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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Radar On Market Access: New Prostate Cancer Treatment Orgovyx Offers Oral Option

Posted by Angela Maas on Feb 11, 2021

People being treated for advanced prostate cancer now have a new oral option. On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer, AIS Health reported. Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

Treatment of advanced prostate cancer usually involves androgen deprivation therapy (ADT), and the current standard of care is luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, which is administered by a health care provider as an injection or implant. It is available as AbbVie Inc.’s Lupron Depot and Eligard from Tolmar Pharmaceuticals, Inc. to treat prostate cancer.

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Topics: Industry Trends, Market Access, Product Release

Radar On Market Access: FDA Approves First Oral Treatment for HAE Attack Prevention

Posted by Angela Maas on Jan 12, 2021

When the FDA approved BioCryst Pharmaceuticals, Inc.'s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks, AIS Health reported. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc's Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

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Topics: Industry Trends, Market Access, Product Release

Radar On Market Access: Supreme Court's ACA Ruling May Upend Biosimilars Market

Posted by Angela Maas on Jan 7, 2021

As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus has been on the people who would lose health insurance coverage and protections for pre-existing conditions if the law is overturned. Another ramification of such a ruling is that the biosimilars market could be completely upended, AIS Health reported.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created the 351(k) biosimilar pathway. After more than one attempt to get a stand-alone bill to pass, lawmakers made it part of the ACA, and it became law on March 23, 2010.

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Topics: Industry Trends, Market Access, Payer

Trends That Matter for Growth Hormone Deficiency Treatments

Posted by Angela Maas on Dec 3, 2020

When the FDA approved Novo Nordisk, Inc.'s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market, AIS Health reported.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin. Differences among the products, all of which are self-administered, include the strengths available and the type of device to deliver the treatment. But all of them must be administered daily. Sogroya, which also is self-administered, is the only FDA-approved product with weekly dosing.
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Topics: Industry Trends, Data & Analytics, Payer

Radar On Market Access: FDA's Approval of Sogroya May Change GH Class Management

Posted by Angela Maas on Nov 5, 2020

When the FDA approved Novo Nordisk, Inc.'s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market, AIS Health reported.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin. Differences among the products, all of which are self-administered, include the strengths available and the type of device to deliver the treatment. But all of them must be administered daily. Sogroya, which also is self-administered, is the only FDA-approved product with weekly dosing.

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Topics: Specialty, Industry Trends, Product Release, Data & Analytics

Trends That Matter for Prostate Cancer Treatments

Posted by Angela Maas on Aug 27, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.'s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).
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Topics: Industry Trends, Data & Analytics, Payer

Radar On Market Access: FDA Approved Two PARP Inhibitors for Prostate Cancer

Posted by Angela Maas on Aug 11, 2020

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients, AIS Health reported.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.'s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate).

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

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