Global Pricing Insights – Last Week In Review – Oct 11 – 15, 2021

PRICENTRIC BRIEF

• The French Government has unveiled the social security financing bill (PLFSS) for 2022, containing plans regarding expenditure linked to COVID-19, a continuation of the Ségur de la santé and the forecast of a social deficit of more than EUR 21 billion; presented to the Council of Ministers on October 7, 2021, the PLFSS is once again heavily impacted by the ongoing effects of COVID
• Belgium, Ireland and the Netherlands have reached an agreement on the price of AveXis/Novartis’ Zolgensma (onasemnogene abeparvovec-xioi); the cross-border collaboration Health Technology Assessment (HTA) determined that the spinal muscular atrophy (SMA) gene therapy will be reimbursed for patients with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of Type 1, and to presymptomatic patients with up to three copies of the SMN2 gene
• The heads of 19 European HTA agencies have inaugurated the Heads of Agencies Group (HAG), a new HTA-focused collaborative network for high-level strategic exchange and discussion; HAG will focus on supporting the development of the basis for joint work on all HTA activities at the European Union (EU) level, guided by the Regulation on HTA

 THE DETAILS

 COVID-19

The World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) has recommended that immunocompromised people should receive an additional vaccine dose as part of an extended primary series to stave off breakthrough COVID-19 infections.

The European Medicines Agency (EMA) has discontinued its rolling review of CVnCoV, CureVac’s COVID-19 vaccine, after Curevac informed the Agency of its decision to withdraw from the approval process.

AstraZeneca has submitted a request to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.

Merck (MSD) and Ridgeback Biotherapeutics announced that Merck has submitted an EUA application to the U.S. FDA for molnupiravir for the treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

PRICING & REIMBURSEMENT

The French Pharmaceutical Companies Association (LEEM) has released its 2020 Economic Report, containing a snapshot of the key figures, highlights and policies from the French healthcare system over the past year. The report details increased investment in France by 1% in 2020, with more than EUR 9 billion invested in research and development and the wider industry.

Japan’s Central Social Insurance Medical Council (Chuikyo) has agreed to apply drug pricing rules for Takeda’s Alofisel (darvadstrocel) for complex perianal fistulas associated with Crohn’s disease.

The Polish Ministry of Health has proposed amendments to the general terms and conditions of drug financing under the country’s Emergency Access to Drug Technologies (RDTL) scheme. The changes stipulate that medical facilities should be able to settle the amounts due for December regarding RDTL drugs in the same month and not wait until January the following year.

DRUG APPROVAL

The U.S. FDA has approved Merck’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without Avastin (bevacizumab), for the first-line treatment of persistent, recurrent or metastatic cervical cancer. The approval covers patients whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. According to a release by the FDA, the approval also applies to Keytruda as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

The European Medicines Agency (EMA) has approved a new, shorter 90-minute Gazyvaro (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL).

Sanofi Canada announced that Health Canada has approved Sarclisa in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

POLICY

The French government has unveiled the social security financing bill (PLFSS) for 2022, containing plans regarding expenditure linked to COVID-19, a continuation of the Ségur de la santé and the forecast of a social deficit of more than EUR 21 billion. Presented to the Council of Ministers on October 7, 2021, the PLFSS is once again heavily impacted by the ongoing effects of COVID.

Ireland’s Finance Minister, Paschal Donohoe, has unveiled the country’s 2022 budget, including EUR 30 million for new medicines. The EUR 30 million allocation is intended to help to give patients access to innovation in pipelines, with potential access to 40 new, innovative medicines next year that could benefit up to 17,500 patients.

HTA

Belgium, Ireland and the Netherlands have reached an agreement on the price of AveXis/Novartis’ Zolgensma (onasemnogene abeparvovec-xioi). The cross-border collaboration Health Technology Assessment (HTA) determined that the spinal muscular atrophy (SMA) gene therapy will be reimbursed for patients with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of Type 1, and to presymptomatic patients with up to three copies of the SMN2 gene.

The National Institute for Health and Care Excellence (NICE) has turned down reimbursement of Janssen’s Ponvory (ponesimod) for the treatment of relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features in adults.

The heads of 19 European HTA agencies have inaugurated the Heads of Agencies Group (HAG), a new HTA-focused collaborative network for high-level strategic exchange and discussion. HAG will focus on supporting the development of the basis for joint work on all HTA activities at the European Union (EU) level, guided by the Regulation on HTA.

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