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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Trends That Matter for FDA Orphan Label Application Reviews

Posted by Angela Maas on Jan 17, 2019

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: GAO Recommends FDA Improve Orphan Label Application Reviews

Posted by Angela Maas on Dec 27, 2018

The Orphan Drug Act (ODA) offers multiple incentives to manufacturers that bring a drug to market with an orphan designation. A recently released U.S. Government Accountability Office (GAO) report revealed that while the number of applications both received and granted for this designation has grown, FDA reviewers were not consistently recording or evaluating required information that is mandated to consider granting this designation, AIS Health reported.

The report, titled Orphan Drugs: FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue (GAO-19-83), shows that from 2008 to 2017, both orphan designation applications received as well as orphan designations granted rose.
 
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Topics: Payer, Specialty, Market Access, Product Release

Radar On Market Access: FDA Approves Second Tissue-Agnostic Drug; Refund Is Available

Posted by Angela Maas on Dec 18, 2018

As the FDA continues to approve drugs targeted toward specific biomarkers, the agency has granted accelerated approval to another tissue-agnostic oncology treatment. While the gene fusion is fairly rare, Loxo Oncology, Inc. and Bayer Corp.'s Vitrakvi (larotrectinib) has shown high overall response rates across multiple solid tumors. Not surprisingly, the medication comes with a high price tag — but also a refund for qualified patients who do not respond within three months of initiating treatment, AIS Health reported.

On Nov. 26, the FDA gave accelerated approval to Vitrakvi for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative therapies or that have progressed after treatment.
 
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Topics: Payer, Specialty, Market Access, Product Release

Trends That Matter for Drug Prices

Posted by Angela Maas on Nov 22, 2018

Pharmaceuticals are expected to undergo a 4.92% price increase from 2018 to 2019, according to the July-August 2018 Drug Price Forecast from Vizient. That's actually a slowing from the 7.61% increase for 2018, AIS Health reported.

The company conducted its analysis using price and volume data from hospital and non-acute facilities participating in its Vizient Pharmacy Program. Among Vizient members, therapeutic classes with the highest spend include many with specialty drugs.

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Topics: Specialty, Data & Analytics, Industry Trends

Perspectives on MA Plans’ Use of Step Therapy in Part B

Posted by Angela Maas on Nov 15, 2018

While many stakeholders have praised CMS's move to allow Medicare Advantage (MA) plans to apply step therapy to drugs covered under Part B, others have cautioned that it could result in delays or restrictions in patients accessing much-needed medications, AIS Health reported.

On Aug. 7, CMS issued new guidance allowing MA plans to use step therapy for Part B drugs as of Jan. 1, 2019. The letter also states that those MA plans that also offer prescription drug coverage may use step therapy to have a beneficiary use a drug under Part D before stepping to one under Part B.

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

Radar On Market Access: IL-17 Inhibitors Becoming More Popular as a First-Line Therapy, Study Finds

Posted by Angela Maas on Oct 25, 2018

The autoimmune therapy class boasts one of the broadest arrays of options within specialty drug classes. And while many physicians in general may tend to prescribe older medications that they have more familiarity with, a recent study shows that this may not necessarily be the case within this therapeutic class, AIS Health reported. The study, led by AllianceRx Walgreens Prime, found that among 5,547 analyzed psoriasis patients, providers may be comfortable with prescribing a newer type of autoimmune biologic as a first-line treatment.

The study assessed the use of two third-generation biologics, Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) and Eli Lilly and Co.’s Taltz (ixekizumab), in the treatment of psoriasis. The FDA approved Cosentyx in January 2015, with Taltz’s approval coming about a year later, in March 2016.

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Topics: Industry Trends, Market Access, Provider, Specialty

Radar On Market Access: Drug Prices Increases Are Expected to Slow

Posted by Angela Maas on Oct 18, 2018

Pharmaceuticals are expected to undergo a 4.92% price increase from 2018 to 2019, according to the recently released July-August 2018 Drug Price Forecast from Vizient. That’s actually a slowing from the 7.61% increase for 2018, AIS Health reported.

The company conducted its analysis using price and volume data from hospital and non-acute facilities participating in its Vizient Pharmacy Program. Among Vizient members, therapeutic classes with the highest spend include many with specialty drugs.

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Topics: Industry Trends, Specialty, Market Access, Data & Analytics

Perspectives on Indication-Based Formularies in Part D

Posted by Angela Maas on Oct 18, 2018

The Trump administration continues to take steps aimed at bringing down drug prices. CMS Administrator Seema Verma said in an Aug. 29 memo to Medicare Part D plan sponsors that they can begin using indication-based formularies in contract year 2020, AIS Health reported.

Starting in 2020, "Part D sponsors may utilize step therapy-like requirements within their [prior authorization] to promote cost-effective drug therapy by requiring the use of one formulary drug for a certain indication prior to authorizing coverage of a second drug for that indication," explains the memo.

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Topics: Payer, Specialty, Market Access, Industry Trends

Radar On Market Access: Opinions Vary on MA Plans’ Use of Step Therapy in Part B

Posted by Angela Maas on Oct 16, 2018

While many stakeholders have praised CMS’s move to allow Medicare Advantage (MA) plans to apply step therapy to drugs covered under Part B, others have cautioned that it could result in delays or restrictions in patients accessing much-needed medications, AIS Health reported.

On Aug. 7, CMS issued new guidance allowing MA plans to use step therapy for Part B drugs as of Jan. 1, 2019. The letter also states that those MA plans that also offer prescription drug coverage may use step therapy to have a beneficiary use a drug under Part D before stepping to one under Part B.

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

Perspectives on Express Scripts’ 2019 National Preferred Formulary

Posted by Angela Maas on Oct 4, 2018

With 48 new exclusions on its 2019 National Preferred Formulary (NPF), Express Scripts Holidn Co. is getting more aggressive in its attempt to broaden access to pharmaceuticals and bring value to its clients, AIS Health reported. But some industry stakeholders are questioning its strategy of excluding more specialty drugs.
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Topics: Payer, Specialty, Market Access