Radar on Drug Benefits

  • New Schizophrenia Drug Will Likely Have Familiar Coverage

    Earlier this month, the FDA approved a drug that the manufacturer touts as “the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.” Drug benefits experts say it could be a good option for patients who have previously been on extended-release drugs for the schizophrenia — with careful monitoring — and will likely be covered similar to existing long-acting treatments.

    The drug is called Invega Hafyera (six-month paliperidone palmitate), a product produced by Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit. It received FDA clearance on Sept. 1 after a randomized, double-blind, non-inferiority Phase III global study that enrolled 702 adults living with schizophrenia from 20 countries, which found that 92.5% of patients treated with Invega Hafyera were relapse-free at 12 months.

  • Study Examines Pandemic’s Effect on Cancer Diagnoses

    Risk of a COVID-19 infection and problems with hospital capacity led to a substantial decline in new cancer cases diagnosed early in the pandemic. Though medical practices reopened after early lockdowns, the number of newly diagnosed patients remained below prepandemic level through March 2021, according to a JAMA Network Open research letter. The study analyzed patients newly diagnosed with eight cancer types in four periods: prepandemic (January 2019 to February 2020), first pandemic period (March to May 2020), second period (June to October 2020) and third period (November 2020 to March 2021). During the first pandemic period, the average monthly number of new diagnoses fell 29.8% from 32,407 to 22,748 for the eight cancers combined. During the second period, the average number only declined 9.6%, statistically at the same level as it was before the pandemic for all cancers except prostate cancer. However, during the third period, average diagnoses showed a significant decline, dropping by 19.1% compared with prepandemic. “Our findings call for planning to address the consequences of delayed diagnoses, including strengthened clinical telehealth offerings supporting patient-clinician interactions,” the study authors wrote.
  • More Anal Cancer Drugs Are Coming Despite Incyte Stumble

    This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.

    Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

  • PhRMA Takes Aim at Medicare Price Negotiation as HHS Digs In

    Policies aimed at slowing price growth in the most expensive drug categories could result in slightly fewer drugs coming to market, according to an analysis of the issue prepared by the Congressional Budget Office (CBO). While the pharmaceutical industry has used the report to back up its longstanding claims that drug development would be irreparably harmed by federal intervention on prices, employer plan sponsors and other payer groups insist that the impact of drug pricing policies on drug development would be marginal at most.

    “The model uses estimates of changes in expected future profits or development costs to estimate the percent change in the number of drug candidates entering the various stages of human clinical trials,” the report says. “The paper considers a legislative change that lowers expected returns for the top-earning drugs. A 15 percent to 25 percent reduction in expected returns for drugs in the top quintile of expected returns is associated with a 0.5 percent average annual reduction in the number of new drugs entering the market in the first decade under the policy, increasing to an 8 percent annual average reduction in the third decade.”

  • Will Rx Startup Targeting Cash-Paying Patients Succeed?

    A new startup, DiRx, has entered the prescription-drug-delivery fray, and will target un- and underinsured consumers with low-cost, generic maintenance medications. Experts say that the market is worth pursuing, but they observe that more established and better capitalized players such as Amazon.com Inc. and GoodRx have a head start on reaching those consumers.

    DiRx launched in late 2020 with a $5 million seed round, and the firm’s CEO, Satish Srinivasan, tells AIS Health that they will close a Series A funding round in coming weeks. Srinivasan says the firm buys drugs directly from manufacturers and wholesalers, then sells directly to consumers. He adds that DiRx does not contract with PBMs and does not accept insurance.

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