ICYMI Multiple Sclerosis

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Serum levels of neurofilament light (NfL) are elevated as long as 6 years before the clinical onset of multiple sclerosis (MS), according to research published in the January issue of JAMA Neurology. These results lend weight to the idea that MS has a prodromal phase, and this phase appears to be associated with neurodegeneration, according to the authors.

Patients often have CNS lesions of various stages of development at the time of their first demyelinating event, and this finding was one basis for neurologists’ hypothesis of a prodromal phase of MS. The finding that one-third of patients with radiologically isolated syndrome develop MS within 5 years also lends credence to this idea. Diagnosing MS early would enable early treatment that could prevent demyelination and the progression of neurodegeneration.
 

Researchers compared presymptomatic and symptomatic samples

With this idea in mind, Kjetil Bjornevik, MD, PhD, a member of the neuroepidemiology research group at Harvard TH Chan School of Public Health in Boston, and colleagues evaluated whether serum levels of NfL, a marker of ongoing neuroaxonal degeneration, were increased in the years before and around the time of clinical onset of MS. For their study population, the investigators chose active-duty U.S. military personnel who have at least one serum sample stored in the U.S. Department of Defense Serum Repository. Samples are collected after routine HIV type 1 antibody testing.

Within this population, Dr. Bjornevik and colleagues identified patients with MS who had at least one presymptomatic serum sample. The date of clinical MS onset was defined as the date of the first neurologic symptoms attributable to MS documented in the medical record. The investigators randomly selected two control individuals from the population and matched them to each case by age, sex, race or ethnicity, and dates of sample collection. Eligible controls were on active duty on the date of onset of the matched case.

Dr. Bjornevik and colleagues identified 245 patients with MS. Among this sample, the researchers selected two groups that each included 30 cases and 30 controls. The first group included patients who had provided at least one serum sample before MS onset and one sample within 2 years after MS onset. The second group included cases with at least two presymptomatic serum samples, one of which was collected more than 5 years before MS diagnosis, and the other of which was collected between 2 and 5 years before diagnosis. The investigators handled pairs of serum samples in the same way and assayed them in the same batch. The order of the samples in each pair was arranged at random.
 

Levels were higher in cases than in controls

About 77% of the population was male. Sixty percent of participants were white, 28% were black, and 6.7% were Hispanic. The population’s mean age at first sample collection was approximately 27 years. Mean age at MS onset was approximately 31 years.

For patients who provided samples before and after the clinical onset of MS, serum NfL levels were higher than in matched controls at both points. Most patients who passed from the presymptomatic stage to the symptomatic stage had a significant increase in serum NfL level (i.e., from a median of 25.0 pg/mL to a median of 45.1 pg/mL). Serum NfL levels at the two time points in controls did not differ significantly. For any given patient, an increase in serum NfL level from the presymptomatic measurement to the symptomatic measurement was associated with an increased risk of MS.

In patients with two presymptomatic samples, serum NfL levels were significantly higher in both samples than in the corresponding samples from matched controls. In cases, the earlier sample was collected at a median of 6 years before clinical onset of MS, and the later sample was collected at a median of 1 year before clinical onset. The serum NfL levels increased significantly between the two points for cases (i.e., a median increase of 1.3 pg/mL per year), but there was no significant difference in serum NfL level between the two samples in controls. A within-patient increase in presymptomatic serum NfL level was associated with an increased risk of MS.
 

Population included few women

“Our study differs from previous studies on the prodromal phase of MS because these have used indirect markers of this phase, which included unspecific symptoms or disturbances occurring before the clinical onset, compared with a marker of neurodegeneration,” wrote Dr. Bjornevik and colleagues. Initiation of treatment with disease-modifying therapy is associated with reductions in serum NfL levels, and this association could explain why some patients in the current study had higher NfL levels before MS onset than afterward. Furthermore, serum NfL levels are highly associated with levels of NfL in cerebrospinal fluid. “Thus, our findings of a presymptomatic increase in serum NfL not only suggest the presence of a prodromal phase in MS, but also that this phase is associated with neurodegeneration,” wrote the investigators.

