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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.

Matt Eyles, president and CEO of America’s Health Insurance Plans, praised the administration’s move. He said, “patients and families deserve the prescription drugs they need at a price they can afford. The new CMS policy helps deliver on that promise while also helping to ensure patients continue to have access to safe, effective, and evidence-based care.”

Meanwhile, some groups expressed their concerns. In a letter to HHS Secretary Alex Azar, the American Medical Association said, “The AMA is concerned about the utilization management tools frequently used by PBMs and health plans to control costs, as they often have little clinical basis and can simply be a means of shifting costs in the system. For example, prior authorization and step therapy protocols can create significant barriers for patients by delaying the start or continuation of necessary medical treatment, which can negatively affect patient health outcomes.”

In an Aug. 8 research note, Leerink analysts noted that “pharmaceutical companies could be enticed to offer rebates back to payers and plans in order to gain preferred status at the front of a step-edit or risk losing volume as a second-line or later agent. In turn, these rebates will lower drug costs for Part B MA plans and patients, but also lower pharmaceutical revenues.”

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

Radar On Market Access: Plans Might Tap Utilization Management for Marijuana-Derived Epilepsy Drug

Posted by Leslie Small on Oct 4, 2018

When a pricey, unique medication for two rare forms of childhood-onset epilepsy comes onto the market — which could happen later this year — payers are likely to cover it but will probably subject the drug to prior authorization, experts tell AIS Health.
 
The drug in question is Epidiolex (cannabidiol), which in June became the first FDA-approved treatment that contains a purified drug substance derived from marijuana. The oral solution, produced by GW Pharmaceuticals plc, is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome for patients ages two and older.
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Topics: Industry Trends, Payer, Specialty, Provider, Data & Analytics

Radar On Market Access: Payers Wait for Gilead’s HCV Generics to Hit Market Soon

Posted by Judy Packer Tursman on Oct 2, 2018

Many payers likely are keeping a close eye on how the pharma industry reacts to Gilead Sciences, Inc.'s Sept. 24 announcement that it intends to soon launch steeply discounted generic versions of two of its chronic hepatitis C virus (HCV) drugs. The biopharma company says these generics will become available in January 2019 in the U.S. — a move that PBM Express Scripts Holding Co. describes as a win for payers and patients alike, AIS Health reported. 
 
According to Gilead, its newly created subsidiary, Asegua Therapeutics, will sell authorized generics of Harvoni and Epclusa "at a list price of $24,000 for the most common course of therapy."
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Topics: Industry Trends, Payer, Specialty, Provider, Data & Analytics

Radar On Market Access: CVS Bid to Lower Drug Launch Prices Sees Pushback

Posted by Leslie Small on Sep 27, 2018

In an effort to pressure drug manufacturers to temper their launch prices for new drugs, CVS Health Corp. is rolling out a program in which drugs that have a price exceeding a certain cost-effectiveness threshold will be excluded from coverage, AIS Health reported.
 
CVS will let clients refuse to cover drugs that have a price tag of more than $100,000 per quality-adjusted life year (QALY), provided they are not designated as "breakthrough" therapies by the FDA.
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Topics: Industry Trends, Payer, Specialty, Provider, Data & Analytics

Perspectives on Step Therapy for Part B Drugs

Posted by Matt Breese on Sep 20, 2018

In a move that industry analysts see as a positive development for the managed care sector, CMS issued new guidance that will allow Medicare Advantage (MA) plans to use step therapy for Part B drugs starting in 2019, AIS Health reported.
 
CMS is giving MA plans that offer a Part D benefit the ability to "cross-manage" drugs across Part B and Part D. In other words, plans could require patients to try alternatives covered within Part D before moving on to relatively expensive physician-administered drugs in Part B, Credit Suisse analyst A.J. Rice explained in a research note.
 
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Topics: Payer, Provider, Specialty

Radar On Market Access: Patients' Perspectives in Value Assessment

Posted by Matt Breese on Sep 11, 2018

Including patients' perspectives in value assessments ultimately will be of more value to payers and providers, particularly as medication becomes more personalized, and manufacturers should make sure they are gathering this information, industry experts tell AIS Health.
 
"Too often, value assessments place greater emphasis on cost compared with humanistic value or societal impacts, such as quality of life and productivity," says Ross Maclean, M.D., Ph.D., senior vice president and head of medical affairs at Precision Health Economics. "Patient factors are often critical to successful treatment, and it is important to understand that patient perceptions and attitudes toward disease burden (including lifestyle impact), mode of administration, treatment frequency and side effects may all affect adherence."
 
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Topics: Industry Trends, Specialty, Provider, Payer

Perspectives on New Class of Migraine Drug

Posted by Matt Breese on Sep 6, 2018

For years, clinicians have mostly prescribed generic prescription drugs to treat migraines. But a new class of relatively high-cost specialty biologic products is threatening to upend payers' calm, AIS Health reported.
 
According to Mesfin Tegenu, R.Ph., president of PerformRx, LLC, current migraine treatments supported by clinical evidence "include beta blockers, tri-cyclic anti-depressants and some seizure medications." The situation changed in mid-May, when Amgen, Inc and Novartis AG's Aimovig got the regulatory greenlight in the U.S., and two more calcitonin gene-related peptide (CGRP) inhibitors — Teva Pharmaceuticals' fremanezumab and Eli Lilly and Co.'s galcanezumab — are under FDA review, says an Institute for Clinical and Economic Review (ICER) report on migraine treatments.
 
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Topics: Industry Trends, Payer, Provider, Specialty, Market Access

Perspectives on Massachusetts’ Medicaid Drug Pricing Plan Rejection

Posted by Matt Breese on Aug 23, 2018

In July, CMS denied a waiver request by Massachusetts to allow its Medicaid program, MassHealth, to use a closed formulary that excludes certain drugs. But the agency also left the door open on the state's pursuit of tighter drug controls, AIS Health reported.
 
According to Jack Hoadley, Ph.D., a research professor emeritus in Georgetown University’s Health Policy Institute, "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. 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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Topics: Payer, Provider, Specialty

Perspectives on REMS Programs

Posted by Matt Breese on Aug 9, 2018

The FDA’s Risk Evaluation and Mitigation Strategy initiative — under which the agency requires pharmacy manufacturers to develop a REMS program for certain therapies in order to manage risks while still allowing people to have access to it — may present challenges to many stakeholders. But manufacturers in particular may use REMS to their advantage, AIS Health reported.
 
According to Glenn Carroll, principal at Deloitte, one of the top challenges that manufacturers may grapple with is the "increasing complexity of developing and administering" REMS. He says, "many of the REMS being developed today are more rigorous to implement than what we’ve seen in the past."
 
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Topics: Industry Trends, Payer, Provider, Specialty

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: Industry Trends, Specialty, Provider, Product Release