Tag Archives: Rebekah Bayram

Pharmacy Briefing: June 2020

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

  • CVS Health publishes 2019 Drug Trend Report
  • Navitus publishes 2019 Drug Trend Report
  • IQVIA publishes weekly report describing the impact of COVID-19 on the pharmaceutical market

FDA Approvals and Launches

  • Darzalex FasPro is approved as a subcutaneous version of Darzalex (daratumumab), a drug used to treat multiple myeloma.
  • Farxiga (dapagliflozin) receives additional indication to treat patients with certain types of heart failure.
  • A generic version of cholesterol drug Vascepa (icosapent ethyl) receives FDA approval.
  • Vesicare LS (solifenacin) is approved to treat bladder dysfunction in patients as young as 2 years of age.
  • Oriahnn (elagolix/estradiol/norethindrone acetate) is approved to treat heavy menstrual bleeding associated with uterine fibroids.

News

CVS Health publishes 2019 Drug Trend Report

  • The PBM reported, net of rebates, a 1.4% overall trend in 2019, despite a specialty trend of 9.3%.

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Navitus publishes 2019 Drug Trend Report

  • The PBM reported a “net cost per member per month (PMPM) of $78.12 in 2019, which is 16% lower than the forecasted industry average of $93.11 PMPM.”
  • Specialty trend increased 13.1%, with the highest proportion of spend being attributed to analgesic and anti-inflammatory specialty drugs.

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IQVIA publishes weekly report describing the impact of COVID-19 on the pharmaceutical market

  • The report provides timelines of major events and government actions, retail pharmacy initiatives, summaries of commercial payer policies, prescription trends, and many other data points.

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FDA discovers carcinogen impurities in some versions of extended-release metformin, a widely-used diabetes drug

  • The agency has recommended voluntary recalls of the products from five manufacturers.

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AmerisourceBergen publishes Biosimilars Pipeline Report

  • The report summarizes currently available, approved, and in-development biosimilar products, grouped by therapeutic class.

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The Coronavirus Aid, Relief, and Economic Security (CARES) Act temporarily suspends sequestration for Retiree Drug Subsidy Program (RDS)

  • Between May 1, 2020, and December 31, 2020, the 2% mandatory payment reduction in the calculated Subsidy Amount will be suspended.

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CMS finalizing policy permitting manufacturer discount programs to contribute toward annual cost-sharing limits for Patient Protection and Affordable Care Act (ACA) plans

  • Discount programs are permitted, by not required, to be counted toward these limits.

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Generic manufacturer Apotex admits to price fixing, pays penalty of $24.1 million

  • Price fixing occurred from May 2013 to at least December 2015 and involved the sale of the cholesterol drug pravastatin.

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Clinical Trials and Research

Mavacamten achieves all primary and secondary endpoints in phase 3 EXPLORER trial

  • The drug is being studied as a treatment for obstructive hypertrophic cardiomyopathy, a genetic heart condition.
  • A New Drug Application is expected to be submitted to the FDA in the first quarter of 2021.

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Ozempic (semaglutide) demonstrates sustained weight loss compared to placebo in phase 3 trial

  • The drug is currently approved for the treatment of type 2 diabetes and may also provide benefits in preventing and mitigating the health consequences associated with obesity.

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Retrospective study links poorly controlled blood glucose with increased COVID-19 mortality

  • Researchers observed a 10 times greater chance of death among type 2 diabetes patients with COVID-19 and poorly controlled blood glucose. 

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Pharmacy Briefing: May 2020

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

  • FDA issues emergency use authorization for remdesivir for the treatment of COVID-19
  • National Council for Prescription Drug Programs (NCPDP) issues guidance for pharmacy-led COVID-19 testing
  • Eli Lilly introduces Lilly Insulin Value Program allowing those with commercial insurance or without any insurance to fill monthly insulin prescriptions for $35
  • Express Scripts publishes “America’s State of Mind Report” examining recent utilization of mental health medications

FDA Approvals and Launches

  • Generic version of Proventil HFA (albuterol sulfate) is approved to prevent and treat bronchospasms.
  • Koselugo (selumetinib) is approved to treat neurofibromatosis type 1 (NF1), a rare genetic disorder.
  • Ontruzant (trastuzumab-dttb) is launched, the fifth biosimilar to Herceptin (trastuzumab).
  • Ongentys (opicapone) is approved as an add-on therapy to treat Parkinson’s disease.
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Pharmacy Briefing: April 2020

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

  • PBMs introduce new policies in response to COVID-19 pandemic (Milliman article)
  • Cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost
  • FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list
  • Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy

FDA Approvals and Launches

  • Generic version of Daraprim (pyrimethamine) is approved to treat toxoplasmosis and malaria
  • Isturisa (osilodrostat) is approved to treat Cushing’s disease
  • Ofev (nintedanib) receives additional approval to treat chronic fibrosing interstitial lung diseases.
  • ArmonAir Digihaler (fluticasone propionate) Inhalation Powder is approved to treat asthma.
  • Zeposia (ozanimod) is approved to treat relapsing forms of multiple sclerosis.
    • The manufacturer announced that the drug’s launch will be delayed indefinitely due to the pandemic.

News

Pharmacy benefit managers (PBMs) introduce new policies in response to COVID-19 pandemic

(Milliman article authored by Andrew Jackson, Brian Anderson, and Marc Guieb)

  • Utilization management changes include automatic extension of prior authorizations, refill-too-soon overrides, and imposing quantity limits on certain drugs.
  • Many health plan members are transitioning to mail-order services to fill prescriptions.

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Yale School of Public Health and Massachusetts General Hospital cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost

  • Descovy and Truvada (emtricitabine/tenofovir disoproxil fumarate) are the only approved medications for use in HIV pre-exposure prophylaxis (PrEP) therapy.

