Global Pricing Insights – Last Week In Review – Jan 24 – 28, 2022

PRICENTRIC BRIEF:

  • The EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization for Pfizer’s oral antiviral medicine, Paxlovid, for adults who do not require supplemental oxygen but are at increased risk of COVID-19 becoming severe. Paxlovid, which contains both PF-07321332 and ritonavir, is the first oral antiviral to become recommended in the EU for the treatment of the disease. Following the recommendation, the European Commission will decide on a conditional marketing authorization for Paxlovid using an expedited process.
  • China’s seventh round of volume-based procurement (VBP) will include the purchase of 58 products covering 208 product specifications. Notable items on the procurement list for round seven include erlotinib (Tarceva), afatinib (Gilotrif), sunitinib (Sutent) and lenvatinib (Lenvima) from Roche, Boehringer Ingelheim, Pfizer and Eisai, respectively; and oseltamivir, omeprazole, metoprolol, zoledronic acid and palonosetron acid. This time, tendering rules will allow for one originator and three generic winners, or four generic winners when no originator is available to compete.
  • Speaking at the National Institute for Health and Care Excellence’s (NICE) most recent board meeting, Program Director Helen Knight suggested that NICE has a few “important areas” yet to address regarding its recent reforms announcement. At the meeting, the board members agreed to pass the amendments to NICE’s current work processes but noted that “more detailed consideration” may be needed before any work is actually done.

THE DETAILS

COVID-19

  • The EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization for Pfizer’s oral antiviral medicine, Paxlovid, for adults who do not require supplemental oxygen but are at increased risk of COVID-19 becoming severe. Paxlovid, which contains both PF-07321332 and ritonavir, is the first oral antiviral to become recommended in the EU for the treatment of the disease. Following the recommendation, the European Commission will decide on a conditional marketing authorization for Paxlovid using an expedited process.
  • GlaxoSmithKline has announced that its monoclonal antibody Xevudy (sotrovimab) is available in Germany via the Federal Ministry of Health’s (BMG) centralized access. The distribution of Xevudy in Germany will be systematically carried out via a network of commissioned pharmacies, and the same applies to the other COVID monoclonal antibodies in Germany. In April 2021, the BMG centrally procured bamlanivimab/etesevimab and REGN-COV (casirivimab/imdevimab).
  • The U.S. Food and Drug Administration (FDA) announced it has revised the authorizations for two COVID-19 treatments due to their limited effectiveness against the omicron variant. With the revisions, Eli Lilly’s bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) — both monoclonal antibody treatments — are not authorized to be administered to U.S. patients since omicron afflicts the vast majority. Meanwhile, the FDA highlighted other therapies that seem to be effective against omicron, including Pfizer’s Paxlovid, sotrovimab, Gilead’s Veklury (remdesivir), and Merck and Ridgeback’s Lagevrio (molnupiravir).
  • The RECOVERY Trial will begin investigating Lagevrio (molnupiravir) in 177 NHS hospital sites across the UK, comparing an 800 mg twice-daily dose for five days to the usual standard of hospital care in adult patients who are hospitalized because of COVID-19. So far, the study has brought to light three treatments for the pandemic: dexamethasone, tocilizumab, and Ronapreve, all of which have been adopted as treatments worldwide. For the sake of the trial, Lagevrio is being provided by the UK Department of Health and Social Care.

POLICY

  • Speaking at the National Institute for Health and Care Excellence’s (NICE) most recent board meeting, Program Director Helen Knight suggested that NICE has a few “important areas” yet to address regarding its recent reforms announcement. At the meeting, the board members agreed to pass the amendments to NICE’s current work processes but noted that “more detailed consideration” may be needed before any work is actually done.
  • Members of the European Parliament (MEPs) have voted 655 to 31, with 8 abstentions, in favor of broadening and reinforcing the European Medicines Agency’s (EMA) powers. According to a release by the Parliament, in the future, the EMA will be better equipped to “monitor and mitigate shortages of medicinal products and medical devices considered to be critical in order to address public health emergencies.” Under the initiative, the EMA would be instructed to improve its system of monitoring possible shortages of medicines and medical devices by creating new structures within the organization, such as task forces for medicines and panels of experts.
  • In response to the upcoming EU Pharmaceutical Legislation review, Medicines for Europe has called the reform a “major opportunity,” suggesting that the policies should focus on “a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.”
  • Due to an increased workload, the Norwegian Medicines Agency has announced it will start a project to streamline method assessments. For over two decades, the Agency has conducted methodological assessments of all medicines being considered for use in Norway and decided which drugs can be approved for reimbursement. According to the Agency, the number of methods has been steadily increasing; in 2021 it prepared 124 compared to 100 in 2017.

