Trump to un­veil pro­pos­al to re­duce prices on doc­tor-ad­min­is­tered drugs as midterms loom

Days away from a con­tentious midterm elec­tion bat­tle, the Trump ad­min­is­tra­tion is once again at­tempt­ing to throw its weight at ex­or­bi­tant drug prices, a hot but­ton is­sue the pres­i­dent has long ral­lied against but has so far done lit­tle about.

DC-based POLITI­CO re­port­ed last night that Trump is set to un­veil a pro­pos­al that would make sweep­ing changes to how Medicare pays for some drugs in a speech to the HHS on Thurs­day af­ter­noon, which some see as a ploy to dis­tract away from the Re­pub­li­can agen­da to over­haul Oba­macare.

The scourge of high drug prices has been met with ire on both sides of the aisle, with De­moc­rats lash­ing out at their GOP coun­ter­parts for not us­ing their con­trol of both Con­gress and the ex­ec­u­tive branch to com­pel changes to the free­wheel­ing fash­ion the in­dus­try op­er­ates on drug prices.  While on the cam­paign trail, both Hillary Clin­ton and Trump chas­tised drug­mak­ers for their pric­ing be­hav­ior and made pledges to hold the in­dus­try ac­count­able. And af­ter cap­tur­ing the pres­i­den­cy, Trump sus­tained his at­tack on the in­dus­try stan­dard of price hikes, pro­claim­ing drug­mak­ers were “get­ting away with mur­der.” In May, Trump an­nounced that drug com­pa­nies would make “mas­sive” price cuts with­in two weeks — none which ma­te­ri­al­ized. An analy­sis of brand­ed pre­scrip­tion drugs, re­leased by the As­so­ci­at­ed Press last month, found that for all in­tents and pur­pos­es it’s been busi­ness as usu­al for drug­mak­ers, with price hikes con­tin­u­ing to out­strip cuts. The on­ly sil­ver lin­ing is that the num­ber of in­creas­es has di­min­ished some­what, and are not as steep as in past years, the AP not­ed.

The mul­ti-pronged pro­pos­al that still needs re­fine­ment and pas­sage through the fed­er­al rule-mak­ing dock­et was sent to the White House last month, and is ex­pect­ed to save Medicare $17 bil­lion over five years, and shave the cost of cer­tain drugs by up to 30 per­cent, ac­cord­ing to POLITI­CO. The plan in­tends to uti­lize Medicare’s in­no­va­tion cen­ter to ne­go­ti­ate the prices for some drugs that are di­rect­ly ad­min­is­tered by doc­tors — not pre­scrip­tions pur­chased by pa­tients at phar­ma­cies — in a bid to keep them on par with low­er prices paid by oth­er na­tions, ac­cord­ing to the re­port.

The pro­pos­al will al­so out­line an “in­ter­na­tion­al pric­ing in­dex,” in which Amer­i­can drug prices would be bench­marked against 16 oth­er na­tions — such as Cana­da, Czech Re­pub­lic, Fin­land, France, Ger­many, Japan, Spain, Swe­den and the Unit­ed King­dom — where tar­get drug prices are col­lec­tive­ly 44 per­cent low­er. Prices would slow­ly be low­ered to in­ter­na­tion­al lev­els over five years. How­ev­er, this part of the pro­pos­al may run in­to trou­ble as many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

An­oth­er part of the new plan in­cludes let­ting pri­vate sec­tor ven­dors ne­go­ti­ate with drug­mak­ers, akin to how health in­sur­ers ne­go­ti­ate prices in Medicare’s part D pro­gram. Medicare would test this ap­proach for cer­tain ex­pen­sive drugs in cer­tain ge­o­graph­ic ar­eas, where par­tic­i­pa­tion would be manda­to­ry for physi­cians and hos­pi­tals. In ad­di­tion, of­fi­cials in­tend to amend the in­cen­tive doc­tors have to pre­scribe ex­pen­sive drugs. Amend­ing that sys­tem to a flat fee, in con­trast to a per­cent­age, could com­pel doc­tors to use the most ef­fec­tive rather than the most ex­pen­sive treat­ments, POLITI­CO said.

In 2016, Pres­i­dent Oba­ma at­tempts to af­fect change in­to the way physi­cian-ad­min­is­tered drugs were paid for fiz­zled out af­ter be­ing thwart­ed by De­moc­rats and Re­pub­li­cans alike, not to men­tion doc­tors, hos­pi­tals and the über-con­nect­ed drug lob­by. De­spite Trump’s sus­tained brava­do, his lat­est pro­pos­al may suf­fer a sim­i­lar fate.

The speech, Trump’s first ad­dress to the health de­part­ment, is ex­pect­ed at 2 pm. It fol­lows some mod­est, al­beit in­di­rect, suc­cess­es for the ad­min­is­tra­tion in push­ing back at the phar­ma­ceu­ti­cal in­dus­try.  This month an HHS pro­pos­al re­quir­ing drug­mak­ers to re­veal prices in their TV ads came to the fore, in ad­di­tion to the pas­sage of a law ban­ning gag-claus­es, which pre­vent phar­ma­cists from in­form­ing cus­tomers when it’s cheap­er to pay in cash for a drug in­stead of us­ing in­sur­ance, as STAT not­ed.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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