Biologics have become increasingly common in the treatment regimen for moderate to severe psoriasis and psoriatic arthritis. As these drugs are more widely prescribed, healthcare providers need to be more educated about everything from the effectiveness and safety of biologics to how to properly administer the medication and the cost of treatment. With this information, physicians will have the tools to better educate patients on these issues and help them make a well-informed decision as to whether biologic treatment is the most appropriate treatment for them. Efficacy and safety were the topics of the first part this Patient Education for Biologic Therapy series; the second part will focus on the administration and cost of biologics.
Factors in Drug Administration
There are now three main groups of biologic therapy that are FDA approved for the treatment of psoriasis and psoriatic arthritis: TNF-α inhibitors, IL-12 and IL-23 antibodies and LFA-3/CD2 inhibitors. Within the TNF-α inhibitors there are three different FDA-approved biologics: entanercept (Enbrel), adalimumab (Humira) and infliximab (Remicade). Each regimen has a very unique administration profile that should be discussed with the patient, which may ultimately help in choosing the right medication.
Etanercept is an anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is 50 mg injected subcutaneously twice weekly for 3 months, with maintenance dosing of 50 mg/week thereafter. For patients who fail to show significant improvement, dose escalations of up to 50 mg injected subcutaneously twice a week indefinitely has shown some benefit.1 Neutralizing antibodies have been reported in 15.2% of patients using etanercept.2
Adalimumab is another anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is a one-time,
80-mg subcutaneous injection followed by a maintenance dose of 40 mg injected every other week starting one week after the initial 80-mg dose. Some efficacy in dose escalations to a maintenance dose of 40 mg every week has been shown in a number of small studies.3 The exact data for the number of patients who develop antibodies against adalimumab is unclear; it has been shown that the presence of antibodies is associated with decreased efficacy once the medication is withdrawn.4
Infliximab is the last anti-TNF-α medication FDA-approved for moderate-to-severe plaque-type psoriasis. The FDA standard dosing regimen is 5 mg/kg infused intravenously at weeks 0, 2 and 6, with maintenance dosing of 5 mg/kg IV at 8-week intervals thereafter. Dose escalations with 10mg/kg IV at the same dosing intervals has shown some increased response efficacy, although fewer patients achieved a PASI 75 score.5 The risk of antibody production to infliximab ranges from 19% to 61% depending on dosing regimen.6
A relatively new medication is the interleukin 12/23 monoclonal antibody ustekinumab (Stelara). It is FDA-approved at this time for moderate-to-severe plaque type psoriasis only. The FDA standard dosing regimen is based on weight, with those ≤100 kg getting a dose of 45 mg injected subcutaneously at 0 and 4 weeks and then in 12-week intervals, while patients ≥100 kg receive an increased dose of 90 mg at the same intervals. Escalations in dosing regimens have been studied with a decreased maintenance time period from 12 to 8 weeks; there seems to be some increased efficacy in those in the 45-mg group, while those in the 90-mg dosing group actually experienced worse response.7 Approximately 5% of patients may form neutralizing antibodies to ustekinumab.8
One of the comorbidities in patients with psoriasis is obesity. Many studies have tried to look at the impact of dosing and response, especially in obese psoriasis patients.9,10 While this is a topic for which clear-cut guidelines have yet to be established, taking this into consideration may be helpful, especially in non-responders who are obese.
