	10 (30.3)	1.00
3	3 (9.1)	1 (3.0)	.30
4	0 (0)	1 (3.0)	1.00

Chemo indicates chemotherapy (cyclophosphamide 3-5 g/m²); MM, multiple myeloma; NHL, non-Hodgkins lymphoma; G-CSF, graulocyte colony stimulating factor.

Mobilization Outcomes 

All patients collected sufficient CD34⁺ cells to proceed to transplantation (minimum of 2 × 10⁶ CD34⁺ cells/kg) with no significant difference in median total CD34⁺ cells/kg collected between the groups (Table 4). Significantly more patients in the study group collected ≥5 × 10⁶ CD34⁺ cells/kg than in the control group (n = 31, 94% and n = 25, 76%, [P = 0.04], respectively) (Table 4).

Table 4. Mobilization and Apheresis Results

Chemo indicates chemotherapy (cyclophosphamide 3-5 g/m²); MM, multiple myeloma; NHL, non-Hodgkin lymphoma; G-CSF, graulocyte-colony stimulating factor.

The median total number of days of apheresis was similar between the groups; however, significantly more patients in the study group collected on their targeted day of apheresis (33/33, 100%) compared to the controls (29/33, 88%) (P = .04) (Table 4). Also, in the control group, 16 patients required weekend apheresis based on when they reached the target peripheral CD34⁺ cell count, whereas no patients in the study group underwent weekend apheresis (Table 4).

Nineteen patients were hospitalized during mobilization in the control group for a median of 1 hospital day (range: 0-2 days), while no patients were hospitalized during mobilization in the study group (Table 5). Seventeen of the 19 control patients were hospitalized for administration of the chemotherapy itself, and 2 patients were hospitalized for neutropenic fever during the nadir from the mobilization chemotherapy. Four control patients required packed red blood cell (PRBC) or platelet transfusions after the chemotherapy mobilization, whereas no patients required transfusions in the study group (Table 5). Significantly more G-CSF was used in the chemotherapy mobilized patients because of the increased number of doses of G-CSF used following chemotherapy (Table 5).

Table 5. Mobilization Outcomes

Chemo indicates chemotherapy (cyclophosphamide 3-5 g/m²); MM, multiple myeloma; NHL, non-Hodgkin lymphoma; G-CSF, granulocyte-colony stimulating factor.

Mobilization Costs 

There was no significant difference in mean or median total cost of mobilization between the G-CSF + plerixafor and G-CSF + chemotherapy mobilized patients. The median periapheresis cost was significantly less in the study group ($3,626) compared to the controls ($6,029) (P = 0.02), but the total median cost in the study group was not significantly less than the controls (Table 6). An additional subanalysis was performed that excluded all costs after arbitrary targets of 3 × 10⁶ CD34⁺ cells/kg were collected in NHL patients and 6 × 10⁶ CD34⁺ cells/kg were collected in MM patients, which also resulted in similar mean and median total costs between the groups (data not shown).

Table 6. Mobilization Costs

	Plerixafor/G-CSF n = 33	Chemo/G-CSF n = 33	P Value
Cost of Pre-Apheresis
Mean	$14,676	$12,316	.07
Median (range)	$10,627 (9,294-31,445)	$11,939 (7,872-20,810)	.50
Cost of Peri-Apheresis
Mean	$5,622	$6,857	.14
Median (range)	$3,626 (3,514-14,334)	$6,029 (2,181-15,137)	.02
Total Cost of Mobilization (Pre + Peri-Apheresis)
Mean	$20, 298	$19,173	.57
Median (range)	$14,224 (12,835-45,779)	$18,824 (10,324-32,195)	.45

Chemo indicates chemotherapy (cyclophosphamide 3 to 5 g/m²).

