News
Early response. The effect of the judge’s decision were felt within days, said Christopher Hatwig, president of Apexus, HRSA’s prime vendor for the 340B program. Hatwig said HRSA’s periodically updated list of orphan-designated products consists of “very common drugs,” including about 55 that are available from Apexus through the prime vendor program. “There’s been a lot of noise created, a lot of confusion, and a lot of phone calls to the national call center,” Hatwig said, referring to the Apexus-run telephone information center for hospitals, manufacturers, and other stakeholders involved in the 340B supply chain. Roy said his hospital’s 340B software vendor “has instructed us that they’re taking no action at this time because the drug manufacturers will take the first action by removing their medications from the 340B pricing file.” By mid-June, Hatwig said, one manufacturer had notified Apexus to cease providing products with orphan designations to hospitals affected by the ruling. And two major wholesalers and one major vendor of split-billing software have stopped processing orders for orphan-designated drugs for hospitals affected by the ruling. “That’s the market forces at work trying to minimize their risk until further information is available,” Hatwig said. He encouraged people with questions about the ruling’s effects to phone the Apexus call center at 888-340-2787. Topoleski said the ruling appears to give drug manufacturers the right to demand refunds from affected entities that previously purchased orphan-designated products at 340B prices. But he said he is unaware of that happening in the immediate aftermath of the judge’s ruling. Choose your exclusion? Clifton J. Cahoon, director of pharmacy at St. Luke’s Magic Valley Regional Medical Center in Twin Falls, Idaho, said he expects the court ruling to result in the loss of about 70% of the hospital’s expected 340B savings. “It’s a big number,” he said. 1156
Cahoon said the hospital can still get a “pretty good discount” on orphandesignated drugs from its group purchasing organization (GPO), but the cost will be higher than the 340B price. He said Magic Valley previously participated in the 340B program as a disproportionate share hospital (DSH) but had to drop out when the hospital no longer met the criteria for that designation. Magic Valley has been participating in the 340B program as a sole community hospital for about a year, he said. DSH facilities are not subject to the orphan drug exclusion, but they cannot purchase outpatient drugs through a GPO [See July 13, 2013, AJHP News]. Sole community hospitals and other entities that gained entry into the 304B program through the ACA are subject to the orphan drug exclusion but not the GPO exclusion. Hatwig said it may be worthwhile for hospitals qualifying as both a DSH and a sole community hospital in the 340B program to determine which designation would make more sense financially. “That’s an individual decision,” he said. “Not every hospital has that op-
tion. But if they do have the option, they can run the numbers either way. They definitely ought to get their finance department involved and the compliance people involved to take a look at it.” Cahoon said Magic Valley plans to remain in the 340B program as a sole community hospital because the savings still available to the facility remain worthwhile. “Also, . . . we’ve just started our first contract pharmacy,” he added. “So we’re going to pursue more contract pharmacies to help compensate for our current loss.” Roy advised pharmacy directors whose hospitals are affected by the ruling to “take a look at how this is going to affect you on a line-item level, looking at each drug and the cost for the year.” “You’ve got to get on top of this one now and find out how many dollars you’re talking about and come up with a plan so that you can take that hit, and you can afford those medications and keep that patient access open,” he said. —Kate Traynor DOI 10.2146/news140050
Effectiveness, costs weigh on HCV treatment decisions
R
ecently approved drugs for the treatment of chronic hepatitis C virus (HCV) infection have been both acclaimed for their effectiveness and called out for their high costs. Simeprevir, marketed as Olysio by Janssen Therapeutics, was approved last November, and Gilead’s sofosbuvir, or Sovaldi, was approved about two weeks later. “There are huge benefits to these drugs,” said Ann McNamara, clinical development manager at Fairview Specialty Pharmacy in Minneapolis. “I think what’s getting lost in this whole thing is they actually are curing patients of a chronic dis-
Am J Health-Syst Pharm—Vol 71 Jul 15, 2014
ease, which just doesn’t happen; especially in pharmacy, you don’t see that.” “The unfortunate thing is, they’re just very expensive,” she said. The reported $1000-per-tablet price of sofosbuvir has even caught the attention of Democrats on the House Committee on Energy and Commerce, who in late March asked the company to brief them on issues related to the drug’s U.S. price. McNamara said that about 360 patients have enrolled in Fairview Specialty Pharmacy’s hepatitis C management program with the goal of completing one of three regimens containing the new drugs: sofosbuvir, ribavirin, and a
