PRICENTRIC BRIEF:
- CONSIP’s dynamic purchasing system (SDAPA) has secured access to a portfolio of all the available COVID-19 antivirals currently authorized in Italy. Following the procurement agency’s successful negotiations, Gilead’s Veklury (remdesivir), Pfizer’s Paxlovid (nirmatrelvir + ritonavir) and MSD’s Lagevrio (molnupiravir) will now be available via the “dynamic” purchasing platform. Since it was first established in 2011, SDAPA has allowed the administration of the NHS to call tenders for the procurement of pharmaceutical products for a total value of over EUR 34 billion, of which EUR 8 billion was achieved in 2021 alone.
- An official regulation giving the European Medicines Agency (EMA) more power in a crisis situation is now in force, as of March 1, 2022. The regulation was published in the Official Journal of the European Union approximately one month ago, cementing the legislation after weeks of preparation. At the end of January, Members of the European Parliament (MEPs) voted 655 to 31, with eight abstentions, in favour of broadening and reinforcing the EMA’s powers.
- A group of lawmakers, including 12 Democrats and Senators Bernie Sanders and Elizabeth Warren, have signed a letter to Stephen Ubl, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), requesting information on the source of “troubling” drug price increases. The interaction comes at the same time as a new PhRMA report. The organization finds that almost 9 of 10 Americans (86%) agree that Congress should crack down on abusive health insurance practices that make it harder for people to get the care they need. The study also found that 43% of people who take prescription medications have (themselves or their families) faced at least one insurance barrier to their care in the past year. More than two in five (43%) Americans report that they had difficulty understanding or navigating their health insurance. Another one in three (31%) avoid going to the doctor because of the cost, and 21% say that they can’t afford to go to the doctor if they need care.
THE DETAILS
COVID-19
CONSIP’s dynamic purchasing system (SDAPA) has secured access to a portfolio of all the available COVID-19 antivirals currently authorized in Italy. Following the procurement agency’s successful negotiations, Gilead’s Veklury (remdesivir), Pfizer’s Paxlovid (nirmatrelvir+ritonavir) and MSD’s Lagevrio (molnupiravir) will now be available via the “dynamic” purchasing platform. Since it was first established in 2011, SDAPA has allowed the administration of the NHS to call tenders for the procurement of pharmaceutical products for a total value of over EUR 34 billion, of which EUR 8 billion was achieved in 2021 alone.
Following an initial assessment, the Committee for Medicinal Products for Human Use (CHMP) has issued Valneva questions regarding the company’s COVID-19 vaccine candidate, VLA2001. In response to CHMP, Valneva stated that it is confident that it will be able to respond to the questions in the coming days. Once answers are submitted, the European Medicines Agency (EMA) will provide a timetable for anticipated conditional approval.
Bahrain’s National Health Regulatory Authority (NHRA) has approved the use of Valneva’s COVID-19 vaccine via an emergency use authorization.
Two companies, Arbutus Biopharma and Genevant Sciences, have alleged that Moderna used their technology in its messenger RNA (mRNA) COVID-19 vaccine after refusing to “engage meaningfully” in licensing negotiations. The two partner companies have filed a lawsuit against Moderna, claiming it infringed on six patents that they hold in regard to the delivery of mRNA. According to the 51-page lawsuit, Arbutus developed the lipid nanoparticles (LNP) that enclose mRNA, the patents related to which were licensed to Genevant Sciences, a joint venture between Arbutus and Roivant Sciences Ltd. However, Moderna has denied the allegations, stating that it will “vigorously defend itself against Genevant’s claims in Court.”
The World Health Organization (WHO) has updated its treatment guidelines to include a conditional recommendation for Merck’s investigational oral antiviral, Molnupiravir, to treat non-severe COVID-19 patients with the highest risk of hospitalization. The recommendation is based on new data from six randomized controlled trials involving 4,796 patients.
US President Joe Biden has announced that his administration has launched a new “test-to-treat” initiative for individuals who test positive for COVID-19. For those who test positive at a pharmacy, Biden said those individuals would be eligible to “receive antiviral pills on the spot, at no cost.” According to Biden, the US has ordered more antiviral pills than anyone in the world, adding that Pfizer will provide one million pills of Paxlovid (ritonavir) by the end of this month and more than double that next month.
POLICY
An official regulation giving the European Medicines Agency (EMA) more power in a crisis situation is now in force, as of March 1, 2022. The regulation was published in the Official Journal of the European Union approximately one month ago, cementing the legislation after weeks of preparation. At the end of January, Members of the European Parliament (MEPs) voted 655 to 31, with eight abstentions, in favour of broadening and reinforcing the EMA’s powers.
Medtronic, China Life Reinsurance and MediTrust Health have agreed to work together to explore commercial health insurance, urban customized commercial medical insurance and innovative payment solutions, as well as jointly improve access to innovative medical technology and help build a multi-level medical security system. Their collaborative effort entails active development of commercial health insurance projects to improve patients’ ability to pay, improve access to therapy through urban insurance projects and carry out payment-side innovation projects under various models. At the same time, the companies have announced the launch of an innovative insulin pump commercial health insurance project for Medtronic MiniMed that will benefit patients aged 22 years and under with type 1 diabetes (T1D) and those aged 40 years and above with type 2 diabetes (T2D).
The Spanish Agency for Medicines and Health Products (AEMPS) has suggested that the majority of issues in the pharmaceutical industry, such as research, development, production, financing and access, require a more “holistic” approach. Speaking at “Farmatalk-European Pharmaceutical Strategy: Challenges and opportunities,” Head of the Department of Medicines for Human Use César Hernández stressed that “we are facing the greatest crisis of access” that he has known in his career. However, he suggested that upcoming drug evaluation changes in Spain could have “important weight” in these areas, particularly regarding digital transformation and evaluation based on data from various sources.
