NICE re­jects No­var­tis' mi­graine drug Aimovig, months af­ter de­clin­ing to en­dorse pricey Kym­ri­ah for adult use

No­var­tis $NVS is will­ing to play ball with UK’s cost-ef­fec­tive­ness watch­dog NICE, who re­ject­ed their mi­graine pre­ven­tion drug in a draft guid­ance on Thurs­day, months af­ter de­clin­ing to en­dorse the Swiss drug­mak­er’s cell ther­a­py Kym­ri­ah in adult lym­phoma pa­tients.

The drug, erenum­ab, is sold as Aimovig in the Unit­ed States by No­var­tis and part­ner Am­gen $AMGN. It forms part of a new crop of bi­o­log­ics tar­get­ing the CGRP pro­tein that trans­mits pain sig­nals in­to the brain, and is con­sid­ered in­stru­men­tal in gen­er­at­ing and main­tain­ing headaches as­so­ci­at­ed with mi­graine. Erenum­ab costs around £5,000 (about $6368) per year, ex­clud­ing a con­fi­den­tial dis­count that would have been grant­ed to Eng­land’s na­tion­al health ser­vice (NHS) had NICE rec­om­mend­ed the drug.

In its re­port, NICE ac­knowl­edged that al­though the drug is a clin­i­cal­ly ef­fec­tive treat­ment, the to­tal­i­ty of the da­ta sup­port­ing the med­i­cine did not in­clude all “rel­e­vant” com­par­isons against ex­ist­ing drugs and out­comes, which prompt­ed its re­jec­tion for NHS use.

Mein­dert Boy­sen

“There was not enough ev­i­dence to sug­gest that it (erenum­ab) is more ef­fec­tive than bot­u­linum tox­in type A (Al­ler­gan’s Botox) for peo­ple with chron­ic mi­graine, which NICE al­ready rec­om­mends. And for both the chron­ic and episod­ic mi­graine pop­u­la­tions there was no ev­i­dence to show that erenum­ab is ef­fec­tive in the long-term in peo­ple for whom 3 pre­vi­ous pre­ven­tive treat­ments had failed,” said NICE’s di­rec­tor of the cen­tre for health tech­nol­o­gy eval­u­a­tion Mein­dert Boy­sen in a state­ment.

No­var­tis pledged to work with NICE to ad­dress the agency’s ques­tions, but sug­gest­ed the watch­dog had not cap­tured the broad­er so­ci­etal im­pact of its med­i­cine.

“NICE does not con­sid­er the im­pact of dis­eases on broad­er so­ci­ety when eval­u­at­ing the cost-ef­fec­tive­ness of med­i­cines. We be­lieve this fails to cap­ture the true val­ue of med­i­cines like Aimovig. As mi­graine pre­dom­i­nant­ly af­fects peo­ple of work­ing age, it costs the UK econ­o­my £8.8 bil­lion per year in lost pro­duc­tiv­i­ty alone,” the drug­mak­er said in a state­ment, un­der­scor­ing that the UK al­ready “lags sig­nif­i­cant­ly be­hind” its oth­er Eu­ro­pean coun­ter­parts in en­sur­ing ac­cess to new med­i­cines.

It is es­ti­mat­ed there are 190,000 mi­graine at­tacks ex­pe­ri­enced every day in Eng­land, ac­cord­ing to NICE. The agency con­ced­ed that ex­ist­ing mi­graine treat­ments in­clud­ing be­ta-block­ers, an­ti­de­pres­sants and epilep­sy med­i­cines can have sig­nif­i­cant side-ef­fects and don’t work for some pa­tients, but for those with chron­ic mi­graine for whom at least 3 pre­vi­ous pre­ven­tive oral treat­ments have failed, Botox re­mains an op­tion.

The pro­vi­sion­al de­ci­sion on erenum­ab comes af­ter the agency re­fused to en­dorse No­var­tis’ CAR-T drug Kym­ri­ah in adults, say­ing it was too ex­pen­sive, in Sep­tem­ber, al­though it did rec­om­mend the treat­ment’s use in pe­di­atric pa­tients in a pre­vi­ous rul­ing.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

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