NAVLIN BRIEF:
- The National Healthcare Security Administration (NHSA) of China has published the “List of Drugs Passing Form Evaluation for Inclusion in the 2022 National Reimbursement Drug List (NRDL).” This year, the NHSA’s national medical insurance information platform received applications for 490 drugs overall, of which 344 made it through the preliminary review: 70% of the total applicants.
- The German Federal Council (Bundesrat) has published a set of recommendations ahead of a meeting on September 16, 2022, in which the plenum will decide which recommendations to follow. The proposals widely criticize the “Financial Stabilization of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill, suggesting that it could “massively jeopardize” the nationwide supply of pharmaceuticals, among other issues.
- Five health technology assessment (HTA) bodies across Australia, Canada, and the UK have signed an international collaboration arrangement to support shared strategic objectives in several priority areas.
Details
COVID-19
EU Member States, Spain, Latvia, and Denmark have begun to receive adapted COVID-19 vaccines following the European Medicines Agency’s (EMA) human medicines committee (CHMP) approval of Pfizer-BioNTech’s Comirnaty bivalent and Moderna’s Spikevax bivalent vaccines against the Omicron variant.
The Italian Medicines Agency’s (AIFA) Scientific-Technical Committee (CTS) has approved the use of Pfizer’s Comirnaty and Moderna’s Spikevax – both bivalent vaccines – for use as booster doses for people aged 12 years and above, following the European Medicines Agency’s (EMA) recent authorization.
The UK’s Joint Committee on Vaccination and Immunization (JCVI) is encouraging everyone who is eligible to have a bivalent COVID-19 booster this autumn.
Pfizer has donated 100,000 courses of its COVID-19 antiviral treatment Paxlovid to a new group that aims to ensure treatments reach patients in low and middle-income countries at an urgent pace.
Policy
The German Federal Council (Bundesrat) has published a set of recommendations ahead of a meeting on September 16, 2022, in which the plenum will decide which recommendations to follow. The proposals widely criticize the “Financial Stabilization of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill, suggesting that it could “massively jeopardize” the nationwide supply of pharmaceuticals, among other issues.
The European Commission’s Regulatory Scrutiny Board has rejected an impact assessment on the EU Pharmaceutical Strategy, meaning the draft will have to be reworked to satisfy the panel’s criteria, leading to delays in the process.
The Pharmaceutical Benefits Scheme (PBS) of Australia announced the release of a new interim report on the value chain behind chemotherapy and cancer treatments, meant to ensure continuous and cost-effective access.
The National Institute for Health and Care Technology (NICE) recently hosted the UK, Brazil & LATAC Conference on Health Technology. Participants discussed rare and oncological diseases, challenges in decision making, and reassessment of technologies, as well as existing positive initiatives that place the Brazilian Commission as a reference in HTA for different countries.
The Indian Medical Association (IMA) has urged Union Government to withdraw the imposition of 5% Goods and Services Tax (GST) on Healthcare services.
The Indian Government Grants ‘in-Principle’ Approval of three Bulk Drug Parks to Himachal Pradesh, Gujarat, and Andhra Pradesh. The scheme, with a financial outlay of Rs. 3,000 crores ($37,80,00,000) notified in 2020, provides financial assistance to these states for establishing Bulk Drug Parks.
Price & Reimbursement
The National Healthcare Security Administration (NHSA) of China has published the “List of Drugs Passing Form Evaluation for Inclusion in the 2022 National Reimbursement Drug List (NRDL).” This year, the NHSA’s national medical insurance information platform received applications for 490 drugs overall, of which 344 made it through the preliminary review: 70% of the total applicants.
The Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Polivy (polatuzumab vedotin) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy is designated an orphan drug, so in Germany the additional medical benefit is already proven through the approval.
The Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Kymriah (tisagenlecleucel) for the treatment of follicular lymphoma (FL). Kymriah is designated an orphan drug, so in Germany the additional medical benefit is already proven through the approval.