The study’s well-defined population helped to minimize selection bias, and the blinded, randomized method of analyzing the serum samples eliminated artifactual differences in serum NfL concentrations. But the small sample size precluded analyses that could have influenced clinical practice, wrote Dr. Bjornevik and colleagues. For example, the researchers could not evaluate distinct cutoffs in serum NfL level that could mark the beginning of the prodromal phase of MS. Nor could they determine whether presymptomatic serum NfL levels varied with age at clinical onset, sex, or race. The small number of women in the sample was another limitation of the study.

The Swiss National Research Foundation and the National Institute of Neurologic Disorders and Stroke funded the study. Several of the investigators received fees from various drug companies that were unrelated to the study, and one researcher received grants from the National Institutes of Health during the study.

[email protected]

SOURCE: Bjornevik K et al. JAMA Neurol. 2020;77(1):58-64.

Serum levels of neurofilament light (NfL) are elevated as long as 6 years before the clinical onset of multiple sclerosis (MS), according to research published in the January issue of JAMA Neurology. These results lend weight to the idea that MS has a prodromal phase, and this phase appears to be associated with neurodegeneration, according to the authors.

Patients often have CNS lesions of various stages of development at the time of their first demyelinating event, and this finding was one basis for neurologists’ hypothesis of a prodromal phase of MS. The finding that one-third of patients with radiologically isolated syndrome develop MS within 5 years also lends credence to this idea. Diagnosing MS early would enable early treatment that could prevent demyelination and the progression of neurodegeneration.
 

Researchers compared presymptomatic and symptomatic samples

With this idea in mind, Kjetil Bjornevik, MD, PhD, a member of the neuroepidemiology research group at Harvard TH Chan School of Public Health in Boston, and colleagues evaluated whether serum levels of NfL, a marker of ongoing neuroaxonal degeneration, were increased in the years before and around the time of clinical onset of MS. For their study population, the investigators chose active-duty U.S. military personnel who have at least one serum sample stored in the U.S. Department of Defense Serum Repository. Samples are collected after routine HIV type 1 antibody testing.

Within this population, Dr. Bjornevik and colleagues identified patients with MS who had at least one presymptomatic serum sample. The date of clinical MS onset was defined as the date of the first neurologic symptoms attributable to MS documented in the medical record. The investigators randomly selected two control individuals from the population and matched them to each case by age, sex, race or ethnicity, and dates of sample collection. Eligible controls were on active duty on the date of onset of the matched case.

Dr. Bjornevik and colleagues identified 245 patients with MS. Among this sample, the researchers selected two groups that each included 30 cases and 30 controls. The first group included patients who had provided at least one serum sample before MS onset and one sample within 2 years after MS onset. The second group included cases with at least two presymptomatic serum samples, one of which was collected more than 5 years before MS diagnosis, and the other of which was collected between 2 and 5 years before diagnosis. The investigators handled pairs of serum samples in the same way and assayed them in the same batch. The order of the samples in each pair was arranged at random.
 

Levels were higher in cases than in controls

About 77% of the population was male. Sixty percent of participants were white, 28% were black, and 6.7% were Hispanic. The population’s mean age at first sample collection was approximately 27 years. Mean age at MS onset was approximately 31 years.

For patients who provided samples before and after the clinical onset of MS, serum NfL levels were higher than in matched controls at both points. Most patients who passed from the presymptomatic stage to the symptomatic stage had a significant increase in serum NfL level (i.e., from a median of 25.0 pg/mL to a median of 45.1 pg/mL). Serum NfL levels at the two time points in controls did not differ significantly. For any given patient, an increase in serum NfL level from the presymptomatic measurement to the symptomatic measurement was associated with an increased risk of MS.

In patients with two presymptomatic samples, serum NfL levels were significantly higher in both samples than in the corresponding samples from matched controls. In cases, the earlier sample was collected at a median of 6 years before clinical onset of MS, and the later sample was collected at a median of 1 year before clinical onset. The serum NfL levels increased significantly between the two points for cases (i.e., a median increase of 1.3 pg/mL per year), but there was no significant difference in serum NfL level between the two samples in controls. A within-patient increase in presymptomatic serum NfL level was associated with an increased risk of MS.
 

