Frequently Asked Questions: Thyrogen Reimbursement
Is Thyrogen covered under major medical or pharmacy?
Thyrogen can be covered under major medical, prescription benefit, or both. The patient’s insurance plan will determine where the drug is covered. This information can be secured by conducting a benefit investigation.
Is the co-pay for Thyrogen the same as the co-pay for other prescription drugs on a patient’s plan?
The out-of- pocket expense for Thyrogen is determined by the patient’s policy. A patient’s out- of-pocket expense for Thyrogen should be confirmed with the patient’s insurance plan.
Is Thyrogen covered by Medicare?
Thyrogen is covered by Medicare Part B when it is administered in the outpatient or MD office setting as an incident to a physician’s service. For information on Medicare coverage for Thyrogen, please contact ThyrogenONE or your local Medicare Part B carrier.
What is the Thyrogen reimbursement rate for Medicare?
Medicare Part B reimburses physicians at 80% of the allowed amount (the allowed amount = ASP+6% or 86% of ASP). As a result of Sequestration Budget Cuts - Activated on 4/1/2013, Medicare reduced this by 2% (2% discount). This translates to a decrease of 1.7% (2%*(80%+6%)=1.7%) , reducing the reimbursement rate to physicians of ASP+6% to ASP+4.3%.
There is no reduction on the beneficiary’s 20% co-payment responsibility. In other words, this cut only applies to the amount that Medicare will pay the physician. The beneficiary (patient) is responsible for the same amount as prior to this change: 20% of ASP+6%.
The allowable amount is updated quarterly the Centers for Medicare and Medicaid Services (CMS) based on data reported by drug manufacturers.
Is Thyrogen covered by Medicaid?
Medicaid eligibility and benefit plans vary from state-to-state, so the local state’s program’s coverage policy should be understood before treatment is initiated. Usually, use of Thyrogen will need to be considered medically necessary in order to be covered under the Medicaid program. Depending on the state, use of Thyrogen may require prior approval by the state Medicaid program. For information on Medicaid coverage for Thyrogen in your state, contact ThyrogenONE or your local Medicaid office.
What is the Thyrogen reimbursement rate for Medicaid?
Medicaid reimbursement rates for Thyrogen will vary from state to state. For information on Medicaid coverage for Thyrogen in your state, contact ThyrogenONE or your local Medicaid office.
Is there a program available to assist patients with out-of-pocket costs?
Thyrogen Co-Pay Assistance Program can help patients with out-of-pocket costs. To be eligible, patients must be US Citizens, have commercial insurance and out-of-pocket costs > $100. For more information this Program or other programs for patients who do not have a commercial health plan, please contact ThyrogenONE at 1.88.THYROGEN (1.888.497.6436).
Is there a program available for patients that are uninsured or those that have been denied payor coverage for Thyrogen?
Sanofi Genzyme is committed to improving access to Thyrogen for all eligible patients, including uninsured and underinsured patients. For further information, please contact ThyrogenONE at 1.88.THYROGEN (1.888.497.6436)
3 ways to access Thyrogen for your patients
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- Purchase direct from Sanofi Genzyme
- Order through a Specialty Pharmacy
- Purchase using a Wholesaler
Depending on the individual insurance plan, Thyrogen may be covered as either a pharmacy or a major medical benefit. Occasionally, additional documentation may be needed in order to obtain prior authorization for coverage and reimbursement of Thyrogen.
Thyrogen® (thyrotropin alfa for injection) 0.9 mg/mL after reconstitution
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of Thyrogen.
There are post marketing reports of stroke in young women with risk factors for stroke, and neurological findings suggestive of stroke (e.g., unilateral weakness) occurring within 72 hours of Thyrogen administration in patients without known central nervous system metastases.
Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with Thyrogen.
Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.
Patients should be well-hydrated prior to treatment with Thyrogen.
Caution should be exercised in patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, specifically in the elderly and those with a known history of heart disease.
Hospitalization for administration of Thyrogen and post-administration observation in patients at risk should be considered.
The most common adverse reactions reported in clinical trials were nausea and headache.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C: Animal reproduction studies have not been conducted with Thyrogen. It is also not known whether Thyrogen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Thyrogen should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thyrogen is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Results from controlled trials do not indicate a difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those over 65 years of age.
Renal Impairment: Elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease patients, resulting in prolonged elevation of TSH levels.
INDICATIONS AND USAGE
Thyrogen is a thyroid stimulating hormone indicated for:
Diagnostic: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.
Limitations of Use:
- Thyrogen -stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.
- Even when Thyrogen -Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.
- Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable.
Ablation: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
Limitations of Use:
- The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.
See full Prescribing Information for more details.