NAVLIN BRIEF
Pfizer has launched “An Accord for a Healthier World,” making all of its patented medicines, including COVID-19 treatment Paxlovid, available at a not-for-profit price to 45 of the world’s lower-income countries. The Accord also aims to establish faster access to Pfizer’s future pipeline medicines and vaccines. To further this commitment, Pfizer, with funding from the Bill & Melinda Gates Foundation, is advancing work on the development of vaccine candidates for the prevention of Group B Streptococcus (GBS), which is a leading cause of stillbirth and newborn mortality in low-income countries. Additionally, Pfizer said it is committed to providing 23 medicines and vaccines that treat infectious diseases, certain cancers, and rare and inflammatory diseases.
China’s National Medical Products Administration (NMPA) has opened a consultation on the draft “Drug Administration Law” and “Vaccine Administration Law” revisions, allowing the industry to have their say on the proposed revisions until June 9, 2022. Published on May 9, the comprehensive draft amendment outlines a number of measures related to pediatric and rare diseases, as well as market exclusivity and new drug approval applications. The draft document proposes up to seven years of market exclusivity for innovative orphan drugs, as well as the use of priority review and accelerated approval for pediatric drugs and up to 12 months of market exclusivity for novel therapies in this area.
Ahead of the recent general election, Medicines Australia set the scene for a major health reform by the next government by alerting hundreds of key stakeholders to get ready to engage in the Health Technology Assessment (HTA) Review, which is due to start in July, Announced in 2021 as part of Medicine Australia’s five-year Strategic Agreement with the Federal Government, the independent Review of Australia’s HTA system is the first of its kind in nearly 30 years. Medicines Australia CEO, Elizabeth de Somer, said, “this is the first step in ensuring the Review includes representation from across the Australian community and that all stakeholders – including patients and patient groups – have enough lead time to understand and participate in the process”.
THE DETAILS
COVID-19
Korean biotechnology company, Genencell, announced it inked an exclusive agreement with UAE-based Ordi Pharma to distribute ES16001, an oral treatment for COVID-19, in the Middle East and Turkey, reported local media. The duo will work together on the production, licensing, distribution and supply of the treatment which is derived from Dampalsu, a plant native to Korea. They aim to distribute 150,000 units of the treatment in Turkey by the middle of next year, as well as launch the drug in the Middle East, including in Saudi Arabia, Kuwait, Oman, Iraq and Iran.
Nigeria has received 4.4 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine from Spain, a government official announced. In a tweet, the CEO of the National Primary Health Care Development Agency (NPHCDA), Dr. Faisal Shuaib, said the donation would greatly support the goal of vaccinating 70% of the eligible population in Nigeria.
The Federal Office of Public Health (FOPH) and the Federal Commission on Vaccination (EKIF) have announced they are adapting the COVID-19 vaccination recommendation for people with a severely weakened immune system. According to a release, it is recommended that people with a severely weakened immune system receive a second booster vaccination with an mRNA vaccine.
The Italian Medicines Agency (aiFA) has expanded the criteria necessary to prescribe COVID-19 antivirals and monoclonal antibodies such as Veklury (remdesivir), Paxlovid (nirmatrelvir/ritonavir) and Legevrio (molnupiravir). The Scientific Technical Committee (CTS) recently chose to standardize the prescription criteria for the two groups of therapies, as they are used to treat the same patient groups – individuals with mild/moderate COVID-19 disease and high risk of developing severe disease. In Italy, the three drugs are available via a “dynamic” purchasing platform. The platform is typically used by Italy’s health service organization to negotiate contracts for supplies of drugs, and is self-described as “highly flexible.”
The Italian Medicines Agency (AIFA) has announced that it will “no longer be possible to reprocess with the Evusheld monoclonal antibody combination (AZD7442; tixagevimab-cilgavimab), for pre-exposure prophylaxis of SARS-CoV-2 infection,” following a change to the drug register. Additionally, the Agency is removing the clause relating to the request for the patient’s informed consent. The changes were announced after the publishing of the Official Gazette no.88, in which the Scientific Technical Committee (CTS) made the decision.
