Pharmacy Briefing: February 2021

Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.

Highlights
  • Consolidated Appropriations Act signed into law
  • CMS Office of the Actuary releases 2019 National Health Expenditures
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • FDA extends review period for investigational Alzheimer’s drug aducanumab
FDA Approvals and Launches
  • Cabenuva (cabotegravir/rilpivirine) is approved as a once-monthly injection for the treatment of HIV.
  • Vocabria (cabotegravir) is approved as one component of a precursor to HIV treatment with Cabenuva (cabotegravir/rilpivirine).
  • Generic version of Glucagon Emergency Kit for Low Blood Sugar is approved to treat cases of severe hypoglycemia in diabetics.
  • Lupkynis (voclosporin) is approved for the treatment of lupus nephritis.
  • Verquvo (vericiguat) is approved for the treatment of heart failure.
News

Consolidated Appropriations Act signed into law

  • The act includes a wide range of provisions regarding COVID-19, medical billing, and pricing transparency, among others.
  • Plans will be required to submit specified pharmacy claims metrics to the federal government on an annual basis.
    • This data collection provision will be used by the government to produce drug pricing trend reports.

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CMS Office of the Actuary releases 2019 National Health Expenditures

  • Retail prescription drug spending grew 5.7% in 2019 compared to 3.8% in 2018.
  • The increased growth rate was driven by an increase in utilization rather than price; retail drug prices declined by 0.4%.

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FDA extends review period for investigational Alzheimer’s drug aducanumab

  • The new action date was extended from March 7 to June 7 to allow for additional review of clinical data.

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Senate Finance Committee releases investigative report on insulin prices

  • The report describes how the relationship among list prices, rebates, and formulary placement has led to increased prices for plan sponsors and consumers.
  • Report authors found that manufacturers also employed “shadow pricing,” a tactic that the report describes as “price increases on related brands of aging products from competing companies that often seem to move in synchronized fashion.”

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Department of Health and Human Services funds report comparing drug prices in the United States with those found internationally

  • After adjusting prices to account for rebates, the authors estimated that U.S. prices were 90% higher than prices found in other countries.

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Maryland State Senate rejects governor’s veto of prescription drug affordability board

  • The drug affordability board was created to help the state create regulations that would attempt to make prescription drugs more affordable by using strategies such as setting payment limits for government payers.

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Consulting firm McKinsey reaches $573 million settlement regarding its role in opioid crisis

  • The firm worked closely with Purdue Pharma, the manufacturer of Oxycontin (oxycodone) extended-release tablets.

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Companies pledge to pay employees for getting the COVID-19 vaccine

  • Companies such as Trader Joe’s, Aldi, and Dollar General will pay employees extra hourly wages as an incentive to get vaccinated but will not make the vaccine mandatory.

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Entrepreneur Mark Cuban launches generic drug company

  • The company’s first drug is antiparasitic drug albendazole but plans to offer over 100 additional drugs by the end of 2021.

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Clinical Trials

Skyrizi (risankizumab) outperforms placebo in phase 3 psoriatic arthritis trial

  • The auto-immune drug is currently only indicated for the treatment of plaque psoriasis.
  • Skyrizi (risankizumab) is considered a successor to Humira (adalimumab) and is currently being studied for the treatment of many overlapping indications.

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Critical Point focuses on U.S. mental health under COVID-19

The COVID-19 pandemic has spurred—and aggravated—a range of mental health and substance use issues in the United States. In this episode of Critical Point, Milliman’s Stoddard Davenport discusses the rising demand for mental health services and how different populations are being affected. Stoddard also highlights recent statistics on the topic and what the road ahead may look like for mental health in America.

To listen to other episodes of Critical Point, click here.

Pharmacy Briefing: January 2021

Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.

Highlights

  • The U.S. Supreme Court upholds Arkansas Act 900 regulating pharmacy benefit manager (PBM) practices
  • Drug manufacturers implement annual price increases
  • Highly publicized joint venture Haven Healthcare disbands
  • CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption

FDA Approvals and Launches

  • Ebanga (ansuvimab-zykl) is approved to treat the ebolavirus.
  • Imcivree  (setmelanotide) is approved for weight management in three rare genetic disorders.
  • Klisyri (tirbanibulin) is approved to treat actinic keratosis.
  • Gemtesa (vibegron) is approved to treat symptoms of an overactive bladder.

News

The U.S. Supreme Court upholds Arkansas Act 900 regulating PBM practices

  • The act mainly regulates PBM reimbursement to pharmacies, ensuring rates higher than the pharmacies’ acquisition costs.
  • The ruling may encourage other states to pass similar laws regulating PBM practices.

