Missile Strikes Lash Defence of Mr. Zelensky

"Russia fired dozens of missiles, including hypersonic weapons, at regions across Ukraine on Thursday, striking civilian infrastructure and the country's defense industry in one of the biggest barrages this year as Moscow's forces continued to take more territory in the east.

Russia launched 81 missiles of different varieties from air, land and sea, in addition to eight Iranian-made attack drones, according to Gen. Valeriy Zaluzhny, the commander-in-chief of Ukraine's armed forces. Four of the drones and 34 cruise missiles were intercepted, Gen. Zaluzhny said.

Russian and Ukrainian officials said six Kinzhal hypersonic missiles were among the missiles used in the strikes.

Russia's Defense Ministry said the barrage was in retaliation for an attack last week in Russia's Bryansk region in which two civilians were killed, and which Moscow blamed on Ukrainian saboteurs. Ukrainian intelligence said it played no part in the incident.

The tempo of Russian attacks has diminished in recent weeks after last year's weekly missile barrages against Ukraine's energy infrastructure. Ukrainian officials say that reflects depleted Russian stockpiles of missiles.

Moscow's use of Kinzhal missiles poses a formidable challenge to Ukrainian air defenses, though the weapons system is costly and in shorter supply compared with more conventional missiles in Russia's arsenal.

The Kinzhal can accelerate to 10 times the speed of sound and strike targets at a range of over 1,200 miles and can be outfitted with both conventional and nuclear warheads weighing around 1,100 pounds, according to Russian state media.

Russia has said it previously used a Kinzhal missile in a strike early in the war, and Russian President Vladimir Putin has vowed to ramp up production and deployment of Kinzhals and other advanced missile systems.

Repair crews were working to restore power after the strikes, which damaged energy generation and distribution facilities in eight regions, Ukraine's Prime Minister Denys Shmyhal said, warning of temporary blackouts.

Before the latest barrage, the power grid in Ukraine had been almost fully operational. Rolling blackouts had largely ended, and most of the country had a steady supply of electricity, heating and water.

Rescue workers were at the scene of explosions in two districts of the capital, Kyiv, Mayor Vitali Klitschko said. About 40% of the city's residents were without heating after Ukraine imposed emergency power outages to protect the grid. An infrastructure facility in the Holosiivskyi district was hit, the Kyiv city military administration said.

The barrage was one of the longest lately but the city's air defenses, including the German-provided Iris-T system, intercepted all but one of the missiles, Mr. Klitschko told the German daily Bild.

There were "air raid alerts from midnight to 7 a.m.," he said. He said Russia used both missiles and drones to try to overwhelm Ukraine's defenses.

Western countries have bolstered Ukraine's air defenses since Russia began targeting the country's infrastructure. The U.S. has provided midrange Nasams and Germany has sent the medium-range Iris-T, as well as Gepard mobile antiaircraft guns, enabling Ukraine to intercept about 80% of Russian missiles and drones, according to the government.

"The United States continues to provide air-defense capabilities to Ukraine and to make sure -- in concert with our allies and partners across the globe -- that we're providing what they need to meet this moment," White House principal deputy press secretary Olivia Dalton said Thursday.

Ukraine's air force says it lacks the capability to shoot down certain missiles, including Kh-22, Kh-47 and S-300. Serhiy Popko, the head of the Kyiv city military administration, said preliminary information suggested a Kh-47 missile had penetrated the capital's air defenses.

Three thermal-power plants were also damaged in the strikes, according to Ukraine's largest private energy generator DTEK. The company's plants have been struck 29 times since the fall, it said." [1]

1. World News: Missile Strikes Lash Ukraine
Coles, Isabel; Kantchev, Georgi.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 10 Mar 2023: A.7.

 

Rinkoje pasirodė nauji vaistai su didelėmis kainų etiketėmis

Šios kainos mokamos už naujų vaistų atradimą visam pasauliui. Mes, Lietuvoje, šiuos vaistus galiausiai vartojame, nemokėdami tiek daug pinigų. Iš kitos pusės, tokios aukštos kainos gali sukelti žmonių pasipiktinimą, todėl politikai gali pakeisti visą sistemą.