Last November, the U.S. Food and Drug Administration (FDA) published “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products” to guide the industry on how clinical study data can be used to make regulatory decisions. At the same time, the organization opened the floor for comments, asking relevant stakeholders and the wider industry to provide feedback on the guidance before official implementation.
HTA
The National Institute for Health and Care Excellence (NICE) has recommended the use of Seagen’s Tukysa (tucatinib) for the treatment of certain patients with HER2-positive locally advanced or metastatic breast cancer after two or more anti-HER2 treatment regimens. The therapy, when used in combination with trastuzumab and capecitabine, has been backed by the HTA body in a final appraisal document (FAD), marking a U-turn from the organization’s initial ruling in October 2021 in which it turned down reimbursement, as the extent of the benefit was uncertain because of differences between the trials submitted. According to the final document, Seagen’s list price is £5,636.84 per pack of 84, 150mg film-coated tablets. NICE also states that the average cost of a course of combination treatment at list prices is £7,016.91 for the loading dose and £6,677.14 for the following cycles.
The High Health Authority (HAS) of France has authorized an early access scheme to Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) with platinum and fluoropyrimidine-based chemotherapy for patients with untreated HER2-negative advanced gastric, gastroesophageal junction or esophageal adenocarcinoma whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥ 5.
The Institute for Quality and Efficiency in Health Care (IQWiG) has determined that Gilead’s Trodelvy (sacituzumab govitecan) offers “major added benefit” in the indication of triple-negative breast cancer (TNBC), the highest possible rating the assessment body can give.
NICE has rejected Roche’s Gavreto (pralsetinib) for the treatment of RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had a RET inhibitor before. The draft appraisal consultation document states that the therapy is not a cost-effective use of resources for treating the indication despite being approved by the European Union in November 2021 and in Britain in January 2022 via the interim route implemented under Brexit. In addition, NICE decided that Gavreto cannot be approved via the Cancer Drugs Fund (CDF) due to issues with the economic model.
PRICING & REIMBURSEMENT
A group of lawmakers, including 12 Democrats and Senators Bernie Sanders and Elizabeth Warren, have signed a letter to Stephen Ubl, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), requesting information on the source of “troubling” drug price increases. The interaction comes at the same time as a new PhRMA report. The organization finds that almost 9 of 10 Americans (86%) agree that Congress should crack down on abusive health insurance practices that make it harder for people to get the care they need. The study also found that 43% of people who take prescription medications have (themselves or their families) faced at least one insurance barrier to their care in the past year. More than two in five (43%) Americans report that they had difficulty understanding or navigating their health insurance. Another one in three (31%) avoid going to the doctor because of the cost, and 21% say that they can’t afford to go to the doctor if they need care.
CANbridge Pharmaceuticals’ maralixibat – also dubbed CAN108 – has been approved for use in treating Alagille syndrome (ALGS) in the Boao Lecheng International Medical Tourism Pilot Zone, which benefits from a preferential “first-to-try” policy that allows for clinically urgently needed drugs not yet approved by the NMPA, such as maralixibat, to be imported for use in hospitals in the region. Maralixibat is currently under priority review in China following acceptance of the New Drug Application for the drug by the National Medical Products Administration (NMPA) at the end of January.
More and more Chinese provinces are joining forces for the centralized procurement of medicines and high-value medical consumables for public hospitals. As it stands, there are as many as 17 inter-provincial alliances across China. Guangdong recently led China’s largest alliance in the record-breaking procurement of 276 kinds of medicines in a single tender, and another notable alliance is the one led by Hubei province, which includes 19 provincial areas.
Clinuvel and the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) have come to an agreement on the pricing of Clinuvel’s orphan drug Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP). According to GKV, as Clinuvel sought to obtain reimbursement for Scenesse in Germany in 2016, an escalation to the German Court of Arbitration was required in 2017 for a legal opinion to be issued confirming the benefits of the first-in-class treatment and its fair clinical value. Then renewed negotiations were mandated between G-BA, GKV-SV and the company because of a fixed review period imposed in 2016 by the German Federal Joint Committee (G-BA).
The Netherlands’ National Health Care Institute has recommended to the Minister of Health, Welfare and Sport (VWS) that Saxenda (liraglutide) should be included in the basic package for patients who are “seriously” overweight, defined as people with a Body Mass Index (BMI) of 35 or higher who already participate in the combined lifestyle intervention (GLI).
DRUG APPROVAL
During its February 2022 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 13 medicines for approval, as well as nine indication extensions. Leading the meeting was Immunocore Ireland’s Kimmtrak (tebentafusp) for the treatment of uveal melanoma, which was designated as an orphan drug on February 19, 2021. Following the positive CHMP opinion, the Committee for Orphan Medicinal Products (COMP) will now assess whether the orphan designation should be maintained.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s Respiratory Syncytial Virus (RSV) vaccine candidate for the prevention of RSV in Infants from birth up to six months of age by active immunization of pregnant women.
The FDA has approved Janssen’s first cell therapy, Carvykti (ciltacabtagene autoleucel), for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The Japanese Ministry of Health, Labour and Welfare has approved the combination of Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib) for treating radically unresectable or metastatic renal cell carcinoma (RCC).
Health Canada has approved BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), making it the third indication for Brukinsa to be approved in Canada following mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM).
Singapore’s Health Sciences Authority (HSA) has granted regulatory approval to Antengene’s Xpovio (selinexor) in three indications, two in relapsed or refractory multiple myeloma (RRMM) and one in relapsed/refractory diffuse large B-cell lymphoma (RR DLBCL).
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