In addition to becoming familiar with the individual dosages of each of the available biologics, it is important that providers know how each is dispensed and administered to patients. While most are dispensed as individual prefilled syringes, each manufacturer has developed their own unique packaged product. Etanercept, for example, is supplied in three forms: a prefilled autoinjector syringe, a standard prefilled syringe and a multiple-use vial.11 The term autoinjector may imply simplicity, but even a skilled practitioner unfamiliar with the product would need to thoroughly read the instructions to properly use this device with safety guards in place and a one-click, release and wait system. Furthermore, the manufacturer has injection-site recommendations that vary depending on the how the drug is dispensed. Recommended injection site for the autoinjector is the thigh, and the thigh, abdomen or posterior upper arms for the standard pre-filled syringes and multiple-use vial. Adalimumab is dispensed as a pen or prefilled syringe and ustekinumab as a prefilled syringe or single use vial, each with their own intricacies.12,13
Once a provider is knowledgeable about how each of the biologics are dispensed and administered, they will need to educate and train patients on the proper use of the medication. Most manufacturers provide startup kits that may include a tester for training purposes as well as instructions with images on the use of each device. Training should take place in the office setting and, if possible, should include family members who may be helping to administer the drug. While this process may be time consuming, it may be beneficial to administer the first few injections in the office under supervision. This will not only assure that the drug is being administered correctly, it may help the patients overcome any fears of self-administering an injection. In addition, patients may need to be educated about the differences between a subcutaneous and intramuscular injection, what it means to rotate sites of injections, what to look for in terms of injection site reactions and how to properly dispose of the used syringes. Just as many internists have a dedicated staff member for diabetes education, if may be helpful to have a staff member become the expert in biologic education.
Cost of Treatment with Biologics
One of the most important factors in choosing a treatment for any condition is cost. Regardless of efficacy and safety, cost of medication and ease of administration will determine which of the many agents to choose. When it comes to prescribing a biologic therapy, there are many variables that must be considered. Does the patient have private insurance? Does the insurer require prior treatment and failure with phototherapy or a non-biologic systemic medication like methotrexate before they will approve coverage? Does the patient qualify for one of the many biologic drug manufacturer programs that offer financial assistance to help with the cost of medication?14 With several biologics to choose from and the many prescription coverage plans in the marketplace, the logistics of determining cost of treatment can be complex.
A study by Yentzer and colleagues looked at three large insurance carriers’ coverage of biologics and phototherapy and performed a cost comparison.15 Out-of-pocket cost, not including copayments and deductibles, for the patient was less for biologics than for phototherapy — $920 versus $3,040 for the first year of treatment — while the cost to the insurer for biologics was significant: $23,408 compared to $76 for in-office phototherapy. In a similar study by Simpson et al, a cost model was developed that incorporated copayments for office visits as well as pharmacy copayments for patients on biologic therapy.16 Estimated annual out-of-pocket expenses for etanercept was $840, while the treatment cost to the managed care organizations was $20,281 annually. It may be more feasible for a patient to pay the cost of a biologic compared to the cost of phototherapy, but the healthcare system as a whole should be considered.17 Because of the high costs, there are time-consuming pre-approval steps for coverage of treatment.
The newest of the biologics, ustekinumab, may seem attractive to many patients and providers because of its dosing schedule of one injection every 3 months, but some insurers require that a patient first experience treatment failure with one of the older anti-TNF-α biologics (a policy that we do not agree with). Ustekinumab’s current wholesale price is about $6,300 per injection, making its annual cost comparable to older biologic therapies.18
To help navigate the complexities of the financial aspect of biologics, most manufacturers provide care coordinators or insurance specialists to help determine the cost of the drug depending on a patient’s specific insurance, as well as help guide them through pre-authorizations and/or appeals of denial of coverage.
Whether a patient is uninsured, insured but cannot afford the medication, or has Medicare or Medicaid, financial assistance is often available. Program details and instructions on how to apply for assistance are available on the pharmaceutical companies’ websites or through dedicated phone lines, which are easily accessible through the National Psoriasis Foundation.14 For example, Amgen and Pfizer, the manufacturers of etanercept, have a payment assistance program called Enbrel Support Program that provides help with out-of-pocket expenses for eligible patients. The Enbrel Support Program covers patients with commercial prescription coverage and provides the first 6 months of treatment at no cost and the next 6 months at $10 or less a month as well as support for copayments, coinsurance and prescription deductibles for up to $4,000 for a 6-month period. Similarly, Abbott offers the Humira Protection Plan, which provides financial assistance regardless of employment or insurance status. Unemployed and uninsured patients are provided assistance through an independent foundation such as the Abbott Patient Assistance Foundation. Patients with Medicare may be eligible for assistance through an independent co-pay foundation. Insured patients who cannot afford the medication are also offered assistance similar to the Enbrel Support card program with reduced out-of-pocket costs.
