Benlyta Case Study
Regarding the testing performed in this patient, multiple questions to be answered.
History:
The patient is a 15-year old male with a history of thrombotic thrombocytopenic purpura (TTP), noted as a severe deficiency of ADAMTS13 through B-cell mediated IgG autoantibodies. He has required multiple treatments thus far to include corticosteroids, anti-platelet therapy, plasma exchange (about 200 plasma exchange procedures), rituximab, bortezomib. After failure of each of these agents, the physician has recommended Benlysta / belimumab, which is approved specifically for the treatment of autoantibody-positive lupus. This medication is described as an IgG1 monoclonal antibody that inhibits the activity of soluble cytokine B-lymphocyte stimulator. …show more content…
The use of Benlysta is under review.
Rationale:
1. Is Benlysta experimental/investigational for the treatment of this member’s condition?
Yes, the use of Benlysta is experimental for the treatment of this member’s given condition, TTP.
2.
Is Benlysta medically necessary for the treatment of this member’s condition?
Yes, the use of Benlysta is medically necessary for the treatment of this patient’s TTP.
3. Is the expected benefit of the recommended or requested health care service or treatment more likely than not to be beneficial to the claimant than any available standard health care service or treatment?
Yes, the expected benefit of the Benlysta is more likely than not to be beneficial to the claimant as there are no other available standard health care services or treatments that have not already been tried.
4. Are the adverse risks of the recommended or requested health care service or treatment substantially increased over those of available standard health care services or treatments?
No, the adverse risks of the recommended treatment with Benlysta is not susbtantially increased over doing nothing for this patient as there are no further standard health care …show more content…
services.
This patient has a diagnosis of thrombotic thrombocytopenic purpura (TTP) which has failed treatment with all known “conventional” therapies to include many plasma exchanges, steroids, rituximab and bortezomib.
The physician is now considering therapy with Benlysta / belimumab, which is an FDA-approved treatment for certain patients with refractory systemic lupus erythematosus (SLE). A quick review of the literature clearly shows an association between SLE and TTP, noting that lupus has many of the clinical features of TTP, with similar findings of microangiopathic hemolytic anemia (MAHA) to include the anti-ADAMTS13 antibody and anti-platelet antibody. Benlysta works agains the activity of soluble cytokine B-lymphocyte stimulator, helping to provide treatment for certain autoimmune disorders such as lupus. The request to use Benlysta for refractory TTP is reasonable, and while the diagnosis of TTP is not specifically associated with Benlysta in the literature, there is an association with Benlysta and lupus, with lupus and TTP, and with Benlysta in the treatment of MAHA associated with lupus. While this treatment must be considered experimental or investigational, it is absolutely medically necessary. There are no other treatment options for this patient’s life-threatening medical condition, and without doing anything such as Benlysta, he will likely die from his disease, making the possibility of adverse risks from Benlysta much less than doing nothing (as there are
no available untried standard health care services or treatments available at this time).
Therefore, based on the clinical information provided for review, the current peer-reviewed medical literature and standards of care in the field, the Benlysta is clinically appropriate and should be approved.
Determination:
The request for Benlysta for this patient is medically necessary.
History:
The patient is a 15-year old male with a history of thrombotic thrombocytopenic purpura (TTP), noted as a severe deficiency of ADAMTS13 through B-cell mediated IgG autoantibodies. He has required multiple treatments thus far to include corticosteroids, anti-platelet therapy, plasma exchange (about 200 plasma exchange procedures), rituximab, bortezomib. After failure of each of these agents, the physician has recommended Benlysta / belimumab, which is approved specifically for the treatment of autoantibody-positive lupus. This medication is described as an IgG1 monoclonal antibody that inhibits the activity of soluble cytokine B-lymphocyte stimulator. …show more content…
The use of Benlysta is under review.
Rationale:
1. Is Benlysta experimental/investigational for the treatment of this member’s condition?
Yes, the use of Benlysta is experimental for the treatment of this member’s given condition, TTP.
2.
Is Benlysta medically necessary for the treatment of this member’s condition?
Yes, the use of Benlysta is medically necessary for the treatment of this patient’s TTP.
3. Is the expected benefit of the recommended or requested health care service or treatment more likely than not to be beneficial to the claimant than any available standard health care service or treatment?
Yes, the expected benefit of the Benlysta is more likely than not to be beneficial to the claimant as there are no other available standard health care services or treatments that have not already been tried.
4. Are the adverse risks of the recommended or requested health care service or treatment substantially increased over those of available standard health care services or treatments?
No, the adverse risks of the recommended treatment with Benlysta is not susbtantially increased over doing nothing for this patient as there are no further standard health care …show more content…
services.
This patient has a diagnosis of thrombotic thrombocytopenic purpura (TTP) which has failed treatment with all known “conventional” therapies to include many plasma exchanges, steroids, rituximab and bortezomib.
The physician is now considering therapy with Benlysta / belimumab, which is an FDA-approved treatment for certain patients with refractory systemic lupus erythematosus (SLE). A quick review of the literature clearly shows an association between SLE and TTP, noting that lupus has many of the clinical features of TTP, with similar findings of microangiopathic hemolytic anemia (MAHA) to include the anti-ADAMTS13 antibody and anti-platelet antibody. Benlysta works agains the activity of soluble cytokine B-lymphocyte stimulator, helping to provide treatment for certain autoimmune disorders such as lupus. The request to use Benlysta for refractory TTP is reasonable, and while the diagnosis of TTP is not specifically associated with Benlysta in the literature, there is an association with Benlysta and lupus, with lupus and TTP, and with Benlysta in the treatment of MAHA associated with lupus. While this treatment must be considered experimental or investigational, it is absolutely medically necessary. There are no other treatment options for this patient’s life-threatening medical condition, and without doing anything such as Benlysta, he will likely die from his disease, making the possibility of adverse risks from Benlysta much less than doing nothing (as there are
no available untried standard health care services or treatments available at this time).
Therefore, based on the clinical information provided for review, the current peer-reviewed medical literature and standards of care in the field, the Benlysta is clinically appropriate and should be approved.
Determination:
The request for Benlysta for this patient is medically necessary.