- The Dubai Health Authority (DHA) has replaced the formularies for each hospital and health insurance plan with a new, unified formulary (SHIFA) under the Insurance System for Advancing Healthcare in Dubai (ISAHD), a DHA initiative seeking to provide healthcare for Dubai residents, nationals, and visitors
- The European Commission has officially implemented new criteria for vaccine exports leaving the European Union, in a move the group believes to be “targeted, proportionate, transparent and temporary”
- Last week, United States Senator Bernie Sanders (I-VT) and Democratic Representatives Ro Khanna, Lloyd Doggett, Peter Welch, and Cori Bush, along with more than two dozen others, introduced a package of bills aimed at “drastically” reducing prescription drug prices in the U.S.
In an interim safety and efficacy analysis of the AstraZeneca-led United States Phase 3 trial, AstraZeneca’s COVID-19 vaccine AZD1222 was shown to offer 79% efficacy at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization. The company plans to submit a primary analysis to the United States Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) in “the coming weeks,” as well as submit the primary analysis for publication in a peer-reviewed journal.
Chengdu Healthcare Security Administration (CHSA) announced it has defined the scope of the protection for rare diseases in Chengdu, China in accordance with a medical, health commission, and financing-released circular seeking the establishment of a special fund and finetuned procurement methods for drugs for rare diseases. To be included in this program, relevant drugs must be breakthrough, innovative orphan drugs whose indications match those found in the national rare disease catalogue, and their medical insurance payment is to be capped at less than 400,000 yuan per year and “personal burden” (i.e. out-of-pocket costs) at less than 60,000 yuan per year.
The European Commission has officially implemented new criteria for vaccine exports leaving the European Union, in a move the group believes to be “targeted, proportionate, transparent and temporary.” Under the new legislation, the Union is prioritizing “reciprocity” and “proportionality”. This means that member States sending vaccines outside the bloc should consider whether the destination country has restricted its own exports and whether the destination country’s individual situation is better or worse than the EU’s.
On the 10th anniversary of Germany adopting AMNOG, the Institute for Quality and Efficiency in Health Care (IQWiG) detailed its recent assessments of 24 drugs ranging in indication from cancer to rare disease, and elaborated on the scope of data submitted in these dossiers.
The U.S. Department of Health and Human Services (HHS) is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” – also known as the SUNSET final rule, which would have added automatic expiration dates to most HHS regulations after 10 years and would have also required HHS to review nearly all its regulations within the next five years. The Plaintiffs’ initial response to the proposed rule claimed that it would “spark regulatory chaos as thousands of critical HHS regulations face automatic elimination in just a few years’ time.
Last week, United States Senator Bernie Sanders (I-VT) and Democratic Representatives Ro Khanna, Lloyd Doggett, Peter Welch, and Cori Bush, along with more than two dozen others, introduced a package of bills aimed at “drastically” reducing prescription drug prices in the U.S.
China has launched the Medicine Connect pilot program in the Greater Bay Area, with the aim of improving access to imported medicine and medical devices for the region’s 75 million residents. Residents of the Greater Bay Area—which includes Guangdong’s nine mega cities, Hong Kong, and Macau— will be granted access to new medicines first in a Shenzhen hospital in Guangdong before these drugs are authorized in the rest of Mainland China, and before the program expands to include other hospitals in the region.
PRICING & REIMBURSEMENT
The Dubai Health Authority (DHA) has replaced the formularies for each hospital and health insurance plan with a new, unified formulary (SHIFA) under the Insurance System for Advancing Healthcare in Dubai (ISAHD), a DHA initiative seeking to provide healthcare for Dubai residents, nationals, and visitors. SHIFA took effect on February 18, 2021, and no other formulary can be used by Dubai’s Essential Benefit Plan (EBP) from the start date.
China Daily reported that Hainan’s Boao Lecheng International Medical Tourism Pilot Zone launched a special commercial medical insurance covering 49 imported innovative drugs to not only lower medical expenses but also boost patient access to drugs they need, which are supported by real-world evidence later used by China’s main drug regulator. Drug affordability has been a withstanding concern, said Liu Zhefeng, Deputy Head of the Boao Lecheng International Medical Tourism Pilot Zone Administration, who added that the Zone’s current medical insurance scheme—dubbed Version 1.0—costs a Hainan resident around only 29 yuan and those from outside the region at most only 159 yuan.
Japan’s MHLW approved 4 drugs:
- Marketing authorization was granted to Bayer’s highly selective TRK inhibitor Vitrakvi (larotrectinib) for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors
- Eisai and MSD’s multiple receptor tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib) was approved for the additional indication of treatment of unresectable thymic carcinoma, marking the first approval for Lenvima in this indication in Japan
- Incyte’s selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinab) secured MHLW approval for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 gene fusion that has worsened after cancer chemotherapy
- Lastly, Insmed’s Arikayce (amikacin liposome inhalation suspension) was approved for the treatment of patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who did not sufficiently respond to prior treatment with a multidrug regimen (MDR)