Discussion
Once it has been determined that biologic therapy is appropriate for the patient, the next step is choosing which one to use. Understanding the administration of each biologic in terms of dosage frequency and how the drug is dispensed is key. While a physician may recommend a particular biologic that they are familiar and comfortable with, an informed patient may desire a different biologic for a variety of reasons, including dosing regime and cost. When it comes to cost, determining whether a biologic is financially appropriate for a patient may take work on both the part of the patient and the physician or staff. As a healthcare provider begins to prescribe biologics, it is important that they be well educated about the many factors that ultimately determine what a patient will pay for treatment. By becoming familiar with each of the programs offered through the manufacturers of biologics, the medical staff can help direct patients to the resources available to determine the cost of medications and the accessibility of financial assistance.
Drs. Daniel and Sandoval are with the Center for Dermatology Research and the department of dermatology at Wake Forest University School of Medicine in Winston-Salem, NC.
Disclosure: The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P.
TABLE: USEFUL PATIENT INFORMATION
1. Administration of biologic treatment
a. Have company products available for demonstration. Most companies can send you patient education and demonstration materials.
b. Get a sense of the patient’s comfort level with doing injections.
c. Make sure that you have a correct weight for the patient and that the weight is checked often to assure that the biologics that have weight-based dosing are being given correctly.
d. Know about the off-label dosing regimens for patients who are not responding.
2. Cost of biologic treatment
a. Provide patients with the resources on how to contact care coordinators or insurance specialist to determine what biologic treatment will cost them.
ii. Enbrel Support
888-436-2735 (888-4ENBREL)
ii. Humira Protection Plan
888-486-4723 (888-4HUMIRA)
iii. Remistart
888-222-3771 (888-ACCESS1)
iv. SimponiOne
877-697-4676 (877-MYSIMPONI)
v. Stelara Support
877-783-5272 (877-STELARA)
b. Explain to patients with no insurance or those with insurance who cannot afford their medication that they may be eligible for financial assistance through manufacturer-sponsored programs.
3. Ask if the patient has any other questions
4. Encourage patients to write down any additional questions that arise following their visit and to bring the list of questions with them to their next office visit
Biologics have become increasingly common in the treatment regimen for moderate to severe psoriasis and psoriatic arthritis. As these drugs are more widely prescribed, healthcare providers need to be more educated about everything from the effectiveness and safety of biologics to how to properly administer the medication and the cost of treatment. With this information, physicians will have the tools to better educate patients on these issues and help them make a well-informed decision as to whether biologic treatment is the most appropriate treatment for them. Efficacy and safety were the topics of the first part this Patient Education for Biologic Therapy series; the second part will focus on the administration and cost of biologics.
Factors in Drug Administration
There are now three main groups of biologic therapy that are FDA approved for the treatment of psoriasis and psoriatic arthritis: TNF-α inhibitors, IL-12 and IL-23 antibodies and LFA-3/CD2 inhibitors. Within the TNF-α inhibitors there are three different FDA-approved biologics: entanercept (Enbrel), adalimumab (Humira) and infliximab (Remicade). Each regimen has a very unique administration profile that should be discussed with the patient, which may ultimately help in choosing the right medication.
