Psoriasis Collection

WAIKOLOA, HAWAII – What’s going to be the biggest development in the field of psoriasis in 2016?

Hint: Look for a repeat of 2015.

The first of the interleukin-17 antagonists, secukinumab, was the biggest development of 2015, explained Dr. Craig L. Leonardi, associate clinical professor of dermatology at Saint Louis University, St. Louis. “It’s always good when we get another mechanism of action.”

2016 should see the debut of another IL-17 antagonist, ixekizumab, which “seems to be more efficacious than secukinumab,” Dr. Leonardi said in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF and this news organization are owned by the same parent company.

WAIKOLOA, HAWAII – What’s going to be the biggest development in the field of psoriasis in 2016?

Hint: Look for a repeat of 2015.

The first of the interleukin-17 antagonists, secukinumab, was the biggest development of 2015, explained Dr. Craig L. Leonardi, associate clinical professor of dermatology at Saint Louis University, St. Louis. “It’s always good when we get another mechanism of action.”

2016 should see the debut of another IL-17 antagonist, ixekizumab, which “seems to be more efficacious than secukinumab,” Dr. Leonardi said in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF and this news organization are owned by the same parent company.

WAIKOLOA, HAWAII – What’s going to be the biggest development in the field of psoriasis in 2016?

Hint: Look for a repeat of 2015.

The first of the interleukin-17 antagonists, secukinumab, was the biggest development of 2015, explained Dr. Craig L. Leonardi, associate clinical professor of dermatology at Saint Louis University, St. Louis. “It’s always good when we get another mechanism of action.”

2016 should see the debut of another IL-17 antagonist, ixekizumab, which “seems to be more efficacious than secukinumab,” Dr. Leonardi said in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF and this news organization are owned by the same parent company.

The evaluation and treatment of psoriasis in older patients have long been issues of interest among clinicians. This population is at risk from comorbidities associated with psoriasis. In addition, the potential for increased side effects of therapies in this population has been a concern.

Takeshita et al¹ recently published a study evaluating the prevalence of psoriasis and its treatments in the elderly population. The authors point out that despite major advances in the field of psoriasis, there are large gaps in knowledge among the increasing elderly population. The authors noted that this study is the first to evaluate the epidemiology and treatment of psoriasis in the US population using Medicare.¹

Utilizing 8 different algorithms, claims-based psoriasis prevalence was calculated for 799,607 beneficiaries in the 2011 Medicare 5% sample (random 5% sample of Medicare beneficiaries) and was found to range from 0.51% to 1.23%. For the main analyses, a diagnosis of psoriasis was established by the presence of at least 2 inpatient or outpatient claims for psoriasis.¹

The authors reported the following characteristics for the study population¹: the mean age was 68.6 years; 43.2% of the participants were male; 88.8% were white; 5.1% were black; 2.2% were Hispanic; and 3.9% were other or unknown race. Regional distribution of residence was as follows: 24.0% in the northeast, 23.0% in the Midwest, 36.2% in the south, and 16.6% in the west. County-level mean per capita income was $40,115; 63.6% of beneficiaries qualified for Medicare based on age alone; 58.4% were not receiving a Medicare Part D low-income subsidy (LIS); and 19.0% were receiving Part D plans with enhanced alternative coverage. The most commonly coded comorbidities were cardiometabolic disorders (67.6% hypertension; 59.9% dyslipidemia; 32.4% diabetes); 23.5% had atherosclerotic outcomes. The prevalence of obesity was relatively low at 9.3% and the prevalence of psoriatic arthritis was 9.4%. Other comorbid diseases of interest included depression (17.1%), renal disease (9.8%), liver disease (5.1%), and inflammatory bowel disease (1.2%).¹

The analysis of psoriatic therapy revealed that topical therapies were used by 76.6% of the total psoriasis sample, the majority of which were topical corticosteroids.¹ Phototherapy was used by 7% and oral systemic medications were used by 14.3% (the majority received methotrexate). Biologics were received by 10.2%, and of those patients, 44.4% received etanercept, 34.2% adalimumab, 22.7% infliximab, and 7.9% ustekinumab.¹

There were several interesting findings in the analysis.¹ Oral systemic medications such as methotrexate were the most common therapies for moderate to severe psoriasis, followed by biologics.¹ Associated comorbidities for which biologic therapy is indicated (ie, ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis) were associated with greater odds of receiving treatment with biologics. Individuals lacking LIS under the Part D plan had 70% lower odds of receiving biologics compared with those with LIS that allowed for lower out-of-pocket costs. The odds of having received biologics were 69% lower for black individuals compared to white patients.¹

This study helps us to further understand the patterns of psoriasis and its treatment in the elderly population. Some of the findings are in line with our current thinking regarding comorbidities and therapies used, while other observations, such as a lower number of untreated patients than expected, are more surprising. Interestingly, this study identified potential financial and racial barriers to the receipt of biologic therapies. These barriers are important issues to address as we strive to better care for our psoriatic population.

The evaluation and treatment of psoriasis in older patients have long been issues of interest among clinicians. This population is at risk from comorbidities associated with psoriasis. In addition, the potential for increased side effects of therapies in this population has been a concern.

Takeshita et al¹ recently published a study evaluating the prevalence of psoriasis and its treatments in the elderly population. The authors point out that despite major advances in the field of psoriasis, there are large gaps in knowledge among the increasing elderly population. The authors noted that this study is the first to evaluate the epidemiology and treatment of psoriasis in the US population using Medicare.¹

Utilizing 8 different algorithms, claims-based psoriasis prevalence was calculated for 799,607 beneficiaries in the 2011 Medicare 5% sample (random 5% sample of Medicare beneficiaries) and was found to range from 0.51% to 1.23%. For the main analyses, a diagnosis of psoriasis was established by the presence of at least 2 inpatient or outpatient claims for psoriasis.¹

The authors reported the following characteristics for the study population¹: the mean age was 68.6 years; 43.2% of the participants were male; 88.8% were white; 5.1% were black; 2.2% were Hispanic; and 3.9% were other or unknown race. Regional distribution of residence was as follows: 24.0% in the northeast, 23.0% in the Midwest, 36.2% in the south, and 16.6% in the west. County-level mean per capita income was $40,115; 63.6% of beneficiaries qualified for Medicare based on age alone; 58.4% were not receiving a Medicare Part D low-income subsidy (LIS); and 19.0% were receiving Part D plans with enhanced alternative coverage. The most commonly coded comorbidities were cardiometabolic disorders (67.6% hypertension; 59.9% dyslipidemia; 32.4% diabetes); 23.5% had atherosclerotic outcomes. The prevalence of obesity was relatively low at 9.3% and the prevalence of psoriatic arthritis was 9.4%. Other comorbid diseases of interest included depression (17.1%), renal disease (9.8%), liver disease (5.1%), and inflammatory bowel disease (1.2%).¹

