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Angela Maas

Managing Editor, Radar on Specialty Pharmacy

Recent Posts

Radar On Market Access: Oncologists Are Concerned With Patients’ Refusal of Treatment

Posted by Angela Maas on Mar 14, 2019

With more targeted and effective therapies launching to treat a variety of cancers, much of the focus has been not only on their efficacy but their costs, particularly to payers. A recent report from the physician perspective highlights their impact as far as cost on not only those stakeholders but also the patients they serve, AIS Health reported.

The Association of Community Cancer Centers released its 2018 Trending Now in Cancer Care Survey in February. Responding to the survey were 205 individuals from community cancer centers, academic centers, teaching hospitals and independent practices.
 
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Topics: Specialty, Industry Trends, Provider, Payer

Radar On Market Access: Firms Are Teaming Up to Offer First Digital Oncology Medicine

Posted by Angela Maas on Mar 12, 2019

As innovations in digital capabilities continue to be used with various health care products, Proteus Digital Health, Inc. is developing a suite of what it terms digital medicines. And while the company has been working on such products for a few years, it recently came out with the first such product within the oncology space, AIS Health reported.

Proteus is partnering with Fairview Health Services and the University of Minnesota Health to offer oral capecitabine combined with an ingestible sensor to treat stage 3 and stage 4 colorectal cancer patients.
 
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Topics: Specialty, Industry Trends, Product Release, Provider, Payer

Perspectives on Biosimilars Market in 2019

Posted by Angela Maas on Mar 7, 2019

Biosimilars are one way that payers had hoped to bring down spending on pharmaceuticals, but as of yet, these products have had little impact in the United States. As of mid-January, the FDA had approved 17 biosimilars, but only a handful actually are available in the U.S. However, the products may pick up more traction in 2019, with some significant ones potentially coming to market, AIS Health reported.

According to Lynn Nishida, R.Ph., vice president of clinical product at WithMe Health, "More biosimilars are in the pipeline, but, sadly, expect continued issues of patent litigations that delay marketing of biosimilars soon after their approval or force biosimilar manufacturers to consider launching products at risk" before a lawsuit has been settled, potentially setting themselves up to be responsible for paying damages if they lose the case.
 
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Topics: Specialty, Industry Trends, Market Access, Product Release, Data & Analytics

Trends That Matter for M&A Activity in Specialty Pharmacy and Infusion Therapy Spaces

Posted by Angela Maas on Feb 14, 2019

The specialty pharmacy and infusion therapy spaces have certainly seen their share of merger and acquisition (M&A) activity over the years. Some challenges within those industries may have helped slow down 2018 activity a bit, observes Reg Blackburn, managing director at The Braff Group. And for 2019, we may see more of the same, AIS Health reported.

As far as specialty pharmacy trends in 2018, Blackburn points out that "the largest specialty pharmacies continue to get even larger. Payer- and chain-owned dominate. Most new entity growth is coming from large academic hospitals starting their own specialty pharmacies."
 
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Topics: Specialty, Industry Trends, Product Release, Data & Analytics

Radar On Market Access: Novel Drugs, High Prices, Ways to Manage Them Remain Hot

Posted by Angela Maas on Feb 14, 2019

With the FDA approving multiple novel new therapies over the past couple of years, we should expect to see more of the same moving forward. But that innovation is not cheap, and the pharmaceutical industry likely will continue to offer products at higher price points than ever before, AIS Health reported.

As payers struggle to rein in high specialty drug prices, many have turned to copay accumulator programs, and this trend shows no signs of slowing. "There was an increased focus on copay accumulator programs in 2018," comments Amy Nash, Pharm.D., president of RelianceRx, the specialty pharmacy affiliate of Independent Health. She tells AIS Health she expects to see "further refinement of copay accumulator programs from payers and additional strategies from pharma to prevent them."
 
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Topics: Specialty, Industry Trends, Product Release, Provider, Payer

Radar On Market Access: Biosimilars Market Is Picking Up Steam, Could See Boom Soon

Posted by Angela Maas on Feb 7, 2019

Biosimilars are one way that payers had hoped to bring down spending on pharmaceuticals, but as of yet, these products have had little impact in the United States. As of mid-January, the FDA had approved 17 biosimilars, but only a handful actually are available in the U.S. However, the products may pick up more traction in 2019, with some significant ones potentially coming to market, AIS Health reported.

According to Lynn Nishida, R.Ph., vice president of clinical product at WithMe Health, "More biosimilars are in the pipeline, but, sadly, expect continued issues of patent litigations that delay marketing of biosimilars soon after their approval or force biosimilar manufacturers to consider launching products at risk" before a lawsuit has been settled, potentially setting themselves up to be responsible for paying damages if they lose the case.
 
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Topics: Specialty, Product Release

Radar On Market Access: 2018 Saw Slowing M&A Activity; Expect More of the Same in ’19

Posted by Angela Maas on Jan 29, 2019

The specialty pharmacy and infusion therapy spaces have certainly seen their share of merger and acquisition (M&A) activity over the years. Some challenges within those industries may have helped slow down 2018 activity a bit, observes Reg Blackburn, managing director at The Braff Group. And for 2019, we may see more of the same, AIS Health reported.

As far as specialty pharmacy trends in 2018, Blackburn points out that "the largest specialty pharmacies continue to get even larger. Payer- and chain-owned dominate. Most new entity growth is coming from large academic hospitals starting their own specialty pharmacies."
 
Read More

Topics: Specialty, Industry Trends, Data & Analytics

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: Specialty, Market Access, Product Release, Payer

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: Specialty, Market Access, Product Release, Payer

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: Specialty, Market Access, Product Release, Payer