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Global Pricing Insights – Last Week In Review – August 15 – 19, 2022

NAVLIN BRIEF:

  • U.S. President Joe Biden has signed the Inflation Reduction Act of 2022. The bill empowers Medicare to negotiate drug prices, caps annual OOP spending at $2,000, caps monthly insulin spending at $35, allows rebates for spending above any thresholds, and addresses cost-sharing and OOP spending on vaccines under government-run health coverage programs. A gamechanger for drug pricing in the U.S., the act has been the source of disdain for the pharma industry, with PhRMA specifically warning the bill will hamper innovation.
  • The FDA has approved Zynteglo from bluebird bio, inc. for treating the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. At first, the FDA planned to decide on Zynteglo in June but pushed back its PDUFA date until August after receiving more clinical data from the company, at its own request. ICER backed the $2.1 million price tag for Zynteglo, to be paid through a five-year outcomes-based agreement for patients with sustained transfusion dependence, along with an 80% payback option for patients who fail to reach this milestone.
  • The National Institute for Health and Care Excellence (NICE) recently published its 2022 – 2023 business plan in which it outlines a number of “tangible” business priorities for the next couple of years. Specifically, the overarching four key goals of the plan – prevention, personalization, performance and “greener NHS” – will continue to contribute to the “priorities of the health system” such as innovative early diagnostics, personalized medicines and a sustainability framework.

THE DETAILS

COVID-19

“Without funding, there will be a lack of treatments,” according to the German Respiratory Society (DGP), as the high costs of providing new treatments are proving to be a challenge for hospitals. For example, with Gilead’s COVID-19 vaccine, Veklury (remdesivir), hospitals can only submit an application for a temporary reimbursement from the health insurance companies, under the new examination and treatment methods (NUB) system. However, Professor Torsten Bauer, President of the DGP, states that “processing can take years and there is no guarantee that the funds will be approved, the hospitals cannot work with this uncertainty. Quality and economy must be reconciled, especially in times of Corona.”

The Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Xevudy (sotrovimab) for the treatment of COVID-19 in adults and adolescents aged 12 years and over with a body weight of at least 40 kg who do not require oxygen supplementation and have an increased risk of severe disease progression from COVID-19. Overall, IQWiG decided that for the indication there is a hint of a considerable added benefit of Xevudy compared with the appropriate comparator therapy according to the doctor’s instructions.

Moderna announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorization for Spikevax Bivalent as a booster dose against COVID-19 in adults.

Following the updated advice from the Joint Committee on Vaccination and Immunization (JCVI) on Monday, the UK’s National Health Service (NHS) has now set out plans for the next phase of its COVID-19 vaccination program, which includes administering Moderna’s mRNA (Spikevax) bivalent vaccine to people aged 18 and older.

New Zealand’s Medsafe has granted expanded provisional approval for the Nuvaxovid COVID-19 vaccine as a first and/or second booster dose in adults, announced Novavax.

According to Indian media, the Chief Executive Officer (CEO) of India’s Serum Institute (SII) anticipates the launch of an Omicron-specific vaccine within the next six months.

POLICY

The Ministry of Heath, Labor and Welfare (MHLW) could be looking at holding the first meeting of its new drug pricing and distribution committee before the end of August. A source familiar with the matter has revealed that the first meeting could be held on August 31, and will be open to the public to attend. The potential date confirms earlier rumors from a senior Japanese health ministry official who suggested that the panel would be set up “by the end of this summer.”

Earlier this year, the Federal Joint Committee of Germany (G-BA) published a set of suggestions to increase efficiency and accelerate its procedures. Following a meeting on May 19, 2022, the G-BA decided to make various changes to the Rules of Procedure (GO) in order to accelerate its procedures. As of August 17, the amendments are now in effect.

For its Canada drug import program, Colorado has tapped AdiraMedica LLC to serve as the state’s foreign seller, Premier Pharmaceuticals, to import, distribute, and sell drugs in Colorado, and the Rocky Mountain Poison and Drug Safety to oversee risk reporting and consumer inquiries. While imports have now been authorized at the federal level, Colorado Gov. Polis preemptively signed SB19-005 to allow prescription drug imports from Canada and expanded the list of possible source countries by then signing SB21-123 last year, in preparation for the federal go-ahead.

HTA

The National Institute for Health and Care Excellence (NICE) recently published its 2022 – 2023 business plan in which it outlines a number of “tangible” business priorities for the next couple of years. Specifically, the overarching four key goals of the plan – prevention, personalization, performance and “greener NHS” – will continue to contribute to the “priorities of the health system” such as innovative early diagnostics, personalized medicines and a sustainability framework.

According to a report by The High Health Authority’s (HAS) Transparency Commission (TC), positive Amélioration du Service Médical Rendu (ASMR) ratings are becoming more frequent as the number of new drugs and indications being given an ASMR rating of I to IV for some or all indications (under the full assessment procedure) increased from 81 in 2017 to 128 in 2021.

The Federal Joint Committee (G-BA) has published a number of recommendations regarding some of Vertex’s cystic fibrosis portfolio; the German health technology assessment (HTA) body assessed Kaftrio (elexacaftor/tezacaftor/ivacaftor) and Kalydeco (ivacaftor) for a number of different subpopulations in the age group of 6 – 11 years old.