The analysis of psoriatic therapy revealed that topical therapies were used by 76.6% of the total psoriasis sample, the majority of which were topical corticosteroids.¹ Phototherapy was used by 7% and oral systemic medications were used by 14.3% (the majority received methotrexate). Biologics were received by 10.2%, and of those patients, 44.4% received etanercept, 34.2% adalimumab, 22.7% infliximab, and 7.9% ustekinumab.¹

There were several interesting findings in the analysis.¹ Oral systemic medications such as methotrexate were the most common therapies for moderate to severe psoriasis, followed by biologics.¹ Associated comorbidities for which biologic therapy is indicated (ie, ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis) were associated with greater odds of receiving treatment with biologics. Individuals lacking LIS under the Part D plan had 70% lower odds of receiving biologics compared with those with LIS that allowed for lower out-of-pocket costs. The odds of having received biologics were 69% lower for black individuals compared to white patients.¹

This study helps us to further understand the patterns of psoriasis and its treatment in the elderly population. Some of the findings are in line with our current thinking regarding comorbidities and therapies used, while other observations, such as a lower number of untreated patients than expected, are more surprising. Interestingly, this study identified potential financial and racial barriers to the receipt of biologic therapies. These barriers are important issues to address as we strive to better care for our psoriatic population.

The evaluation and treatment of psoriasis in older patients have long been issues of interest among clinicians. This population is at risk from comorbidities associated with psoriasis. In addition, the potential for increased side effects of therapies in this population has been a concern.

Takeshita et al¹ recently published a study evaluating the prevalence of psoriasis and its treatments in the elderly population. The authors point out that despite major advances in the field of psoriasis, there are large gaps in knowledge among the increasing elderly population. The authors noted that this study is the first to evaluate the epidemiology and treatment of psoriasis in the US population using Medicare.¹

Utilizing 8 different algorithms, claims-based psoriasis prevalence was calculated for 799,607 beneficiaries in the 2011 Medicare 5% sample (random 5% sample of Medicare beneficiaries) and was found to range from 0.51% to 1.23%. For the main analyses, a diagnosis of psoriasis was established by the presence of at least 2 inpatient or outpatient claims for psoriasis.¹

The authors reported the following characteristics for the study population¹: the mean age was 68.6 years; 43.2% of the participants were male; 88.8% were white; 5.1% were black; 2.2% were Hispanic; and 3.9% were other or unknown race. Regional distribution of residence was as follows: 24.0% in the northeast, 23.0% in the Midwest, 36.2% in the south, and 16.6% in the west. County-level mean per capita income was $40,115; 63.6% of beneficiaries qualified for Medicare based on age alone; 58.4% were not receiving a Medicare Part D low-income subsidy (LIS); and 19.0% were receiving Part D plans with enhanced alternative coverage. The most commonly coded comorbidities were cardiometabolic disorders (67.6% hypertension; 59.9% dyslipidemia; 32.4% diabetes); 23.5% had atherosclerotic outcomes. The prevalence of obesity was relatively low at 9.3% and the prevalence of psoriatic arthritis was 9.4%. Other comorbid diseases of interest included depression (17.1%), renal disease (9.8%), liver disease (5.1%), and inflammatory bowel disease (1.2%).¹

The analysis of psoriatic therapy revealed that topical therapies were used by 76.6% of the total psoriasis sample, the majority of which were topical corticosteroids.¹ Phototherapy was used by 7% and oral systemic medications were used by 14.3% (the majority received methotrexate). Biologics were received by 10.2%, and of those patients, 44.4% received etanercept, 34.2% adalimumab, 22.7% infliximab, and 7.9% ustekinumab.¹

There were several interesting findings in the analysis.¹ Oral systemic medications such as methotrexate were the most common therapies for moderate to severe psoriasis, followed by biologics.¹ Associated comorbidities for which biologic therapy is indicated (ie, ankylosing spondylitis, inflammatory bowel disease, psoriatic arthritis) were associated with greater odds of receiving treatment with biologics. Individuals lacking LIS under the Part D plan had 70% lower odds of receiving biologics compared with those with LIS that allowed for lower out-of-pocket costs. The odds of having received biologics were 69% lower for black individuals compared to white patients.¹

This study helps us to further understand the patterns of psoriasis and its treatment in the elderly population. Some of the findings are in line with our current thinking regarding comorbidities and therapies used, while other observations, such as a lower number of untreated patients than expected, are more surprising. Interestingly, this study identified potential financial and racial barriers to the receipt of biologic therapies. These barriers are important issues to address as we strive to better care for our psoriatic population.

Questions linger as to whether federal health care payment policies will encourage – or stifle – the entry of more biosimilars into the marketplace.

Getting the biosimilar approval process right “doesn’t matter unless we get the charging/reimbursement process right,” Rep. Joe Barton (R-Tex.), chairmen emeritus of the House Energy and Commerce Committee, said Feb. 4 during a Health Subcommittee hearing. Without a workable reimbursement process “there’s no incentive to create the drug in the first place. Nobody’s going to do it.”

©Mathier/thinkstockphotos.com

At issue is how the Centers for Medicare & Medicaid Services plans to pay for biosimilars. The 2016 Medicare Physician Fee Schedule establishes that biosimilars would receive the same reimbursement code as their biologic innovator product and be paid at a weighted average of the average sales price of all biosimilars in that code, plus 6% of the innovator product.

Rep. Frank Pallone (D-N.J.), ranking member of the subcommittee, expressed concern over the policy. “I worry that this inappropriately treats biosimilars like generic drugs and will disincentivize manufacturers from entering the biosimilars marketplace. ... Biosimilars are not generics. Each is its own unique product and biosimilars go through a much more stringent approval process.”

Sean Cavanaugh, deputy administrator and director of the CMS, testified that in terms of market forces, there are enough similarities between generic drugs and biosimilars to maintain that kind of similarity. He added, however, that the CMS is open to changing reimbursement methodology “if we thought that our payment policy was not accomplishing what we expected it to.”

Rep. Brett Guthrie (R-Ky.), vice chairman of the subcommittee, said the reimbursement scheme could lead to “inappropriate switching between biosimilars – switching to a lower cost that is not the same [and] a less vibrant biosimilar market altogether.”

Mr. Cavanaugh noted that the CMS spends more than $1 billion on each of the top six drugs it pays for, all of which are biologics. “I think that alone creates the opportunity for a very vibrant market in biosimilars,” he said.

In addition, he did not see switching as an issue.

“Physicians do not order biologics or other drug products by billing code,” Mr. Cavanaugh said. “Similarly, pharmacists do not derive what switchings they are allowed to do based on billing codes.”

[email protected]

Questions linger as to whether federal health care payment policies will encourage – or stifle – the entry of more biosimilars into the marketplace.