Etanercept is an anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is 50 mg injected subcutaneously twice weekly for 3 months, with maintenance dosing of 50 mg/week thereafter. For patients who fail to show significant improvement, dose escalations of up to 50 mg injected subcutaneously twice a week indefinitely has shown some benefit.1 Neutralizing antibodies have been reported in 15.2% of patients using etanercept.2
Adalimumab is another anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is a one-time,
80-mg subcutaneous injection followed by a maintenance dose of 40 mg injected every other week starting one week after the initial 80-mg dose. Some efficacy in dose escalations to a maintenance dose of 40 mg every week has been shown in a number of small studies.3 The exact data for the number of patients who develop antibodies against adalimumab is unclear; it has been shown that the presence of antibodies is associated with decreased efficacy once the medication is withdrawn.4
Infliximab is the last anti-TNF-α medication FDA-approved for moderate-to-severe plaque-type psoriasis. The FDA standard dosing regimen is 5 mg/kg infused intravenously at weeks 0, 2 and 6, with maintenance dosing of 5 mg/kg IV at 8-week intervals thereafter. Dose escalations with 10mg/kg IV at the same dosing intervals has shown some increased response efficacy, although fewer patients achieved a PASI 75 score.5 The risk of antibody production to infliximab ranges from 19% to 61% depending on dosing regimen.6
A relatively new medication is the interleukin 12/23 monoclonal antibody ustekinumab (Stelara). It is FDA-approved at this time for moderate-to-severe plaque type psoriasis only. The FDA standard dosing regimen is based on weight, with those ≤100 kg getting a dose of 45 mg injected subcutaneously at 0 and 4 weeks and then in 12-week intervals, while patients ≥100 kg receive an increased dose of 90 mg at the same intervals. Escalations in dosing regimens have been studied with a decreased maintenance time period from 12 to 8 weeks; there seems to be some increased efficacy in those in the 45-mg group, while those in the 90-mg dosing group actually experienced worse response.7 Approximately 5% of patients may form neutralizing antibodies to ustekinumab.8
One of the comorbidities in patients with psoriasis is obesity. Many studies have tried to look at the impact of dosing and response, especially in obese psoriasis patients.9,10 While this is a topic for which clear-cut guidelines have yet to be established, taking this into consideration may be helpful, especially in non-responders who are obese.
In addition to becoming familiar with the individual dosages of each of the available biologics, it is important that providers know how each is dispensed and administered to patients. While most are dispensed as individual prefilled syringes, each manufacturer has developed their own unique packaged product. Etanercept, for example, is supplied in three forms: a prefilled autoinjector syringe, a standard prefilled syringe and a multiple-use vial.11 The term autoinjector may imply simplicity, but even a skilled practitioner unfamiliar with the product would need to thoroughly read the instructions to properly use this device with safety guards in place and a one-click, release and wait system. Furthermore, the manufacturer has injection-site recommendations that vary depending on the how the drug is dispensed. Recommended injection site for the autoinjector is the thigh, and the thigh, abdomen or posterior upper arms for the standard pre-filled syringes and multiple-use vial. Adalimumab is dispensed as a pen or prefilled syringe and ustekinumab as a prefilled syringe or single use vial, each with their own intricacies.12,13
Once a provider is knowledgeable about how each of the biologics are dispensed and administered, they will need to educate and train patients on the proper use of the medication. Most manufacturers provide startup kits that may include a tester for training purposes as well as instructions with images on the use of each device. Training should take place in the office setting and, if possible, should include family members who may be helping to administer the drug. While this process may be time consuming, it may be beneficial to administer the first few injections in the office under supervision. This will not only assure that the drug is being administered correctly, it may help the patients overcome any fears of self-administering an injection. In addition, patients may need to be educated about the differences between a subcutaneous and intramuscular injection, what it means to rotate sites of injections, what to look for in terms of injection site reactions and how to properly dispose of the used syringes. Just as many internists have a dedicated staff member for diabetes education, if may be helpful to have a staff member become the expert in biologic education.
