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.

 

Topics: Payer, Specialty, Market Access, Product Release

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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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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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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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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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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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."

 

Topics: Industry Trends, Specialty, Provider, Product Release

Continuing the Trump administration's spate of actions aimed at lowering prescription drug costs, the FDA recently unveiled the 11-step "Biosimilar Action Plan" designed to help get more biosimilar drugs to the market that can compete with pricey biologics, AIS Health reported. 

 

While the FDA has approved 11 biosimilars, only three are currently being marketed in the U.S., FDA Commissioner Scott Gottlieb said. "Competition is, for the most part, anemic," he concluded, adding that an FDA analysis showed Americans could have saved $4.5 billion in 2017 if all the approved biosimilars were available to consumers.

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CMS recently denied a waiver request by Massachusetts to allow its Medicaid program, MassHealth, to use a closed formulary that excludes certain drugs. But the agency, in its June 27 decision, left the door open on the state's pursuit of tighter drug controls, AIS Health reported.

 

"The Massachusetts proposal brought to the table a new approach to increase its leverage to get lower drug prices, but an approach that left many unanswered questions," says Jack Hoadley, Ph.D., a research professor emeritus in Georgetown University’s Health Policy Institute. "Its rejection by CMS should not stop states from continuing to seek new ways to achieve lower prices. The key is how to balance maintaining access to needed drugs with tools to get lower prices."

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For safety concerns, the FDA can require pharmacy manufacturers to have a Risk Evaluation and Mitigation Strategy (REMS) for a therapy in order to manage those risks while still allowing people to have access to it. Although the programs may present challenges to many stakeholders, manufacturers in particular may use them to their advantage, AIS Health reported.

 

One of the top challenges that manufacturers may grapple with is the "increasing complexity of developing and administering" REMS, says Glenn Carroll, principal at Deloitte. "Many of the REMS being developed today are more rigorous to implement than what we’ve seen in the past."

Topics: Industry Trends, Market Access, Product Release, Specialty