In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.

The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.

Medical Illustrations, Canterbury District Health Board

[email protected]

In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.

The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.

Medical Illustrations, Canterbury District Health Board

[email protected]

In the treatment of gout, dose escalation of allopurinol to achieve target serum urate levels at or below 6 mg/dL appears safe and effective, even among patients with chronic kidney disease, according to a new open-label, extension study. The results build on a 12-month study that had shown safety and efficacy of the strategy.

The new results compared adverse events and serum urate levels between patients who stayed at increased allopurinol doses after achieving target serum urate levels, and control patients who were switched to a strategy of treating to target.

Medical Illustrations, Canterbury District Health Board

[email protected]

The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.

In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.

[email protected]

The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.

In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.

[email protected]

The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.

In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.

[email protected]

The European Commission has approved tivozanib for the treatment of advanced renal cell carcinoma (RCC) in adult patients in the European Union, Norway, and Iceland.

Tivozanib (Fotivda) is a vascular endothelial growth factor receptor tyrosine kinase inhibitor, taken orally once daily. It is indicated for first-line treatment of patients, naive to both vascular endothelial growth factor receptors and mTOR pathway inhibitors, experiencing disease progression following one cytokine therapy treatment, according to the press release.

Its approval is based on superior progression-free survival (PFS) in TIVO-1, a phase 3 trial comparing the efficacy and tolerability of tivozanib (1.5 mg once daily) with that of sorafenib (400 mg twice daily). In the overall trial population of 517 patients with advanced RCC, PFS was 11.9 months for patients treated with tivozanib, compared with 9.1 months for those treated with sorafenib (hazard ratio, 0.797; 95% confidence interval, 0.639-0.993; P = .042).

Patients in the tivozanib arm also experienced fewer cases of diarrhea and hand-foot syndrome, and required fewer dose reductions because of adverse effects than did those taking sorafenib.

The approval follows a recommendation from the Committee for Medical Products for Human Use.

The Food and Drug Administration rejected the New Drug Application for tivozanib in 2013, based on TIVO-1 data. Aveo Oncology plans to reapply in the United States with data from TIVO-3, expected in early 2018, they said in the press release.

[email protected]

The European Commission has approved tivozanib for the treatment of advanced renal cell carcinoma (RCC) in adult patients in the European Union, Norway, and Iceland.

Tivozanib (Fotivda) is a vascular endothelial growth factor receptor tyrosine kinase inhibitor, taken orally once daily. It is indicated for first-line treatment of patients, naive to both vascular endothelial growth factor receptors and mTOR pathway inhibitors, experiencing disease progression following one cytokine therapy treatment, according to the press release.

Its approval is based on superior progression-free survival (PFS) in TIVO-1, a phase 3 trial comparing the efficacy and tolerability of tivozanib (1.5 mg once daily) with that of sorafenib (400 mg twice daily). In the overall trial population of 517 patients with advanced RCC, PFS was 11.9 months for patients treated with tivozanib, compared with 9.1 months for those treated with sorafenib (hazard ratio, 0.797; 95% confidence interval, 0.639-0.993; P = .042).

Patients in the tivozanib arm also experienced fewer cases of diarrhea and hand-foot syndrome, and required fewer dose reductions because of adverse effects than did those taking sorafenib.

The approval follows a recommendation from the Committee for Medical Products for Human Use.

The Food and Drug Administration rejected the New Drug Application for tivozanib in 2013, based on TIVO-1 data. Aveo Oncology plans to reapply in the United States with data from TIVO-3, expected in early 2018, they said in the press release.

[email protected]

The European Commission has approved tivozanib for the treatment of advanced renal cell carcinoma (RCC) in adult patients in the European Union, Norway, and Iceland.

Tivozanib (Fotivda) is a vascular endothelial growth factor receptor tyrosine kinase inhibitor, taken orally once daily. It is indicated for first-line treatment of patients, naive to both vascular endothelial growth factor receptors and mTOR pathway inhibitors, experiencing disease progression following one cytokine therapy treatment, according to the press release.

Its approval is based on superior progression-free survival (PFS) in TIVO-1, a phase 3 trial comparing the efficacy and tolerability of tivozanib (1.5 mg once daily) with that of sorafenib (400 mg twice daily). In the overall trial population of 517 patients with advanced RCC, PFS was 11.9 months for patients treated with tivozanib, compared with 9.1 months for those treated with sorafenib (hazard ratio, 0.797; 95% confidence interval, 0.639-0.993; P = .042).

Patients in the tivozanib arm also experienced fewer cases of diarrhea and hand-foot syndrome, and required fewer dose reductions because of adverse effects than did those taking sorafenib.

The approval follows a recommendation from the Committee for Medical Products for Human Use.

The Food and Drug Administration rejected the New Drug Application for tivozanib in 2013, based on TIVO-1 data. Aveo Oncology plans to reapply in the United States with data from TIVO-3, expected in early 2018, they said in the press release.

[email protected]

With Republican efforts to “repeal and replace” the Affordable Care Act stalled, tentative bipartisan initiatives are in the works to shore up the fragile individual insurance market that serves roughly 17 million Americans.

The Senate Health, Education, Labor and Pensions Committee launches hearings the week Congress returns in September on “stabilizing premiums in the individual insurance market” that will feature state governors and insurance commissioners. A bipartisan group in the House is also working to come up with compromise proposals.

Both before and after implementation of the federal health law, this market – serving people who don’t get coverage through work or the government – has proved problematic. Before the law, many people with preexisting health conditions could not get insurance at any price. Now, consumers in the individual market often face higher out-of-pocket costs and fewer choices of health care providers and insurers than in past years. More than 12 million people buy that insurance through the ACA’s marketplaces, while another 5 million buy it outside of the exchanges.

Policy makers generally agree on what immediate efforts to stabilize the market might include. At the top of most lists is ensuring federal payment of subsidies to insurers to pay the out-of-pocket expenses – such as deductibles and copayments – to protect customers with the lowest incomes. Insurers also want the federal government to continue enforcing the requirement that most Americans either have insurance or pay a tax penalty, and continuing efforts to get uninsured people to sign up for coverage during the upcoming open enrollment period, from Nov. 1 to Dec. 15. Those efforts are essential, insurers say, to help keep healthy customers in their risk pools to defray the costs of beneficiaries with medical needs.

But what about ideas that go beyond the oft-repeated ones? Here are five proposals that are more controversial but generating buzz.
 

1. Allow people into Medicare starting at age 55.

Getting slightly younger people into Medicare, the federal program for the disabled and Americans 65 and older, is a longtime goal of Democrats. It dates at least to the Clinton administration and was nearly included in the Affordable Care Act in 2010. A Medicare buy-in is not exactly the same as a “public option,” which many Democrats, including former President Barack Obama, have embraced. A true public option would offer government coverage to those of any age.

Lowering the age for Medicare eligibility (whether by allowing people to purchase coverage early or letting them join on the same terms as those aged 65) is controversial. Some Democrats support it as a first step toward a single-payer, Medicare-for-all system. Most Republicans oppose it on those same grounds – as a step toward government-run health care.

