PRICENTRIC BRIEF:
- Japan’s health ministry has announced new National Health Insurance (NHI) prices for listed medicines, which will take effect on April 1. The list contains some substantial price decreases, such as a 15.8% slash for Takeda’s Takecab (vonoprazan) and up to 11.1% for injectable GLP-1 agents, but some therapies will be subject to cuts as severe as 76.8%A total of 23 active pharmaceutical ingredients (API), or 86 products, will see their prices changed by Japan’s special repricing rules in the FY2022 price revision in April. The 23 drugs will be subject to repricing rules, including market expansion repricing and “huge-seller” repricing, both of which were passed by the Central Social Insurance Medical Council (Chuikyo) on January 19, 2022.
- Speaking at a plenary session, Members of the European Parliament (MEP) have supported a call from the Parliament’s regional affairs committee urging for better access to advanced therapy medicinal products (ATMPs). In the resolution, the committee asks the Commission to ensure that the existing coordinating bodies “facilitate cross-border treatments based on ATMPs and ensure that patients across the EU enjoy equitable access to innovative therapies.” The Parliament’s resolution repeatedly stresses the importance of cross-border cooperation on health for all European regions and the need to find solutions for cross-border healthcare, in particular for border regions where citizens cross the border on a daily basis. The group ultimately calls on the Member States to “authorize access to these innovative treatments [in regard to ATMPs] abroad in an effective and timely manner and to accelerate the reimbursement process for patients.”
- The National Institute for Health and Care Excellence (NICE) has recommended against the use of Merck’s Keytruda (pembrolizumab) for the treatment of advanced triple-negative breast cancer. Despite NICE deeming Keytruda plus chemotherapy to be more effective than paclitaxel or nab-paclitaxel, the long-term benefit is “uncertain,” the organization explained. There was also no trial data directly comparing Keytruda plus chemotherapy with Tecentriq (atezolizumab) with chemotherapy, another targeted treatment that NICE already recommends. Ultimately, the group decided that the cost-effectiveness estimates for the Keytruda combination in this indication are higher than it normally considers an acceptable use of NHS resources, but it has requested more information from the company about the comparison between Keytruda plus chemotherapy with Tecentriq plus chemotherapy.
THE DETAILS
COVID-19
The Pharmaceutical Benefits Advisory Committee (PBAC) of Australia has recommended that Merck’s Lagevrio (molnupiravir) can be added to the Pharmaceutical Benefits Scheme (PBS) for use in treating patients with mild to moderate COVID-19 who are at risk of developing severe disease requiring hospitalization. In a statement, the PBAC said that the expedited consideration of the company’s submission to add Lagevrio to the PBS was in recognition of the urgent public health need related to the prevention, management or treatment of SARS-CoV-2 infections.
The U.S. Food and Drug Administration (FDA) has chosen not to issue an emergency use approval (EUA) for Ocugen’s Covaxin – the company’s COVID-19 vaccine – for use in individuals 2 to 18 years of age.
Moderna announced its global public health strategy, which involves a set of four initiatives related to the advancement of mRNA vaccines. One of the initiatives is the company’s goal to broaden its global public health portfolio to include 15 programs with vaccine candidates reaching clinical development in priority targets by 2025.
The Africa Centers for Disease Control and Prevention (CDC) has signed a Memorandum of Understanding (MoU) with Pfizer for supplies of Paxlovid, the company’s antiviral COVID-19 therapy. John Nkengasong, head of the Africa CDC, noted: “For the Pfizer situation, we have the MOU. The memorandum of understanding is with the legal office at the AU [African Union].” Speaking in an online briefing, he added, “Once that is cleared, we will formally make an announcement with Pfizer and provide details.”
China’s state-owned Meheco Corp will take over commercialization of Pfizer’s oral COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir) in China under a supply contract announced with the international drugmaker. Paxlovid bagged conditional approval from the National Medical Products Administration (NMPA) last month for the treatment of adults with mild to moderate COVID-19 who are at risk of disease progression, such as hospitalization. It’s the first foreign-developed drug for COVID-19 to be approved in China.
POLICY
Speaking at a plenary session, Members of the European Parliament (MEP) have supported a call from the Parliament’s regional affairs committee, urging for better access to advanced therapy medicinal products (ATMPs). In the resolution, the committee asks the Commission to ensure that the existing coordinating bodies “facilitate cross-border treatments based on ATMPs and ensure that patients across the EU enjoy equitable access to innovative therapies.” The Parliament’s resolution repeatedly stresses the importance of cross-border cooperation on health for all European regions and the need to find solutions for cross-border healthcare, in particular for border regions where citizens cross the border on a daily basis. The group ultimately calls on the Member States to “authorize access to these innovative treatments [in regard to ATMPs] abroad in an effective and timely manner and to accelerate the reimbursement process for patients.”
Medicines for Europe has called for economic and regulatory systemic reforms, such as on procurement, to be put in place and provisions to be made to access funds for the manufacturing of essential medicines post-COVID-19 to strengthen the European Union’s supply chain resilience.