Cost of Treatment with Biologics
One of the most important factors in choosing a treatment for any condition is cost. Regardless of efficacy and safety, cost of medication and ease of administration will determine which of the many agents to choose. When it comes to prescribing a biologic therapy, there are many variables that must be considered. Does the patient have private insurance? Does the insurer require prior treatment and failure with phototherapy or a non-biologic systemic medication like methotrexate before they will approve coverage? Does the patient qualify for one of the many biologic drug manufacturer programs that offer financial assistance to help with the cost of medication?14 With several biologics to choose from and the many prescription coverage plans in the marketplace, the logistics of determining cost of treatment can be complex.
A study by Yentzer and colleagues looked at three large insurance carriers’ coverage of biologics and phototherapy and performed a cost comparison.15 Out-of-pocket cost, not including copayments and deductibles, for the patient was less for biologics than for phototherapy — $920 versus $3,040 for the first year of treatment — while the cost to the insurer for biologics was significant: $23,408 compared to $76 for in-office phototherapy. In a similar study by Simpson et al, a cost model was developed that incorporated copayments for office visits as well as pharmacy copayments for patients on biologic therapy.16 Estimated annual out-of-pocket expenses for etanercept was $840, while the treatment cost to the managed care organizations was $20,281 annually. It may be more feasible for a patient to pay the cost of a biologic compared to the cost of phototherapy, but the healthcare system as a whole should be considered.17 Because of the high costs, there are time-consuming pre-approval steps for coverage of treatment.
The newest of the biologics, ustekinumab, may seem attractive to many patients and providers because of its dosing schedule of one injection every 3 months, but some insurers require that a patient first experience treatment failure with one of the older anti-TNF-α biologics (a policy that we do not agree with). Ustekinumab’s current wholesale price is about $6,300 per injection, making its annual cost comparable to older biologic therapies.18
To help navigate the complexities of the financial aspect of biologics, most manufacturers provide care coordinators or insurance specialists to help determine the cost of the drug depending on a patient’s specific insurance, as well as help guide them through pre-authorizations and/or appeals of denial of coverage.
Whether a patient is uninsured, insured but cannot afford the medication, or has Medicare or Medicaid, financial assistance is often available. Program details and instructions on how to apply for assistance are available on the pharmaceutical companies’ websites or through dedicated phone lines, which are easily accessible through the National Psoriasis Foundation.14 For example, Amgen and Pfizer, the manufacturers of etanercept, have a payment assistance program called Enbrel Support Program that provides help with out-of-pocket expenses for eligible patients. The Enbrel Support Program covers patients with commercial prescription coverage and provides the first 6 months of treatment at no cost and the next 6 months at $10 or less a month as well as support for copayments, coinsurance and prescription deductibles for up to $4,000 for a 6-month period. Similarly, Abbott offers the Humira Protection Plan, which provides financial assistance regardless of employment or insurance status. Unemployed and uninsured patients are provided assistance through an independent foundation such as the Abbott Patient Assistance Foundation. Patients with Medicare may be eligible for assistance through an independent co-pay foundation. Insured patients who cannot afford the medication are also offered assistance similar to the Enbrel Support card program with reduced out-of-pocket costs.
Discussion
Once it has been determined that biologic therapy is appropriate for the patient, the next step is choosing which one to use. Understanding the administration of each biologic in terms of dosage frequency and how the drug is dispensed is key. While a physician may recommend a particular biologic that they are familiar and comfortable with, an informed patient may desire a different biologic for a variety of reasons, including dosing regime and cost. When it comes to cost, determining whether a biologic is financially appropriate for a patient may take work on both the part of the patient and the physician or staff. As a healthcare provider begins to prescribe biologics, it is important that they be well educated about the many factors that ultimately determine what a patient will pay for treatment. By becoming familiar with each of the programs offered through the manufacturers of biologics, the medical staff can help direct patients to the resources available to determine the cost of medications and the accessibility of financial assistance.
Drs. Daniel and Sandoval are with the Center for Dermatology Research and the department of dermatology at Wake Forest University School of Medicine in Winston-Salem, NC.
Disclosure: The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P.