But proponents argue it would help the current individual market by excluding the oldest people, thereby lowering the average age of the risk pool. Since older patients, on average, cost more to insure, the change could lower premiums for everyone left in the ACA market. That’s the stated goal of a Medicare buy-in bill introduced earlier this month by Sen. Debbie Stabenow (D-Mich.) and seven other Democratic senators. That bill would allow Obamacare market customers ages 55-64 to purchase Medicare coverage instead, but would also let them use ACA tax credits if they are eligible for those. The cost of such policies, however, has not been worked out.

“The way we’ve structured it actually both helps Medicare by having younger people in that pool, and it helps private insurance by taking higher-cost individuals out of their pool,” Sen. Stabenow told The Detroit News.

Conservative health analysts don’t buy that, though. “This is just a way of saying we’re going to take these people out of the exchanges and put them where there are bigger subsidies,” said Joseph Antos of the conservative-leaning American Enterprise Institute (AEI).
 

2. Allow people to ‘buy in’ to Medicaid.

An alternative to letting people buy in to Medicare is letting them buy in to Medicaid, the joint federal-state program for those with low incomes.

Medicaid buy-ins already exist – for example, in 2005 Congress passed the Family Opportunity Act, which allows families earning up to three times the poverty level to purchase Medicaid coverage for their disabled children who aren’t otherwise eligible. Medicaid has typically provided richer benefits for those with disabilities than private health insurance.

Earlier this year, Gov. Brian Sandoval (R-Nev.) vetoed a bill that would have allowed Nevada residents to buy Medicaid coverage through the state’s insurance exchange.

Now Sen. Brian Schatz (D-Hawaii) is pushing a federal Medicaid buy-in plan, which he described to Vox.com last week. It would give states the option to allow people with incomes over current Medicaid eligibility thresholds to pay a premium to join the program. Like the Medicare buy-in bill, it would allow those who qualify for federal tax credits to use them to pay the premiums.

The proposal would also raise the amounts Medicaid pays to doctors, hospitals and other health care providers to the same level as it pays for Medicare patients. Traditionally, low Medicaid payment rates have kept many doctors, particularly specialists, from taking Medicaid.

As with the Medicare expansion, the idea of a further Medicaid expansion does not sit well with conservative policy analysts. “It’s completely unworkable,” Avik Roy of the Foundation for Research on Equal Opportunity, told Vox. He predicted it would raise Medicaid spending by $2 trillion over 10 years.
 

3. Get younger adults off their parents’ insurance and back into the individual market.

Allowing young adults up to age 26 to stay on their parents’ health plans is unquestionably one of the most popular ACA provisions. Democrats have touted it proudly while Republicans have dared not touch it in almost any of their overhaul proposals.

Yet what has been a boon to 3 million young adults (and a relief to their parents) has come at a cost to the individual marketplace itself, where only an estimated 28% of those buying coverage in state exchanges were ages 18-34 in 2016. That is well below the 40% most analysts said was necessary to keep the market stable.

“Frankly, it was really stupid,” to keep those young people out of the individual market, said Mr. Antos of AEI. The result has been a lack of people in the risk pool who are “young, healthy and whose parents will pay their premiums.”

But rolling back that piece of the law might be nearly impossible, said Mr. Antos, because “this is a middle-class giveaway.”
 

4. Require insurers who participate in other government programs to offer marketplace coverage.

One clear shortcoming of the individual marketplace is a lack of insurer competition, particularly in rural areas. While there appear to be no counties left with no company offering coverage for the coming year, the percentage of counties with only one insurer seems certain to rise from 2017’s 33%.

In an effort to more strongly encourage private companies to step up and offer coverage, several analysts have suggested tying access to participation in other government programs to a willingness to offer individual ACA policies as well.

For example, some have suggested insurers be required to provide policies in the marketplaces as a condition of being able to offer coverage to federal workers. Others have suggested that private insurers who offer profitable Medicare Advantage plans could also be required to offer individual exchange coverage, although the same rural areas with a lack of private individual market insurers also tend to lack Medicare Advantage coverage.
 

5. Let people use HSA contributions to pay health insurance premiums.

A little-noticed provision in one of the versions of the Senate GOP health bill that failed to pass in July would have allowed people to use money from tax-preferred health savings accounts (HSAs) to pay their insurance premiums. A little-noticed proposal from a group of ideologically diverse health care experts included a similar idea.

HSAs are linked to high-deductible insurance plans, and consumers use the money in the account to pay their out-of-pocket expenses. The money put into the account and the earnings are not taxable.

With a few exceptions, people with HSAs have not been allowed to use those funds to pay monthly premiums. But the change would be one way to provide relief to people who buy their own insurance, earn too much to get federal premium subsidies, and cannot deduct premiums from their taxes because they are not technically self-employed. Such people, though likely small in number, have been disproportionately hurt by rising premiums in the individual market since the ACA took full effect.

Still, the change would involve some trade-offs.

Roy Ramthun, who helped design HSAs as a Senate staffer in the early 2000s and helped implement them while at the Treasury Department during the George W. Bush administration, said that, generally, “Republicans have preferred to subsidize insurance premiums through tax deductions and credits and leave the HSA for out-of-pocket expenses.” Allowing premiums to be paid from HSA funds, he said, “could eat up the entire balance of the account and leave nothing for out-of-pocket expenses.” There are limits to how much money can be put into an HSA. For 2017, the maximum is $3,400 for an individual and $6,750 for a family.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

With Republican efforts to “repeal and replace” the Affordable Care Act stalled, tentative bipartisan initiatives are in the works to shore up the fragile individual insurance market that serves roughly 17 million Americans.

The Senate Health, Education, Labor and Pensions Committee launches hearings the week Congress returns in September on “stabilizing premiums in the individual insurance market” that will feature state governors and insurance commissioners. A bipartisan group in the House is also working to come up with compromise proposals.

Both before and after implementation of the federal health law, this market – serving people who don’t get coverage through work or the government – has proved problematic. Before the law, many people with preexisting health conditions could not get insurance at any price. Now, consumers in the individual market often face higher out-of-pocket costs and fewer choices of health care providers and insurers than in past years. More than 12 million people buy that insurance through the ACA’s marketplaces, while another 5 million buy it outside of the exchanges.

Policy makers generally agree on what immediate efforts to stabilize the market might include. At the top of most lists is ensuring federal payment of subsidies to insurers to pay the out-of-pocket expenses – such as deductibles and copayments – to protect customers with the lowest incomes. Insurers also want the federal government to continue enforcing the requirement that most Americans either have insurance or pay a tax penalty, and continuing efforts to get uninsured people to sign up for coverage during the upcoming open enrollment period, from Nov. 1 to Dec. 15. Those efforts are essential, insurers say, to help keep healthy customers in their risk pools to defray the costs of beneficiaries with medical needs.

But what about ideas that go beyond the oft-repeated ones? Here are five proposals that are more controversial but generating buzz.
 