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Drug manufacturers implement annual price increases

  • List prices, which don’t reflect net prices paid after rebates, increased by an average of 3.3%.

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Highly publicized joint venture Haven Healthcare disbands

  • In 2018, Amazon, Berkshire Hathaway, and JPMorgan Chase founded Haven Healthcare with a goal of addressing issues in the employer healthcare market.

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CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption

  • 28% of people surveyed were interested in receiving a vaccine as soon as possible whereas 17% did not plan to receive the vaccine at all.

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Employers consider whether to mandate COVID-19 vaccinations

  • Employers may consider public safety, the benefits of a safer work environment, and the concerns of those who worry about the safety of the vaccine before exercising the legal right to mandate vaccination.

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Centene acquires Magellan Health and specialty pharmacy PANTHERx

  • Centene will acquire 5.5 million members on government-sponsored plans, 2 million PBM members, and 16 million medical pharmacy members
  • PANTHERx specializes in providing care to patients with rare conditions and will work under the umbrella of Centene’s Evolve Pharmacy Solutions program.

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Federal Trade Commission (FTC) issues report describing Hatch-Waxman patent settlements

  • The report describes patent settlements occurring in 2017 between brand and generic manufacturers.
    • The total amount of final settlements remained close to the record high set in 2016.
    • The number of reverse-payment agreements, otherwise known as “pay-for-delay” agreements, remains low compared to previous years.

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Amgen releases 2020 Biosimilars Trends Report

  • The report describes trends among the 28 FDA-approved and 18 market-launched biosimilar products.
    • The report includes comparisons between biosimilar and reference product prices, market share trends, and class-specific trends.

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Elixir drug pipeline report highlights six developments to watch in 2021

  • Developments include increases in the orphan drug and gene therapy markets, an investigational type 1 diabetes drug, and commentary on the COVID-19 vaccine.

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Clinical Trials

Long-acting injectable HIV drug combination produces positive results in phase 3b study

  • The combination of cabotegravir and rilpivirine given intramuscularly every eight weeks was found to be non-inferior to dosing given every four weeks.
    • This investigational treatment has the potential to increase adherence over standard treatments that must be dosed daily.

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How has COVID-19 affected physician interest in Direct Contracting?

COVID-19 has had a financially debilitating effect on many medical practices. Some practices are not expected to survive. The impact has been felt by physicians as well as other healthcare entities and led to severe declines in fee-for-service revenue. The pandemic also caused the Center for Medicare and Medicaid Innovation to make adjustments to its Direct Contracting (DC) program. DC adjustments include adding a second cohort that begins January 2022, providing a capitation payment glide path, and increasing physician capitation choices. 

These changes create an opportunity for organizations considering becoming Direct Contracting Entities (DCEs) to attract physicians who may not have been interested in the program previously. The application window for the second cohort of DCEs opens in March 2021. In this brief, Milliman’s Coleen YoungHugh Larson, and Annie Man discuss DC and the impact of COVID-19 on physicians. 

Will Amazon Pharmacy transform the pharmacy industry?

Amazon Pharmacy, the tech giant’s latest venture into healthcare, launched a mail-order pharmacy in November 2020. The venture provides mail prescription delivery for all patients, as well as the additional benefits of two-day prescription delivery and discounted medication prices for Amazon Prime members through the Prime Rx program. Patients can have providers send prescriptions directly to Amazon or Amazon can contact the provider on the patient’s behalf. Amazon Pharmacy complements Amazon PillPack, which sorts medications into small, individual packages based on the date and time of day they are to be taken. 

Effectively, Amazon is joining the existing pharmacy supply chain. Amazon Pharmacy works with pharmacy benefit managers to ensure its mail-order pharmacy service is included in pharmacy networks when prescriptions are filled with insurance. When insurance is not used, Amazon offers Prime members discounted pricing through its mail-order pharmacy or at participating retail locations. 

In this paper, Milliman professionals discuss whether Amazon Pharmacy will disrupt, conform, or lay the groundwork for future transformation in the pharmacy industry. 

COVID-19 results in the expansive use of telehealth

The COVID-19 crisis and the enforced lockdowns and shelter-in-place orders worldwide have accelerated the relevance and usage of telehealth, which has major implications for health insurers. The usage of telehealth has been limited historically. For example, 92% of U.S. consumers reported that they were not using telehealth prior to the onset of the COVID-19 pandemic. 

In this paper, Milliman professionals examine the current status of telehealth in major geographic markets, including the U.S., Europe, and Asia. They develop a framework for telehealth with its key market participants, including a typology of models of virtual care. They also explore insurer proposition design and cost containment.