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The Daily Scan

October 19, 2018

Last Updated: 1:00 PM EST

Medicaid

 

  • Virginia Governor Ralph Northam announced yesterday that beginning on November 1, 2018, state agencies will accept applications from Virginia adults newly eligible for health coverage under Medicaid expansion. “When both sides of the aisle came together earlier this year to pass Medicaid expansion, the Commonwealth set a realistic, aggressive timeline for implementation and I’m proud to report the remarkable progress we’re making on these goals in close coordination with our federal partners,” said Governor Northam. “Virginia will begin accepting applications for expanded health coverage on November 1. I encourage all Virginians to get acquainted with the new eligibility rules and learn how they and their family members qualify for access to quality health coverage.”

    Eligible adults will begin receiving services starting January 1, 2019. The new coverage is available to men and women ages 19 through 64 who are not eligible for Medicare and who meet income requirements, which vary by family size. For example, a single adult with an annual income at or below $16,754 may be eligible for coverage. An adult in a three-person family with a total household annual income at or below $28,677 may be eligible. (Governor.Virginia.gov)

Litigation

  • A pharmacist at a Meijer store who is accused of denying medication to a miscarrying woman because of his religious beliefs is no longer an employee, the company said Thursday. "Meijer strives to treat its pharmacy customers with dignity and respect," company spokeswoman Christina Fecher told the Detroit Free Press in an email. "The pharmacist identified by recent reports has not been employed by Meijer since early July 2018. While we cannot comment on any pharmacy customer matter, we apologize for any customer experience that does not align with our core values." (USAToday.com)

Funding & Finance

  • Yesterday, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) announced $293 million in awards to primary health care clinicians and students through the National Health Service Corps (NHSC) and Nurse Corps programs. “These programs connect primary care providers with the rural, urban, and tribal communities across the country that need them most,” said HRSA Administrator George Sigounas, MS, Ph.D. “In addition to providing essential medical and dental care, these clinicians are on the front lines helping to fight pressing public health issues, like the growing opioid epidemic.” The NHSC and Nurse Corps programs build healthy communities by providing scholarships and loan repayment to health care providers in exchange for working in areas of the U.S. with limited access to care. Currently, an estimated 13 million patients receive care from more than 12,500 NHSC and Nurse Corps clinicians. Another 1,725 primary care students are either in school or in residency preparing for future service with the Corps programs. (HHS.gov)

Regulation

  • The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday released an untitled letter sent earlier this month to Eisai for a sales representative’s comments on off-label uses for Fycompa (perampanel). According to a complaint made to OPDP, the Eisai sales representative “made statements that provide evidence that Fycompa is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.” The heavily redacted untitled letter also notes that the sales representative gave a lunch presentation with comments about how to use Fycompa off-label. “Additionally, during the presentation, the sales representative minimized serious, life-threatening, risks associated with Fycompa. Specifically, while the sales representative acknowledged the Boxed Warning risk of homicidal ideations and aggressive behavior, the representative downplayed these risks by suggesting the healthcare practitioners should not worry about it,” the untitled letter says. As far as corrective actions, OPDP requests that Eisai immediately cease violating the Food Drug & Cosmetic Act, and submit a written response listing all promotional materials for Fycompa that contain violations such as those described in the untitled letter. (RAPS.org)

Private Sector

  • Endocyte, Inc., a biopharmaceutical company developing targeted therapeutics for cancer treatment, today announced that it has entered into an agreement and plan of merger with Novartis AG pursuant to which Novartis will acquire Endocyte for $24 per share, or a total equity value of approximately $2.1 billion, in cash. This offer represents a premium of 54% percent to Endocyte’s closing price of $15.56 on October 17, 2018.  The transaction was unanimously approved by the board of directors of Endocyte. “Since acquiring exclusive worldwide rights to develop and commercialize PSMA-617 agents in 2017, the entire Endocyte team, along with our partners, have worked tirelessly to build a leading radioligand (RLT) portfolio and create value for patients and shareholders alike. We are thrilled that Novartis recognizes the potential for 177Lu-PSMA-617 to change the treatment landscape for men with metastatic castration-resistant prostate cancer (mCRPC), as well as the broader role that RLTs may potentially play in the treatment of cancer,” said Mike Sherman, president and CEO of Endocyte. “The global reach and expertise of Novartis in developing and commercializing RLT therapies will be critical in efforts for patients to benefit from these therapies as quickly as possible.” Completion of the transaction is expected in the first half of 2019. (Investors.Endocyte.com)

 

 

 

 

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