1. Allow people into Medicare starting at age 55.

Getting slightly younger people into Medicare, the federal program for the disabled and Americans 65 and older, is a longtime goal of Democrats. It dates at least to the Clinton administration and was nearly included in the Affordable Care Act in 2010. A Medicare buy-in is not exactly the same as a “public option,” which many Democrats, including former President Barack Obama, have embraced. A true public option would offer government coverage to those of any age.

Lowering the age for Medicare eligibility (whether by allowing people to purchase coverage early or letting them join on the same terms as those aged 65) is controversial. Some Democrats support it as a first step toward a single-payer, Medicare-for-all system. Most Republicans oppose it on those same grounds – as a step toward government-run health care.

But proponents argue it would help the current individual market by excluding the oldest people, thereby lowering the average age of the risk pool. Since older patients, on average, cost more to insure, the change could lower premiums for everyone left in the ACA market. That’s the stated goal of a Medicare buy-in bill introduced earlier this month by Sen. Debbie Stabenow (D-Mich.) and seven other Democratic senators. That bill would allow Obamacare market customers ages 55-64 to purchase Medicare coverage instead, but would also let them use ACA tax credits if they are eligible for those. The cost of such policies, however, has not been worked out.

“The way we’ve structured it actually both helps Medicare by having younger people in that pool, and it helps private insurance by taking higher-cost individuals out of their pool,” Sen. Stabenow told The Detroit News.

Conservative health analysts don’t buy that, though. “This is just a way of saying we’re going to take these people out of the exchanges and put them where there are bigger subsidies,” said Joseph Antos of the conservative-leaning American Enterprise Institute (AEI).
 

2. Allow people to ‘buy in’ to Medicaid.

An alternative to letting people buy in to Medicare is letting them buy in to Medicaid, the joint federal-state program for those with low incomes.

Medicaid buy-ins already exist – for example, in 2005 Congress passed the Family Opportunity Act, which allows families earning up to three times the poverty level to purchase Medicaid coverage for their disabled children who aren’t otherwise eligible. Medicaid has typically provided richer benefits for those with disabilities than private health insurance.

Earlier this year, Gov. Brian Sandoval (R-Nev.) vetoed a bill that would have allowed Nevada residents to buy Medicaid coverage through the state’s insurance exchange.

Now Sen. Brian Schatz (D-Hawaii) is pushing a federal Medicaid buy-in plan, which he described to Vox.com last week. It would give states the option to allow people with incomes over current Medicaid eligibility thresholds to pay a premium to join the program. Like the Medicare buy-in bill, it would allow those who qualify for federal tax credits to use them to pay the premiums.

The proposal would also raise the amounts Medicaid pays to doctors, hospitals and other health care providers to the same level as it pays for Medicare patients. Traditionally, low Medicaid payment rates have kept many doctors, particularly specialists, from taking Medicaid.

As with the Medicare expansion, the idea of a further Medicaid expansion does not sit well with conservative policy analysts. “It’s completely unworkable,” Avik Roy of the Foundation for Research on Equal Opportunity, told Vox. He predicted it would raise Medicaid spending by $2 trillion over 10 years.
 

3. Get younger adults off their parents’ insurance and back into the individual market.

Allowing young adults up to age 26 to stay on their parents’ health plans is unquestionably one of the most popular ACA provisions. Democrats have touted it proudly while Republicans have dared not touch it in almost any of their overhaul proposals.

Yet what has been a boon to 3 million young adults (and a relief to their parents) has come at a cost to the individual marketplace itself, where only an estimated 28% of those buying coverage in state exchanges were ages 18-34 in 2016. That is well below the 40% most analysts said was necessary to keep the market stable.

“Frankly, it was really stupid,” to keep those young people out of the individual market, said Mr. Antos of AEI. The result has been a lack of people in the risk pool who are “young, healthy and whose parents will pay their premiums.”

But rolling back that piece of the law might be nearly impossible, said Mr. Antos, because “this is a middle-class giveaway.”
 

4. Require insurers who participate in other government programs to offer marketplace coverage.

One clear shortcoming of the individual marketplace is a lack of insurer competition, particularly in rural areas. While there appear to be no counties left with no company offering coverage for the coming year, the percentage of counties with only one insurer seems certain to rise from 2017’s 33%.

In an effort to more strongly encourage private companies to step up and offer coverage, several analysts have suggested tying access to participation in other government programs to a willingness to offer individual ACA policies as well.

For example, some have suggested insurers be required to provide policies in the marketplaces as a condition of being able to offer coverage to federal workers. Others have suggested that private insurers who offer profitable Medicare Advantage plans could also be required to offer individual exchange coverage, although the same rural areas with a lack of private individual market insurers also tend to lack Medicare Advantage coverage.
 

5. Let people use HSA contributions to pay health insurance premiums.

A little-noticed provision in one of the versions of the Senate GOP health bill that failed to pass in July would have allowed people to use money from tax-preferred health savings accounts (HSAs) to pay their insurance premiums. A little-noticed proposal from a group of ideologically diverse health care experts included a similar idea.

HSAs are linked to high-deductible insurance plans, and consumers use the money in the account to pay their out-of-pocket expenses. The money put into the account and the earnings are not taxable.

With a few exceptions, people with HSAs have not been allowed to use those funds to pay monthly premiums. But the change would be one way to provide relief to people who buy their own insurance, earn too much to get federal premium subsidies, and cannot deduct premiums from their taxes because they are not technically self-employed. Such people, though likely small in number, have been disproportionately hurt by rising premiums in the individual market since the ACA took full effect.

Still, the change would involve some trade-offs.

Roy Ramthun, who helped design HSAs as a Senate staffer in the early 2000s and helped implement them while at the Treasury Department during the George W. Bush administration, said that, generally, “Republicans have preferred to subsidize insurance premiums through tax deductions and credits and leave the HSA for out-of-pocket expenses.” Allowing premiums to be paid from HSA funds, he said, “could eat up the entire balance of the account and leave nothing for out-of-pocket expenses.” There are limits to how much money can be put into an HSA. For 2017, the maximum is $3,400 for an individual and $6,750 for a family.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

With Republican efforts to “repeal and replace” the Affordable Care Act stalled, tentative bipartisan initiatives are in the works to shore up the fragile individual insurance market that serves roughly 17 million Americans.

The Senate Health, Education, Labor and Pensions Committee launches hearings the week Congress returns in September on “stabilizing premiums in the individual insurance market” that will feature state governors and insurance commissioners. A bipartisan group in the House is also working to come up with compromise proposals.

Both before and after implementation of the federal health law, this market – serving people who don’t get coverage through work or the government – has proved problematic. Before the law, many people with preexisting health conditions could not get insurance at any price. Now, consumers in the individual market often face higher out-of-pocket costs and fewer choices of health care providers and insurers than in past years. More than 12 million people buy that insurance through the ACA’s marketplaces, while another 5 million buy it outside of the exchanges.