The Saudi Food and Drug Administration (SFDA) has updated its Principles of Registering Pharmaceutical, Herbal & Health Manufacturers & their Products Guidelines. The newly published comprehensive guidelines pertain to manufacturers and include new, updated procedures and considerations covering patent policy, local manufacturing opportunities, and registering a product on the Saudi market.
Janssen has reached a stalemate with the German Pharmaceuticals Market Reorganization Act (AMNOG) procedure, as it believes the system would “not reflect the added value” of its relapsed and refractory multiple myeloma (RRMM) bispecific antibody, Tecvayli (teclistamab), with the “data available at this time.”
The High Health Authority (HAS) of France is in favor of reimbursing Delstrigo (tenofovir disoproxil/doravirine/lamivudine) for the treatment of adolescents aged 12 to under 18, and weighing at least 35 kg with HIV-1 without previous or current evidence of resistance to the class of non-nucleoside inhibitors of reverse transcriptase (NNRTI).
HTA
Five health technology assessment (HTA) bodies across Australia, Canada, and the UK have signed an international collaboration arrangement to support shared strategic objectives in several priority areas.
The High Health Authority (HAS) of France is in favor of reimbursing Global Blood Therapeutics’ Oxbryta (voxelotor) either as monotherapy or in combination with hydroxycarbamide to treat severe hemolytic anemia caused by sickle cell disease in people aged 12 years and older.
The Institute for Quality and Efficiency in Health Care’s (IQWiG) 2021 annual report highlights IQWiG’s ongoing efforts to commit to joint benefit assessments of medicines at the European level, preparing for the EUnetHTA 21 launch, as well as explaining its hopes for a growing appreciation of evidence-based medicine.
The National Institute for Health and Care Excellence (NICE) has released a Final Appraisal Document (FAD), recommending the use of Bristol Myers Squibb’s (BMS) Onureg (azacitidine tablets) for maintenance therapy in adult patients with acute myeloid leukemia (AML).
The National Institute for Health and Care Excellence (NICE) has recommended the use of Celgene’s Zeposia (ozanimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Drug Approval
After issuing an initial rejection, a U.S. Food and Drug Administration expert panel has voted in favor of the amyotrophic lateral sclerosis (ALS) treatment candidate, known as AMX0035 (sodium phenylbutyrate and taurursodiol), by Amylyx Pharmaceuticals.
The European Medicines Agency (EMA) has classified Myrtelle’s lead candidate as an Advanced Therapy Medicinal Product (ATMP) for the treatment of Canavan disease. Canavan disease is a progressive, inherited neurological disorder that deteriorates white matter in the brain, ultimately leading to death.
China’s National Medical Products Administration (NMPA) has approved the emergency use of CanSino BIO’s recombinant COVID-19 vaccine, Convidecia Air, as a booster.
China’s National Medical Products Administration (NMPA) has granted priority review to Innocare’s relapsed or refractory marginal zone lymphoma (R/R MZL) treatment, orelabrutinib.
The U.S. Food and Drug Administration (FDA) has approved the sixth Neulasta biosimilar, Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Moleculin Biotech’s WP1122 in the treatment of Glioblastoma Multiforme (GBM), the most vicious and prevalent malignant primary tumor of the brain.
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Avacta’s lead pre|CISION platform drug candidate, AVA6000, for treatment of soft tissue sarcoma.
China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in patients at risk of progression with and without type-2 diabetes (T2D).
The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi (durvalumab) for the treatment of locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
Other
Charles River Laboratories and Cure AP-4 announced a manufacturing collaboration. Charles River will provide High Quality (HQ) plasmid DNA for Cure AP-4’s Phase I/II gene therapy trials against AP-4 HSP.
Roche is set to acquire biopharma firm Good Therapeutics after signing a definitive merger agreement to the tune of $250M in cash, which will ultimately lead to the formation of a new company called Bonum Therapeutics
The Spanish Agency for Medicines and Health Products (AEMPS) says in the first half of 2022, drug supply problems have increased by 31% compared to the second half of 2021.
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