User login
Dabigatran
To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,1 which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al2 found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.3 Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.
Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.
- Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009; 15(suppl 1):9S–16S.
- Yank V, Tuohy CV, Logan AC, et al. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med 2011; 154:529–540.
- Silverman E. Novo Nordisk pays $25M for off-label marketing. Pharmalot. www.pharmalot.com/2011/06/novo-nordisk-pays-25m-for-off-label-marketing. Accessed February 9, 2012.
To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,1 which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al2 found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.3 Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.
Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.
To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,1 which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al2 found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.3 Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.
Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.
- Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009; 15(suppl 1):9S–16S.
- Yank V, Tuohy CV, Logan AC, et al. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med 2011; 154:529–540.
- Silverman E. Novo Nordisk pays $25M for off-label marketing. Pharmalot. www.pharmalot.com/2011/06/novo-nordisk-pays-25m-for-off-label-marketing. Accessed February 9, 2012.
- Stangier J, Clemens A. Pharmacology, pharmacokinetics, and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor. Clin Appl Thromb Hemost 2009; 15(suppl 1):9S–16S.
- Yank V, Tuohy CV, Logan AC, et al. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med 2011; 154:529–540.
- Silverman E. Novo Nordisk pays $25M for off-label marketing. Pharmalot. www.pharmalot.com/2011/06/novo-nordisk-pays-25m-for-off-label-marketing. Accessed February 9, 2012.
Shingles vaccine
To the Editor: In their 1-Minute Consult, Drs. Singh and Englund give a thorough review of Zostavax, the vaccine to prevent shingles.1 Unfortunately, the information they provided on cost and reimbursement is incomplete.
As they noted, this vaccine is not covered by Medicare part B and is mandated to be covered by Medicare part D as a “prescription drug.” Furthermore, the vaccine administration charge cannot be billed to Medicare part B. Since physician offices do not bill prescription drug plans, physicians are permitted to administer the vaccine, charge the patient for the vaccine and administration, and have the patient submit the receipt to his or her prescription drug provider for reimbursement. There is no fee schedule for this vaccine, so physicians are free to charge a fee that they deem reasonable. For patients without part D, it is reasonable to ask them to call their prescription provider and inquire about coverage before vaccination, since many commercial plans will not cover the vaccine, and the $200 or more price may be unaffordable for many.
Alternatively, physician offices may enroll with a private vendor, eDispense Vaccine Manager, at enroll.edispense.com, and submit charges for Zostavax electronically to the patient’s Medicare part D provider; eDispense is contracted with most of the large part D providers. This service allows the physician to input the patient’s demographics and get an immediate response, showing the patient’s coverage and copayment, and allowing the physician to submit the claim electronically. There is no charge to the physician, and the reimbursement covers the cost of the vaccine, the administration cost, and a small profit. If the patient wishes to pay for the vaccine, the system can produce a receipt containing all the information needed for submission by the patient to the insurer. (Note: I have no financial or ownership interest in eDispense.com or Merck.)
Since recommending and administering Zostavax is soon to become the standard of care, the availability of these options will provide better care than the authors’ recommendation that patients pick up the vaccine and transport it back to the physician’s office on ice, which risks defrosting and inactivating the vaccine, or leaving patients to find a vaccine provider on their own.
- Singh A, Englund K. Who should receive the shingles vaccine? Cleve Clin J Med 2009; 76:45–48.
To the Editor: In their 1-Minute Consult, Drs. Singh and Englund give a thorough review of Zostavax, the vaccine to prevent shingles.1 Unfortunately, the information they provided on cost and reimbursement is incomplete.
As they noted, this vaccine is not covered by Medicare part B and is mandated to be covered by Medicare part D as a “prescription drug.” Furthermore, the vaccine administration charge cannot be billed to Medicare part B. Since physician offices do not bill prescription drug plans, physicians are permitted to administer the vaccine, charge the patient for the vaccine and administration, and have the patient submit the receipt to his or her prescription drug provider for reimbursement. There is no fee schedule for this vaccine, so physicians are free to charge a fee that they deem reasonable. For patients without part D, it is reasonable to ask them to call their prescription provider and inquire about coverage before vaccination, since many commercial plans will not cover the vaccine, and the $200 or more price may be unaffordable for many.
Alternatively, physician offices may enroll with a private vendor, eDispense Vaccine Manager, at enroll.edispense.com, and submit charges for Zostavax electronically to the patient’s Medicare part D provider; eDispense is contracted with most of the large part D providers. This service allows the physician to input the patient’s demographics and get an immediate response, showing the patient’s coverage and copayment, and allowing the physician to submit the claim electronically. There is no charge to the physician, and the reimbursement covers the cost of the vaccine, the administration cost, and a small profit. If the patient wishes to pay for the vaccine, the system can produce a receipt containing all the information needed for submission by the patient to the insurer. (Note: I have no financial or ownership interest in eDispense.com or Merck.)
Since recommending and administering Zostavax is soon to become the standard of care, the availability of these options will provide better care than the authors’ recommendation that patients pick up the vaccine and transport it back to the physician’s office on ice, which risks defrosting and inactivating the vaccine, or leaving patients to find a vaccine provider on their own.