Policy makers generally agree on what immediate efforts to stabilize the market might include. At the top of most lists is ensuring federal payment of subsidies to insurers to pay the out-of-pocket expenses – such as deductibles and copayments – to protect customers with the lowest incomes. Insurers also want the federal government to continue enforcing the requirement that most Americans either have insurance or pay a tax penalty, and continuing efforts to get uninsured people to sign up for coverage during the upcoming open enrollment period, from Nov. 1 to Dec. 15. Those efforts are essential, insurers say, to help keep healthy customers in their risk pools to defray the costs of beneficiaries with medical needs.

But what about ideas that go beyond the oft-repeated ones? Here are five proposals that are more controversial but generating buzz.
 

1. Allow people into Medicare starting at age 55.

Getting slightly younger people into Medicare, the federal program for the disabled and Americans 65 and older, is a longtime goal of Democrats. It dates at least to the Clinton administration and was nearly included in the Affordable Care Act in 2010. A Medicare buy-in is not exactly the same as a “public option,” which many Democrats, including former President Barack Obama, have embraced. A true public option would offer government coverage to those of any age.

Lowering the age for Medicare eligibility (whether by allowing people to purchase coverage early or letting them join on the same terms as those aged 65) is controversial. Some Democrats support it as a first step toward a single-payer, Medicare-for-all system. Most Republicans oppose it on those same grounds – as a step toward government-run health care.

But proponents argue it would help the current individual market by excluding the oldest people, thereby lowering the average age of the risk pool. Since older patients, on average, cost more to insure, the change could lower premiums for everyone left in the ACA market. That’s the stated goal of a Medicare buy-in bill introduced earlier this month by Sen. Debbie Stabenow (D-Mich.) and seven other Democratic senators. That bill would allow Obamacare market customers ages 55-64 to purchase Medicare coverage instead, but would also let them use ACA tax credits if they are eligible for those. The cost of such policies, however, has not been worked out.

“The way we’ve structured it actually both helps Medicare by having younger people in that pool, and it helps private insurance by taking higher-cost individuals out of their pool,” Sen. Stabenow told The Detroit News.

Conservative health analysts don’t buy that, though. “This is just a way of saying we’re going to take these people out of the exchanges and put them where there are bigger subsidies,” said Joseph Antos of the conservative-leaning American Enterprise Institute (AEI).
 

2. Allow people to ‘buy in’ to Medicaid.

An alternative to letting people buy in to Medicare is letting them buy in to Medicaid, the joint federal-state program for those with low incomes.

Medicaid buy-ins already exist – for example, in 2005 Congress passed the Family Opportunity Act, which allows families earning up to three times the poverty level to purchase Medicaid coverage for their disabled children who aren’t otherwise eligible. Medicaid has typically provided richer benefits for those with disabilities than private health insurance.

Earlier this year, Gov. Brian Sandoval (R-Nev.) vetoed a bill that would have allowed Nevada residents to buy Medicaid coverage through the state’s insurance exchange.

Now Sen. Brian Schatz (D-Hawaii) is pushing a federal Medicaid buy-in plan, which he described to Vox.com last week. It would give states the option to allow people with incomes over current Medicaid eligibility thresholds to pay a premium to join the program. Like the Medicare buy-in bill, it would allow those who qualify for federal tax credits to use them to pay the premiums.

The proposal would also raise the amounts Medicaid pays to doctors, hospitals and other health care providers to the same level as it pays for Medicare patients. Traditionally, low Medicaid payment rates have kept many doctors, particularly specialists, from taking Medicaid.

As with the Medicare expansion, the idea of a further Medicaid expansion does not sit well with conservative policy analysts. “It’s completely unworkable,” Avik Roy of the Foundation for Research on Equal Opportunity, told Vox. He predicted it would raise Medicaid spending by $2 trillion over 10 years.
 

3. Get younger adults off their parents’ insurance and back into the individual market.

Allowing young adults up to age 26 to stay on their parents’ health plans is unquestionably one of the most popular ACA provisions. Democrats have touted it proudly while Republicans have dared not touch it in almost any of their overhaul proposals.

Yet what has been a boon to 3 million young adults (and a relief to their parents) has come at a cost to the individual marketplace itself, where only an estimated 28% of those buying coverage in state exchanges were ages 18-34 in 2016. That is well below the 40% most analysts said was necessary to keep the market stable.

“Frankly, it was really stupid,” to keep those young people out of the individual market, said Mr. Antos of AEI. The result has been a lack of people in the risk pool who are “young, healthy and whose parents will pay their premiums.”

But rolling back that piece of the law might be nearly impossible, said Mr. Antos, because “this is a middle-class giveaway.”
 

4. Require insurers who participate in other government programs to offer marketplace coverage.

One clear shortcoming of the individual marketplace is a lack of insurer competition, particularly in rural areas. While there appear to be no counties left with no company offering coverage for the coming year, the percentage of counties with only one insurer seems certain to rise from 2017’s 33%.

In an effort to more strongly encourage private companies to step up and offer coverage, several analysts have suggested tying access to participation in other government programs to a willingness to offer individual ACA policies as well.

For example, some have suggested insurers be required to provide policies in the marketplaces as a condition of being able to offer coverage to federal workers. Others have suggested that private insurers who offer profitable Medicare Advantage plans could also be required to offer individual exchange coverage, although the same rural areas with a lack of private individual market insurers also tend to lack Medicare Advantage coverage.
 

5. Let people use HSA contributions to pay health insurance premiums.

A little-noticed provision in one of the versions of the Senate GOP health bill that failed to pass in July would have allowed people to use money from tax-preferred health savings accounts (HSAs) to pay their insurance premiums. A little-noticed proposal from a group of ideologically diverse health care experts included a similar idea.

HSAs are linked to high-deductible insurance plans, and consumers use the money in the account to pay their out-of-pocket expenses. The money put into the account and the earnings are not taxable.

With a few exceptions, people with HSAs have not been allowed to use those funds to pay monthly premiums. But the change would be one way to provide relief to people who buy their own insurance, earn too much to get federal premium subsidies, and cannot deduct premiums from their taxes because they are not technically self-employed. Such people, though likely small in number, have been disproportionately hurt by rising premiums in the individual market since the ACA took full effect.

Still, the change would involve some trade-offs.

Roy Ramthun, who helped design HSAs as a Senate staffer in the early 2000s and helped implement them while at the Treasury Department during the George W. Bush administration, said that, generally, “Republicans have preferred to subsidize insurance premiums through tax deductions and credits and leave the HSA for out-of-pocket expenses.” Allowing premiums to be paid from HSA funds, he said, “could eat up the entire balance of the account and leave nothing for out-of-pocket expenses.” There are limits to how much money can be put into an HSA. For 2017, the maximum is $3,400 for an individual and $6,750 for a family.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

[email protected]

The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

[email protected]

The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release.

[email protected]

Office based-testing is convenient and often useful.

Often, but not always.

Sadly, a number of practices are increasingly turning to tests of questionable value as a way to make up for decreasing reimbursements. While I have nothing against making money, I have to question where this trend is going. I see many of them even being done by physicians outside of their fields.

Graffoto8/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Office based-testing is convenient and often useful.

Often, but not always.

Sadly, a number of practices are increasingly turning to tests of questionable value as a way to make up for decreasing reimbursements. While I have nothing against making money, I have to question where this trend is going. I see many of them even being done by physicians outside of their fields.

