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Global Pricing Insights – Last Week In Review – Feb 21 – 25, 2022

PRICENTRIC BRIEF:

  • Following a successful pilot starting in May 2019, the Netherlands’ National Health Care Institute (Zorginstituut/ZIN) is officially implementing a new parallel assessment procedure that has the potential to cut market access by up to three months. Typically, a drug must first pass quality, safety and efficacy assessment by the Medicines Evaluation Board (MEB) before ZIN can decide on its eligibility for inclusion in the Medicines Reimbursement System (GVS). However, when assessed under the new parallel pathway, a therapy can undergo concurrent drug registration review by the MEB and reimbursement review by ZIN simultaneously.
  • As financial pressures increase under Germany’s statutory health insurance system (GKV), Josef Hecken, impartial chairman of the Federal Joint Committee (G-BA), has revealed plans for “short-term cost-containment measures,” among a number of other measures in the G-BA’s work program for 2022.
  • Health Canada has become the first regulator to approve Medicago and GlaxoSmithKline’s (GSK) COVID-19 vaccine Covifenz (plant-based virus-like particles [VLP], recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 64 years. Canadian approval of Covifenz follows a review of scientific data submitted by Medicago as part of their rolling submission that began in April 2021 and has since concluded with the filing of a New Drug Submission.

THE DETAILS

COVID-19

Health Canada has become the first regulator to approve Medicago and GlaxoSmithKline’s (GSK) COVID-19 vaccine Covifenz (plant-based virus-like particles [VLP], recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 64 years. Canadian approval of Covifenz follows a review of scientific data submitted by Medicago as part of their rolling submission that began in April 2021 and has since concluded with the filing of a New Drug Submission.

The European Union (EU) has stood by its refusal to lift patent protections on COVID vaccines, despite the African Union (AU) countries seeking to include a patent waiver in the joint conclusions of the EU-AU summit. Internal documents seen by Agence France-Presse (AFP) show that the AU reiterates its support for the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver request and urges the EU to engage constructively toward the conclusion of a targeted and “time-limited waiver,” which is critical to a WTO response to the COVID-19 pandemic.

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended granting an extension of indication to Moderna’s COVID-19 vaccine Spikevax, to include use in children aged 6 to 11 within the European Union (EU).

Sanofi and GlaxoSmithKline (GSK) will seek regulatory authorization, including in the United States and Europe, for their COVID-19 vaccine with the availability of data from their booster and phase 3 efficacy trials.

POLICY

The Japanese Liberal Democratic Party’s (LDP) health committee has approved a draft bill amending the Pharmaceuticals and Medical Devices (PMD) Law, which as a key feature proposes the creation of a full emergency approval system. A number of COVID-19 vaccines, such as Pfizer’s Comirnaty, were approved under an existing fast-track system based on data from countries where the vaccines were approved and being rolled out. However, even under this system Japan waited longer for vaccines and therapies than a number of other countries, so based on learnings from the pandemic, Japan will now look to operating a full emergency use system, akin to the U.S.’s Emergency Use Authorization (EUA) pathway.

As financial pressures increase under Germany’s statutory health insurance system (GKV), Josef Hecken, impartial chairman of the Federal Joint Committee (G-BA), has revealed plans for “short-term cost-containment measures,” among a number of other measures in the G-BA’s work program for 2022.

The Quebec Court of Appeal has found the plan to introduce new economic factors and require the disclosure of confidential rebates under the Patented Medicine Prices Review Board (PMPRB) amendments to be invalid while supporting the reference basket shakeup – dubbed the PMPRB 11.

Norway’s decision-making council for new methods (Nye Metoder) has approved a new framework for the decision-making and financing of drugs outside their approved indication. The framework includes treatment with marketed medicines when the use takes place outside the approved preparation label – also known as “off-label” use – and treatment with medicines without a Norwegian marketing authorization, or “off-license” use.

The BeNeLuxA initiative has published a response to the European Commission’s pharmaceutical legislation review, suggesting that a more “holistic” approach to legislation is required.

