FDA Rejections

The Food and Drug Administration (FDA) recently rejected Gilead’s filing for approval of filgotinib for rheumatoid arthritis. With the FDA asking to see data from an ongoing clinical trial, Gilead is unlikely to be able to refile until mid-2021, pushing it further behind its competitors for the Janus Kinase (JAK) inhibitor market. These drugs suppress the immune system to prevent damage to the joints.

The FDA rejected BioMarin’s Roctavian for hemophilia A. This expensive gene therapy was expected to revolutionize the treatment of this disease. However, the manufacturer will be required to complete an ongoing late-stage patient study which means it won’t likely be approved before late 2022.

The FDA denied the approval of the new peanut allergy treatment, Viaskin Peanut, due to concerns related to “the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.” This means that Palforzia will be the only FDA treatment available for patients requiring desensitization.

Drug Recall

Recently, on the recommendation of the FDA, five manufacturers issued voluntary recalls for certain extendedrelease metformin formulations due to detection of N-Nitrosodimethylamine (NDMA) levels to the consumer level. Metformin is prescribed to help manage blood glucose levels for many people who have type 2 diabetes.

For patients who use the metformin ER formulation to manage their condition, and for plan sponsors, such recalls can be concerning. Fortunately there have not been any recalls for the immediate release formulation of the drug so members can speak to their physicians about changing to this safer product.

FDA Safety Announcement 

The FDA made a formal recommendation that health care professionals discuss the availability of naloxone and consider prescribing it to patients who are at increased risk of opioid overdose, such as patients who are also using benzodiazepines or other medicines that depress the central nervous system, who have a history of opioid use disorder, or who have experienced a previous opioid overdose. Health care professionals should also consider prescribing naloxone if the patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

FDA Reports Shortages of Generic Versions of Zoloft (sertraline) 

The newly reported shortages could be caused by increased utilization of anxiety drugs due to the COVID-19 pandemic as well as manufacturing difficulties associated with obtaining active pharmaceutical ingredients (APIs).

Litigation 

Several independent pharmacies sue OptumRx over alleged price discrimination.

In addition to price discrimination, the pharmacies accuse the pharmacy benefit manager (PBM) of charging health plans brand prices while paying pharmacies generic prices, using differing brand/generic definitions to generate extra revenue. The plaintiff’s claim the following:

  • Reimbursements are dictated without notice or proper contractual negotiation, and often the dictated rates are grossly unrelated to the pharmacies’ actual wholesale acquisition costs.
  • Optum engages in a pattern of conduct where health care plans are charged brand prices while pharmacies are paid the lower generic price per prescription. Thus, the pharmacies allege the company is arbitraging prescriptions merely by changing its description.
  • Optum intentionally built a wall of secrecy around its conduct by forcing network pharmacies into confidentiality agreements that illegally conceal the truth about Optum’s business practices, specifically how much Optum is paid by insurance plans for prescriptions, how much Optum receives in rebates from drug manufacturers, and how little Optum pays to pharmacies.
Six BCBS insurers sue CVS Health over its Health Savings Pass drug discount program.

The lawsuit alleges that CVS Health set higher reimbursement rates from health plans than the cash prices it charged patients through discount programs.

  • A group of Blues insurers has sued CVS Health, alleging that the healthcare giant’s pharmacy chain overcharged them for generic drugs while hiding the true cash prices for those medications.
  • In the suit, the Blues plans allege that CVS charged significantly lower cash prices for hundreds of generic drugs through customer discount programs while seeking reimbursement from health plans at higher prices for the same medications.
  • CVS Spokesperson Michael DeAngelis said in a statement to Fierce Healthcare that the allegations in the lawsuit are “baseless… We did not overcharge plans for prescription drugs, and we will vigorously defend against these baseless allegations, which are without merit.”

ADDITIONAL RESOURCE 

DRUG PIPELINE UPDATE (PDF)

This report includes:

  • FDA Rejections
  • New Generic Approvals
  • New FDA Drug Approvals
  • Approvals for New Indications

As you read through the report, you’ll also see RX Team Tips from our Pharmacy Consultants

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Bob Eisendrath

National Pharmacy Practice Leader