TABLE: USEFUL PATIENT INFORMATION
1. Administration of biologic treatment
a. Have company products available for demonstration. Most companies can send you patient education and demonstration materials.
b. Get a sense of the patient’s comfort level with doing injections.
c. Make sure that you have a correct weight for the patient and that the weight is checked often to assure that the biologics that have weight-based dosing are being given correctly.
d. Know about the off-label dosing regimens for patients who are not responding.
2. Cost of biologic treatment
a. Provide patients with the resources on how to contact care coordinators or insurance specialist to determine what biologic treatment will cost them.
ii. Enbrel Support
888-436-2735 (888-4ENBREL)
ii. Humira Protection Plan
888-486-4723 (888-4HUMIRA)
iii. Remistart
888-222-3771 (888-ACCESS1)
iv. SimponiOne
877-697-4676 (877-MYSIMPONI)
v. Stelara Support
877-783-5272 (877-STELARA)
b. Explain to patients with no insurance or those with insurance who cannot afford their medication that they may be eligible for financial assistance through manufacturer-sponsored programs.
3. Ask if the patient has any other questions
4. Encourage patients to write down any additional questions that arise following their visit and to bring the list of questions with them to their next office visit
Biologics have become increasingly common in the treatment regimen for moderate to severe psoriasis and psoriatic arthritis. As these drugs are more widely prescribed, healthcare providers need to be more educated about everything from the effectiveness and safety of biologics to how to properly administer the medication and the cost of treatment. With this information, physicians will have the tools to better educate patients on these issues and help them make a well-informed decision as to whether biologic treatment is the most appropriate treatment for them. Efficacy and safety were the topics of the first part this Patient Education for Biologic Therapy series; the second part will focus on the administration and cost of biologics.
Factors in Drug Administration
There are now three main groups of biologic therapy that are FDA approved for the treatment of psoriasis and psoriatic arthritis: TNF-α inhibitors, IL-12 and IL-23 antibodies and LFA-3/CD2 inhibitors. Within the TNF-α inhibitors there are three different FDA-approved biologics: entanercept (Enbrel), adalimumab (Humira) and infliximab (Remicade). Each regimen has a very unique administration profile that should be discussed with the patient, which may ultimately help in choosing the right medication.
Etanercept is an anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is 50 mg injected subcutaneously twice weekly for 3 months, with maintenance dosing of 50 mg/week thereafter. For patients who fail to show significant improvement, dose escalations of up to 50 mg injected subcutaneously twice a week indefinitely has shown some benefit.1 Neutralizing antibodies have been reported in 15.2% of patients using etanercept.2
Adalimumab is another anti-TNF-α medication FDA approved for moderate-to-severe plaque psoriasis and psoriatic arthritis. The FDA-approved standard dosing regimen is a one-time,
80-mg subcutaneous injection followed by a maintenance dose of 40 mg injected every other week starting one week after the initial 80-mg dose. Some efficacy in dose escalations to a maintenance dose of 40 mg every week has been shown in a number of small studies.3 The exact data for the number of patients who develop antibodies against adalimumab is unclear; it has been shown that the presence of antibodies is associated with decreased efficacy once the medication is withdrawn.4
Infliximab is the last anti-TNF-α medication FDA-approved for moderate-to-severe plaque-type psoriasis. The FDA standard dosing regimen is 5 mg/kg infused intravenously at weeks 0, 2 and 6, with maintenance dosing of 5 mg/kg IV at 8-week intervals thereafter. Dose escalations with 10mg/kg IV at the same dosing intervals has shown some increased response efficacy, although fewer patients achieved a PASI 75 score.5 The risk of antibody production to infliximab ranges from 19% to 61% depending on dosing regimen.6
A relatively new medication is the interleukin 12/23 monoclonal antibody ustekinumab (Stelara). It is FDA-approved at this time for moderate-to-severe plaque type psoriasis only. The FDA standard dosing regimen is based on weight, with those ≤100 kg getting a dose of 45 mg injected subcutaneously at 0 and 4 weeks and then in 12-week intervals, while patients ≥100 kg receive an increased dose of 90 mg at the same intervals. Escalations in dosing regimens have been studied with a decreased maintenance time period from 12 to 8 weeks; there seems to be some increased efficacy in those in the 45-mg group, while those in the 90-mg dosing group actually experienced worse response.7 Approximately 5% of patients may form neutralizing antibodies to ustekinumab.8
One of the comorbidities in patients with psoriasis is obesity. Many studies have tried to look at the impact of dosing and response, especially in obese psoriasis patients.9,10 While this is a topic for which clear-cut guidelines have yet to be established, taking this into consideration may be helpful, especially in non-responders who are obese.