POLICY
China’s National Medical Products Administration (NMPA) has opened a consultation on the draft “Drug Administration Law” and “Vaccine Administration Law” revisions, allowing industry to have their say on the proposed revisions until June 9, 2022. Published on May 9, the comprehensive draft amendment outlines a number of measures related to pediatric and rare diseases, as well as market exclusivity and new drug approval applications. The draft document proposes up to seven years of market exclusivity for innovative orphan drugs, as well as the use of priority review and accelerated approval for pediatric drugs and up to 12 months of market exclusivity for novel therapies in this area. The amendments also stipulate that first-to-market generics could be entitled to a market exclusivity period of either the remaining patent term or 12 months, whichever is shorter. As per the amendments, relevant parties under the State Council will be able to “periodically assess and dynamically adjust” the EDL every three years maximum. Additionally, drugs that are newly approved and marketed and offer a significantly improved efficacy and “reasonable” price compared with those already listed, can be included in a “timely manner,” suggesting that they could be added to the EDL at any time and not have to wait for the planned revisions.
As of May 20, Japan has officially implemented its new Emergency Approval system under the amended Pharmaceuticals and Medical Devices (PMD) Law. The bill was cleared by the Upper House on May 16, paving the way for the pathway to be officially launched within days. According to a notification from the Ministry of Health, Labor and Welfare (MHLW), the pathway is most likely to be used in the event of infectious diseases, such as COVID-19. It was approved by a majority vote at the committee meeting and entails that among other measures, emergency approval would be granted to products with “presumed” efficacy while still requiring the “confirmation” of safety, i.e., the safety profile of products would be reviewed at the same level of thoroughness as for the normal approval process.
The European Medicines Agency (EMA) has published a final revised guideline on the evaluation of human medicines for treating bacterial infections. The revised document reflects the outcome of discussions between the EU, the United States and Japan, and now includes clarifications on recommended clinical development programs for antimicrobials intended to address an unmet need, as well as updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics.
U.S. Senators Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.) announced the introduction of legislation that would enable the Federal Trade Commission (FTC) to rein in certain practices by pharmacy benefit managers (PBMs) that inflate prescription drug costs. Specifically, the Pharmacy Benefit Manager Transparency Act of 2022 would crack down on deceptive pricing schemes; ban arbitrary clawbacks of funds paid to pharmacies; and force PBMs to inform the FTC on profits made by way of pharmacy fees and spread pricing. Included in the legislation are incentives backing fair PBM practices such as liability exceptions if they hand over full rebate amounts to payers or insurance plans; and disclosure of rebate and pricing information to federal agencies, payers, insurance plans and pharmacie
HTA
Ahead of the recent general election, Medicines Australia set the scene for a major health reform by the next government by alerting hundreds of key stakeholders to get ready to engage in the Health Technology Assessment (HTA) Review, which is due to start in July. Announced in 2021 as part of Medicine Australia’s five-year Strategic Agreement with the Federal Government, the independent Review of Australia’s HTA system is the first of its kind in nearly 30 years. Medicines Australia CEO, Elizabeth de Somer, said, “this is the first step in ensuring the Review includes representation from across the Australian community and that all stakeholders – including patients and patient groups – have enough lead time to understand and participate in the process.”
The Federal Joint Committee of Germany (G-BA) has said that Opdivo (nivolumab) offers a “hint of a considerable added benefit” for the treatment of adults with locally advanced or metastatic, untreatable, HER2-negative adenocarcinoma of the stomach, gastroesophageal junction, or esophagus with PD-L1-expressing tumors. The HTA body determined that OPDIVO offers an advantage in overall survival when used in combination with FOLFOX (5-fluorouracil + folinic acid + oxaliplatin) or XELOX (capecitabine + oxaliplatin). According to a release by the committee, the annual therapy cost per patient for OPDIVO in combination with FOLFOX or XELOX is EUR 76,217.74.
The Federal Joint Committee (G-BA) has published an assessment document stating that the added benefit of Verzenios (abemaciclib) in combination with fulvestrant is “not proven” for the treatment of breast cancer. As published in the G-BA’s final determination, Verzenios plus fulvestrant cost EUR 27,346.30 annually per patient.
The High Health Authority of France (HAS) has published a favorable opinion for reimbursing two new indications to Ferring’s Firmagon (degarelix). HAS stated that the indications include the treatment of high-risk or locally advanced localized hormone-dependent prostate cancer in combination with radiation therapy – and as neoadjuvant treatment with radiotherapy in patients with high-risk or locally advanced localized hormone-dependent prostate cancer. In a release, HAS concluded that the medical service rendered (SMR) by Firmagon in both indications is “Important” while the actual therapeutic benefit is “Absence V” in the management of high-risk or locally advanced localized hormone-dependent prostate cancer by neoadjuvant to radiotherapy or in combination with radiotherapy.