News
pegylated interferon alfa product; sofosbuvir and ribavirin; or sofosbuvir and simeprevir. She said the regimens vary depending on the viral genotype and the patient’s health and previous response to therapy. Treatment regimens follow recently published HCV treatment guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. McNamara said about 100 patients have finished their course of therapy so far, and the overall completion rate— about 90%—is much higher than before the current generation of direct-acting anti-HCV drugs became available. “We’re going to see a lot more cures with this therapy,” McNamara predicted. According to the Centers for Disease Control and Prevention, about 3.2 million Americans have chronic HCV infection. Without effective treatment, chronic liver disease will develop in about 60–70% of those people; of those, 5–20% will eventually progress to cirrhosis and 1–5% will die as a consequence of the infection, according to the agency. Less than five years ago, standard therapy for chronic HCV infection consisted of weekly injections of pegylated interferon alfa plus daily oral ribavirin for up to 48 weeks. According to FDA, fewer than half of HCV-infected patients treated with this regimen had a sustained virologic response (SVR), indicating the elimination of the virus. With the approval in 2011 of the first HCV NS3/4A protease inhibitors, boceprevir and telaprevir, standard treatment regimens shifted to a shorter course of pegylated interferon alfa and ribavirin followed by several weeks of treatment with boceprevir or telaprevir. Regimens that include these anti-HCV drugs led to an SVR in up to 80% among clinical trial participants. Treatment regimens containing the NS3/4A protease inhibitor simeprevir or the HCV NS5B RNA-dependent RNA polymerase inhibitor sofosbuvir resulted in an SVR rate of up to 95% in clinical trial participants. Sofosbuvir is the first anti-HCV therapy labeled for use in without a con-
comitant interferon in certain patients. Other interferon-free regimens, some involving investigational HCV inhibitors, are currently being evaluated and may soon offer additional treatment options for patients. McNamara said the current treatment regimens require less-frequent viral load monitoring and are better tolerated overall by patients than the older regimens. But she said adverse events still occur, in part because the new regimens still contain ribavirin and an interferon. “With ribavirin and peginterferon, there are still some side effects, like anemia. And there are still some rashes that become a problem, and some insomnia that can be problematic,” McNamara said. She noted that although adherence is better with the current regimens, patients who have cognitive problems related to advanced liver disease can struggle with their therapy. And McNamara said the issue of cost can affect compliance in unexpected ways. “One patient wanted to get a replacement pill because their pill fell under the refrigerator. It’s a thousand-dollar pill. So simple things like that come into play,” she said. She said the pharmacy has a “point person” who manages prior authorizations and other utilization management issues to ensure that patients have access to the new HCV medications. Another issue the specialty pharmacy deals with is communicating with prescribers to ensure that their patients have a blood test three months after completing therapy to measure their viral load. “We want to make sure [patients] come back, and their viral load is undetectable. They may think they’re cured and not come back for that last test,” she said. McNamara said some physicians may be counseling their patients to wait a few months before starting treatment for chronic HCV infection to see if even better treatment options become available. “And we’re hoping for some competitive cost savings, too; I think that’s what payers are hoping for,” she said. —Kate Traynor DOI 10.2146/news140051
News Brief • The Massachusetts Society of Health-System Pharmacists (MSHP) recently renamed its Outstanding Service Award to honor William A. Gouveia, M.S., D.H.L. (Hon), FASHP, FMSHP. Gouveia, a 50-year MSHP member, served as the organization’s president in 1969 and as a member of the board of directors for many years thereafter. He was the first person designated a Fellow of MSHP. In May, at the organization’s annual meeting, Gouveia became an honorary MSHP member and received a citation from the governor in recognition of his longstanding commitment and dedication to health-system pharmacy practice in Massachusetts. Bestowment of the honorary membership was based on his contributions to Boston’s New England Medical Center, MSHP, and ASHP, including decades as an author and contributing editor for AJHP. Gouveia served as a member of the ASHP Board of Directors in 1986–89. Ross Thompson, director of pharmacy at Tufts Medical Center, is the first recipient of the William A. Gouveia Outstanding Service Award. The medical center had formerly been known as the New England Medical Center.