Getting the biosimilar approval process right “doesn’t matter unless we get the charging/reimbursement process right,” Rep. Joe Barton (R-Tex.), chairmen emeritus of the House Energy and Commerce Committee, said Feb. 4 during a Health Subcommittee hearing. Without a workable reimbursement process “there’s no incentive to create the drug in the first place. Nobody’s going to do it.”

©Mathier/thinkstockphotos.com

At issue is how the Centers for Medicare & Medicaid Services plans to pay for biosimilars. The 2016 Medicare Physician Fee Schedule establishes that biosimilars would receive the same reimbursement code as their biologic innovator product and be paid at a weighted average of the average sales price of all biosimilars in that code, plus 6% of the innovator product.

Rep. Frank Pallone (D-N.J.), ranking member of the subcommittee, expressed concern over the policy. “I worry that this inappropriately treats biosimilars like generic drugs and will disincentivize manufacturers from entering the biosimilars marketplace. ... Biosimilars are not generics. Each is its own unique product and biosimilars go through a much more stringent approval process.”

Sean Cavanaugh, deputy administrator and director of the CMS, testified that in terms of market forces, there are enough similarities between generic drugs and biosimilars to maintain that kind of similarity. He added, however, that the CMS is open to changing reimbursement methodology “if we thought that our payment policy was not accomplishing what we expected it to.”

Rep. Brett Guthrie (R-Ky.), vice chairman of the subcommittee, said the reimbursement scheme could lead to “inappropriate switching between biosimilars – switching to a lower cost that is not the same [and] a less vibrant biosimilar market altogether.”

Mr. Cavanaugh noted that the CMS spends more than $1 billion on each of the top six drugs it pays for, all of which are biologics. “I think that alone creates the opportunity for a very vibrant market in biosimilars,” he said.

In addition, he did not see switching as an issue.

“Physicians do not order biologics or other drug products by billing code,” Mr. Cavanaugh said. “Similarly, pharmacists do not derive what switchings they are allowed to do based on billing codes.”

[email protected]

Questions linger as to whether federal health care payment policies will encourage – or stifle – the entry of more biosimilars into the marketplace.

Getting the biosimilar approval process right “doesn’t matter unless we get the charging/reimbursement process right,” Rep. Joe Barton (R-Tex.), chairmen emeritus of the House Energy and Commerce Committee, said Feb. 4 during a Health Subcommittee hearing. Without a workable reimbursement process “there’s no incentive to create the drug in the first place. Nobody’s going to do it.”

©Mathier/thinkstockphotos.com

At issue is how the Centers for Medicare & Medicaid Services plans to pay for biosimilars. The 2016 Medicare Physician Fee Schedule establishes that biosimilars would receive the same reimbursement code as their biologic innovator product and be paid at a weighted average of the average sales price of all biosimilars in that code, plus 6% of the innovator product.

Rep. Frank Pallone (D-N.J.), ranking member of the subcommittee, expressed concern over the policy. “I worry that this inappropriately treats biosimilars like generic drugs and will disincentivize manufacturers from entering the biosimilars marketplace. ... Biosimilars are not generics. Each is its own unique product and biosimilars go through a much more stringent approval process.”

Sean Cavanaugh, deputy administrator and director of the CMS, testified that in terms of market forces, there are enough similarities between generic drugs and biosimilars to maintain that kind of similarity. He added, however, that the CMS is open to changing reimbursement methodology “if we thought that our payment policy was not accomplishing what we expected it to.”

Rep. Brett Guthrie (R-Ky.), vice chairman of the subcommittee, said the reimbursement scheme could lead to “inappropriate switching between biosimilars – switching to a lower cost that is not the same [and] a less vibrant biosimilar market altogether.”

Mr. Cavanaugh noted that the CMS spends more than $1 billion on each of the top six drugs it pays for, all of which are biologics. “I think that alone creates the opportunity for a very vibrant market in biosimilars,” he said.

In addition, he did not see switching as an issue.

“Physicians do not order biologics or other drug products by billing code,” Mr. Cavanaugh said. “Similarly, pharmacists do not derive what switchings they are allowed to do based on billing codes.”

[email protected]

The level of serum squamous cell carcinoma antigen 2 – an isoform of SCCA that is widely used as a tumor marker for SCC – was significantly higher in both skin and serum of patients with psoriasis, compared with healthy volunteers in a recent study, correlating with psoriasis severity score and reflecting treatment efficacy.

The intensity of skin and serum levels of SCCA2 was correlated in patients with psoriasis, and the study results also suggest that Th17 cytokines (IL-17 and IL-22) induce SCCA 2 elevation in serum and skin. “Significant elevation of SCCA2 is associated with disease severity and reflects treatment efficacy. SCCA2 may be a useful biomarker in psoriasis, reflecting Th17-type inflammation – the main determinant of the severity of psoriasis,” wrote Dr. Yuko Watanabe of Yokohama (Japan) City University and associates (Br J Derm. 2016 Jan 29. doi: 10.1111/bjd.14426).

According to the investigators, the commonly used psoriasis area severity index (PASI) is suboptimal because it is not truly quantitative and varies among clinicians. Since there are several new treatment options for psoriasis, including biologics, the authors believe that a new serum marker for psoriasis is needed to evaluate disease activity and manage treatment.

The prospective, cross-sectional study included 123 patients with psoriasis and 25 healthy controls. Serum SCCA2 levels were significantly higher in patients with psoriasis, compared with controls: a median of 2.7 ng/mL versus 0.70 ng/mL, respectively (P <.0001). Serum SCCA2 levels were positively correlated with PASI for all patients with psoriasis, regardless of subtype. In 38 patients on monotherapy or combination therapy with drugs to treat psoriasis, SCCA2 levels decreased in the 35 patients whose PASI improved on treatment (P <.0001) and increased in the three cases of clinical deterioration.

The study was supported by a grant from Japan’s Ministry of Education, Culture, Sports, Science and Technology. The investigators declared that they had no conflicts of interest.

The level of serum squamous cell carcinoma antigen 2 – an isoform of SCCA that is widely used as a tumor marker for SCC – was significantly higher in both skin and serum of patients with psoriasis, compared with healthy volunteers in a recent study, correlating with psoriasis severity score and reflecting treatment efficacy.

The intensity of skin and serum levels of SCCA2 was correlated in patients with psoriasis, and the study results also suggest that Th17 cytokines (IL-17 and IL-22) induce SCCA 2 elevation in serum and skin. “Significant elevation of SCCA2 is associated with disease severity and reflects treatment efficacy. SCCA2 may be a useful biomarker in psoriasis, reflecting Th17-type inflammation – the main determinant of the severity of psoriasis,” wrote Dr. Yuko Watanabe of Yokohama (Japan) City University and associates (Br J Derm. 2016 Jan 29. doi: 10.1111/bjd.14426).

According to the investigators, the commonly used psoriasis area severity index (PASI) is suboptimal because it is not truly quantitative and varies among clinicians. Since there are several new treatment options for psoriasis, including biologics, the authors believe that a new serum marker for psoriasis is needed to evaluate disease activity and manage treatment.