Population included few women

“Our study differs from previous studies on the prodromal phase of MS because these have used indirect markers of this phase, which included unspecific symptoms or disturbances occurring before the clinical onset, compared with a marker of neurodegeneration,” wrote Dr. Bjornevik and colleagues. Initiation of treatment with disease-modifying therapy is associated with reductions in serum NfL levels, and this association could explain why some patients in the current study had higher NfL levels before MS onset than afterward. Furthermore, serum NfL levels are highly associated with levels of NfL in cerebrospinal fluid. “Thus, our findings of a presymptomatic increase in serum NfL not only suggest the presence of a prodromal phase in MS, but also that this phase is associated with neurodegeneration,” wrote the investigators.

The study’s well-defined population helped to minimize selection bias, and the blinded, randomized method of analyzing the serum samples eliminated artifactual differences in serum NfL concentrations. But the small sample size precluded analyses that could have influenced clinical practice, wrote Dr. Bjornevik and colleagues. For example, the researchers could not evaluate distinct cutoffs in serum NfL level that could mark the beginning of the prodromal phase of MS. Nor could they determine whether presymptomatic serum NfL levels varied with age at clinical onset, sex, or race. The small number of women in the sample was another limitation of the study.

The Swiss National Research Foundation and the National Institute of Neurologic Disorders and Stroke funded the study. Several of the investigators received fees from various drug companies that were unrelated to the study, and one researcher received grants from the National Institutes of Health during the study.

[email protected]

SOURCE: Bjornevik K et al. JAMA Neurol. 2020;77(1):58-64.

Serum levels of neurofilament light (NfL) are elevated as long as 6 years before the clinical onset of multiple sclerosis (MS), according to research published in the January issue of JAMA Neurology. These results lend weight to the idea that MS has a prodromal phase, and this phase appears to be associated with neurodegeneration, according to the authors.

Patients often have CNS lesions of various stages of development at the time of their first demyelinating event, and this finding was one basis for neurologists’ hypothesis of a prodromal phase of MS. The finding that one-third of patients with radiologically isolated syndrome develop MS within 5 years also lends credence to this idea. Diagnosing MS early would enable early treatment that could prevent demyelination and the progression of neurodegeneration.
 

Researchers compared presymptomatic and symptomatic samples

With this idea in mind, Kjetil Bjornevik, MD, PhD, a member of the neuroepidemiology research group at Harvard TH Chan School of Public Health in Boston, and colleagues evaluated whether serum levels of NfL, a marker of ongoing neuroaxonal degeneration, were increased in the years before and around the time of clinical onset of MS. For their study population, the investigators chose active-duty U.S. military personnel who have at least one serum sample stored in the U.S. Department of Defense Serum Repository. Samples are collected after routine HIV type 1 antibody testing.

Within this population, Dr. Bjornevik and colleagues identified patients with MS who had at least one presymptomatic serum sample. The date of clinical MS onset was defined as the date of the first neurologic symptoms attributable to MS documented in the medical record. The investigators randomly selected two control individuals from the population and matched them to each case by age, sex, race or ethnicity, and dates of sample collection. Eligible controls were on active duty on the date of onset of the matched case.

Dr. Bjornevik and colleagues identified 245 patients with MS. Among this sample, the researchers selected two groups that each included 30 cases and 30 controls. The first group included patients who had provided at least one serum sample before MS onset and one sample within 2 years after MS onset. The second group included cases with at least two presymptomatic serum samples, one of which was collected more than 5 years before MS diagnosis, and the other of which was collected between 2 and 5 years before diagnosis. The investigators handled pairs of serum samples in the same way and assayed them in the same batch. The order of the samples in each pair was arranged at random.
 

Levels were higher in cases than in controls

About 77% of the population was male. Sixty percent of participants were white, 28% were black, and 6.7% were Hispanic. The population’s mean age at first sample collection was approximately 27 years. Mean age at MS onset was approximately 31 years.

For patients who provided samples before and after the clinical onset of MS, serum NfL levels were higher than in matched controls at both points. Most patients who passed from the presymptomatic stage to the symptomatic stage had a significant increase in serum NfL level (i.e., from a median of 25.0 pg/mL to a median of 45.1 pg/mL). Serum NfL levels at the two time points in controls did not differ significantly. For any given patient, an increase in serum NfL level from the presymptomatic measurement to the symptomatic measurement was associated with an increased risk of MS.

