1、Drug pricing update: strategies and trends 2 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Executive Summary Global spending on medicines will continue to increase through 2024, but at a lower rate than the previous five years due to the impact of discounts, rebates and pate
2、nt expirations. Global spending on prescription drugs hasnt been expected to take a major downturn, but the IQVIA Institute for Human Data Science said the growth rate is likely to decelerate over the next five years due to factors such as discounting and rebates, generic/biosimilar erosion and pres
3、sures created by the continued high volume of new drugs reaching the market. In the Global Use of Medicine Spending and Usage Trends: Outlook to 2024 report issued on 17 March, the institute projects that global medicine spending will increase by 2%-5% from this year through 2024 on a net basis, lik
4、ely down from the annualized increase of 4.2% over the previous decade. Releasing this report in the midst of the COVID-19 outbreak, however, IQVIA had to couch its estimates to account for current volatility in health care and financial markets. (Also see “Coronavirus Update: Drug Launches Could Be
5、 Hit, New Twist In CureVac Controversy, Moderna Doses First Patient” - Scrip, 17 Mar, 2020.) The projections included in the report were made before the COVID-19 outbreak was termed a pandemic and do not explicitly factor in any impact. “The overall impact on medicine spending and use to date is tho
6、ught to be very small, though this may change depending on the length and severity of disruption to communities and health systems,” IQVIA said in a same-day statement. The institute has not seen any significant impact on medicine volume consumption domestically or globally, so far, but a longer dis
7、ruption to everyday life likely will impact both prescription refills and patient starts on new therapies, IQVIA said. “Health care services and facilities may be diverted from normal practice, resulting in a knock-on effect on medicine use. The impact will inevitably differ by country and region as
8、 well as by disease area,” the institute added. IQVIA also pointed out that previous major public health events, such as the H1N1 and SARS outbreaks, did not lead to major changes in the medicine consumption rates seen in the US or worldwide. To date, supply chain disruptions that could lead to medi
9、cation shortages have not yielded a measurable impact, it said. Some delays in new drug launches can be expected, however, due to factors including disruption in clinical trials, regulatory filings and reviews, and reduced dissemination of new information and data as medical meetings are postponed o
10、r cancelled. Pharma companies have also ended in-person promotions by their sales reps. (Also see “Bad For Pharma: Sales Reps And Patients Are Staying Home” - Scrip, 18 Mar, 2020.) Pricing Pressures Largely Offset Cost Impact Of Breakthrough Therapies Institute director Murray Aitken notes that glob
11、al medicine spending is growing at historically low rates, despite heightened focus on the cost of drugs. Even though expensive breakthrough therapies including cell and gene therapies are reaching the market, the impact of these products on the overall system is muted by cost reductions from generi
12、c and biosimilar competition to established branded therapies and price negotiations that result in a wide disparity Drug Spending Growth Will Decelerate Due To Pricing Pressures, IQVIA Finds 3 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) between invoice prices and what the
13、 US health care system often ends up paying. IQVIA expects aggregate global spending on prescription drugs to top $1.1tn in 2024, but the rate of growth for increases from the $955bn in spending estimated for 2019 will be slowed by these pricing pressures. The report says net annual price changes fo
14、r branded drugs in the US will range from -1% to 2% over the 2020-2024 time span, while declining by 2%-5% in other developed nations due to payer and government actions. While aggregate drug spending increased 23% from $777bn in 2014 to $955bn last year, the gap between invoice pricing and net reve
15、nue is increasing for drug makers. “Net market size in 2019 was $255bn lower than invoice spending, a difference expected to exceed $400bn by 2024 as the dynamics driving greater discounts and rebates including payer negotiations and subsidies with coupons or cost assistance for patients are expecte
16、d to continue,” the report notes. Spending growth has been lower and more stable in developed markets such as the US and the five largest EU markets, while spending growth in emerging markets has been higher on an annual basis. The impact of this on the biopharma industry is limited, however, becaus
17、e developed markets continue to comprise a majority of drug spending. In developed markets, the compound annual growth rate (CAGR) for drug spending was 2.6% from 2009 to 2014 and 3.3% from 2014 to 2019. In “pharmerging” markets, the CAGR was 12.2% from 2009 to 2014, declining to 7.7% from 2014 to 2
18、019. In 2019, developed markets accounted for 64% of drug spending, according to IQVIA, while emerging markets accounted for 26%. However, the developed market portion of drug spending is expected to decline to 60%-61% in 2024, while emerging markets are expected to make up 28%- 30% of total drug sp
19、ending that year. IQVIA has moderated some of its projections since the report it published in January 2019, when it projected a 3%-6% CAGR for global drug spending through 2023, reaching a peak of $1.5tn that year. (Also see “Global Pharma Growth Poised To Moderate, IQVIA Predicts “ - Scrip, 29 Jan
20、, 2019.) However, as in the current report, the institute did predict a deceleration overall, as drug spending had increased by 6.3% from 2013 to 2018. Downward pressure on drug prices will also be exerted over the next five years by patent expirations. The report predicts that losses of exclusivity
21、 will cost the industry $139bn less in sales in developed markets from 2020-2024, compared to $107bn in lost revenue from 2014- 2019. The institute noted that the patent cliff will be greatest in 2023 the year that AbbVie Inc.s multibillion-dollar blockbuster Humira (adalimumab) loses exclusivity in
