Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
HHS Secures Free HIV Prevention Donation
Earlier this year, the Trump administration announced its goal to eliminate new cases of HIV in the US. Their plan is to target areas across the US with significant HIV burden and provide additional experts, technology, and resources. The goal is a 75% reduction in new HIV cases within 5-years and at least a 90% reduction in 10-years.
In support of this effort, Gilead Sciences has agreed to donate pre-exposure prophylaxis (PrEP) medication for up to 200,000 people each year for up to 11 years. The agreement between the Department of Health and Human Services (HHS) and Gilead will provide Truvada to individuals who are at risk for HIV and who are uninsured. Once Gilead’s second-generation HIV preventative medication becomes available, they will replace Truvada with Descovy and they will continue to donate Descovy until its generic hits the market (or 11 years whichever comes first).
FDA Approves $2.1 Million Rare Disease Gene Therapy
The FDA has approved a novel gene therapy, Zolgensma, for the treatment of spinal muscular atrophy (SMA) in children up to age 2. SMA is a genetic disorder that impacts infants by progressively weakening muscles, including those required for swallowing and breathing. The mortality rate can be as high as 90% by age 2 if untreated.
Zolgensma is approved as a one-time intravenous infusion of gene therapy for the treatment of children less than 2 years old. Zolgensma is designed to address the genetic root cause of SMA by replacing the defective or missing SMN1 gene and thus stopping the disease’s progression.
Prior to approval, Novartis publicly stated the drug price would be around $4 million to $5 million, however, at launch they lowered the price tag to $2.125 million. Due to the intravenous infusion and supportive care required to administer Zolgensma we expect claims would be processed on the medical benefit rather than the PBM benefit. Novartis is offering insurers the ability to pay $425,000 a year over five years in order to help payors afford this drug’s price tag.
HHS Requires List Price to be Included in TV Drug Advertisements
In an effort to lower drug prices, the Department of Health and Human Services (HHS) has announced it will require prescription drug ads to include the drug’s list price. All direct to consumer TV ads for prescription drugs covered by Medicare or Medicaid and priced over $35 per month must include the Wholesale Acquisition Cost (WAC) beginning in July 2019.
This is the first finalized rule within President Trump’s American Patients First blueprint to improve drug price transparency and inform consumer decision making. Pharmaceutical Research and Manufacturers of America (PhRMA) has already issued a public statement. They believe that “…requiring list prices in direct-to-consumer (DTC) television advertising could be confusing for patients and may discourage them from seeking needed medical care.” PhRMA may also be gearing up to challenge the legal merits of this rule as they have already said the “final rule raises First Amendment and statutory concerns.”
Truveris is helping manufacturers by providing a comprehensive service with a real-time benefits check product that provides the exact cost the patient can expect to pay at the pharmacy under their specific Rx benefit design. Truveris’ TruCheck solution not only enhances the patient’s out-of-pocket certainty but gives Life Sciences companies the power to effectively and efficiently manage rising costs, develop successful patient engagement strategies, provide transparency, and increase fulfillment.