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China Releases Full 2022 NRDL

After pandemic-related delays, the National Healthcare Security Administration (NHSA) has released the finalized 2022 National Reimbursement Drug List (NRDL)147 products were considered for addition to the list, with 121 achieving successful negotiations or bids, representing an 82.3% success rate. The NHSA added 111 drugs to the list and the average price drop for newly listed drugs is 60.1%The updated medical insurance catalog is planned for implementation on March 1, 2023

Commission’s Rolling Plan Details EU HTA Strategy up…

The European Commission has published an updated rolling plan of activities that it intends to carry out in preparation for the implementation of the joint EU HTA regulationFollowing the adoption of the Regulation in 2021, it is slated to begin in January 2025, but implementation efforts have now been ongoing for a while; the Commission is working on setting up the necessary governance structure and preparatory documents to ensure effective application from this dateThe plan comes at a convenient time, as some German industry associations recently suggested that the regulation is at a “standstill” one year after it took effect, adding, “There must now be a correction in direction because the goals set cannot be achieved in this way.”

Drugmakers Increased Prices of Over 450 Drugs in U.S.…

Drug pricing non-profit 46brooklyn recently reported that as of January 1, pharmaceutical manufacturers have increased the list prices of 452 medications in the U.S. by 5 percent overall and more price hikes are expectedThis new data follows an initial report published by Reuters, which cited preliminary data and analysis from research organization 3 Axis Advisors and 46brooklyn stating that pharmaceutical companies plan to raise prices on more than 350 unique drugsAccording to 46brooklyn, this number is less than January 1 in 2022 (540) and January 1 in 2021 (602). However, the non-profit cautions that this initial decrease does not necessarily indicate fewer drug price increases in the month of January overall

NICE Backs Ngenla Under New Proportionate Assessment…

The National Institute for Health and Care Excellence (NICE) has recommended Ngenla (somatrogon) for the treatment of growth disturbance caused by growth hormone deficiency in children and young people aged three years and overIn its “proportionate” assessment, NICE determined that the Pfizer drug is as effective as one preparation of the current standard of care, Genotropin (somatropin). Ngenla works similarly but is a weekly injection instead of a daily one, allowing for easier administration and less burdenAccording to NICE’s final draft guidance, the price is £166.08 per 1.2 ml vial containing 24 mg of Ngenla or £415.20 for a 1.2 ml vial containing 60 mg of Ngenla (excluding VAT, company submission, December 2022). At the recommended dose of 0.66 mg per kg per week, the estimated annual cost for a 40 kg patient is £9,500. However, costs may vary in different settings because of negotiated procurement discounts

FDA Approves Eisai and Biogen’s New Alzheimer’s…

The U.S. Food and Drug Administration (FDA) approved Eisai and Biogen’s new Alzheimer’s drug, Leqembi (lecanemab-irmb), under the Agency’s accelerated approval pathway on Friday, fueling a growing debate regarding the drug’s safety and efficacyEisai has set a launch price of $26,500 per year for Leqembi (based on 10mg/kg IV biweekly for average U.S. patient weight of 75kg)Patient advocacy organization excitement over the FDA’s approval of Leqembi is clouded by growing safety concerns around the drug and follows months of controversy regarding the FDA’s decision to grant accelerated approval to Aduhelm, a different Alzheimer’s treatment also developed by Eisai and Biogen

Japan to Grant Additional Premiums in FY2023 Repricing…

Japan has announced details of an addition to the existing Price Maintenance Premium (PMP) for next year’s “off-year repricing,” under which additional premiums will be granted to compensate for 95% of the price reduction anticipated for eligible on-patent medicinesThe addition to the PMP was agreed by Cabinet ministers and Chuikyo, who decided that the two bottom tiers should be granted additional premiums to raise their new prices to a level “comparable” to their pre-revision prices. The ministers, however, have not published an official figureAccording to local Japanese media, in FY2023, 600 patented products will be granted the PMP. 450 of these will be granted a full price maintenance. However, the PMP will not be granted for products that became ineligible after the FY2022 price revision, for example, due to generic entry

Brazilian Health System and Novartis Agree to…

Brazil’s Ministry of Health signed an innovative, outcomes-based agreement with Novartis to cover the cost of Zolgensma, the company’s virus vector-based gene therapy indicated for the treatment of certain pediatric patients with spinal muscular atrophy (SMA)The Brazilian National Health System (or SUS) will receive access to up to 250 doses of Zolgensma in the first two years, with the possibility of an additional 40 doses at no additional costThe SUS will pay R$5.7 million (US$1.1 million/€1 million) per dose in a series of five equal annuities of 20%Payments will be tied to patient outcomes and clinical milestones

German Health Minister Announces More Major Changes to…

German Health Minister, Karl Lauterbach, is not resting on his laurels just yet; Mere weeks after implementing the “Financial Stabilization of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill - some of the most significant changes to the German healthcare system since the introduction of AMNOG in 2011 - the Minister has now published a “key issues paper” detailing his plans to change the framework for the off-patent drug market, relax discount and fixed price rules and potentially change reference pricesAt the core of the key issues paper, he notes, are measures to avoid future drug shortages, to improve the supply of pediatric drugs, and to strengthen the EU as a drug production location. The measures are intended to stabilize the supply of medicines in Germany in the long term.Lauterbach explains: “We have overdone it with the economization also in the supply of medicines with off-patent medicines…The discounter policy has continuously worsened the supply of medicines for decades. Reversing that won't happen overnight”

ICER Updates Health-Benefit Price Benchmark for…

The Institute for Clinical and Economic Review (ICER) updated the health benefit price benchmark (HBPB) for Paxlovid for the treatment of COVID-19, proposing a new range of $563-$906 per treatment courseThe update is based on evolving data regarding the COVID-19 pandemic, as well as the expectation that in early to mid-2023, paying for Paxlovid will begin to shift from federal contracts to new pricing and payment arrangements between Pfizer and commercial insurersICER President Steven Pearson, MD, MSc, said, “The evidence on outpatient treatments for COVID-19 must be viewed as highly sensitive to the evolving landscape of COVID-19 variants and vaccination status in the U.S.”

Chuikyo Greenlights FY2023 Off-year Price Revision…

Japan's Central Social Insurance Medical Council (Chuikyo) has approved the Cabinet ministers’ final logistics for the 2023 “off-year” repricing, under which they will retain the “0.625 times” threshold with an exemption for “unprofitable” drugs and certain patented productsThe FY2023 revision will cover products with discrepancy rates between national health insurance (NHI) prices and market prices more than 0.625 times the 7% average worked out in the September drug price survey, thus focusing on products with a gap higher than 4.375% - The revision is set to cover 69% of all listed products and 48% of all listed products will face price cuts, where 6% will have their prices raised via the upward re-pricing rule for unprofitable productsThe reaction to the repricing rules has been mixed; some have expressed “relief,” whereas others “feel like [they] lost”

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