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DATA COMPILATION #PharmaFlow

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America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data
Nearly every year, drugmakers ring in the new year with drug price increases in the US. This year too, prices of over 450 prescription medicines increased by an average of around 5 percent at the start of January. This, when high drug prices have been one of the biggest political issues in the US over the last few years. PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed. View US Medicare Part D 2019 Drug Spending (Free Excel Available) Rising healthcare, drug spends in US Over the last several years, we have repeatedly heard political leaders in the US complain about high drug prices. Yet, drug prices and healthcare spends have risen unabated. America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8 trillion, accounting for 17.7 percent of the gross domestic product (GDP). During the year, prescription drug spend increased by 5.7 percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7 percent to US$ 799.4 billion. President Joe Biden recently stressed on the need to cap the prices of essential drugs, and said that the average American pays the highest prices for prescription drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.  Pharma companies, on the other hand, have vehemently argued against any price cuts in the US, saying price cuts would hinder drug research and development for all diseases. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Patented drugs account for 80.3 percent of total Part D spend Medicare is the US federal government’s program that provides health insurance to most people who are 65 years or older. Medicare’s Part D plan provides outpatient drug coverage through private insurance companies that have contracts with the federal government. Eligible people have to choose and enroll in a private prescription drug plan for Part D coverage. Medicare Part B, on the other hand, covers a wide variety of medically necessary outpatient services and some preventative services. Prescription drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent of the total spend for the year. Generic drugs made up for the remaining 19.7 percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8 billion were sold under Part D, accounting for 21 percent of the total spend under the program. View US Medicare Part D 2019 Drug Spending (Free Excel Available)   Eliquis ranks highest on Medicare’s brand drug spend Under Part D, endocrinology and oncology were the two therapeutic areas that generated maximum revenue for pharma companies, driving home sales of over US$ 31.8 billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of around US$ 22.9 billion. Among branded drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018. Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each under the program. Amongst generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the overall dosage units sold also jumped higher by 2.25 billion units to 111.35 billion.  The sales ranking of Part D does bare some similarities with the global ranking of highest selling drugs. In 2020, Humira had retained its position as the highest selling drug in the world, generating sales of US$ 20.4 billion. Both Eliquis and Revlimid had retained their ranking as the third and fourth most selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global sales in 2020. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Medicare’s inability to negotiate prices costs American taxpayers billions of dollars Over the years, drug companies have used Medicare’s inability to negotiate prices under Part D to increase the prices of their drugs significantly and rip off huge profits, a three-year-long US House Oversight Committee investigation has revealed. US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between 2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.   Elsewhere in the world, the same drugmakers are bending over backwards to get into medical insurance programs. For instance, China reported that several international pharma firms, many of them headquartered in the US, slashed the prices of their drugs by up to 94 percent to get into the country’s national medical insurance coverage. In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022 if an expensive Alzheimer’s drug, Aduhelm, is included in the list. In order to ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights. View US Medicare Part D 2019 Drug Spending (Free Excel Available)  Our view President Biden's Build Back Better legislation, which the House passed last month, is up for vote in the Senate. The legislation contains provisions that would allow Medicare to negotiate the prices of some expensive drugs, penalize drugmakers who raise prices faster than inflation and cap out-of-pocket costs for insulin at US$ 35 per month. However, chances of the bill being passed in its present form are slim. Even if the Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025. The number would increase over the years, reaching 100 in six years, and hence forth grow by 20 drugs a year. It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.  View US Medicare Part D 2019 Drug Spending (Free Excel Available)    