The median total mobilization costs for patients separated by their successive days of apheresis are described in Figure 3. The median mobilization costs through a single day of apheresis were less for the G-CSF + plerixafor group ($13,692.00) compared to the G-CSF + chemotherapy group ($15,460.00) (P = 0.05). However, the median total cost of mobilization with G-CSF + plerixafor was greater for patients requiring 2 ($24,267 versus $20,601, P = 0.001), 3 ($35,121 versus $30,869, P = 0.037), or 4 ($45,286 versus $27,144, P = 0.245) apheresis days, respectively. Twenty-one of 33 (64%) study patients completed their apheresis in 1 day compared to 13 of 33 (39%) control patients (P = 0.049).

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• Figure 3 

  Total median costs associated with successive days to mobilization. The total cost of mobilization for each patient was determined through the indicated day of apheresis and medians were calcultaed for each group in each day of apheresis. The upper boundary of the box represents the 75th percentile and the lower boundary the 25th percentile; the line represents the median for each group.

Transplantation Outcomes 

All patients in both groups proceeded to transplantation and there was no significant difference in the time to both neutrophil and platelet engraftment. The median time to platelet engraftment was 17 (range: 10-61) days in the study group and 14 (range: 10-67) days in the control group. The median time to neutrophil engraftment was 12 (range: 9-23) days and 11 (range: 10-13) days in the study and control groups, respectively.

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Discussion 

Mobilization of autologous hematopoietic progenitors may be accomplished by cytokines alone, G-CSF + plerixafor, and chemotherapy-based approaches that combine chemotherapy with G-CSF or granulocyte macrophage colony stimulating factor (GM-CSF). Chemotherapy may be preferred when immediate control of the underlying disease is required during the mobilization process. However, studies have also described the toxicities associated with chemotherapy used to mobilize autologous HSC, including neutropenic fever and sepsis, blood product transfusions, and bleeding risks [8]. Hospitalization for febrile neutropenia in cancer patients has been associated with increased risk of morbidity and mortality, as well as increased cost [18]. However, situations also exist that do not require cytotoxic therapy during mobilization immediately prior to high-dose chemotherapy and autologous HSC transplantation. An international consensus conference has agreed that cytokine-only mobilization of autologous HSC is adequate for most patients with well-controlled MM [11]. Also, prior studies have shown no difference in malignant cell contamination in apheresis products after chemotherapy or cytokine only mobilization [19].

This retrospective study of patients mobilized with G-CSF + plerixafor compared to matched historical controls that underwent G-CSF + chemotherapy mobilization showed similar clinical outcomes in the number of total CD34⁺ cells collected and transplant engraftment outcomes. However, G-CSF + plerixafor mobilization resulted in more predictable days of collection, no weekend apheresis procedures, and no unscheduled hospital admissions. The primary objective of the EAP was to provide plerixafor to transplant centers to build experience and safety data of plerixafor in patients who were otherwise candidates for autologous HSCT and undergoing first mobilization attempt. Study and control patients were not necessarily at high risk for stem cell mobilization failure and had not failed prior stem cell mobilization, which may explain the large median dose of stem cells collected. The prior use of lenalidomide in multiple myeloma patients was similar in both groups and did not seem to impair stem cell mobilization with either technique.

The total median and mean costs of mobilization were similar in the G-CSF + plerixafor and G-CSF + chemotherapy group in this study. The acquisition cost of plerixafor was offset primarily by the increased G-CSF use in the G-CSF + chemotherapy group. Investigators at both centers agreed that they would most commonly stop mobilization if ≥3 × 10⁶ CD34⁺ cells/kg were collected in NHL patients, or ≥6 × 10⁶ cells/kg were collected in MM patients. Restricting the analysis to these thresholds found more patients in the study group reached these minimum CD34⁺ cell/kg levels; however, the difference was not significant, and the reevaluation of the cost analysis with these limits again found no significant difference in total cost between the groups. Differences may exist at other institutions that could positively or negatively affect the cost of mobilization after chemotherapy and G-CSF. For example, waiting to start G-CSF until several days after the cyclophosphamide is delivered or using a lower dose of G-CSF may decrease the cost of G-CSF use. Also, using a different threshold of peripheral CD34⁺ cell count to trigger starting apheresis may alter the number of doses of G-CSF delivered and days of apheresis.

