Interferon beta-1a, glatiramer acetate prove cost effective for long-term MS treatment

BOSTON - Treatment with interferon beta-1a or glatiramer acetate, if used long term, has the potential to be cost effective and to alter the natural history of relapsing-remitting multiple sclerosis, according to findings from a 6-year observational study.

In 4,137 patients with relapsing-remitting MS who were followed for a median of 6 years, the observed increase in the Expanded Disability Status Scale (EDSS) scores was lower than the increase seen in a natural history cohort that served as a comparator group (relative rates, 0.76 using a continuous Markov model and 0.61 using a multilevel model). The observed progression for utility – a quality of life measure derived from the EDSS scores, and the primary outcome of the study – was consistent with this finding (relative rates of 0.58 and 0.56 according to the two models, respectively), Dr. Jacqueline Palace reported at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

The outcome – essentially a reduction of about 42% on the primary outcome measure, compared with the natural history cohort – was better than the 38% reduction that was predicted, said Dr. Palace, leader of the multiple sclerosis and neuromyelitis group at Oxford University Hospitals Trust in England.

A range of sensitivity analyses that examined the potential for various biases consistently demonstrated better outcomes in the treated patients, compared with the natural history cohort, Dr. Palace noted.

If sustained over 20 years, the magnitude of the treatment effect observed in this study would be consistent with a predefined cost-effectiveness target of about $58,400 per quality-adjusted life-year, she said.

Patients included in this study were adults with a mean age of 38 years and a mean age at disease onset of 31 years. Most (76%) were women. Disease duration was a mean of 7.7 years at baseline, and the patients had a mean of three relapses over the prior 2 years. Baseline EDSS score was 3.06.

“In 2002, the National Institute of Clinical Excellence [NICE], which is the U.K. body that sets the guidelines that decide what should be available under the National Health Service, concluded that beta-interferon and glatiramer acetate were not cost effective during the short-term, and thus it recommended that it couldn’t be available under the NHS at that stage,” Dr. Palace explained.

The NICE did notice, however, that if the drug effect was maintained over the long term it might be cost effective and invited the Department of Health to “try and find a way to make the drugs available in a cost-effective manner,” she said.

“This was the birth of the Risk-Sharing Scheme, and it is a way of providing disease-modifying therapies to patients cost effectively,” she said.

At the start of the scheme, the drug prices were reduced in line with a cost-effective requirement using the NICE model, which equated to about $58,400/quality-adjusted life-year..

“We were allowed to reach this target over a 20-year lifespan, and the idea was to monitor a clinical cohort of patients, measuring their EDSS scores,” she said.

The natural history dataset was used as a “virtual placebo,” and a price adjustment would be required if the outcomes of the treated patients were less than predicted to be on target for cost effectiveness.

The findings of this study – the largest observational study to measure the effect and cost-effectiveness of interferon beta-1a and glatiramer acetate – provide evidence that the treatment alters the natural history of relapsing-remitting MS in the real life setting, she concluded.

Dr. Palace reported receiving support for scientific meetings and honorariums for advisory work from Teva, which makes glatiramer acetate, and Bayer Schering, which makes interferon beta-1a, as well as other companies that market drugs for MS. She’s also received unrestricted grants from Bayer Schering and other companies that market drugs for MS.

BOSTON - Treatment with interferon beta-1a or glatiramer acetate, if used long term, has the potential to be cost effective and to alter the natural history of relapsing-remitting multiple sclerosis, according to findings from a 6-year observational study.

In 4,137 patients with relapsing-remitting MS who were followed for a median of 6 years, the observed increase in the Expanded Disability Status Scale (EDSS) scores was lower than the increase seen in a natural history cohort that served as a comparator group (relative rates, 0.76 using a continuous Markov model and 0.61 using a multilevel model). The observed progression for utility – a quality of life measure derived from the EDSS scores, and the primary outcome of the study – was consistent with this finding (relative rates of 0.58 and 0.56 according to the two models, respectively), Dr. Jacqueline Palace reported at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

The outcome – essentially a reduction of about 42% on the primary outcome measure, compared with the natural history cohort – was better than the 38% reduction that was predicted, said Dr. Palace, leader of the multiple sclerosis and neuromyelitis group at Oxford University Hospitals Trust in England.

A range of sensitivity analyses that examined the potential for various biases consistently demonstrated better outcomes in the treated patients, compared with the natural history cohort, Dr. Palace noted.

If sustained over 20 years, the magnitude of the treatment effect observed in this study would be consistent with a predefined cost-effectiveness target of about $58,400 per quality-adjusted life-year, she said.

Patients included in this study were adults with a mean age of 38 years and a mean age at disease onset of 31 years. Most (76%) were women. Disease duration was a mean of 7.7 years at baseline, and the patients had a mean of three relapses over the prior 2 years. Baseline EDSS score was 3.06.