The prospective, cross-sectional study included 123 patients with psoriasis and 25 healthy controls. Serum SCCA2 levels were significantly higher in patients with psoriasis, compared with controls: a median of 2.7 ng/mL versus 0.70 ng/mL, respectively (P <.0001). Serum SCCA2 levels were positively correlated with PASI for all patients with psoriasis, regardless of subtype. In 38 patients on monotherapy or combination therapy with drugs to treat psoriasis, SCCA2 levels decreased in the 35 patients whose PASI improved on treatment (P <.0001) and increased in the three cases of clinical deterioration.

The study was supported by a grant from Japan’s Ministry of Education, Culture, Sports, Science and Technology. The investigators declared that they had no conflicts of interest.

The level of serum squamous cell carcinoma antigen 2 – an isoform of SCCA that is widely used as a tumor marker for SCC – was significantly higher in both skin and serum of patients with psoriasis, compared with healthy volunteers in a recent study, correlating with psoriasis severity score and reflecting treatment efficacy.

The intensity of skin and serum levels of SCCA2 was correlated in patients with psoriasis, and the study results also suggest that Th17 cytokines (IL-17 and IL-22) induce SCCA 2 elevation in serum and skin. “Significant elevation of SCCA2 is associated with disease severity and reflects treatment efficacy. SCCA2 may be a useful biomarker in psoriasis, reflecting Th17-type inflammation – the main determinant of the severity of psoriasis,” wrote Dr. Yuko Watanabe of Yokohama (Japan) City University and associates (Br J Derm. 2016 Jan 29. doi: 10.1111/bjd.14426).

According to the investigators, the commonly used psoriasis area severity index (PASI) is suboptimal because it is not truly quantitative and varies among clinicians. Since there are several new treatment options for psoriasis, including biologics, the authors believe that a new serum marker for psoriasis is needed to evaluate disease activity and manage treatment.

The prospective, cross-sectional study included 123 patients with psoriasis and 25 healthy controls. Serum SCCA2 levels were significantly higher in patients with psoriasis, compared with controls: a median of 2.7 ng/mL versus 0.70 ng/mL, respectively (P <.0001). Serum SCCA2 levels were positively correlated with PASI for all patients with psoriasis, regardless of subtype. In 38 patients on monotherapy or combination therapy with drugs to treat psoriasis, SCCA2 levels decreased in the 35 patients whose PASI improved on treatment (P <.0001) and increased in the three cases of clinical deterioration.

The study was supported by a grant from Japan’s Ministry of Education, Culture, Sports, Science and Technology. The investigators declared that they had no conflicts of interest.

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – “Why say ‘noncompliant patient’? It’s redundant!”

That’s what Dr. Steven R. Feldman jokingly told an audience at this year’s Caribbean Dermatology Symposium, provided by the Global Academy for Medical Education.

In this video interview, Dr. Feldman, the director of the Psoriasis Treatment Center at Wake Forest University, Winston-Salem, N.C., recounts anecdotes that led him to understand what it takes to get patients to comply with treatment, also shares his tips for getting patients to take a more active role in healing what ails them, whether it be psoriasis or any other illness.

Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – When considering the use of biologic therapy for psoriasis patients who are at greater risk of cancer or of serious infection, Dr. Kenneth B. Gordon advises clinicians to “look at the patient in front of you” and the impact the disease is having on them.

In an interview at the annual Caribbean Dermatology Symposium, Dr. Gordon, professor of dermatology at Northwestern University, Chicago, discusses the use of biologics to treat psoriasis in patients with a history of cancer, patients at an increased risk for serious infections (such as those with chronic renal disease or diabetes), as well as patients with HIV, who can have significant psoriasis.

He also provides some recommendations on counseling patients and discusses the use of biologics in children with psoriasis.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

This article was updated 1/31/2016.

GRAND CAYMAN – When considering the use of biologic therapy for psoriasis patients who are at greater risk of cancer or of serious infection, Dr. Kenneth B. Gordon advises clinicians to “look at the patient in front of you” and the impact the disease is having on them.

In an interview at the annual Caribbean Dermatology Symposium, Dr. Gordon, professor of dermatology at Northwestern University, Chicago, discusses the use of biologics to treat psoriasis in patients with a history of cancer, patients at an increased risk for serious infections (such as those with chronic renal disease or diabetes), as well as patients with HIV, who can have significant psoriasis.

He also provides some recommendations on counseling patients and discusses the use of biologics in children with psoriasis.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

This article was updated 1/31/2016.

GRAND CAYMAN – When considering the use of biologic therapy for psoriasis patients who are at greater risk of cancer or of serious infection, Dr. Kenneth B. Gordon advises clinicians to “look at the patient in front of you” and the impact the disease is having on them.

In an interview at the annual Caribbean Dermatology Symposium, Dr. Gordon, professor of dermatology at Northwestern University, Chicago, discusses the use of biologics to treat psoriasis in patients with a history of cancer, patients at an increased risk for serious infections (such as those with chronic renal disease or diabetes), as well as patients with HIV, who can have significant psoriasis.

He also provides some recommendations on counseling patients and discusses the use of biologics in children with psoriasis.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

This article was updated 1/31/2016.

Laws recently passed or under consideration in state legislatures may offer some relief to physicians and patients dogged by the “step” or “fail-first” therapy protocols mandated by insurers, but until better clinical evidence is available to support treatment decisions and biosimilars reduce costs, clinicians must strategize to get patients through the step pathways as fast as possible.

Rheumatologists, gastroenterologists, and dermatologists all confront fail-first policies in their practices, particularly when prescribing the biologic agents that have been game changers in treating rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, among other diseases.

In RA, for example, a patient might be required to fail a series of disease-modifying antirheumatic drugs (DMARDs), including methotrexate, before starting a biologic. In Crohn’s disease, patients might have to first fail on steroids and immunosuppressants.

Most clinicians consider cost concerns fair as a basis for insurance decisions. But they can also have strong rationales for making exceptions. This may mean starting patients on a biologic early, particularly those they deem unlikely to respond to first- or second-line treatments – which may be cheaper but are not necessarily safer.

In egregious cases, a patient already stable on a biologic who has changed insurance plans may be forced to go backwards in the treatment pathway, and fail first- and second-line therapies all over again before resuming – a process unlikely to be cost-effective in the long term, and also rife with ethical concerns, say clinicians.

“Making a patient fail to get a less toxic drug sort of violates our ‘do no harm’ principle,” Dr. Stephen B. Hanauer, medical director of the Digestive Health Center at Northwestern University, Chicago, said in an interview.

“I always say that if biologics cost a dollar, we’d be using them for everybody. If you take away the steroids and the immunosuppressants, these are very safe drugs for IBD, far safer than steroids – but steroids are cheap,” Dr. Hanauer said.