The cost determination in this study attached CMS reimbursement rates to each procedure for each patient, and valued each medication associated with mobilization using ASP. This created a uniform system for determining the costs of mobilization with G-CSF + plerixafor and G-CSF + chemotherapy. The cost analysis was applied to each individual patient in both the study and control groups, and then the mean and median cost for the groups was calculated. The advantage of this methodology allowed the cost analysis to be done for each day of apheresis as the number of patients finishing apheresis changed from day to day. The majority of study patients (64%) finished apheresis in 1 day compared to only 39% of the control patients, and the total median cost of mobilization through 1 day of apheresis was less in the study group. However, the median total cost of mobilization becomes greater for the G-CSF + plerixafor group on the second and subsequent days of apheresis (Figure 3) because of the added costs of plerixafor on those days. Therefore, patients who require repeated dosing of plerixafor for upfront mobilization may have higher costs of mobilization compared to other methods of mobilization.

Additional costs associated with weekend apheresis procedures were omitted from this cost analysis because there was no reasonable way to create a generalized system for valuing weekend apheresis. CMS does not recognize differences in reimbursement based on week days or weekend days. Therefore, no adjustment to the costs of mobilization between the groups was made, although significantly more patients receiving chemotherapy mobilization required apheresis on the weekend. Many institutions may experience higher overhead costs associated with weekend mobilization because of pay differentials for flow cytometry technicians, apheresis nurses, and cell therapy lab staff. There may be an uncalculated cost savings, as well as staffing and logistical ease that are afforded with a more predictable start of apheresis after HSC mobilization with G-CSF + plerixafor.

In addition to its relatively small size and retrospective nature, a limitation of this study is that the cost estimate does not reflect the actual reimbursement and institutional overhead associated with mobilization from the study centers that participated in this study, and there may be regional and institutional differences in how some CMS and ASP costs are applied. Another limitation is that the ASP used for medication costs may underestimate the costs of medications in smaller facilities that purchase medications in lower volume or receive fewer discounts, incentives, and rebates. Also, the procedures and medications used for mobilization in this study were done at 2 similar community-based transplant programs, so differences in procedures and mobilization regimens used at other university or nonuniversity-associated centers may drive cost differences. Some centers collect stem cells upon recovery from chemotherapy that was delivered as part of the necessary therapy of the underlying malignancy and, therefore, may not consider this as separate mobilization therapy and associated cost. However, a strength of this study is that by avoiding actual institutional costs, which are subject to contractual arrangements and difficult to obtain from institutions, our standardized costing methodology may be more broadly applicable to many different types of transplant centers. To our knowledge, this is the first multicenter report that compares clinical and economic factors between 2 specific mobilization regimens.

More important than the cost differences in mobilizing autologous HSC is the safety and quality of life of the patients during the procedures. Significantly more patients in the G-CSF + chemotherapy mobilized group of patients required hospitalization, either to safely administer the chemotherapy or because of neutropenic fever. Patients in this group also required more daily subcutaneous administration of G-CSF prior to apheresis. The retrospective nature of this study precluded a formal quality-of-life survey or toxicity scoring during the mobilization procedures.

In conclusion, G-CSF + plerixafor can mobilize autologous HSC as well as G-CSF + chemotherapy, with similar transplant engraftment outcomes. The cost of plerixafor did not increase collection costs overall, and can be offset by the increased utilization of G-CSF after chemotherapy mobilization. G-CSF + plerixafor mobilization may also afford patients less toxicity compared to chemotherapy mobilization, and provide more predictable days of apheresis, which could ease hospital or clinic staffing and logistical issues. To more fully address these questions future prospective studies with larger numbers of patients comparing G-CSF + plerixafor to chemotherapy mobilization are warranted.

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Acknowledgments 

This study was supported by a research grant from Genzyme.

Financial disclosure: Paul Shaughnessy, Michael Maris, and Peter McSweeney all received honoraria and research funding from Genzyme. Sheryl Selvey did consultancy and a fellowship with Genzyme. Matthew Silva and Michael Steinberg did consultancy with Genzyme. All other authors report no potential conflicts of interest.

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