Correction
ar Layar
Use of argatroban and catheterdirected thrombolysis with alteplase in an oncology patient with heparin-induced thrombocytopenia with thrombosis (May 1, 2014, Case Report). On page 713, Table 1, the superscripts under Day 7 and Day 14 should be d. DOI 10.2146/cor140003
Am J Health-Syst Pharm—Vol 71 Jul 15, 2014
1157
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Early response. The effect of the judge’s decision were felt within days, said Christopher Hatwig, president of Apexus, HRSA’s prime vendor for the 340B program. Hatwig said HRSA’s periodically updated list of orphan-designated products consists of “very common drugs,” including about 55 that are available from Apexus through the prime vendor program. “There’s been a lot of noise created, a lot of confusion, and a lot of phone calls to the national call center,” Hatwig said, referring to the Apexus-run telephone information center for hospitals, manufacturers, and other stakeholders involved in the 340B supply chain. Roy said his hospital’s 340B software vendor “has instructed us that they’re taking no action at this time because the drug manufacturers will take the first action by removing their medications from the 340B pricing file.” By mid-June, Hatwig said, one manufacturer had notified Apexus to cease providing products with orphan designations to hospitals affected by the ruling. And two major wholesalers and one major vendor of split-billing software have stopped processing orders for orphan-designated drugs for hospitals affected by the ruling. “That’s the market forces at work trying to minimize their risk until further information is available,” Hatwig said. He encouraged people with questions about the ruling’s effects to phone the Apexus call center at 888-340-2787. Topoleski said the ruling appears to give drug manufacturers the right to demand refunds from affected entities that previously purchased orphan-designated products at 340B prices. But he said he is unaware of that happening in the immediate aftermath of the judge’s ruling. Choose your exclusion? Clifton J. Cahoon, director of pharmacy at St. Luke’s Magic Valley Regional Medical Center in Twin Falls, Idaho, said he expects the court ruling to result in the loss of about 70% of the hospital’s expected 340B savings. “It’s a big number,” he said. 1156
Cahoon said the hospital can still get a “pretty good discount” on orphandesignated drugs from its group purchasing organization (GPO), but the cost will be higher than the 340B price. He said Magic Valley previously participated in the 340B program as a disproportionate share hospital (DSH) but had to drop out when the hospital no longer met the criteria for that designation. Magic Valley has been participating in the 340B program as a sole community hospital for about a year, he said. DSH facilities are not subject to the orphan drug exclusion, but they cannot purchase outpatient drugs through a GPO [See July 13, 2013, AJHP News]. Sole community hospitals and other entities that gained entry into the 304B program through the ACA are subject to the orphan drug exclusion but not the GPO exclusion. Hatwig said it may be worthwhile for hospitals qualifying as both a DSH and a sole community hospital in the 340B program to determine which designation would make more sense financially. “That’s an individual decision,” he said. “Not every hospital has that op-
tion. But if they do have the option, they can run the numbers either way. They definitely ought to get their finance department involved and the compliance people involved to take a look at it.” Cahoon said Magic Valley plans to remain in the 340B program as a sole community hospital because the savings still available to the facility remain worthwhile. “Also, . . . we’ve just started our first contract pharmacy,” he added. “So we’re going to pursue more contract pharmacies to help compensate for our current loss.” Roy advised pharmacy directors whose hospitals are affected by the ruling to “take a look at how this is going to affect you on a line-item level, looking at each drug and the cost for the year.” “You’ve got to get on top of this one now and find out how many dollars you’re talking about and come up with a plan so that you can take that hit, and you can afford those medications and keep that patient access open,” he said. —Kate Traynor DOI 10.2146/news140050
Effectiveness, costs weigh on HCV treatment decisions
R
ecently approved drugs for the treatment of chronic hepatitis C virus (HCV) infection have been both acclaimed for their effectiveness and called out for their high costs. Simeprevir, marketed as Olysio by Janssen Therapeutics, was approved last November, and Gilead’s sofosbuvir, or Sovaldi, was approved about two weeks later. “There are huge benefits to these drugs,” said Ann McNamara, clinical development manager at Fairview Specialty Pharmacy in Minneapolis. “I think what’s getting lost in this whole thing is they actually are curing patients of a chronic dis-
Am J Health-Syst Pharm—Vol 71 Jul 15, 2014
ease, which just doesn’t happen; especially in pharmacy, you don’t see that.” “The unfortunate thing is, they’re just very expensive,” she said. The reported $1000-per-tablet price of sofosbuvir has even caught the attention of Democrats on the House Committee on Energy and Commerce, who in late March asked the company to brief them on issues related to the drug’s U.S. price. McNamara said that about 360 patients have enrolled in Fairview Specialty Pharmacy’s hepatitis C management program with the goal of completing one of three regimens containing the new drugs: sofosbuvir, ribavirin, and a