In addition to becoming familiar with the individual dosages of each of the available biologics, it is important that providers know how each is dispensed and administered to patients. While most are dispensed as individual prefilled syringes, each manufacturer has developed their own unique packaged product. Etanercept, for example, is supplied in three forms: a prefilled autoinjector syringe, a standard prefilled syringe and a multiple-use vial.11 The term autoinjector may imply simplicity, but even a skilled practitioner unfamiliar with the product would need to thoroughly read the instructions to properly use this device with safety guards in place and a one-click, release and wait system. Furthermore, the manufacturer has injection-site recommendations that vary depending on the how the drug is dispensed. Recommended injection site for the autoinjector is the thigh, and the thigh, abdomen or posterior upper arms for the standard pre-filled syringes and multiple-use vial. Adalimumab is dispensed as a pen or prefilled syringe and ustekinumab as a prefilled syringe or single use vial, each with their own intricacies.12,13
Once a provider is knowledgeable about how each of the biologics are dispensed and administered, they will need to educate and train patients on the proper use of the medication. Most manufacturers provide startup kits that may include a tester for training purposes as well as instructions with images on the use of each device. Training should take place in the office setting and, if possible, should include family members who may be helping to administer the drug. While this process may be time consuming, it may be beneficial to administer the first few injections in the office under supervision. This will not only assure that the drug is being administered correctly, it may help the patients overcome any fears of self-administering an injection. In addition, patients may need to be educated about the differences between a subcutaneous and intramuscular injection, what it means to rotate sites of injections, what to look for in terms of injection site reactions and how to properly dispose of the used syringes. Just as many internists have a dedicated staff member for diabetes education, if may be helpful to have a staff member become the expert in biologic education.
Cost of Treatment with Biologics
One of the most important factors in choosing a treatment for any condition is cost. Regardless of efficacy and safety, cost of medication and ease of administration will determine which of the many agents to choose. When it comes to prescribing a biologic therapy, there are many variables that must be considered. Does the patient have private insurance? Does the insurer require prior treatment and failure with phototherapy or a non-biologic systemic medication like methotrexate before they will approve coverage? Does the patient qualify for one of the many biologic drug manufacturer programs that offer financial assistance to help with the cost of medication?14 With several biologics to choose from and the many prescription coverage plans in the marketplace, the logistics of determining cost of treatment can be complex.
A study by Yentzer and colleagues looked at three large insurance carriers’ coverage of biologics and phototherapy and performed a cost comparison.15 Out-of-pocket cost, not including copayments and deductibles, for the patient was less for biologics than for phototherapy — $920 versus $3,040 for the first year of treatment — while the cost to the insurer for biologics was significant: $23,408 compared to $76 for in-office phototherapy. In a similar study by Simpson et al, a cost model was developed that incorporated copayments for office visits as well as pharmacy copayments for patients on biologic therapy.16 Estimated annual out-of-pocket expenses for etanercept was $840, while the treatment cost to the managed care organizations was $20,281 annually. It may be more feasible for a patient to pay the cost of a biologic compared to the cost of phototherapy, but the healthcare system as a whole should be considered.17 Because of the high costs, there are time-consuming pre-approval steps for coverage of treatment.