The National Pharmaceutical Pricing Authority (NPPA) of India has decided to forgo plans to study drug pricing policies in other countries due to “administrative exigencies.” NPPA last month announced it would open a tender in March for bidders for an agency to conduct research on drug pricing policies in different countries and regions to gain insight into access to medicines at affordable prices.

HTA

The Federal Joint Committee (G-BA) has given “Unquantifiable Added Benefit” to Amicus’s orphan gene therapy Galafold (migalastat) for the treatment of Fabry disease in adolescents aged 12 years and older with amenable mutation. According to a release, Galafold is priced at EUR 18,768.85 for 14 hard capsules (123 mg), a 15% discount from its launch price, which would see the annual therapy cost of around EUR 245,000 for the target population of 1 to 20 patients.

The National Institute of Health and Care Excellence (NICE) has recommended Merck Sharp & Dohme’s (MSD) immuno-oncology blockbuster, Keytruda (pembrolizumab), as an option through the Cancer Drugs Fund (CDF) for treating relapsed or refractory classical Hodgkin lymphoma in people aged three and older. In an appraisal document, the organization confirmed that the list price of Keytruda is £2,630 for one 100-mg. vial; however, the company has a commercial arrangement, which makes Keytruda available at a discount.

NICE has also issued a final appraisal determination to the 20th cancer treatment to go through the Cancer Drugs Fund (CDF), recommending GlaxoSmithKline’s once-a-day capsule, Zejula (niraparib), for the treatment of some forms of ovarian, fallopian tube and peritoneal cancer.

Orchard Therapeutics has confirmed plans to submit Libmeldy (atidarsagene autotemcel) via the BeNeLuxA initiative, sparking ongoing consultations between the group and the company. The end of the joint health technology assessment (HTA) procedure is scheduled for June 2022, but the timeline does not take into account possible clock stops at different times during the procedure.

The Italian Medicines Agency (AIFA) has recognized Merck Sharp & Dohme’s (MSD) immuno-oncology blockbuster, Keytruda (pembrolizumab), as an innovative treatment for the first-line treatment of metastatic colorectal cancer (CRC) that is described as microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) in adults.

According to the Official Gazette, France has expanded reimbursement of Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Symkevi (ivacaftor/tezacaftor) for cystic fibrosis.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has released a health economic assessment of Orchard Therapeutics’ Libmeldy (autologous CD34+ cells encoding ARSA gene), the world’s most expensive drug for the treatment of children with metachromatic leukodystrophy (MLD). The assessment is part of a collaboration in health economic evaluations between three Nordic authorities in Finland, Norway and Sweden: Fimea, NoMA and TLV (FINOSE). FINOSE determined that the cost per quality-adjusted year of life (QALY) is estimated at SEK 3.2 million for the first scenario and SEK 3.1 million for the second scenario.

PRICING & REIMBURSEMENT

Following a successful pilot starting in May 2019, the Netherlands’ National Health Care Institute (Zorginstituut/ZIN) is officially implementing a new parallel assessment procedure that has the potential to cut market access by up to three months. Typically, a drug must first pass quality, safety and efficacy assessment by the Medicines Evaluation Board (MEB) before ZIN can decide on its eligibility for inclusion in the Medicines Reimbursement System (GVS). However, when assessed under the new parallel pathway, a therapy can undergo concurrent drug registration review by MEB and reimbursement review by ZIN simultaneously.

It was recently unveiled that collectively, companies still owe the Italian Medicines Agency (AIFA) EUR 734 million in payback for 2019 and 2020. However, in a report released last Thursday, the remaining figure has been revised to EUR 373 million due to companies paying their way.

DRUG APPROVAL

The National Medical Products Administration (NMPA) of China has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults and children aged 12 years and up and weighing more than 40 kg. with refractory, moderate-to-severe atopic dermatitis (AD) who have had an inadequate response to or are not suitable for treatment with other systemic therapies.

The European Commission has approved the use of Bayer’s Kerendia (finerenone) for the treatment of chronic kidney disease patients who have stage 3 and 4 with albuminuria when associated with type 2 diabetes.

Merck has announced that the European Commission (EC) has approved its once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy or platinum-based chemotherapy.

BeiGene announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Applications (MAAs) for Brukinsa (zanubrutinib) in chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

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