And with some debilitating disease presentations, such as severe Crohn’s, “being told that we have to try conventional therapies and the patient has to fail them can mean putting the patient through progression of their disease, and suffering,” Dr. David T. Rubin, codirector of the Digestive Diseases Center at the University of Chicago, said in an interview. “We really struggle with this.”

Dr. Joseph S. Eastern, a dermatologist practicing in Belleville, N.J., said his specialty faces similar challenges with step therapy. “Dermatologists as a group are pretty risk averse. When given the opportunity, we do an excellent job of prescribing conventional medications, ultraviolet therapy, and biologics in the most cost-efficient possible way,” he said in an email.

Yet “third-party payers tell us, for example, that a patient must fail methotrexate before we can use a biologic, when the whole advantage of biologic therapy for many of these patients is the avoidance of organotoxicity and other serious risks.”

As a result, Dr. Eastern said, “I write a lot more vehement letters to payers about the biologics these days.”

Choice vs. cost

Rheumatologists are among the clinicians most affected by fail-first and step therapy mandates, as the diseases they treat – particularly RA – are the most established indications for biologic therapies, and for which the largest number of these are approved.

Courtesy Dr. Norman Gaylis

Though Medicare and Medicaid allow physicians considerable leeway, private insurers often tightly circumscribe the timing and choice of biologics in RA. As insurers’ first-choice biologic drug changes frequently, and varies from plan to plan, a patient who is stable on one agent might be asked to switch to another, a phenomenon known as nonmedical switching.

Insurers are seldom transparent about their reasons for establishing certain biologic drugs as their go-to agents, clinicians say, while making it difficult for physicians to prescribe others. “There’s a tremendous amount of discounting going on that we are oblivious to as physicians. I’ve seen situations where drug A is the first one you have to use this month and the next month, drug C,” said Dr. Norman Gaylis, a rheumatologist practicing in Aventura, Fla.

Attempting to start a patient on a nonpreferential biologic will generate paperwork and delays, Dr. Gaylis said, which can cost patients valuable time. “There’s a window of opportunity to treat these diseases, and by creating a step therapy pathway we’re closing the window at least partially.”

“As an example, rituximab in most payer plans is not tiered as a first-line biologic treatment option despite the fact that there are frequent scenarios where the clinical and serological presentation of a patient would suggest it to be preferable as a first-line treatment choice over an anti-TNF [tumor necrosis factor],” Dr. Gaylis said.

“There is no room for clinical decision making based upon the unique presentation of each different patient when choosing the best treatment option,” he said.

Rheumatologists often become overwhelmed with authorization paperwork, “and still in many instances end up with a denial of their request.”

Dr. Karen Kolba, a rheumatologist in private practice in Santa Maria, Calif., said that she agreed in principle with the way step therapy protocols have been established, and that some of the frustration with step therapy amounts to a tendency among specialist clinicians to bristle at being told what to do.

“Physicians hate protocol,” Dr. Kolba said. “But comparing one protocol to another is the only way we are going to make advances.” It took the rheumatology community about 30 years to come to terms with the use of methotrexate in RA, she noted, and the stepped approach grew naturally from the treatment of methotrexate failures with biologic agents when these first emerged in the late 1990s.

A majority of RA patients started on a stepped approach using DMARDs will respond, Dr. Kolba said, and for those who must move into the biologic realm, the vast majority will succeed on the first anti-TNF agent prescribed. And there is little science to establish that one TNF inhibitor is superior – only that patients can sometimes succeed with one and fail another.

“As far as which biologic to initiate, my personal opinion is I don’t care, and I tell the patients that I don’t mind if the insurer picks out of this category because I’m flipping a coin as well,” she said.

Step mandates become objectionable, Dr. Kolba said, when they are purportedly based in science that doesn’t exist, or when they seem to exist only to wear down the provider.

“With private insurance not only do they have the drug of the year, they’re going to make me battle for every single prescription. When I say I have tried this patient on maximal tolerable doses of all these DMARDs, they ought to believe me. Yet I get six-page forms back saying, ‘Give me the start and stop dates of all the drugs you’ve used.’”

States constrain fail first

For many specialists treating patients with biologics, some of these hurdles are already getting lowered.

Concerns about physician choice, a lack of transparency in insurer decision making, and the ethics of forcing patients to fail have led advocacy groups to press hard in recent years for legislation limiting step therapy – with successes in a dozen states.

While the state legislation is not disease or drug specific, it has important implications for clinicians treating with biologics. “Step therapy in its genesis was a good idea – it’s OK to try to reduce costs in the health care system,” said Patrick Stone, state government relations manager at the National Psoriasis Foundation in Annapolis, Md., a group that works extensively on step therapy issues. “But when these protocols were first crafted, medications like biologics weren’t in use.”

Jeff Okazaki, associate director of the Coalition of State Rheumatology Organizations, a group based in Schaumberg, Ill., said lawmakers are starting to accept that in terms of cost of care, “somebody not being treated appropriately and down the line has organ damage or comorbidity because of incorrect treatment decisions due to step therapy is a higher burden.”

Moreover, he said, “we’d seen protocols requiring five or more steps, and for each step you have to try it at least 90 days.” For a patient with rheumatic or autoimmune disease, “getting through something like that can just be devastating.”

In 2011, Connecticut, Mississippi, and Arkansas became the first states to pass legislation limiting some aspect of step therapy. Since then, nine additional states have passed legislation varying in focus and scope.

In Kentucky, for example, patients cannot be forced by their insurer to remain on an ineffective therapy for more than 30 days, and insurers must respond to physician requests for an override within 2 days. Mississippi allows physicians to override insurer decisions with proof of clinical evidence. In California, legislation passed last year aims to reduce bureaucracy and speed up response to physician requests for overrides.

Mr. Stone and Mr. Okazaki are working in a coalition with other dermatology, rheumatology, and GI groups to push bills in seven more states, including New York, North Carolina, and Ohio.

While all the bills differ in what they attempt to limit, the model legislation has three basic objectives, Mr. Okazaki said. “We want a clear set of clinical guidelines, a quick review process, and overrides that allow for exceptions in cases where patients shouldn’t have to go through step therapy.”

Clinical strategies and research gaps

New legislation undoubtedly will help providers and patients get access to their choice of treatment agents. But so long as biologics are expensive – and it will be a while before the first biosimilar drugs, which will have efficacy and safety similar to their reference biologics, reduce prices in any meaningful way – step therapy will likely remain the norm.

One of the key difficulties providers face when pushing back on an insurer in favor of a biologic drug is insufficient clinical evidence.

With IBD, Dr. Rubin said, “we need a need more longitudinal understanding” and better prognostic indicators “in order to justify spending the extra money or going to one of these therapies.”

Dr. Hanauer said one of the limitations he faces in practice is insufficient clinical evidence for biologics early in the treatment pathway for IBD.

