FDA approves Akorn’s generic Voltaren gel
Specialty generic company Akorn has received the Food and Drug Administration’s clearance for its generic Voltaren gel (diclofenac sodium topical gel 1%).
Diclofenac sodium topical gel is indicated for the relief of pain of osteoarthritis of joints amenable to topical treatment, including knees and hands.
The product had a market value of approximately $357 million for the 12 months ended September 2018, according to IQVIA data.
CMS’ proposed DIR fee reform garners industry support
The latest effort from the Centers for Medicare and Medicaid Services is garnering industry attention. CMS on Tuesday unveiled a proposed rule, titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses,” which includes provisions focused on direct and indirect remuneration, or DIR, fee reform.
The proposed rule is interested, among other things, in transparently pricing drugs, and seeks to redefine what constitutes “negotiated prices” under Medicare Part D to mean “the lowest amount a pharmacy could receive as reimbursement” for Part D drugs through its contract with the plan sponsor or intermediary. This would require PBMs and plan sponsors to include the lowest possible reimbursement in their claims processing systems.
It also would add a definition for “price concession” in Part D to include “all forms of discounts and direct or indirect subsidies or rebates that serve to reduce the costs incurred under Part D plans by Part D sponsors.”
The National Association of Chain Drug Stores, the National Community Pharmacists Association and the National Association of Specialty Pharmacy jointly praised the proposed rule, noting that it includes many changes related to direct and indirect remuneration, or DIR, fee reform that they have advocated for in the past.
“The proposed rule raises the need for policies related to DIR fee reform that will lower patients’ out-of-pocket costs at the pharmacy counter and lead to a more competitive and efficient Medicare Part D program,” the organizations said. “We believe pharmacy DIR fee reform will greatly advance the goal of the Trump administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs — addressing the high and rising out-of-pocket costs for patients.”
CMS noted in the proposed rule that it also is considering developing a standard set of metrics upon which pharmacies and plans could base their contracts, and is seeking feedback on whether they could be designed to offer pharmacies more predictability regarding reimbursements while still letting plans negotiate terms.
“A standardized pharmacy performance program should incentivize pharmacies for performing on measures based on pharmacy-specific, proven and achievable criteria, based on the drug dispensed and the disease state being managed,” NACDS, NCPA and NASPA said. “This would drive quality improvements and system efficiencies while also reducing unnecessary administrative burdens placed on pharmacies as a result of disparate measures and assessment methodologies by plans.”
CMS said that the changes in the proposed rule could happen as soon as 2020 — a timeline industry organizations said they would welcome.
“We remain committed to continuing to work with CMS as it advances these important pharmacy DIR fee reform concepts,” they said. “CMS has indicated that the related policies could be in place for Contract Year 2020, and it is imperative for the benefit of patients and for the competitiveness and efficiency of the Medicare Part D program that pharmacy DIR fee reform take effect as soon as possible.”
Loxo, Bayer get FDA nod for Vitrakvi
The Food and Drug Administration has granted accelerated approval to Loxo Oncology’s Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature, or biomarker.
This is the second time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released earlier this year.
Developed in collaboration with Bayer, Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase, or NTRK, gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
“Today’s approval of Vitrakvi is the culmination of years of hard work and research by many people to bring the first-ever treatment to patients with TRK fusion cancer. TRK fusions are rare, but occur across many different tumor types. In this era of precision medicine, we are delivering on Bayer’s commitment to advance the future of cancer care while providing value for patients and physicians,” said Robert LaCaze, a member of the executive committee of Bayer’s pharmaceuticals division and head of the oncology strategic business unit. “It is very rewarding to provide a therapy specifically for patients with advanced solid tumors harboring an NTRK gene fusion.”
“Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body,” FDA commissioner Scott Gottlieb said. “This new site agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.”