Global Pricing Insights – Last Week In Review – Nov 8 – 12, 2021

PRICENTRIC BRIEF:

  • The Oklahoma Supreme Court scrapped a 2019 ruling that said Johnson & Johnson owed the state $465 million for allegedly contributing to the opioid epidemic. The state’s highest court voted 5-1 to reject the state’s argument that Johnson & Johnson violated “public nuisance” laws by exaggerating the benefits of its opioid painkillers and understating the risks. The judges said the company could not be held “perpetually liable” for its products, especially considering the fact that the company has refrained from promoting its opioid products in the past few years and even sold one of its product lines in 2015
  • China’s sixth round of volume-based procurement (VBP), which is focused solely on insulins, will take place on November 26, 2021, according to the “National Drug Centralized Procurement Document (Insulin Special)” issued by the Joint Procurement Office. In September, the Shanghai Sunshine Medical Procurement All-In-One (SMPA) office announced that round six would cover 81 products (mealtime insulin, basal human insulin, premised human insulin, etc.) from both domestic companies, such as Tonghua Dongbao, Gan & Lee, and Jiangsu Wanbang; and major international drugmakers, including Novo Nordisk, Eli Lilly, and Sanofi. In total, there are six procurement groups and 11 bidding units, covering 25 specifications and 11 companies
  • The Federal Joint Committee (G-BA) has decided to restrict the prescription of Novartis’s Leqvio (inclisiran). The G-BA has approved the therapy for some adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in addition to dietary therapy; however, the assessment document states that G-BA finds it “justified to restrict the prescription of inclisiran,” as the “reimbursement amount will regularly be uneconomical”

THE DETAILS

COVID-19

Novavax announced that it has completed its rolling submission to the World Health Organization (WHO) seeking Emergency Use Listing (EUL) of its COVID-19 vaccine candidate, NVX-CoV2373.

Chief Medical Adviser Susan Hopkins, UK Health Security Agency, told the BBC on Sunday that the UK is likely to roll out MSD’s (Merck) Lagevrio (formerly known as molnupiravir) COVID-19 antiviral pill through a drug trial starting next month. The announcement follows the UK’s Department of Health and Social Care (DHSC) deal in October of this year, to secure 480,000 courses of MSD’s Lagevrio and 250,000 courses of Pfizer’s ritonavir antiviral treatments for COVID-19.

The U.S. government has agreed to pay approximately $1 billion for 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA). The federal government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022.

The European Commission has approved an agreement under which Valneva would supply up to 60 million doses of its COVID-19 vaccine candidate, VLA2001, over two years, with 27 million doses expected in 2022.

Under the European Commission Strategy on COVID-19 Therapeutics, the European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) has recommended authorizing two monoclonal antibody medicines for COVID-19, Roche’s Ronapreve (casirivimab/imdevimab) and Celltrion Healthcare’s Regkirona (regdanvimab).

POLICY

The Oklahoma Supreme Court scrapped a 2019 ruling that said Johnson & Johnson owed the state $465 million for allegedly contributing to the opioid epidemic. The state’s highest court voted 5-1 to reject the state’s argument that Johnson & Johnson violated “public nuisance” laws by exaggerating the benefits of its opioid painkillers and understating the risks. The judges said the company could not be held “perpetually liable” for its products, especially considering the fact that the company has refrained from promoting its opioid products in the past few years and even sold one of its product lines in 2015.

The Federal Joint Committee (G-BA) has published a new summary of the minimum quality assurance requirements for gene and cell therapies. The framework includes the generally applicable minimum requirements for treatment facilities, including certain spatial and medical equipment and a minimum number of cases.

A group of 19 Europe-based healthcare organizations have penned an open letter to the Commission’s Health Emergency Preparedness and Response Authority (HERA) initiative, calling for more transparency and accountability. In the open letter, the industry organizations urge HERA to prioritize the public interest, remain accountable to citizens and ensure equitable and affordable access to medical tools. In an accompanying statement, the 19 groups added: “The letter welcomes the creation of the EU HERA but proposes some recommendations to ensure that HERA will work for the public interest, focus R&D on public health needs/priorities, remain accountable to EU citizens, and ensure the EU as a global leader leveraging equitable and affordable access to medical tools.”