 PRICING & REIMBURSEMENT

 U.S. President Joe Biden has signed the Inflation Reduction Act of 2022. The bill empowers Medicare to negotiate drug prices, caps annual OOP spending at $2,000, caps monthly insulin spending at $35, allows rebates for spending above any thresholds, and addresses cost-sharing and OOP spending on vaccines under government-run health coverage programs. A gamechanger for drug pricing in the U.S., the act has been the source of disdain for the pharma industry, with PhRMA specifically warning the bill will hamper innovation.

The Italian Medicines Agency (AIFA) has announced that as of August 14, 2022, Aspaveli (pegcetacoplan) is covered on the country’s SSN reimbursement scheme for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who continue to have anemia despite treatment with a C5 inhibitor for at least three months.

The National Institute for Health and Care Excellence (NICE) has recommended Vifor Pharma’s Tavneos (avacopan) in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), two main forms of AAV. According to NICE’s Final Appraisal Document (FAD), Tavneos costs £5,547.95 per pack of 180×10 mg capsules. However, Vifor has a simple discount patient access scheme arrangement that makes the therapy available to the NHS with a discount.

DRUG APPROVAL

The FDA has approved Zynteglo from bluebird bio, inc. (capped?) for treating the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. At first, the FDA planned to decide on Zynteglo in June but pushed back its PDUFA date until August after receiving more clinical data from the company, at its own request. ICER backed the $2.1 million price tag for Zynteglo, to be paid through a five-year outcomes-based agreement for patients with sustained transfusion dependence, along with an 80% payback option for patients who fail to reach this milestone.

The Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China has approved IASO Biotherapeutics’ Investigational New Drug (IND) application for equecabtagene autoleucel (equ-cel) for the expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for Merck (MSD) and AstraZeneca’s supplemental New Drug Application (sNDA) for a Lynparza (olaparib) combination treatment in metastatic castration-resistant prostate cancer (mCRPC), announced the companies.

The European Commission has approved Vegzelma, Celltrion’s bevacizumab biosimilar referencing Roche’s Avastin (bevacizumab), for the treatment of metastatic breast cancer, non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (RCC), metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.

The European Commission has accepted Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar to Roche’s RoActemra (tocilizumab). Approval is expected to come in 2023.

Patient groups and industry representatives have expressed “disappointment” at the Department of Health and Social Care’s (DHSC) decision not to offer AstraZeneca’s Evusheld (tixagevimab/cilgavimab) in the UK, citing “currently insufficient data on the duration of protection offered” by the drug “in relation to the Omicron variant.”

AUM Biosciences has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for AUM601, an oral small molecule that inhibits pan-TKR (TKRA, TRKB, and TRKC), along with resistance mutations of TRKs.

Based on findings from a benchmarking study jointly conducted by pharmaceutical companies and Swissmedic, the Swissmedic approval for new active substances is shorter than that of the European Medicines Agency (EMA) for the first time. This time around, the report assessed applications processed through initiatives such as the Access Consortium, and Project Orbis and found that the share of Project Orbis and Access Consortium applications increased “significantly” from 7% to 26% and the share of temporary authorization procedures from 4% to 10%. As a result of these processes being used more frequently, Swissmedic had a quicker processing time on average than the EMA – 391 calendar days, compared to the EMA’s 401 –for orphan drugs, the average approval time was 394 days; 26% faster than the previous year.

The U.S. Food and Drug Administration (FDA) has approved Auvelity (dextromethorphan HBr -bupropion HCl) tablets for the treatment of major depressive disorder (MDD) in adults, announced the CNS-focused biopharmaceutical company, Axsome Therapeutics. Associated with significant efficacy at one week, compared to placebo, Auvelity is the first FDA-approved rapid-acting pill for MDD.

The Swiss Agency for Therapeutic Products (Swissmedic) has approved Kapruvia for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients, announced Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics. The first treatment to become available for this indication, Kapruvia was also recently approved by regulatory agencies in the U.S., EU, UK, and Canada.

M&A and Other

The United Nations Children’s Fund (UNICEF) announced a newly inked $170 million contract with GSK for the first ever supply of a malaria vaccine. Over the span of three years, GSK will supply 18 million doses of its vaccine through UNICEF, which is the world’s largest buyer of vaccines.

The small molecule company, Atomwise, announced a new collaboration with Sanofi for the discovery and research of up to five drug targets. Atomwise specializes in the use of artificial intelligence (AI) in structure-based drug design which is enabled by a proprietary library of more than 3 trillion synthesizable compounds. In the end, compounds discovered by the duo will be exclusive to Sanofi, and payments related to key research, development, and sales milestones could exceed $1 billion.

Merck (MSD) and the circular RNA (oRNA) therapy company, Orna Therapeutics, announced a new partnership in which they will discover, develop, and commercialize vaccines and therapeutics related to infectious disease and oncology. The duo will make use of Orna’s oRNA-LNP technology platform which converts linear RNAs into circular RNAs (oRNAs) which have shown greater stability in vivo and may produce greater quantities of therapeutic proteins.

The European Investment Bank (EIB) announced it is providing €22 million, or more than 100 million polish zlotys, in financing to the Polish pharmaceutical company, Ryvu Therapeutics. The funding, which is tailored for “high-growth innovative companies” will help Ryvu finance its small molecule oncology pipeline from discovery through clinical development with a particular focus on hematologic and solid tumors.

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