HTA

  • The Federal Joint Committee (G-BA) is set to begin a real-world data (RWD) collection drive for Novartis’s Zolgensma (onasemnogene abeparvovec) starting February 1. The RWD scheme will collect further evidence on the added benefit of the gene therapy, on top of existing clinical studies and data collection.
  • The National Institute for Health and Care Excellence (NICE) has rejected coverage of Astellas’s Evrenzo (roxadustat) for the treatment of symptomatic anemia associated with chronic kidney disease in adults, citing “inappropriate” data pooling.
  • The Federal Joint Committee (G-BA) has assessed the additional benefit for Amgen’s orphan drug, Blincyto (blinatumomab), as “significant” for a new indication in the treatment of pediatric patients with high-risk first-relapse B-precursor acute lymphoblastic leukemia (ALL).
  • The Danish Medicines Agency has rejected Diurnal’s orphan drug, Efmody (hydrocortisone), for the treatment of an inherited condition called congenital adrenal hyperplasia (CAH) in patients 12 years old and above.
  • The Scottish Medicines Consortium (SMC) has accepted Bial’s Ongentys (opicapone) for use within NHS Scotland as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) with end-of-dose motor fluctuations to treat adult patients with Parkinson’s disease who cannot be stabilized on those combinations.
  • REvalMed’s Coordination Group has published a Therapeutic Positioning Report (IPT) with economic evaluation for Kite Pharma’s Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed/refractory mantle cell lymphoma following two or more lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor.

PRICING & REIMBURSEMENT

  • China’s seventh round of volume-based procurement (VBP) will include the purchase of 58 products covering 208 product specifications. Notable items on the procurement list for round seven include erlotinib (Tarceva), afatinib (Gilotrif), sunitinib (Sutent) and lenvatinib (Lenvima) from Roche, Boehringer Ingelheim, Pfizer and Eisai, respectively; and oseltamivir, omeprazole, metoprolol, zoledronic acid and palonosetron acid. This time, tendering rules will allow for one originator and three generic winners, or four generic winners when no originator is available to compete.
  • The Mark Cuban Cost Plus Drug Pharmacy (MCCPDP) has officially launched, offering over 100 generic drugs at prices lower than those found in retail pharmacies because there is no middleman (dubbed “Pharmacy Benefits Managers” or “PBMs”). The “radically transparent” approach allows drugs to be bought without any extreme markups. The pharmaceutical wholesaler purchases drugs directly from manufacturers and sells them with a 15% markup to support operations and a minimal $3.00 “pharmacy labor” fee.
  • It was recently unveiled that collectively, companies still owe the Italian Medicines Agency (AIFA) EUR 850 million in payback for 2019 and 2020. However, in a report released on Tuesday, the remaining figure has been revised to EUR 734 million due to companies paying their way.
  • According to the pharmaceutical procurement service for the five regional authorities in Denmark (Amgros), expenditure on medicines in 2021 increased by DKK 108 million, a 1.2% rise compared to 2020.
  • Data from Spain’s Ministry of Health shows that prescriptions dispensed by Spain’s National Health Service (SNS) topped EUR 1 billion in 2021, a 4.44% increase compared to 2020. According to the data, the turnover amounted to more than EUR 11,747 million, up 6.05% compared to 2020, which also represents the highest annual growth since 2009, while the average expenditure per prescription has shown an increase of only 1.54%.
  • The President of the Association of Pharmaceutical Companies of Greece (SFEE), Mr. Olympios Papadimitriou, has raised his concerns about new drugs coming into Greece as he highlighted that “economic conditions in Greece are probably the worst in the European Union.”
  • Chile’s National Supply Center (CENABAST) announced it has become the largest state purchaser, having facilitated 12% of public acquisitions through 1,209 tenders and 340 suppliers.

DRUG APPROVAL

  • Under the UK’s Early Access to Medicines Scheme (EAMS), the Medicines and Healthcare products Regulatory Agency (MHRA) has given a positive opinion to Global Blood Therapeutics’ (GBT) Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in patients 12 years of age and older.
  • The U.S. Food and Drug Administration (FDA) has granted priority review to Genentech’s supplemental new drug application (sNDA) for the use of Evrysdi (risdiplam) in the treatment of pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA).
  • The MHRA has given a positive opinion to Novartis’s investigational treatment Scemblix (asciminib) as a third-line treatment option for adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) without T315I mutation under the UK EAMS.
  • Incyte has announced it is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).
  • Health Canada has approved Ipsen’s Sohonos (palovarotene capsules) to reduce the formation of heterotopic ossification (HO) in adults and children aged 8 years and above for females and 10 years and up for males with fibrodysplasia ossificans progressive (FOP).
  • Sino Biopharmaceutical’s biosimilar adalimumab, Taibowei – referencing AbbVie’s blockbuster immunosuppressant Humira (adalimumab) – was approved by China’s National Medical Products Administration (NMPA).

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