PRICENTRIC BRIEF:
- The High Health Authority (HAS) has announced an internal reorganization in order to support “structural changes accelerated by the COVID-19 crisis.” Following a reshuffle, the newly instated Department of Assessment and Access to Innovation (DEAI) will be responsible for the assessment of health technologies in addition to public health issues
- The Italian Medicines Agency (AIFA) has temporarily suspended the evaluation of new applications for coverage of drugs through its 5% Fund. According to AIFA, the fund, which is supported by a contribution from companies on promotional expenses, has seen resources decrease over the years and is officially no longer able to satisfy requests for new drugs
- The U.S. Institute for Clinical and Economic Review (ICER) has released its third report on unsupported price increases (UPI), calling out seven drugs in particular that were predominantly responsible for unnecessary price hikes in 2020. ICER ultimately found that seven products cost the U.S. health system an additional $1.67 billion without the existence of any additional clinical evidence to justify their price increases, and nearly $1.4 billion of the additional cost was attributed to Humira alone, making it by far the biggest contributor
THE DETAILS
COVID-19
The European Commission has officially authorized the use of Celltrion’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab) for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
The U.S. has signed contracts worth about $1B to secure Xevudy — formerly known as sotrovimab — the antibody-based COVID-19 treatment developed by GlaxoSmithKline (GSK) and U.S.-based Vir Biotechnology.
Pfizer announced it has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for the company’s COVID-19 oral antiviral treatment candidate, which is administered in combination with a low dose of the HIV medicine ritonavir. The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sublicenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.
Pending approval from the United States Food and Drug Administration (FDA), Pfizer has announced that it will supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, Paxlovid (PF-07321332, ritonavir), in an agreement with the U.S. government.
POLICY
The $1.2 trillion Infrastructure Investment and Jobs Act (H.R. 3684) was approved by the U.S. House of Representatives in a final vote of 228-206, and it is expected that U.S. President Joe Biden will sign it today, Monday. H.R 3684 is focused primarily on the U.S.’s physical infrastructure, planning major investments in roads, bridges and waterways, but it includes provisions on drug wastage for most drugs and biologics covered by Medicare Part B.
Spain’s President, Pedro Sánchez, has presented the Strategic Projects for Economic Recovery and Transformation (Perte) for Vanguard Health, which entails “a historic budgetary commitment for Spain.” Sánchez explains, “Between 2021 and 2023 we will invest more than EUR 1.469M. From this, more than EUR 982M will be invested in the public sector, and about EUR 487M will be invested in the private sector.”
HTA
Following an evaluation of new data and collection of real-world evidence (RWE), the National Institute for Health and Care Excellence (NICE) has turned down BioMarin’s Vimizin (elosulfase alfa) for the treatment of mucopolysaccharidosis type 4A (MPS 4A).
The High Health Authority (HAS) has announced an internal reorganization in order to support “structural changes accelerated by the COVID-19 crisis.” Following a reshuffle, the newly instated Department of Assessment and Access to Innovation (DEAI) will be responsible for the assessment of health technologies in addition to public health issues.
The National Institute for Health and Care Excellence (NICE) has approved Janssen’s Rekambys (rilpivirine injection) in combination with ViiV’s Vocabria (cabotegravir injection), the first long-acting injectable treatment for HIV-1 infection in adults.
PRICING & REIMBURSEMENT
The Italian Medicines Agency (AIFA) has temporarily suspended the evaluation of new applications for coverage of drugs through its 5% Fund. According to AIFA, the fund, which is supported by a contribution from companies on promotional expenses, has seen resources decrease over the years and is officially no longer able to satisfy requests for new drugs.
The U.S. Institute for Clinical and Economic Review (ICER) has released its third report on unsupported price increases (UPI), calling out seven drugs in particular that were predominantly responsible for unnecessary price hikes in 2020. ICER ultimately found that seven products cost the U.S. health system an additional $1.67 billion without the existence of any additional clinical evidence to justify their price increases, and nearly $1.4 billion of the additional cost was attributed to Humira alone, making it by far the biggest contributor.
Earlier this month, Lebanese Health Minister Firass Abiad announced a plan to gradually lift subsidies on certain types of medication, including those used to treat cardiovascular issues, high cholesterol and high blood pressure, a move which would cause drug prices to increase by as much as five or six times their original price. The Ministry officially issued a new price list on the afternoon of November 15, which was put into place the following day. Medical subsidies have now been reduced from $120 million per month to about $35 million, according to Assem Araji, head of the parliament’s health committee.
DRUG APPROVAL
An advisory panel for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voted against the approval of Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s disease.
The European Commission has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three additional eosinophil-driven diseases.
During its July meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval, as well as six indication extensions.
CONFERENCES
During the virtual ISPOR EMEA Health Policy Update Meeting, a few experts shared insights related to updates and revisions in drug assessment and reimbursement processes in their respective countries, including the Czech Republic, Hungary and Egypt. Read about it here.
Speaking at the VWV PING conference 2021, Alex Mclaughlin, Head of Strategy at the Office for Life Sciences, elaborated on the organization’s hopes for the UK’s Life Science Vision. The Life Science Vision 10-year strategy, which was initially announced in July this year, foresees the sector building on the successful response to the COVID-19 pandemic, with £1 billion in funding available to the UK’s most promising life sciences companies to approach solving major healthcare problems, including cancer and dementia.
Speaking at the VWV PING conference 2021, Claire Foreman, Director of Medicines Policy & Strategy at NHS England, spoke on the implementation of new pathways in the MHRA to help the regulatory body become a “world leader” in its field. Foreman highlighted the advent of the Innovative Medicines Fund, noting how the pandemic ultimately lengthened the time the Fund will take to take full effect, as the organization recognized that the NHS had a focus in other areas.
Learn more about Pricentric ONE and our Global Pricing Solutions!
Contact us with your questions and global pricing needs, and an expert will follow up shortly.