To the Editor: In their 1-Minute Consult, Drs. Singh and Englund give a thorough review of Zostavax, the vaccine to prevent shingles.1 Unfortunately, the information they provided on cost and reimbursement is incomplete.
As they noted, this vaccine is not covered by Medicare part B and is mandated to be covered by Medicare part D as a “prescription drug.” Furthermore, the vaccine administration charge cannot be billed to Medicare part B. Since physician offices do not bill prescription drug plans, physicians are permitted to administer the vaccine, charge the patient for the vaccine and administration, and have the patient submit the receipt to his or her prescription drug provider for reimbursement. There is no fee schedule for this vaccine, so physicians are free to charge a fee that they deem reasonable. For patients without part D, it is reasonable to ask them to call their prescription provider and inquire about coverage before vaccination, since many commercial plans will not cover the vaccine, and the $200 or more price may be unaffordable for many.
Alternatively, physician offices may enroll with a private vendor, eDispense Vaccine Manager, at enroll.edispense.com, and submit charges for Zostavax electronically to the patient’s Medicare part D provider; eDispense is contracted with most of the large part D providers. This service allows the physician to input the patient’s demographics and get an immediate response, showing the patient’s coverage and copayment, and allowing the physician to submit the claim electronically. There is no charge to the physician, and the reimbursement covers the cost of the vaccine, the administration cost, and a small profit. If the patient wishes to pay for the vaccine, the system can produce a receipt containing all the information needed for submission by the patient to the insurer. (Note: I have no financial or ownership interest in eDispense.com or Merck.)
Since recommending and administering Zostavax is soon to become the standard of care, the availability of these options will provide better care than the authors’ recommendation that patients pick up the vaccine and transport it back to the physician’s office on ice, which risks defrosting and inactivating the vaccine, or leaving patients to find a vaccine provider on their own.
- Singh A, Englund K. Who should receive the shingles vaccine? Cleve Clin J Med 2009; 76:45–48.
- Singh A, Englund K. Who should receive the shingles vaccine? Cleve Clin J Med 2009; 76:45–48.
Medical causes of back pain
To the Editor: In their otherwise excellent review, “Masquerade: Medical causes of back pain” (Cleve Clin J Med 2007; 74:905–913), Dr. Klineberg et al seem to confuse two distinct pathologic processes—aortic dissection and rupture of an aortic aneurysm. Parts of their description seem to fit the pathology of abdominal aortic aneurysm, with a pulsatile abdominal mass, sentinel bleeding, and rupture risk with a size over 6 cm, whereas other parts seem to correspond to aortic dissection, with severe, ripping pain and an association with Marfan syndrome. They also use the terminology “dissecting aortic aneurysm,” which again implies a single entity, when in fact the two conditions rarely occur together. The authors are not alone in their use of this misnomer: a review of the Web sites of renowned universities reveals use of the same terminology. The readers would have been better served if the authors had discussed “acute aortic dissection” and “ruptured aortic aneurysm” as two separate causes of back pain, with a note that in rare cases an aortic aneurysm can develop a dissection.
To the Editor: In their otherwise excellent review, “Masquerade: Medical causes of back pain” (Cleve Clin J Med 2007; 74:905–913), Dr. Klineberg et al seem to confuse two distinct pathologic processes—aortic dissection and rupture of an aortic aneurysm. Parts of their description seem to fit the pathology of abdominal aortic aneurysm, with a pulsatile abdominal mass, sentinel bleeding, and rupture risk with a size over 6 cm, whereas other parts seem to correspond to aortic dissection, with severe, ripping pain and an association with Marfan syndrome. They also use the terminology “dissecting aortic aneurysm,” which again implies a single entity, when in fact the two conditions rarely occur together. The authors are not alone in their use of this misnomer: a review of the Web sites of renowned universities reveals use of the same terminology. The readers would have been better served if the authors had discussed “acute aortic dissection” and “ruptured aortic aneurysm” as two separate causes of back pain, with a note that in rare cases an aortic aneurysm can develop a dissection.
To the Editor: In their otherwise excellent review, “Masquerade: Medical causes of back pain” (Cleve Clin J Med 2007; 74:905–913), Dr. Klineberg et al seem to confuse two distinct pathologic processes—aortic dissection and rupture of an aortic aneurysm. Parts of their description seem to fit the pathology of abdominal aortic aneurysm, with a pulsatile abdominal mass, sentinel bleeding, and rupture risk with a size over 6 cm, whereas other parts seem to correspond to aortic dissection, with severe, ripping pain and an association with Marfan syndrome. They also use the terminology “dissecting aortic aneurysm,” which again implies a single entity, when in fact the two conditions rarely occur together. The authors are not alone in their use of this misnomer: a review of the Web sites of renowned universities reveals use of the same terminology. The readers would have been better served if the authors had discussed “acute aortic dissection” and “ruptured aortic aneurysm” as two separate causes of back pain, with a note that in rare cases an aortic aneurysm can develop a dissection.