May 14th 2024
The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
State Insurance Commissioners and Governors Testify Before the Senate HELP Committee
September 8th 2017The US Senate’s Committee on Health, Education, Labor, and Pensions held the first 2 of its 4 full committee hearings on stabilizing the Affordable Care Act’s individual insurance market. Testifying on Wednesday and Thursday were state insurance commissioners and state governors, respectively. Across the 2 days of testimony, key themes emerged.
Could Biosimilar Suffixes Stand in the Way of Pharmacovigilance?
September 6th 2017The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.
EAHP Position on Biosimilars Contrasts With US Regulation on Naming, Interchangeability
September 2nd 2017The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.
Amgen, Sandoz File Supplemental Briefs in Ongoing Appeal
August 31st 2017Following the Supreme Court’s decision in Sandoz v Amgen, both drug makers have filed, in compliance with the Federal Circuit court’s order, supplemental briefs. These briefs state the parties’ opinions on the appropriate action to be taken after the Supreme Court remanded the case to the lower courts.
Reference Pricing Has a Significant Impact on Drug Selection, Spending
August 29th 2017In recent years, drug spending has increased with the launches of new, high-cost drugs and with price hikes for established drugs. One method of controlling such increases in drug spending is reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class.
Biosimilar Endocrinology Roundup: August
August 28th 2017August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.
CSR Payments Continue in August, HELP Committee Schedules Hearings on Stabilizing Markets
August 23rd 2017The White House confirmed last week that it will continue to make cost-sharing reduction (CSR) payments for the month of August. The Trump administration has been making decisions on whether to continue to fund CSRs on a monthly basis, and had previously suggested that it might soon put an end to CSRs.
Stakeholder Groups Praise Enactment of FDARA
August 22nd 2017Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.
Budget Impact Analysis Shows a Need for Deep Discounts for Biosimilar Infliximab
August 16th 2017Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets.
EMA Scales Back Activities, Prioritizes Tasks to Cope With Brexit
August 15th 2017The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.
Ireland Seeks to Overhaul Biosimilar Drugs Policy
August 14th 2017Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”
Roche Withdraws SLP Against Biocon and Mylan's Trastuzumab Biosimilar
August 14th 2017Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.
ACA Uncertainty Gives Rise to Stark 2018 Premium Changes
August 11th 2017Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.