Hu­mana spells out its con­di­tion­al Ex­ondys 51 cov­er­age pol­i­cy — strings at­tached

Hu­mana’s de­ci­sion to cov­er Sarep­ta’s $SRPT con­tro­ver­sial Duchenne mus­cu­lar dy­s­tro­phy drug Ex­ondys 51 (eteplirsen) comes with some thick strings at­tached to it.

In a new cov­er­age pol­i­cy post­ed at the big in­sur­er, Hu­mana says that it will on­ly pro­vide cov­er­age for the $300,000-plus ther­a­py pro­vid­ed pa­tients are still am­bu­la­to­ry, con­tin­ue to prove that they re­main able to walk and meet the cri­te­ria for pa­tients who may ben­e­fit from an Ex­on 51-skip­ping drug.

Un­der con­di­tions for cov­er­age, Hu­mana notes: “The mem­ber re­mains am­bu­la­to­ry (e.g. able to walk with as­sis­tance, not wheel­chair de­pen­dent).”

Trans­la­tion: Any pa­tient who con­tin­ues to de­te­ri­o­rate to the point that they re­quire a wheel­chair will no longer be cov­ered.

That pol­i­cy cov­er­age de­ci­sion fol­lows An­them’s ver­dict that it won’t cov­er the drug be­cause in their view it re­mains ex­per­i­men­tal, even though the FDA has ap­proved it for mar­ket­ing. Oth­er big in­sur­ers have said that they will cov­er it, but have not yet post­ed their con­di­tions.

Janet Wood­cock

Janet Wood­cock’s de­ci­sion to over­rule the point­ed ob­jec­tions of the re­view team as well as se­nior-lev­el col­leagues — wide­ly cel­e­brat­ed in the DMD com­mu­ni­ty that fought for this drug — con­tin­ues to draw heavy crit­i­cism in some cir­cles. Ear­li­er this week two FDA pol­i­cy ex­perts fret­ted over the “wor­ri­some mod­el” that the agency had en­dorsed in back­ing eteplirsen for an ap­proval, urg­ing a fresh look at how sim­i­lar drugs backed by pa­tient ad­vo­cates ahead of con­vinc­ing da­ta should be han­dled in the fu­ture, in­clud­ing a sug­ges­tion to make them avail­able with­out al­low­ing a prof­it. In­side the FDA, mean­while, John Jenk­ins has been ea­ger to sug­gest that that Sarep­ta was a once-off, with all the same tra­di­tion­al de­mands on ef­fi­ca­cy and safe­ty da­ta still in place.

That con­tro­ver­sy is now spilling over in­to the pay­er com­mu­ni­ty, and some clear­ly don’t like the idea of cov­er­ing a drug that some be­lieve re­mains ex­per­i­men­tal, re­gard­less of the FDA’s de­ci­sion.

Jef­feries’ Gena Wang, who bet against an ap­proval, says she wasn’t sur­prised by the de­ci­sion. And more such con­di­tion­al poli­cies may ap­pear. Her note in­clud­ed:

Re­call we had pre­vi­ous­ly not­ed that pay­ers ranked ev­i­dence of clin­i­cal ben­e­fit high­er than FDA ap­proval sta­tus and in­de­pen­dent analy­sis would be like­ly re­quired. Hu­mana’s de­ci­sion to lim­it cov­er­age with­in am­bu­la­to­ry pts is al­so in-line with our ex­pec­ta­tions of ad­di­tion­al re­stric­tions based on clin­i­cal tri­al de­mo­graph­ics (am­bu­la­to­ry pts with base­line age 7-10). Fur­ther­more, the 6 month ini­tial ap­proval pe­ri­od and the re­quire­ment for pts to re­main am­bu­la­to­ry for con­tin­u­al treat­ment, al­so echo the feed­back we re­ceived from pay­ers on pos­si­ble con­tin­u­ous mon­i­tor­ing of drug ef­fi­ca­cy. Among oth­er large pay­ers, Aet­na plans to con­duct a full clin­i­cal re­view (ac­cord­ing to Reuters), Unit­ed (via our com­mu­ni­ca­tion with a spokesper­son) have not­ed their in­ter­est in cov­er­ing the drug with a pri­or au­tho­riza­tion (de­tails undis­closed) and Cigna has con­firmed in­ter­est in pro­vid­ing cov­er­age (via email to Bloomberg). Ex­press Scripts al­so has plans to con­duct a full clin­i­cal re­view but de­tails are un­known.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.