RA “is much more common than Crohn’s disease is. In trials, it’s much easier to recruit hundreds of patients [for an RA trial], while with Crohn’s it’s very hard to enroll more than a couple a year at most sites,” he said. “And as you move earlier in the treatment pathway that becomes somewhat more difficult as well.”

His solution for now, he said, is to follow established step pathways in an accelerated way, for “a rapid transition toward highly effective therapies” without having to face extensive pushback from insurers.

“The idea is to initiate immunosuppressants for any patients with sufficient disease activity to justify steroids,” Dr. Hanauer said. “Their steroids are then tapered, and while on immunosuppressants, patients are in a perfect setup to get combination therapy with an immunosuppressive and a biologic – and that’s a 2- to 3-month transition, not 2-3 years.”

Dr. Kolba said that despite the wide array of options for treating RA, the specialty suffers from a dearth of understanding as to why some patients fail drugs while others succeed, even within the same drug class.

Rheumatologists’ prescribing choices would be highly influenced by better biomarkers, were they to become available, she said. And they’d have far better arguments when confronted with payer pushback.

“We’re all looking for that magic biologic marker to tell me which drug to use,” Dr. Kolba said, “because God knows if I had a blood test that said ‘this is the drug,’ I would go to the mat with the insurer.”

Laws recently passed or under consideration in state legislatures may offer some relief to physicians and patients dogged by the “step” or “fail-first” therapy protocols mandated by insurers, but until better clinical evidence is available to support treatment decisions and biosimilars reduce costs, clinicians must strategize to get patients through the step pathways as fast as possible.

Rheumatologists, gastroenterologists, and dermatologists all confront fail-first policies in their practices, particularly when prescribing the biologic agents that have been game changers in treating rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, among other diseases.

In RA, for example, a patient might be required to fail a series of disease-modifying antirheumatic drugs (DMARDs), including methotrexate, before starting a biologic. In Crohn’s disease, patients might have to first fail on steroids and immunosuppressants.

Most clinicians consider cost concerns fair as a basis for insurance decisions. But they can also have strong rationales for making exceptions. This may mean starting patients on a biologic early, particularly those they deem unlikely to respond to first- or second-line treatments – which may be cheaper but are not necessarily safer.

In egregious cases, a patient already stable on a biologic who has changed insurance plans may be forced to go backwards in the treatment pathway, and fail first- and second-line therapies all over again before resuming – a process unlikely to be cost-effective in the long term, and also rife with ethical concerns, say clinicians.

“Making a patient fail to get a less toxic drug sort of violates our ‘do no harm’ principle,” Dr. Stephen B. Hanauer, medical director of the Digestive Health Center at Northwestern University, Chicago, said in an interview.

“I always say that if biologics cost a dollar, we’d be using them for everybody. If you take away the steroids and the immunosuppressants, these are very safe drugs for IBD, far safer than steroids – but steroids are cheap,” Dr. Hanauer said.

And with some debilitating disease presentations, such as severe Crohn’s, “being told that we have to try conventional therapies and the patient has to fail them can mean putting the patient through progression of their disease, and suffering,” Dr. David T. Rubin, codirector of the Digestive Diseases Center at the University of Chicago, said in an interview. “We really struggle with this.”

Dr. Joseph S. Eastern, a dermatologist practicing in Belleville, N.J., said his specialty faces similar challenges with step therapy. “Dermatologists as a group are pretty risk averse. When given the opportunity, we do an excellent job of prescribing conventional medications, ultraviolet therapy, and biologics in the most cost-efficient possible way,” he said in an email.

Yet “third-party payers tell us, for example, that a patient must fail methotrexate before we can use a biologic, when the whole advantage of biologic therapy for many of these patients is the avoidance of organotoxicity and other serious risks.”

As a result, Dr. Eastern said, “I write a lot more vehement letters to payers about the biologics these days.”

Choice vs. cost

Rheumatologists are among the clinicians most affected by fail-first and step therapy mandates, as the diseases they treat – particularly RA – are the most established indications for biologic therapies, and for which the largest number of these are approved.

Courtesy Dr. Norman Gaylis

Though Medicare and Medicaid allow physicians considerable leeway, private insurers often tightly circumscribe the timing and choice of biologics in RA. As insurers’ first-choice biologic drug changes frequently, and varies from plan to plan, a patient who is stable on one agent might be asked to switch to another, a phenomenon known as nonmedical switching.

Insurers are seldom transparent about their reasons for establishing certain biologic drugs as their go-to agents, clinicians say, while making it difficult for physicians to prescribe others. “There’s a tremendous amount of discounting going on that we are oblivious to as physicians. I’ve seen situations where drug A is the first one you have to use this month and the next month, drug C,” said Dr. Norman Gaylis, a rheumatologist practicing in Aventura, Fla.

Attempting to start a patient on a nonpreferential biologic will generate paperwork and delays, Dr. Gaylis said, which can cost patients valuable time. “There’s a window of opportunity to treat these diseases, and by creating a step therapy pathway we’re closing the window at least partially.”

“As an example, rituximab in most payer plans is not tiered as a first-line biologic treatment option despite the fact that there are frequent scenarios where the clinical and serological presentation of a patient would suggest it to be preferable as a first-line treatment choice over an anti-TNF [tumor necrosis factor],” Dr. Gaylis said.

“There is no room for clinical decision making based upon the unique presentation of each different patient when choosing the best treatment option,” he said.

Rheumatologists often become overwhelmed with authorization paperwork, “and still in many instances end up with a denial of their request.”

Dr. Karen Kolba, a rheumatologist in private practice in Santa Maria, Calif., said that she agreed in principle with the way step therapy protocols have been established, and that some of the frustration with step therapy amounts to a tendency among specialist clinicians to bristle at being told what to do.

“Physicians hate protocol,” Dr. Kolba said. “But comparing one protocol to another is the only way we are going to make advances.” It took the rheumatology community about 30 years to come to terms with the use of methotrexate in RA, she noted, and the stepped approach grew naturally from the treatment of methotrexate failures with biologic agents when these first emerged in the late 1990s.

A majority of RA patients started on a stepped approach using DMARDs will respond, Dr. Kolba said, and for those who must move into the biologic realm, the vast majority will succeed on the first anti-TNF agent prescribed. And there is little science to establish that one TNF inhibitor is superior – only that patients can sometimes succeed with one and fail another.

“As far as which biologic to initiate, my personal opinion is I don’t care, and I tell the patients that I don’t mind if the insurer picks out of this category because I’m flipping a coin as well,” she said.

Step mandates become objectionable, Dr. Kolba said, when they are purportedly based in science that doesn’t exist, or when they seem to exist only to wear down the provider.

“With private insurance not only do they have the drug of the year, they’re going to make me battle for every single prescription. When I say I have tried this patient on maximal tolerable doses of all these DMARDs, they ought to believe me. Yet I get six-page forms back saying, ‘Give me the start and stop dates of all the drugs you’ve used.’”