In patients with two presymptomatic samples, serum NfL levels were significantly higher in both samples than in the corresponding samples from matched controls. In cases, the earlier sample was collected at a median of 6 years before clinical onset of MS, and the later sample was collected at a median of 1 year before clinical onset. The serum NfL levels increased significantly between the two points for cases (i.e., a median increase of 1.3 pg/mL per year), but there was no significant difference in serum NfL level between the two samples in controls. A within-patient increase in presymptomatic serum NfL level was associated with an increased risk of MS.
 

Population included few women

“Our study differs from previous studies on the prodromal phase of MS because these have used indirect markers of this phase, which included unspecific symptoms or disturbances occurring before the clinical onset, compared with a marker of neurodegeneration,” wrote Dr. Bjornevik and colleagues. Initiation of treatment with disease-modifying therapy is associated with reductions in serum NfL levels, and this association could explain why some patients in the current study had higher NfL levels before MS onset than afterward. Furthermore, serum NfL levels are highly associated with levels of NfL in cerebrospinal fluid. “Thus, our findings of a presymptomatic increase in serum NfL not only suggest the presence of a prodromal phase in MS, but also that this phase is associated with neurodegeneration,” wrote the investigators.

The study’s well-defined population helped to minimize selection bias, and the blinded, randomized method of analyzing the serum samples eliminated artifactual differences in serum NfL concentrations. But the small sample size precluded analyses that could have influenced clinical practice, wrote Dr. Bjornevik and colleagues. For example, the researchers could not evaluate distinct cutoffs in serum NfL level that could mark the beginning of the prodromal phase of MS. Nor could they determine whether presymptomatic serum NfL levels varied with age at clinical onset, sex, or race. The small number of women in the sample was another limitation of the study.

The Swiss National Research Foundation and the National Institute of Neurologic Disorders and Stroke funded the study. Several of the investigators received fees from various drug companies that were unrelated to the study, and one researcher received grants from the National Institutes of Health during the study.

[email protected]

SOURCE: Bjornevik K et al. JAMA Neurol. 2020;77(1):58-64.

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).

Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).

Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).

Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.

Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.

Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).

Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).

Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).

Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.

Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.

Key clinical point: Higher serum concentrations of 25-hydroxyvitamin D (25(OH)D) are associated with a reduced risk for multiple sclerosis (MS).

Major finding: Being in the top 25(OH)D quintile was significantly associated with a reduced risk of multiple sclerosis (odds ratio, 0.68; 95% confidence interval, 0.50-0.93).

Study details: A nested case-control study using data from 6 Swedish biobanks (665 cases and an equal number of matched controls).

Disclosures: This study was supported by the Swedish Research Council and through a regional agreement between Umea University and the Vasterbotten County Council. One author received speaking fees from Merck-Serono and served on advisory boards for Merck-Serono and Biogen and another received honoraria for lectures from Genzyme and for advisory board roles from Roche and Novartis.

Citation: Biström M et al. Mult Scler J Exp Transl Clin. 2019 Dec 6. doi: 10.1177/2055217319892291.

Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.

Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.

Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.

Disclosures: The authors reported having no conflicts of interest.

Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.

Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.

Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.

Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.

Disclosures: The authors reported having no conflicts of interest.

Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.

Key clinical point: In patients with relapsing multiple sclerosis, fingolimod has a superior effect on clinical and magnetic resonance imaging (MRI) outcomes than placebo and presents an acceptable safety profile.

Major finding: Compared with placebo, fingolimod (0.5, 1.25, and 5 mg/day doses) had a significant reduction in annualized relapse rate. Fingolimod demonstrated beneficial effects on MRI outcomes, including the number of gadolinium-enhancing T1 lesions, and improved patient quality of life. No significant difference was found between the groups in terms of adverse events.

Study details: This was a systematic review and meta-analysis of 10 studies, including 6,547 participants.

Disclosures: The authors reported having no conflicts of interest.

Citation: Yang T et al. Br J Clin Pharmacol. 2019 Dec 23. doi: 10.1111/bcp.14198.