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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Perspectives on How Drug Pricing Legislation Impacts Innovation

Posted by Angela Maas on Nov 14, 2019

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

One of the proposals is the International Pricing Index, an effort by HHS to bring payments for Medicare Part B closer to what 16 other "developed economies" pay for these drugs. The Senate's Prescription Drug Pricing Reduction Act of 2019 proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. And the House’s Lower Drug Costs Now Act proposes, among other things, requiring HHS to negotiate the prices of up to 250 drugs in Medicare without competitors. Companies not coming to an agreement would be subject to financial penalties.
 
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Topics: Specialty, Industry Trends, Product Release, Provider, Payer

Radar On Market Access: Analysts Question Issues Surrounding Beovu's Uptake in Full Anti-VEGF Market

Posted by Angela Maas on Nov 12, 2019

Last month, the FDA approved Beovu (brolucizumab-dbll) from Novartis Pharmaceuticals Corp. for the treatment of neovascular (wet) age-related macular degeneration (AMD). The intravitreal injection will compete in a fairly crowded anti-vascular endothelial growth factor (anti-VEGF) market that is led by Eylea (aflibercept) from Regeneron Pharmaceuticals, Inc., AIS Health reported.

Novartis priced Beovu at $1,850 per vial — the same per-dose price as Eylea. Following three initial monthly doses, Beovu can be administered every eight to 12 weeks. Eylea also has three initial monthly doses and then may be administered every four, eight or 12 weeks.

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Topics: Specialty, Market Access, Data & Analytics, Provider, Payer

Trends That Matter for IL-17 Use in Psoriasis

Posted by Angela Maas on Nov 7, 2019

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA's approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens, AIS Health reported.

The first IL-17 inhibitor on the U.S. market was Cosentyx (secukinumab) from Novartis Pharmaceuticals Corp., which launched in 2015. The next therapy was Taltz (ixekizumab) from Eli Lilly and Co., and then on Feb. 15, 2017, the agency approved Siliq (brodalumab) from Ortho Dermatologics.
 
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Topics: Industry Trends, Data & Analytics

Radar On Market Access: Would Drug Pricing Legislation Impact Innovation?

Posted by Angela Maas on Oct 17, 2019

Many innovative new therapies are coming onto the market, but they also are launching with increasingly higher price tags, even as lawmakers and regulators launch a flurry of activity aimed at bringing down drug prices. Some industry experts caution that a few of the bills, if passed, could endanger the research and development efforts around these novel drugs, while others question that hypothesis, AIS Health reported.

One of the proposals is the International Pricing Index, an effort by HHS to bring payments for Medicare Part B closer to what 16 other "developed economies" pay for these drugs. The Senate's Prescription Drug Pricing Reduction Act of 2019 proposes multiple changes to Medicare Part B and Part D, as well as Medicaid. And the House’s Lower Drug Costs Now Act proposes, among other things, requiring HHS to negotiate the prices of up to 250 drugs in Medicare without competitors. Companies not coming to an agreement would be subject to financial penalties.
 
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Topics: Specialty, Industry Trends, Product Release, Provider, Payer

Radar On Market Access: Study Shows Growing IL-17 Use in Psoriasis

Posted by Angela Maas on Oct 15, 2019

For many years, the psoriasis treatment landscape was dominated by tumor necrosis factor (TNF) inhibitors. But with the FDA's approval of three interleukin-17 (IL-17) inhibitors — as well as other drugs with different mechanisms of action — for the condition, those therapies are becoming more common among treatment regimens, AIS Health reported.

The first IL-17 inhibitor on the U.S. market was Cosentyx (secukinumab) from Novartis Pharmaceuticals Corp., which launched in 2015. The next therapy was Taltz (ixekizumab) from Eli Lilly and Co., and then on Feb. 15, 2017, the agency approved Siliq (brodalumab) from Ortho Dermatologics.

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Topics: Specialty, Market Access, Product Release, Provider, Payer

Trends That Matter for AML Therapy Class

Posted by Angela Maas on Oct 10, 2019

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it's critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

"Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed," said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.
 
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Topics: Industry Trends, Data & Analytics

Radar On Market Access: AML Therapy Class Has Seen Boom Over Past Couple of Years

Posted by Angela Maas on Sep 19, 2019

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it's critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

"Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed," said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.
 
 
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Topics: Specialty, Industry Trends, Market Access, Provider, Payer

Trends That Matter for RM/AT Products

Posted by Angela Maas on Sep 12, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.'s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio's Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.
 
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Topics: Specialty, Industry Trends, Product Release, Data & Analytics

Radar On Market Access: Novartis’ Zolgensma Crisis May Not Impact Pickup

Posted by Angela Maas on Sep 12, 2019

The FDA in August put out a statement addressing "data accuracy issues" with Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy to treat spinal muscular atrophy in people less than two years old who have bi-allelic mutations in the survival motor neuron 1 gene, AIS Health reported.

The FDA approved the drug from AveXis, Inc., which was acquired by Novartis AG last year, on May 24. On June 28, AveXis notified the FDA that there was "a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA."
 
 
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Topics: Specialty, Industry Trends, Market Access, Provider, Payer

Radar On Market Access: More Than 1,000 RM/AT Products Are in Pipeline

Posted by Angela Maas on Aug 15, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.'s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio's Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.
 
Read More

Topics: Specialty, Industry Trends, Market Access, Provider, Payer