Global Pricing Insights – Last Week In Review – Nov 1 – 5, 2021

PRICENTRIC BRIEF:

  • Senator Chuck Schumer (D-NY) has announced that Democrats reached a deal regarding prescription drug pricing that would allow the government to negotiate prices for some drugs—according to a draft measure circulated by lobbyists and cited by U.S. media outlets, the Democrats’ plan would empower Medicare to negotiate the cost of 30 drugs by 2028, specifically only drugs that have been on the market for several years that have surpassed their market exclusivity periods
  • As put forth in “Catalyze Research & Development and Innovation in the Pharma-MedTech Sector in India,” India’s Department of Pharmaceuticals of the Ministry of Chemicals and Fertilizers is calling on India to pay greater attention to R&D in pharmaceuticals and medical devices to create an ecosystem of innovation—to achieve this goal, there should be a greater emphasis on R&D that encourages the domestic development of cutting-edge products and technologies, said the department—as such, the policy proposal is based on three focus areas: strengthening the regulatory framework, incentivizing investments, and creating a facilitatory ecosystem for innovation
  • The Italian Medicines Agency (AIFA) has published its pharmaceutical expenditure monitoring report for the first six months of 2021, detailing a total expenditure of EUR 9.8 billion, amounting to an overspend of approximately EUR 806 million

THE DETAILS

COVID-19

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved MSD’s molnupiravir, under the trade name of Lagevrio, to reduce the risk of hospitalization and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease.

The British Government has announced that it will donate 20 million more Oxford/AstraZeneca vaccine doses by the end of the year to countries in need, as part of the UK’s 100 million commitment. In addition, the UK will also donate all 20 million Janssen doses ordered by the government to the COVAX initiative.

Pfizer and BioNTech’s Comirnaty can be used to vaccinate children aged 5 to 11 years old against COVID-19 after the Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, M.D., M.P.H., endorsed the recommendation from the CDC’s Advisory Committee on Immunization Practices.

The U.S. government has purchased an additional 614,000 doses of Eli Lilly’s bamlanivimab and etesevimab at a total of $1.29 billion.

The European Medicines Agency (EMA) has ended its rolling review of Elli Lilly’s antibody-based treatments for COVID-19, bamlanivimab and etesevimab, following a withdrawal letter from Lilly.

POLICY

Senator Chuck Schumer (D-NY) has announced that Democrats reached a deal regarding prescription drug pricing that would allow the government to negotiate prices for some drugs. According to a draft measure circulated by lobbyists and cited by U.S. media outlets, the Democrats’ plan would empower Medicare to negotiate the cost of 30 drugs by 2028, specifically only drugs that have been on the market for several years that have surpassed their market exclusivity periods.

U.S. President Joe Biden has also unveiled the framework for the “Build Back Better” plan, a $1.75 trillion social spending bill that excludes any measures on lowering the cost of prescription drugs.

As put forth in “Catalyze Research & Development and Innovation in the Pharma-MedTech Sector in India,” India’s Department of Pharmaceuticals of the Ministry of Chemicals and Fertilizers is calling on India to pay greater attention to R&D in pharmaceuticals and medical devices to create an ecosystem of innovation. To achieve this goal, there should be a greater emphasis on R&D that encourages the domestic development of cutting-edge products and technologies, said the department. As such, the policy proposal is based on three focus areas: strengthening the regulatory framework, incentivizing investments, and creating a facilitatory ecosystem for innovation. India is accepting feedback on the proposal until November 6, 2021.

Belgium’s Constitutional Court has ruled against an appeal to the 2020 legal provision that exempts producers of low-cost drugs from the country’s “clawback” tax. The appeal, which was brought before the court by branded drug companies such as AstraZeneca, Pfizer, Janssen and Eli Lilly, called for the reversal of a legislation that means generic producers were not liable for Belgium’s clawback criteria.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced the launch of a pilot to support the repurposing of medicines. The initiative is a follow-up to the European Commission’s (EC) Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework, and it has been launched with the aim of supporting not-for-profit organizations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication.

Brazil and the United Kingdom are partnering to strengthen research into genomic medicine, specifically diagnosing and treating serious diseases such as cancer and rare diseases.

Scotland’s Digital Health and Care Strategy is to be updated and refreshed to offer the prospect of new “significant benefits” to the public and those who work in the health and care system.

Irish Minister for Health Stephen Donnelly has announced an additional €20 million in funding for cancer services in Budget 2022.

PRICING & REIMBURSEMENT

Next year, Malta’s 2022 budget will expand the list of free medicines for patients. In total, the health budget is €972 million, with €9.9 million specifically reserved for medicines.

Norway’s decision-making council for new methods (Nye Metoder) has announced that in the future, it will publish not only the outcome of a health assessment but also an overview showing how much time has been spent in the various phases leading up to the decision.

The Italian Medicines Agency (AIFA) has published its pharmaceutical expenditure monitoring report for the first six months of 2021, detailing a total expenditure of EUR 9.8 billion, amounting to an overspend of approximately EUR 806 million.

DRUG APPROVAL

Janssen of Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022, for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA).

UNION Therapeutics has received U.S. FDA Fast Track designation for orismilast, a treatment for moderate to severe atopic dermatitis (AD).

Health Canada has granted marketing authorization for Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) as a treatment for heart failure with reduced ejection fraction (HFrEF) as an adjunct to standard care of therapy in adults with an eGFR as low as 20 mL/min/1.73m2.

HTA

The Federal Joint Committee (G-BA) has assessed the additional benefit of Orchard’s Libmeldy (autologous CD34+ cells encoding the ARSA gene) for the treatment of metachromatic leukodystrophy (MLD) and Novartis’s Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA). The group announced “considerable additional benefit” for Libmeldy but added that it did not find any additional benefit in the Zolgensma assessment compared to the comparator therapy for any patient group on the basis of the available data.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Lupin’s Namuscla (mexiletine) as an option for treating symptoms of myotonia in adults with non-dystrophic myotonic disorders.

NICE has recommended Novartis’s Adakveo (crizanlizumab), making it the first sickle cell disease (SCD) treatment available on the NHS in two decades.

In its October meeting, Norway’s decision-making council for new methods (Nye Metoder) has recommended the use of Novartis’s Zolgensma (onasemnogene abeparvovec) for the treatment of spinal muscular atrophy (SMA).

At its 61st council meeting, the Danish Medicines Agency made four new recommendations and updated three recommendations.

The Finnish Medicines Agency (Fimea) has launched new therapeutic and financial assessments for Trodelvy (sacituzumab govitecan) and Rybrevant (amivantamab) after they were both granted positive opinions by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

NICE has recommended Eli Lilly’s Retsevmo (selpercatinib) for the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and or Lenvatinib.

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