Graffoto8/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Office based-testing is convenient and often useful.

Often, but not always.

Sadly, a number of practices are increasingly turning to tests of questionable value as a way to make up for decreasing reimbursements. While I have nothing against making money, I have to question where this trend is going. I see many of them even being done by physicians outside of their fields.

Graffoto8/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The U.S. Food and Drug Administration has approved tisagenlecleucel (Kymriah), a first-of-its-kind chimeric antigen receptor T-cell (CAR T) therapy, for the treatment of children and young adults up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Tisagenlecleucel will carry a boxed warning regarding the CRS risk. Additionally, due to the CRS risk and risk of neurological events, the approval requires a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use, according to an FDA press release.

Special certification will be required for hospitals and associated clinics that dispense tisagenlecleucel. As part of certification, staff will be trained in the prescribing, dispensing, or administering of the therapy, and to recognize and manage CRS and neurological events.

Novartis, the maker of tisagenlecleucel, will be required to conduct postmarketing observational study.

Courtesy Novartis

Indeed, FDA commissioner Scott Gottlieb, MD, said the approval marks the entry to a “new frontier in medical innovation.”

“New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses,” he said in the press statement.

Tisagenlecleucel is a genetically modified autologous T-cell immunotherapy involving customized treatment created using a patient’s own T cells. The T cells are genetically modified to include a chimeric antigen receptor that directs the T cells to target and kill leukemia cells with CD19 surface antigen, and are then infused back into the patient. 

In a phase 2 clinical trial, the overall remission rate with tisagenlecleucel therapy was 83% in 63 children and young adults with relapsed/refractory B-cell precursor ALL for whom at least two prior lines of therapy had failed; the therapy was granted Fast Track, Priority Review, and Breakthrough Therapy designations.

“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research said in the press statement.

“Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that shows promising remission and survival rates in clinical trials.”

At its meeting in July, the FDA ODAC agreed nearly unanimously that the risk mitigation plan put forward by Novartis, including planned 15-year follow-up and other mitigation measures, would be adequate for detecting serious consequences of CAR T-cell therapy.

[email protected] 

This article was updated August 30, 2017.

The U.S. Food and Drug Administration has approved tisagenlecleucel (Kymriah), a first-of-its-kind chimeric antigen receptor T-cell (CAR T) therapy, for the treatment of children and young adults up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Tisagenlecleucel will carry a boxed warning regarding the CRS risk. Additionally, due to the CRS risk and risk of neurological events, the approval requires a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use, according to an FDA press release.

Special certification will be required for hospitals and associated clinics that dispense tisagenlecleucel. As part of certification, staff will be trained in the prescribing, dispensing, or administering of the therapy, and to recognize and manage CRS and neurological events.

Novartis, the maker of tisagenlecleucel, will be required to conduct postmarketing observational study.

Courtesy Novartis

Indeed, FDA commissioner Scott Gottlieb, MD, said the approval marks the entry to a “new frontier in medical innovation.”

“New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses,” he said in the press statement.

Tisagenlecleucel is a genetically modified autologous T-cell immunotherapy involving customized treatment created using a patient’s own T cells. The T cells are genetically modified to include a chimeric antigen receptor that directs the T cells to target and kill leukemia cells with CD19 surface antigen, and are then infused back into the patient. 

In a phase 2 clinical trial, the overall remission rate with tisagenlecleucel therapy was 83% in 63 children and young adults with relapsed/refractory B-cell precursor ALL for whom at least two prior lines of therapy had failed; the therapy was granted Fast Track, Priority Review, and Breakthrough Therapy designations.

“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research said in the press statement.

“Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that shows promising remission and survival rates in clinical trials.”

At its meeting in July, the FDA ODAC agreed nearly unanimously that the risk mitigation plan put forward by Novartis, including planned 15-year follow-up and other mitigation measures, would be adequate for detecting serious consequences of CAR T-cell therapy.

[email protected] 

This article was updated August 30, 2017.

The U.S. Food and Drug Administration has approved tisagenlecleucel (Kymriah), a first-of-its-kind chimeric antigen receptor T-cell (CAR T) therapy, for the treatment of children and young adults up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Tisagenlecleucel will carry a boxed warning regarding the CRS risk. Additionally, due to the CRS risk and risk of neurological events, the approval requires a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use, according to an FDA press release.

Special certification will be required for hospitals and associated clinics that dispense tisagenlecleucel. As part of certification, staff will be trained in the prescribing, dispensing, or administering of the therapy, and to recognize and manage CRS and neurological events.

Novartis, the maker of tisagenlecleucel, will be required to conduct postmarketing observational study.

Courtesy Novartis

Indeed, FDA commissioner Scott Gottlieb, MD, said the approval marks the entry to a “new frontier in medical innovation.”

“New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses,” he said in the press statement.

Tisagenlecleucel is a genetically modified autologous T-cell immunotherapy involving customized treatment created using a patient’s own T cells. The T cells are genetically modified to include a chimeric antigen receptor that directs the T cells to target and kill leukemia cells with CD19 surface antigen, and are then infused back into the patient. 

In a phase 2 clinical trial, the overall remission rate with tisagenlecleucel therapy was 83% in 63 children and young adults with relapsed/refractory B-cell precursor ALL for whom at least two prior lines of therapy had failed; the therapy was granted Fast Track, Priority Review, and Breakthrough Therapy designations.

“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research said in the press statement.

“Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that shows promising remission and survival rates in clinical trials.”

At its meeting in July, the FDA ODAC agreed nearly unanimously that the risk mitigation plan put forward by Novartis, including planned 15-year follow-up and other mitigation measures, would be adequate for detecting serious consequences of CAR T-cell therapy.

[email protected] 

This article was updated August 30, 2017.

BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.

Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.

[email protected]

BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.

Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.

[email protected]

BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.

Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.

[email protected]

Low malignant potential tumors of the ovary – otherwise known as borderline tumors – include ovarian tumors with atypical cellularity, which lack stromal invasion that differentiates them from low grade and high grade invasive carcinomas. They can coexist with extraovarian disease, however, in the setting of borderline tumors these foci are referred to as “implants” rather than metastases. As discussed below, these implants can exhibit the presence of invasion or not.

Classification

The two most common histologic categories of borderline tumors are serous and mucinous cell types. Rarer histologic types such as endometrioid, clear cell, and Brenner also exist. However, these are so infrequent that they will not be covered in this discussion as there are very limited data to make generalizations about these histologies.

