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The U.S House of Representatives has passed the BIOSECURE Act, a bill aiming to cut ties between US biotech firms and Chinese partners, by 306 to 81 votes; the U.S. Senate has yet to pass the billThe Act allows companies until 2032 to end such collaborations, increasing opportunities for firms in India, Europe, and Japan, while posing extra regulatory hurdles for smaller foreign companies trying to collaborate with U.S partnersCompanies are already acknowledging the changing landscape with some, such as AstraZeneca, planning new manufacturing facilities outside China, while others review activities such as legal compliance and supplier diversification. However, only 2% of companies have started to replace existing Chinese partners just yet
Eli Lilly has started selling its weight loss medicine, Zepbound (tirzepatide), in single-dose vials of 2.5mg and 5mg through LillyDirect at a signficant discountThe prices for these doses will cost consumers $399 to $549 per month, respectively. This represents a $250 discount compared to the $650 per month Lilly currently charges patients for the pen version of ZepboundThe decision is also expected to increase the availability of Zepbound, which is usually sold in auto-injector pens and has been facing supply issues over the past year
We are pleased to announce that NAVLIN Daily is an official media partner with the World Orphan Drug Congress (WODC) Europe, taking place October 22-25, 2024, in everyone’s favorite sunny Barcelona!The event convenes leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapiesAs a valued NAVLIN Daily customer, you can use our ND50 registration discount code for an exclusive 50% discount
DAK Gesundheit has released its 2024 report, highlighting the rising costs of patented medicine in Germany. The report notes an 18% rise in spending, compared to the same period in 2023The report issues updates on all the key measures of the Financial Stabilization Act (GKV-FinStG), including the controversial guardrails, the orphan drug threshold and combination discounts Based on its findings, DAK Gesundheit calls for a critical reassessment of recent reforms and for the introduction of more robust transparency measures, particularly in hospital drug spending
The Biden Administration published its long-awaited final prices for the first ten prescription drugs selected for negotiation under the Inflation Reduction Act (IRA), with discounts ranging from 47-80% compared to current list prices obtained through NAVLIN Price & Access Data (versus CMS’ use of 2023 list prices)Although the published prices establish a starting point for Medicare’s new ability to negotiate with manufacturers and provide useful insight for future rounds of negotiation, several questions about the program and its long-term impact remainKey developments to watch as prices are implemented include: whether or not most beneficiaries in Medicare Part D will directly benefit from the savings generated by Medicare-negotiated discounts; how pharmacy benefit managers (PBMs) and insurers will respond to negotiated prices; and whether CMS will implement any safeguards to ensure that PBMs and plans maintain beneficiary access to drugs selected for negotiation
After much anticipation, the Spanish Ministry of Health has released the draft Royal Decree regulating the assessment of health technologies, which clearly separates clinical evaluations from non-clinical assessmentsThe new regulation is based on nine key considerations: four clinical criteria, including healthcare issue identification, technical analysis, safety, and efficacy, and five non-clinical factors, such as cost, ethical, organizational, social, and legal aspectsThe public consultation on the draft will remain open until September 20, 2024
The Association of the British Pharmaceutical Industry (ABPI) has raised concerns about the National Institute for Health and Care Excellence’s (NICE) severity modifier, which is used to prioritize treatments for severe conditionsIn a recent blog post, the ABPI suggests NICE's goal of keeping the severity modifier financially neutral is limiting broader patient access to these treatments. The group also asserts that the severity modifier is being applied too conservatively. As a result, some cancer treatments that were previously eligible for consideration under the end-of-life modifier are now failing to qualify for the highest severity weighting, thereby preventing some patients from accessing potential life-extending treatmentsTo resolve this, the ABPI suggests that NICE revise the severity modifier by lowering severity cutoff levels, so more medicines can get higher weightings. It also urges NICE to abandon the cost-neutral approach in favor of an evidence-based method that prioritizes treatments for severe diseases as per societal preferences.
The Scottish Medicines Consortium (SMC) has given interim approval for Hemgenix (etranacogene dezaparvovec) for adults with haemophilia B, allowing its use while additional evidence is collected; the move follows the National Institute for Health and Care Excellence's (NICE) recommendation for the gene therapy SMC Chair Dr Scott Muir highlighted the balance between optimism for Hemgenix due to promising clinical evidence, and the need for further research into long-term effectiveness, adding: "The committee look forward to reviewing the updated evidence when available to ensure that this treatment offers good value to patients in NHSScotland"In the same meeting, the SMC also approved Lonsurf (trifluridine/tipiracil) in combination with bevacizumab for adults with advanced colorectal cancer who have undergone two prior treatments
In its final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended Vertex's Casgevy (exagamglogene autotemcel), the world's first CRISPR-based gene therapy, for individuals aged 12 and over with severe beta-thalassaemia who require regular blood transfusions and are eligible for a blood and bone marrow transplant but lack a suitable donorNICE acknowledges uncertainty in the clinical evidence and suggests that collecting more data through a managed access agreement via the Innovative Medicines Fund (IMF) may help resolve some of these uncertaintiesThe treatment costs £1,651,000 per course at its list price, but the company has a commercial arrangement, including a managed access agreement and a commercial access agreement
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released its 2023/2024 Annual Report, in which it recaps highlights from the Agency’s last working year. Notables include Mounjaro for weight loss, Tepkinly for lymphoma, Litfulo for alopecia, Jemperli for advanced endometrial cancer, and Casgevy for sickle cell disease via CRISPR techThe report mentions progress on the International Recognition Procedure (IRP), a new approval pathway for UK. Through this, the MHRA can use decisions from trusted reference regulators, including from the U.S., EU, and Singapore. All applications reviewed through this pathway to date have met their target deadlines According to the report, applications assessed through the IRP pathway have been approved 100% within target timelines. However, the group is working with other UK-based bodies to develop revised eligibility criteria for the Innovative Licensing and Access Pathway (ILAP), as there were just 57 applications for the in the year ending 31 March 2024, down from 178 the previous year
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