News
pegylated interferon alfa product; sofosbuvir and ribavirin; or sofosbuvir and simeprevir. She said the regimens vary depending on the viral genotype and the patient’s health and previous response to therapy. Treatment regimens follow recently published HCV treatment guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. McNamara said about 100 patients have finished their course of therapy so far, and the overall completion rate— about 90%—is much higher than before the current generation of direct-acting anti-HCV drugs became available. “We’re going to see a lot more cures with this therapy,” McNamara predicted. According to the Centers for Disease Control and Prevention, about 3.2 million Americans have chronic HCV infection. Without effective treatment, chronic liver disease will develop in about 60–70% of those people; of those, 5–20% will eventually progress to cirrhosis and 1–5% will die as a consequence of the infection, according to the agency. Less than five years ago, standard therapy for chronic HCV infection consisted of weekly injections of pegylated interferon alfa plus daily oral ribavirin for up to 48 weeks. According to FDA, fewer than half of HCV-infected patients treated with this regimen had a sustained virologic response (SVR), indicating the elimination of the virus. With the approval in 2011 of the first HCV NS3/4A protease inhibitors, boceprevir and telaprevir, standard treatment regimens shifted to a shorter course of pegylated interferon alfa and ribavirin followed by several weeks of treatment with boceprevir or telaprevir. Regimens that include these anti-HCV drugs led to an SVR in up to 80% among clinical trial participants. Treatment regimens containing the NS3/4A protease inhibitor simeprevir or the HCV NS5B RNA-dependent RNA polymerase inhibitor sofosbuvir resulted in an SVR rate of up to 95% in clinical trial participants. Sofosbuvir is the first anti-HCV therapy labeled for use in without a con-
comitant interferon in certain patients. Other interferon-free regimens, some involving investigational HCV inhibitors, are currently being evaluated and may soon offer additional treatment options for patients. McNamara said the current treatment regimens require less-frequent viral load monitoring and are better tolerated overall by patients than the older regimens. But she said adverse events still occur, in part because the new regimens still contain ribavirin and an interferon. “With ribavirin and peginterferon, there are still some side effects, like anemia. And there are still some rashes that become a problem, and some insomnia that can be problematic,” McNamara said. She noted that although adherence is better with the current regimens, patients who have cognitive problems related to advanced liver disease can struggle with their therapy. And McNamara said the issue of cost can affect compliance in unexpected ways. “One patient wanted to get a replacement pill because their pill fell under the refrigerator. It’s a thousand-dollar pill. So simple things like that come into play,” she said. She said the pharmacy has a “point person” who manages prior authorizations and other utilization management issues to ensure that patients have access to the new HCV medications. Another issue the specialty pharmacy deals with is communicating with prescribers to ensure that their patients have a blood test three months after completing therapy to measure their viral load. “We want to make sure [patients] come back, and their viral load is undetectable. They may think they’re cured and not come back for that last test,” she said. McNamara said some physicians may be counseling their patients to wait a few months before starting treatment for chronic HCV infection to see if even better treatment options become available. “And we’re hoping for some competitive cost savings, too; I think that’s what payers are hoping for,” she said. —Kate Traynor DOI 10.2146/news140051
News Brief • The Massachusetts Society of Health-System Pharmacists (MSHP) recently renamed its Outstanding Service Award to honor William A. Gouveia, M.S., D.H.L. (Hon), FASHP, FMSHP. Gouveia, a 50-year MSHP member, served as the organization’s president in 1969 and as a member of the board of directors for many years thereafter. He was the first person designated a Fellow of MSHP. In May, at the organization’s annual meeting, Gouveia became an honorary MSHP member and received a citation from the governor in recognition of his longstanding commitment and dedication to health-system pharmacy practice in Massachusetts. Bestowment of the honorary membership was based on his contributions to Boston’s New England Medical Center, MSHP, and ASHP, including decades as an author and contributing editor for AJHP. Gouveia served as a member of the ASHP Board of Directors in 1986–89. Ross Thompson, director of pharmacy at Tufts Medical Center, is the first recipient of the William A. Gouveia Outstanding Service Award. The medical center had formerly been known as the New England Medical Center.
Correction
ar Layar
Use of argatroban and catheterdirected thrombolysis with alteplase in an oncology patient with heparin-induced thrombocytopenia with thrombosis (May 1, 2014, Case Report). On page 713, Table 1, the superscripts under Day 7 and Day 14 should be d. DOI 10.2146/cor140003
Am J Health-Syst Pharm—Vol 71 Jul 15, 2014
1157
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