Serous borderline tumors contain cellularity similar to that of fallopian tubal epithelium. Approximately 25% of all serous ovarian tumors exhibit borderline features. Compared with mucinous tumors, they are more commonly bilateral and smaller in size (mean size of 12 cm) at the time of diagnosis and they are more likely to be associated with extraovarian implants (typically peritoneal). In fact, up to 25% of serous borderline tumors have concomitant extraovarian implants. Cancer antigen (CA) 125 is commonly a tumor marker for these tumors (elevated in 45% of early stage disease and 80% of advanced stage disease).¹

Courtesy Dr. Julia Manny

Incidence

The incidence of borderline ovarian tumors is 2.5 per 100,000 woman years in the United States. About 70% are diagnosed at stage I.³ They arise in a younger population compared with invasive ovarian carcinomas. Risk factors for development of borderline tumors are similar to those of invasive ovarian carcinomas (such as nulliparity) but there may be a stronger association between the development of borderline ovarian tumors and infertility, as well as prior use of infertility treatment.⁴

Diagnosis

The diagnosis of borderline tumors of the ovaries occurs almost exclusively at the time of surgical pathology (either frozen section or definitive pathology).

Preoperative assessments with imaging and tumor markers – usually CA 125 and carcinoembryonic antigen (CEA) – are nonspecific for this tumor type. Preoperative imaging will typically reveal complex ovarian cysts with papillations and vascularity. However, in the case of mucinous borderline tumors, unilocular cysts are common.¹ The presence of ascites and peritoneal implants can be observed on preoperative imaging of serous borderline tumors with extraovarian disease. However, it is not possible for this imaging to accurately differentiate borderline tumors with implants from low grade and high grade carcinomas with metastases.

Surgical management

Borderline tumors are commonly diagnosed in women of reproductive age and decisions need to be made regarding fertility sparing surgery, ovarian sparing surgery, and whether staging is performed. The recommended surgery for women who have completed child bearing is complete hysterectomy with bilateral salpingo-oophorectomy. However, cystectomy or unilateral salpingo-oophorectomy can be considered for women who desire fertility preservation. Conservative fertility preserving surgery is associated with an increased risk of recurrence, but with no negative impact on survival.¹

Staging – with at least omentectomy and comprehensive evaluation of the peritoneal cavity, with or without peritoneal biopsies – can be considered, though staging is not associated with improved survival. Lymphadenectomy is also not associated with improved oncologic outcomes and routine lymphadenectomy is not recommended for borderline tumors.¹ However, about a quarter of patients with gross evidence of extraovarian disease have implants within lymph nodes. Bulky lymph nodes should be removed, particularly in this group of patients.

Complete removal of extraovarian implants is the surgical intervention that is most important for survival and recurrence.¹ This requires that surgeons thoroughly evaluate the peritoneal cavity and retroperitoneum, and possess the capability to completely resect all sites of disease.

Historically appendectomy was part of surgical staging of mucinous borderline tumors in order to identify a primary appendiceal lesion, but only 1% of patients with a grossly normal appearing appendix have significant pathology identified. This is no longer recommended.²

Treatment

The primary treatment for borderline tumors of the ovary is surgery. A minimally invasive approach is appropriate when feasible, though it may be associated with an increased risk of cyst rupture, particularly if cystectomy is attempted. Outcomes are best when extraovarian implants are completely resected. Adjuvant chemotherapy is not associated with improved survival and is not routinely recommended, though the guidelines from the National Comprehensive Cancer Network include this as an option for patients with advanced stage disease that is either completely or incompletely resected.⁵

Prognosis

In general, prognosis is excellent for borderline tumors with 5- and 10-year survival of 99% and 97%, 98% and 90%, and 96% and 88% for stages I, II and III tumors, respectively.¹ However, several pathologic, molecular, and anatomic features are important in predicting who is at highest risk for recurrence.

Serous borderline tumors with invasive implants (as opposed to desmoplastic implants) and incompletely resected extraovarian implants are associated with increased recurrence and poor prognosis.Micropapillary features and stromal invasion are histologic features that have historically been associated with worse prognosis, but it is unclear if these are independent risk factors, or instead associated with invasive implants. For mucinous borderline tumors, intraepithelial carcinoma has been inconclusively associated with poor prognosis.^1,6

Surveillance

Recurrences do occur in patients with a history of borderline tumors of the ovary, however these typically occur late. For this reason, surveillance is important and should continue for many years after diagnosis. Most recurrences are within the peritoneal cavity and are treated with surgical excision and patients should be counseled regarding symptoms of recurrence that include gastrointestinal symptoms, bloating, and pain.

In accordance with guidelines from the Society of Gynecologic Oncology, surveillance examinations can take place annually as there is no evidence that more frequent evaluations improve outcomes. These visits should include physical examinations (with pelvic examinations), symptom assessment, and, if elevated preoperatively, assessment of relevant tumor markers (typically CA 125 and/or CEA).⁷ Surveillance should continue for at least 10 years postoperatively.

Routine imaging is not recommended for all patients in surveillance. However, for patients who have had fertility-sparing surgery, imaging with pelvic ultrasound is recommended, particularly for women with a history of cystectomy or serous borderline tumor (who are at increased risk for bilateral tumors).

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Lancet Oncol. 2012 Mar;13(3):e103-15.

2. Arch Gynecol Obstet. 2016 Nov;294(6):1283-9.

3. Cancer. 2002 Dec 1;95(11):2380-9.

4. Am J Epidemiol. 2002 Feb 1;155(3):217-24.

5. J Natl Compr Canc Netw. 2016 Sep;14(9):1134-63.

6. BJOG. 2016 Mar;123(4):498-508.

7. Gynecol Oncol. 2017 Jul;146(1):3-10.

Low malignant potential tumors of the ovary – otherwise known as borderline tumors – include ovarian tumors with atypical cellularity, which lack stromal invasion that differentiates them from low grade and high grade invasive carcinomas. They can coexist with extraovarian disease, however, in the setting of borderline tumors these foci are referred to as “implants” rather than metastases. As discussed below, these implants can exhibit the presence of invasion or not.

Classification

The two most common histologic categories of borderline tumors are serous and mucinous cell types. Rarer histologic types such as endometrioid, clear cell, and Brenner also exist. However, these are so infrequent that they will not be covered in this discussion as there are very limited data to make generalizations about these histologies.

Serous borderline tumors contain cellularity similar to that of fallopian tubal epithelium. Approximately 25% of all serous ovarian tumors exhibit borderline features. Compared with mucinous tumors, they are more commonly bilateral and smaller in size (mean size of 12 cm) at the time of diagnosis and they are more likely to be associated with extraovarian implants (typically peritoneal). In fact, up to 25% of serous borderline tumors have concomitant extraovarian implants. Cancer antigen (CA) 125 is commonly a tumor marker for these tumors (elevated in 45% of early stage disease and 80% of advanced stage disease).¹

Courtesy Dr. Julia Manny

Incidence

The incidence of borderline ovarian tumors is 2.5 per 100,000 woman years in the United States. About 70% are diagnosed at stage I.³ They arise in a younger population compared with invasive ovarian carcinomas. Risk factors for development of borderline tumors are similar to those of invasive ovarian carcinomas (such as nulliparity) but there may be a stronger association between the development of borderline ovarian tumors and infertility, as well as prior use of infertility treatment.⁴

Diagnosis

The diagnosis of borderline tumors of the ovaries occurs almost exclusively at the time of surgical pathology (either frozen section or definitive pathology).

