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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Trends That Matter for DMD Therapies

Posted by Angela Maas on Jul 2, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. "CK is an enzyme found in abnormally high levels when muscle is damaged," Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. "The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD."
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Topics: Industry Trends, Market Access, Data & Analytics

Radar On Market Access: Uncertainties Over Effectiveness and High Costs Surround DMD Therapies

Posted by Angela Maas on Jun 11, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. "CK is an enzyme found in abnormally high levels when muscle is damaged," Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. "The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD."

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Topics: Market Access, Provider, Payer

Radar On Market Access: COVID-19 Pandemic Drives Home Infusion Utilization

Posted by Angela Maas on May 21, 2020

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space, AIS Health reported.

"If you can do infusion at home, you need to do it there," maintains Ashraf Shehata, KPMG national sector leader for Healthcare & Life Sciences. "This is about controlling infection risk in the near term, and many home infusion candidates are in a high-risk category. Longer term, there has been a shift toward delivering care in the most economical and clinically appropriate setting, largely driven by payers."

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Topics: Industry Trends, Data & Analytics, Provider, Payer

Perspectives on New Generic HIV Drug

Posted by Angela Maas on Apr 2, 2020

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

Gilead Sciences, Inc.'s Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved by the FDA in 2004 to treat HIV infection in combination with other antiretroviral drugs. In 2012, it also was approved as the first drug for PrEP. In March 2019, Gilead announced that it had entered into an agreement with Teva Pharmaceutical Industries Ltd. to allow the company to launch its generic version on Sept. 30, 2020.
 
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Topics: Industry Trends, Provider, Payer

Radar On Market Access: New Generic HIV Drug May Impact PrEP Coverage, Not HIV Coverage

Posted by Angela Maas on Mar 5, 2020

A generic version of Truvada coming on the market later this year will affect how payers cover pre-exposure prophylaxis (PrEP), but it will not significantly change how payers cover HIV drugs, experts tell AIS Health.

Gilead Sciences, Inc.'s Truvada (emtricitabine/tenofovir disoproxil fumarate) was approved by the FDA in 2004 to treat HIV infection in combination with other antiretroviral drugs. In 2012, it also was approved as the first drug for PrEP. In March 2019, Gilead announced that it had entered into an agreement with Teva Pharmaceutical Industries Ltd. to allow the company to launch its generic version on Sept. 30, 2020.

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

Radar On Market Access: Tenn. Blues’ White Bagging Policy Sees Pushback from Providers

Posted by Angela Maas on Mar 3, 2020

BlueCross BlueShield of Tennessee, Inc. has received tremendous pushback from physicians on its decision to implement a policy requiring them to get provider-administered therapies from specialty pharmacies, AIS Health reported.

Providers traditionally have acquired therapies they administer through a practice known as buy and bill, by which they will purchase a drug from a wholesaler or distributor, keep it in their office and administer it to patients as needed, submitting a claim to the payer afterwards.

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Topics: Market Access, Provider, Payer

Radar On Market Access: New Oncology Biosimilar Launches Could Prompt Preferencing

Posted by Angela Maas on Feb 11, 2020

So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products and, in turn, realizing savings in some costly therapeutic classes.

Although the FDA had approved 26 biosimilars as of the end of January, only half of them are available in the U.S., with many of the drugmakers tied up in patent litigation with reference drug manufacturers.

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

Trends That Matter for Anti-VEGF Market

Posted by Angela Maas on Dec 19, 2019

In October 2019, 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: Industry Trends, Data & Analytics

Radar On Market Access: Highmark's New Hemophilia Initiative Aims to Improve Care, Reduce Costs

Posted by Angela Maas on Dec 10, 2019

With an eye on reducing spending and improving care among members with hemophilia, Highmark Inc. will launch a comprehensive program focused on the condition on Jan. 1. The health plan will partner exclusively with three companies — Option Care Health, Inc., Soleo Health and the Hemophilia Center of Western Pennsylvania — on the initiative, which has the potential to improve member care, reduce costs and cut down on fraud, waste and abuse, AIS Health reported.

Highmark chose hemophilia to focus on for a few reasons, says Sean Burke, manager of specialty pharmacy services at the plan. "We have a pretty comparatively high population" of people with hemophilia, and "clients were coming to us" for effective management strategies. New therapies — as well as a crowded pipeline — mean there is "a big opportunity to potentially save money."

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

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