PRICING & REIMBURSEMENT
In its May meeting, Norway’s decision-making council for new methods (Nye Metoder) kicked off the meeting by recommending the use of Xevudy (sotrovimab) for the treatment of COVID-19, adding it to the already existing arsenal of Kineret (anakinra), RoActemra (tocilizumab), Olumiant (baricitinib), and Veklury (remdesivir). The board also recommended the use of OPDIVO (nivolumab) and Yervoy (ipilumumab) for the treatment of advanced malignant melanoma, regardless of treatment line, and Lorviqua (lorlatinib) was greenlighted to treat adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have not been previously treated with an ALK inhibitor. The group also rejected coverage of a few products, including Myalepta (metreleptin), which missed out on coverage as a replacement therapy to treat complications of leptin deficiency in patients with lipodystrophy (LD), and Xromi (hydroxycarbamide), as no price offer has been received from the company.
The Ministry of Health (SAM) of Lithuania announced that its plan to make changes in the pricing and reimbursement of medicines, which could potentially lead to patients saving money, has been approved by the government. Earlier this year, SAM proposed the introduction of the calculation of the basic price of all reimbursable medicines (not only those from one supplier) on the basis of the average lowest-priced EU countries. This measure is expected to generate savings of around EUR 16 million per year. According to SAM, the legal acts regulating the new procedure could come into force as early as January 1, 2023.
The Dutch Ministry of Health has proposed a modernization of the Medicines Reimbursement System (GVS). – in a letter to Parliament on April 19, the Minister of Health, Ernst Kuipers announced the amendment, which could potentially lead to savings of EUR 140 million. The Health Minister proposes a recalculation with one or more mitigating measures – the future pharmaceutical policy will be discussed by the House of Representatives on June 9.
The National Institute for Health and Care Excellence (NICE) has recommended UCB Pharma’s Evenity (romosozumab) as an option for treating severe osteoporosis in people after menopause at high risk of fracture. Evenity followed by alendronic acid was found to be more effective at reducing the risk of fracture than alendronic acid alone, while Evenity compared indirectly to other bisphosphates and other medicines suggests it is likely to be as effective at reducing fracture risk in postmenopausal people with osteoporosis; however, the extent of this benefit is uncertain due to differences between trial populations and indirect comparison. But the most likely cost-effectiveness ranges for Evenity followed by alendronic acid compared to alendronic acid are acceptable for NICE – UCB’s drug costs £427.75 for 2 pre-filled pens administered subcutaneously as a single monthly dose, although the company has a commercial arrangement in place that makes Evenity available to the NHS at a confidential discount.
The Italian Medicines Agency (AIFA) has announced that following the publication of the AIFA Determination in the Official Gazette no. 117, Venclyxto (venetoclax) is reimbursed on the national health system in combination with obinutuzumab for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) who are not candidates for first-line FCR-type immunochemotherapy.
At its 68th meeting, the Danish Medicines Council made two new recommendations on Novartis’ Piqray (alpelisib) and Astellas’ Xospata (gilteritinib). The Council stated that it does not recommend Piqray plus fulvestrant as a first-line treatment for patients with PIK3CA-mutated locally advanced or metastatic ER+/HER2 breast cancer. According to the Council, it is uncertain whether the combo is as effective in increasing patient survival as current treatment with CDK4/6 inhibitors in combination with fulvestrant – “at the same time, treatment may be associated with worse side effects,” added the Council
DRUG APPROVAL
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. Dupixent is the first drug in the U.S. specifically indicated for EoE.
The European Medicines Agency (EMA) is in support of granting orphan designation to Synlogic’s application for SYNB1618 in phenylketonuria (PKU), announced the company. Synlogic, which focuses on metabolic and immunological diseases, is developing SYNB1618 as “an oral non-systemically absorbed drug candidate” for the purpose of treating the inherited metabolic disease, PKU, according to a company press release.
The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab), an anti- PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence. The combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC.
Dermavant Sciences has announced that the U.S. Food and Drug Administration (FDA) has approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This approval makes Vtama cream the first and the only FDA-approved steroid-free topical medication in its class in 25 Years.
Elevation Oncology has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.
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