States constrain fail first

For many specialists treating patients with biologics, some of these hurdles are already getting lowered.

Concerns about physician choice, a lack of transparency in insurer decision making, and the ethics of forcing patients to fail have led advocacy groups to press hard in recent years for legislation limiting step therapy – with successes in a dozen states.

While the state legislation is not disease or drug specific, it has important implications for clinicians treating with biologics. “Step therapy in its genesis was a good idea – it’s OK to try to reduce costs in the health care system,” said Patrick Stone, state government relations manager at the National Psoriasis Foundation in Annapolis, Md., a group that works extensively on step therapy issues. “But when these protocols were first crafted, medications like biologics weren’t in use.”

Jeff Okazaki, associate director of the Coalition of State Rheumatology Organizations, a group based in Schaumberg, Ill., said lawmakers are starting to accept that in terms of cost of care, “somebody not being treated appropriately and down the line has organ damage or comorbidity because of incorrect treatment decisions due to step therapy is a higher burden.”

Moreover, he said, “we’d seen protocols requiring five or more steps, and for each step you have to try it at least 90 days.” For a patient with rheumatic or autoimmune disease, “getting through something like that can just be devastating.”

In 2011, Connecticut, Mississippi, and Arkansas became the first states to pass legislation limiting some aspect of step therapy. Since then, nine additional states have passed legislation varying in focus and scope.

In Kentucky, for example, patients cannot be forced by their insurer to remain on an ineffective therapy for more than 30 days, and insurers must respond to physician requests for an override within 2 days. Mississippi allows physicians to override insurer decisions with proof of clinical evidence. In California, legislation passed last year aims to reduce bureaucracy and speed up response to physician requests for overrides.

Mr. Stone and Mr. Okazaki are working in a coalition with other dermatology, rheumatology, and GI groups to push bills in seven more states, including New York, North Carolina, and Ohio.

While all the bills differ in what they attempt to limit, the model legislation has three basic objectives, Mr. Okazaki said. “We want a clear set of clinical guidelines, a quick review process, and overrides that allow for exceptions in cases where patients shouldn’t have to go through step therapy.”

Clinical strategies and research gaps

New legislation undoubtedly will help providers and patients get access to their choice of treatment agents. But so long as biologics are expensive – and it will be a while before the first biosimilar drugs, which will have efficacy and safety similar to their reference biologics, reduce prices in any meaningful way – step therapy will likely remain the norm.

One of the key difficulties providers face when pushing back on an insurer in favor of a biologic drug is insufficient clinical evidence.

With IBD, Dr. Rubin said, “we need a need more longitudinal understanding” and better prognostic indicators “in order to justify spending the extra money or going to one of these therapies.”

Dr. Hanauer said one of the limitations he faces in practice is insufficient clinical evidence for biologics early in the treatment pathway for IBD.

RA “is much more common than Crohn’s disease is. In trials, it’s much easier to recruit hundreds of patients [for an RA trial], while with Crohn’s it’s very hard to enroll more than a couple a year at most sites,” he said. “And as you move earlier in the treatment pathway that becomes somewhat more difficult as well.”

His solution for now, he said, is to follow established step pathways in an accelerated way, for “a rapid transition toward highly effective therapies” without having to face extensive pushback from insurers.

“The idea is to initiate immunosuppressants for any patients with sufficient disease activity to justify steroids,” Dr. Hanauer said. “Their steroids are then tapered, and while on immunosuppressants, patients are in a perfect setup to get combination therapy with an immunosuppressive and a biologic – and that’s a 2- to 3-month transition, not 2-3 years.”

Dr. Kolba said that despite the wide array of options for treating RA, the specialty suffers from a dearth of understanding as to why some patients fail drugs while others succeed, even within the same drug class.

Rheumatologists’ prescribing choices would be highly influenced by better biomarkers, were they to become available, she said. And they’d have far better arguments when confronted with payer pushback.

“We’re all looking for that magic biologic marker to tell me which drug to use,” Dr. Kolba said, “because God knows if I had a blood test that said ‘this is the drug,’ I would go to the mat with the insurer.”

Laws recently passed or under consideration in state legislatures may offer some relief to physicians and patients dogged by the “step” or “fail-first” therapy protocols mandated by insurers, but until better clinical evidence is available to support treatment decisions and biosimilars reduce costs, clinicians must strategize to get patients through the step pathways as fast as possible.

Rheumatologists, gastroenterologists, and dermatologists all confront fail-first policies in their practices, particularly when prescribing the biologic agents that have been game changers in treating rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, among other diseases.

In RA, for example, a patient might be required to fail a series of disease-modifying antirheumatic drugs (DMARDs), including methotrexate, before starting a biologic. In Crohn’s disease, patients might have to first fail on steroids and immunosuppressants.

Most clinicians consider cost concerns fair as a basis for insurance decisions. But they can also have strong rationales for making exceptions. This may mean starting patients on a biologic early, particularly those they deem unlikely to respond to first- or second-line treatments – which may be cheaper but are not necessarily safer.

In egregious cases, a patient already stable on a biologic who has changed insurance plans may be forced to go backwards in the treatment pathway, and fail first- and second-line therapies all over again before resuming – a process unlikely to be cost-effective in the long term, and also rife with ethical concerns, say clinicians.

“Making a patient fail to get a less toxic drug sort of violates our ‘do no harm’ principle,” Dr. Stephen B. Hanauer, medical director of the Digestive Health Center at Northwestern University, Chicago, said in an interview.

“I always say that if biologics cost a dollar, we’d be using them for everybody. If you take away the steroids and the immunosuppressants, these are very safe drugs for IBD, far safer than steroids – but steroids are cheap,” Dr. Hanauer said.

And with some debilitating disease presentations, such as severe Crohn’s, “being told that we have to try conventional therapies and the patient has to fail them can mean putting the patient through progression of their disease, and suffering,” Dr. David T. Rubin, codirector of the Digestive Diseases Center at the University of Chicago, said in an interview. “We really struggle with this.”

Dr. Joseph S. Eastern, a dermatologist practicing in Belleville, N.J., said his specialty faces similar challenges with step therapy. “Dermatologists as a group are pretty risk averse. When given the opportunity, we do an excellent job of prescribing conventional medications, ultraviolet therapy, and biologics in the most cost-efficient possible way,” he said in an email.

Yet “third-party payers tell us, for example, that a patient must fail methotrexate before we can use a biologic, when the whole advantage of biologic therapy for many of these patients is the avoidance of organotoxicity and other serious risks.”

As a result, Dr. Eastern said, “I write a lot more vehement letters to payers about the biologics these days.”

Choice vs. cost

Rheumatologists are among the clinicians most affected by fail-first and step therapy mandates, as the diseases they treat – particularly RA – are the most established indications for biologic therapies, and for which the largest number of these are approved.

