Global Pricing Insights – Last Week In Review – August 29 – September 2, 2022

NAVLIN BRIEF:

The European Medicines Agency’s (EMA) human medicines committee (CHMP), has recommended the approval of the first adapted COVID-19 booster vaccines, Pfizer-BioNTech’s Comirnaty Original/Omicron BA.1 and Moderna’s Spikevax bivalent Original/Omicron BA.1.

The Netherlands’ Basic Package Advisory Committee (ACP) has advised the Zorginstituut (ZIN) to not include Orchard’s Libmeldy (atidarsagene autotemcel) in the Medicines Reimbursement System (GVS) unless there is a significant price reduction and a pay-for-performance agreement.

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the Accelerating Clinical Trials in the EU’s (ACT EU) 2022-2026 workplan. The work plan lays out deliverables and timelines structured in line with the 10 priority actions for ACT EU, prepared around recommendations of the EMA network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

Details

COVID-19

The European Medicines Agency’s (EMA) human medicines committee (CHMP), has recommended the approval of the first adapted COVID-19 booster vaccines, Pfizer-BioNTech’s Comirnaty Original/Omicron BA.1 and Moderna’s Spikevax bivalent Original/Omicron BA.1.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted an extension to Nuvaxovid, the COVID-19 vaccine developed by Novavax, to its existing UK approval, for 12- to 17-year-olds.

Swissmedic is also among one of the first regulators to grant temporary authorization for the use of Moderna’s Omicron-targeting bivalent booster vaccine.

Japan’s Ministry of Health, Labor, and Welfare (MHLW) has announced that the Committee on Pharmaceuticals, Pharmaceutical Affairs, and Food Sanitation Council has approved the use of AstraZeneca’s Evusheld for the prevention of COVID-19, and expanded Pfizer-BioNTech’s Comirnaty indication to include children aged five to 11 years of age.

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

Policy

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the Accelerating Clinical Trials in the EU’s (ACT EU) 2022-2026 workplan. The work plan lays out deliverables and timelines structured in line with the 10 priority actions for ACT EU, prepared around recommendations of the EMA network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

The National Association of Statutory Health Insurance Funds (GKV-S) has officially “reject[ed]” the recently passed “Financial Stabilization of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill, suggesting that it represents a “further and serious restriction of the financial sovereignty of the self-governing bodies.”

As part of the EU4Health program, the European Commission has awarded funding to the “Strengthening voluntary non-remunerated plasma collection capacity in Europe” (SUPPLY) project, which is set to begin in September this year and last 18 months.

Florida Gov. DeSantis has filed a lawsuit against the FDA in a Tampa court for failing to comply with a FOIA request.

The Pharmaceutical Manufacturers Association (JPMA) of Japan has announced a new proposal for a value-based pricing system for innovative drugs.

The Indian Government plans to fix trade margin rationalization (TMR) in a phased manner and has identified 139 formulations which include drugs like Remdesivir, Tocilizumab, influenza drugs, and some patented drugs, among others.

HTA

The Italian Medicines Agency (AIFA) has announced that as of August 27, 2022, both Imcivree (setmelanotide) and Bylvay (odevixibat sesquidrato) are to be covered on the country’s SSN reimbursement scheme.

Evenity (romosozumab) is reimbursed for the treatment of osteoporosis in Italy, following the publication of the Italian Medicines Agency’s (AIFA) Determination in the Official Gazette No. 201.

Pfizer’s Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) has been placed in Sweden’s high-cost protection with limited subsidy.

The National Institute for Health and Care Excellence (NICE) has recommended a faecal microbiota transplant (FMT) for patients who have been treated for two or more Clostridium difficile (C. difficile) infections without success.

Germany’s Federal Joint Committee (G-BA) has found the added benefit of Rayaldee (calcifediol) to be “not proven”, for the treatment of secondary hyperparathyroidism (sHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D deficiency.

Price & Reimbursement

The National Healthcare Institute’s (Zorginstituut) international strategic agenda (ISA) 2022/2023 highlights the organization’s “increasing” participation in international activities, as well as outlining its activities heading into 2023. One of the key changes occurring in Europe is the advent of a joint European Union (EU) health technology assessment (HTA) body.

Biogen has expressed its discontent over CADTH’s final recommendation against public reimbursement of Spinraza (nusinersen) for adults with spinal muscular atrophy (SMA).

The Netherlands’ Basic Package Advisory Committee (ACP) has advised the Zorginstituut (ZIN) to not include Orchard’s Libmeldy (atidarsagene autotemcel) in the Medicines Reimbursement System (GVS) unless there is a significant price reduction and a pay-for-performance agreement.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has placed Lumykras (sotorasib) in the country’s high-cost protection with a limited subsidy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation whose disease has progressed after previous treatment.

According to a decree published in France’s Official Journal on August 4, 2022, Novartis’ Gilenya (fingolimod) is approved for use by hospitals in France and will be covered by health insurance for (RRMS) in children 10 years of age and older.

The Danish Medicines Council has made six new recommendations at its latest meeting on Nucala (mepolizumab), Skyrizi (risankizumab), Besremi (ropeginterferon alfa-2b), Revestive (teduglutide), Nexviadyme (avalglucosidase alfa) and Aspaveli (pegcetacoplan).

The General Health Insurance Company of the Czech Republic has come to a joint conclusion with the Working Group for Cystic Fibrosis that Kaftrio (elexacaftor/tezacaftor/ivacaftor) should be reimbursed for children six and up.

The Italian Medicines Agency (AIFA) has announced that Sanofi and Regeneron’s Libtayo (cemiplimab) will be reimbursed for first-line treatment of some adult patients with non-small cell lung cancer (NSCLC), with PD-L1 expression (in ≥50% of tumor cells), without EGFR, ALK or ROS1 aberrations, and adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) whose disease has progressed or who are intolerant to a Hedgehog pathway inhibitor (HHI).

Drug Approval

The European Commission (EC) has approved Novartis’ Scemblix (asciminib) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), announced the company.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lupin’s Lutio (tiotropium bromide inhalation powder), a generic version of Spiriva, for the treatment of chronic obstructive pulmonary disease (COPD).

The National Medical Products Administration (NMPA) of China has approved Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for the treatment of adults with heart failure with preserved ejection fraction (HFpEF).

China’s NMPA has approved Soliris (eculizumab) for PNH and aHUS, marking the arrival of AstraZeneca’s (AZ) first rare disease drug in China.

MSD’s 9-valent human papillomavirus vaccine – known as Gardasil 9 – was approved by the NMPA for women aged 9 to 45 years.

Other

Austria is currently facing a shortage of approximately 350 drugs, which are either totally unavailable or only partially available.

Spanish and Italian health authorities have approved the dose-sparing technique for Bavarian Nordic’s monkeypox vaccine, Imvanex, due to the limited supply of the drug.

Brazil’s National Health Surveillance Agency (ANVISA) has authorized the import and use of Bavarian Nordic’s Jynneos and tecovirimat – branded as Tpoxx by SIGA – for use against monkeypox.

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