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Trends That Matter for Migraine Drugs

Posted by Jane Anderson on Jan 3, 2019

Therapy for chronic migraine — a condition that's been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

These new calcitonin gene-related peptide (CGRP) inhibitors — Amgen, Inc. and Novartis AG’s Aimovig (erenumab), Teva Pharmaceuticals’ Ajovy (fremanezumab) and Eli Lilly and Co.’s Emgality (galcanezumab) — also may usher in an era of value-based contracting for migraine products, with plan sponsors willing to pay more to get better results, Machaon Bonafede, Ph.D., outcomes research practice leader at IBM Watson Health, told attendees Oct. 23 at the Academy of Managed Care Pharmacy Nexus annual meeting, AIS Health reported.
 
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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

Radar On Market Access: New Migraine Drugs Could Spark Value-Based Contracting

Posted by Jane Anderson on Nov 29, 2018

Therapy for chronic migraine — a condition that's been notoriously difficult to treat and which often leads to significant direct and indirect health care costs — has been upended with the recent approval of three injectable monoclonal antibody products in a new preventive medication class that’s significantly more effective than older preventive migraine drugs, a researcher says.

These new calcitonin gene-related peptide (CGRP) inhibitors — Amgen, Inc. and Novartis AG’s Aimovig (erenumab), Teva Pharmaceuticals’ Ajovy (fremanezumab) and Eli Lilly and Co.’s Emgality (galcanezumab) — also may usher in an era of value-based contracting for migraine products, with plan sponsors willing to pay more to get better results, Machaon Bonafede, Ph.D., outcomes research practice leader at IBM Watson Health, told attendees Oct. 23 at the Academy of Managed Care Pharmacy Nexus annual meeting, AIS Health reported.
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: New Biosimilars Help Crohn’s Cost, but Boost Oversight Needs

Posted by Jane Anderson on Nov 27, 2018

New biosimilars for Janssen Biotech, Inc.'s Remicade (infliximab) have helped to moderate costs for Crohn's disease as they’ve launched over the last two years, but plans still rely on utilization management strategies, including site-of-service programs, to keep the cost of treating the condition under control, experts tell AIS Health.

Additional biosimilars — notably, three biosimilars for AbbVie Inc.'s Humira (adalimumab) — eventually will enter the marketplace as well, but the Humira biosimilars currently are mired in patent litigation and likely won't launch until 2023, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: FDA’s OK of Opioid Makes ‘Diversion of Even One Tablet’ Risky

Posted by Judy Packer Tursman on Nov 15, 2018

When a highly potent new opioid formulation was approved by his agency on Nov. 2, FDA Commissioner Scott Gottlieb, M.D., downplayed safety concerns about AcelRx’s Dsuvia. He stressed the importance of the painkiller for military use and the "very tight restrictions being placed on the distribution and use of this product," AIS Health reported.

In general, PBM and health plan experts say such restrictions likely will hold and keep the drug within its proper niche, and the regulatory green light for Dsuvia shouldn't interfere with broad ongoing efforts to better manage opioid use in the U.S.
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: Sensor-Equipped Pills Draw Plans’ Interest

Posted by Matt Breese on Sep 25, 2018

In a move that one expert says Medicaid plans will be watching closely, Magellan Health and the drug manufacturer Otsuka America Pharmaceutical, Inc. said Aug. 30 that they will work together to allow "select regional provider networks" contracted through Magellan to opt into a program involving the Abilify MyCite system, AIS Health reported.
 
Abilify (aripiprazole) treats schizophrenia and other mental illnesses. The MyCite system comprises Abilify tablets embedded with sensors; patches that detect and record the date and time of the pill's ingestion as well as physiological data like activity level; an app that lets patients review their data and enter additional information; and a web-based dashboard that lets providers and caregivers display and track a patient's drug ingestion patterns over time.
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: New EpiPen Generic May Avert Shortages

Posted by Matt Breese on Aug 28, 2018

The FDA recently approved Teva Pharmaceuticals' generic version of Mylan N.V.'s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details, AIS Health reported.
 
"The approved ANDA [abbreviated new drug application] generic for EpiPen is a welcomed addition to the market," says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. "While it is not out yet and we are not certain of the pricing, we are assuming it will be priced at the minimum similar or cheaper than the authorized generic manufactured by Mylan."
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: Alnylam Launches New Gene Silencing Drug

Posted by Matt Breese on Aug 23, 2018

A new first-of-its-kind therapy is launching onto the U.S. marketplace with a costly price tag — and value-based deals with a handful of health insurers that should help with patient access while assuring them that they are paying for value, AIS Health reported. 
 
On Aug. 10, the FDA approved Alnylam Pharmaceuticals, Inc.'s Onpattro (patisiran) for the treatment of adults with polyneuropathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis. It is the first drug the agency has approved for this condition, as well as the first in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
 
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Topics: Specialty, Market Access, Product Release, Payer

Radar On Market Access: Drug-Diagnostic Co-Development

Posted by Matt Breese on Aug 7, 2018

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostic but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach, AIS Health reported.
 
Previously some companies would develop both the drug and the diagnostic, but the number that now do so has declined. According to Amit Agarwal at Deloitte Consulting LLP, "diagnostic is a very different margin and business model than the pharmaceutical industry….The economics of it differ pretty dramatically."
 
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Topics: Specialty, Industry Trends, Product Release, Provider