On July 11, 2022 Sanofi reported the launch of its new investment fund, dubbed Impact, to support the distribution of 30 Sanofi medicines in 40 lower-income countries (Press release, EVERSANA, JUL 11, 2022, View Source [SID1234616582]). Launched under an entirely new brand, the fund will see standard of care medicines produced by Sanofi for disease areas such as diabetes, cardiovascular disease, tuberculosis, malaria and cancer, dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries . At the same time, the French pharma giant also announced the beginning of a fund, also under the brand of Impact, that will support startup companies and other innovators that can deliver "scalable solutions for sustainable healthcare in underserved regions," including business financing and technical assistance.
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The German Ministry of Health has published an updated draft version of the "Financial Stabilisation of the Statutory Health Insurance System" (GKV-Finanzstabilisierungsgesetz) bill. The current draft, which replaces the premature release in March that caused uproar across the pharma industry, became public at the beginning of this week but has not been made available on the Ministry’s website. The new draft has been slightly amended from its previous incarnation but still contains some of the "most problematic provisions," suggested Alexander Natz, General Secretary of EUCOPE in a statement emailed to EVERSANA. In Natz’s eyes, the new draft also contains "further measures which negatively affect the pharmaceutical industry."
With a newly released revised proposal, Democrats are hoping to finally unleash a dormant economic package this summer, at the earliest, to lower the prices of drugs for seniors. The revisions come after Senate Majority Leader Charles E. Schumer (D-New York) spent weeks speaking privately with Senator Joe Manchin (D-West Virginia) who had reservations about a past bill called the Build Back Better Act. Manchin resisted the $2 trillion Build Back Better Act over concerns that it would add too much federal debt and further drive inflation. The proposal aims to give the federal government the authority to negotiate prices of certain drugs covered by Medicare, limit drug costs for Medicare beneficiaries to $2,000 per annum and penalize companies that pad drug prices at a faster rate than inflation.
THE DETAILS
COVID-19
The European Medicines Agency (EMA) has stated that regulators worldwide have agreed on fundamental principles for adapting vaccines to tackle COVID-19 variants. According to EMA, International Coalition of Medicines Regulatory Authorities (ICMRA) members and the World Health Organization (WHO) agreed that authorized COVID-19 vaccines continue to offer protection against severe disease, hospitalization, and death and encouraged their use, where available, both as primary series and as booster doses.
Novavax is expecting to provide a COVID-19 vaccine targeting Omicron in Q4 2022 as it accelerates the development of shots to protect against the BA.4 and BA.5 subvariants. The company said it is already "well underway" in its variant program and will focus on Omicron BA.4/5, as recommended by the U.S. Food and Drug Administration’s (FDA) independent experts on the Vaccines and Related Biological Products Advisory Committee in their guidance on June 30.
The U.S. Food and Drug Administration has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to enable state-licensed pharmacists to prescribe the pill. "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19," said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research.
The Africa Centres for Disease Control and Prevention (CDC) announced it inked a memorandum of understanding with Pfizer for the supply of Paxlovid (nirmatrelvir and ritonavir), an antiviral pill for the treatment of COVID-19. The Memorandum of Understanding (MOU) will enable members of the African Union to access Paxlovid at cost, according to Ahmed Ogwell Ouma, acting director of the CDC.
POLICY
With a newly released revised proposal, Democrats are hoping to finally unleash a dormant economic package this summer, at the earliest, to lower the prices of drugs for seniors. The revisions come after Senate Majority Leader Charles E. Schumer (D-New York) spent weeks speaking privately with Senator Joe Manchin (D-West Virginia) who had reservations about a past bill called the Build Back Better Act. Manchin resisted the $2 trillion Build Back Better Act over concerns that it would add too much federal debt and further drive inflation. The proposal aims to give the federal government the authority to negotiate prices of certain drugs covered by Medicare, limit drug costs for Medicare beneficiaries to $2,000 per annum and penalize companies that pad drug prices at a faster rate than inflation.
The German Ministry of Health has published an updated draft version of the "Financial Stabilisation of the Statutory Health Insurance System" (GKV-Finanzstabilisierungsgesetz) bill. The current draft, which replaces the premature release in March that caused uproar across the pharma industry, became public at the beginning of this week but has not been made available on the Ministry’s website. The new draft has been slightly amended from its previous incarnation but still contains some of the "most problematic provisions," suggested Alexander Natz, General Secretary of EUCOPE in a statement emailed to EVERSANA. In Natz’ eyes, the new draft also contains "further measures which negatively affect the pharmaceutical industry."