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FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list

  • Truvada (emtricitabine/tenofovir disoproxil fumarate), with $2.64 billion in 2019 sales, tops the list.
    • A generic version of Truvada is expected to be released in September 2020.

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Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy

  • The manufacturer was charged for conspiring with four generic drug companies to fix the price of several drug products.

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Sanofi publishes “Prescription Medicine Pricing: Our Principles and Perspectives” annual pricing report

  • In 2019, the average aggregate list price of Sanofi products increased 2.9% whereas the average aggregate net price of these same products decreased 11.1%.

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FDA adds Black Box Warning for Singulair and generic montelukast equivalents

  • Serious side effects found during an observational study include suicidal thought and actions.

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Costco purchases equity interest in Navitus Health

  • Equity interest includes a stake in Lumicera Health Services, Navitus’s specialty pharmacy.

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Health insurers and drug manufacturers spar over 2021 CMS manufacturer coupon proposal

  • The Centers for Medicare and Medicaid Services (CMS) proposal would allow insurance providers to determine whether manufacturer coupons apply to patient cost-sharing accumulator programs.

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Brand and authorized generic EpiPen (epinephrine auto-injector) may contain manufacturing defects 

  • Patients and pharmacists should inspect their products and contact the manufacturer if defects are discovered.

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Pharmacy Briefing: March 2020

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

  • Express Scripts publishes “2019 Drug Trend Report”
  • FDA issues 2019 Novel Coronavirus (COVID-19) statement, warns of potential supply chain disruptions
  • Clarivate identifies 11 potential blockbuster drugs in 2020 edition of “Drugs to Watch” list 
  • OptumRx publishes “Drug Pipeline Insights Report”
  • Four indicted in prescription scam involving compounding pharmacy and physicians

FDA Approvals and Launches

  • A generic version of ProAir HFA (albuterol sulfate), one of the most commonly prescribed asthma inhalers, is approved.
  • Nexletol (bempedoic acid), a once-daily oral medication, is approved to treat high cholesterol as a secondary option to statin therapy.
  • Voltaren (diclofenac gel) and Pataday (olopatadine ophthalmic solution) are approved for over-the-counter (OTC) use for pain/inflammation and allergic conjunctivitis, respectively.
  • Pizensy (lactitol) is approved for the treatment of chronic idiopathic constipation.
  • Twirla (levonorgestrel/ethinyl estradiol) transdermal patch is approved for use as once-weekly contraceptive.
  • Trulicity (dulaglutide) receives additional indication to reduce cardiovascular events in patients with type 2 diabetes with or without established cardiovascular disease.
  • Nurtec ODT (rimegepant) orally disintegrating tablets are approved for the acute treatment of migraines.
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Pharmacy Briefing: February 2020

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

  • Allergan reaches $300 million settlement in pay-for-delay lawsuit
  • California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause 
  • Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
  • Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
  • Pfizer announces introduction of three new biosimilars
  • Coronavirus outbreak may affect the U.S. drug supply chain

FDA Approvals and Launches

  • Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) is approved for the mitigation of allergic reactions due to peanut exposure in children.
  • Reyvow (lasmiditan), a novel treatment for patients with acute migraines, launches at a list price of $640 per eight pills.
  • Trijardy XR (empagliflozin/linagliptin/metformin) is approved to treat patients with type 2 diabetes.  
  • Ozempic (semaglutide) receives additional indication to reduce risk of major cardiovascular events in patients with type 2 diabetes and heart disease.
  • Valtoco (diazepam) nasal spray is approved as an acute treatment for epilepsy.
  • Ajovy (fremanezumab-vfrm) receives approval for administration through an auto-injector dose delivery system.
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CMS proposed rules would impact Part D drug costs and plan designs

On November 16, 2017, the Centers for Medicare and Medicaid Services (CMS) released 713 pages of proposed changes to Medicare Advantage (MA) and the Medicare Part D prescription drug benefit. The proposed changes (file code CMS-4182-P) would take effect for contract year 2019 and are intended to manage utilization of opioids, reduce costs, and provide more plan choices. The updates present major changes to the way the programs operate. According to CMS, “the proposed changes would result in an estimated $195 million in savings a year for the Medicare program over 5 years (2019 through 2023).”

Some significant impacts on Part D that plans need to be aware of would include:

Midyear formulary changes: Plans would have more flexibility to immediately incorporate generic drugs as soon as they are available.

• Plans could assess the cost impact of each new generic drug based on member utilization to weigh against administration and disruption issues.
• This proposed rule could be significant, especially if the increases in generic approvals continue. According to Milliman’s internal research, there were about 14 and 31 significant first generic launches in 2015 and 2016, respectively. And this year the U.S. Food and Drug Administration (FDA) has continued to speed up the generic approval process.

Opioid treatment: Plans would be able to restrict access and manage opioid utilization. The proposed rules codify and expand upon the current Part D Opioid Drug Utilization Review Policy and Overutilizing Monitoring System.

Biosimilars: Plans would be able to categorize certain low-cost biosimilars as generics for low-income subsidy (LIS) cost sharing and non-LIS catastrophic cost sharing. Because the LIS copays in 2018 will be $3.35 for generics and $8.35 for brands, this is likely not to have a large impact on 1) lowering member costs, or 2) increasing biosimilar utilization.

Point-of-sale costs: The proposal includes a request for information (RFI) regarding applying price concessions and rebates at the point of sale, which could lower member cost sharing when taking brand medications that offer rebates, but may increase premiums and government cost.

Meaningful differences testing: With the elimination or modification of this testing, plans may be able to add more enhanced alternative Part D plans to their product portfolios in the same region.

A link to the Fact Sheet issued by CMS can be found here. CMS is accepting comments until January 16, 2018.