Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.
CMS has released updated versions of its online Drug Spending Dashboards, which are intended to help consumers, researchers, policy makers, and other stakeholders understand how spending on prescription drugs per dosage is changing over time.
This update of the dashboards includes year-over-year spending changes for individual drugs and highlights the drugs prescribed most under Medicare and Medicaid. Data from the dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.
Under Medicare Part B, which covers drugs that are generally administered by healthcare providers rather than by patients themselves, spending on innovator infliximab (Remicade) grew by 6.0%, with average monthly per beneficiary spending reaching $1910. Two biosimilars (Renflexis and Inflectra), both of which launched at discounts to Remicade, are FDA approved and currently available.
Spending on innovator rituximab (Rituxan), for which multiple companies are developing biosimilars, grew by 5.6%, with average monthly spending reaching $1985. Spending on pegfilgrastim (Neulasta), which is also targeted by biosimilar developers, grew by 8.5%, with average spending of $1195.
Under Medicare Part D, which generally covers self-administered drugs, several products that have approved (but unlaunched) biosimilars or approved follow-ons were among the products that also saw significant increases in pricing. Spending on adalimumab (in the Humira pen presentation) rose by 18.0% to $2835 per month. Currently, 2 adalimumab biosimilars are approved by the FDA, but neither is expected to launch prior to 2023. Spending on Etanercept (Enbrel) rose by 18.2% to $2741. One etanercept biosimilar has gained the FDA’s approval, but no launch date has been announced, as patents concerning the reference etanercept continue to be the subject of ongoing litigation, a trial for which is slated to begin in September 2018.
The 2 presentations of insulin glargine (Lantus and Lantus Solostar) rose by 18.3% to $209 and 14.2% to $196, respectively. Basaglar, a follow-on insulin glargine, is FDA approved and commercially available, and Lusduna, another follow-on, has been tentatively approved pending the conclusion of patent litigation.
Spending on many of the same drugs increased under Medicaid as well; spending on Humira rose by 17.5%, on Enbrel by 17.6%, on Lantus by 18.7%, and on Lantus Solostar by 14.3% under Medicaid.
In a statement concerning the new dashboards, CMS Administrator Seema Verma said that “Publishing how much individual drugs cost from one year to the next will provide much-needed clarity and will empower patients and doctors with the information they need. As [HHS] Secretary Azar has repeatedly pointed out, for years Medicare incentives have actually encouraged higher list prices for drugs, and this updated and enhanced dashboard is an important step to bringing transparency and accountability to what has been a largely hidden process.”
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.