“In 2002, the National Institute of Clinical Excellence [NICE], which is the U.K. body that sets the guidelines that decide what should be available under the National Health Service, concluded that beta-interferon and glatiramer acetate were not cost effective during the short-term, and thus it recommended that it couldn’t be available under the NHS at that stage,” Dr. Palace explained.

The NICE did notice, however, that if the drug effect was maintained over the long term it might be cost effective and invited the Department of Health to “try and find a way to make the drugs available in a cost-effective manner,” she said.

“This was the birth of the Risk-Sharing Scheme, and it is a way of providing disease-modifying therapies to patients cost effectively,” she said.

At the start of the scheme, the drug prices were reduced in line with a cost-effective requirement using the NICE model, which equated to about $58,400/quality-adjusted life-year..

“We were allowed to reach this target over a 20-year lifespan, and the idea was to monitor a clinical cohort of patients, measuring their EDSS scores,” she said.

The natural history dataset was used as a “virtual placebo,” and a price adjustment would be required if the outcomes of the treated patients were less than predicted to be on target for cost effectiveness.

The findings of this study – the largest observational study to measure the effect and cost-effectiveness of interferon beta-1a and glatiramer acetate – provide evidence that the treatment alters the natural history of relapsing-remitting MS in the real life setting, she concluded.

Dr. Palace reported receiving support for scientific meetings and honorariums for advisory work from Teva, which makes glatiramer acetate, and Bayer Schering, which makes interferon beta-1a, as well as other companies that market drugs for MS. She’s also received unrestricted grants from Bayer Schering and other companies that market drugs for MS.

BOSTON - Treatment with interferon beta-1a or glatiramer acetate, if used long term, has the potential to be cost effective and to alter the natural history of relapsing-remitting multiple sclerosis, according to findings from a 6-year observational study.

In 4,137 patients with relapsing-remitting MS who were followed for a median of 6 years, the observed increase in the Expanded Disability Status Scale (EDSS) scores was lower than the increase seen in a natural history cohort that served as a comparator group (relative rates, 0.76 using a continuous Markov model and 0.61 using a multilevel model). The observed progression for utility – a quality of life measure derived from the EDSS scores, and the primary outcome of the study – was consistent with this finding (relative rates of 0.58 and 0.56 according to the two models, respectively), Dr. Jacqueline Palace reported at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

The outcome – essentially a reduction of about 42% on the primary outcome measure, compared with the natural history cohort – was better than the 38% reduction that was predicted, said Dr. Palace, leader of the multiple sclerosis and neuromyelitis group at Oxford University Hospitals Trust in England.

A range of sensitivity analyses that examined the potential for various biases consistently demonstrated better outcomes in the treated patients, compared with the natural history cohort, Dr. Palace noted.

If sustained over 20 years, the magnitude of the treatment effect observed in this study would be consistent with a predefined cost-effectiveness target of about $58,400 per quality-adjusted life-year, she said.

Patients included in this study were adults with a mean age of 38 years and a mean age at disease onset of 31 years. Most (76%) were women. Disease duration was a mean of 7.7 years at baseline, and the patients had a mean of three relapses over the prior 2 years. Baseline EDSS score was 3.06.

“In 2002, the National Institute of Clinical Excellence [NICE], which is the U.K. body that sets the guidelines that decide what should be available under the National Health Service, concluded that beta-interferon and glatiramer acetate were not cost effective during the short-term, and thus it recommended that it couldn’t be available under the NHS at that stage,” Dr. Palace explained.

The NICE did notice, however, that if the drug effect was maintained over the long term it might be cost effective and invited the Department of Health to “try and find a way to make the drugs available in a cost-effective manner,” she said.

“This was the birth of the Risk-Sharing Scheme, and it is a way of providing disease-modifying therapies to patients cost effectively,” she said.

At the start of the scheme, the drug prices were reduced in line with a cost-effective requirement using the NICE model, which equated to about $58,400/quality-adjusted life-year..

“We were allowed to reach this target over a 20-year lifespan, and the idea was to monitor a clinical cohort of patients, measuring their EDSS scores,” she said.

The natural history dataset was used as a “virtual placebo,” and a price adjustment would be required if the outcomes of the treated patients were less than predicted to be on target for cost effectiveness.

The findings of this study – the largest observational study to measure the effect and cost-effectiveness of interferon beta-1a and glatiramer acetate – provide evidence that the treatment alters the natural history of relapsing-remitting MS in the real life setting, she concluded.

Dr. Palace reported receiving support for scientific meetings and honorariums for advisory work from Teva, which makes glatiramer acetate, and Bayer Schering, which makes interferon beta-1a, as well as other companies that market drugs for MS. She’s also received unrestricted grants from Bayer Schering and other companies that market drugs for MS.