Preoperative assessments with imaging and tumor markers – usually CA 125 and carcinoembryonic antigen (CEA) – are nonspecific for this tumor type. Preoperative imaging will typically reveal complex ovarian cysts with papillations and vascularity. However, in the case of mucinous borderline tumors, unilocular cysts are common.¹ The presence of ascites and peritoneal implants can be observed on preoperative imaging of serous borderline tumors with extraovarian disease. However, it is not possible for this imaging to accurately differentiate borderline tumors with implants from low grade and high grade carcinomas with metastases.

Surgical management

Borderline tumors are commonly diagnosed in women of reproductive age and decisions need to be made regarding fertility sparing surgery, ovarian sparing surgery, and whether staging is performed. The recommended surgery for women who have completed child bearing is complete hysterectomy with bilateral salpingo-oophorectomy. However, cystectomy or unilateral salpingo-oophorectomy can be considered for women who desire fertility preservation. Conservative fertility preserving surgery is associated with an increased risk of recurrence, but with no negative impact on survival.¹

Staging – with at least omentectomy and comprehensive evaluation of the peritoneal cavity, with or without peritoneal biopsies – can be considered, though staging is not associated with improved survival. Lymphadenectomy is also not associated with improved oncologic outcomes and routine lymphadenectomy is not recommended for borderline tumors.¹ However, about a quarter of patients with gross evidence of extraovarian disease have implants within lymph nodes. Bulky lymph nodes should be removed, particularly in this group of patients.

Complete removal of extraovarian implants is the surgical intervention that is most important for survival and recurrence.¹ This requires that surgeons thoroughly evaluate the peritoneal cavity and retroperitoneum, and possess the capability to completely resect all sites of disease.

Historically appendectomy was part of surgical staging of mucinous borderline tumors in order to identify a primary appendiceal lesion, but only 1% of patients with a grossly normal appearing appendix have significant pathology identified. This is no longer recommended.²

Treatment

The primary treatment for borderline tumors of the ovary is surgery. A minimally invasive approach is appropriate when feasible, though it may be associated with an increased risk of cyst rupture, particularly if cystectomy is attempted. Outcomes are best when extraovarian implants are completely resected. Adjuvant chemotherapy is not associated with improved survival and is not routinely recommended, though the guidelines from the National Comprehensive Cancer Network include this as an option for patients with advanced stage disease that is either completely or incompletely resected.⁵

Prognosis

In general, prognosis is excellent for borderline tumors with 5- and 10-year survival of 99% and 97%, 98% and 90%, and 96% and 88% for stages I, II and III tumors, respectively.¹ However, several pathologic, molecular, and anatomic features are important in predicting who is at highest risk for recurrence.

Serous borderline tumors with invasive implants (as opposed to desmoplastic implants) and incompletely resected extraovarian implants are associated with increased recurrence and poor prognosis.Micropapillary features and stromal invasion are histologic features that have historically been associated with worse prognosis, but it is unclear if these are independent risk factors, or instead associated with invasive implants. For mucinous borderline tumors, intraepithelial carcinoma has been inconclusively associated with poor prognosis.^1,6

Surveillance

Recurrences do occur in patients with a history of borderline tumors of the ovary, however these typically occur late. For this reason, surveillance is important and should continue for many years after diagnosis. Most recurrences are within the peritoneal cavity and are treated with surgical excision and patients should be counseled regarding symptoms of recurrence that include gastrointestinal symptoms, bloating, and pain.

In accordance with guidelines from the Society of Gynecologic Oncology, surveillance examinations can take place annually as there is no evidence that more frequent evaluations improve outcomes. These visits should include physical examinations (with pelvic examinations), symptom assessment, and, if elevated preoperatively, assessment of relevant tumor markers (typically CA 125 and/or CEA).⁷ Surveillance should continue for at least 10 years postoperatively.

Routine imaging is not recommended for all patients in surveillance. However, for patients who have had fertility-sparing surgery, imaging with pelvic ultrasound is recommended, particularly for women with a history of cystectomy or serous borderline tumor (who are at increased risk for bilateral tumors).

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Lancet Oncol. 2012 Mar;13(3):e103-15.

2. Arch Gynecol Obstet. 2016 Nov;294(6):1283-9.

3. Cancer. 2002 Dec 1;95(11):2380-9.

4. Am J Epidemiol. 2002 Feb 1;155(3):217-24.

5. J Natl Compr Canc Netw. 2016 Sep;14(9):1134-63.

6. BJOG. 2016 Mar;123(4):498-508.

7. Gynecol Oncol. 2017 Jul;146(1):3-10.

Low malignant potential tumors of the ovary – otherwise known as borderline tumors – include ovarian tumors with atypical cellularity, which lack stromal invasion that differentiates them from low grade and high grade invasive carcinomas. They can coexist with extraovarian disease, however, in the setting of borderline tumors these foci are referred to as “implants” rather than metastases. As discussed below, these implants can exhibit the presence of invasion or not.

Classification

The two most common histologic categories of borderline tumors are serous and mucinous cell types. Rarer histologic types such as endometrioid, clear cell, and Brenner also exist. However, these are so infrequent that they will not be covered in this discussion as there are very limited data to make generalizations about these histologies.

Serous borderline tumors contain cellularity similar to that of fallopian tubal epithelium. Approximately 25% of all serous ovarian tumors exhibit borderline features. Compared with mucinous tumors, they are more commonly bilateral and smaller in size (mean size of 12 cm) at the time of diagnosis and they are more likely to be associated with extraovarian implants (typically peritoneal). In fact, up to 25% of serous borderline tumors have concomitant extraovarian implants. Cancer antigen (CA) 125 is commonly a tumor marker for these tumors (elevated in 45% of early stage disease and 80% of advanced stage disease).¹

Courtesy Dr. Julia Manny

Incidence

The incidence of borderline ovarian tumors is 2.5 per 100,000 woman years in the United States. About 70% are diagnosed at stage I.³ They arise in a younger population compared with invasive ovarian carcinomas. Risk factors for development of borderline tumors are similar to those of invasive ovarian carcinomas (such as nulliparity) but there may be a stronger association between the development of borderline ovarian tumors and infertility, as well as prior use of infertility treatment.⁴

Diagnosis

The diagnosis of borderline tumors of the ovaries occurs almost exclusively at the time of surgical pathology (either frozen section or definitive pathology).

Preoperative assessments with imaging and tumor markers – usually CA 125 and carcinoembryonic antigen (CEA) – are nonspecific for this tumor type. Preoperative imaging will typically reveal complex ovarian cysts with papillations and vascularity. However, in the case of mucinous borderline tumors, unilocular cysts are common.¹ The presence of ascites and peritoneal implants can be observed on preoperative imaging of serous borderline tumors with extraovarian disease. However, it is not possible for this imaging to accurately differentiate borderline tumors with implants from low grade and high grade carcinomas with metastases.