 

     „Naujas Amgen Inc. plaučių vėžio gydymas Lumakras, kai jis pasirodė 2021 m., turėjo didelę kainą: 17 900 dolerių vienam pacientui per mėnesį.

 

     Praėjus kiek daugiau, nei metams, 2022 m. gruodį, antrojo vaisto nuo tos pačios rūšies vėžio, Krazati iš Mirati Therapeutics Inc., kaina buvo dar didesnė: 19 750 dolerių per mėnesį – 10 proc. daugiau.

 

     Kadangi vaistų gamintojai susiduria su didėjančiu spaudimu pažaboti pakartotinį ar metinį esamų vaistų kainų padidėjimą, į rinką ateina nauji firminiai vaistai su vis aukštesnėmis kainomis. Anksčiau įmonės atidžiai svarstydavo, ar, pateikdamos vaistą į rinką, įveikti dideles kainų kliūtis, pvz., 5000 dolerių, o vėliau 10 000 dolerių per mėnesį. Dabar daugelis naujų vaistų nuo vėžio ir retųjų ligų paprastai viršija šias kainų ribas ir dažnai kainuoja daugiau, nei 20 000 dolerių per mėnesį.

 

     Šios didesnės pradinės naujų vaistų kainos prisidėjo prie didesnių pacientų išlaidų ir ištemptų privačių draudikų bei federalinių programų, įskaitant Medicare, biudžetų.

 

     Remiantis analize, kurią „The Wall Street Journal“ atliko Ohajo valstijoje įsikūrusi ne pelno organizacija 46brooklyn Research, analizuojanti vaistų kainų duomenis, medianinė naujai patvirtinto vaisto pradinė kaina 2022 m. padidėjo beveik tris kartus iki 7 034 dolerių vienam pacientui per mėnesį, palyginti su 2 624 dolerių 2011 m.

 

     Vaistų gamintojai teigė, kad kainos atspindi klinikinę naujų vaistų naudą. Bendrovės teigė, kad dauguma žmonių nemoka mažmeninės kainos, nes taiko nuolaidas  darbdaviams, vaistinių tiekėjų vadybininkams ir draudikams. Ir įmonės dažnai teikia pagalbą, kad padėtų padengti pacientų išlaidas.

 

     46Brooklyn analizė sutelkė dėmesį į 485 receptinių vaistų, kuriuos Maisto ir vaistų administracija patvirtino nuo 2011 m., kainas, kurių veiklioji medžiaga anksčiau nebuvo patvirtinta FDA.

 

     Analizė apėmė kai kuriuos naujus produktus, pavyzdžiui, brangią genų terapiją, kurią ketinama skirti vieną kartą. Jame nebuvo įtraukti kai kurie vaistai, kurių sąrašo kainos nebuvo prieinamos.

 

     Du nauji vaistai nuo vėžio, patvirtinti JAV sausio mėnesį – Eli Lilly & Co Jaypirca mantijos ląstelių limfomai gydyti ir Stemline Therapeutics Inc. Orserdu krūties vėžio gydymas – kiekvienas kainuoja mažiausiai 21 000 dolerių per mėnesį arba daugiau, nei 250 000 dolerių už visus naudojimo metus.

 

     Kai kurių naujų vaistų, skirtų vienkartiniam gydymui, pradinė kaina vienam pacientui siekia milijonus dolerių. CSL Ltd. Hemgenix, kraujo sutrikimo hemofilijos B genų terapija, debiutavo su 3,5 mln. CSL teigė, kad kainodara atspindi gydymo naudą pacientams, todėl jie gali būti apsaugoti nuo pakartotinio senesnio vaisto dozavimo.

 

     Ši naujų vaistų kainų infliacijos tendencija atsiranda, nes nauji teisės aktai daro spaudimą galimybei didinti senesnių vaistų kainas.