Medicines for Europe has suggested a number of policy reforms to help strengthen European health systems’ use of off-patent medicines. Speaking at the Medicines for Europe annual conference, the group suggested that when revising the EU pharmaceutical legislation, the EU must encourage the use of generic, biosimilar and value-added medicines to increase patient access to medicines and ensure budgetary sustainability, among other initiatives.
The Netherlands’ House of Representatives has voted on seven motions submitted in response to a debate held on pharmaceuticals policy on June 9. The majority of the House voted in favor of a motion by the Den Haan faction, which calls on the cabinet to accelerate the authorization of medicines in the Netherlands.
HTA
EUnetHTA has issued a statement notifying that the public consultations for Applicability of Evidence; Validity of clinical studies and Guidance for JCA Submission Dossier Template are now open. The three deliverables, known as D4.5, D4.6 and D5.1 are now open until August 2, 2022 at midnight. In its release, EUnetHTA 21 specified that comments received from organizations outside EU/EEA countries are welcome but may not be considered by EUnetHTA 21 if the organization is not directly impacted by the regulation (HTAR). In addition, only one consolidated comment form per organization is accepted. If multiple are submitted, the first will be considered the intended submission.
The Italian Medicines Agency (AIFA) has confirmed Zolgensma’s (onasemnogene abeparvovec) requirement for therapeutic innovation following a re-evaluation after one year, for the treatment of spinal muscular atrophy (SMA) 5q in patients weighing up to 13.5 kg.
Economist Impact and Roche have released a report on the "Value of Real-World Evidence in Health Technology Assessment (HTA)," exploring the value that Real-World Evidence (RWE) can add for assessing relative treatment effects during the first HTA of innovative new medicines. The researchers also found that positive language was only used in two of the assessments – Evrysdi and Zolgensma – in one or more final HTA reports about the impact of RWE for decision making. More often than not, RWE was either not cited, considered but disregarded, or discussed "but in a neutral or ambiguous manner."
PRICING & REIMBURSEMENT
Sanofi has announced the launch of its new investment fund, dubbed Impact, to support the distribution of 30 Sanofi medicines in 40 lower-income countries. Launched under an entirely new brand, the fund will see standard of care medicines produced by Sanofi for disease areas such as diabetes, cardiovascular disease, tuberculosis, malaria and cancer, dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries. At the same time, the French pharma giant also announced the beginning of a fund, also under the brand of Impact, that will support startup companies and other innovators that can deliver "scalable solutions for sustainable healthcare in underserved regions," including business financing and technical assistance.
The High Health Authority (HAS) of France has published a favorable opinion for reimbursing Amgen’s Lumykras (sotorasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, whose disease has progressed after at least one line of prior systemic treatment.
France’s High Authority for Health (HAS) has published a favorable opinion for maintaining reimbursement of Kymriah (tisagenlecleucel) to treat diffuse large B-cell lymphoma (DLBCL).
The National Institute for Health and Care Excellence (NICE) has recommended Janssen’s Tremfya (guselkumab), either alone or with methotrexate, for the treatment of active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. The cost of a 100 mg prefilled disposable injection of Tremfya is £2,250.00, but Janssen has agreed to both a simple discount patient access scheme and a complex patient access scheme that make the therapy available to the NHS with a discount.
The Italian Medicines Agency (AIFA) has amended the Yescarta (axicabtagene ciloleucel) register to allow treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and refractory or relapsed primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy up to 75 years of age.
DRUG APPROVAL
The European Commission has approved Sanofi’s Nexviadyme (avalglucosidase alfa) for the treatment of both late-onset and infantile-onset Pompe disease. The enzyme replacement therapy (ERT) is now the first approved medicine for the rare, progressive, and debilitating muscle disorder since 2006 – since Myozyme (alglucosidase alfa) was greenlit.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Phanes’ PT886 for the treatment of pancreatic cancer.
Health Canada has approved Pfizer’s Cibinqo (abrocitinib) for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, announced the company.
The U.S. Food and Drug Administration (FDA) has accepted Eiasai and Biogen’s Biologics License Application (BLA) under the accelerated approval pathway for lecanemab, the companies’ Alzheimer’s candidate.
The U.S. Food and Drug Administration (FDA) has accepted Roche and Genentech’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
GlaxoSmithKline (GSK) has announced that Health Canada has accepted its New Drug Submission (NDS) for daprodustat for the potential treatment of patients with anemia of chronic kidney disease (CKD).