In response to the Centers for Medicare & Medicaid Services’ (CMS) proposed rule for the Medicare Advantage (MA) program in 2023, the American Hospital Association (AHA) published a letter calling for MA plans to disregard prior authorization requirements during public health emergencies. “While many plans worked with providers to waive or relax onerous prior authorization requirements during the COVID-19 emergency, others did not or only did so during the initial stages, exacerbating capacity issues, delaying patient care and resulting in inappropriate denials,” stated the letter.
A 2022 omnibus spending bill the U.S. Congress released to the public this week would extend telehealth flexibilities until September 14, enabling Medicare coverage of video and some audio-only telehealth visits for Americans age 65 and older. The bill also pushes back the requirement that older mental health patients must have an in-person appointment six months after a virtual visit, and eligibility to provide telehealth services is extended to more specialists, including physical therapists, occupational therapists, audiologists and speech-language pathologists.
HTA
The National Institute for Health and Care Excellence (NICE) has recommended against the use of Merck’s Keytruda (pembrolizumab) for the treatment of advanced triple-negative breast cancer. Despite NICE deeming Keytruda plus chemotherapy to be more effective than paclitaxel or nab-paclitaxel, the long-term benefit is “uncertain,” the organization explained. There was also no trial data directly comparing Keytruda plus chemotherapy with Tecentriq (atezolizumab) with chemotherapy, another targeted treatment that NICE already recommends. Ultimately, the group decided that the cost-effectiveness estimates for the Keytruda combination in this indication are higher than it normally considers an acceptable use of NHS resources, but it has requested more information from the company about the comparison between Keytruda plus chemotherapy with Tecentriq plus chemotherapy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Innovative Licensing and Access Pathway (ILAP), adding information about a health technology assessment (HTA) access tool. The tool is intended to promote understanding of the market access approaches that can optimize the route to patient access by unpacking market access challenges and addressing these upfront through early engagement with system stakeholders, ultimately achieving timely patient access.
The Federal Joint Committee (G-BA) of Germany has published an evaluation of Pfizer’s Xeljanz (tofacitinib) for the treatment of juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (JPsA), determining that the therapy offers “no added benefit.”
Roche’s Evrysdi (risdiplam) has been rejected as “innovative” in Italy, following a comparison with both Novartis’ Zolgensma (onasemnogene abeparvovec) and Biogen’s Spinraza (nusinersen) in a health technology assessment.
PRICING & REIMBURSEMENT
Japan’s health ministry has announced new National Health Insurance (NHI) prices for listed medicines, which will take effect on April 1. The list contains some substantial price decreases, such as a 15.8% slash for Takeda’s Takecab (vonoprazan) and up to 11.1% for injectable GLP-1 agents, but some therapies will be subject to cuts as severe as 76.8% A total of 23 active pharmaceutical ingredients (API), or 86 products, will see their prices changed by Japan’s special repricing rules in the FY2022 price revision in April. The 23 drugs will be subject to repricing rules, including market expansion repricing and “huge-seller” repricing, both of which were passed by the Central Social Insurance Medical Council (Chuikyo) on January 19.
The Scottish Medicines Consortium (SMC) has published advice on seven new medicines, three of which were previously awarded Innovation Passports within the new Innovative Licensing and Access Pathway (ILAP). SMC chairman Mark MacGregor said: “Trodelvy, Lumykras and Lorviqua are the first medicines the SMC Committee has considered after the award of an Innovation Passport in the new ILAP process. We’re delighted that this exciting new collaboration with partners in MHRA, NICE and AWTTC is progressing well, and patients in Scotland can now access these three medicines. Leading the advice is Gilead’s Trodelvy, which the SMC accepted for use within NHSScotland for the treatment of some adult patients with triple-negative breast cancer (TNBC).
Amazon Pharmacy is partnering with five Blue Cross and Blue Shield insurers, giving enrollees access to its prescription drug discount card, announced Amazon Pharmacy Chief Medical Officer Dr. Nworah Ayogu at a ViVE panel. During checkout on Amazon Pharmacy, enrollees will be able to compare PBM and discount card prices, said Ayogu, and payments with the discount card will factor into out-of-pocket maximums and deductibles.
DRUG APPROVAL
The European Commission (EC) has granted marketing authorization for Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for the treatment of symptomatic chronic heart failure in adults.
Innovent has bagged National Medical Products Administration (NMPA) approval for two new indications of its biosimilar bevacizumab, branded as Dayoutong/Byvasda.
The Therapeutic Goods Administration (TGA) has approved Xpovio (selinexor) for the treatment of two indications: adult patients with multiple myeloma (MM) who have received at least one prior therapy and in combination with dexamethasone (Xd) for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory medicinal product (IMiD) and an anti-CD38 monoclonal antibody (mAb).
Ixaka announced that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to the company’s Chemically Encapsulated Lentiviral vector-powered CAR T-cell therapy. Ixaka’s approach, which powers the company’s lead TNP program for CD19 haematological malignancies, does not require ex vivo genetic modification, as do cell therapy products currently available on the market.
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