 

     2022 m. JAV infliacijos mažinimo įstatymu siekiama pažaboti vaistų išlaidas, reikalaujant, kad vaistų gamintojai mokėtų nuolaidas federalinei Medicare programai, jei tam tikras vaistų kainų padidėjimas viršija bendrą infliacijos lygį, ir suteikiant Medicare agentūrai įgaliojimus derėtis dėl tam tikrų vaistų kainų po jų pristatymo.

 

     Tačiau naujasis įstatymas tiesiogiai netrukdo vaistų gamintojams imti didelę kainą už visiškai naują vaistą, išleidžiant į rinką, o vaistų kainų sergėtojai teigė, kad mažai tikrinama, kokia kaina gali pakilti. Naujasis įstatymas galėtų prisidėti prie didesnių paleidimo kainų, jei įmonės tai supras, kaip būdą kompensuoti savo galimybių didinti kainas naujam vaistui po to, kai jis bus išleistas į rinką.

 

     „Jums bus daromas spaudimas nustatyti aukštesnes kainas, kad per kelerius metus padidėtų pralaidumas, kai negalėsite rimtai pabranginti“, – sakė Antonio Ciaccia, „46brooklyn“ generalinis direktorius.

 

     Pasak vaistų kainų tyrinėtojų, tarp kitų veiksnių, skatinančių aukštas paleidimo kainas, yra padidėjęs vaistų pramonės dėmesys, kuriant naujus vaistus, skirtus ligoms, turinčioms mažą pacientų populiaciją, pvz., genetiniams sutrikimams ir tam tikroms vėžio formoms.

 

     Įmonės jau seniai pateisina aukštas tokių „retųjų“ vaistų kainas, nes yra mažiau pacientų, iš kurių būtų galima gauti pakankamai pardavimų, kad būtų atsipirktos brangios investicijos į mokslinius tyrimus ir plėtrą. Dabar tokie vaistai sudaro didesnę pramonės produkcijos dalį. Agentūros duomenimis, 2022 m. 54 % naujų vaistų, patvirtintų FDA, buvo skirti retoms ligoms gydyti, o 2012 m. – 33 %.

 

     Skirtingai nuo kai kurių kitų išsivysčiusių šalių, JAV nekontroliuoja naujų vaistų pradinių kainų.

 

     „Niekas netrukdo gamintojams imti tokią didelę kainą, kokią priims rinka“, – sakė vaistų kainas tyrinėjantis Harvardo medicinos mokyklos medicinos instruktorius Benjaminas Rome'as. "Ir dėl to gamintojai gali ir toliau taikyti didesnes kainas, jei tik turi naujų produktų." [1]

1. New Drugs Hit Market With Hefty Price Tags
Loftus, Peter.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 10 Mar 2023: A.1. 

New Drugs Hit Market With Hefty Price Tags

These prices pay for discovery of new medicines of whole world. We in Lithuania are using these medicines eventually without paying such big money. On the other hand, these high prices can cause people to resent it, so politicians can change the whole system.

"A new Amgen Inc. lung-cancer treatment, Lumakras, carried a hefty price tag when it came out in 2021: $17,900 per patient monthly.

Just over a year later, in December 2022, a second drug for the same type of cancer, Krazati from Mirati Therapeutics Inc., had an even higher price: $19,750 a month -- a 10% premium.

As drugmakers face rising pressure to rein in repeat or annual price increases on existing drugs, new brand-name medicines are coming to market with ever-higher price tags. Previously, companies would carefully consider whether to crack big price barriers when launching a drug, like $5,000 and then $10,000 a month. Now, many new drugs for cancer and rare diseases routinely exceed those price thresholds, often coming in at more than $20,000 a month.

These higher starting prices for new drugs have contributed to higher out-of-pocket costs for patients and stretched budgets for private insurers and federal programs including Medicare.

The median starting price for a newly approved drug nearly tripled to $7,034 per patient monthly in 2022, from $2,624 in 2011, according to an analysis conducted for The Wall Street Journal by 46brooklyn Research, an Ohio-based nonprofit that analyzes drug price data.