Courtesy Dr. Norman Gaylis

Though Medicare and Medicaid allow physicians considerable leeway, private insurers often tightly circumscribe the timing and choice of biologics in RA. As insurers’ first-choice biologic drug changes frequently, and varies from plan to plan, a patient who is stable on one agent might be asked to switch to another, a phenomenon known as nonmedical switching.

Insurers are seldom transparent about their reasons for establishing certain biologic drugs as their go-to agents, clinicians say, while making it difficult for physicians to prescribe others. “There’s a tremendous amount of discounting going on that we are oblivious to as physicians. I’ve seen situations where drug A is the first one you have to use this month and the next month, drug C,” said Dr. Norman Gaylis, a rheumatologist practicing in Aventura, Fla.

Attempting to start a patient on a nonpreferential biologic will generate paperwork and delays, Dr. Gaylis said, which can cost patients valuable time. “There’s a window of opportunity to treat these diseases, and by creating a step therapy pathway we’re closing the window at least partially.”

“As an example, rituximab in most payer plans is not tiered as a first-line biologic treatment option despite the fact that there are frequent scenarios where the clinical and serological presentation of a patient would suggest it to be preferable as a first-line treatment choice over an anti-TNF [tumor necrosis factor],” Dr. Gaylis said.

“There is no room for clinical decision making based upon the unique presentation of each different patient when choosing the best treatment option,” he said.

Rheumatologists often become overwhelmed with authorization paperwork, “and still in many instances end up with a denial of their request.”

Dr. Karen Kolba, a rheumatologist in private practice in Santa Maria, Calif., said that she agreed in principle with the way step therapy protocols have been established, and that some of the frustration with step therapy amounts to a tendency among specialist clinicians to bristle at being told what to do.

“Physicians hate protocol,” Dr. Kolba said. “But comparing one protocol to another is the only way we are going to make advances.” It took the rheumatology community about 30 years to come to terms with the use of methotrexate in RA, she noted, and the stepped approach grew naturally from the treatment of methotrexate failures with biologic agents when these first emerged in the late 1990s.

A majority of RA patients started on a stepped approach using DMARDs will respond, Dr. Kolba said, and for those who must move into the biologic realm, the vast majority will succeed on the first anti-TNF agent prescribed. And there is little science to establish that one TNF inhibitor is superior – only that patients can sometimes succeed with one and fail another.

“As far as which biologic to initiate, my personal opinion is I don’t care, and I tell the patients that I don’t mind if the insurer picks out of this category because I’m flipping a coin as well,” she said.

Step mandates become objectionable, Dr. Kolba said, when they are purportedly based in science that doesn’t exist, or when they seem to exist only to wear down the provider.

“With private insurance not only do they have the drug of the year, they’re going to make me battle for every single prescription. When I say I have tried this patient on maximal tolerable doses of all these DMARDs, they ought to believe me. Yet I get six-page forms back saying, ‘Give me the start and stop dates of all the drugs you’ve used.’”

States constrain fail first

For many specialists treating patients with biologics, some of these hurdles are already getting lowered.

Concerns about physician choice, a lack of transparency in insurer decision making, and the ethics of forcing patients to fail have led advocacy groups to press hard in recent years for legislation limiting step therapy – with successes in a dozen states.

While the state legislation is not disease or drug specific, it has important implications for clinicians treating with biologics. “Step therapy in its genesis was a good idea – it’s OK to try to reduce costs in the health care system,” said Patrick Stone, state government relations manager at the National Psoriasis Foundation in Annapolis, Md., a group that works extensively on step therapy issues. “But when these protocols were first crafted, medications like biologics weren’t in use.”

Jeff Okazaki, associate director of the Coalition of State Rheumatology Organizations, a group based in Schaumberg, Ill., said lawmakers are starting to accept that in terms of cost of care, “somebody not being treated appropriately and down the line has organ damage or comorbidity because of incorrect treatment decisions due to step therapy is a higher burden.”

Moreover, he said, “we’d seen protocols requiring five or more steps, and for each step you have to try it at least 90 days.” For a patient with rheumatic or autoimmune disease, “getting through something like that can just be devastating.”

In 2011, Connecticut, Mississippi, and Arkansas became the first states to pass legislation limiting some aspect of step therapy. Since then, nine additional states have passed legislation varying in focus and scope.

In Kentucky, for example, patients cannot be forced by their insurer to remain on an ineffective therapy for more than 30 days, and insurers must respond to physician requests for an override within 2 days. Mississippi allows physicians to override insurer decisions with proof of clinical evidence. In California, legislation passed last year aims to reduce bureaucracy and speed up response to physician requests for overrides.

Mr. Stone and Mr. Okazaki are working in a coalition with other dermatology, rheumatology, and GI groups to push bills in seven more states, including New York, North Carolina, and Ohio.

While all the bills differ in what they attempt to limit, the model legislation has three basic objectives, Mr. Okazaki said. “We want a clear set of clinical guidelines, a quick review process, and overrides that allow for exceptions in cases where patients shouldn’t have to go through step therapy.”

Clinical strategies and research gaps

New legislation undoubtedly will help providers and patients get access to their choice of treatment agents. But so long as biologics are expensive – and it will be a while before the first biosimilar drugs, which will have efficacy and safety similar to their reference biologics, reduce prices in any meaningful way – step therapy will likely remain the norm.

One of the key difficulties providers face when pushing back on an insurer in favor of a biologic drug is insufficient clinical evidence.

With IBD, Dr. Rubin said, “we need a need more longitudinal understanding” and better prognostic indicators “in order to justify spending the extra money or going to one of these therapies.”

Dr. Hanauer said one of the limitations he faces in practice is insufficient clinical evidence for biologics early in the treatment pathway for IBD.

RA “is much more common than Crohn’s disease is. In trials, it’s much easier to recruit hundreds of patients [for an RA trial], while with Crohn’s it’s very hard to enroll more than a couple a year at most sites,” he said. “And as you move earlier in the treatment pathway that becomes somewhat more difficult as well.”

His solution for now, he said, is to follow established step pathways in an accelerated way, for “a rapid transition toward highly effective therapies” without having to face extensive pushback from insurers.

“The idea is to initiate immunosuppressants for any patients with sufficient disease activity to justify steroids,” Dr. Hanauer said. “Their steroids are then tapered, and while on immunosuppressants, patients are in a perfect setup to get combination therapy with an immunosuppressive and a biologic – and that’s a 2- to 3-month transition, not 2-3 years.”

Dr. Kolba said that despite the wide array of options for treating RA, the specialty suffers from a dearth of understanding as to why some patients fail drugs while others succeed, even within the same drug class.

Rheumatologists’ prescribing choices would be highly influenced by better biomarkers, were they to become available, she said. And they’d have far better arguments when confronted with payer pushback.

“We’re all looking for that magic biologic marker to tell me which drug to use,” Dr. Kolba said, “because God knows if I had a blood test that said ‘this is the drug,’ I would go to the mat with the insurer.”