22、 the US costing drug makers an estimated $39bn that year. 4 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Rhetoric Doesnt Square With Reality, Sanofi Drug Pricing Report Says Executive Summary Sanofi said the aggregate US net price of its drugs declined by 11.1% in 2019, whi
23、le list prices increased 2.9%. Sanofi took a strike against attacks on the high prices of insulin products in its 2019 drug pricing report, claiming that the debate around insulin prices doesnt match the companys drug pricing history. “Despite the rhetoric about skyrocketing insulin prices, the net
24、price of insulin has been falling for five consecutive years, making our insulins significantly less expensive for insurance companies,” Sanofi said in the report released on 4 March. Sanofi is one of several drug makers that has begun issuing annual drug pricing reports in an effort to be more tran
25、sparent about drug prices, amid pushback from the public and legislators. These reports, also issued by companies lik eJohnson Alphabet has a number of health ventures, including prediction algorithms for disease and automatic sensors; and Microsoft is venturing into data transparency and performanc
26、e analysis. Joining them are companies like Amazon and Walmart, big retailers with histories of disrupting supply chains,” the editorial states. Add in other large employers pushing for lower spending on health care, and Cutler queries whether this will “lower pharmaceutical prices and thus profitab
27、ility? Or will pharmaceuticals be spared at the expense of other care products and services? The answer will most likely be known in the next few years.” 14 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) High-Priced Entries Drive 17% Rise In Spending On Anti- Inflammatory Dru
28、gs Executive Summary But declines in other categories held overall spending on US retail pharmacy drugs covered by commercial plans to a marginal 2.3% increase in 2019, Express Scripts reports. Commercial health plan spending on prescription drugs for inflammatory conditions surged ahead 17.1% in 20
29、19, led by higher costs for recently introduced treatments, according to Express Scripts Holding Co.s latest Drug Trend Report. The spending increase for drugs to treat rheumatoid arthritis, psoriasis and other autoimmune conditions reflects a “shift to newer, more expensive brand alternatives for w
30、hich there are no available biosimilars,” the report notes. The Drug Trend report offers a snapshot of US retail pharmacy sales based on spending patterns among Express Scripts clients. Among the recent entrants driving the inflammatory drug trend is Novartis AG Cosentyx (secukinumab) for psoriasis,
31、 psoriatic arthritis and ankylosing spondylitis. US sales for the drug rose 33% to $2.2bn in 2019 and the company is seeking a number of additional indications to broaden the Cosentyx label. Eli Lilly & Co.s Taltz for plaque psoriasis and psoriatic arthritis is another contributor to higher costs fo
32、r payers. US sales for the drug rose 38% in 2019 to top $1bn. Sanofi and Regeneron Pharmaceuticals Inc.s nearly three-year old Dupixent (dupilumab) for atopic dermatitis is an anti-inflammatory blockbuster on a strong growth trajectory. Revenues for the drug reached $1.8bn in the US in 2019, up 140%
33、 compared to the prior year. A wave of other new therapies for inflammatory conditions like ulcerative colitis and atopic dermatitis are expected in the next few years and are expected to boost spending by insurers. (Also see “Atopic Dermatitis: Ruxolitinib And Baricitinib Spearheading New Therapies
34、” - Scrip, 30 Jan, 2020.) AbbVie Inc. recently added two anti- inflammatories as it seeks to shore up its franchise against US biosimilar competition to its mainstay Humira (adalimumab), which is set to begin in 2023. AbbVies Skyrizi (risankizumab) and Rinvoq (upadacitinib) launched in the second ha
35、lf of 2019 and have already begun to make inroads to the US market. The company reported in its recent year-end earnings presentation that Skyrizi now holds roughly 25% of the US psoriasis category and Rinvoq has collected a 9% share so far in rheumatoid arthritis. US sales for Skyrizi and Rinvoq at
36、 year-end totaled $311m and $47m, respectively. (Also see “Countdown To The Allergan Merger, And More From AbbVies Q4 Earnings” - Scrip, 7 Feb, 2020.) After inflammatory drugs, oncology treatments recorded the next largest increase in spending among commercial plans, with a 10.8% rise. The report no
37、tes that drugs to treat multiple myeloma, certain types of lymphoma, and breast and lung cancers contributed to the increase, and that it mainly reflected higher prices. An 8.1% increase in spending on drugs for HIV reflected higher utilization and higher unit costs for newly approved brands drug as
38、 well as Gilead 15 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Sciences Inc.s pre-exposure prophylaxis (PrEP) therapy, Express Scripts noted. Spending on diabetes agents also rose more than 8%, but the increase “was influenced primarily by 3.2% higher utilization for commo
39、nly used generics.” The increases in spending for the four categories were offset by reduced spending in treatments for pain/inflammation, asthma, antidepressants and high cholesterol in 2019, the report notes. (See chart.) A nearly 16% decrease in asthma spending was attributed to a “sharp decline”
40、 in the cost of branded drugs and a 9.4% drop in spending on cholesterol drugs included 46.7% lower prices for Sanofi and Regenerons Praluent (alirocumab) and Amgen Inc.s Repatha (evolocumab). Overall, drug spending by commercial plans managed by Express Scripts rose 2.3% in 2019, in line with the C
41、onsumer Price Index. That compares with an increase of just 0.4% in 2018 and a 1.5% rise in 2017. Commenting on the year-to-year changes in spending, an Express Script spokesperson explained: “Each year brings changes to market dynamics new drug approvals, new innovations, policy changes, drug maker consolidation, price changes and those changes have an impact on trend.” Retail Pharmacy Drug Trends By Category, 2019 Spending trends across Express Scripts commercial plan clients from the pharmacy benefit managers latest Drug Trend Report