The U.S. Food and Drug Administration (FDA) published Acting Commissioner Janet Woodcock’s opening statement to the 2021 GRx+Biosims Conference outlining the agency’s progress and future goals for boosting access to biosimilars.

Italy has officially approved its new “Consolidated Law on Rare Diseases,” providing a framework for the regulation and research of rare disease therapies in Italy.

The Patented Medicine Prices Review Board (PMPRB) has published the seventh edition of its CompassRx report, a review of patented medicine prices, expenditures and public drug plan utilization in 2019/20.

PRICING & REIMBURSEMENT

China’s sixth round of volume-based procurement (VBP), which is focused solely on insulins, will take place on November 26, 2021, according to the “National Drug Centralized Procurement Document (Insulin Special)” issued by the Joint Procurement Office. In September, the Shanghai Sunshine Medical Procurement All-In-One (SMPA) office announced that round six would cover 81 products (mealtime insulin, basal human insulin, premised human insulin, etc.) from both domestic companies, such as Tonghua Dongbao, Gan & Lee, and Jiangsu Wanbang; and major international drugmakers, including Novo Nordisk, Eli Lilly, and Sanofi. In total, there are six procurement groups and 11 bidding units, covering 25 specifications and 11 companies.

The Federal Joint Committee (G-BA) has decided to restrict the prescription of Novartis’s Leqvio (inclisiran). The G-BA has approved the therapy for some adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in addition to dietary therapy; however, the assessment document states that G-BA finds it “justified to restrict the prescription of inclisiran,” as the “reimbursement amount will regularly be uneconomical.”

Argentina’s government announced it will roll back prescription drug prices to what they retailed for on November 1, 2021, and will freeze these prices until January 7, 2022.

Spain has secured reimbursement for Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) to be used on the National Health System (SNS).

DRUG APPROVAL

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Menarini’s SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML) and to MEI Pharma and Kyowa Kirin’s zandelisib for the treatment of follicular lymphoma (FL). It also granted ODDs to two separate cancer drug candidates: PureTech Health’s  LYT-200, for the treatment of pancreatic cancer, and Elevar Therapeutics’ rivoceranib for the treatment of hepatocellular carcinoma (HCC).

Health Canada has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).

Bayer announced the company has filed applications in the EU and Japan for a new therapeutic indication for aflibercept (solution for injection) in premature babies with treatment-requiring Retinopathy of Prematurity (ROP).

HTA

Due to the potential risk of thrombotic microangiopathy (TMA), France’s High Health Authority’s (HAS) Transparency Commission has called for a re-evaluation of Novartis’s Zolgensma (onasemnogene abeparvovec) in a year after data is collected from clinical studies and an authorized temporary use (ATU) scheme.

The HAS has also evaluated an extension of indication for Ipsen’s Cabometyx (cabozantinib) in combination with BMS’s Opdivo (nivolumab), granting a favorable opinion to the reimbursement of the drug as a treatment for patients with advanced renal cell carcinoma (aRCC) or with clear cell contingent.

The HAS is against the reimbursement of GSK’s Jemperli (dostarlimab) for the treatment of adult patients with recurrent or advanced endometrial cancer (EC) who have high microsatellite instability (MSI-H)/mismatch repair deficient (dMMR) progressing after or during platinum-based chemotherapy.

At its November 2021 meeting, the Scottish Medicines Consortium backed three medicines —AstraZeneca’s Tagrisso (osimertinib), Roche’s Tecentriq (atezolizumab) and MSD’s Keytruda (pembrolizumab) — for routine use by NHS Scotland. Both Tagrisso and Tecentriq were recommended for non-small cell lung cancer (NSCLC), while Keytruda was backed in relapsed or refractory (R/R) Hodgkin lymphoma in patients aged three years and over.

The National Institute for Health and Care Excellence (NICE) has published guidance stating that it is unable to make a recommendation on Nanobiotix’s NBTXR-3, as the company has not submitted the necessary data for the appraisal, meaning that it will not be launching the technology in the UK.

NICE has also recommended Kyowa Kirin’s Poteligeo (mogamulizumab) as a treatment option for Sézary syndrome in adults who have had at least one systemic treatment.

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