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Radar On Market Access: Orphan Drug Act Has Been Overused, A New Study Shows

Posted by Peter Johnson on Mar 18, 2021

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

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Topics: Specialty, Industry Trends, Product Release, Data & Analytics

Radar On Market Access: Ohio Names New Medicaid PBM, Sues One of Current Vendors

Posted by Leslie Small on Mar 16, 2021

Ohio recently cleared a key hurdle in its plan to revamp how Medicaid enrollees' pharmacy benefits are managed, choosing Gainwell Technologies as the single PBM that will replace big-name firms including Cigna Corp.'s Express Scripts, CVS Heath Corp.'s Caremark, UnitedHealth Group's OptumRx and Centene Corp.'s Envolve Pharmacy Solutions, AIS Health reported.

Although PBMs and insurers generally oppose state moves to carve out pharmacy benefits from their Medicaid managed care contracts, Ohio says it expects the new single-PBM approach will "drive transparency, reduce pharmacy costs and simplify provider administration."

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Topics: Industry Trends, Market Access, Payer

Trends That Matter for New Prostate Cancer Treatment

Posted by Angela Maas on Mar 11, 2021

People being treated for advanced prostate cancer now have a new oral option. On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer, AIS Health reported. Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

Treatment of advanced prostate cancer usually involves androgen deprivation therapy (ADT), and the current standard of care is luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, which is administered by a health care provider as an injection or implant. It is available as AbbVie Inc.’s Lupron Depot and Eligard from Tolmar Pharmaceuticals, Inc. to treat prostate cancer.
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Topics: Industry Trends, Market Access, Product Release, Data & Analytics

Radar On Market Access: Cigna's Evernorth to Acquire MDLive in Telehealth Expansion

Posted by Peter Johnson on Mar 11, 2021

Health insurers have begun to consolidate their position in the telehealth market, as indicated by a recent move by Cigna Corp. to acquire MDLive Inc. Meanwhile, lawmakers are beginning to consider the future of telehealth regulation and payment, AIS Health reported.

Cigna's Evernorth health services arm announced on Feb. 26 that it had reached an agreement with MDLive to acquire the virtual care provider, according to MDLive's website. MDLive has been available in-network as a primary care option to all members of Cigna's commercial plans since January 2020.

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Topics: Industry Trends, Data & Analytics, Payer

Radar On Market Access: FDA's Breyanzi Approval May Not Change NHL Management

Posted by Angela Maas on Mar 9, 2021

With the FDA's approval of Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space, AIS Health reported.

On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

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Topics: Industry Trends, Market Access, Product Release

Perspectives on Pass-Through Rebate Models

Posted by Peter Johnson on Mar 4, 2021

With the Trump administration's rebate rule delayed and possibly slated for repeal by Democrats in Congress, major changes in how the PBM industry distributes rebate revenue will have to come from the private sector, AIS Health reported.

The Biden administration will suspend implementation until 2023 of the so-called "rebate rule," a Trump administration regulation that would have revamped the Medicare prescription drug rebate system, and DC insiders expect the regulation will be repealed by Congress before then. Meanwhile, a growing number of PBMs that deal in the commercial market have pitched plan sponsors on a 100% pass-through rebate structure, in which the PBM collects its compensation through a fee or surcharges rather than diverting a share of rebate revenue.
 
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Topics: Industry Trends, Data & Analytics

Radar On Market Access: 2020 Was 'Breakout Year' for Digital Engagement in Health Care

Posted by Jane Anderson on Mar 4, 2021

Health care organizations, eager for innovative ways to engage members in the midst of the pandemic, ramped up their use of email and texts in 2020 and found they were highly effective at prompting consumer action, a recent survey on health care consumer engagement found.

The survey, conducted annually for the past five years by consulting and research firm Engagys, found when it polled around 100 health care entities in November that 2020 had been a "breakout year" for use of more efficient digital channels and personalized messages, Kathleen Ellmore, the firm's co-founder and managing director, tells AIS Health.

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Topics: Industry Trends, Data & Analytics, Payer

Radar On Market Access: New Heart Failure Drugs Offer More Therapy Options

Posted by Jane Anderson on Mar 2, 2021

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis' Entresto (sacubitril/valsartan) and Amgen's Corlanor (ivabradine) — are important additions to prescribers' clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

"Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy," says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. "However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%."

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Topics: Industry Trends, Market Access, Product Release

Trends That Matter for Rx Benefits in Medicaid

Posted by Leslie Small on Feb 25, 2021

Beginning in April, California and New York will join a growing list of states that have opted to carve out prescription drug benefits from their Medicaid contracts with insurers, wagering that the state can do a better job at negotiating drug prices with manufacturers than managed care organizations and their contracted PBMs, AIS Health reported.

"I think the pharmacy benefit overall will be something that states are looking at in order to find savings in some way — whether through carveouts or through another policy — just because there are limited levers that the state is going to be able to pull to save money," says Rachel Dolan, a senior policy analyst with the Kaiser Family Foundation’s Program on Medicaid and the Uninsured.
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Topics: Industry Trends, Market Access, Data & Analytics, Payer

Radar On Market Access: Analysts Downplay Stock Selloff Following CVS 4Q Earnings Report

Posted by Leslie Small on Feb 25, 2021

Although CVS Health Corp.'s stock price dropped about 5% after the company reported its fourth-quarter and full-year 2020 financial results on Feb. 16, equities analysts seemed to be unshaken in their view that the firm — which owns health insurer Aetna — has strong fundamentals, AIS Health reported.

For the fourth quarter of 2020, CVS's net income of $975 million was down 44% compared with the prior-year period, a result the company partially attributed to lower operating income driven by the impact of the COVID-19 pandemic on its Health Care Benefits and Retail/Long-Term Care segments. For the full year 2020, CVS's operating income and net income increased relative to 2019.

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Topics: Industry Trends, Data & Analytics, Payer