Impressions: 2691

https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data

#PharmaFlow by PHARMACOMPASS
06 Jan 2022

STOCK RECAP #PipelineProspector

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Pipeline Prospector Nov 2023: Lilly, Novo post sharp rise in Q3 sales; AbbVie buys ImmunoGen for US$ 10.1 billion
Through much of 2023, markets remained volatile, with pharma indices managing to inch up only in some months. November bucked the trend — the Nasdaq Biotechnology Index (NBI) rose by 4 percent at 3,902.97 after an 8 percent drop in October. The SPDR S&P Biotech ETF index (XBI) spiked 12 percent to 75.52, compared to a drop of 12 percent in October. And the S&P Biotechnology Select Industry Index (SPSIBI) gained 12 percent to 5,882.09 after plunging 9 percent in October.The indices mirrored the bullish activity witnessed in the US stock markets, with the S&P 500 rebounding 8.92 percent in November. Importantly, healthcare stocks outperformed all 11 major sectors of the S&P 500.The month witnessed another significant deal in the antibody-drug conjugates (ADCs) space after Pfizer acquired Seagen in March for US$ 43 billion. As November drew to a close, AbbVie picked up ImmunoGen for US$ 10.1 billion, including its first-in-class ADC, Elahere, approved for platinum-resistant ovarian cancer (wherein patients relapse within six months of receiving platinum-based chemotherapy). ADCs are fast-growing, innovative biopharmaceutical products that target cancer cells, while protecting the healthy cells.In other big news, the United Kingdom became the first country to grant regulatory approval to a medical treatment involving the revolutionary CRISPR gene editing tool. And the month also saw several drugmakers announce their third quarter (Q3) results.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) Astra joins obesity med jamboree with Eccogene deal; Lilly, Novo ride GLP-1 waveNovember was a good month for Eli Lilly (stock up by 7 percent) as both the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved its weight-loss injection Zepbound (tirzepatide). Moreover, the drugmaker’s Q3 revenue increased by an impressive 37 percent, driven by the growth of its GLP-1 diabetes treatment Mounjaro (tirzepatide) and breast cancer drug Verzenio (abemaciclib).The other drugmaker that rode on the popularity of GLP-1 meds is Novo Nordisk (up by 4 percent). The Danish drugmaker posted a rise in sales of 29 percent in the first nine months of 2023. Its diabetes and obesity care meds saw a gain of 36 percent, bringing in DKK 153.8 billion (US$ 20.6 billion) for Novo in the first nine months of 2023. Out of this, the GLP-1 meds (Saxenda, Ozempic, Rybelsus, Wegovy) contributed DKK 30.4 billion (or US$ 4.1 billion). The company also plans to expand its manufacturing capacities with an investment of over DKK 42 billion (US$ 6 billion) in Kalundborg (Denmark), and an additional investment of DKK 16 billion (US$ 2.3 billion) at its Chartres (France) facility to capitalize on the burgeoning market for weight loss drugs. Its weight loss med Wegovy has also shown heart protection benefits in a phase 3 trial.Not wanting to miss out on the bourgeoning market for weight loss drugs (estimated to reach an annual market size of US$ 100 billion by 2030), AstraZeneca (up by 2 percent) has entered into an exclusive license agreement worth US$ 2 billion with Chinese biopharma Eccogene for its investigational treatment ECC5004 for obesity, type-2 diabetes, and other cardio-metabolic conditions. The company has reported a 5 percent rise in its Q3 revenues (at US$ 11 billion), fueled by good performances in oncology, cardiovascular renal management, and rare diseases.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)  GSK’s RSV jab nears US$ 1 bn in sales; Novartis, Sanofi post positive trial updatesLaunched in early May 2023, GSK’s (stock up by 3 percent) RSV vaccine, Arexvy, has made an impressive debut. GSK’s Q3 results show that its total sales increased by 10 percent, fueled by a 33 percent surge in vaccine sales. This includes £0.8 billion (US$ 0.97 billion) from sales of its shingles vaccine (Shingrix) and £0.7 billion (US$ 0.85 billion) from sales of Arexvy.  In its first year of launch, Arexvy sales are poised to cross £1 billion (US$ 1.26 billion).In crucial phase 3 trials, Novartis’ (up by 4 percent) highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib showed clinically significant results in treating chronic spontaneous urticaria (CSU). Currently, H1-antihistamines are the only recourse for people plagued by chronic hives.Sanofi (up by 2 percent) also made trial gains as its blockbuster drug Dupixent (dupilumab) showed “overwhelming positive efficacy” in a second, large phase 3 trial undertaken to test it as a cure for chronic obstructive pulmonary disease (COPD). Sanofi now plans to seek FDA approval to expand its use for COPD. If approved, Dupixent will be the first biologic to treat the disease.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)  UK okays CRISPR therapy for thalassemia, Madrigal’s NASH drug posts trial gainsIn a world first, the UK’s MHRA has given the go-ahead for CRISPR Therapeutics (up by 61 percent) and Vertex Pharmaceuticals’ (down by 4 percent) gene therapy Casgevy for patients aged 12 and above to cure the genetic conditions — β-thalassemia and sickle-cell disease (SCD). This renders it the first treatment ever that uses the gene-editing tool CRISPR, whose inventors won the 2020 Nobel Prize.Large-cap Alnylam (up by 8 percent) achieved robust Q3 commercial results, reporting US$ 313 million in revenue, driven by the successful launch of Amvuttra, a rare heart disease drug.Mid-cap Madrigal (up by 53 percent) announced positive data from a late-stage trial demonstrating broad treatment effects of resmetirom on nonalcoholic steatohepatitis (NASH) with liver fibrosis. It is the only investigational therapy for NASH that has achieved both fibrosis improvement and NASH resolution primary endpoints in a phase 3 trial. Among small-cap companies, FDA approved SpringWorks Therapeutics’ (up by 42 percent) Ogsiveo (nirogacestat) for adults suffering from rare desmoid tumors, rendering it the first approved treatment for the non-cancerous condition.Among losers, Bayer (down by 22 percent) scrapped a significant late-stage trial assessing the efficacy of a new anti-clotting drug, asundexian, compared to Eliquis (apixaban) in patients with atrial fibrillation at risk of a stroke.  The drugmaker had hoped asundexian would generate revenues in excess of €5 billion (US$ 5.5 billion) and compensate for the drop in revenues of its blood thinner Xarelto, set to lose protection from key European patents in 2026. Bayer also voluntarily recalled a single lot of its cancer drug Vitrakvi due to microbial contamination.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)  Our viewIn the US, the Federal Reserve left interest rates unchanged in its meeting in November. This has raised investor expectations, and hopes of inflation cooling down this winter.However, given the rise in bankruptcy filings, layoffs, weaker availability of finance to small and medium-sized businesses and larger concerns of a slowdown in the global economy, we would exercise caution before putting inflationary and other economic concerns to rest.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)  

Impressions: 2676

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-nov-2023-lilly-novo-post-sharp-rise-in-q3-sales-abbvie-buys-immunogen-for-us-10-1-billion

#PharmaFlow by PHARMACOMPASS
07 Dec 2023

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217810

FDA
15 Oct 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213114

FDA
11 Oct 2024

https://www.towayakuhin.co.jp/english/assets/release240815.pdf

PRESS RELEASE
15 Aug 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208549

FDA
26 Jun 2024

https://www.globenewswire.com/news-release/2024/06/06/2894638/0/en/Anthos-Therapeutics-Announces-84-of-Eligible-Patients-Have-Transitioned-to-Abelacimab-in-the-AZALEA-TIMI-71-Extension-Study-of-Atrial-Fibrillation-Patients-at-a-Moderate-to-High-Ri.html

GLOBENEWSWIRE
06 Jun 2024

https://www.reuters.com/legal/jj-bristol-myers-lose-challenges-us-drug-price-negotiation-program-2024-04-29/

Brendan Pierson REUTERS
30 Apr 2024