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The European Federation of Pharmaceutical Industries and Associations (EFPIA) has revealed its latest annual W.A.I.T. Indicator for 2024The report reveals that the average time for EU patients to access approved drugs has risen to 578 days, an increase of over a month from 2023. The availability of centrally approved innovative medicines has also decreased, with 46% available to patients, and just 29% of those fully available through public reimbursementEFPIA blames several factors for these delays, including differing health technology assessments (HTAs), reimbursement processes, evidence requirements across countries, and regional fragmentation. The federation proposes guiding principles for novel pricing and payment models, as well as reviving proposals like equity-based tiered-pricing (EBTP)
India's Central Drugs Standard Control Organisation (CDSCO) is inviting comments on updated guidelines for biosimilars. The guidelines address changes in regulatory requirements for marketing authorisations The guidelines are in line with the latest international guidelines, including Guidelines on Evaluation of Similar Biologics, World Health Organization Technical Report Series (WHO) TRS No. 1043, 2022 (Replacement of Annex 2 of WHO Technical Report Series, No. 977)The revision also includes improved sections on the manufacturing quality, non-clinical and clinical evaluations, plus a new framework for approving similar biosimilars in India
For two months, Brazil’s Chamber for the Regulation of the Drug Market (CMED) will collect public feedback on the criteria used for price-settingThe current price-setting criteria were established more than two decades ago and must be updated to accommodate innovation in the sectorThe consultation also covers a revised basket of countries for reference pricing, rules for applying provisional prices, and more
The UK has signed a major free trade deal with India, set to cut down tariffs for several industries. However, the Association of the British Pharmaceutical Industry (ABPI) is disappointed with the lack of intellectual property (IP) protections in the agreement.The ABPI says the absence of such protections in the Indian market might hamper the potential of this deal for the pharma sector. The association also expressed concerns about the deal's potential impact on UK life science innovatorsRichard Torbett, ABPI Chief Executive, called the situation a missed opportunity and urged the government to negotiate deals with other key trading partners that better support the pharma industry
Victoria Jordan, Head of Value and Access Policy at the Association of the British Pharmaceutical Industry (ABPI) has highlighted that despite high levels of positive NICE recommendations, NHS patients in England are facing increasingly restricted access to new medicinesShe notes in a recent blog post that this is due to increased appraisal terminations and “optimized” decisions. While 84% of NICE appraisals since 2000 have resulted in positive recommendations, this figure does not tell the full story, she arguesEngland has fallen to sixth in Europe for overall availability of new medicines launched between 2020 and 2023 – a modest improvement on the previous year. However, when factoring in restricted access due to optimization, England falls to tenth place
Cypriot Health Minister Michalis Damianos and Deputy Health Minister of Greece, Marios Themistocleous, have signed an updated public health agreement that covers the cooperation of both countries in purchasing drugs to address shortages and possible collective purchasing where possible, as well as developing cooperation on pharmaceutical regulations.“The agreement helps Cyprus in the event of shortages as we have a much bigger market to buy from,” Damianos told the Cyprus Mail.The direct purchase of medicines would be facilitated by allowing the Health Insurance Agency (HIO) to purchase medicines directly from Greece if necessary, and by allowing joint procurement of medicines at better prices for both countries.
U.S. Senators Josh Hawley (R-Mo.) and Peter Welch (D-Vt.) have introduced a bipartisan act aimed at reducing the price of prescription drugs in the U.S. - the "Fair Prescription Drug Prices for Americans Act" proposes a cap on the amount pharma companies can charge U.S. consumers, with the rate set at the average price of a medicine across a basket of six reference countries: Canada, France, Germany, Japan, Italy, and the UKThe proposal also features financial penalties for companies that exceed this price benchmark; the penalty would be ten times the per-unit price difference between the U.S. list price and the basket averageThe plan echoes President Trump's "most favored nation" (MFN) policy, which aimed to apply international reference pricing (IRP) to Medicare drugs, but was blocked in court during his first administration
U.S. President Donald Trump is pressing congressional Republicans to force pharma companies to accept lower prices on prescriptions covered by Medicaid, similar to prices charged in specific other markets. The move again signals Trump's interest in implementing some form of international reference pricing (IRP) in the U.S.The Trump administration has requested proposals that would cut drug costs by pursuing a “most favored nation” (MFN) policy, under which drug manufacturers would be made to choose between raising their prices in other countries to maintain prices in the U.S. or lowering their U.S. prices to match the lowest price offered among comparator nationsThe implications of IRP are complex and global. If a market as large and important as the U.S. chooses to reference other countries, companies could potentially delay launches in the chosen markets to avoid price cuts in the U.S., or avoid launching in other markets that would be included in the U.S.’s basket of reference countries altogether
Denmark's Health Minister Sophie Løhde has faced a barrage of probing questions from members of the Folketing’s Health Committee on a legislative proposal for a three-year pilot for confidential drug pricesSeveral politicians have expressed concerns about the effects of confidential pricing on market dynamics and patient costs. Risks such as patients potentially having to pay for medications they previously received for free in hospitals were acknowledged. However, Løhde assured that patients will always be offered the cheapest available drug at the pharmacy, and annual out-of-pocket costs would be cappedThe legislative proposal, Bill No. L 134 on confidential pricing for selected medicines, was formally tabled on February 6, 2025. It was referred to the Health Committee on February 21, 2025, where it has since been under detailed scrutiny. A second reading is scheduled for May 13, 2025, with a third and final reading scheduled for May 15, 2025. If adopted, the bill will enable the Danish Medicines Agency to implement the pilot scheme from July 1, 2025, through June 30, 2028, as set out in the legislative text
Join us at NAVLIN’s Pharma Pricing Innovation Conference (PPIC), which will take place on June 3-5 at the Movenpick in Basel, SwitzerlandJoin a cohort of peers and industry executives at the event’s 2025 incarnation, hosted by NAVLIN by EVERSANAConference registration includes access to pre-conference workshops, the two-day conference, exclusive networking events, and dinners. After the event, copies of all presentations will be available to attendees
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