The newest of the biologics, ustekinumab, may seem attractive to many patients and providers because of its dosing schedule of one injection every 3 months, but some insurers require that a patient first experience treatment failure with one of the older anti-TNF-α biologics (a policy that we do not agree with). Ustekinumab’s current wholesale price is about $6,300 per injection, making its annual cost comparable to older biologic therapies.18
To help navigate the complexities of the financial aspect of biologics, most manufacturers provide care coordinators or insurance specialists to help determine the cost of the drug depending on a patient’s specific insurance, as well as help guide them through pre-authorizations and/or appeals of denial of coverage.
Whether a patient is uninsured, insured but cannot afford the medication, or has Medicare or Medicaid, financial assistance is often available. Program details and instructions on how to apply for assistance are available on the pharmaceutical companies’ websites or through dedicated phone lines, which are easily accessible through the National Psoriasis Foundation.14 For example, Amgen and Pfizer, the manufacturers of etanercept, have a payment assistance program called Enbrel Support Program that provides help with out-of-pocket expenses for eligible patients. The Enbrel Support Program covers patients with commercial prescription coverage and provides the first 6 months of treatment at no cost and the next 6 months at $10 or less a month as well as support for copayments, coinsurance and prescription deductibles for up to $4,000 for a 6-month period. Similarly, Abbott offers the Humira Protection Plan, which provides financial assistance regardless of employment or insurance status. Unemployed and uninsured patients are provided assistance through an independent foundation such as the Abbott Patient Assistance Foundation. Patients with Medicare may be eligible for assistance through an independent co-pay foundation. Insured patients who cannot afford the medication are also offered assistance similar to the Enbrel Support card program with reduced out-of-pocket costs.
Discussion
Once it has been determined that biologic therapy is appropriate for the patient, the next step is choosing which one to use. Understanding the administration of each biologic in terms of dosage frequency and how the drug is dispensed is key. While a physician may recommend a particular biologic that they are familiar and comfortable with, an informed patient may desire a different biologic for a variety of reasons, including dosing regime and cost. When it comes to cost, determining whether a biologic is financially appropriate for a patient may take work on both the part of the patient and the physician or staff. As a healthcare provider begins to prescribe biologics, it is important that they be well educated about the many factors that ultimately determine what a patient will pay for treatment. By becoming familiar with each of the programs offered through the manufacturers of biologics, the medical staff can help direct patients to the resources available to determine the cost of medications and the accessibility of financial assistance.
Drs. Daniel and Sandoval are with the Center for Dermatology Research and the department of dermatology at Wake Forest University School of Medicine in Winston-Salem, NC.
Disclosure: The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P.
TABLE: USEFUL PATIENT INFORMATION
1. Administration of biologic treatment
a. Have company products available for demonstration. Most companies can send you patient education and demonstration materials.
b. Get a sense of the patient’s comfort level with doing injections.
c. Make sure that you have a correct weight for the patient and that the weight is checked often to assure that the biologics that have weight-based dosing are being given correctly.
d. Know about the off-label dosing regimens for patients who are not responding.
2. Cost of biologic treatment
a. Provide patients with the resources on how to contact care coordinators or insurance specialist to determine what biologic treatment will cost them.
ii. Enbrel Support
888-436-2735 (888-4ENBREL)
ii. Humira Protection Plan
888-486-4723 (888-4HUMIRA)
iii. Remistart
888-222-3771 (888-ACCESS1)
iv. SimponiOne
877-697-4676 (877-MYSIMPONI)
v. Stelara Support
877-783-5272 (877-STELARA)
b. Explain to patients with no insurance or those with insurance who cannot afford their medication that they may be eligible for financial assistance through manufacturer-sponsored programs.
3. Ask if the patient has any other questions
4. Encourage patients to write down any additional questions that arise following their visit and to bring the list of questions with them to their next office visit