Drugmakers said the prices reflect the clinical benefits the new drugs provide. The companies said most people don't pay list prices because they offer rebates and discounts to employers, pharmacy-benefit managers and insurers. And companies often provide assistance to help defray out-of-pocket costs for patients.

The 46brooklyn analysis focused on the list prices for 485 prescription drugs approved by the Food and Drug Administration since 2011 that had an active ingredient not previously approved by the FDA.

The analysis included some new products, such as the costly gene therapies that are intended to be given once. It didn't include some drugs for which list prices weren't available.

Two new cancer drugs approved in the U.S. in January -- Eli Lilly & Co's Jaypirca for mantle-cell lymphoma and Stemline Therapeutics Inc.'s Orserdu breast-cancer treatment -- each cost at least $21,000 a month, or more than $250,000 for a full year of use.

Some new drugs that are intended to be one-time treatments now carry starting prices in the millions of dollars per patient. CSL Ltd.'s Hemgenix, a gene therapy for the blood disorder hemophilia B, made its debut with a list price of $3.5 million after it was approved by U.S. regulators in November. CSL said the pricing reflects the treatment's benefit to patients, potentially sparing them from repeat dosing of an older, costly drug.

This launch-price inflationary trend for new medicines comes as new legislation is putting pressure on price increases for older drugs.

The U.S. Inflation Reduction Act of 2022 aims to curb drug costs by requiring drugmakers to pay rebates to the federal Medicare program if certain drug-price increases exceed the general inflation rate, and by giving the Medicare agency the authority to negotiate prices for certain drugs several years after they are introduced.

But the new law doesn't directly stop drugmakers from charging a high price for a brand new drug at launch, and drug-price watchdogs said there are few checks on how high the price can go. The new law could contribute to higher launch prices if companies see that as a way to offset limits on their ability to raise prices for a new drug after it is launched.

"It will put pressure on you to launch prices at higher levels to give you increased bandwidth in years further down the line when you are not able to put your foot fully on the gas," said Antonio Ciaccia, chief executive of 46brooklyn.

Among the other factors fueling high launch prices is the drug industry's increased focus on developing new medicines for diseases with small patient populations, like genetic disorders and certain cancers, drug-price researchers said.

Companies have long justified high prices for such "orphan" drugs because there are fewer patients from whom to generate enough sales for a return on costly research-and-development investments. Now, such drugs make up a bigger portion of the industry's output. In 2022, 54% of new drugs approved by the FDA were for rare diseases, versus 33% in 2012, according to the agency.

Unlike some other developed countries, the U.S. doesn't have price controls on starting prices for new drugs.

"There is nothing restricting manufacturers from charging as high a price as the market will bear," said Benjamin Rome, an instructor of medicine at Harvard Medical School who researches drug prices. "And as a result, the manufacturers can continue to charge higher prices, as long as you have new products."

Dr. Rome and colleagues published an analysis in the Journal of the American Medical Association last year finding that 47% of the new drugs approved in 2020 and 2021 had annual list prices of at least $150,000, versus only 9% of drugs approved from 2008 to 2013.

The $21,000-a-month list price for Lilly's new lymphoma drug Jaypirca is higher than the starting price for other, similar drugs, known as BTK inhibitors, that have been approved in the past 10 years.

BeiGene Ltd.'s Brukinsa had a starting price of $12,935 a month when it was approved for mantle-cell lymphoma in 2019. Imbruvica from Johnson & Johnson and AbbVie had a launch price of $10,900 a month when it was approved for mantle-cell lymphoma in 2013. List prices for those drugs have since risen as they have been approved for new uses such as leukemia.

A Lilly spokesman said the company doesn't believe comparing prices between Jaypirca and the older BTK drugs is appropriate because its drug is approved for a different patient population. Jaypirca is the first BTK drug approved to treat relapsed or refractory mantle-cell lymphoma after two lines of prior treatment that includes another BTK drug.

Lilly said it prices its medicines based on the value they bring to patients and the scientific innovation they represent."  [1]

1. New Drugs Hit Market With Hefty Price Tags
Loftus, Peter.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 10 Mar 2023: A.1.