Surgical management

Borderline tumors are commonly diagnosed in women of reproductive age and decisions need to be made regarding fertility sparing surgery, ovarian sparing surgery, and whether staging is performed. The recommended surgery for women who have completed child bearing is complete hysterectomy with bilateral salpingo-oophorectomy. However, cystectomy or unilateral salpingo-oophorectomy can be considered for women who desire fertility preservation. Conservative fertility preserving surgery is associated with an increased risk of recurrence, but with no negative impact on survival.¹

Staging – with at least omentectomy and comprehensive evaluation of the peritoneal cavity, with or without peritoneal biopsies – can be considered, though staging is not associated with improved survival. Lymphadenectomy is also not associated with improved oncologic outcomes and routine lymphadenectomy is not recommended for borderline tumors.¹ However, about a quarter of patients with gross evidence of extraovarian disease have implants within lymph nodes. Bulky lymph nodes should be removed, particularly in this group of patients.

Complete removal of extraovarian implants is the surgical intervention that is most important for survival and recurrence.¹ This requires that surgeons thoroughly evaluate the peritoneal cavity and retroperitoneum, and possess the capability to completely resect all sites of disease.

Historically appendectomy was part of surgical staging of mucinous borderline tumors in order to identify a primary appendiceal lesion, but only 1% of patients with a grossly normal appearing appendix have significant pathology identified. This is no longer recommended.²

Treatment

The primary treatment for borderline tumors of the ovary is surgery. A minimally invasive approach is appropriate when feasible, though it may be associated with an increased risk of cyst rupture, particularly if cystectomy is attempted. Outcomes are best when extraovarian implants are completely resected. Adjuvant chemotherapy is not associated with improved survival and is not routinely recommended, though the guidelines from the National Comprehensive Cancer Network include this as an option for patients with advanced stage disease that is either completely or incompletely resected.⁵

Prognosis

In general, prognosis is excellent for borderline tumors with 5- and 10-year survival of 99% and 97%, 98% and 90%, and 96% and 88% for stages I, II and III tumors, respectively.¹ However, several pathologic, molecular, and anatomic features are important in predicting who is at highest risk for recurrence.

Serous borderline tumors with invasive implants (as opposed to desmoplastic implants) and incompletely resected extraovarian implants are associated with increased recurrence and poor prognosis.Micropapillary features and stromal invasion are histologic features that have historically been associated with worse prognosis, but it is unclear if these are independent risk factors, or instead associated with invasive implants. For mucinous borderline tumors, intraepithelial carcinoma has been inconclusively associated with poor prognosis.^1,6

Surveillance

Recurrences do occur in patients with a history of borderline tumors of the ovary, however these typically occur late. For this reason, surveillance is important and should continue for many years after diagnosis. Most recurrences are within the peritoneal cavity and are treated with surgical excision and patients should be counseled regarding symptoms of recurrence that include gastrointestinal symptoms, bloating, and pain.

In accordance with guidelines from the Society of Gynecologic Oncology, surveillance examinations can take place annually as there is no evidence that more frequent evaluations improve outcomes. These visits should include physical examinations (with pelvic examinations), symptom assessment, and, if elevated preoperatively, assessment of relevant tumor markers (typically CA 125 and/or CEA).⁷ Surveillance should continue for at least 10 years postoperatively.

Routine imaging is not recommended for all patients in surveillance. However, for patients who have had fertility-sparing surgery, imaging with pelvic ultrasound is recommended, particularly for women with a history of cystectomy or serous borderline tumor (who are at increased risk for bilateral tumors).

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Lancet Oncol. 2012 Mar;13(3):e103-15.

2. Arch Gynecol Obstet. 2016 Nov;294(6):1283-9.

3. Cancer. 2002 Dec 1;95(11):2380-9.

4. Am J Epidemiol. 2002 Feb 1;155(3):217-24.

5. J Natl Compr Canc Netw. 2016 Sep;14(9):1134-63.

6. BJOG. 2016 Mar;123(4):498-508.

7. Gynecol Oncol. 2017 Jul;146(1):3-10.

With the increasing concern about rising rates of opioid abuse in the general population, including women of reproductive age and pregnant and breastfeeding women, clear guidelines regarding treatment in pregnancy and lactation are needed.

The Committee on Obstetric Practice of the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine addressed this issue comprehensively in the ACOG Committee Opinion issued in August 2017.¹ In this document, universal screening and medication-assisted treatment for opioid use disorder were recommended. Opioid agonists including methadone and buprenorphine were considered the treatments with the most evidence of benefit, and limited concern about adverse fetal effects, other than predictable and treatable neonatal abstinence syndrome.

BackyardProduction/Thinkstock

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures.

References

1. Obstet Gynecol. 2017 Aug;130(2):e81-e94.

2. Curr Neuropharmacol. 2008 Jun;6(2):125–50.

3. Aust N Z J Obstet Gynaecol. 2001 Nov;41(4):424-8.

4. Aust N Z J Obstet Gynaecol. 2002 Feb;42(1):104-5.

5. Int J Gynaecol Obstet. 2004 May;85(2):170-1.

6. Drugs. 2017 Jul;77(11):1211-9.
 

With the increasing concern about rising rates of opioid abuse in the general population, including women of reproductive age and pregnant and breastfeeding women, clear guidelines regarding treatment in pregnancy and lactation are needed.

The Committee on Obstetric Practice of the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine addressed this issue comprehensively in the ACOG Committee Opinion issued in August 2017.¹ In this document, universal screening and medication-assisted treatment for opioid use disorder were recommended. Opioid agonists including methadone and buprenorphine were considered the treatments with the most evidence of benefit, and limited concern about adverse fetal effects, other than predictable and treatable neonatal abstinence syndrome.

BackyardProduction/Thinkstock

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures.

References

1. Obstet Gynecol. 2017 Aug;130(2):e81-e94.

2. Curr Neuropharmacol. 2008 Jun;6(2):125–50.

3. Aust N Z J Obstet Gynaecol. 2001 Nov;41(4):424-8.

4. Aust N Z J Obstet Gynaecol. 2002 Feb;42(1):104-5.

5. Int J Gynaecol Obstet. 2004 May;85(2):170-1.

6. Drugs. 2017 Jul;77(11):1211-9.
 

With the increasing concern about rising rates of opioid abuse in the general population, including women of reproductive age and pregnant and breastfeeding women, clear guidelines regarding treatment in pregnancy and lactation are needed.

The Committee on Obstetric Practice of the American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine addressed this issue comprehensively in the ACOG Committee Opinion issued in August 2017.¹ In this document, universal screening and medication-assisted treatment for opioid use disorder were recommended. Opioid agonists including methadone and buprenorphine were considered the treatments with the most evidence of benefit, and limited concern about adverse fetal effects, other than predictable and treatable neonatal abstinence syndrome.

BackyardProduction/Thinkstock

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures.

References

1. Obstet Gynecol. 2017 Aug;130(2):e81-e94.

2. Curr Neuropharmacol. 2008 Jun;6(2):125–50.

3. Aust N Z J Obstet Gynaecol. 2001 Nov;41(4):424-8.

4. Aust N Z J Obstet Gynaecol. 2002 Feb;42(1):104-5.

5. Int J Gynaecol Obstet. 2004 May;85(2):170-1.

6. Drugs. 2017 Jul;77(11):1211-9.