Large coali­tion joins drug lob­by in de­nounc­ing Trump pro­pos­al to im­port drug prices for Medicare

Trump’s Oc­to­ber pro­pos­al to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries has elicit­ed the ire of not just the all-pow­er­ful bio­phar­ma lob­by, but al­so a large coali­tion rep­re­sent­ing 339 or­ga­ni­za­tions which ear­li­er this week de­tailed their con­cern, deem­ing the pro­pos­al an “un­prece­dent­ed, manda­to­ry ex­per­i­ment” that could ir­repara­bly af­fect the 59 mil­lion Amer­i­cans who re­ly on the Medicare Part B pro­gram.

The HHS pro­pos­al — de­signed to save Medicare more than $17 bil­lion over five years — was re­vealed in late Oc­to­ber ahead of a con­tentious mid-term bat­tle. As part of the plan, the agency out­lined an “in­ter­na­tion­al pric­ing in­dex (IPI)” in which prices for drugs uti­lized by Medicare — the world’s largest drug pur­chas­er — would be bench­marked against oth­er na­tions, in­stead of the way drugs are cur­rent­ly priced: by cal­cu­lat­ing the av­er­age sales price and adding 6% for the providers who man­age the drug sup­ply. Es­sen­tial­ly, in­stead of al­low­ing cheap­er drugs to be im­port­ed in­to the Unit­ed States, Trump’s ba­sic plan is to hold on to the drugs and im­port the price.

Da­ta sug­gests that the Unit­ed States spends near­ly twice as much as 10 high-in­come coun­tries on health care — dri­ven by high cost of la­bor and goods, in­clud­ing phar­ma­ceu­ti­cals and de­vices — but ac­tu­al­ly per­forms worse on a num­ber of pop­u­la­tion health out­comes.

Fac­ing an un­prece­dent­ed change to the sta­tus quo by the po­ten­tial im­po­si­tion of for­eign price con­trols on US shores did not, un­sur­pris­ing­ly, in­spire cheer from the drug lob­by, with PhRMA and BIO is­su­ing state­ments dis­play­ing their con­tempt for the plan. On Mon­day, the Part B Ac­cess for Se­niors and Physi­cians (ASP) coali­tion wrote to top Wash­ing­ton law­mak­ers ex­press­ing con­cern that the mod­el would be a net neg­a­tive for pa­tients and providers, but like­ly a pos­i­tive for the bot­tom lines of ven­dors such as PBMs.

“Use of for­eign pay­ment poli­cies risks im­port­ing ac­cess de­lays to Medicare ben­e­fi­cia­ries, lim­it­ing pa­tient choice of provider, and po­ten­tial­ly im­ped­ing de­vel­op­ment of more ef­fec­tive med­i­cines for pa­tients. The pro­posed mod­el would put ven­dors with no clin­i­cal or med­ical ex­per­tise be­tween pa­tients and doc­tors. Ven­dors would in­evitably im­pose re­stric­tions on ben­e­fi­cia­ry ac­cess to drugs through for­mu­la­ries, dis­rupt­ing or de­lay­ing care in the pur­suit of prof­it,” they wrote.

The IPI mod­el could al­so slash ac­cess to treat­ment, they said, cit­ing a re­cent analy­sis that sug­gests the Unit­ed King­dom’s NICE en­sured near­ly 92% of on­col­o­gy treat­ments were sub­ject­ed to ac­cess re­stric­tions be­tween 2013 and 2017.

How­ev­er, de­spite hav­ing faster ac­cess to treat­ment in the Unit­ed States, crit­ics have ar­gued that a num­ber of drugs that are sanc­tioned ap­proval by the FDA do not con­fer large enough ef­fi­ca­cy im­prove­ments over ex­ist­ing med­ica­tions to war­rant the prices they com­mand, which ex­plains why agen­cies such as NICE de­lay or re­ject their do­mes­tic adop­tion.

Trump has long chas­tised drug­mak­ers for “get­ting away with mur­der,” and this pro­pos­al is one of the two that have been re­leased in re­cent months. But Trump’s gen­er­al brava­do against the phar­ma in­dus­try may not nec­es­sar­i­ly trans­late to ma­te­r­i­al change. In the first nine months of 2018, there were 96 price hikes for every price cut, ac­cord­ing to an analy­sis by the As­so­ci­at­ed Press pub­lished this Sep­tem­ber, and more re­cent­ly Pfiz­er $PFE said it planned to in­crease prices on 41 of its drugs in Jan­u­ary.


Im­age: Don­ald Trump. WHITE HOUSE BROAD­CAST

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.